Mets Day 1120: Second clinical trial scan shows good results

Yesterday I had my second CT scan as part of the nivolumab clinical trial. This scan took place after I had received six of the experimental infusions, or 12 weeks after I started the trial. The first scan showed that my targeted tumors had shrunk 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 possibly due to variation in slice selection and patient positioning, there is slight interval decrease in the size of the left level 3 lymph node as demonstrated on image 569 of series 4, now measuring 1.4 x 0.8 cm (previously 1.5 x 1.1 cm). The left level 4 lymph node previously measuring 1.3 x 0.9 cm currently measures 1.3 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 shrunk by another 25%. Yay!

The only bad news is that, according to the neck scan, I am 82 years old (the abdomen and chest scan had my age correctly noted). I emailed the clinical trial nurse and said that she'd have to report accelerated neck aging as one of the side effects of the study. Her response: "I love your attitude and sense of humor."

I'll go in next week for my seventh infusion, and will talk with Dr. Hahn about 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 tested on metastatic melanoma. A March 2014 report found that the results were durable for two or more years, and that some  patients had ongoing beneficial effects even after stopping therapy. A September 2014 report on the use of nivolumab on metastatic renal cell carcinoma also found durable results, with the best results going to those who stayed on the drug.  A November 2014 follow-up report on metastatic melanoma patients receiving nivolumab showed ongoing durability, with a median follow-up of 55 months, which according to the report "is the longest follow-up of an anti-PD-1 agent done to date." That report also said that, of the the patients who had an overall response, more than half were maintaining that overall 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 acceptable toxicity in large phase I studies involving patients with advanced melanoma, NSCLC, renal cell carcinoma (RCC) and Hodgkin’s disease . . . .

None of these reports were specific to bladder cancer, however. Although there are a number of reports noting the fact that nivolumab is being tested on mets bladder cancer patients, I have not been able to locate any data on the durability on my type of cancer. The best 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 an effective immunotherapy agent on my metastatic bladder cancer.
2. I have had an objective response -- specific, measurable results -- as a result of the nivolumab.
3. I am continuing to see tumor shrinkage as a result of the nivolmab.
4. This last scan likely has put me in the category of a complete response, meaning that my metastatic tumors have shrunk to under 1 cm in size on the short axis.
5. I still have measurable disease, however, so I not yet at NED (no evidence of disease).
6. I should continue with the nivolumab as long as possible, since that is what has provided the best results to patients taking nivolumab for other cancers. So that means no trips away from Hopkins for more than two weeks. I can live with that.

median follow-up is 55 months, which represents the longest follow-up of an anti-PD-1 agent done 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 follow-up is 55 months, which represents the longest follow-up of an anti-PD-1 agent done 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 follow-up is 55 months, which represents the longest follow-up of an anti-PD-1 agent done 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