Thank you for clarifying about the clinical trial. I have spent a few days reading your past postings and tried to understand BCa with adenocarcinoma better. I have a clarification and some questions.
76 yrs old is not old for BCa. It is about the average age of being diagnosed with bladder cancer. Of 80,000 newly diagnosed BCa patients every year in the US, 5% are metastatic and 20% are muscle-invasive. As most metastatic and muscle-invasive BCa patients go through systemic chemotherapy including neoadjuvant/adjuvant chemotherapy for RC, so I estimate about 10,000 new patients who are the same or older than your husband will go through systemic chemotherapy every year.
You have listed the hospital proposed three options for the treatment.
1. Surveillance at every three months by CT.
2. Chemotherapy + Radiation
3. The clinical trial: Cisplatin + Radiation + immunotherapy (Opdivo)
1. Surveillance by CT scan
What will be the treatment if cancer returns?
There are a few studies that investigated the relationship between the number of positive lymph nodes and recurrence-free survival after radical cystectomy. Note that the studies were for urothelial carcinoma and some patients had adjuvant chemotherapy.
USC studied 1,600 patients who had RC. 181 patients had 1 or 2 positive lymph nodes. Estimated 5 and 10-year recurrence-free survival was 43.8% and 40.9% respectively for the 181 patients. Adjuvant chemotherapy was associated with a lower risk.
University of Ulsan College of Medicine, Korea analyzed data on 525 patients who had a radical cystectomy in their hospital. 54 had 1 positive lymph node and 23 had 2 positive lymph nodes. Five-year recurrence-free and disease-specific survival rates were 36.9% and 52.2% in patients with 1 positive lymph node. Five-year recurrence-free and disease-specific survival rates were 16.3% and 21.7% in patients with 2 positive lymph nodes.
2. Chemotherapy + Radiation
Since the doctor is saying cisplatin does not work well for adenocarcinoma, which chemo drug is the doctor recommending to use?
The presentation by Dr. Andrea B Apolo of the National Cancer Institute in Nov 2019 told that there has been chemotherapy borrowed from the treatment for colon cancers, but the samples were too small to determine the efficacy of those chemotherapies.
Also, because adenocarcinoma in the bladder is rare, the doctor should consider endoscopy and colonoscopy to exclude that it came from the stomach or colon. I understand the PET scan did not show cancer in other organs, so I do not know if endoscopy and colonoscopy are required. Incidentally, I have done endoscopy and colonoscopy several times in the past. I was put in pseudo sleep and did not feel anything. I had my wife drive me home as I was not supposed to drive 24 hours.
3. The clinical trial: Cisplatin + Radiation + immunotherapy ( Nivolumab: trade name Opdivo)
I could not find the clinical trial Chemotherapy + Radiation + Nivolumab in the directory of clinical trials. What I have found is the clinical trial in which MOFFITT is involved in the clinical trial NCT04610671- "Study of CG0070 Combined with Nivolumab in Cisplatin Ineligible Patients with MIBC".
Inclusion criteria say
MIBC (T2-T4a), N0-N1, pure or mixed histology urothelial carcinoma. I think the pathology would have shown also urothelial carcinomas.
Also, participants must be ineligible for cisplatin-based chemotherapy due to any of the following. Ineligibility includes "Refusing to undergo cisplatin chemotherapy. So, your husband does not have to have chemotherapy for this trial.
Incidentally, CG0070 is called oncolytic adenovirus. Adenovirus is like a virus of common cold without harmful virus genes. They use gene-editing technology to take out genes that make us sick. Oncolytic adenovirus contains anti-cancer agents in the adenovirus. CG0070 will penetrate into bladder cancer cells and it releases anti-cancer agent and kill the cancer cells. Google says CG0070 was developed y Cell Genesys in San Francisco in early 2005 and the paper was published in 2006. Incidentally, the technology of adenovirus has been used by Oxford–AstraZeneca for their covid-19 vaccine. In this case, adenovirus which contains DNA of S protein of covid-19 virus goes into the nucleus of muscle cells and other cells after the injection to our arm, and messenger RNAs of S protein are made in the cell and the S protein go outside of the cell and our immune system makes anti-body for S protein of Covid-19. Anyway, oncolytic adenovirus technology is field-proven.
The description of the clinical trial says that CG0070 will be administered intravesically similar to BCG treatment.
Opdivo will be administered intravenously.
You may want to confirm with MOFFITT about the clinical trial. If this is the clinical trial they are proposing,
your husband does not go through cisplatin chemotherapy, which you are concerned about possibly affecting the quality of control.
The link to the clinical trial. Clinical trial at MOFFITT