For the past several days I have been further researching my clinical trial options. I have boiled it down to three choices:
1. Dr. Dawson's MPDL3280a trial at Georgetown; or
2. The nivolumab trial at either Hopkins or Memorial Sloan-Kettering in NYC; or
3. Dr. Apolo's cabozantinib trial.
In the past couple of days, Dr. Apolo and I have exchanged several emails, and yesterday she called me to give me a further update. She said that she has been in contact with both MSKCC and Hopkins about their nivolumab trials. She learned that Hopkins had not been accepting patients with mets bladder cancer for their trial. She asked that they make an exception for me, which they apparently are considering. She had better luck with MSKCC; they have only a few slots left in their trial, but they said they would hold a slot for me. Dr. Apolo suggested that I take a trip to NYC to speak with either Dr. Rosenberg or Dr. Bajorin about my options, since she respected both of them and knew that deciding on the next treatment was a subjective decision. I have the wheels in motion to get that scheduled; MSKCC needs my NIH records before setting up the appointment.
Today Dr. Aragon-Ching called me to talk about my choices. She said that, if I was going to got an immunotherapy drug, now was probably the best time to get it, while my tumor burden was relatively low. She saw no significant difference between the Roche's MPDL3280a drug and Squibb's nivolumab drug. She cautioned, however, that the nivolumab trial also had a cohort that combined that drug with ipilimumab. She explained that ipilimumab (marketed under the name of Yervoy) is is a monoclonal antibody that works to activate the immune system by targeting a protein receptor called CTLA-4 that downregulates the immune system. Cytotoxic T lymphocytes
(CTLs) can recognize and destroy cancer cells, but the body generally inhibits the CTL mechanizem. Ipilimumab
turns off this inhibitory mechanism and allows CTLs to to
destroy cancer cells. But it also has a number of significant side effects. It has a higher number of toxicities than nivolumab or other
PD-L1 immunotherapies. She said that I should be aware of the possible auto-immune
problems that the combined ipi/nivo can cause. Yikes.
Dr. Apolo and Dr. Aragon-Ching also tried to reassure me about the side effects to cabozantinib. They both said that most patients found the side effects to be minimal, and tolerable.
Yesterday I also exchanged emails with Dr. Spira at Inova Fairfax. He confirmed that his MPDL3280a trial was not open to me, since I was not chemo naive. But he invited me to keep tomorrow's appointment so we could discuss other possible clinical trials. I figure that getting opinions of knowledgeable doctors is probably a good thing, so I'll meet with Dr. Spira tomorrow.
Currently, I'm leaning towards doing a PD-L1 trial. My first choice would be the MPDL3280a trial at Georgetown, but there's only a 50/50 chance that I'd be randomized into the arm that I want. If I get put into the taxene arm, I'd probably withdraw. My backup plan is to enroll in the nivolumab trial, hopefully at Hopkins (since it's much closer), but if not, the one at MSKCC.
Meanwhile, I am aware that my cancer is spreading. For the first time, I can palpitate the enlarged nodes in my neck. The largest node under my clavicle is hard to manipulate, but there are a couple of other nodes on the left side of my neck that I can feel. Fortunately, I am not in any pain, but I am aware that the clock is ticking.
Thursday, January 29, 2015
Tuesday, January 27, 2015
Mets Day 1019: Georgetown's clinical trial
Today I met with Dr. Nancy A. Dawson at Georgetown University Hospital to discuss the MPDL3280a trial. She explained that the only trial that she had open was the Phase III trial that compared patients who received the anti-PD-L1 drug to patients receiving a taxene-based chemotherapy. The Phase II trial that had everyone getting the anti-PD-L1 drug had been fully subscribed last Fall, and was closed to all patients who had previously received chemotherapy (the so-called "cohort 2" of the trial). The reason why that Phase II trial showed on clinicaltrials.gov that it was still recruiting was that it still had openings in cohort 1, which was limited to patients who had metastatic bladder cancer and who never had received chemotherapy. She added that she was not aware of any currently open clinical trials that ensured that all patients would receive the MPDL3280a drug.
Dr. Dawson also spent some time dialing back my expectations for the MPDL3280a drug. While she acknowledged that the preliminary results that were reported at the 2014 ASCO meeting showing a 50% response rate were very promising, she said that those data did not match her own personal experience, or the experiences of other doctors that she had spoken with who were helping run the Phase II trial. She said that she had enrolled 13 patients in the Phase II trial, and of those 13, one had a complete response, and two had a partial response. The tumors of the other 10 patients continued to grow non-stop. She said that other doctors had also told her that they were seeing a 20% response rate. Based upon that, she said that she would not be surprised if the Phase III trial showed that the response rate for MPDL3280a was about the same as for the taxene-based chemo.
