It worries me that some patients seem to be looking a BAT through rose-colored glasses, and pressuring their doctors to do it off-trial. I've been following BAT since its inception, and even donated money when it lost NIH funding. I am still hoping that they will be able to pre-identify patients who will respond to it vs those who get worse because of it. So far, there is no evidence that it extends survival, and may make matters worse. It should only be done in carefully watched clinical trials now ongoing at Johns Hopkins, UW Seattle, and UC Denver.
•Schweitzer et al. found that half the patients did not respond at all, and PSA continued to rise
• Markowski et al. reported that using a PSMA PET scan (DCFPyL) 3 months into BAT treatment revealed that half of them had already progressed to having new metastases.
• Teply et al reported that 43% saw PSA increase from baseline; in 17%, PSA more than doubled.
• Sena et al. reported that in Arm C of the RESTORE trial (ADT only),
- PSA more than doubled in 52%, and increased markedly in 14% more.
- Only 14% had a reduction in their metastases. All of those had lymph node metastases only.
- Musculoskeletal pain was experienced by 40%. Other prevalent side effects were: hypertension (21%), breast tenderness (21%), leg swelling (17%), fatigue (14%), and difficulty breathing (10%). One patient died of a stroke.
- There weren't any discernable genomic determinants of response.
• The TRANSFORMER trial found that:
- There was no statistically significant difference in overall survival between those who went from Zytiga -> BAT -> Xtandi and those who went from Zytiga -> Xtandi
- Comparing BAT to Xtandi (before crossover), there were no significant differences in the time to clinical or radiographic progression (5.7 months in both groups) or reduction in PSA by ≥ 50% "PSA50" (28% and 25%)
• The COMBAT trial (adding Opdivo) found that in 27% PSA got much worse after BAT
Based on this, it is incredibly irresponsible to advocate use of BAT outside of clinical trials.
Here's a full analysis: