Mets Day 1034 I’m becoming a member of the nivolumab trial

Mets Day 1034 I'm becoming a member of the nivolumab trial

Image source:

For the past two weeks I have been doing an entire lot of follow-up research on the most efficient clinical trial for me. On Friday, January 30, I met with Dr. Alex Spira at Inova Fairfax. I had previously spoken with his clinical trial nurse, which evolved into a considerable sort of email exchanges. Eventually she realized that the technical and distinctive nature of my questions put me outside the area of most patients, and she forwarded my emails to Dr. Spira for direct reaction. He told me that the MPDL-3280a trial he was running was closed to patients like me who had previous platinum-primarily founded chemotherapy. He nonetheless provided to satisfy with me and evaluate other clinical trial probabilities. When we met, he reviewed my clinical trial probabilities, and recommended that I pursue the nivolumab trial at Hopkins. He said that a PD-1 or PD-L1 drug was most likely the most promising option at this aspect. He additionally provided to maintain following me and be handy if I had additional questions, which I appreciated.
On Monday, February 2, I came all through a up to this point article in Lancet Oncology said that MPDL3280a worked most efficient in patients with PD-L1-positive tumor-infiltrating immune cells. I additionally did a piece analysis on Foundation Medicine, and their cancer genome testing program. I sent emails to Drs. Apolo and Aragon-Ching, asking no matter if my tumor tested had been tested for that characteristic, and if that could be so, no matter if it is going to influence the trial I must join. Dr. Apolo responded that, when NIH did the sequencing of my cancer, they didn't test no matter if my immune cells have been PD-L1-positive. In a later conversation, she explained that there was an entire lot of debate in the cancer research community over how to measure for PD-L1-positive qualities: was it 1% of all cells, or 5% of all cells, or more? In addition, she said that researchers have been learning that PD-L1 expression was not an immutable static trait, but may possibly vary over time, and was not permanently understood. She urged me to go forward with a PD-1 or PD-L1 trial without reference to no matter if my tumor had been tested for that characteristic, because it was one of the trials that showed brilliant promise.

(What is the difference among PD-1 and PD-L1? "PD" stands for Programmed Death. As I know it, PD-1 is an inhibitory T-cell co-receptor – a type of protein – that negatively regulates T cell responses. PD-L1 is a ligand of the PD-1 protein that could be expressed on the tumor. The theory is that interactions among PD-1 and the PD-L1 ligand can lead to antitumor immune suppression. The PD immunotherapy drugs in improvement are designed to interact PD-1 on effector T cells, allowing T cells to fight cancer. Scientists are nonetheless making an attempt to determine which kind of tumors respond most efficient to PD drugs, as nicely as knowing the correct dosages without causing unacceptable facet effortlessly on the patient. That's what these trials are for.)

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions among PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in improvement are designed to interrupt those interactions, allowing T cells to fight cancer. – See more at:

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions among PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in improvement are designed to interrupt those interactions, allowing T cells to fight cancer. – See more at:
PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions among PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in improvement are designed to interrupt those interactions, allowing T cells to fight cancer. – See more at:
PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions among PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in improvement are designed to interrupt those interactions, allowing T cells to fight cancer. – See more at: Anyway, Dr. Aragon-Ching responded to my email of last week asserting that Dr. Spira had told her that he was going to request that my tumor samples be sent to Foundation Medicine for testing, and that I must learn with him. I did not recall discussing that with him on Friday, so I emailed him to find out. He responded in minutes, asserting that even sooner than we met, he had requested that my tissue on file at NIH be sent to Foundation Medicine. He said it would possibly take a considerable sort of weeks to get results. I thanked him for his proactivity.
On Tuesday, February 3, the clinical trial nurse from Johns Hopkins called me to deploy an appointment together with her and the doctors participating in the trial. She invited me to satisfy together with her on Thursday to review the trial forms and solution my questions. We spent more than an hour talking concerning the trial. She confirmed that I met the clinical trial eligibility guidelines. She additionally said that the Phase I nivolumab-only cohort was closed, but that the Phase II trial was open. There are two cohorts in the Phase II trial; the first cohort gets 3 mg nivolumab and 1 mg ipilimumab every 3 weeks for four rounds, then 3 mg nivolumab only every other week thereafter. The 2nd cohort gets 1 mg nivolumab and three mg ipilimumab every 3 weeks for four rounds, then 3 mg nivolumab only every other week thereafter. In either cohort, I'd get the nivolumab drug. Patients are randomized into every one cohort, and they know which cohort they are in. She thought that I would possibly deserve to wait for the Foundation Medicine DNA test results sooner than making the final decision to go into her trial (or any other trial, for that be counted). She is tentatively holding an neighborhood for me. I have a gathering scheduled with Dr. Noah Hahn next Tuesday. Should I enroll the nivolumab trial, he would coordinate my care with Dr. Dung Le, the primary investigator.

