Efficacy and Safety of Every Other Week Gemcitabine and Docetaxel (GEMDOC) in Heavily Pretreated Metastatic Castration Resistant Prostate Cancer: A Retrospective Real-world Analysis.

INTRODUCTION/BACKGROUND: Metastatic castration resistant prostate cancer (mCRPC) is a life-limiting phase marked by progression despite androgen deprivation therapy (ADT) with a median overall survival (OS) of approximately 25 months. Gemcitabine plus docetaxel (GEMDOC) has antitumor activity in other solid tumors, but its efficacy in mCRPC is unclear. This study evaluates biweekly GEMDOC in heavily pretreated mCRPC patients. PATIENTS AND METHODS: We conducted a retrospective, single-institution cohort study at Emory Winship Cancer Institute (2017-2025). Eligible patients had progressed after, declined, or were unsuitable for further approved mCRPC therapies. Patients received gemcitabine (1500 mg/m2) plus docetaxel (50 mg/m2) every other week of a 28-day cycle. Demographics, prior therapies, PSA, progression-free survival (PFS), OS, and toxicities were extracted from medical records. Univariate analyses evaluated outcomes by race, prior treatment, visceral metastasis, and de novo metastatic presentation. RESULTS: Among 34 patients (median age: 72.5 years), 23 (67.7%) were White, 11 (32.3%) were Black. Most patients (91.2%) had prior docetaxel, 35.3% de novo metastatic disease, and 20.6% visceral involvement. Median prior lines of therapy were 3 (range 1-6). PSA declines of ≥90%, ≥50%, and ≥30% were observed in 5.9%, 50%, and 64.7% of patients, respectively. Median PFS was 4.17 months, and median OS was 11.6 months. Grade 4 neutropenia occurred in two patients (6%), and grade 3 febrile neutropenia in one patient (3%). CONCLUSION: Biweekly GEMDOC may be a feasible salvage regimen in heavily pretreated mCRPC patients who have exhausted or are ineligible for standard options. Prospective studies are warranted to further investigate these findings.