A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment Journal Article
| Authors: | Barakat, R. R.; Almadrones, L.; Venkatraman, E. S.; Aghajanian, C.; Brown, C.; Shapiro, F.; Curtin, J. P.; Spriggs, D. |
| Article Title: | A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment |
| Abstract: | Purpose. To determine the efficacy of three courses of intraperitoneal (ip) cisplatin (CDDP) and etoposide (VP-16) as consolidation therapy following pathologically negative second-look surgical reassessment for Stage IIC-IV epithelial ovarian cancer (EOC). Patients and Methods. Between September 1988 and April 1996, 40 patients were treated with three cycles of ip CDDP (100 mg/m2)/VP-16 (200 mg/m2) as consolidation therapy. Survival was compared to that of a group of 46 contemporaneous patients undergoing observation only. Results. Median age of the 36 eligible patients was 52 years (range 30-70 years). Stage distribution was II (3), III (31), and IV (2); histologic grade was 1 (2), 2 (7), 3 (25), and not recorded (2); and residual disease at completion of initial surgery was none/microscopic in 13/36 (36%) patients. Median age of the 46 patients who did not receive consolidation was 52 years (range, 27-80 years); stage distribution was II (18), III (26), and IV (2); histologic grade was 1 (5), 2 (12), 3 (28), and not recorded (1). With a median follow-up of 36 months in both groups, 14136 (39%) of the protocol group have recurred compared with 25/46 (54%) of those undergoing observation alone. Median disease-free survival (DFS) for the observed patients is 28.5 months and has not been reached in the consolidation group. Disease-free survival distribution between the two groups was compared using the log-rank test and was found to be significant (P = 0.03). Multivariate analysis revealed that the only significant predictor of improved DFS was protocol treatment (P < 0.01). Conclusion. Intraperitoneal consolidation with CDDP/VP-16 following negative second-look reassessment in patients with advanced EOC resulted in a significant increase in DFS compared to nonprotocol patients treated concurrently who underwent observation alone. |
| Keywords: | adult; cancer survival; clinical article; aged; clinical trial; neutropenia; cisplatin; drug efficacy; cancer staging; cancer grading; ovary cancer; phase 2 clinical trial; etoposide; leukopenia; nausea; vomiting; abdominal pain; fever; second look surgery; intraperitoneal drug administration; human; female; priority journal; article |
| Journal Title: | Gynecologic Oncology |
| Volume: | 69 |
| Issue: | 1 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 1998-04-01 |
| Start Page: | 17 |
| End Page: | 22 |
| Language: | English |
| DOI: | 10.1006/gyno.1998.4973 |
| PUBMED: | 9570993 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 12 December 2016 -- Source: Scopus |
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