We also discussed how the randomization would work if I was to enroll in the Phase III trial. She said that, as soon as she certified that I met the criteria, Hoffman-La Roche would enter my information, would conduct the computer-based randomization, and we'd be told of the results. She encouraged me to be ready to go through with the trial regardless of the results -- she did not want me (or other patients) to shop for clinical trials, dropping out if I don't get into the arm that I wanted. I understand that from the viewpoint of the objective of the clinical trial, but from my own selfish point of view, I'd rather get the anti-PL-L1 drug than the taxene.
Dr. Dawson asked whether I had considered Dr. Apolo's current cabozanatinib clinical trial. I told her that Dr. Apolo and I had discussed it, and that the preliminary results did not appear to be as compelling as those for MPDL3280a, and the side effects were much more serious.
We discussed other clinical trials involving anti-PD-L1 drugs that were also available to me. She said that a number of companies were studying those drugs: Merck has pembrolizumab (MK-3475) that is in a Phase III trial for metastatic bladder cancer (No. NCT02256436). Bristol-Myers Squibb has nivolumab (BMS-936558) that is in a Phase 1/2 trial at Johns Hopkins for metastatic bladder cancer (No. NCT01928394). Dr. Apolo is planning a Phase I trial for nivolumab and cabozantinib on bladder cancer patients (No. NCT02308943), but that is not yet open. CureTech is working on pidilizumab, which is being studied for lymphoma and myeloma, but is not in any clinical trials for metastatic bladder cancer.
Dr. Dawson said that she would email Dr. Rosen and MSKCC to determine whether he was in fact running a trial relating to PD-L1. I will email Drs. Apolo and Aragon-Ching and get their thoughts. My initial thoughts are that I'll roll the dice and with the MPDL3280a trial and see if I'm randomized into the immunotherapy arm. If so, I'll do it. If not, I'll decide whether to get the taxene chemo, or stall while I look into either the Merck or Bristol-Myers trials relating to PD-L1.
In almost unrelated news, this afternoon I received an email from Dr. Agarwal's nurse, reporting on the results of the samples he took from my neobladder during the cystoscopy:
Dr. Dawson also spent some time dialing back my expectations for the MPDL3280a drug. While she acknowledged that the preliminary results that were reported at the 2014 ASCO meeting showing a 50% response rate were very promising, she said that those data did not match her own personal experience, or the experiences of other doctors that she had spoken with who were helping run the Phase II trial. She said that she had enrolled 13 patients in the Phase II trial, and of those 13, one had a complete response, and two had a partial response. The tumors of the other 10 patients continued to grow non-stop. She said that other doctors had also told her that they were seeing a 20% response rate. Based upon that, she said that she would not be surprised if the Phase III trial showed that the response rate for MPDL3280a was about the same as for the taxene-based chemo.
We also discussed how the randomization would work if I was to enroll in the Phase III trial. She said that, as soon as she certified that I met the criteria, Hoffman-La Roche would enter my information, would conduct the computer-based randomization, and we'd be told of the results. She encouraged me to be ready to go through with the trial regardless of the results -- she did not want me (or other patients) to shop for clinical trials, dropping out if I don't get into the arm that I wanted. I understand that from the viewpoint of the objective of the clinical trial, but from my own selfish point of view, I'd rather get the anti-PL-L1 drug than the taxene.
Dr. Dawson asked whether I had considered Dr. Apolo's current cabozanatinib clinical trial. I told her that Dr. Apolo and I had discussed it, and that the preliminary results did not appear to be as compelling as those for MPDL3280a, and the side effects were much more serious.
We discussed other clinical trials involving anti-PD-L1 drugs that were also available to me. She said that a number of companies were studying those drugs: Merck has pembrolizumab (MK-3475) that is in a Phase III trial for metastatic bladder cancer (No. NCT02256436). Bristol-Myers Squibb has nivolumab (BMS-936558) that is in a Phase 1/2 trial at Johns Hopkins for metastatic bladder cancer (No. NCT01928394). Dr. Apolo is planning a Phase I trial for nivolumab and cabozantinib on bladder cancer patients (No. NCT02308943), but that is not yet open. CureTech is working on pidilizumab, which is being studied for lymphoma and myeloma, but is not in any clinical trials for metastatic bladder cancer.
Dr. Dawson said that she would email Dr. Rosen and MSKCC to determine whether he was in fact running a trial relating to PD-L1. I will email Drs. Apolo and Aragon-Ching and get their thoughts. My initial thoughts are that I'll roll the dice and with the MPDL3280a trial and see if I'm randomized into the immunotherapy arm. If so, I'll do it. If not, I'll decide whether to get the taxene chemo, or stall while I look into either the Merck or Bristol-Myers trials relating to PD-L1.
