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Aim To investigate the efficacy and safety of olanzapine in combination with palonosetron and dexamethasone for patients receiving cisplatin (≥50 mg/m2), because this antiemetic therapy has not been sufficiently examined in patients receiving cisplatin. Methods We conducted a phase II study to evaluate the efficacy and safety of olanzapine in combination with palonosetron and dexamethasone for chemotherapy naive patients receiving cisplatin (≥50 mg/m2). Patients received prophylactic dexamethasone (20 mg IV, day 1), palonosetron (0.75 mg IV, day 1), and olanzapine (10 mg, days 1–4). The patients were monitored for emesis and nausea for 120 h after chemotherapy. The primary endpoint was the complete response (CR) rate, which was defined as no vomiting episodes and no use of rescue medication for the overall period. CR rates of 65% and 45% would indicate the potential usefulness and the lower limit of interest, respectively. Results Fifty-one patients, including 37 esophageal cancer patients were enrolled, of whom 41 (80%) completed the treatment protocol as planned. The complete response rate for the overall period was 43% (95% confidence interval: 29–58); the primary endpoint was not met. Vomiting was frequently observed, with the overall rate of 51%. Most events occurred during 24–72 h after chemotherapy. Somnolence was observed in 73% of the patients, but it was well tolerated in most cases. Conclusions Olanzapine combined with palonosetron and dexamethasone did not prevent chemotherapy-induced nausea and vomiting induced by cisplatin as expected. The safety of this antiemetic therapy was confirmed.

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/m(2)) and cisplatin (70-75 mg/m(2)) on day 1, and continuous infusion of fluorouracil (750 mg/m(2)/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).

Background and Aim: Various techniques using magnifying endoscopy (ME) have been developed to enhance images of early gastric cancer (EGC) demarcations, which are often obscure. We investigated four ME methods to determine which is most effective in enhancing the recognition of EGC demarcations: conventional ME (CME), ME with narrow band imaging (NBI-ME), enhanced-magnification endoscopy with acetic acid (EME), and ME with NBI and acetic acid (NBI-EME). Methods: Thirty-seven successive patients having a total of 40 EGCs participated in the investigation. The endoscope was fixed and magnification images of EGC demarcations in each patient were recorded using four different ME methods (CME, NBI-ME, EME and NBI-EME). Eight experts and eight non-experts scored each of the four images of each lesion for ease of recognition of demarcation (1 to 4, with 4 being easiest). Results: The mean scores of expert and non-expert judges, respectively, for images acquired using each technique were: CME 1.23, 1.24; NBI-ME 2.61, 2.95; EME 2.62, 2.32 and NBI-EME 3.54, 3.50. There were significant differences between the mean scores for the four techniques (P