Mets Day 1120 Second scientific trial scan signifies potent results

Mets Day 1120 Second scientific trial scan signifies potent results

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Yesterday I had my moment CT scan as part of the nivolumab clinical trial. This scan took vicinity after I had received six of the experimental infusions, or 12 weeks after I began the trial. The first scan showed that my targeted tumors had reduced in size by 50%. This scan showed that the tumors continued to shrink, although not at the same rate. Here's the key language from the neck scan:

Findings: Although more than likely as a consequence of model in slice selection and patient positioning, there is slight interval decrease in the dimensions of the left level three lymph node as demonstrated on image 569 of series 4, now measuring 1.4 x 0.eight cm (previously 1.5 x 1.1 cm). The left level 4 lymph node previously measuring 1.three x 0.9 cm currently measures 1.three x 0.7 cm. Other smaller lymph nodes are either unchanged or smaller compared to the prior examination in the bilateral neck. There is no new lymphadenopathy. No mass or pathologic fluid collection is identified in the neck.
The scans of the chest and abdomen found no new tumors. The supraclavicular node is now "subcentimeter" in size and is "stable." There is no evidence of pulmonary embolisms, either. So the bottom line is that, in the past six weeks, the two target tumors reduced in size by another 25%. Yay!
The only poor news is that, consistent with the neck scan, I am 82 years historical (the abdomen and chest scan had my age correctly noted). I emailed the clinical trial nurse and mentioned that she'd have to report accelerated neck aging as one of the side consequences of the study. Her response: "I love your attitude and experience of humor."

I'll go in next week for my seventh infusion, and can communicate with Dr. Hahn concerning the durability of the nivolumab therapy. As far as I can tell, there is no publicly released data regarding the durability of nivolumab on metastatic bladder cancer patients. Nivolumab was first examined on metastatic melanoma. A March 2014 report found that the effects were durable for two or more years, and that some patients had ongoing beneficial consequences even after stopping therapy. A September 2014 report on the use of nivolumab on metastatic renal cell carcinoma also found durable results, with the ultimate results going to folks who stayed on the drug. A November 2014 exercise-up report on metastatic melanoma patients receiving nivolumab showed ongoing durability, with a median exercise-up of fifty five months, which consistent with the report "is the longest exercise-up of an anti-PD-1 agent carried out to date." That report also mentioned that, of the the patients who had an entire response, more than 0.5 were affirming that entire response. And a April 9, 2015 review of immunotherapy trials published by the British Cancer Journal found that

The most extensive clinical experience with PD-1 antibodies has been obtained with both nivolumab and pembrolizumab, which have demonstrated highly durable response rates with proper toxicity in tremendous phase I studies involving patients with advanced melanoma, NSCLC, renal cell carcinoma (RCC) and Hodgkins illness . . . .
None of those reports were true to bladder cancer, nevertheless. Although there are a host of reports noting the incontrovertible reality that nivolumab is being examined on mets bladder cancer patients, I have not been able to locate any data on the durability on my variety of cancer. The ultimate I can do is to extrapolate from the data from other cancers. From what I've been able to gather, here are the conclusions that I am drawing:
1. Nivolumab is a nice immunotherapy agent on my metastatic bladder cancer.
2. I have had an objective response — true, measurable results — as a consequence of the nivolumab.
three. I am persevering with to see tumor shrinkage as a consequence of the nivolmab.
4. This last scan likely has positioned me in the category of a complete response, meaning that my metastatic tumors have reduced in size to under 1 cm in size on the short axis.
5. I still have measurable illness, nevertheless, so I not yet at NED (no evidence of illness).
6. I should continue with the nivolumab as long as possible, since that is what has provided the ultimate results to patients taking nivolumab for other cancers. So that means no trips away from Hopkins for more than two weeks. I can stay with that.

