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| Making Punkins!! |
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| A ghoulish process! |
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| The Man with The Tools!!! |
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| Every year, Bentie...making punkins...for 23 years!!! |
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| Now that's not so scary! |
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| Trick or Treat!!! |
Check it out! Cause I can't help myself!!! Happy Halloween!!! - c
Thursday, October 31, 2013
Happy Halloween
Check it out! Cause I can't help myself!!! Happy Halloween!!! - c
Monday, October 28, 2013
The Melanoma Avengers!!!!!
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| Yep!!! The weekend came for our 1/2 Marathon relay in Kingsport!!! |
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| RACE DAY!!! Iron Man, Thor, The Hulk and The Black Widow! Melanoma doesn't stand a chance!! |
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| My boys!!! |
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| Cool Iron Man! Sexy Black Widow! |
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| Can Iron Man handle all this??? |
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| Uh oh!!!! He may crack under the pressure!!! |
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| Want to know my secret? I'm ALWAYS angry!!!! |
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| The best HULK ever!!! |
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| The best Melanoma Avengers a girl could ever have!!!! |
WE WON!!!!! We were all there. Together. Strong. Happy. Alive. With love. NOW!
Take that...melanoma!!!! - c
Thursday, October 24, 2013
Make new friends, but keep the old....
Friends, old and new, have been so...
You know? Words can't even describe the support and love that all of you have so generously given. I don't know how I would have made it through these past years without my besties!!! All my Peds Care peeps have been amazing! Dan and Don! Les and Kay! Keith and Janara! What would I have done without all of you?!!! There are new peeps...now dear. Jonathan, Jeanne, Steven. Through it all, some old ones have followed and supported me onward. Terri, my sweet friend/twin, you have no idea how much knowing you were there, behind it all, has meant to me. And over the past years and days....other oldies have surprised me, by their remembering, and reading, with support and kind thoughts. Thanks to you all...David (gotta learn how that 'Jo' got in there!!!), Terrie, Scott, Lisa.
Make new friends, but keep the old...
Love to you all....old and new - c
You know? Words can't even describe the support and love that all of you have so generously given. I don't know how I would have made it through these past years without my besties!!! All my Peds Care peeps have been amazing! Dan and Don! Les and Kay! Keith and Janara! What would I have done without all of you?!!! There are new peeps...now dear. Jonathan, Jeanne, Steven. Through it all, some old ones have followed and supported me onward. Terri, my sweet friend/twin, you have no idea how much knowing you were there, behind it all, has meant to me. And over the past years and days....other oldies have surprised me, by their remembering, and reading, with support and kind thoughts. Thanks to you all...David (gotta learn how that 'Jo' got in there!!!), Terrie, Scott, Lisa.
Make new friends, but keep the old...
Love to you all....old and new - c
Sunday, October 20, 2013
Side Effects of Nivolumab....final thoughts....
Cumulative - Increasing by successive additions. Increasing with severity with repetition of the offense.
I found reviewing my blog posts relative to the side effects I experienced enlightening. Symptoms started earlier than I remembered. Wheezing every 1-2 weeks after a treatment was far more obvious and consistent than I had realized. I ended up missing three days of work all told, due to such symptoms over the 2 1/2 years of treatment. While not noted on my blog, many of my arthralgias included not just pain in the joint affected, but redness and some swelling as well....much like that experienced by a patient with rheumatoid arthritis. The mouth issues have been a recurring nightmare and clearly cumulative...ie increasing in quantity and duration as I progressed through the trial...as has my vitiligo. Therefore, I have a bit of a bone to pick with docs who continue to tell their patients that the side effects from this drug are NOT cumulative. Nobody got colitis, pneumonitis, or thyroid failure with one dose. It was something they developed over time. So....while it is hard to know exactly what we can and cannot attribute to anti-PD1, I feel that many side effects are consistent over multiple patients and do, in fact, increase with increased dosing.
As far as evaluating pain and fatigue is concerned...I have long wanted to develop a "pain-o-meter"! It would be ever so helpful to have when evaluating patients or reporting how you really feel as the patient!!!! Was my fatigue and aches and pains less than many of the other patients in the study? Maybe so. Or....maybe I'm just really stubborn. Who knows? Hang in there, my ratties! Hang in there!
Finally, it is very strange to feel (sort-of) like I am looking at all this from the other side. I've been thinking a lot about that lately. It seems a very odd and unlikely place to be.
For my fellow ratties! You can do this! I KNOW you CAN!!!! - c
I found reviewing my blog posts relative to the side effects I experienced enlightening. Symptoms started earlier than I remembered. Wheezing every 1-2 weeks after a treatment was far more obvious and consistent than I had realized. I ended up missing three days of work all told, due to such symptoms over the 2 1/2 years of treatment. While not noted on my blog, many of my arthralgias included not just pain in the joint affected, but redness and some swelling as well....much like that experienced by a patient with rheumatoid arthritis. The mouth issues have been a recurring nightmare and clearly cumulative...ie increasing in quantity and duration as I progressed through the trial...as has my vitiligo. Therefore, I have a bit of a bone to pick with docs who continue to tell their patients that the side effects from this drug are NOT cumulative. Nobody got colitis, pneumonitis, or thyroid failure with one dose. It was something they developed over time. So....while it is hard to know exactly what we can and cannot attribute to anti-PD1, I feel that many side effects are consistent over multiple patients and do, in fact, increase with increased dosing.
As far as evaluating pain and fatigue is concerned...I have long wanted to develop a "pain-o-meter"! It would be ever so helpful to have when evaluating patients or reporting how you really feel as the patient!!!! Was my fatigue and aches and pains less than many of the other patients in the study? Maybe so. Or....maybe I'm just really stubborn. Who knows? Hang in there, my ratties! Hang in there!
Finally, it is very strange to feel (sort-of) like I am looking at all this from the other side. I've been thinking a lot about that lately. It seems a very odd and unlikely place to be.
For my fellow ratties! You can do this! I KNOW you CAN!!!! - c
Saturday, October 19, 2013
Side Effects of Nivolumab....my story....
