The induction chemotherapy (ICT) with triweekly TPF had been considered as an effective treatment in locally advance squamous cell carcinoma of head and neck (SCCHN). However, the treatment needs inpatient care and may have more toxicities for Asian patients. We conducted a phase 2 study of alternative biweekly TPFL as induction chemotherapy and evaluated the outcome and toxicities.
Patients with locally advanced SCCHN were enrolled in the study. Induction chemotherapy with Docetaxel 50mg/m2, cisplatin 50mg/m2, 5-fluorouracil 2500 mg/m2 and leucovorin 250 mg/m2 was administered biweekly for six cycles, followed by local treatment including concurrent chemoradiotherapy, bio-radiotherapy or surgery plus adjuvant RT. Our primary endpoint is response rate after ICT.
Total 58 patients were enrolled in the study from June 2014 to September 2015. The median age is 53 years (from 28 to 69 y/o). The patients’ characteristics was mentioned as: primary site of oral cavity/oropharynx/hypopharynx: 18/25/15; stage IVa/IVb: 35/23; male /female: 54/4; performance status ECOG 0-1/2:57/1. In the oropharyngeal cancer patients neither p16 nor HPV16 status was not studied. Of those 58 patients, 56 patients received at least 4 cycles of chemotherapy. The overall response rate after ICT was 89.6 % (CR: 31% PR: 58.6%). Two patients escaped during induction chemotherapy. Grade 3/4 neutropenia was 25/9%; grade 3/4 mucositis was 1.7%; grade 3/4 diarrhea was 1.7%. Infection rate was 19%. The response rate after following treatment was 75 % (CR: 66.0%, PR: 9.0 %) The median follow-up time was 31.8 months. The overall 3 years PFS/OS was 34.3 %/56.1%. Local recurrence rate was 29.3% and distant metastasis rate was 10.3%. Six patients had second primary tumor. (10.3%) The 3 years PFS of patients with CR/PR were 59.3%/25.5%. The 3 years OS of patients with CR/PR were 81.7%/49.1%.
Biweekly TPFL induction chemotherapy has excellent response rate in locally advanced SCCHN. In addition, the grade 3/4 adverse event was acceptable. The patients achieved CR after induction chemotherapy had very good outcomes.
Clinical trial identification
Legal entity responsible for the study
Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital.
Sanofi, Taiwan branch.
All authors have declared no conflicts of interest.