Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin–a gynecologic oncology group study

TitleAdjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin–a gynecologic oncology group study
Publication TypeJournal Article
Year of Publication2003
AuthorsYoung, RC, Brady, MF, Nieberg, RK, Long, HJ, Mayer, AR, Lentz, SS, Hurteau, JA, Alberts, DS
JournalJ Clin Oncol
Volume21
Pagination4350-5
KeywordsAdenocarcinoma, Adjuvant Chromium Compounds/administration & dosage/adverse effects/*therapeutic use Cisplatin/administration & dosage Combined Modality Therapy Cyclophosphamide/administration & dosage Cystadenocarcinoma, Endometrioid/mortality/pathology/therapy Chemotherapy, Intraperitoneal Middle Aged Neoplasm Recurrence, Local/epidemiology Ovarian Neoplasms/mortality/pathology/*therapy Phosphates/administration & dosage/adverse effects/*therapeutic use Phosphorus Radioisotopes Prospective Studies Survival Rate Treatment Outcome, Mucinous/mortality/pathology/therapy Adult Aged Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use Carcinoma, Serous/mortality/pathology/therapy Disease-Free Survival Female Humans Injections
Abstract

PURPOSE: To conduct a prospective study of intraperitoneal radioactive chromic phosphate (32P) versus cyclophosphamide-cisplatin (CP) in women with early ovarian cancer at high risk for recurrence (International Federation of Gynecology and Obstetrics stage Ia or Ib grade 3 or Ic or stage II, no macroscopic residual disease) and to compare cumulative incidence of recurrence, overall survival, and relative toxicity. MATERIALS AND METHODS: A total of 251 patients were randomly assigned to treatment with 32P or CP. Twenty-two (8.7%) were ineligible following centralized pathology review. Of the 229 patients included in the analysis, 110 received 32P, and 119 received CP. RESULTS: The cumulative incidence of recurrence at 10 years was 35% (95% CI, 27% to 45%) for patients receiving 32P and 28% (95% CI, 21% to 38%) for those receiving CP. Patients receiving CP had a recurrence rate 29% lower than that of those receiving 32P (P =.15, two-tail test). The death rate for patients treated with CP was 17% lower than that for patients treated with 32P (difference not significant). Combining both arms, the 10-year cumulative incidence of recurrence for all stage I patients was 27% (95% CI, 20% to 34%) compared with 44% (95% CI, 32% to 56%) for stage II patients (P =.01). Both regimens were reasonably well tolerated, but problems with inadequate distribution (7%) and small-bowel perforation (3%) make the otherwise less toxic 32P less acceptable. CONCLUSION: Although there are no statistically significant differences in survival, the lower cumulative recurrence seen with CP and complications of 32P administration make platinum-based combinations the preferred adjuvant therapy for early ovarian cancer patients at high-risk for recurrence.