The clinical trial in on clinicaltrials.gov NCT03171025
Adjuvant Nivolumab Following Chemo-Radiation in Localized MIBC
The clinical trial starts after the chemo-radiation to see if Opdivo is effective in adenocarcinoma originating in the bladder. My husband does not have cancer in any other major organs. He has had every test available.
MRIs, colonoscopy, PET scans CT scans etc.
The oncologist at Moffitt believes he should enter the trial. The local oncologist remembers my husband telling him he did not want any aggressive treatments. That is why he is not in favor of the chemo.
It is a tough decision, since he has other health issues.
He has to make up his mind by Wednesday since the radiation starts on Monday, Jan.4.
Thanks for the confirmation and some background. I might have seen it but the clinical directory said it was only offered at the University of Utah, so I did not think it was being offered at Moffitt.
My background is in computer science and electrical engineering. I moved to sales and business development later in my career till I retired. I did a lot of business analysis. I was diagnosed with BCa 3 years ago. I have been running a local bladder cancer support group for 2.5 years, mostly learning from the participants. I did not even know even the anatomy of my own bladder till I was diagnosed with BCa. Just as other many patients, I have been learning mostly from Professor Google.
This is my perspective. It may sound like a sales pitch.
1. Your husband can withdraw from the program even in the middle of the program it becomes too hard.
2. Your husband had passed the inclusion criteria.
The immune system is working. The blood counts are normal.
The liver is functioning normally.
The kidneys are functioning normally.
3. Your husband had passed the exclusion criteria.
The oncologist does not consider that your husband has active co-morbidity which is severe enough to exclude him from the trial.
So, the oncologist thinks your husband can bear the treatment with the help of known drugs for side effects if required.
4. You mentioned that you have to drive 6 hours. I am concerned about how you manage the frequency of visiting the hospital while your husband is on the program.
4.1 I think every treatment, testing your husband receives is free. Immunotherapy drug costs $10K to $15K per treatment.
5. I am curious why they included transitional carcinoma (urothelial carcinoma), adenocarcinoma, squamous-cell and sarcomatoid carcinoma, but excluded other variants such as nested pattern, microcystic, micropapillary, lymphoepithelial-like, plasmacytoid and lymphoma-like, giant cell, trophoblastic differentiation, clear cell, lipid cell.
It may be because Opdivo (Nivolumab) has experience with adenocarcinoma, squamous-cell carcinoma, and sarcomatoid carcinoma for other cancer with some successful data, but not with other variants.
"Most (about 90% to 95%) cancers of the stomach are adenocarcinomas" American Cancer Society
Depression makes patients less proactive to the new treatment
You have mentioned that your husband is depressed. According to a study, those who are diagnosed with depression make less proactive to the new treatment. The concern is that a treatment decision by a patient is affected by the patient's mental condition. I have been aware for some time of the profession called psyco-oncology. Some large hospitals have an in-house psychologist who specifically deals with cancer patients and the family. I am wondering if your husband was depressed when he mentioned to his urologist that he did not want aggressive treatment.
Below is the study in 2000
We report on the degree of acceptance of adjuvant chemotherapy in patients with breast cancer who have concomitant depression. Only 20 (51.3%) of the study group accepted and received the proposed chemotherapy compared with 75 (92.2%) of the control group (p<0.0001). Treatment of depression might be essential for tailoring adjuvant treatments with chemotherapy.