I sent Drs. Apolo and Aragon-Ching summaries of this news, and asked no matter if the different dosages of ipilimumab would possibly put me at more desirable risk of facet effortlessly, for the reason that I had two prior rounds of cheno. They both responded that the risks need to be manageable, fantastically in moderate of my overall absence of co-morbidities and low tumor burden. Both endorsed the concept I participate in that trial.

Last Friday, Memorial Sloan Kettering called to schedule an appointment for their nivolumab trial. I told the scheduler that I was already deep into discussions with Hopkins about an equal trial. Keep us in mind in the fate, they said.

Last weekend, I did more research on nivolumab. According to the NCI drug dictionary, nivolumab is

A permanently human monoclonal antibody directed against the horrific immunoregulatory human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1/PCD-1) with immunopotentiation exercise. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands PD-L1 and PD-L2, resulting in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and effector operate thru the suppression of P13k/Akt pathway activation.
I learned that, in December 2104, the FDA gave approval to Bristol-Myers Squibb (BMS) for nivolumab for treatment of unresectable or metastatic melanoma. BMS's manufacturer name for nivolumab is Opdivo. The FDA press release observed that

Opdivo works by inhibiting the PD-1 protein on cells, which blocks the bodys immune gadget from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.
BMS's January 27, 2015 release of its fourth quarter and full year 2014 results trumpeted its successes with Opdivo. BMS it appears that could be spending more than $one hundred million in different Opdivo clinical trials. Some biotech stock analysts think that Opdivo is going to be a blockbuster drug for BMS, with 2020 sales projected to be more than $7 billion. Big pharma indeed.
Today I went back up to Hopkins and met with Dr. Noah Hahn, head of Hopkins' urologic oncology group. He joined JHU last April from Indiana University, and seems to be an additional brilliant advisor. Assuming I enroll into the trial, he would be for my section following my case. He seemed excited to work with a younger patient with few co-morbidities and low tumor burden — he said that most of his patients have been in their mid-70s or older and that many have been battling other complications besides cancer. I had the required screening CT scan, EKG, and blood work. I additionally met again with the clinical trial nurse, who told me that she would put up my application to enroll in the trial. She said that she expected me to be commonplace by BMS with no disorders. She would then be advised by BMS into which cohort I had been randomized. She said that she may possibly work with me on scheduling my visits, as I am alleged to be in Utah early next month for a granddaughter visit, then in late March to Florida to visit my individuals.

I feel good about this trial. As a result of my research, I have four nicely-respected oncologists endorsing my decision. I realize that the odds are low that I will have a complete reaction (e.g., all tumors shrinking to below pathological level). The odds are somewhat more desirable that I will have a partial reaction (e.g., more than 20% tumor shrinkage, but not a complete reaction), or steady disease (e.g., less than 20% shrinkage or growth). But there additionally is a 50% or more chance that my tumors won't respond, and keep growing. There is not satisfactory information about nivolumab to show long-term results, and no one is expecting it to be a "cure" (e.g., complete reaction and no subsequent tumor improvement for 5 years). But this trial seems to be the right remedy on the right time.