While this is my story of MY side effects, the way drugs affect different people will vary greatly. My regimen was to be given an IV infusion of anti-PD1 (Nivolumab, formerly BMS 936558, and before that - MDX1106) at 1mg/kg dosage, every 2 weeks for six months, then every three months for 2 more years. Additionally, since I was simultaneously given 6 intramuscular injections of peptide vaccines every 2 weeks WITH the anti-PD1 infusion for the first 6 months...my side effects related to granulomas, with pain and redness in my thighs, and the development of inguinal nodes, will not apply to those of you getting anti-PD1 alone. Which is good!!! Research in my study and others determined that the vaccines didn't help a bit and are no longer used in trials at Moffitt. I thought of different ways to present this data...but decided that my own words from prior blog posts at the time they were occurring was best. My infusions (apart from the first one) always took place on a Friday. My normal work schedule has been 12-hour shifts on Mon, Tue, and Wed. Here goes:
Dose 1 = 12/27/2010
Sites of the local injections to my thighs were red and tender.
Dose 2 = 1/14/2011
Thigh at injection site = sore and bruised. Already getting "contra-lateral" reaction...meaning the leg that was injected LAST time...became red and tender as well, within 2-3 days after infusion/injections.
Dose 3 = 1/28/2011
Twenty-four hours after my third dose I felt beat up and sore all over "like [I had had] a big work out the day prior" but had not!
Dose 4 = 2/11/2011
Two days after this dose, I noted the development of vitiligo on my hands and arms. Ten days later: "really tired". Brent pointed out that at this point the half lives of the medication had converged and therefore remained at a steady state somewhere following the 3-4th dose. This was later confirmed by Dr. Weber.
Dose 5 = 2/25/2011
On Sunday, after Friday's infusion, "I feel like something the cat dragged in...after Zeno played with it for an hour!" That's not good y'all!!! I took my first Monday off from work.
Dose 6 = 3/11/2011...3 MONTHS DONE!!!!
At my visit, Weber reports that fatigue is the most common side effect being reported in my study. Since I was still working and running, he assigned my fatigue, as I reported it above, to be a "1" on a 1-4 scale with 4 being the highest. He was pleased to note the enlarging lymph nodes in my groin. Pain in legs at injection sites continues.
Dose 7 = 3/25/2011
My scans at the 3 Month evaluation showed "ground glass appearance" in the right lower lobe of my lung. I was also having wheezing at the time. Scans were reviewed by the tumor board at Moffitt and determined to be related to my asthma or an inflammatory process that Weber had seen before in patients on ipi. Wheezing gradually improved on albuterol and inhaled corticosteroid; symbicort. Perhaps most importantly, the 3mm something???? in my brain on my MRI when I started is GONE!
Dose 8 = 4/8/2011
Was told a patient in my study had developed retinitis. Vitiligo increasing. Hemoglobin decreased, possibly due to leukophoresis. Sore, itching legs. I smell and taste bad....at least to me. Others report no notice of smell. I have developed mouth ulcers. For the past couple of rounds my mouth had felt "dry and weird" immediately following my infusion, for which Ruthie would get me a lemonade, that helped.
Dose 9 = 4/22/2011
Weber reports that rash, itching and fatigue are being commonly reported at my visit. His conclusion: I am less tired than most. Patient in 3mg/kg cohort had to be removed from study due to partial blindness following inflammation of the optic nerve, but was improving with steroids and discontinuation of meds. When I reported mouth ulcers that had decreased for the moment, Weber noted that I am the second person to develop mucositis.
Dose 10 = 5/6/2011
Mouth ulcers are present by the afternoon of treatment, along with significant joint aches and rash....red papular and itchy to back and legs. But, 2 weeks later mouth lesions have faded.
Dose 11 = 5/20/2011
More of the same.
Dose 12 = 6/3/2011....6 MONTHS DONE!!!!....last every 2 week infusion!
Vitiligo increased, now to arms, back and chest. Very itchy....sometimes with visible rash, sometimes not. By August, itching continues and I think that maybe it gets worse in areas just before they develop vitiligo. Hard to tell.
Dose 13 = 9/13/2011
First dose of anti-PD1 with NO VACCINES!!! Administration seemed like a breeze. Weber took pics of my vitiligo this time. Tried to explain various skin lesions to Weber. Sometimes it is more like a "rash" with scattered red papules. At other times, there are "papular, rough nodules that grow in size, scab over and then gradually resolve though this can take weeks. He felt they were due to inflammation and its resolution as cells were destroyed." Had "persimmon mouth by noon". Within 24 hours, arms and legs "felt as though they weighed a zillion pounds a piece" with aches in ankles and knees. I posted my first pics of my vitiligo on my blog that month.
The strangest lesion I developed during this entire 2 1/2 year period occurred in November 2011. Brent remains convinced that had the lesion described below been biopsied, it would have been melanoma.....
Dose 14 = 12/9/2011...1 YEAR DONE!!!!
"I know it is time for my bug juice since I feel fully energized, though nightly itching, occasional weird rashes, ever increasing vitiligo, and the sensation that my tongue has been run over by a road grader...continues." We were told at this visit that "3-4 of 50" patients in my study have developed vitiligo. Even at that time, Weber spoke of his desire for a "sandwich study" with patients getting a couple of months of anti-PD1 followed by ipi then finished with some prescribed quantity of anti-PD1.
I was very itchy for weeks after this infusion with a rash to the torso and flares of prior vaccine injection sites (granulomas becoming red, hot, swollen....again!) even though it has been 6 months since any vaccines were given. It is becoming clear that I always have an "asthma flare" about 1-2 weeks after each infusion! Hmmmmm.....
Dose 15 = 3/2/2012
At this visit I learn that there have been 2 patients in my study to develop colitis...with one currently hospitalized...and two episodes of patients with pneumonitis. It remains unclear whether patients on the 3 or 10mg/kg are having increased side effects since they are still so early in their trial. For the first time, 20 minutes into the infusion of anti-PD1, I developed a small itchy and specific, obvious blotch (hive/urticaria) to my right cheek that faded within 30 minutes or so after the infusion. I later learned they are premedicating groups at a higher dosing level with Benadryl and Zantac. Within days of the infusion there are significant arthralgias in my ankles, knees, elbows, and wrists. My mouth feels dry and "weird" but no lesions so far. Feel "stinky" and smell and taste myself!!! And, that's not good!