In almost unrelated news, this afternoon I received an email from Dr. Agarwal's nurse, reporting on the results of the samples he took from my neobladder during the cystoscopy:
Good news there, at least.Good news, the pathology from your recent procedure looked fine – no sign of tumor. Likewise, Dr. Agarwal did not see any strictures, lesions, or any other obvious source of the bleeding you’ve been experiencing.If you’d like to further discuss the results with Dr. Agarwal or myself, just let us know!
Friday, January 23, 2015
Mets Days 1015: Which MPDL320a trial?
In my discussions this week with Dr. Apolo and Dr. Aragon-Ching, the MPDL3280a study that we were considering was a Phase II single-arm trial (ClinicalTrials.gov Identifier NCT02108652), where all patients would receive the MPDL3280a immunotherapy drug. Both Drs. Apolo and Aragon-Ching understood that Georgetown's Lombardi Cancer Center was offering that trial; both of them contacted Dr. Nancy Dawson on my behalf; and yesterday I was scheduled for an appointment with Dr. Dawson for next Tuesday.
I asked Dr. Dawson's research nurse to email me the clinical trial consent forms so I could review them and compile a list of questions. This morning I started reading through the 40 pages of information, disclosures, warnings, and disclaimers, and was surprised to learn that the clinical trial that Geogetown was running was actually a Phase III double-armed study comparing patients who received MPDL3280a to patients receiving a taxene-based chemotherapy (ClinicalTrials.gov Identifier NCT02302807). Half the patients in that trial would be randomized into the chemotherapy arm, and the other half in the MPDL3280a arm.
I have no interest in getting chemotherapy at this time. Been there, done that, got the neuropathy to show it. Maybe at some later point, I'll get a platinum and taxene-based chemo, but only when my tumors are widespread. The Phase III trial chemotherapy arm is only a single-drug regimen, although some would be given vinflunine, and others would get either paclitaxel, or docetaxel. Strangely enough, Georgetown's list of clinical trials for bladder cancer identifies the Phase II trial that I'm interested in, but does not include the Phase III trial. I've sent an email to Dr. Dawson's research nurse seeking clarification, since I don't want to go down the path for randomization into the Phase III chemo arm. Of course, if I randomized into the MPDL3280a arm, that would be just fine. But if Georgetown is also doing the Phase II study, then I'd prefer enrolling in that instead of rolling the dice on randomization.
I did some more digging and found that, aside from Georgetown, the other local medical center that is participating in the Phase II MPDL3280a trial (where everyone gets the drug) is Fairfax Inova. The Phase II trial appears on their list of clinical trials. I called Dr. Alexander Spira, who is heading that study, and spoke with his research nurse, who scheduled me for an appointment next Friday at 2 pm. So it looks like I'll have the choice between MPDL3280a trials.
I asked Dr. Dawson's research nurse to email me the clinical trial consent forms so I could review them and compile a list of questions. This morning I started reading through the 40 pages of information, disclosures, warnings, and disclaimers, and was surprised to learn that the clinical trial that Geogetown was running was actually a Phase III double-armed study comparing patients who received MPDL3280a to patients receiving a taxene-based chemotherapy (ClinicalTrials.gov Identifier NCT02302807). Half the patients in that trial would be randomized into the chemotherapy arm, and the other half in the MPDL3280a arm.
I have no interest in getting chemotherapy at this time. Been there, done that, got the neuropathy to show it. Maybe at some later point, I'll get a platinum and taxene-based chemo, but only when my tumors are widespread. The Phase III trial chemotherapy arm is only a single-drug regimen, although some would be given vinflunine, and others would get either paclitaxel, or docetaxel. Strangely enough, Georgetown's list of clinical trials for bladder cancer identifies the Phase II trial that I'm interested in, but does not include the Phase III trial. I've sent an email to Dr. Dawson's research nurse seeking clarification, since I don't want to go down the path for randomization into the Phase III chemo arm. Of course, if I randomized into the MPDL3280a arm, that would be just fine. But if Georgetown is also doing the Phase II study, then I'd prefer enrolling in that instead of rolling the dice on randomization.
I did some more digging and found that, aside from Georgetown, the other local medical center that is participating in the Phase II MPDL3280a trial (where everyone gets the drug) is Fairfax Inova. The Phase II trial appears on their list of clinical trials. I called Dr. Alexander Spira, who is heading that study, and spoke with his research nurse, who scheduled me for an appointment next Friday at 2 pm. So it looks like I'll have the choice between MPDL3280a trials.
