(4) A second dose reduction was https://www.selleckchem.com/products/Bleomycin-sulfate.html considered to be necessary (Table 1). Table 1 Dose-Reduction Criteria and Dose to be selected at Dose-Reduction Item   Oxaliplatin 5-FU (bolus) 5-FU (infusion) Neutrophil count < 500/mm 3 85 → 85 400 → 0 2,400 → 2,400 Platelet count < 50,000/mm 3 85 → 85 400 → 0 2,400 → 2,400 Non-hematological toxicity ≥ Grade 3 85 → 65 400 → 300 2,400 → 2,000 Skin symptoms ≥ Grade 3 85 → 85 400 → 300 2,400 → 2,000 Peripheral neuropathy Grade 2 85 → 65 400 → 400 2,400 → 2,400 Acute* 1 laryngopharyngeal dysesthesia (feeling of difficulty in breathing)   85 → 85 Infusion time is prolonged to 6 hours* 2 400 → 400 2,400

→ 2,400 Peripheral neuropathy ≥ Grade 3 Discontinuation     PS ≥ 3 Discontinuation     Abbreviation: PS, performance status *1 During Selleck Capmatinib the period from administration of oxaliplatin to 2 hours after completion of administration. *2 Administration of 5-FU should not be started until the completion of administration of oxaliplatin.   (5) Peripheral neuropathy of grade 3 or 4 occurred.   (6) The PS became 3 or higher.   (7) The patient refused further treatment.   (8) The investigator judged that continuation of the study was Geneticin supplier difficult for any

other reason.   Endpoints The incidence and severity of adverse events were assessed as the primary endpoints, while the duration of treatment, antitumor effect (response rate, tumor stabilization rate, and duration of response), and the safety and efficacy in elderly patients were assessed as the secondary endpoints. Adverse events and therapeutic efficacy were assessed according to the NCI-CTC (version 3) (Cancer Therapy Evaluation Program, NCI, Bethsada, Md., USA) and the RECIST guidelines (version 3) [4]. Extramural review was performed for judgment of the eligibility and handling of registered

patients, as well as for safety and efficacy assessment. Statistical analysis The chi-square test for independence, Fisher’s exact probability test, and the Mann-Whitney U test were check details used to compare patient characteristics, treatment status, adverse events, and antitumor effect. A probability (P) value of less than 0.05 was considered statistically significant for comparisons between the younger and elderly groups. The Kaplan-Meier method was used to estimate the time to treatment failure (TTF). Results Patient profile All of the 22 patients enrolled in this study were eligible. Their median age was 66 years (range: 39–79 years), including 14 non-elderly patients with a median age of 63.5 years (range: 39–69 years: younger group) and 8 elderly patients with a median age of 74.5 years (range: 71–79 years: elderly group). Although the elderly group had a higher incidence of colon cancer (P = 0.011), there were no marked differences of the other background factors (Table 2). Table 2 Patients Characteristics   < 70 Years (n = 14) ≥ 70 Years (n = 8) P values Age (median) 63.5 [39–69] 74.