Clinical report 941 A phase II study of intra-arterial chemotherapy of 5-fluorouracil, cisplatin, and mitomycin C for advanced nonresectable gastric cancer Maoquan Li a , Jiaxing Zhang a , Daoyuan Wang a , Baoliang Zhong b , Steven Tucker c , Chenhui Lu a , Jie Cheng a , Chuanwu Cao a , Jiahua Xu a , Jichong Xu a and Hui Pan a 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/m 2 , cisplatin 50 mg/m 2 , and mitomycin C 10 mg/m 2 (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/m 2 , cisplatin 50 mg/m 2 , and mitomycin C 10 mg/m 2 is a tolerated treatment modality with promising activity in patients with previously untreated AGC. Anti-Cancer Drugs 20:941–945  c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins. Anti-Cancer Drugs 2009, 20:941–945 Keywords: advanced gastric cancer, cisplatin, 5-fluorouracil, intra-arterial infusion chemotherapy, mitomycin C a Department of Interventional Radiology, Shanghai 10th People Hospital, Tongji University, Shanghai, b School of Public Health, Peking University, Beijing, PR China and c Pacific 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: drmaoquan.li@gmail.com Received 11 July 2009 Revised form accepted 9 August 2009 Introduction Although the incidence of gastric carcinoma has fallen in most Western countries, it remains a significant problem in terms of global health and is the second most common cause of cancer mortality worldwide [1]. Gastric cancer is often diagnosed at a very advanced stage, with approxi- mately half of all patients presenting with unresectable, locally advanced, or metastatic disease. Four randomized studies comparing best-supportive care with best-supportive care and chemotherapy for advanced gastric cancer (AGC) have shown that chemotherapy can improve survival and quality of life (QoL) [2–5]. Since then, various combina- tion chemotherapy regimens and methods were tested in trials in patients with AGC. The development of more effective and less toxic treatment options for gastric cancer is the goal of many researchers. Intravenous (i.v.) chemotherapy is usually performed, but for improved curability or operability, intra-arterial chemotherapy has also been performed effectively [6,7]. Kosaka et al. [7] investigated the therapeutic efficacy of intra-arterial infusion chemotherapy for AGC, and found that the response rate (RR) of tumors to intra-arterial infusion chemotherapy was significantly higher than that to systemic infusion chemotherapy (31 vs. 13%). The theoretical advantages of intra-arterial chemotherapy over i.v. chemotherapy are that it provides increased drug concentrations at the tumor site and decreased systemic drug levels and toxicity, and allows for continuous tumor exposure to chemotherapeutic agents with the possibility of systemic rescue. The lymph nodes draining the stomach (which are also supplied by the celiac axis) receive cytotoxic perfusion, and the liver is also infused directly by higher concentrations of cytotoxic agents from both the hepatic artery and the portal venous circulation [8]. On the basis of these encouraging results, we con- ducted a phase II trial to assess the efficacy and safety of intra-arterial infusion chemotherapy of 5-fluorouracil (5-FU), cisplatin, and mitomycin C (MMC) for pre- viously untreated patients with AGC. Patients and methods Eligibility criteria All the patients involved in this study had histologically confirmed metastatic or recurrent gastric adenocarcinoma 0959-4973  c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/CAD.0b013e328331af3a Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.