Today was one of my quickest infusion days at Hopkins: 3.5 hours from entry to exit. My labs were ready since I had my blood drawn on Tuesday (I spent most of yesterday at the FDA). Today I chatted with Dr. Hahn and two of his fellows - one from Brazil and the other from Portugal. I mentioned that I had attended the SITC conference on November 7, and learned just how quickly changing was the field of immunotherapy cancer research. Dr. Hahn had a conflict and was unable to attend the conference, but agreed that the field was white hot.
As part of his usual checkup, I said that I recently had noticed a light rash on my lower legs, especially around my calves. My legs badly itched as soon as I put them in a bathtub of hot water, or the hot tub, but otherwise were fine. He examined the rash carefully, and asked if I had a rash anywhere else. I replied that it did not think so, although at times I would catch myself scratching around my neck. He did not see any visible rash around my neck, and said that it could be nothing, or it could be an indicator that my body was beginning to react to the nivolumab. He urged me to let him know if the rash got any worse, or if my body showed any other unusual symptoms. Barring any toxicity issues, he said that he agreed that I should keep going with the treatments. I was already scheduled through December, so we scheduled infusions through the end of February.
I waited in the infusion waiting room for about an hour for a chair to open up, but once I was seated the drug was ready and waiting - a first! Better yet, the infusion nurse said that I was no longer required to have my vitals taken three times during the infusion. My port was quickly accessed and and in 70 minutes I was done.
Each day Jennifer and I give thanks that my cancer has retreated and that my life has been extended. Each day is a gift from God, and I try to live my life with an attitude of gratitude.
Thursday, November 19, 2015
Wednesday, November 18, 2015
CR Day 148: FDA hearing; summary of my case
Today I gave testimony at a committee hearing at the Food and Drug Administration. The forum was the FDA's joint Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC) meeting. They were considering an application to approve a new drug named MCNA for non muscle invasive bladder cancer. Although I have not been treated with that particular drug, I was asked by BCAN's executive director, Monica Smith, to provide a brief statement of my journey with bladder cancer to illustrate the need for new drugs, and to remind the committee of the importance of their work. My statement followed Monica's statement, who spoke of the extent of bladder cancer and the fact that the FDA has not approved a significant new bladder cancer drug for nearly 30 years.
For what it's worth, following is the outline that I prepared for my statement:
Name
Although I'm a patent attorney, I'm here as a BC patient. No financial relationship or compensation by any person or entity.
Blogging re journey: search for Ken's Cancer Blog. About 350 entries, hundreds of thousand of views. No ads or compensation. BCAN volunteer.
Diagnosed in Nov 2011 at age 49
Uro: BCG candidate if NMIBC
1st TURBT inconclusive for staging
Intense review of literature and consultations to know options
Second TURBT: MIBC, primary tumor T2b, plus 10 other tumors T1 and CIS. High grade micropappillary
Baseline CT and PET negative for mets
Concluded bladder could not be saved
Consensus: neoadjuvant GemCis chemo
CT after 3 rounds showed mets in multiple nodes
Discontinued chemo, rushed into surgery (RC with neo, prostectomy, 61 nodes)
Surgical pathology trifecta: upgrade to T3, andenocarcinoma in prostate, and 12 positive nodes
NCI SEER data show that 85% of mets BC die within 5 years.
No established second line therapy
Enrolled in clinical trial sponsored by Dendreon but randomized into control group: watchful waiting. Ongoing neobladder issues (strictures, nocturnal incontinence, sleep deprivation).
15 months later, distant mets found in supraclavicular node, confirmed by biopsy
Debate among treatment team re next therapy: 3 supported more chemo, 2 opposed
Commenced ddMVAC in Sept 2013. Discontinued after 3 rounds. Peripheral neuropathy. Mets stable for 9 more months.
Distant mets resumed growth in fall 2014. While being evaluated for a clinical trial at NIH, CT scan found extensive PE. Treated with LMWH.
By Jan of 2015, tumors were extensive, growing at >1 cm/month
Evaluated multiple immunotherapy trials, first mets BC patient in nivolumab trial at JHUH
Nivolumab (Opdivo) is an anti-PD1 drug being developed by BMS
After 6 rounds, CR, target tumors NED.
As of 11/5, Largest non-target tumor is 7 mm on long axis.
20th infusion tomorrow. Protocol calls for up to 2 years of drug.
Durability unknown.
I get lots of Q's through my blog and BCANs web site: crying need for new therapies
Not a doc. No medical advice. Encourage patients to be proactive, seek 2d opinions, look at clinical trials.
Grateful to my health care team, researchers, pharma, NIH, and members of this committee.
No position on MCNA. Many patients and their families rely and depend upon your work to evaluate and decide whether to approve new therapies. The need is great.
Thank you.
For what it's worth, following is the outline that I prepared for my statement:
Name
Although I'm a patent attorney, I'm here as a BC patient. No financial relationship or compensation by any person or entity.
