Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer.

TitleNeoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer.
Publication TypeJournal Article
Year of Publication2010
AuthorsVergote, IB, Tropé, CG, Amant, F, Kristensen, GB, Ehlen, T, Johnson, N, Verheijen, RHM, van der Burg, MEL, Lacave, AJ, Panici, PBenedetti, Kenter, GG, Casado, A, Mendiola, C, Coens, C, Verleye, L, Stuart, GCE, Pecorelli, S, Reed, NSimon
Corporate AuthorsEuropean Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG), NCIC Clinical Trials Group
JournalN Engl J Med
Volume363
Issue10
Pagination943-53
Date Published2010 Sep 2
ISSN1533-4406
KeywordsAdult, Aged, Aged, 80 and over, Antineoplastic Agents, Chemotherapy, Adjuvant, Female, Humans, Intention to Treat Analysis, Middle Aged, Multivariate Analysis, Neoadjuvant Therapy, Neoplasm Staging, Ovarian Neoplasms, Proportional Hazards Models, Quality of Life, Survival Analysis
Abstract

BACKGROUND: Primary debulking surgery before initiation of chemotherapy has been the standard of care for patients with advanced ovarian cancer.METHODS: We randomly assigned patients with stage IIIC or IV epithelial ovarian carcinoma, fallopian-tube carcinoma, or primary peritoneal carcinoma to primary debulking surgery followed by platinum-based chemotherapy or to neoadjuvant platinum-based chemotherapy followed by debulking surgery (so-called interval debulking surgery).RESULTS: Of the 670 patients randomly assigned to a study treatment, 632 (94.3%) were eligible and started the treatment. The majority of these patients had extensive stage IIIC or IV disease at primary debulking surgery (metastatic lesions that were larger than 5 cm in diameter in 74.5% of patients and larger than 10 cm in 61.6%). The largest residual tumor was 1 cm or less in diameter in 41.6% of patients after primary debulking and in 80.6% of patients after interval debulking. Postoperative rates of adverse effects and mortality tended to be higher after primary debulking than after interval debulking. The hazard ratio for death (intention-to-treat analysis) in the group assigned to neoadjuvant chemotherapy followed by interval debulking, as compared with the group assigned to primary debulking surgery followed by chemotherapy, was 0.98 (90% confidence interval [CI], 0.84 to 1.13; P=0.01 for noninferiority), and the hazard ratio for progressive disease was 1.01 (90% CI, 0.89 to 1.15). Complete resection of all macroscopic disease (at primary or interval surgery) was the strongest independent variable in predicting overall survival.CONCLUSIONS: Neoadjuvant chemotherapy followed by interval debulking surgery was not inferior to primary debulking surgery followed by chemotherapy as a treatment option for patients with bulky stage IIIC or IV ovarian carcinoma in this study. Complete resection of all macroscopic disease, whether performed as primary treatment or after neoadjuvant chemotherapy, remains the objective whenever cytoreductive surgery is performed. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003636.)

DOI10.1056/NEJMoa0908806
Alternate JournalN. Engl. J. Med.
PubMed ID20818904
Grant List2U10 CA11488-28 / CA / NCI NIH HHS / United States
2U10 CA11488-29 / CA / NCI NIH HHS / United States
2U10 CA11488-30 / CA / NCI NIH HHS / United States
2U10 CA11488-31 / CA / NCI NIH HHS / United States
2U10 CA11488-32 / CA / NCI NIH HHS / United States
2U10 CA11488-33 / CA / NCI NIH HHS / United States
2U10 CA11488-34 / CA / NCI NIH HHS / United States
2U10 CA11488-35 / CA / NCI NIH HHS / United States
2U10 CA11488-36 / CA / NCI NIH HHS / United States