Mets Day 1021 Notes on clinical trial characteristics

Mets Day 1021 Notes on clinical trial characteristics

Image source:

For the past several days I have been further studying my clinical trial alternate functions. I have boiled all of it the manner down to 3 choices:

1. Dr. Dawson's MPDL3280a trial at Georgetown; or
2. The nivolumab trial at either Hopkins or Memorial Sloan-Kettering in NYC; or
three. 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 provide me yet yet one more update. She mentioned that she has been in contact with the 2 MSKCC and Hopkins about their nivolumab trials. She learned that Hopkins had now now not been accepting patients with mets bladder cancer for his or her trial. She asked that they make an exception for me, which they apparently are desirous about. She had larger luck with MSKCC; they have only several slots left in their trial, but they mentioned they would hold a slot for me. Dr. Apolo counseled that I take a shuttle to NYC to speak with either Dr. Rosenberg or Dr. Bajorin about my alternate functions, since she respected the 2 of them and knew that settling on a neater treatment became a subjective decision. I have the wheels in motion to get that scheduled; MSKCC calls for my NIH historical past previously putting in place the appointment.

Today Dr. Aragon-Ching called me to speak about my choices. She mentioned that, if I became going to obtained an immunotherapy drug, now became achievable the amazing time to get it, even as my tumor burden became 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 blended that drug with ipilimumab. She explained that ipilimumab (marketed now not up to the identify of Yervoy) is is a monoclonal antibody that works to activate the immune gadget simply by targeting a protein receptor called CTLA-four that downregulates the immune gadget. Cytotoxic T lymphocytes (CTLs) can identify and destroy cancer cells, but the body in the leading inhibits the CTL mechanizem. Ipilimumab turns off this inhibitory mechanism and allows CTLs to to destroy cancer cells. But it also has a huge number of significant aspect outcomes. It has a closer number of toxicities than nivolumab or other PD-L1 immunotherapies. She mentioned that I deserve to be conscious about the imaginable auto-immune difficulties that the blended ipi/nivo can intent. Yikes.
Dr. Apolo and Dr. Aragon-Ching also tried to reassure me about the aspect outcomes to cabozantinib. They the 2 mentioned that most patients found out the aspect outcomes to be minimum, and tolerable.

Yesterday I also exchanged emails with Dr. Spira at Inova Fairfax. He established that his MPDL3280a trial became now now not open to me, since I became now now not chemo naive. But he invited me to keep tomorrow's appointment so we may smartly probably discuss other imaginable clinical trials. I figure that getting opinions of a professional medical pros is achievable an honest thing, so I'll meet with Dr. Spira tomorrow.

Currently, I'm leaning towards doing a PD-L1 trial. My first preference stands out as the MPDL3280a trial at Georgetown, but there may be 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 achievable withdraw. My backup plan is to sign on in the nivolumab trial, hopefully at Hopkins (since or now now not it's much closer), but if now now 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 now not up to my clavicle is tough to manipulate, but there are several other nodes on the left aspect of my neck that I can feel. Fortunately, I am now now not in any soreness, but I am aware that the clock is ticking.

Mets Day 1019 Georgetown’s scientific trial

Mets Day 1019 Georgetown's scientific trial

Image source:

Today I met with Dr. Nancy A. Dawson at Georgetown University Hospital to talk about the MPDL3280a trial. She explained that the best trial that she had open was the Phase III trial that compared patients who obtained 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 earlier obtained chemotherapy (the so-from time to time known as "cohort 2" of the trial). The reason why that Phase II trial showed on 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 obtained chemotherapy. She added that she was not responsive to any currently open clinical trials that ensured that each one patients would acquire the MPDL3280a drug.
Dr. Dawson also spent a while dialing back my expectations for the MPDL3280a drug. While she mentioned that the preliminary outcomes that were reported at the 2014 ASCO meeting showing a 50% response cost were very promising, she said that those facts didn't in construction her own individual competencies, 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 entire response, and two had a partial response. The tumors of the other 10 patients continued to grow non-beat back. She said that other doctors had also told her that they were seeing a 20% response cost. Based upon that, she said that she would not be amazed if the Phase III trial showed that the response cost for MPDL3280a was about similar to for the taxene-based chemo.