One week later....mouth lesions are full blown. There are red flared granulomas to prior injection sites and continued increased size to bilateral inguinal nodes. Arthralgias continue off and on.
By April first, mouth lesions are gone and aches and pains are much improved.
April 14: Awakened from sleep at 2AM tongue hurting, joints throbbing. Spent the next couple of days feeling as though I had just been given the med, but gradually improved.
Dose 16 = 6/8/2012...1 1/2 YEARS DONE!!!!
Side effects were not too bad this time. There was sensitivity and tenderness to my tongue, but no lesions. Pain in hands, wrists, and elbows....at first enough to waken from sleep....but then just dull and achy.
Dose 17 = 9/7/2012
Had another episode of hives to my face during the infusion. Very tired after. Worked the Monday following with all my peeps saying..."You look tired!" "You're pale. Are you okay?" Had muscle aches like you might feel with a high fever....but....NO fever! On Tuesday, sore muscles were better but had pains in wrists and ankles. Two weeks later - all side effects were better, though aches to shoulders and wrists continued.
Dose 18 = 12/14/2012...2 YEARS DONE!!!!
On 12/16 I wrote: "Itchy, Stinky, Achy, and Tired...the Four Horsemen of anti-PD1!! Just finished an INSANITY workout...Yeah, yeah...it was only the cardio recovery set...and yes, I did feel like I was going to throw up once...but...I DID IT!!!"
Dose 19 = 3/15/2013
During the first week following this infusion I had tender cheeks and gums, such that brushing my teeth was very painful. I was awakened three days later with mouth pain. My tongue was raw with deep painful lesions underneath. Shoulders, elbows, and wrists were sore. In one more week I was wheezing badly, my nurses were quite alarmed (as always...don't know why we can't get used to the cycle!!!) and urging me to take a Decadron shot. No can do!! But, with nebulized albuterol and atrovent, and an increased dose of my symbicort, I gradually got better. Vitiligo continued to increase and I posted another set of pics on the blog. By May 20th my tongue was raw with a host of new lesions. It had been getting better!!!! What the tub?????
Dose 20 = 6/7/2013...2 1/2 YEARS on anti-PD1...LAST DOSE!!!!!
Got confirmation at this visit that no more peptide vaccines would be used at Moffitt as a treatment strategy. Weber was duly impressed by my mouth lesions. On the 8th I noted, "Extremely tired this morning with anti-PD1 aches in my ankles, knees and toes and road rash on my tongue."
In August, the arthralgias had abated. Mucositis with mouth and tongue ulcerations, bleeding gums, tender lips....had demonstrated NO improvement.
Recheck after completion of meds = 9/13/2013
Learned that I was the ONLY patient out of 120 who had developed mouth ulcers. Others had developed sore, tender gums and mouth with mucositis...but no ulcers!!! So, there's hope for the rest of you!!! Anyhow, though Weber (and my dentist) continued to be very impressed/aghast with the ulcers remaining after treating with Peridex and 24 hours worth of Valcyclovir...I am happy since they are ever so much better and almost pain free.....finally. Weber also spontaneously noted that my vitiligo had continued to increase since my last visit.
Note: There has been some discussion in the press, on boards and with Dr. Weber regarding 5 patients out of the 120 in my study who developed shingles. The jury is still out on whether that is a direct result of anti-PD1, since the age of most of the patients in the study is such that they are the folks who would be most likely to contract shingles with anti-PD1 or without it.
TODAY
Feeling well. Running 3-4 miles at least 3-4 times a week...occasionally more often. My mouth ulcers remained minimal for about 4 weeks, but then began to rear their ugly head again. Restarting the antibacterial mouth wash did nothing to help. Currently, they are not as bad as they had been, but I do have a fairly large eroded place with exudate to both sides of my inner cheeks by my molars and under my tongue is raw, red, and tender. Perhaps the meds that I thought so highly of did nothing, and it was just time for the lesions to wane. OR.....perhaps I HAD developed a secondary infection in the lesions since they had been there for over 4 months...nonstop....that the meds did help with...and this is just another anti-PD1 flare, with no infection. Just anti-PD1. Doing its thing. In the words of Weber...."This stuff is WEIRD!!!"
Best. - c
Dose 1 = 12/27/2010
Sites of the local injections to my thighs were red and tender.
Dose 2 = 1/14/2011
Thigh at injection site = sore and bruised. Already getting "contra-lateral" reaction...meaning the leg that was injected LAST time...became red and tender as well, within 2-3 days after infusion/injections.
Dose 3 = 1/28/2011
Twenty-four hours after my third dose I felt beat up and sore all over "like [I had had] a big work out the day prior" but had not!
Dose 4 = 2/11/2011
Two days after this dose, I noted the development of vitiligo on my hands and arms. Ten days later: "really tired". Brent pointed out that at this point the half lives of the medication had converged and therefore remained at a steady state somewhere following the 3-4th dose. This was later confirmed by Dr. Weber.
Dose 5 = 2/25/2011
On Sunday, after Friday's infusion, "I feel like something the cat dragged in...after Zeno played with it for an hour!" That's not good y'all!!! I took my first Monday off from work.
Dose 6 = 3/11/2011...3 MONTHS DONE!!!!
At my visit, Weber reports that fatigue is the most common side effect being reported in my study. Since I was still working and running, he assigned my fatigue, as I reported it above, to be a "1" on a 1-4 scale with 4 being the highest. He was pleased to note the enlarging lymph nodes in my groin. Pain in legs at injection sites continues.
Dose 7 = 3/25/2011
My scans at the 3 Month evaluation showed "ground glass appearance" in the right lower lobe of my lung. I was also having wheezing at the time. Scans were reviewed by the tumor board at Moffitt and determined to be related to my asthma or an inflammatory process that Weber had seen before in patients on ipi. Wheezing gradually improved on albuterol and inhaled corticosteroid; symbicort. Perhaps most importantly, the 3mm something???? in my brain on my MRI when I started is GONE!