median exercise-up is fifty five months, which represents the longest exercise-up of an anti-PD-1 agent carried out to date, – See more at: http://www.ajmc.com/conferences/SMR2014/Nivolumab-Shows-Durable-Response-in-Heavily-Pre-treated-Patients-with-Advanced-Melanoma#sthash.RLZL9hR2.dpuf
median exercise-up is fifty five months, which represents the longest exercise-up of an anti-PD-1 agent carried out to date, – See more at: http://www.ajmc.com/conferences/SMR2014/Nivolumab-Shows-Durable-Response-in-Heavily-Pre-treated-Patients-with-Advanced-Melanoma#sthash.RLZL9hR2.dpuf
median exercise-up is fifty five months, which represents the longest exercise-up of an anti-PD-1 agent carried out to date, – See more at: http://www.ajmc.com/conferences/SMR2014/Nivolumab-Shows-Durable-Response-in-Heavily-Pre-treated-Patients-with-Advanced-Melanoma#sthash.RLZL9hR2.dpuf

Mets Day 1112 Sixth Opdivo infusion

Mets Day 1112

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Last night I watched the TV coverage of the rioters in Baltimore burning and looting, and carefully studied the map to see if I would be driving through the place similtaneously going to and from Hopkins. My route would cross the troubled place, but I doubted that I would have any problems. I checked once more this morning and saw that there had been some overnight rioting near the Johns Hopkins campus, but things currently were quiet and the hospital was open. Just in case, I pulled my Glock out of my safe, eliminated the trigger lock (it took a transient time to keep in mind the place I had put the important factor), slid in a magazine, and put it below the driver's seat. Nothing's going to stop me from getting my nivolumab. Of course, nothing happened on drive in or out. I passed a looted Seven-Eleven (primarily? Slurpees and churros?), and saw National Guardsmen in rebellion gear with M-16's posted at the doors of the Sidney Kimmel cancer center. Welcome to Charm City.
I didn't ought to wait as long as earlier than, because the day gone by I had my blood drawn at a vicinity lab, and they had despatched the outcomes to Hopkins, enabling the drugstore to mix up my meds in advance. I met with Dr. Hahn and the clinical trial research nurse, who pointed out that there were several cancellations today as other patients decided to stay away. Dr. Hahn palpitated my nodes and said that they felt "mushy" which is more top quality than firm. I guess urologists would know the adaptation amongst both. Dr. Hahn said that our purpose was getting an entire response (CR), observed by no evidence of disease (NED). CR/NED sounds first rate to me.

The infusion was routine – an hour within the chair, three checks of my vitals, and I was on my way domestic. I'll be again subsequent Tuesday for my 2d post-nivolumab CT scan. Hopefully, my tumors will be even smaller than earlier than.

May is bladder cancer awareness month. BCAN's annual fundraiser walk is this Saturday, May 2, on the National Mall. You can donate here. Do now not bring your Glock to the walk.

Mets Day 1098 fifth Opdivo infusion; three year mets milestone

Mets Day 1098

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Today I spent each other amusing-filled day at Johns Hopkins for my 5th nivolumab infusion. The nurse become unable to get a blood return via my port, despite fiddling with it for approximately an hour. She turned me over to a tech for a regular IV. The tech missed on her first stick attempt, then missed on the 2nd. She switched arms and straight away blew my vein on her 0.33 attempt. I suggested that perhaps somebody else try, and she turned me over to a nurse who finally drew blood. Since the lab needed three hours to organize my infusion, I become assured at spending the whole day at Hopkins. Fortunately, my fantastic friend Cynthia came up with me, and we handed the day in conversation.
In the interim, I visited with Dr. Hahn. He said how three new patients had mentioned my weblog regarding the nivolumab clinical trial and wanted in. He become extremely joyful that word become getting out, and become happy with my evangelizing. I should send him a bill for my time.

I asked if he had similarly thoughts on the length of my getting the drug, should I achieve complete recovery (CR). He said that it become not some thing that become spelled out in the clinical trial documents, but rather become a topic to be decided among affected person and doctor. One view become that patients should continue with therapy if it gave the look to be running and doing no harm. But once a affected person has achieved CR, there's no reliable method to degree whether there's ongoing benefit to receiving the therapy. So the opposite view become that, if there become no method to degree whether the therapy become running, it should not be continued.

Since there's almost no data on whether patients with metastatic bladder cancer continue to profit by receiving nivolumab after CR, there's no informed basis to make a choice one method or the opposite. Dr. Hahn suggested that the drug institution might not are seeking to discourage patients from ending using the drug, since (once approved), continuing patients on the drug meant more revenue. But he added that data would accrue with what took place to patients who elected to prevent taking the drug as hostile to those who stayed on it. He added that it would be productive to notice whether the sponsor would enable patients who went off the drug to soar again if their tumors returned. He said he would verify on that. But first, we need to get to CR.

