CLINICAL REPORTSA phase II study of intra-arterial chemotherapy of 5-fluorouracil, cisplatin, and mitomycin C for advanced nonresectable gastric cancerLi, Maoquana; Zhang, Jiaxinga; Wang, Daoyuana; Zhong, Baoliangb; Tucker, Stevenc; Lu, Chenhuia; Cheng, Jiea; Cao, Chuanwua; Xu, Jiahuaa; Xu, Jichonga; Pan, HuiaAuthor Information aDepartment of Interventional Radiology, Shanghai 10th People Hospital, Tongji University, Shanghai bSchool of Public Health, Peking University, Beijing, PR China cPacific Cancer Centre, Singapore Correspondence to Dr Maoquan Li, MD, PhD, Departments of Interventional Radiology, Shanghai 10th People Hospital, Tongji University, No. 301, Yanchang Road, Shanghai 200072, PR China Tel: +86 21 6630058; fax: +86 21 6630058; e-mail: [email protected] Received 11 July 2009 Revised form accepted 9 August 2009 Anti-Cancer Drugs: November 2009 - Volume 20 - Issue 10 - p 941-945 doi: 10.1097/CAD.0b013e328331af3a Buy Metrics Abstract The best choice of chemotherapy regimen for patients with advanced gastric cancer (AGC) is still a matter of controversy and requires further investigation. This study was performed to evaluate the efficacy and safety of intra-arterial infusion chemotherapy of 5-fluorouracil 1000 mg/m2, cisplatin 50 mg/m2, and mitomycin C 10 mg/m2 (FCM) repeated every 6 weeks, as first-line treatment for AGC. Forty-seven (95.9%) of the 49 patients were assessable for response. Four cases of complete response and 28 cases of partial response were confirmed, giving an overall response rate of 65.3% [95% confidence interval (CI): 52.0–78.6%]. The median time to progression and overall survival for all patients was 8.3 months (95% CI: 6.8–9.8 months) and 14.5 months (95% CI: 12.0–17.0 months). The estimate of overall survival at 12 and 24 months was 55.1% (95% CI: 41.2–69.0%) and 18.4% (95% CI: 7.5–29.2%), respectively. Most patients experienced neutropenia during their course of therapy with 21.3% of patients (n = 10) for grade 3/4 neutropenia. Grade 3 stomatitis, lethargy, and palmar-plantar erythema were observed in two (4.3%), eight (17.0%), and one (2.1%) patients, respectively. Yet, no grade 4 nonhematological toxicity was observed. Intra-arterial infusion chemotherapy of 5-fluorouracil 1000 mg/m2, cisplatin 50 mg/m2, and mitomycin C 10 mg/m2 is a tolerated treatment modality with promising activity in patients with previously untreated AGC. © 2009 Lippincott Williams & Wilkins, Inc.