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The combination of docetaxel, cisplatin, and 5-fluorouracil ( DCF) as preoperative treatment for esophageal squamous cell carcinoma ( ESCC) has not been investigated. We carried out a multicenter phase II feasibility study of preoperative chemotherapy with DCF for ESCC. Patients with clinical stage II/ III ESCC ( International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy consisted of i.v. docetaxel (70-75 mg/m2) and cisplatin (70-75 mg/m2) on day 1, and continuous infusion of fluorouracil (750 mg/m2/day) on days 1-5. Antibiotic prophylaxis on days 5-15 was mandatory. This regimen was repeated every 3 weeks with a maximum of three cycles allowed. After completion of chemotherapy, esophagectomy with extended lymphadenectomy was carried out. The primary endpoint was the completion rate of protocol treatment. Forty-two eligible patients were enrolled. During chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (83%), anorexia (7%), and stomatitis (5%). Forty-one (98%) patients underwent surgery. The completion rate of protocol treatment was 90.5% (38/42). No treatment-related death was observed and the incidence of operative morbidity was tolerable. According to RECIST, the overall response rate after the completion of DCF was 64.3%. Pathological complete response was achieved in 17%. The estimated 2-year progression-free survival and overall survival were 74.5% and 88.0%, respectively. Although these data are preliminary, preoperative DCF was well tolerated. Antitumor activity was highly promising and warrants further investigation. This trial was registered with University Hospital Medical Information Network (no. UMIN000002396). [ABSTRACT FROM AUTHOR]

This phase II, open-label, single-arm study investigated sunitinib + FOLFIRI in Japanese patients with treatment-naïve unresectable/metastatic colorectal cancer. Patients received i.v. FOLFIRI (levo-leucovorin 200 mg/m2 + irinotecan 180 mg/m2, followed by 5-fluorouracil 400 mg/m2 bolus then 2400 mg/m2 46-h infusion) every 2 weeks, and oral sunitinib 37.5 mg/day on Schedule 4/2 (4 weeks on, 2 weeks off), until disease progression or treatment withdrawal. Progression-free survival ( PFS) was the primary endpoint, with a target median of 10.8 months (35% improvement over FOLFIRI alone). Seventy-one patients started a median of 3 (range 1-11) sunitinib cycles (median relative dose intensity, <60%). The median PFS was 6.7 months (95% confidence interval, 4.7-9.2) by independent review, 7.2 months (95% confidence interval, 5.4-9.5) by investigator assessment. Objective response rate (complete responses + partial responses) was 36.6% (independent review) and 42.3% (investigator assessment). Clinical benefit rate (complete responses + partial responses + stable disease) was 83.1% (independent review) and 88.7% (investigator assessment). Common all-causality, any-grade, adverse events were: neutropenia and leukopenia (both 97.2%); thrombocytopenia (84.5%); diarrhea and nausea (both 78.9%); decreased appetite (74.6%); and fatigue (66.2%). Neutropenia (96%) was the most frequent grade 3/4 adverse event. This study was closed early due to findings from a concurrent phase III study of sunitinib + FOLFIRI in non- Japanese patients with metastatic colorectal cancer. In conclusion, the median PFS for sunitinib + FOLFIRI in Japanese patients was shorter than the 10.8 month target, indicating that sunitinib did not add to the antitumor activity of FOLFIRI. This study was registered with ( NCT00668863). ( Cancer Sci 2012; 103: 1502-1507) [ABSTRACT FROM AUTHOR]

Background: Radiotherapy is often used to treat patients with unresectable advanced hepatocellular carcinoma (HCC). The present study examines the nature and frequency of adverse events with respect to liver function in such patients after radiotherapy. Methods: Forty-six patients with HCC who underwent radiotherapy were retrospectively examined. Radiotherapy was applied using coplanar 2–3-beam arrangements to a target dose of 50 Gy/5 weeks. The adverse hepatic events were evaluated according to the National Cancer Institute Common Toxicity Criteria and the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Late Radiation Morbidity Scoring Scheme during the acute phase and the late phase by following the patients for up to 1 year. The influence on survival by adverse hepatic events and other factors was analyzed. Results: The full irradiation dose of 50 Gy was given to 40 patients (87.0%). Grade 3 or 4 toxicity was observed in 18 (39.1%) within 3 months after radiotherapy and in 11 (33.3%) of 33 thereafter, respectively. The most frequent and serious adverse events were hyperbilirubinemia, hypoalbuminemia, and ascites. The independent adverse prognostic factors for survival were portal vein tumor thrombus ( P = 0.0012), tumor response ( P = 0.011), acute adverse hepatic event ( P = 0.012), and late adverse hepatic event ( P = 0.015). Conclusions: Hypoalbuminemia, hyperbilirubinemia, and ascites were important hepatic adverse events that developed after applying radiotherapy to treat advanced HCC. These adverse events seriously affected survival. [ABSTRACT FROM AUTHOR]

A previous randomized trial showed gemcitabine was superior to 5-fluorouracil in overall patient survival. However, the incremental improvement in survival was minimal. It is 2.5 years since gemcitabine has become available for the treatment of pancreatic cancer in clinical practice in Japan. The current study was conducted to examine whether treatment outcomes have changed since the introduction of gemcitabine therapy.Ninety-one consecutive patients with metastatic pancreatic cancer treated with systemic chemotherapy at the National Cancer Center Hospital East were surveyed. Patients admitted before April 2001 received 5-fluorouracil, and those admitted subsequently received gemcitabine. The patients were divided into the gemcitabine group (n = 50) and the non-gemcitabine group (n = 41), and these groups were compared for five outcomes, objective response rate, non-progressive disease rate, carbohydrate antigen (CA)19-9 response rate, actual survival time, and difference between estimated and observed survivals. The estimated survival time was determined using the prognostic index reported in the previous study.Except for the objective response rate, the four other outcomes in the gemcitabine group were significantly superior to those in the non-gemcitabine group. The frequency of non-progressive disease, CA19-9 response, and favorable prognosis compared with the estimated survival, were 58%, 22%, and 60%, respectively, in the gemcitabine group, and 22%, 6%, 30%, respectively, in the non-gemcitabine group. The median survival time in the gemcitabine and non-gemcitabine group was 5.73 and 2.87 months, respectively.It is suggested that there was a definite improvement in pancreatic cancer treatment after gemcitabine was introduced. [ABSTRACT FROM AUTHOR]