Early Salvage Hormonal Therapy for Biochemical Failure Improved Survival in Prostate Cancer Patients After Neoadjuvant Hormonal Therapy Plus Radiation Therapy—A Secondary Analysis of Irish Clinical Oncology Research Group 97-01

• Published in: International journal of radiation oncology, biology, physics Vol. 85; no. 1; pp. 101 - 108
• Main Authors: Mydin, Aminudin R., MBBS, FRCR, Dunne, Mary T., MSc, Finn, Marie A, Armstrong, John G., FFRRCSI
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 2013
• Subjects: Adenocarcinoma - blood; Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adenocarcinoma - radiotherapy; Adenocarcinoma - secondary; Aged; Analysis of Variance; ANTIGENS; Antineoplastic Agents, Hormonal - therapeutic use; CARCINOMAS; Drug Administration Schedule; FAILURES; HEALTH HAZARDS; Hematology, Oncology and Palliative Medicine; HORMONES; Humans; Male; METASTASES; Middle Aged; MULTIVARIATE ANALYSIS; Neoadjuvant Therapy - methods; Neoplasm Recurrence, Local - blood; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - pathology; Neoplasm Recurrence, Local - radiotherapy; PATIENTS; PROSTATE; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Prostatic Neoplasms - radiotherapy; Radiology; RADIOLOGY AND NUCLEAR MEDICINE; RADIOTHERAPY; Salvage Therapy - methods; Salvage Therapy - mortality; Survival Analysis; Time Factors
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/j.ijrobp.2012.03.001

Purpose To assess the survival benefit of early vs late salvage hormonal therapy (HT), we performed a secondary analysis on patients who developed recurrence from Irish Clinical Oncology Research Group 97-01, a randomized trial comparing 4 vs 8 months neoadjuvant HT plus radiation therapy (RT) in intermediate- and high-risk prostate adenocarcinoma. Methods and Materials A total of 102 patients from the trial who recurred were analyzed at a median follow-up of 8.5 years. The patients were divided into 3 groups based on the timing of salvage HT: 57 patients had prostate-specific antigen (PSA) ≤10 ng/mL and absent distant metastases (group 1, early), 21 patients had PSA >10 ng/mL and absent distant metastases (group 2, late), and 24 patients had distant metastases (group 3, late). The endpoint analyzed was overall survival (OS) calculated from 2 different time points: date of enrolment in the trial (OS1) and date of initiation of salvage HT (OS2). Survival was estimated using Kaplan-Meier curves and a Cox regression model. Results The OS1 differed significantly between groups ( P <.0005): OS1 at 10 years was 78% in group 1, 42% in group 2, and 29% in group 3. The OS2 also differed significantly between groups ( P <.0005): OS2 at 6 years was 70% in group 1, 47% in group 2, and 22% in group 3. Group 1 had the longest median time from end of RT to biochemical failure compared with groups 2 and 3 (3.3, 0.9, and 1.7 years, respectively; P <.0005). Group 1 also had the longest median PSA doubling time compared with groups 2 and 3 (9.9, 3.6, and 2.4 months, respectively; P <.0005). On multivariate analysis, timing of salvage HT, time from end of RT to biochemical failure, and PSA nadir on salvage HT were significant predictors of survival. Conclusion Early salvage HT based on PSA ≤10 ng/mL and absent distant metastases improved survival in patients with prostate cancer after failure of initial treatment with neoadjuvant HT plus RT.