As conventional, the correct infusion become easy. The clinical trial nurse suggested that I can keep away from the long wait if I have my lab work done at a native lab the day before. I'll taker up on that, I suppose.

Meanwhile, the day gone by become the 0.33 year year anniversary that I learned that my cancer had metastasized outside of my bladder. The Kaplan-Meiersurvival curve for metastatic bladder cancer is grim. The NCI publishes measures of cancer survival using its SEER software, and probing it for mets BC data is depressing. Suffice it to say that historic data reveal that, five years after a mets lookup, fewer than 10% of patients are alive. In fact, a 2011 British study came across that fewer that 25% of patients diagnosed with T4 bladder cancer were alive 30 months after lookup. So my hitting the three years mark is reason to celebrate!

More importantly, these data are historic. They do not take into account the progress of immunotherapy treatments such as nivolumab or MPDL3280A. I'm hoping that these new medicine are game-changers, and five years from now we're going to be celebrating a lots higher survival price which, God willing, will include me.

Mets Day 1088 A reluctance to raise my eyes

Mets Day 1088 A reluctance to raise my eyes

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Mets Day 1086 Second supplemental take a look at consequences

Mets Day 1086 Second supplemental take a look at consequences

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This morning Hopkins posted a third interpretation of my scan outcomes. This one concentrated on my supraclavicular nodes — the unique location of my metastatic cancer that turned into first detected in August 2013. Perhaps this report turned into triggered by my query to Dr. Le on Monday about the measurement of that node, which she turned into unable to reply because she couldn't pull up that scan. My January 2015 scan at NIH showed that the nodes within the neighborhood had begun to merge together. The 2/10/15 baseline scan at Hopkins defined this node cluster as a single node: "There is a lymph node lateral to the jugular vein at the level of the clavicular head considered on collection 6 slice seventy four which measures style of two.5 cm in transverse dimension."
Yesterday's report concentrated on that node cluster. The radiologist went back to the 2/10/15 scan and tried to measure equally nodes one after the opposite, and concluded that brief axis measurement of 1 turned into 12 mm, and other other turned into 11 mm. The radiologist then when compared those nodes to my 3/24 scan, and concluded that the 12 mm node had reduced in measurement to 6 mm, and the 11 mm node had reduced in measurement to 8 mm. Good news on Good Friday!

Mets Day 1083 More at the gratifying consequences; fourth Opdivo infusion

Mets Day 1083

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Yesterday I returned to Hopkins for my fourth nivolumab infusion. We moved it to Monday somewhat than my usual Tuesday so I might fly to Florida for spring holiday. Jennifer and Garrett had flown down on Saturday, and Kirsten and I were planning on joining them after my infusion. I found that Mondays at Hopkins' cancer middle was much busier than Tuesdays. My blood was drawn an hour late, which supposed that my labs were an hour late, which supposed that the pharmacy was behind schedule in making ready the custom-made nivolumab dose. All this would have been fine, but I had a aircraft to catch!
While I was waiting, I met with Dr. Dung Thi Le, the principal investigator at Hopkins for this trial. I asked her about the math in the supplemental reading of my CT scan, which showed that the size of two of my focused tumors had decreased from 32 mm to 16 mm. She explained that 32 mm was the sum of the transient axis measurements of those two tumors as shown in the baseline scan on 2/10/15. 16 mm was the sum of the the transient axis measurements of those same two tumors from my 3/24/15 scan.

I knew that Dr. Le did not specialize in bladder cancer — she's a GI oncologist — so I asked if she was surprised at the 50% discount in size of my tumors after just three infusions. Although I was her first bladder cancer patient in this trial, she said that she had received favorable reports from different trial locations in regards to the outcome of nivolumab on metastatic bladder cancer. As a result, she said that she was not surprised by the discount in my tumors, because "we notice it works on bladder cancer." Then she smiled and said that she was still more than happy to look the resultseasily.

She added that the trial had firstly sought about four hundred patients, and more than 800 have enrolled. There has been very high demand for this immunotherapy drug. And in seeing my resultseasily, one can bear in mind why.