Wednesday, January 21, 2015
Mets Day 1014: Wheels in motion for the MPDL3280a trial
This morning I spent a good deal of time lining things up for the MPDL3280a clinical trial. Last night I had sent an email to Dr. Aragon-Ching summarizing the day's events, asking for her clearance to restart the Xarelto, and seeking her input on which clinical trial I should enter. She called me this morning and we had a good discussion about my options. Regarding clinical trials, she said that she saw three options for me: Dr. Apolo's cabozantinib trial, the immunotherapy trial with MPDL3280a, or another regimen of chemotherapy. She then recommended holding off on the chemo until I really needed it, i.e., when I had lots of tumors in my organs. She noted that there were some trials combining platinum-based chemo regimes with taxenes, which is something we previously had discussed in 2012 and 2013. Apparently the research is still going on taxenes. For now, she agreed that I should look into the MPDL3280a immunotherapy clinical trial. She offered to contact Dr. Dawson at Georgetown on my behalf. She also endorsed my resuming the Xarelto.
While I was talking to Dr. Aragon-Ching on my land line, Dr. Dawson's research nurse called my cell phone. Dr. Dawson apparently had been emailed by Dr. Apolo, and asked her nurse to follow up post haste. I returned her call, and got the wheels turning for seting up an appointment with Dr. Dawson. The nurse emailed me Georgetown's 11 page new patient form, which I completed and returned. I also filled out the NIH records request form, asking that they overnight all of my records to Dr. Dawson, and NIH confirmed that it would do so. Once Dr. Dawson's nurse receives them, she'll schedule an appointment, probably some time next week. It's great when things fall into place quickly. I am grateful to my doctors for looking out for me and acting quickly to enlarge my team when appropriate.
Faithful blog readers may recall that I have been following news about PD-L1 research for some time. Back in September 2013, when I was considering whether to do dose dense MVAC, my oncologist at Fox Chase Cancer Center advised that I research the emerging trials involving PD-L1. In May of 2014, I had a conversation with Dr. Aragon-Ching about emerging therapies, and she said that the most promising research was with regard to immunotherapy and the PD-1 and PD-L1 inhibitors. In Spetember of last year, she gave me a set of slides from a presentation she had just given regarding the PD-L1 clinical trial that I am now investigating, and told me at that time that, once my nodes were sufficiently large, she thought that was probably the best option for me. Now that I'm at that point, it seems that is the most reasonable choice.
I also reviewed several of the posts regarding patients actual experiences with the MPDL3280a trial on BCAN's forum at www.inspire.com. The comments mirror the preliminary results - some patients credit the drug with stopping their metastatic disease; for others, it did not work. But the data indicate that about 50% of patients with metastatic disease see at least some slowing of the disease. Until there is a cure (and we are a long way from that point), slowing the disease down is the best I can hope for.
While I was talking to Dr. Aragon-Ching on my land line, Dr. Dawson's research nurse called my cell phone. Dr. Dawson apparently had been emailed by Dr. Apolo, and asked her nurse to follow up post haste. I returned her call, and got the wheels turning for seting up an appointment with Dr. Dawson. The nurse emailed me Georgetown's 11 page new patient form, which I completed and returned. I also filled out the NIH records request form, asking that they overnight all of my records to Dr. Dawson, and NIH confirmed that it would do so. Once Dr. Dawson's nurse receives them, she'll schedule an appointment, probably some time next week. It's great when things fall into place quickly. I am grateful to my doctors for looking out for me and acting quickly to enlarge my team when appropriate.
Faithful blog readers may recall that I have been following news about PD-L1 research for some time. Back in September 2013, when I was considering whether to do dose dense MVAC, my oncologist at Fox Chase Cancer Center advised that I research the emerging trials involving PD-L1. In May of 2014, I had a conversation with Dr. Aragon-Ching about emerging therapies, and she said that the most promising research was with regard to immunotherapy and the PD-1 and PD-L1 inhibitors. In Spetember of last year, she gave me a set of slides from a presentation she had just given regarding the PD-L1 clinical trial that I am now investigating, and told me at that time that, once my nodes were sufficiently large, she thought that was probably the best option for me. Now that I'm at that point, it seems that is the most reasonable choice.
I also reviewed several of the posts regarding patients actual experiences with the MPDL3280a trial on BCAN's forum at www.inspire.com. The comments mirror the preliminary results - some patients credit the drug with stopping their metastatic disease; for others, it did not work. But the data indicate that about 50% of patients with metastatic disease see at least some slowing of the disease. Until there is a cure (and we are a long way from that point), slowing the disease down is the best I can hope for.
Tuesday, January 20, 2015
Mets day 1013: Cytoscopy and clinical trial options
Today was a long day at NIH. The nurses at NIH repeatedly had insisted that I needed to have someone accompany me, but today was the first day of classes at George Mason University, which meant that both Jennifer (for her MSW classes) and Spencer (for his biology undergrad degree) were otherwise booked. Fortunately, Kirsten was available, having come home from CNU.
