Induction chemotherapy (IC) and concomitant chemoradiotherapy (CCRT) for locally advanced head and neck cancer (LAHNC)

Abstract

5600 Background: In LAHNC, CCRT has been shown to improve locoregional control and overall survival; the efficacy of IC before radiation therapy is controversial, but results from meta-analyses show a possible advantage with regimens containing cisplatin (C) and fluorouracil (FU). The value of adding IC and CCRT remains debatable. We designed a phase II study in order to evaluate the feasibility and activity of this approach. Methods: Patients (pts) with stage III-IVA squamous cell carcinoma of the head and neck or with nasopharyngeal (NP) undifferentiated carcinoma were eligible. Main endpoint was complete response to IC + CCRT. In order to differentiate between an unacceptable response rate (RR) of 70% and one acceptable of 90%, 28 pts should be enrolled (optimal design, α=.1, β=.1). Treatment consisted of 2–3 cycles of C 100 mg/m2 i.v. on day 1 and FU 1000 mg/m2/day on days 1 to 5 as i.v. continuous infusion, followed by external beam radiotherapy (RT) using a shrinking-field technique (66 to 70 Gy) with concomitant either C 100 mg/m2 on days 1–22-43 (11 pts with NP cancer) or Carboplatin AUC 1,5 every week for 7 cycles (11 pts, other tumor sites). All pts received prophylactic treatment for mucositis with benzhydamine from the first day of RT. Results: Twenty-two pts (median age 53 years, range 28–71; nasopharynx: 11, oropharynx: 8, larynx: 3) have been enrolled. During IC grade 1–2 hematologic and gastrointestinal toxicity was observed in 7 pts. Toxicity due to subsequent CCRT was: grade 3–4 mucositis in 10 pts (45,4%) with oral candidiasis in 2 pts; grade 3–4 hematologic toxicity in 5 pts; grade 3 emesis in 2 pts; grade 2 dermatitis in 10 pts; grade 2 neuropathy in 2 pts. Anemia was not observed in our series. One patient died of pneumonitis and sepsis following grade 3 neutropenia during CCRT. Dose intensity CT was 93% of planned dose. Four patients stopped RT but were able to complete the programmed dose resuming RT a few days later. Twenty-one pts were evaluable for response: 4 pts (18,2%) had progressive disease, 5 pts (22,7%) had partial response and 12 pts (54,5%) had complete clinical response (overall RR 77,3%). Conclusions: These preliminary findings suggest that IC followed by CCRT is feasible and active in LAHNC. No significant financial relationships to disclose.