393TiP A phase II trial of nedaplatin, 5-fluorouracil and docetaxel for induction chemotherapy with local advanced squamous cell carcinoma of the head and neck

Abstract

Background Local advanced squamous cell carcinoma of the Head and Neck treated induction chemotherapy. That regimen was TPF (docetaxel 75mg/m2 on day1, cisplatin 75mg/m2 on day 1, and fluorouracil 750mg/m2 per day on days 1through5) at 3-week intervals. TPF was high response rate and high advance events. Response rate was 68-72%. Advanced events were 30-80% of Grade 3 to 4 neutropenia, 5-15% of febrile neutropenia, 10% of Grade 3 to 4 anorexia. But subsequent therapy, such as radiation or chemoradiation, surgery was 70-78%. The reasons were all most advance events and progression. So we think that high response rate and low advance events is regimen. That regimen was Nedaplatin, 5FU and docetaxel (UDON) for squamous esophagus cancer in Japan. Response rate of UDON was 78%. Advance events of UDON were very low. No Grade 4 or higher advance events was observed. Grade 3 neutropenia was 55%. No patient developed a febrile neutropenic infection. Non-hematological advance events higher than grade 3 were not observed. So we recommended UDON regimen with local advanced squamous cell carcinoma of the Head and Neck. Trial design: Its primary objective was completion rate of treatment. The secondary objectives of the study were to obtain toxicity, response rate, progression free survival and overall survival data. Eligible patients received 2 cycles of UDON (docetaxel 35mg/m2 on day1 and 15, nedaplatin 90mg/m2 on day 1, and fluorouracil 800mg/m2 per day on days 1through5) at 4week intervals. Patients eligible for inclusion in this study were aged 20-75 years at the time of registration and were local advanced squamous cell carcinoma of the Head and Neck. All patients had previously untreated. Inclusion criteria also included an Eastern Cooperative Oncology Group performance status of 0 or 1, as well as adequate liver, bone marrow, renal, and cardiovascular functions, as evidenced by the following measures. Patients with tumors of the nasopharynx and the nasal and paranasal cavities were excluded. Eligible patients signed an informed consent form before being included in the trial. If completion rate of treatment was 90%, a sample size of 28 patients would ensure a power of at least 80% at a one-sided significance level of 2.5%. Clinical trial indentification This study has been registered with UMIN Clinical Trials Registry, number UMIN 000022191. Legal entity responsible for the study Department of Medical Oncology Nara hospital Kindai University School of Medicine Funding Department of Medical Oncology Nara hospital Kindai University School of Medicine Disclosure All authors have declared no conflicts of interest.