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Japanese Journal of Clinical Oncology 2007 37(12):930-935; doi:10.1093/jjco/hym131
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Phase II Study of Oxaliplatin with Low-dose Leucovorin and Bolus and Continuous Infusion 5-Fluorouracil (Modified FOLFOX-4) for Gastric Cancer Patients with Malignant Ascites

Sung Yong Oh1,, Hyuk-Chan Kwon1, Suee Lee1, Dong Mee Lee1, Hyun Seung Yoo1, Sung-Hyun Kim1, Jin Seok Jang1, Min Chan Kim2, Jin-Sook Jeong3 and Hyo-Jin Kim1,

1 Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea
2 Department of Surgery Dong-A University College of Medicine, Busan, South Korea
3 Department of Pathology, Dong-A University College of Medicine, Busan, South Korea

1 For reprints and all correspondence: Hyo-Jin Kim, Department of Internal Medicine, Dong-A University College of Medicine, 3-1 Dongdaeshin-dong, Seo-gu, Busan 602-715, South Korea. E-mail: kimhj{at}dau.ac.kr

Received August 8, 2007; accepted September 12, 2007

Background: Clinical studies regarding chemotherapy for gastric cancer patients with malignant ascites have been classically rather limited in scope, largely because peritoneal seeding produces no measurable lesions, and patients generally exhibited poor performance status. Herein, we have evaluated the efficacy and toxicity of a fortnightly modified FOLFOX-4 (m-FOLFOX) regimen.

Methods: Gastric cancer patients with cytologically confirmed malignant ascites were treated with cycles of oxaliplatin at 85 mg/m2 plus leucovorin 20 mg/m2 on the first day of treatment, followed by 5-fluorouracil (5-FU) via a 400 mg/m2 bolus and a 22 h continuous infusion of 600 mg/m2 5-FU on Days 1–2 at 2-week intervals.

Results: Forty-eight patients participated in this study. Twenty-two patients (45.8%) were treated with m-FOLFOX-4 as a first line palliative treatment. Twenty-one patients (43.8%) were adjudged to have an Eastern Cooperative Oncology Group (ECOG) performance status of 2. Thirty-six patients were assessable and exhibited measurable lesions. Twelve (33.3%) patients evidenced partial responses. Decreases or disappearances of ascites levels were observed in 17 (35.4%) patients. The median time to progression and overall survival time were 3.5 (95% CI: 2.9–4.1) months and 8.4 (95% CI: 4.9–11.9) months, respectively. Major hematologic toxicities included Grades 1–2 anemia (53.9%), neutropenia (41.6%) and, Grades 3–4 neutropenia (15.8%). The most frequently detected non-hematological toxicities were Grades 2 and 3 nausea/vomiting (17%). We noted no deaths related to treatment.

Conclusion: The m-FOLFOX-4 regimen utilized herein was determined to be both safe and feasible even for gastric cancer patients with malignant ascites in poor performance status.

Key Words: oxaliplatin • low-dose leucovorin • 5-fluorouracil • advanced gastric cancer • malignant ascites


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