We arrived at 7:30 am to prepare for my cytoscopy by Dr. Agarwal. We ended up waiting for more than two hours before I was called into the preop. The anesthesiologist twice tried to access my port, but could not get a return of blood flow from my port, so I ended up getting an IV on the back of my hand - my least favorite location, since it always leaves a nice bruise and is tender for a week or so. Dr. Agarwal explained how he intended to thoroughly check out my neobladder and ureters for possible reasons for my bloody urine. The anesthesiologist gave me a sedative, and within 10 seconds I was out.
About 90 minutes later, I came to in the recovery room. Kirsten was sitting next to me with a a bemused expression. Dr. Agarwal was also there, patiently answering my questions. Kirsten later told me that I had been asking the same questions to him, the anesthesiologist, and the nurses: would they get my daughter who was in the waiting room (Kirsten has been sitting beside me for a while, but that fact had not registered with me); I was just fine driving home (sure you are, Mr. Brothers); and tell me again about the contrast media that you used. For what it's worth, I have no recollection of asking those questions, and certainly do not recall the answers.
Once I stopped repeating my questions, they realized that I finally had emerged from the anesthesia. Dr. Agarwal said that everything looked fine in the neobladder and ureters - there was no evidence of any cancer, or anything else bad. There was one area in my neobladder that looked a little irritated and raw, but it was nothing to worry about. Kirsten showed me the pictures of my neobladder that Dr. Agarwal took - they looked like two photographs of Mars. Good news, then.
After I dressed, I went to get lab work in advance of my clinic appointment with Dr. Apolo. Even though the surgery nurse had left in the IV in my right hand, the phlebotomist declined to use it for my blood draw, instead accessing my left arm. Something about not wanting any heparin in the blood samples. A minor irritant, but still. I was also directed to provide a urine sample, but since I had not had anything to drink for 15 hours, and because my neoladder had been completely filled, them emptied, during the cystoscopy, when I tried to void, all that came out were drops of blood. That was not a comforting sight.
The phlebotomist told me to get a lot to drink and provide a sample when I could. Kirsten and I walked down to the NIH cafeteria, where I sucked down about three liters of Diet Coke. After that, producing a sample was easy-peasy, although it was still a bit bloody. (The fellow who did my screening before I met with Dr. Apolo commented on how the urinalysis showed a lot of blood, so she correctly guessed that I had provided it after the cystoscopy.)
We ended up waiting 90 minutes past the appointment time from Dr. Apolo. She apologized for running late; it was because yesterday was a federal holiday, so they were squeezing two clinic days into one. We discussed the results of my January 8 CT scan, which showed that three of my supraclavicular lymph nodes had essentially merged together, resulting in a total short axis size of 2.4 cm. Dr. Apolo had told me over the phone on January 12 that she and the radiologist had tried to distinguish the original nodes from each other, but it turned into a guessing game with no useful purpose. So I have blasted way past the 1.5 cm threshold for clinical trials.
We then discussed in detail Dr. Apolo's current clinical trial of cabozantinib for advanced urothelial cancer. Preliminary data from patients already in the trial were publicized at ASCO's 2014 meeting; Dr. Apolo said that the most current results showed that about 20% of patients were seeing a decrease in tumor size, and about 30% were stable. If I was to participate in this trial, I likely would need to have another needle biopsy. I'd also likely have to stop taking Xarelto, and go back on one of the injectable blood thinners, such as Lovenox or fondaparinux. If the reaction kicked in again, they would have to get written permission from the maker of the drug to put me back onto Xarelto.
We discussed the potential side effects; some of the more unusual of the drug in this trial (called XL184) include skin sloughing off the feet and palms; as a result, she said that patients should not immerse their feet in hot water (including hot tubs), and that showers should be lukewarm and short. The XL184 drug also frequently causes fatigue in about 80% of patients, loss of appetite (about 50%) and change of taste (about 30%). There were a long list of other, less common, side effects. Oh, and XL184 also tended to turn hair white.
I asked Dr. Apolo to compare the cabozantinib trial to the immunotherapy trials for MPDL-3280a. To her great credit, Dr. Apolo did not campaign for her trial. She instead said that it was likely that I would do both trials, and that she had no data on which one I should do first. There simply is no side-by-side data to validly compare them to each other. She proposed that she contact Dr. Nancy Dawson, one of the lead researchers at Georgetown for the MPDL3280a trial, so I could examine that option. (The same trial is also being offered at Fairfax Hospital, which is about the same distance from me.)