Dr. Le pulled up the aspect-by-aspect images of the earlier than and after CT scans of my tumors on the computer screen, and showed how the nodes had reduced in size. Her researchers formerly had intently made the measurements and saved them on the scanned images. I asked about the size of my supraclavicular node — the explicit metastatic site — but she was unable to pull up that photograph. It was reputedly not one amongst my target nodes, so I'm not sure how much that has changed in size.

We mentioned how long I would hinder going on the trial. She said that their goal was for me to have a "complete response" (or CR) on all of my tumors. CR is defined as the tumors shrinking to lower than 10 mm on the transient axis. CR isn't a similar as being "cured" of cancer, on the different hand it — the standard definition of a "cure" is five years with no detectible ailment. If and when I achieve CR, then we will refer to the oncologists how much longer I will stay on the nivolumab. That decision will be impressed by the pointers for the clinical trial. One of the things that Bristol Myers Squibb requirements to find out out is how long the drug works to hinder the metastatic cancer suppressed. There is insufficient statistics on how long nivolumab works on mets BC after CR has been completed, and the trial can last as long as two years, as long as the drug appears to be to be working and the patient is willing.

But we're getting ahead of ourselves. My new goal is to get to CR first. So I made my way over to the infusion area and waited. I was supposed to leap my infusion at 12:30, and my flight from BWI to Florida was at four:20. Infusion takes a minimum of an hour. I was still waiting at 1:30. My nurse said that the nivolumab had still not arrived from the pharmacy. I told my nurse about my flight, and so he were given me organize in a chair and went to bug the pharmacy. Finally, at 2 pm the drug arrived and I was hooked up. I was calculating times in my head – how long to force from Hopkins to the airport, how long to park and get to the terminal, how long security would take, etc. It would be tight.

At 3:02 pm, the infusion was done, and I bolted out of the hospital. Kirsten was waiting in the car, and we took off for the airport. Traffic was light, parking was easy, the shuttle was waiting, no person was in the security line, our flight was at the nearest gate to security, and we arrived just earlier than boarding started. Another religion selling rumor is born.

Mets Day 1078 More CT lookup displays 50% tumor shrinkage

Mets Day 1078 More CT lookup displays 50% tumor shrinkage

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Last night Hopkins posted an alternative analysis of my CT scan. The clinical trial team it appears wished to measure as precisely as viable the sizes of both objective tumors. I'm no longer bound I understand how the maths is executed, alternatively the base line conclusion is that these two tumors have gotten smaller by 50% after three rounds of Opdivo.
Here's the language of the supplemental analysis:
______________________________________

Exam 1: CHZ 8080 – CT SUPPLEMENTAL READ R0 – Mar 24, 2015 thirteen:forty seven

RESULT: This report is dictated with chose measurement of index
lesions as RECIST 1.1. Please see the unique clinical report of the CT
scan of the neck from three/24/2015.

COMPARISON: 2/10/2015.
RECIST 1.1:
Longest unidimensional measurement in mm for non-nodal disease.
Short axis measurements for nodes.

TARGET LESIONS:
TL1: Left degree 5 lymph node measures 9 x 12 mm at slice state of affairs 208
compared to sixteen x 18 mm previously.

TL2: Left degree 4 lymph node measures 7 x 9 mm at slice state of affairs 256
compared to sixteen x 20 mm previously.

NON-TARGET LESIONS:
None

NEW LESIONS:
None.
IMPRESSION: Decrease in SOD from 32 mm at baseline to sixteen mm.
______________________________________

This is gorgeous documents. I am humbled and choked with gratitude. I am grateful to God, and all the ones that proceed to specific faith on my behalf. Thank you.

Mets Day 1077 Awesome CT results

Mets Day 1077 Awesome CT results

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I simply acquired the resultseasily of the previous day's CT scan, and the resultseasily are suitably, suitably first rate. The entire length of the cluster of tumors in my neck and shoulder have decreased by roughly 20% after three infusions of Opdivo. I'm doing slightly blissful dance here. This is the first time this is why my melanoma used to be clinically decided that that any CT scan has detected a decrease in tumor length. I have to assert that I like this kind of rfile some distance higher than some other 20+ reports I've receved over the past three and a half years.
Before writing this post I texted the news to my circle of relatives. The responses are like the Lego Movie subject matter song. Yay!

