A pilot study of modified neoadjuvant docetaxel/cisplatin/5-FU (TPF) to concomitant chemoradiotherapy (CT/RT) in locally advanced head and neck cancer (LAHNC): Preliminary results

Abstract

6039 Background: Sequential treatment with induction CT followed by CT/RT is highly active and under study in ongoing randomized trials. We started a pilot phase II trial to explore the efficacy, toxicity profile and organ preservation of a modified neoadjuvant TPF to concurrent CT/RT in both resectable (R) and unresectable (UR) LAHNC. Methods: One hundred seventy patients(p) with stage III-IV, PS ECOG 0–2, were included to receive 3 cycles of docetaxel 75 mg/m2 iv day(d) 1, cisplatin(P) 75 mg/m2 iv d2 and 5-FU 750 mg/m2 iv continuous infusion d2–5, every 3 weeks with prophylactic ciprofloxacin 500 mg twice daily from d6–15 of each cycle and granulocyte colony-stimulating factor as secondary or primary setting, followed by P 100 mg/m2 iv d1, 22, 43 concomitant with RT (66–70 Gy, conventional fractionation). Neck dissection was planned for p with stage N2–3 after induction CT or salvage surgery for resectable p with persistent disease at the end of treatment. Results: Main p characteristics were: median age 58 years (39–77), male 89%, ECOG 0/1/2 47%/50.6%/2.4%, stage IV 62.7%, larynx/hipopharynx/oral cavity/oropharynx 45%/12%/17.3%/25.7% and R/UR 41.8%/58.2%. Median TPF/P cycles administered were 3/3. Neoadjuvant CT/total treatment overall response rate evaluation (R/UR): 70% (73%/68%)/86% (84%/88%). Neck dissection was performed in 16 p and salvage surgery in 6 p. Organ preservation was achieved in 90.8% of R p. Main G3–4 toxicity during TPF treatment was neutropenia 11.2%, febrile neutropenia 11.2%, mucositis 11.2%, and during CT/RT mucositis 16.5%, neutropenia 16.5%. Median time to progression was 19.5 m(R:15.6, UR:20.3), and median overall survival was not reached (R:not reached, UR:32.8). Conclusions: Preliminary results indicate that modified neoadjuvant TPF followed by CT/RT is an active and well tolerated regimen in LAHNC, with satisfactory organ preservation and survival. No significant financial relationships to disclose.