In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 21, No. 15 ( 2003-08-01), p. 2849-2855
Abstract:
Purpose: The objectives of this prospective randomized study of consolidation therapy were to evaluate recurrence-free survival (RFS), overall survival (OS), and the morbidity of intraperitoneal (IP) chromic phosphate suspension ( 32 P) therapy in patients with stage III epithelial ovarian carcinoma who have no detectable evidence of disease at the second-look laparotomy (SLL) procedure after primary chemotherapy. Patients and Methods: In a multi-institution clinical cooperative trial, 202 eligible patients with a negative SLL were randomly selected to receive either 15 mCi IP 32 P (n = 104) or no further therapy (NFT; n = 98). Results: With a median follow-up of 63 months in living patients, 68 patients in the IP 32 P group (65%) and 63 patients in the NFT group (64%) have developed tumor recurrence. The relative risk of recurrence is 0.90 (IP 32 P to NFT) (90% confidence interval [CI], 0.68 to 1.19). The 5-year RFS rate is 42% and 36% for the IP 32 P and NFT groups, respectively; the difference is not statistically significant (log-rank test, P = .27). There was no statistically significant difference in OS (P = .19). The relative risk of death is 0.85 (IP 32 P to NFT) (90% CI, 0.62 to 1.16). Sixteen patients (8%) experienced grade 3 or 4 adverse effects, with eight in each respective group. Conclusion: Intraperitoneal chromic phosphate did not decrease the risk of relapse or improve survival for patients with stage III epithelial ovarian cancer after a negative SLL. Despite complete pathologic remission at SLL after initial surgery and platinum-based chemotherapy, 61% of stage III ovarian cancer patients had tumor recurrence within 5 years of negative SLL. This indicates a need for more effective initial therapy and further studies of consolidation therapy.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2003.11.018
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2003
detail.hit.zdb_id:
2005181-5
