989P - Phase II study of combination chemotherapy with oral S-1 and oxaliplatin (SOX) in patients with mucinous adenocarcinoma of the ovary

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Ovarian Cancer
Therapy
Biological Therapy
Presenter Shin Nishio
Authors S. Nishio1, M. Shimada2, T. Kamura3, K. Ishitani4, K. Ochiai5, N. Takeshima6, Y. Yokoyama7, H. Furumoto8, T. Sugiyama9, J. Kigawa2
  • 1Gynecologic Oncology, Kurume University School of Medicine, 8300011 - Kurume/JP
  • 2Obstetrics And Gynecology, Tottori University, Yonago/JP
  • 3Obstetrics And Gynecology, Kurume University School of Medicine, Kurume/JP
  • 4Obstetrics And Gynecology, Tokyo Women's Medical University, Tokyo/JP
  • 5Obstetrics And Gynecology, Jikei University School of Medicine, Tokyo/JP
  • 6Gynecology, Cancer Institute Hospital, Tokyo/JP
  • 7Obstetrics And Gynecology, Hirosaki University Graduate School of Medicine, Hirosaki/JP
  • 8Obstetrics And Gynecology, The University of Tokushima Graduate School, Tokushima/JP
  • 9Obstetrics And Gynecology, Iwate Medical University School of Medicine, Morioka/JP

Abstract

We previously reported that patients with advanced or recurrent ovarian mucinous adenocarcinoma (MAC) had poor outcomes. Owing to similar biologic characteristics, chemotherapy for MAC has been based on standard chemotherapeutic regimens for colorectal cancer. Our basic studies also showed that a combination of oxaliplatin (L-OHP) and 5-fluorouracil was effective against MAC cells. This is the first phase II study of combination chemotherapy with oral S-1 and L-OHP (SOX) in patients with advanced or recurrent MAC. From July 2008 through December 2011, 40 patients, including 16 with recurrent disease, were enrolled. Two patients could not receive SOX chemotherapy because their performance status suddenly deteriorated after enrollment. L-OHP was administered at a dose of 100 mg/m2 on day 1, and S-1 (80-120 mg/day) was given in 2 divided doses daily for 2 weeks followed by a 1-week rest. This treatment schedule was repeated every 3 weeks until progressive disease. Tumor responses were evaluated according to the Response Evaluation Criteria in Solid Tumors, and toxicity was assessed with the Common Terminology Criteria for Adverse Events (version 3.0). Central pathological review (CPR) was also performed. On CPR, primary MAC was diagnosed in 13 patients, metastatic MAC in 15, endometrioid adenocarcinoma in 7, and other histological subtypes in 5. Of the 28 patients with a diagnosis of MAC, the objective response rate (RR) as assessed by an independent response review committee was 18% (complete response: 0, partial response: 5), and the disease control rate (CDR), including 14 patients with stable disease, was 68%. Among the 13 patients with primary MAC, the objective RR was 31%. Among the 38 patients who received SOX therapy, 2 discontinued the regimen because of toxicity. Grade 3 or 4 hematologic toxicities were neutropenia (28%), anemia (21%), and thrombocytopenia (10%). The most common grade 3 or 4 nonhematologic toxicities were anorexia (8%) and hyponatremia (8%). The present study showed a promising RR and good tolerance, suggesting that SOX therapy might contribute to prolonging survival.

Disclosure

All authors have declared no conflicts of interest.