Infusion 73 and a lesson in patient advocacy

Yesterday I had infusion #73. Everything went smoothly. My labs were unremarkable. I'll have one more infusion next month, then I'll suspend my therapy and be on surveillance with scans every 12 weeks. I wonder how long it will take for the rash on my face, scalp, and other portions of my body to go away. I wonder if my GI tract will settle down. Stay tuned for some crappy reading.

I'm a Patient Advocate on the Bladder Cancer Task Force on the Genitourinary Steering Committee, sponsored by the National Cancer Institute of the National Institute of Health. That mouthful is sometimes abbreviated as BCTF GUSC NCI NIH. Most of the BCTF members are bladder cancer clinicians and researchers at NCI centers. Three of the committee members have been active in my care: Dr. Andrea Apolo at the NIH NIC; Dr. Noah Hahn at Hopkins; and Dr. Betsy Plimack at Fox Chase. Every month the BCTF has an online meetings, primarily to evaluate proposed clinical trials, and to help set research priorities in bladder cancer research. My job as a patient advocate is to review proposed clinical trials and speak for the people who will be on the pointy end of the needle.

Today the BCTF had its May meeting. The entire agenda was dedicated to how to improve clinical trials from the patient advocate's point of view. More than 30 people were on the call. Stephanie Cooper Greenberg, the other patient advocate on the BCTF, and I, led the discussion on the following points:

Topics of most interest to BC patients:

#1: Greatest need for a better supply of BCG and BCG alternatives. This includes whether shorter or lower doses are acceptable, and whether BCG maintenance has been proved to be effective.

#2: Bladder preservation above all; MIBC patients continue to feel stampeded to RC

#3: Patient desire for Immunotherapy or other therapeutics early on for NMIBC

#4: Trials that acknowledge different variants of BC: i.e: upper track disease, adenocarcinoma, etc. There is a need for more “niche” trials.

Impediments to trial accrual

-       Trials are not often available locally – they often require herculean efforts to be part of a trial – travel long distances with frequent visits, which come with a financial burden that is not reimbursed.

-       Some trials require a lot of visits and therapies where showing up may no longer be possible

-       Existing clinical trial paradigms permit many patient visits to be moved out of central NCI’s to local clinics and virtual visits, including labs, CT’s, some drug administration, patient assessment, and surveillance.

Trials in a COVID world

-       How can trials achieve accrual when patients can’t or don’t want to come to the clinic?

-       How can visits for treatments and surveillance be minimized? Fewer infusions of existing or new treatments? Are there low interpersonal contact options that minimize the risk of COVID exposure? For example: a urine cytology or FISH test that could be done at home? Or done in the clinic instead of higher interpersonal contacts like cystoscopy and TUR-BT?

-       How can you incorporate telemedicine and treatment at home (oral drugs or other possibilities) into trial protocols? Trials can have home-based telemedicine consult and enrollment, when the patient has more time to think and absorb the information

-       Not all trials will be able to move forward in the next 18-24 months: create trials that are high impact that save lives

We had a good discussion. Committee members observed that they had rapidly pivoted to telemedicine during the ongoing coronavirus restrictions, and we considered whether and how to make permanent some of those changes. We also discussed the need to better communicate to patients the fact that BCG was far and away the best treatment for non-muscle invasive bladder cancer, as well as the emerging data on bladder preservation and trimodal therapy. It seemed to be a good discussion.