For now, I don't have to make an immediate decision. I'm going to talk to Dr. Aragon-Ching and get her input, and also will meet with one or more of the doctors running the MPDL3280a trial. Because of all of the side effects of the cabozantinib, I am leaning away from doing that one. But it's nice to have choices.
We arrived at 7:30 am to prepare for my cytoscopy by Dr. Agarwal. We ended up waiting for more than two hours before I was called into the preop. The anesthesiologist twice tried to access my port, but could not get a return of blood flow from my port, so I ended up getting an IV on the back of my hand - my least favorite location, since it always leaves a nice bruise and is tender for a week or so. Dr. Agarwal explained how he intended to thoroughly check out my neobladder and ureters for possible reasons for my bloody urine. The anesthesiologist gave me a sedative, and within 10 seconds I was out.
About 90 minutes later, I came to in the recovery room. Kirsten was sitting next to me with a a bemused expression. Dr. Agarwal was also there, patiently answering my questions. Kirsten later told me that I had been asking the same questions to him, the anesthesiologist, and the nurses: would they get my daughter who was in the waiting room (Kirsten has been sitting beside me for a while, but that fact had not registered with me); I was just fine driving home (sure you are, Mr. Brothers); and tell me again about the contrast media that you used. For what it's worth, I have no recollection of asking those questions, and certainly do not recall the answers.
Once I stopped repeating my questions, they realized that I finally had emerged from the anesthesia. Dr. Agarwal said that everything looked fine in the neobladder and ureters - there was no evidence of any cancer, or anything else bad. There was one area in my neobladder that looked a little irritated and raw, but it was nothing to worry about. Kirsten showed me the pictures of my neobladder that Dr. Agarwal took - they looked like two photographs of Mars. Good news, then.
After I dressed, I went to get lab work in advance of my clinic appointment with Dr. Apolo. Even though the surgery nurse had left in the IV in my right hand, the phlebotomist declined to use it for my blood draw, instead accessing my left arm. Something about not wanting any heparin in the blood samples. A minor irritant, but still. I was also directed to provide a urine sample, but since I had not had anything to drink for 15 hours, and because my neoladder had been completely filled, them emptied, during the cystoscopy, when I tried to void, all that came out were drops of blood. That was not a comforting sight.
The phlebotomist told me to get a lot to drink and provide a sample when I could. Kirsten and I walked down to the NIH cafeteria, where I sucked down about three liters of Diet Coke. After that, producing a sample was easy-peasy, although it was still a bit bloody. (The fellow who did my screening before I met with Dr. Apolo commented on how the urinalysis showed a lot of blood, so she correctly guessed that I had provided it after the cystoscopy.)
We ended up waiting 90 minutes past the appointment time from Dr. Apolo. She apologized for running late; it was because yesterday was a federal holiday, so they were squeezing two clinic days into one. We discussed the results of my January 8 CT scan, which showed that three of my supraclavicular lymph nodes had essentially merged together, resulting in a total short axis size of 2.4 cm. Dr. Apolo had told me over the phone on January 12 that she and the radiologist had tried to distinguish the original nodes from each other, but it turned into a guessing game with no useful purpose. So I have blasted way past the 1.5 cm threshold for clinical trials.
We then discussed in detail Dr. Apolo's current clinical trial of cabozantinib for advanced urothelial cancer. Preliminary data from patients already in the trial were publicized at ASCO's 2014 meeting; Dr. Apolo said that the most current results showed that about 20% of patients were seeing a decrease in tumor size, and about 30% were stable. If I was to participate in this trial, I likely would need to have another needle biopsy. I'd also likely have to stop taking Xarelto, and go back on one of the injectable blood thinners, such as Lovenox or fondaparinux. If the reaction kicked in again, they would have to get written permission from the maker of the drug to put me back onto Xarelto.
We discussed the potential side effects; some of the more unusual of the drug in this trial (called XL184) include skin sloughing off the feet and palms; as a result, she said that patients should not immerse their feet in hot water (including hot tubs), and that showers should be lukewarm and short. The XL184 drug also frequently causes fatigue in about 80% of patients, loss of appetite (about 50%) and change of taste (about 30%). There were a long list of other, less common, side effects. Oh, and XL184 also tended to turn hair white.
I asked Dr. Apolo to compare the cabozantinib trial to the immunotherapy trials for MPDL-3280a. To her great credit, Dr. Apolo did not campaign for her trial. She instead said that it was likely that I would do both trials, and that she had no data on which one I should do first. There simply is no side-by-side data to validly compare them to each other. She proposed that she contact Dr. Nancy Dawson, one of the lead researchers at Georgetown for the MPDL3280a trial, so I could examine that option. (The same trial is also being offered at Fairfax Hospital, which is about the same distance from me.)