Dose 8 = 4/8/2011
Was told a patient in my study had developed retinitis. Vitiligo increasing. Hemoglobin decreased, possibly due to leukophoresis. Sore, itching legs. I smell and taste bad....at least to me. Others report no notice of smell. I have developed mouth ulcers. For the past couple of rounds my mouth had felt "dry and weird" immediately following my infusion, for which Ruthie would get me a lemonade, that helped.
Dose 9 = 4/22/2011
Weber reports that rash, itching and fatigue are being commonly reported at my visit. His conclusion: I am less tired than most. Patient in 3mg/kg cohort had to be removed from study due to partial blindness following inflammation of the optic nerve, but was improving with steroids and discontinuation of meds. When I reported mouth ulcers that had decreased for the moment, Weber noted that I am the second person to develop mucositis.
Dose 10 = 5/6/2011
Mouth ulcers are present by the afternoon of treatment, along with significant joint aches and rash....red papular and itchy to back and legs. But, 2 weeks later mouth lesions have faded.
Dose 11 = 5/20/2011
More of the same.
Dose 12 = 6/3/2011....6 MONTHS DONE!!!!....last every 2 week infusion!
Vitiligo increased, now to arms, back and chest. Very itchy....sometimes with visible rash, sometimes not. By August, itching continues and I think that maybe it gets worse in areas just before they develop vitiligo. Hard to tell.
Dose 13 = 9/13/2011
First dose of anti-PD1 with NO VACCINES!!! Administration seemed like a breeze. Weber took pics of my vitiligo this time. Tried to explain various skin lesions to Weber. Sometimes it is more like a "rash" with scattered red papules. At other times, there are "papular, rough nodules that grow in size, scab over and then gradually resolve though this can take weeks. He felt they were due to inflammation and its resolution as cells were destroyed." Had "persimmon mouth by noon". Within 24 hours, arms and legs "felt as though they weighed a zillion pounds a piece" with aches in ankles and knees. I posted my first pics of my vitiligo on my blog that month.
The strangest lesion I developed during this entire 2 1/2 year period occurred in November 2011. Brent remains convinced that had the lesion described below been biopsied, it would have been melanoma.....
Sunday,
November 6, 2011
Ever since my last infusion of
anti-PD1 in September my skin has been flared up and irritable.
The granulomas on my thighs have remained red, hard,
inflamed and itchy. Back and arms very itchy. Bilateral inguinal
nodes have remained constant (they used to come and go) with the one on the
right measuring about 2cm and the largest on the left measuring about
1.5cm, followed with another of about 0.5cm, and a tiny one finishing out the
trio. Vitiligo continues to increase. Just before our trip to California
(10/4 or 5), during a very itchy flare on my back, I noticed a small circular
patch of dry skin just below the scar from my initial lesion. I completely
forgot about it during our vacation. But, when we returned (10/15),
I was very surprised to feel a lump there. The documentation
follows:
10/15 - 8.1 X 5.5mm smooth, flesh colored, circular, domed lesion in the exact same location as the dry patch below my original excision scar.
10/17 - size unchanged, texture the same, color now = dark pink.
10/20 - lesion remains same color, size now 7 X 5.5mm.
10/21 - lesion now 5 X 5.5mm with a black scab covering 15% of the top edge.
10/22 - more of a scab has developed, size = 5X4mm.
10/23 - 5 X 3.5mm, with surface now dull and a greater area is covered with a scab.
10/25 - 5 X 2.5mm, lesion now mostly flat scab
10/26 - scab missing, flat pink macule is all that remains.
Today - Brent can find nothing more than a flat, ovoid, pink area.
So...what was all that business???? Brent was very worried. At first he wanted me straight to derm to have it removed and analyzed. Then, worried about being kicked off my trial, we decided to watch and wait. Was it one of the lesions that Weber, Ruthie, Brent and the NP already observed...some inflammatory nodule often occurring before more vitiligo? Was it a met...which I think is what Brent feels it was? Melanoma mets can be black, or bluish, or pink, or red. I don't know. It was truly weird and unlike the other lesions was very smooth, at least initially. The others have been almost like a pimple or a bug bite for the first couple of days, rapidly turning brown and rough...but never with a black scab. Brent worries for this posting. But, perhaps, one day, such documentation will make a difference. Anti-PD1 is new...and nobody is talking. Given how challenging the last infusion was, I can't say that I'm looking forward to my next trip to Tampa on Dec. 8th for infusion on the 9th...given, of course, that scans are clear on Dec 2. Then again...maybe it's still fighting off cooties and is the only reason I'm still here!
10/15 - 8.1 X 5.5mm smooth, flesh colored, circular, domed lesion in the exact same location as the dry patch below my original excision scar.
10/17 - size unchanged, texture the same, color now = dark pink.
10/20 - lesion remains same color, size now 7 X 5.5mm.
10/21 - lesion now 5 X 5.5mm with a black scab covering 15% of the top edge.
10/22 - more of a scab has developed, size = 5X4mm.
10/23 - 5 X 3.5mm, with surface now dull and a greater area is covered with a scab.
10/25 - 5 X 2.5mm, lesion now mostly flat scab
10/26 - scab missing, flat pink macule is all that remains.
Today - Brent can find nothing more than a flat, ovoid, pink area.
So...what was all that business???? Brent was very worried. At first he wanted me straight to derm to have it removed and analyzed. Then, worried about being kicked off my trial, we decided to watch and wait. Was it one of the lesions that Weber, Ruthie, Brent and the NP already observed...some inflammatory nodule often occurring before more vitiligo? Was it a met...which I think is what Brent feels it was? Melanoma mets can be black, or bluish, or pink, or red. I don't know. It was truly weird and unlike the other lesions was very smooth, at least initially. The others have been almost like a pimple or a bug bite for the first couple of days, rapidly turning brown and rough...but never with a black scab. Brent worries for this posting. But, perhaps, one day, such documentation will make a difference. Anti-PD1 is new...and nobody is talking. Given how challenging the last infusion was, I can't say that I'm looking forward to my next trip to Tampa on Dec. 8th for infusion on the 9th...given, of course, that scans are clear on Dec 2. Then again...maybe it's still fighting off cooties and is the only reason I'm still here!
