Neoadjuvant hormone therapy before radical prostatectomy: Update on the memorial Sloan-Kettering Cancer Center trials

We report here the latest follow-up of the Phase II and III trials evaluati ng pathologic results and relapse-free survival, as judged by serum prostat e specific antigen (PSA), in patients with localized prostate cancer who ha d radical prostatectomy performed at the Memorial Sloan-Kettering Center (M SKCC) either with or without neoadjuvant hormone therapy (NHT), Pelvic lymp hadenectomy (PLND), radical prostatectomy, or both with or without NHT was performed in 141 patients enrolled in a Phase II trial comparing patients r eceiving NHT with concurrent controls and 140 patients in a randomized Phas e III trial. In the Phase II study, there was a significant difference in t he pathologic results, with only 35 (49%) of the 72 patients in the control group having organ-confined margin-negative disease compared with 48 (70%) of the 69 patients in the NHT arm (P = 0.0057; chi(2) test), With a median follow-up of 57 months, there was no significant difference in the PSA rel apse rates in the two arms (P = 0.92; log-rank test). In the Phase III stud y, 39 (59%) of the 66 patients in the control arm had organ-confined margin -negative disease compared with 52 (70%) of the 74 patients in the NHT arm (P = 0.17; chi(2) test), However, the positive-margin rate was significantl y lower in the NHT arm (19%) than in the control arm (37%) (P = 0.023; chi( 2) test). With a median follow-up of 35 months, there was no significant di fference in the PSA relapse rates in the two arms (P = 0.73; log-rank test) . Thus, although NHT improves the pathologic results, further follow-up is necessary to determine if this marked reduction in the positive-margin rate will translate into improved disease-free survival.