We also discussed how the randomization would work if I was to join the Phase III trial. She said that, as soon as she qualified that I met the criteria, Hoffman-La Roche would enter my files, would conduct the computer-based randomization, and we would be told of the results. She genuinely beneficial me to be able to move because of with the trial regardless of the results — she didn't want me (or other patients) to keep for clinical trials, throwing in the towel if I don't get into the arm that I sought after. I recognize that from the perspective of the objective of the clinical trial, but from my own egocentric viewpoint, I'd as an selection get the anti-PL-L1 drug than the taxene.

Dr. Dawson asked even if I had taken into consideration Dr. Apolo's provide cabozanatinib clinical trial. I told her that Dr. Apolo and I had discussed it, and that the preliminary outcomes didn't appear to be as compelling as those for MPDL3280a, and the unwanted side effects were heaps more critical.

We discussed other clinical trials involving anti-PD-L1 drugs that were also manageable to me. She said that a host of businesses were studying those drugs: Merck has pembrolizumab (MK-3475) that may be in a Phase III trial for metastatic bladder cancer (No. NCT02256436). Bristol-Myers Squibb has nivolumab (BMS-936558) that may be in a Phase half of 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 may be not very yet open. CureTech is engaged on pidilizumab, which is being studied for lymphoma and myeloma, but is not very in any clinical trials for metastatic bladder cancer.

Dr. Dawson said that she would email Dr. Rosen and MSKCC to decide even if he was actually running a trial on the subject material of 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 even if to get the taxene chemo, or stall while I study either the Merck or Bristol-Myers trials on the subject material of PD-L1.

In essentially unrelated news, this afternoon I obtained an email from Dr. Agarwal's nurse, reporting on the result of the samples he took from my neobladder during the cystoscopy:

Good news, the pathology from your recent procedure looked quality no signal of tumor. Likewise, Dr. Agarwal didn't see any strictures, lesions, or any other obvious source of the bleeding youve been experiencing.If youd like to additional speak about the results with Dr. Agarwal or myself, basically let us know! Good news there, as a minimum.

Mets Day 1014 Wheels in motion for the MPDL3280a trial

Mets Day 1014

Image source:

This morning I spent an honest deal of time lining matters up for the MPDL3280a medical trial. Last night I had sent an email to Dr. Aragon-Ching summarizing the day's eventualities, asking for her clearance to restart the Xarelto, and trying her input on which medical trial I must enter. She called me this morning and we had an honest discussion about my trade tools. Regarding medical trials, she said that she noticed three trade tools for me: Dr. Apolo's cabozantinib trial, the immunotherapy trial with MPDL3280a, or one other regimen of chemotherapy. She then recommended holding off on the chemo until I genuinely obligatory it, i.e., when i had an awful lot of tumors in my organs. She talked about that there have been some trials combining platinum-basically depending chemo regimes with taxenes, which is whatever we formerly had discussed in 2012 and 2013. Apparently the research remains going on taxenes. For now, she agreed that I must look into the MPDL3280a immunotherapy medical trial. She provided to contact Dr. Dawson at Georgetown on my behalf. She also endorsed my resuming the Xarelto.
While I became conversing to Dr. Aragon-Ching on my land line, Dr. Dawson's research nurse called my mobile phone. Dr. Dawson apparently had been emailed with the aid of Dr. Apolo, and asked her nurse to follow up post haste. I returned her name, and acquired the wheels turning for seting up an appointment with Dr. Dawson. The nurse emailed me Georgetown's 11 page new patient form, which I done and returned. I also filled out the NIH records request form, asking that they in a single day all of my records to Dr. Dawson, and NIH proven that it's going to achieve that. Once Dr. Dawson's nurse receives them, she'll time table an appointment, broadly a long-term next week. It's great when matters fall into subject quickly. I am grateful to my doctors for having a look out for me and performing quickly to make bigger my group when related.

Faithful blog readers would possibly well also recall that I have been following news about PD-L1 research for a long-term. Back in September 2013, when i became considering whether to do dose dense MVAC, my oncologist at Fox Chase Cancer Center entreated that I research the emerging trials involving PD-L1. In May of 2014, I had a chat with Dr. Aragon-Ching about emerging therapies, and she said that the most promising research became with regard to immunotherapy and the PD-1 and PD-L1 inhibitors. In Spetember of last 12 months, she gave me a gaggle of slides from a presentation she had just given concerning the PD-L1 medical trial that I am now investigating, and instructed me at that time that, once my nodes have been sufficiently immense, she thought that became broadly the most efficient option for me. Now that I'm at that facet, it quite feels that is the most affordable option.

I also reviewed a bunch of of the posts concerning patients real experiences with the MPDL3280a trial on BCAN's forum at The reviews mirror the initial results – some patients credits the drug with stopping their metastatic ailment; for others, it didn't work. But the small print indicate that about 50% of patients with metastatic ailment see at least some slowing of the ailment. Until there would possibly be a cure (and we are a long method from that facet), slowing the ailment down is the most efficient I can wish for.

Mets day 1013 Cytoscopy and medical trial selections

Mets day 1013 Cytoscopy and medical trial selections

Image source:

Today was once a long day at NIH. The nurses at NIH repeatedly had insisted that I needed to have man or girl accompany me, nevertheless in these days was once the first day of lessons at George Mason University, which meant that either Jennifer (for her MSW lessons) and Spencer (for his biology undergrad degree) were otherwise booked. Fortunately, Kirsten was once handy, having come domicile from CNU.
We arrived at 7:30 am to practice for my cytoscopy by Dr. Agarwal. We ended up waiting for more than two hours earlier than I was once called into the preop. The anesthesiologist twice tried to access my port, nevertheless couldn't get a return of blood flow from my port, so I ended up getting an IV on the again of my hand – my least favourite location, since it invariably leaves a nice bruise and is tender for in line with week or so. Dr. Agarwal explained how he intended to completely check my neobladder and ureters for possible reasons for my bloody urine. The anesthesiologist gave me a sedative, and within 10 seconds I was once out.

About ninety minutes later, I came to in the recovery room. Kirsten was once sitting next to me with a a bemused expression. Dr. Agarwal was once additionally there, patiently answering my questions. Kirsten later told me that I had been asking a similar inquiries to him, the anesthesiologist, and the nurses: would they get my daughter who was once in the waiting room (Kirsten has been sitting beside me for a long time, nevertheless that fact had not registered with me); I was once just exotic driving domicile (certain you are, Mr. Brothers); and tell me again about the contrast media that you only used. For what it's really worth, I have no recollection of asking those questions, and absolutely don't recall the answers.

Once I stopped repeating my questions, they found that I finally had emerged from the anesthesia. Dr. Agarwal said that every unmarried thing seemed exotic in the neobladder and ureters – there was once no facts of any cancer, or anything bad. There was once one house in my neobladder that seemed just a little irritated and raw, nonetheless it was once not anything to worry about. Kirsten showed me the images of my neobladder that Dr. Agarwal took – they appeared like two photographs of Mars. Good news, then.

After I dressed, I went to get lab work earlier of my clinic appointment with Dr. Apolo. Even though the surgical procedure nurse had left in the IV in my right hand, the phlebotomist declined to apply it for my blood draw, as an alternative gaining access to my left arm. Something about not wanting any heparin in the blood samples. A minor irritant, nevertheless still. I was once additionally directed to supply a urine sample, nevertheless since I had not had anything to drink for 15 hours, and since my neoladder had been totally filled, them emptied, all of the process through the cystoscopy, once i tried to void, all that came out were drops of blood. That was once not a comforting sight.