"I know it is time for my bug juice since I feel fully energized, though nightly itching, occasional weird rashes, ever increasing vitiligo, and the sensation that my tongue has been run over by a road grader...continues." We were told at this visit that "3-4 of 50" patients in my study have developed vitiligo. Even at that time, Weber spoke of his desire for a "sandwich study" with patients getting a couple of months of anti-PD1 followed by ipi then finished with some prescribed quantity of anti-PD1.
I was very itchy for weeks after this infusion with a rash to the torso and flares of prior vaccine injection sites (granulomas becoming red, hot, swollen....again!) even though it has been 6 months since any vaccines were given. It is becoming clear that I always have an "asthma flare" about 1-2 weeks after each infusion! Hmmmmm.....
Dose 15 = 3/2/2012
At this visit I learn that there have been 2 patients in my study to develop colitis...with one currently hospitalized...and two episodes of patients with pneumonitis. It remains unclear whether patients on the 3 or 10mg/kg are having increased side effects since they are still so early in their trial. For the first time, 20 minutes into the infusion of anti-PD1, I developed a small itchy and specific, obvious blotch (hive/urticaria) to my right cheek that faded within 30 minutes or so after the infusion. I later learned they are premedicating groups at a higher dosing level with Benadryl and Zantac. Within days of the infusion there are significant arthralgias in my ankles, knees, elbows, and wrists. My mouth feels dry and "weird" but no lesions so far. Feel "stinky" and smell and taste myself!!! And, that's not good!
One week later....mouth lesions are full blown. There are red flared granulomas to prior injection sites and continued increased size to bilateral inguinal nodes. Arthralgias continue off and on.
By April first, mouth lesions are gone and aches and pains are much improved.
April 14: Awakened from sleep at 2AM tongue hurting, joints throbbing. Spent the next couple of days feeling as though I had just been given the med, but gradually improved.
Dose 16 = 6/8/2012...1 1/2 YEARS DONE!!!!
Side effects were not too bad this time. There was sensitivity and tenderness to my tongue, but no lesions. Pain in hands, wrists, and elbows....at first enough to waken from sleep....but then just dull and achy.
Dose 17 = 9/7/2012
Had another episode of hives to my face during the infusion. Very tired after. Worked the Monday following with all my peeps saying..."You look tired!" "You're pale. Are you okay?" Had muscle aches like you might feel with a high fever....but....NO fever! On Tuesday, sore muscles were better but had pains in wrists and ankles. Two weeks later - all side effects were better, though aches to shoulders and wrists continued.
Dose 18 = 12/14/2012...2 YEARS DONE!!!!
On 12/16 I wrote: "Itchy, Stinky, Achy, and Tired...the Four Horsemen of anti-PD1!! Just finished an INSANITY workout...Yeah, yeah...it was only the cardio recovery set...and yes, I did feel like I was going to throw up once...but...I DID IT!!!"
Dose 19 = 3/15/2013
During the first week following this infusion I had tender cheeks and gums, such that brushing my teeth was very painful. I was awakened three days later with mouth pain. My tongue was raw with deep painful lesions underneath. Shoulders, elbows, and wrists were sore. In one more week I was wheezing badly, my nurses were quite alarmed (as always...don't know why we can't get used to the cycle!!!) and urging me to take a Decadron shot. No can do!! But, with nebulized albuterol and atrovent, and an increased dose of my symbicort, I gradually got better. Vitiligo continued to increase and I posted another set of pics on the blog. By May 20th my tongue was raw with a host of new lesions. It had been getting better!!!! What the tub?????
Dose 20 = 6/7/2013...2 1/2 YEARS on anti-PD1...LAST DOSE!!!!!
Got confirmation at this visit that no more peptide vaccines would be used at Moffitt as a treatment strategy. Weber was duly impressed by my mouth lesions. On the 8th I noted, "Extremely tired this morning with anti-PD1 aches in my ankles, knees and toes and road rash on my tongue."
In August, the arthralgias had abated. Mucositis with mouth and tongue ulcerations, bleeding gums, tender lips....had demonstrated NO improvement.
Recheck after completion of meds = 9/13/2013
Learned that I was the ONLY patient out of 120 who had developed mouth ulcers. Others had developed sore, tender gums and mouth with mucositis...but no ulcers!!! So, there's hope for the rest of you!!! Anyhow, though Weber (and my dentist) continued to be very impressed/aghast with the ulcers remaining after treating with Peridex and 24 hours worth of Valcyclovir...I am happy since they are ever so much better and almost pain free.....finally. Weber also spontaneously noted that my vitiligo had continued to increase since my last visit.
Note: There has been some discussion in the press, on boards and with Dr. Weber regarding 5 patients out of the 120 in my study who developed shingles. The jury is still out on whether that is a direct result of anti-PD1, since the age of most of the patients in the study is such that they are the folks who would be most likely to contract shingles with anti-PD1 or without it.
TODAY
Feeling well. Running 3-4 miles at least 3-4 times a week...occasionally more often. My mouth ulcers remained minimal for about 4 weeks, but then began to rear their ugly head again. Restarting the antibacterial mouth wash did nothing to help. Currently, they are not as bad as they had been, but I do have a fairly large eroded place with exudate to both sides of my inner cheeks by my molars and under my tongue is raw, red, and tender. Perhaps the meds that I thought so highly of did nothing, and it was just time for the lesions to wane. OR.....perhaps I HAD developed a secondary infection in the lesions since they had been there for over 4 months...nonstop....that the meds did help with...and this is just another anti-PD1 flare, with no infection. Just anti-PD1. Doing its thing. In the words of Weber...."This stuff is WEIRD!!!"
Best. - c
Thursday, October 17, 2013
Side effects of Nivolumab/Opdivo
A question I get often, in person, in emails, and sometimes try to answer on forums...is: What were the side effects you experienced on anti-PD1 (now Nivolumab)? So...I will try to put a clear answer together for you here.
When thinking about the side effects of any drug, you first have to think about what it is the drug is supposed to do. Then, you have to remember that no drug is a silver bullet that will address only the problem it is supposed to fix. There is always collateral damage.
