Objectives: The purpose of this study was to assess the clinical activity and toxicity of weekly topotecan in a large cohort of epithelial ovarian (EOC), primary peritoneal (PPC), and tubal cancer patients.
Methods: Records of patients with recurrent EOC, PPC, and tubal cancer who were treated with weekly topotecan (4.0 mg/m2 on days 1, 8, and 15 on a 28-day cycle) after failure of more than 1 prior regimen were retrospectively reviewed in 8 centers in Israel.
Results: Two hundred four patients were evaluated for efficacy and toxicity. Median age was 62 years (range, 27–89 years); 121 (59.3%) were platinum sensitive. Patients were exposed to a median of 2 previous lines (range, 1–9), and 48.5% received only 1 prior chemotherapy regimen. Median follow-up was 15.5 months (range, 2.5–112 months). Overall response rate was 26.5%, of which 11 patients (5.4%) had complete response, and 43 patients (21.1%) had partial response. Clinical benefit rate (complete response + partial response + stable disease) was 65.7%. Median progression-free survival was 4.0 months (95% confidence interval [CI], 3.5–4.5 months). There was no significant difference between platinum-sensitive and platinum-resistant patients regarding response rate or progression-free survival. Median overall survival from disease diagnosis was 45.0 months (95% CI, 40.04–49.6 months) and 16.0 months (95% CI, 12.3–19.7 months) from initiation of topotecan therapy. Overall survival was significantly different between patients with platinum-sensitive and platinum-resistant disease (19.9 vs 10.8 months, respectively, P = 0.003; 95% CI, 8.1–16.3 months). Multivariate analysis showed that only platinum sensitivity and topotecan line were associated with overall survival. Weekly topotecan was well tolerated—with only 16.7% of patients experiencing grade 3 to 4 hematologic toxicities. There were no other grade 4 toxicities, and only 6.9% grade 3 toxicities.
Conclusions: In this large cohort of recurrent EOC, PPC, and tubal cancer, weekly topotecan was well tolerated with good clinical benefit rate, comparable to previous studies.
*Department of Oncology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv; †Department of Internal Medicine, St Luke’s–Roosevelt Hospital Center, New York, NY; ‡Department of Oncology, Kaplan Medical Center, Rehovot and Faculty of Medicine, Hebrew University, Jerusalem; §Gyneco-oncology Division, Meir Medical Center, Kfar Saba and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv; ∥Unit of Gyneco-oncology, Soroka University Medical Center and Ben Gurion University; ¶Oncology Institute, Barzilai Medical Center, Ashkelon and Ben Gurion University, Beer Sheva; #Gynecological Oncology Unit, Baruch Pedah Medical Center, Poria and Faculty of Medicine, Bar Ilan University, Ramat Gan; **Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Wolfson Medical Center, Holon and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv; and ††Oncology Institute, Shaare Zedek Medical Center, Jerusalem and Faculty of Medicine, Hebrew University, Jerusalem, Israel.
Address correspondence and reprint requests to Tamar Safra, MD, Oncology Department, Tel Aviv Sourasky Medical Center, 6 Weizmann St. Tel Aviv 64239, Israel. E-mail: email@example.com.
Drs Levy and Rosengarten contributed equally to this work.
The authors declare no conflicts of interest.
Received October 28, 2012
Accepted January 7, 2013