OP044: Paclitaxel (P) and cisplatin (C) concurrent with radiotherapy (RT) for larynx preservation (LP) in advanced resectable laryngeal (L) and hypopharyngeal (HP) squamous cell carcinoma (SCC): Final results of a prospective multicenter phase II trial

Abstract

Background Since the results of the RTOG 9111 trial, cisplatin-based chemoradiation (CRT) has been the standard of care forLPin advanced laryngeal SCC. Recently, the role of taxanes in managing locally advanced head and neck SCC has been studied. In 2002 we reported the interim results of a phase II clinical study designed to test the efficacy of P and C concurrent with RT for organ preservation in advanced L and HP SCC. Here we report the long term survival and LP rates. Methods Eligible patients had untreated advanced L and HP SCC, stage T3N0 or higher and suitable for radical total laryngectomy. Treatment consisted of weekly P (30 mg/m2) and C (20 mg/m 2 ) concurrent to RT up to 7040 cGy in 180 cGy/day fractions. Response evaluation was performed at 5040 cGy and at 4 weeks after completing RT. Salvage surgery was planned for patients not responding at 5040 cGy, residual tumor at the end of RT or at the time of local recurrence. Neck dissection was planned for clinically positive neck (cN1-3). Written informed consent was obtained from all recruited patients. Results Between 06/1999 and 02/2009, 74 patients were enrolled in three institutions in Brazil (55 L; 19 HP), 62 male and 12 female with a 58-year median age (39–74). Toxicity analysis was done in an initial set of 48 patients and grade (G) 3 and 4 mucositis was noted in 27% of patients, G 3-4 odynophagia in 50%, G 3-4 radiodermatitis in 35% and G 3-4 leucopenia in 13% with no treatment-related death. The confirmedcomplete response rate to treatment was 86%. At a median follow up of 54 months the LP rate at 2 and 5 years were 70% and 67%, respectively. Recurrence free survival (RFS) was 52% at 2 and 42% at 5 years and overall survival (OS) was 81% and 56% at 2 and 5 years, respectively. Conclusion The finding of similar LP rate and survival compared to the recent reports of high-dose cisplatin CRT and neoadjuvant 3-drugCT followed by CRT in an advanced disease population suggests a role for platinum plus taxane as a radiosensitizer regimen in this scenario with acceptable toxicity, but further evaluation in a direct comparative trial with the standard regimen is needed.