Anti-PD1 (Nivolumab in my case, but Merck's product is practically equivalent) falls in the category of drugs that stimulate the immune system. Interferon is given in hopes of doing that as well. As does ipilimumab (with much better effect) and IL2 for that matter. So, what does that mean? Well, let's step back and look at the opposite drug category...drugs that suppress the immune system. I'm sure you've seen all the ads for Enbrel, Remicade, Humera, plus the original Methotrexate and even prednisone. These drugs work via different mechanisms, but their job is to DECREASE the "auto" immune response people with anything from rheumatoid arthritis, ankylosing, psoriasis, various types of colitis, and even asthma are having, and thereby minimize their symptoms and misery. SO...drugs given to stimulate the immune system with the hope of having the body attack various nasty cancer cells...melanoma in this case...can CAUSE the very symptoms that folks with autoimmune diseases have: joint pain, rashes, wheezing, colitis. Clear as mud? OK!
Well documented side effects from the data reported at ASCO and in published research papers...as experienced by ratties like myself include:
Rashes - very common. Anything from general itchiness, to red papular lesions.
Fatigue - very common. Reported frequently. Varies person to person with some folks unable to work, others just tired generally, with episodes that wax and wane.
Arthralgias - joint pain is frequently reported. Inflammation triggered by the immune response does not make joints happy.
Mucositis - irritation of the mucus membranes, from redness and tenderness to pain and lesions. (The gut is just one long tube that starts in the mouth after all....see Colitis below.)
Hypothyroidism - not as common, but certainly has happened. One lady in my study gradually lost thyroid function, and is now maintained on thyroid hormone in pill form, synthroid.
Colitis - irritation and inflammation in the bowel that can cause diarrhea and bleeding. Sometimes, causing dehydration and the need for hospitalization, fluids, discontinuation of the drug for a time or permanently, and at times prednisone to stop the progression. This is a fairly common cause of patients being taken off ipi and anti-PD1.
Pneumonitis - significant inflammation in the lungs that may be treated as noted above and has even been a cause of death for patients on ipi and anti-PD1, and obviously removal from a trial or treatment.
Pituitary failure and vision problems related to the optic nerve, as well as retinitis, have occurred but are not reported as common events.
Vitiligo - the depigmentation of the skin (and/or hair), leaving white patches. Thought to occur because of the shared antigens located on melanoma cells and normal pigment cells. It is considered a good prognostic sign that the drug is working against melanoma and occurs in 5-9% of patients on ipi or anti-PD1.
My experiences to follow.... c
When thinking about the side effects of any drug, you first have to think about what it is the drug is supposed to do. Then, you have to remember that no drug is a silver bullet that will address only the problem it is supposed to fix. There is always collateral damage.
Anti-PD1 (Nivolumab in my case, but Merck's product is practically equivalent) falls in the category of drugs that stimulate the immune system. Interferon is given in hopes of doing that as well. As does ipilimumab (with much better effect) and IL2 for that matter. So, what does that mean? Well, let's step back and look at the opposite drug category...drugs that suppress the immune system. I'm sure you've seen all the ads for Enbrel, Remicade, Humera, plus the original Methotrexate and even prednisone. These drugs work via different mechanisms, but their job is to DECREASE the "auto" immune response people with anything from rheumatoid arthritis, ankylosing, psoriasis, various types of colitis, and even asthma are having, and thereby minimize their symptoms and misery. SO...drugs given to stimulate the immune system with the hope of having the body attack various nasty cancer cells...melanoma in this case...can CAUSE the very symptoms that folks with autoimmune diseases have: joint pain, rashes, wheezing, colitis. Clear as mud? OK!
Well documented side effects from the data reported at ASCO and in published research papers...as experienced by ratties like myself include:
Rashes - very common. Anything from general itchiness, to red papular lesions.
Fatigue - very common. Reported frequently. Varies person to person with some folks unable to work, others just tired generally, with episodes that wax and wane.
Arthralgias - joint pain is frequently reported. Inflammation triggered by the immune response does not make joints happy.
Mucositis - irritation of the mucus membranes, from redness and tenderness to pain and lesions. (The gut is just one long tube that starts in the mouth after all....see Colitis below.)
Hypothyroidism - not as common, but certainly has happened. One lady in my study gradually lost thyroid function, and is now maintained on thyroid hormone in pill form, synthroid.
Colitis - irritation and inflammation in the bowel that can cause diarrhea and bleeding. Sometimes, causing dehydration and the need for hospitalization, fluids, discontinuation of the drug for a time or permanently, and at times prednisone to stop the progression. This is a fairly common cause of patients being taken off ipi and anti-PD1.
Pneumonitis - significant inflammation in the lungs that may be treated as noted above and has even been a cause of death for patients on ipi and anti-PD1, and obviously removal from a trial or treatment.
Pituitary failure and vision problems related to the optic nerve, as well as retinitis, have occurred but are not reported as common events.
Vitiligo - the depigmentation of the skin (and/or hair), leaving white patches. Thought to occur because of the shared antigens located on melanoma cells and normal pigment cells. It is considered a good prognostic sign that the drug is working against melanoma and occurs in 5-9% of patients on ipi or anti-PD1.
My experiences to follow.... c
Wednesday, October 9, 2013
Cause we could all use a smile.....
what does the fox say
How do they keep such straight faces?????
Have a great day! - c
(Thanks, Shay!)
Saturday, October 5, 2013
Nurse Jackie!
I've worked in nursing since I was 18, taught nurses, worked as a nurse practitioner for the past decade, experienced my first hospitalization (that I really remember) when having my babies, and spent the past ten years as a melanoma patient! You know what all that means? I've known a lot of nurses!
There are certainly stand-outs along the way! If I am a decent pediatric provider at all, it is due to the training, kindness and examples so generously shared with me: the newly graduated, newly hired, teen, (YIKES!!), fresh off the farm, "charge nurse" for 3-11 at our local Children's Hospital....by the two LPN's I worked most shifts with...Jackie McCabe and Delana Treadwell. I have thanked them in person, but many zillion times more in my head and heart over the years. You two are at the tip top of my great nurses list, you guys!