Blogging re journey: search for Ken's Cancer Blog. About 350 entries, hundreds of thousand of views. No ads or compensation. BCAN volunteer.
Diagnosed in Nov 2011 at age 49
Uro: BCG candidate if NMIBC
1st TURBT inconclusive for staging
Intense review of literature and consultations to know options
Second TURBT: MIBC, primary tumor T2b, plus 10 other tumors T1 and CIS. High grade micropappillary
Baseline CT and PET negative for mets
Concluded bladder could not be saved
Consensus: neoadjuvant GemCis chemo
CT after 3 rounds showed mets in multiple nodes
Discontinued chemo, rushed into surgery (RC with neo, prostectomy, 61 nodes)
Surgical pathology trifecta: upgrade to T3, andenocarcinoma in prostate, and 12 positive nodes
NCI SEER data show that 85% of mets BC die within 5 years.
No established second line therapy
Enrolled in clinical trial sponsored by Dendreon but randomized into control group: watchful waiting. Ongoing neobladder issues (strictures, nocturnal incontinence, sleep deprivation).
15 months later, distant mets found in supraclavicular node, confirmed by biopsy
Debate among treatment team re next therapy: 3 supported more chemo, 2 opposed
Commenced ddMVAC in Sept 2013. Discontinued after 3 rounds. Peripheral neuropathy. Mets stable for 9 more months.
Distant mets resumed growth in fall 2014. While being evaluated for a clinical trial at NIH, CT scan found extensive PE. Treated with LMWH.
By Jan of 2015, tumors were extensive, growing at >1 cm/month
Evaluated multiple immunotherapy trials, first mets BC patient in nivolumab trial at JHUH
Nivolumab (Opdivo) is an anti-PD1 drug being developed by BMS
After 6 rounds, CR, target tumors NED.
As of 11/5, Largest non-target tumor is 7 mm on long axis.
20th infusion tomorrow. Protocol calls for up to 2 years of drug.
Durability unknown.
I get lots of Q's through my blog and BCANs web site: crying need for new therapies
Not a doc. No medical advice. Encourage patients to be proactive, seek 2d opinions, look at clinical trials.
Grateful to my health care team, researchers, pharma, NIH, and members of this committee.
No position on MCNA. Many patients and their families rely and depend upon your work to evaluate and decide whether to approve new therapies. The need is great.
Thank you.
Monday, November 9, 2015
CR Day 139: Two videos explaining immunotherapy
From time to time I've been asked to explain how Opdivo (nivolumab) works. I usually mumble something about how the drug uses the body's immune system to attack cancers cells by using an anti-PD-L1 mechanism to defeat the cancer cell's defenses. Most people politely nod and have no idea what I'm talking about. Neither do I. But here are a couple of short videos that explain what's going on in lay terms. First, a whiteboard sketch from Dana Farber Cancer Institute. Second, a film from Cambridge University showing killer T cells attacking cancer. There are about 5 million T cells in each teaspoon of blood, and Opdivo gives them the ability to detect and kill cancer cells that previously were ignored because they didn't look like cancer cells. It's amazing to think about everything that is going on inside the human body. I'm glad that my clinical trial has been working n my cancer.
On Saturday, I attended a forum regarding recent advances in immunotherapy, and heard from doctors regarding the latest advancements in fighting cancer. I hope to post a more detailed summary, but their enthusiasm of how we are entering a new stage in defeating cancer was infectious. I am more hopeful now of my long-term prognosis than I ever have been since I was diagnosed with metastatic cancer. I am grateful to the ongoing research efforts and am glad that, by participating in a clinical trial, I might be helping others in the future.
On Saturday, I attended a forum regarding recent advances in immunotherapy, and heard from doctors regarding the latest advancements in fighting cancer. I hope to post a more detailed summary, but their enthusiasm of how we are entering a new stage in defeating cancer was infectious. I am more hopeful now of my long-term prognosis than I ever have been since I was diagnosed with metastatic cancer. I am grateful to the ongoing research efforts and am glad that, by participating in a clinical trial, I might be helping others in the future.
Thursday, November 5, 2015
CR Day 135: 18th infusion, clear CT
Today was another long day at Hopkins. Two hours each way in rush hour traffic. My port was easily accessed and gave a strong return of blood for my lab work -- whatever problems I had earlier in the year with a sheath growing over the tip have been resolved. I went upstairs for the CT scan and was told that someone had forgotten to obtain insurance company preapproval for today's scan. I could either wait for hours while Hopkins tried to get the approval; skip the scan; or sign a waiver that I would pay in case Hopkins could not get approval. I chose door 3, signed the form, and had the scan.