For now, I don't have to make an immediate decision. I'm going to talk to Dr. Aragon-Ching and get her input, and also will meet with one or more of the doctors running the MPDL3280a trial. Because of all of the side effects of the cabozantinib, I am leaning away from doing that one. But it's nice to have choices.
Wednesday, January 14, 2015
Mets Day 1007: Nothing unexpected from last week's scans
Dr. Apolo and I had been trading calls since last Friday. Today she got hold of me to pass along the highlights from last week's scans. It's the classic good news/bad news that is consistent with the story line for the past six months:
Dr. Apolo said that, now that my nodes were of sufficient size to enter clinical trials, we should consider whether I should enter a trial, and if so, which one. NIH is currently running five clinical trials for patients with stage 4 bladder cancer. One is a Phase I trial of an AdHER2 vaccination. This is the clinical trial that I was being evaluated for in October when my PE was discovered. Another is a Phase II study of cabozantinib, a new chemical entity that inhibits multiple receptor tyrosine kinases with growth-promoting and angiogenic properties. The primary targets of cabozantinib are MET, VEGFR2, and RET. Dr. Apolo is the principal investigator of this trial, so I think she has a bias towards having me participate in it.
In addition, there are also clinical trials outside of NIH that I could consider. The most compelling choice is a Hoffman-Laroche sponsored study of MPDL3280a. I've previously blogged about this drug; initial results have shown great promise, helping slow or stop tumor growth in 50% of patients. The drug was designated a "breakthrough therapy" by the FDA last summer. I'll be meeting with Dr. Apolo on Tuesday after my cytoscopy, and will be questioning her in detail about my clinical trial options.
- The size of the metastatic lymph nodes under my left clavicle have continued to slowly increase in size. They have now passed the threshold of 1.5 cm in the short axis, which means that I now am eligible to participate in NIH's clinical trials. More on that later.
- The scans showed that there were some slightly enlarged nodes in my abdomen. Those nodes are not pathologically significant, which means that they are under 1.0 cm in size. Those nodes were also noted in the last couple of scans. We don't now if they are growing because of metastatic activity or some other reason, since they did not show up as "hot" in my last PET scan in September 2014. But it's more likely than not that the growth is related to metastatic activity.
- There was no evidence of tumors in my liver, lungs, bones, or any other organs.
- The CT urogram showed no evidence of kidney cancer.
- The pulmonary embolisms and clots in my main hepatic portal have been completely resolved.
Dr. Apolo said that, now that my nodes were of sufficient size to enter clinical trials, we should consider whether I should enter a trial, and if so, which one. NIH is currently running five clinical trials for patients with stage 4 bladder cancer. One is a Phase I trial of an AdHER2 vaccination. This is the clinical trial that I was being evaluated for in October when my PE was discovered. Another is a Phase II study of cabozantinib, a new chemical entity that inhibits multiple receptor tyrosine kinases with growth-promoting and angiogenic properties. The primary targets of cabozantinib are MET, VEGFR2, and RET. Dr. Apolo is the principal investigator of this trial, so I think she has a bias towards having me participate in it.
In addition, there are also clinical trials outside of NIH that I could consider. The most compelling choice is a Hoffman-Laroche sponsored study of MPDL3280a. I've previously blogged about this drug; initial results have shown great promise, helping slow or stop tumor growth in 50% of patients. The drug was designated a "breakthrough therapy" by the FDA last summer. I'll be meeting with Dr. Apolo on Tuesday after my cytoscopy, and will be questioning her in detail about my clinical trial options.
Friday, January 9, 2015
Mets Day 1002: Another day at NIH
Yesterday I spent about 5 hours at NIH. Traffic was light on the drive over, perhaps because school had been canceled due to the bone-numbing cold and -20 degree wind chill. I started with the typical blood draws and urine sample, then had and EKG and met with the anesthesia team, who wanted to assure themselves that all would be well for my surgery on the 20th.
I then had to wait for nearly two hours before I was called for the CT scans of my neck, chest, pelvis, and a separate scan of my urothelium and kidneys. The tech wrapped me in a warm blanket and I almost fell asleep as I passed back an forth through the spinning magnets. I felt the familiar warmth of the contrast as it was injected through my port, spreading though my body in about five heartbeats, and eventually settling in my neobladder. The tech reminded me to drink lots of fluids to flush the contrast from my system.
I didn't have a clinic appointment after the scans, so I did not find out the results. Hopefully, I'll learn that my pulmonary embolisms are no longer detectable; that I have no evidence of clotting in my main hepatic portal or any other veins; that there is no evidence the blood in my urine is due to cancer in my kidneys; that the tumors in the lymphatic nodes under my left clavicle have not increased in size; and that my liver, lungs and bones show no evidence of metastatic cancer. Realistically, I understand that there is a very high likelihood that at some point one of these scans will detect that my cancer is spreading. But I'll cross that bridge when I come to it.