The phlebotomist told me to get a lot to drink and supply a sample once i may. Kirsten and I walked down to the NIH cafeteria, the place I sucked down about three liters of Diet Coke. After that, producing a sample was once judicious-peasy, in spite of the fact that it was once still a chew bloody. (The fellow who did my screening earlier than I met with Dr. Apolo commented on how the urinalysis showed loads of blood, so she correctly guessed that I had provided it after the cystoscopy.)

We ended up waiting ninety minutes past the appointment time from Dr. Apolo. She apologized for working late; it was once contemplating that yesterday was once 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 whole short axis size of 2.four cm. Dr. Apolo had told me over the telephone on January 12 that she and the radiologist had tried to distinguish the original nodes from every unmarried and every unmarried varied, nonetheless it turned into a guessing game without a valuable objective. So I have blasted process past the 1.5 cm threshold for clinical trials.

We then discussed in element Dr. Apolo's current clinical trial of cabozantinib for evolved 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 once to participate on this trial, I likely would must have an alternative needle biopsy. I'd additionally likely have to stop taking Xarelto, and go again on one of the injectable blood thinners, comparable to 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 again onto Xarelto.

We discussed the abilties side effects; just highly among the more unusual of the drug on this trial (called XL184) consist of dermis sloughing off the feet and palms; as a result, she said that patients aren't immerse their feet in hot water (including hot tubs), and that showers would most probably be lukewarm and short. The XL184 drug additionally in general causes fatigue in about 80% of patients, loss of appetite (about 50%) and trade of flavor (about 30%). There were a long list of varied, less consistent, side effects. Oh, and XL184 additionally tended to turn hair white.

I requested Dr. Apolo to evaluate the cabozantinib trial to the immunotherapy trials for MPDL-3280a. To her firstclass credit, Dr. Apolo didn't marketing campaign for her trial. She as an alternative said that it was once likely that I would do either trials, and that she had no data on which one I must do first. There simply is no side-by-side data to validly evaluate them to every unmarried and every unmarried varied. She proposed that she contact Dr. Nancy Dawson, one of the lead researchers at Georgetown for the MPDL3280a trial, so I may study that choice. (The same trial additionally is being offered at Fairfax Hospital, which is about a similar distance from me.)

For now, I haven't got to make an immediate decision. I'm going to consult with Dr. Aragon-Ching and get her input, and additionally will meet with one or more of the doctors working the MPDL3280a trial. Because of all of the side effects of the cabozantinib, I am leaning a ways from doing that one. But it's nice to have offerings.

Mets Day 1007 Nothing surprising from handiest week’s scans

Mets Day 1007

Image source:

Dr. Apolo and I had been trading calls since last Friday. Today she have been given hold of me to stream along the highlights from last week's scans. It's the vintage unparalleled news/bad news which is steady with the story line for the past six months:

The size of the metastatic lymph nodes under my left clavicle have continued to slowly boost in size. They have now passed the threshold of 1.5 cm inside the fast axis, which signifies that I now am eligible to take part in NIH's clinical trials. More on that later.
The scans showed that there have been a host of a little bit enlarged nodes in my abdomen. Those nodes aren't pathologically significant, which signifies that they are under 1.0 cm in size. Those nodes have been also widespread inside the last couple of scans. We don't now if they are turning out to be because of metastatic online game or a host of other reason, since they failed to categorical up as "hot" in my last PET scan in September 2014. But it is pretty more likely than now not that the boom is associated to metastatic online game.
There became 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 important hepatic portal have been thoroughly resolved.