Insurance company approval is needed because, although I am in a clinical trial sponsored by Bristol-Myers Squibb, Hopkins still seeks insurance company payment for costs that are customary for ongoing monitoring of a metastatic patient. That apparently includes CT scans every 6 weeks, and the accompanying lab work and doctor's visits. Bristol-Myers apparently pays for the nivolumab drug and the associated costs to infuse it, as well as various supporting costs such as a portion of the salaries of the clinical trial nurse and other health care professionals. Running those trials is not cheap, and I am glad that I'm not having to pay for the drug. According to a recent Wall Street Journal article, the retail cost of Opdivo to treat metastatic melanoma is over $12,000 per month.
After the scan, I had to wait a couple of hours for the results to be read and my drug to be released from the pharmacy. I read the newspaper in the Hopkins cafeteria while I drank a couple of liters of Diet Coke to flush the radioactive contrast out of my kidneys. Eventually, I met with Dr. Park, one of Dr. Hahn's fellows, and put him through the paces while getting his views on the durability of nivolumab. He was not as up to date on the literature as I was, and took some time to do some searches and skim the latest articles before telling me that there was no data on point, and the best he could do was extrapolate from the same articles that I discussed in my post of two weeks ago. We also discussed how long I should continue with the trial, saying that I was of the view that I should ride this horse as long as it would carry me. He was inclined to agree, but said that we should discuss it with Dr. Hahn, who fortuitously entered soon thereafter. Dr. Hahn saw no reason to stop treatment, and said that, as long as there was no progression of disease, the only thing that I should keep in mind was the chance of toxicity, although the risks of that are relatively low, and this review suggests.
I noted how I had noticed an increase in leaking from my neobladder at night, or any time I was in a horozontal position, for that matter. We discussed whether I should increase my dosage of imipramine, or try something else. Dr. Hahn said he wanted to discuss that with some of his colleagues, and I said that I would make a more conscious effort to track the frequency and circumstances of when my neobladder leaked.
Dr. Hahn said that the results of my CT scan of my neck, chest, abdomen and pelvis showed no change from my last scan in August: no evidence of disease, no inflamed nodes, no suspicious tumors. The pulmonary inflammation from my post-Africa infection had dissipated, and everything looked clear. Yay! I went up to the infusion center and had 377 ml of Opdivo pumped into my body, along with a liter of saline. When I reclined back, I started to leak. I smiled as I hurried to the bathroom, pulling along my infusion machine: I'd much rather deal with peeing my pants than dying of cancer.
Insurance company approval is needed because, although I am in a clinical trial sponsored by Bristol-Myers Squibb, Hopkins still seeks insurance company payment for costs that are customary for ongoing monitoring of a metastatic patient. That apparently includes CT scans every 6 weeks, and the accompanying lab work and doctor's visits. Bristol-Myers apparently pays for the nivolumab drug and the associated costs to infuse it, as well as various supporting costs such as a portion of the salaries of the clinical trial nurse and other health care professionals. Running those trials is not cheap, and I am glad that I'm not having to pay for the drug. According to a recent Wall Street Journal article, the retail cost of Opdivo to treat metastatic melanoma is over $12,000 per month.
After the scan, I had to wait a couple of hours for the results to be read and my drug to be released from the pharmacy. I read the newspaper in the Hopkins cafeteria while I drank a couple of liters of Diet Coke to flush the radioactive contrast out of my kidneys. Eventually, I met with Dr. Park, one of Dr. Hahn's fellows, and put him through the paces while getting his views on the durability of nivolumab. He was not as up to date on the literature as I was, and took some time to do some searches and skim the latest articles before telling me that there was no data on point, and the best he could do was extrapolate from the same articles that I discussed in my post of two weeks ago. We also discussed how long I should continue with the trial, saying that I was of the view that I should ride this horse as long as it would carry me. He was inclined to agree, but said that we should discuss it with Dr. Hahn, who fortuitously entered soon thereafter. Dr. Hahn saw no reason to stop treatment, and said that, as long as there was no progression of disease, the only thing that I should keep in mind was the chance of toxicity, although the risks of that are relatively low, and this review suggests.
I noted how I had noticed an increase in leaking from my neobladder at night, or any time I was in a horozontal position, for that matter. We discussed whether I should increase my dosage of imipramine, or try something else. Dr. Hahn said he wanted to discuss that with some of his colleagues, and I said that I would make a more conscious effort to track the frequency and circumstances of when my neobladder leaked.
Dr. Hahn said that the results of my CT scan of my neck, chest, abdomen and pelvis showed no change from my last scan in August: no evidence of disease, no inflamed nodes, no suspicious tumors. The pulmonary inflammation from my post-Africa infection had dissipated, and everything looked clear. Yay! I went up to the infusion center and had 377 ml of Opdivo pumped into my body, along with a liter of saline. When I reclined back, I started to leak. I smiled as I hurried to the bathroom, pulling along my infusion machine: I'd much rather deal with peeing my pants than dying of cancer.
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