A few days ago, ESPN commentator Stuart Scott died at age 49 from his seven-year battle with cancer. I had read a few articles about his approach, which in many ways was the opposite of mine. He did not want to know any of the details of his diagnosis, staging, treatment, or prognosis. I want to know all of that information. He did not want to stop working, and at times went from chemotherapy to the ESPN set. I tried that early in my treatment, but soon realized that I spending time with family was far more important than spending time at the office. Last July I watched Scott's ESPYS speech and understood his heartfelt sentiment: “When you die it does not mean that you lose to cancer. You beat cancer by how you live, why you live, and in the manner in which you live.”
I am constantly aware that the days of my mortality are limited. I am grateful for each day that I have. Each night, I give thanks to God that my life has been extended another day, and that I have had another day with my loved ones. I try to live each day showing my gratitude, not sweating the small stuff, and finding joy and rejoicing in my posterity.
I then had to wait for nearly two hours before I was called for the CT scans of my neck, chest, pelvis, and a separate scan of my urothelium and kidneys. The tech wrapped me in a warm blanket and I almost fell asleep as I passed back an forth through the spinning magnets. I felt the familiar warmth of the contrast as it was injected through my port, spreading though my body in about five heartbeats, and eventually settling in my neobladder. The tech reminded me to drink lots of fluids to flush the contrast from my system.
I didn't have a clinic appointment after the scans, so I did not find out the results. Hopefully, I'll learn that my pulmonary embolisms are no longer detectable; that I have no evidence of clotting in my main hepatic portal or any other veins; that there is no evidence the blood in my urine is due to cancer in my kidneys; that the tumors in the lymphatic nodes under my left clavicle have not increased in size; and that my liver, lungs and bones show no evidence of metastatic cancer. Realistically, I understand that there is a very high likelihood that at some point one of these scans will detect that my cancer is spreading. But I'll cross that bridge when I come to it.
A few days ago, ESPN commentator Stuart Scott died at age 49 from his seven-year battle with cancer. I had read a few articles about his approach, which in many ways was the opposite of mine. He did not want to know any of the details of his diagnosis, staging, treatment, or prognosis. I want to know all of that information. He did not want to stop working, and at times went from chemotherapy to the ESPN set. I tried that early in my treatment, but soon realized that I spending time with family was far more important than spending time at the office. Last July I watched Scott's ESPYS speech and understood his heartfelt sentiment: “When you die it does not mean that you lose to cancer. You beat cancer by how you live, why you live, and in the manner in which you live.”
I am constantly aware that the days of my mortality are limited. I am grateful for each day that I have. Each night, I give thanks to God that my life has been extended another day, and that I have had another day with my loved ones. I try to live each day showing my gratitude, not sweating the small stuff, and finding joy and rejoicing in my posterity.
Thursday, January 1, 2015
Mets Day 993: New NIH schedule
Yesterday afternoon I received an email from Dr. Agarwal's patient care coordinator with a revised schedule for my NIH appointments. Instead of going in next Monday, I will go in on Thursday, January 8, for blood work, the CT urogram, and the regular CT scan that had been scheduled for January 20. I'll also have an EKG and meet with the anesthesiologist to prep for the cystography that will take place on the 20th.
The NIH coordinator also noted that I should seek confirmation from Dr. Aragon-Ching to discontinue taking Xarelto on January 10, 10 days before the surgery. I forwarded that request to her, and she responded:
Happy new year!
The NIH coordinator also noted that I should seek confirmation from Dr. Aragon-Ching to discontinue taking Xarelto on January 10, 10 days before the surgery. I forwarded that request to her, and she responded:
I often advise to only stop Xarelto for about 2-3 days prior to a procedure. While a longer interval may be desired for a higher bleeding risk procedure, the concern for thrombosis (new clots) that develops in patients with cancer undergoing surgery is equally a concern as well. If this is possible and would not unduly compromise Dr. Agarwal's ability to properly (and safely) evaluate you, then it's preferable. If not, then go with the plans as outlined (I'm cc'ing Dr. Agarwal here as well). Xarelto can also be resumed postoperatively when hemostasis has been achieved, perhaps 24 - 48 hours after (depending on how the bleeding was peri-operatively and your ability to take in pills orally), at the same dose of 20 mg thereafter daily. Intravenous heparin would be an alternative if oral administration becomes a problem for whatever reason.It's an interesting tension, between stopping the drug to avoid bleeding problems, and continuing the drug to reduce the risk of pulmonary embolisms.
Happy new year!
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