There is nothing unusual from these outcomes. I've familiar since September that my superclavicular nodes have metastatic online game. Each scan since then has shown a slow boost in size, of roughly 1 mm per month. In November 2014, the node became measured to be 1.forty two cm on the fast axis. Now it is pretty over 1.5 cm. No wonder there. The unparalleled news is the absence of tumors in assorted places, at the side of ruling out that the refreshing blood in my urine became due to the kidney cancer.
Dr. Apolo pointed out that, now that my nodes have been of ok size to go into clinical trials, we may though talk about whether I may though 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 became being evaluated for in October when my PE became found. Another is a Phase II study of cabozantinib, a new chemical entity that inhibits multiple receptor tyrosine kinases with boom-promoting and angiogenic properties. The functional goals of cabozantinib are MET, VEGFR2, and RET. Dr. Apolo is the principal investigator of this trial, so I think she has a bias toward having me participate in it.

In addition, there are also clinical trials exterior of NIH that I could talk about. The highest compelling option is a Hoffman-Laroche sponsored study of MPDL3280a. I've previously blogged roughly this drug; initial outcomes have shown nice promise, supporting slow or cease tumor boom in 50% of patients. The drug became designated a "breakthrough treatment" by the FDA last summer. I'll be meeting with Dr. Apolo on Tuesday after my cytoscopy, and may be questioning her in detail roughly my clinical trial percentages.

Mets Day 1002 Another day at NIH

Mets Day 1002 Another day at NIH

Image source:

Yesterday I spent approximately 5 hours at NIH. Traffic was easy on the drive over, most in all likelihood given that school had been canceled because of the bone-numbing bloodless and -20 degree wind chill. I started with the original blood draws and urine sample, then had and EKG and met with the anesthesia team, who wanted to assure themselves that each one ought to be smartly for my surgical procedure on the twentieth.
I then had to wait for nearly two hours earlier than 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 virtually 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 approximately 5 heartbeats, and eventually settling in my neobladder. The tech reminded me to drink such a lot of fluids to flush the contrast from my system.

I didn't have a clinic appointment after the scans, so I failed to find out out the results. Hopefully, I'll be informed that my pulmonary embolisms are not any longer detectable; that I have no evidence of clotting in my main hepatic portal or each 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 below my left clavicle haven't increased in size; and that my liver, lungs and bones exhibit no evidence of metastatic cancer. Realistically, I keep in mind that there is an extraordinarily high likelihood that at some portion 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 combat with cancer. I had read plenty of articles approximately his approach, which in some ways was the other of mine. He failed to want to know any of the details of his analysis, staging, treatment, or prognosis. I want to know all of that guidance. He failed to want to stop working, and now and again went from chemotherapy to the ESPN set. I attempted that early in my treatment, but soon realized that I spending time with circle of relatives was much extra very important than spending time at the office. Last July I watched Scott's ESPYS speech and understood his heartfelt sentiment: When you die it doesn't mean that you lose to cancer. You beat cancer by how you live, why you live, and in the demeanour in which you live.

I am forever conscious that the days of my mortality are limited. I am thankful for each day that I have. Each night, I give thanks to God that my life has been extended a additional day, and that I have had a additional day with my family. I are attempting to live each day showing my gratitude, not sweating the small stuff, and finding joy and rejoicing in my posterity.

Mets Day 993 New NIH schedule

Mets Day 993 New NIH schedule

Image source:×993.png

Yesterday afternoon I gained 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 eight, for blood work, the CT urogram, and the fixed CT scan that had been scheduled for January 20. I'll moreover have an EKG and meet with the anesthesiologist to prep for the cystography that will take region on the twentieth.
The NIH coordinator moreover noted that I  look for affirmation from Dr. Aragon-Ching to discontinue taking Xarelto on January 10, 10 days earlier than the surgery. I forwarded that request to her, and he or she responded:

I most often suggest to easiest give up Xarelto for roughly 2-3 days in advance of a system. While a longer interval  be needed for a much more desirable bleeding possibility system, the priority for thrombosis (new clots) that develops in patients with cancer undergoing surgery is equally a priority as correctly. If this can be potential and wouldn't unduly compromise Dr. Agarwal's capability to competently (and safely) compare you, then it absolutely is preferable. If not, then go with the plans as outlined (I'm cc'ing Dr. Agarwal here as correctly). Xarelto moreover might even be resumed postoperatively when hemostasis has been carried out, perhaps 24 – forty eight hours after (depending on how the bleeding turned into peri-operatively and your capability to take up pills orally), at an analogous dose of 20 mg thereafter each and on a daily basis. Intravenous heparin would be an alternative if oral administration becomes a hardship for  reason.
It's a sexy tension, between stopping the drug to avoid bleeding problems, and persevering with the drug to lessen the chance of pulmonary embolisms.
Happy new yr!

