Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216)

Background In an effort to optimize nonoperative therapy in patients with locoregionally advanced head and neck squamous cell cancer, the Southwest Oncology Group conducted a phase II trial combining 3‐drug taxane‐containing induction chemotherapy with accelerated fractionation/concomitant boost radiation and concomitant single‐agent cisplatin. Methods Two induction courses using docetaxel (75 mg/m2 on day 1), cisplatin (100 mg/m2 on day 1), and fluorouracil (1000 mg/m2/day continuous intravenous infusion days 1–4) were given, with an interval of 21 days. Patients who were stable or responded to the chemotherapy received definitive accelerated fractionation/concomitant boost radiation with concurrent cisplatin (100 mg/m2) on days 1 and 22 of radiation. Results There were 74 eligible and evaluable patients enrolled between March 1, 2003, and August 15, 2004; 52 (70%) had stage IV disease. At least 1 grade 3‐4 toxicity was experienced by 63 patients (85%) during induction. A total of 61 patients completed induction and began concurrent chemoradiotherapy; 50 (68%) completed all planned treatment. At least 1 grade 3‐4 toxicity was noted in 53 of the 58 patients (91%) evaluated for toxicity from concurrent chemoradiotherapy. Two patients died during induction, and 2 during chemoradiation. With a median follow‐up of 36 months (range, 14–50), the 2‐year and 3‐year overall survival estimates were 70% and 64%, with 2‐year and 3‐year progression‐free survival estimates of 66% and 61%, respectively. Conclusions Three‐drug induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin is toxic but feasible within a cooperative group. In this patient cohort with advanced head and neck squamous cell cancer, overall and progression‐free survivals were encouraging, justifying further study of this approach. © 2009 Wiley Periodicals, Inc. Head Neck, 2010