Here's the language from the findings section:

Since prior studies dated 2/10/2015, there is slightly decreased lymphadenopathy in the left posterior triangle, minimize jugular chain, and anterior mediastinum. Index measurements are as follows: (outside be trained dated 1/eight/2015 used to be reconstructed in the axial plane to supply index AP x TV measurements):
Largest stage IV lymph node (22/sixty eight) measures 1.four x 1.2 centimeter (previously 1.eight x 1.5 cm).
Largest stage 5 lymph node (22/57) measures 1.2 x 0.nine cm (previously 1.5 x 1.eight cm).
Largest anterior mediastinal node (22/seventy six) measures 1.0 x 0.eight cm (previously 1.1 x 0.5 cm).
No new or enlarging lymph nodes are seen.
I am so grateful to hear this news. I don't know whether the nivolumab drug will protect shrinking my tumors, or how long the last result will last, nonetheless I'll take all I can get. I'll of route continue to be on the medical trial for so long as there are first rate resultseasily (or two years, whichever comes first).
I'll be curious to see how other metastatic bladder melanoma patients are doing during this drug. I'm the first mets BC patient during this trial at Johns Hopkins, so with any luck the drug can provide a lot of more patients with this roughly response.

I forwarded the reports to Drs. Apolo and Aragon-Ching, with this phrase:

Enclosed are the resultseasily of the first scan this is why I started the nivolumab medical trial (three infusions so some distance). Yeah, I'm blissful. I'll protect riding this horse so long as it's going to carry me. Next scan is 5/5/15. I'll protect you revealed. Thanks once more for your ongoing care.
They each responded inside of an hour ("terrific news" and "stunning!"). I agree. Everything is terrific!

Mets Day 1076 How to now no longer do a CT scan

Mets Day 1076 How to now no longer do a CT scan

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Today was my first CT scan since I started out the nivolumab clinical trial. The scan is intended to provide a prestige document on the sizes of my various tumors. It shall be some days formerly than I get the consequences. The trial protocol requires two scans formerly than the doctors can make any determination of whether the Opdivo drug is working, so at present's scan should not definitive.
Anyway, so I arrived on the Hopkins scan at about 10:30 am, handiest to have the nurse tell me that Hopkins has not gained approval from my wellbeing and fitness insurance company to do the scan. I explained that this scan was a part of a clinical trial, which was news to the nurse. She disappeared to make some calls, then came to come back and told me that, even though I was in a clinical trial, Hopkins judicious this scan to be within the common primary of care, so it was appropriate to ask the insurance company to canopy it. She pointed out that an someone was calling the insurance company now to get the approval. She pointed out that an someone should have flagged this formerly than, and apologized for the wait.

After an hour of waiting, the nurse came to come back and told me that United wellbeing and fitness care had accredited the scan. At about the same time, the analysis nurse for the clinical trial showed up and also apologized for not acquiring the approval in advance. She assured me that future scans would get the approval in advance. I asked about the relationship between the clinical trial sponsor, who was supposed to canopy the costs on the topic of the trial, and the call to seek reimbursement from UHC for the scans. The answer is that any care that is consistent with the primary of care is billable to the insurance company, regardless of whether it occurs within a clinical trial.

With the approval in hand, I was escorted to come back to have my port accessed, then led into the CT scan room. I was to have scans of my neck, chest, and stomach without, then with, contrast. After the scans without contrast, a nurse hooked me up to an infusion pump that would feed the glucose-rich media with iodine through my port and into my bloodstream, in which it'd be distributed at some level of my body in about five heartbeats. I was used to this procedure, having undergone it more than 20 times ago three years.

Instead of getting that familiar warmth as spread through the body and gather in the loins upon the pump activation, on the other hand, the connection between the pump and my port broke aside, spraying my face, arms, torso, and the internal of the CT doughnut with sticky goo. I yelled out to keep at bay the scan, and three nurses and techs came running out bearing bowled over expressions. They were more rattled than I was. The nurse who had hooked me time and again apologized, saying that had never happened to him formerly than. (Me either.) They hooked a different bag of contrast up, double-checking the connection line to my port, then ran me through the scan.