Mets Day 991 Welcome to NIH’s Urology Department

Mets Day 991 Welcome to NIH's Urology Department

Image source:

Today I met with Dr. Piyush Agarwal, NIH's chief urologist, and his nurse practitioner, Rebecca Dolan. THis became my first contact with NIH's urology department. It is an competent and well-oiled workforce. I reviewed my case history with Ms. Dolan, who closely questioned my on when i started and stopped each blood thinner, and when my bleeding began. I had to refer again to my prior cyber internet publication entries to be positive a few of the dates. I also pointed out an odd little rash that lately had shaped on my knees. I told her that I hadn't reworked any soaps or lotions or detergents, and that the I noticed the rash a few weeks after I started taking the Xeralto. She allowed as that it became an opportunity that both might also moderately well be linked, despite doubted it. Keep an eye on it, she mentioned. She became way more emphatic that there has been a comparatively clear purpose and effect amongst my taking the Xeralto and the gross hematuria.
When Dr. Agarwal joined us, he mentioned that there has been comparatively little enjoy with Xarelto, metastatic cancer, and neobladders. Although he suspected that my gross hematuria became the likely end result of the Xeralto loosening some tissue in my neobladder, he mentioned that he desired to rule out the prospect that my metastatic cancer had emerged in either my kidneys, ureters, or in different places in my urothelium. So next Monday I'll have a CT urogram to have a look at and (really) rule that out. He also scheduled me for a cystogram for January 20. I'll be underneath commonplace anesthesia for that, so in case he sees something that must be cauterized, he can contend with it. He'll do that the very first thing in the morning. I became ahead of scheduled to have a CT that morning followed by a clinic visit with Dr. Apolo; we're going to see if we will put off that by a couple of hours so I can walk myself to the CT scanner.

Dr. Agarwal advisable that I resume taking the Xeralto, although I may want to cease it two days ahead of coming in for the cystography. He mentioned that having gross hematuria became better than having pulmonary embolisms. He mentioned that it became a shame that I became allergic to the low molecular weight heparins, and mused that, if I became unable to continue on the Xeralto, I might well need to acquire as factual with anIVC filter. I'm not excited approximately that theory. It's an update to acquire as factual with later, and only if I need to.

Mets Day 987 Merry Bloody Christmas

Mets Day 987 Merry Bloody Christmas

Image source:

A couple of days in the beyond Dr. Aragon-Ching advocated that I restart the Xarelto, which I did on Christmas Eve. Sure sufficient, on Christmas Day, I had blood in my urine. We've commonly founded set off and result. So it was a red Christmas in the end.
I have an appointment at NIH's leader urologist subsequent Tuesday afternoon. I assume that he will do an cystoscopy and verify the state of affairs of my neobladder. I am to circulation my Xarelto dose on Monday and Tuesday. Hopefully he will be in a position to assess the state of affairs of my neobladder, and the style crucial the lesions. It's unlikely that the bleeding is introduced about by melanoma in the neobladder, nonetheless is as an alternative just an facet effects of the Xarelto. I suspect we'll agree with option blood thinners.

Several americans have shared with me their technologies with warfarin. I understand that NIH is simply not partial to using warfarin with patients with metastatic melanoma, as it comprises with it a considerably accelerated range of facet outcomes and headaches (a style of which are summarized on this Medscape article). I'm not explicit what the medical doctors will put forward, so I'll just be patient.