IMR Press / EJGO / Volume 19 / Issue 1 / pii/1998101

European Journal of Gynaecological Oncology (EJGO) is published by IMR Press from Volume 40 Issue 1 (2019). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with S.O.G.

Open Access Original Research

Prospective sequential trials of induction weekly cisplatin followed by monthly cisplatin, doxorubicin, cyclophosphamide and paclitaxel and cisplatin in optimal (≤1 cm) stage III and IV ovarian cancer

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1 Department of Gynecologic Oncology, Roswell Park Cancer Institute, Buffalo, New York, USA
2 Biomathematics Resource, Roswell Park Cancer Institute, Buffalo, New York, USA
Eur. J. Gynaecol. Oncol. 1998, 19(1), 5–10;
Published: 10 February 1998
Abstract

Purpose of Investigation: This study was conduced to assess the results of paclitaxel plus cisplatin given over six months as first­line therapy in women with stage III and IV epithelial ovarian cancer with residual disease <1 cm and compare it to our previous standard of cisplatin, adriamycin, and cyclophosphamide given over ten months in two sequential trials totaling 100 patients. Methods: We compared induction weekly cisplatin (1 mg/kg × 4) followed by monthly cisplatin (50 mg/m2), doxorubicin (50 mg/m2) and cyclophosphamide (750 mg/m2) × 10 (n = 56) versus induction cisplatin (1mg/kg × 4) followed by cisplatin (75 mg/m2) and paclitaxel (135 mg/m2) monthly over six months (n = 44). Results: The two groups were similar in age, histologic subtypes, grade, performance status, and substage. The mean dose of cisplatin in the PAC patients was 617.1 (± 92.7) mg/m2 as compared to 567.1 (± 89.2) mg/m2 in the TP patients (p < 0.0001). Surgical response was assessed in 83.9% of the PAC and 86.4% of the TP patients. The incidence of nausea and vomiting, myelotoxicity, and renal toxicity were similar in the two groups. Peripheral neuropathy occurred more frequently following TP (57% vs 16%; p = 0.001). Cardiac toxicity (grade 1) occurred in 39% of the PAC patients and in 4.5% of the TP patients (p < 0.0OI). The overall response rate (75% vs 88.7%), surgical response rate (67.9% vs 79.5%), complete surgical responses (37.5% vs 40.9%), estimated two-year survival (80.2% vs 79.6%), progression-free median survival (36 months vs 30.4 months) and two-year progression/recur­rence rates (32.3% vs 46.9%), respectively, of PAC and TP patients were not statistically significant (p = NS). Conclusions: Given the discussed limitations of the study, compared with PAC, TP did not improve overall and surgical response rates, two-year survival, two year disease-free survival, or median time of recurrence in patients with optimal (<1 cm) stage III and IV ovarian cancer and resulted in higher peripheral neuropathy rates.

Keywords
Ovarian cancer
Chemotherapy
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