As the table was moved out of the doughnut, the nurses returned to wash me up. The media on my arm had started out to harden, like sugar glaze exposed to air. The nurses were unable to in finding a towel, so they grabbed one of the clean sheets for the table, wetted it, and wiped off my arms, face, and hair. Another one wiped out the machine, then the 3rd escorted me out to have my port de-accessed, repeating her apologies. (Please don't tell the administration, she silently pointed out. Don't be concerned, I silently thought to come back. I'll just submit it on my net publication.)

As soon as my port entry was removed, one of the CT techs came running to come back to get me. It seems that they didn't do the contrast scan of the stomach – they just did the neck and chest. Since I'd just had the contrast, they pointed out I didn't need more. So they slapped me to come back on the table, ran me through the scanner, then sent me on my way. They were visibly rattled. I'm convinced they didn't come to a decision to crank up the scanner strength and nuke me. Or maybe they did and I don't realize it.

I'll get the leads to an afternoon or two. And next Monday, I'll have a different infusion. We'll stay the course until as a minimum early May, when I'll have the second scan after six rounds of infusions, and we'll come to a decision whether this trial is doing me any good.

Speaking of clinical trials, yesterday the New York Times ran anarticle about he low percentage of adult cancer sufferers who entered clinical trials. While eighty to 90 percentage of pediatric cancer sufferers participate in clinical trials, the article pointed out, fewer than 5% of adults with cancer participate. I'm amazed at that figure. Upon some reflection, I assume it's because adults wish to assume that their course of treatment will result in a cure, not an experiment. And their doctors are obliging them, and not telling them about clinical trial alternate options. I assume that there desires to be greater humility by oncologists who treat adults, moreover to their sufferers. There is so a substantive deallots we simply don't know about cancer.

Mets Day 1070 Third Opdivo infusion

Mets Day 1070

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Yesterday I spent a protracted day at Johns Hopkins getting my 3rd infusion of nivolumab. I left my home in Northern Virginia at 9 am and arrive at JHU at more or less 10:15 am and had a short wait before I was referred to as in for my lab work. The nurse could not get a return from my port, so she ended up drawing blood the vintage-fashioned approach. Since it takes three hours for the pharmacy to custom designed-make the infusion, I walked over to the cafeteria and read the paper whereas trying to ignore the inanities of "the Price Is Right" on the TV.
My appointment with Dr. Hahn was at 12:forty, so I wandered back down to the waiting room and was referred to as in quickly thereafter. Because the clinical trial Sponsor wants to note any doubtless side effects, I told Dr. Hahn more or less a strange pain in around left ear that began more or less 5 days ago. He checked it out – no inflammation to the ear drum – shrugged, and said to let him know if it persisted.

At 1:30 I was referred to as into the infusion area, where the nurse placed another IV for the Opdivo drug mix. At the related time, he fiddled around with my port, flushing a mixture of saline and heparin, and sooner or later ordered a clot-busting drug that might dissolve something was blocking the top of the port from enabling a return. I'd had an identical issue with this port in 2102 when the top were given lodged in the side of my vein. I sooner or later had an interventional radiologist snake a line up through my femoral artery to pass the top. This time, after soaking for an hour or so, the clot-busting drug appeared to do the trick and my nurse was capable of get a return. I were given back home by 5 pm.

The main the reason is, the visit appeared longer than usual was that I had began to feel sick the day before, and didn't sleep well. I must have picked up a computer virus whereas flying home from Utah on Sunday March 15. I had spent 10 days out there spending time with my granddaughter, touring with the numerous family, and playing with my granddaughter. I went skiing with my brother and was reminded just how out of shape I am. My quads and hamstrings protested for days after. But I'm recovered now.

Next week I have a CT scan, which could be the first glimpse of whether the Opdivo has shrunk my tumors in my neck and shoulder. The doctors will compare that scan to my baseline scan of early February, and determine whether my cancer has progressed, held stable, or shrunk. The doctors caution that they desire to see the results defined by two scans (scheduled for March 24 and May 5), so next week's scan will not be definitive. It will, nevertheless it, give some idea as to what mischief my cancer is up to.