Sadly, I've met nurses that fall to the bottom. Laziness is the cause of many failings! Lack of knowledge and a disinterest in learning...medicine changes daily!...is another. A focus on yourself, disorganization, lack of respect....and the absence of "heart"...comes through to co-workers and patients alike.
Nursing is hard. If a nurse is really doing her job....no matter the setting....she (or he) is not sitting around! There are ALWAYS tasks to be done, patients to sit with and check on, new medicines and treatments to learn about, providers needing assistance. The physical demands of changing beds, even for babies, pushing equipment, moving patients who may or may not be ambulatory, running back and forth, and back and forth again, is physically demanding. It is emotionally draining. Parents of sick babies are not happy people. Families are anxious, if not downright angry that their loved one is in this position. Having to tell families bad news will break your heart, then, and later, when you remember. Patients you come to love and care for like your own, will die. In pediatrics you WILL take care of abused children. And, if that is not enough, the person who is, by all evidence and report the perpetrator, may be allowed to continue to visit the child...until proven guilty. Nurses may say nothing, nor exhibit any disrespect. Hard....does not even begin to describe that challenge. Patients will be non-compliant. They will not take their meds. They will not eat and exercise properly. They will not be clean. They will not all be nice. Nurses are to offer help, education, and acceptance...always. Nurses are not to judge...ever.
As a patient, I have seen the best and worst in nursing. Once in my room after the delivery of my first child, my nurse told me about how important it was to empty my bladder within the next hour, that she would be massaging my fundus every couple hours, and that checking my bleeding was very important, blah, blah, blah. Stuff I already knew....luckily....as it turned out! Twelve hours later...her first reappearance since her sermon at 0700...with a bit of a panic on her face and no preamble blurted, "Did you ever get up and pee?" You have no idea how close I was to saying, "No, ma'am. Is that a problem?"
Post lung surgery, some idgit nurse decided that 2 in the morning was the perfect time to rattle papers around, put his weight on my mattress, and tape a sign above my bed with a statement about blood pressures....only to return an hour later and change it. There was the nurse who kept her back to me and my husband as she did an intake interview before surgery. When he answered a history question with a date I was unsure of, she told him that he was not to speak! It is a wonder that woman is alive today!!
Luckily, I have been witness to a great deal of wonderful care, given gladly and expertly by many good nurses. The girls I work with today impress me daily with the care and concern they give our families. Nurses from my time in NICU and PICU were some of the smartest and most hard working I have known. I saw a great deal of strength in many of my students and am certain that at least a few of them have lived up to their potential. The nurses at Moffitt have been amazing. Always busy, dealing with new trials and complicated patients everyday.
But, the all time best nurse in my whole world? Nurse Jackie! She knew her shit. She knew the trials and what was happening with the patients in them. She knew the side effects, what the doctors were thinking, and how to take a history. She remembered her patients. She was organized and had created a tray to simultaneously carry and label the peptide vaccines that the other nurses happily utilized. She shared enough of herself to make her likable and human, but not so much that it became the Jackie Show. She always kept the focus on the patient. And, it wasn't just for me. Sorry, guys...but yes, we can hear what you are saying to other patients through those curtains!!! She was clearly a valuable resource for her coworkers. She was expert at starting IV's, drawing blood, and giving those horrible peptide injections.
The peptide vaccines were a painful nightmare, one which poor Ruthie may have dreaded more than I did! The great solution Weber had adopted for pain control, was ice applied to the injection site...20 minutes or so before the injections. This is total bullshit, by the way. You just end up shivering for the duration with a minor freezer burn to the affected area and vaccines that still hurt like a mother. At any rate...that was the deal. So, after vital signs, an IV start, lab draw and pee in a cup, it was off to see Weber. He would give the ok to send up the meds after checking my scans and labs. Then, it was back over to the CRU (Clinical Research Unit) for the infusion and vaccines. We would be sent to a room and await the ice packs. Once, as Jackie came in with them, Ruthie began...."Ding da da ding ding ding ding. Ding da da ding ding ding ding." Jackie never batted an eye. Just began a conga line around the bed with her ice bags moving in time, and joined in..."Ice, ice, baby! Ice, ice baby!!!" Now, that's what I'm talking about!!!
On top of that, she always sent the med order to pharmacy with the label "PTC!!!!" (Plane to catch!) It really did make such a difference. But....back to the vaccines. Ruthie saved up stories throughout the two prior weeks to tell me while I was getting them to take my mind off of them. Sometimes there were even notes!! Her sweet boys even contributed! On one occasion, as Jackie began to give the injections...Ruthie grabbed my hand and started...."So....OK....this was crazy! I had to go to this funeral..." Jackie, never looking up, said, "Oh, a happy story!" She was great.
When I mentioned once that I thought I smelled and tasted weird after the infusions. She didn't act like I was insane. She said, "Oh, I bet that's from the DMSO they use as a preservative. Canned corn, don't you think?" When I began to develop vitiligo, rather than look at it with distaste, as one of the asinine techs did, she said, "That is a really great sign! Dr. Weber's little bow tie spins round and round when he sees things like that!" On one of my last infusion visits, I overheard a nurse telling a patient about the trial she was apparently just starting with anti-PD1, and while her report wasn't exactly inaccurate, it certainly left a lot out, and she added, "Yeah, this is so new we don't really know much about it and it doesn't even have a name yet!" WRONG! Yes, it did. Nivolumab! Not the worst transgression in the world I suppose, but still. Woman, YOU are supposed to KNOW this stuff!!! And...again...we can hear you through curtains!!!! But, never fear...a little later, Jackie was at the newbie's side...explaining the trial, telling her about her newly named drug. Being herself. Being the best nurse ever.
So, Jackie. You mean so much to so many. You make a difference. You helped me more than you will ever know. You even noticed that Ruth and Brent called me Celeste, then, you did, too. Thank you. Love - c
There are certainly stand-outs along the way! If I am a decent pediatric provider at all, it is due to the training, kindness and examples so generously shared with me: the newly graduated, newly hired, teen, (YIKES!!), fresh off the farm, "charge nurse" for 3-11 at our local Children's Hospital....by the two LPN's I worked most shifts with...Jackie McCabe and Delana Treadwell. I have thanked them in person, but many zillion times more in my head and heart over the years. You two are at the tip top of my great nurses list, you guys!
