Gastrointestinal Oncology

Introduction
The Gastrointestinal Oncology Division currently focuses on chemotherapy with or without radiation therapy against gastrointestinal malignancies.We treat many patients practically, and participate in many clinical studies to develop a new or standard treatment prospectively. We also investigate the relationship among clinicopathological features, biological characteristics and clinical outcomes of each treatment for the purpose of developing treatment-oriented diagnosis, stratification or individualization of treatment.

Routine Activities　
We participate in many clinical studies. A number of inpatients has been increasing year by year. We indicate outpatient-based chemotherapy for possible candidates including new patients. In 2001, 51 patients started chemotherapy at outpatient division, and more than 20 patients receive chemotherapy everyday. The average hospital stay of patients treated with chemotherapy or palliative therapy was as short as 15.1 (median, 10) days. The most appropriate treatments for all patients are determined in case conferences consisting of medical, surgical, radiation oncologists, and diagnostic radiologists, and are initiated after obtaining patientsi informed consent.

New Developments
1. Esophageal Cancer
For potentially resectable esophageal cancer, our retrospective study showed a comparable survival after chemoradiotherapy (CRT) with 5-FU + CDDP + RT to surgical resection, and a phase II study of the same regimen for stage II/III esophageal cancer is going on (JCOG9906). To select a suitable treatment, CRT or surgery, we investigated relationship between clinicopathological and biological markers and their treatment effects, and reported that lymph node metastasis and factors related to malignant potential might be an indicator(ASCO #632). We also reported that CRT has a curative potential for T4 suquamous cell carcinoma of the esophagus, even in patients with malignant fistula (ASCO #642). For development of new treatments, in a phase I/II study of nedaplatin + 5-FU + RT for T4 disease (JCOG-DI), the recommended dose has been determined,and it has moved to the phase II step. Against metastatic esophageal cancer, a phase II study of taxotere has been completed, and a phase II study of nedaplatin + 5-FU (JCOG9905) is underway. Our endoscopic criteria of complete remission in primary lesions appears to be an appropriate surrogate endpoint for survival (ASCO#638), and has been proposed to Guide Lines for the Clinical and Pathologic Studies on Carcinoma of the Esophagus.
2. Gastric Cancer
During 2001, about 100 patients was enrolled to the phase III study, 5-FU vs CPT-11 + CDDP vs S-1, in advanced gastric cancer patients (JCOG9912). In a phase I/II study of S-1+CDDP the recommended dose was determined, and objective responses were seen in 19 of the 25 patients with a response rate of 76% (ASCO#656). A global randomized phase II trial of Iressa, an inhibitor of EGFR, has been completed. Retrospective analysis of a total of 643 patients enrolled onto four phase II and one phase III JCOG studies for advanced gastric cancer between 1985 and 1997 showed a 5-year survival rate of 2%, and performance status and number of involved organs were prognostic factors. Japanese nation-wide post marketing survey of S-1 showed this agent is safe for patients with appropriate indication, and confirmed our previous report that impairment of renal unction was a risk factor for severe toxicities. In our clinical practice of S-1, consecutive 51 patients showed 2-year survival rate of 35%, and this result seemed to be outstanding among recent chemotherapy regimens.
3. Colorectal Cancer
Phase I study of oxaliplatin (l-OHP) has determined the recommended dose, and its phase II study for metastatic colorectal cancer refractory to 5-FU has been initiated. We are going to report the final results of the phase II study of UFT + oral leucovorine, which is the first bridging study between Japan and the United States.
4. Gastric Lymphoma
A multi-institutional prospective study of stomach preserving treatment including eradication of H. pylori,radiation and chemotherapy against localized gastric lymphoma is now underway. This study would define new non-surgical treatment strategy for localized gastric lymphoma.

F. NAGASHIMA

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