5 mg/dl) and liver (serum bilirubin ≤ 1.5 mg/dl) functions, normal cardiac function, absence of second primary tumour other than BYL719 datasheet non-melanoma skin cancer or in situ cervical carcinoma, no CNS involvement, no prior radiotherapy in parameter lesions, no concurrent uncontrolled medical illness. The protocol was approved and carried out according to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines,

and all patients gave their written informed consent to participate onto the trial. Treatment Treatment consisted of epirubicin 50 mg/m2 by intravenous bolus followed, 15 minutes later by docetaxel 60 mg/m2 diluted in 500 ml of normal saline as 1 h infusion, and oxaliplatin 100 mg/m2 diluted in 500 ml 5% dextrose as a 2 h infusion. All drugs were administered on day 1 of each 21-day cycle. Antiemetic treatment consisted of palonosetron 250 μg plus dexamethasone in a 10 minutes infusion before starting chemotherapy. In addition, orally prednisone premedication was used for prophylaxis of docetaxel-induced hypersensitivity and fluid retention. selleck compound Granulocyte colony-stimulating factor (G-CSF)

was used only as secondary prophylaxis once patients had febrile neutropenia or documented neutropenic infection. Treatment was postponed by a maximum of 2 weeks if the absolute neutrophil count was less than 1,500/μl or the platelet count was less than 100,000/μl. The dose of epirubicin was reduced by 25% of the previous dose in case of grade ≥ 3 stomatitis or diarrhea, whereas oxaliplatin was reduced by 25% in case of grade ≥ 2 peripheral neuropathy TCL or grade ≥ 3 diarrhea, and docetaxel by 25% in case of the following toxicities: grade ≥ 3 neutropenia lasting more than 7 days (or in SNS-032 presence of fever), second incidence of febrile neutropenia despite G-CSF support administered

after the first occurrence, grade ≥ 3 diarrhea, and grade ≥ 3 stomatitis. Chemotherapy was generally administered on an outpatient basis for a maximum of eight cycles for patients with objective responses and of six cycles for patients with stable disease (SD). Treatment was discontinued in case of unacceptable toxicity, treatment delay longer than 2 weeks, disease progression, or patients refusal. Pretreatment and Follow-Up Studies Pretreatment evaluation included clinical history and physical examination, automated blood cell count, biochemical profile, ECG, and computed tomography of thorax and abdomen. Endoscopy was performed only in case of complete remission of all measurable lesions. Blood counts were obtained weekly; biochemical profile was repeated every 3 weeks. All measurable parameters of disease were reevaluated every 6 weeks, and every 2 months during the follow-up period. Evaluation of Response and Toxicity Patients were evaluated for response to chemotherapy every two cycles of treatment.