Sadly, I've met nurses that fall to the bottom. Laziness is the cause of many failings! Lack of knowledge and a disinterest in learning...medicine changes daily!...is another. A focus on yourself, disorganization, lack of respect....and the absence of "heart"...comes through to co-workers and patients alike.
Nursing is hard. If a nurse is really doing her job....no matter the setting....she (or he) is not sitting around! There are ALWAYS tasks to be done, patients to sit with and check on, new medicines and treatments to learn about, providers needing assistance. The physical demands of changing beds, even for babies, pushing equipment, moving patients who may or may not be ambulatory, running back and forth, and back and forth again, is physically demanding. It is emotionally draining. Parents of sick babies are not happy people. Families are anxious, if not downright angry that their loved one is in this position. Having to tell families bad news will break your heart, then, and later, when you remember. Patients you come to love and care for like your own, will die. In pediatrics you WILL take care of abused children. And, if that is not enough, the person who is, by all evidence and report the perpetrator, may be allowed to continue to visit the child...until proven guilty. Nurses may say nothing, nor exhibit any disrespect. Hard....does not even begin to describe that challenge. Patients will be non-compliant. They will not take their meds. They will not eat and exercise properly. They will not be clean. They will not all be nice. Nurses are to offer help, education, and acceptance...always. Nurses are not to judge...ever.
As a patient, I have seen the best and worst in nursing. Once in my room after the delivery of my first child, my nurse told me about how important it was to empty my bladder within the next hour, that she would be massaging my fundus every couple hours, and that checking my bleeding was very important, blah, blah, blah. Stuff I already knew....luckily....as it turned out! Twelve hours later...her first reappearance since her sermon at 0700...with a bit of a panic on her face and no preamble blurted, "Did you ever get up and pee?" You have no idea how close I was to saying, "No, ma'am. Is that a problem?"
Post lung surgery, some idgit nurse decided that 2 in the morning was the perfect time to rattle papers around, put his weight on my mattress, and tape a sign above my bed with a statement about blood pressures....only to return an hour later and change it. There was the nurse who kept her back to me and my husband as she did an intake interview before surgery. When he answered a history question with a date I was unsure of, she told him that he was not to speak! It is a wonder that woman is alive today!!
Luckily, I have been witness to a great deal of wonderful care, given gladly and expertly by many good nurses. The girls I work with today impress me daily with the care and concern they give our families. Nurses from my time in NICU and PICU were some of the smartest and most hard working I have known. I saw a great deal of strength in many of my students and am certain that at least a few of them have lived up to their potential. The nurses at Moffitt have been amazing. Always busy, dealing with new trials and complicated patients everyday.
But, the all time best nurse in my whole world? Nurse Jackie! She knew her shit. She knew the trials and what was happening with the patients in them. She knew the side effects, what the doctors were thinking, and how to take a history. She remembered her patients. She was organized and had created a tray to simultaneously carry and label the peptide vaccines that the other nurses happily utilized. She shared enough of herself to make her likable and human, but not so much that it became the Jackie Show. She always kept the focus on the patient. And, it wasn't just for me. Sorry, guys...but yes, we can hear what you are saying to other patients through those curtains!!! She was clearly a valuable resource for her coworkers. She was expert at starting IV's, drawing blood, and giving those horrible peptide injections.
The peptide vaccines were a painful nightmare, one which poor Ruthie may have dreaded more than I did! The great solution Weber had adopted for pain control, was ice applied to the injection site...20 minutes or so before the injections. This is total bullshit, by the way. You just end up shivering for the duration with a minor freezer burn to the affected area and vaccines that still hurt like a mother. At any rate...that was the deal. So, after vital signs, an IV start, lab draw and pee in a cup, it was off to see Weber. He would give the ok to send up the meds after checking my scans and labs. Then, it was back over to the CRU (Clinical Research Unit) for the infusion and vaccines. We would be sent to a room and await the ice packs. Once, as Jackie came in with them, Ruthie began...."Ding da da ding ding ding ding. Ding da da ding ding ding ding." Jackie never batted an eye. Just began a conga line around the bed with her ice bags moving in time, and joined in..."Ice, ice, baby! Ice, ice baby!!!" Now, that's what I'm talking about!!!
On top of that, she always sent the med order to pharmacy with the label "PTC!!!!" (Plane to catch!) It really did make such a difference. But....back to the vaccines. Ruthie saved up stories throughout the two prior weeks to tell me while I was getting them to take my mind off of them. Sometimes there were even notes!! Her sweet boys even contributed! On one occasion, as Jackie began to give the injections...Ruthie grabbed my hand and started...."So....OK....this was crazy! I had to go to this funeral..." Jackie, never looking up, said, "Oh, a happy story!" She was great.
When I mentioned once that I thought I smelled and tasted weird after the infusions. She didn't act like I was insane. She said, "Oh, I bet that's from the DMSO they use as a preservative. Canned corn, don't you think?" When I began to develop vitiligo, rather than look at it with distaste, as one of the asinine techs did, she said, "That is a really great sign! Dr. Weber's little bow tie spins round and round when he sees things like that!" On one of my last infusion visits, I overheard a nurse telling a patient about the trial she was apparently just starting with anti-PD1, and while her report wasn't exactly inaccurate, it certainly left a lot out, and she added, "Yeah, this is so new we don't really know much about it and it doesn't even have a name yet!" WRONG! Yes, it did. Nivolumab! Not the worst transgression in the world I suppose, but still. Woman, YOU are supposed to KNOW this stuff!!! And...again...we can hear you through curtains!!!! But, never fear...a little later, Jackie was at the newbie's side...explaining the trial, telling her about her newly named drug. Being herself. Being the best nurse ever.
So, Jackie. You mean so much to so many. You make a difference. You helped me more than you will ever know. You even noticed that Ruth and Brent called me Celeste, then, you did, too. Thank you. Love - c
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