Is laryngeal preservation (LP) with induction chemotherapy (ICT) safe in the treatment of hypopharyngeal SCC? Final results of the phase III EORTC 24891 trial

Abstract

5531 Background: In 1986, the EORTC HNCCG initiated a randomized phase III trial to assess whether LP using ICT followed by radiation therapy (XRT) was as safe as the conventional treatment: total laryngectomy with partial pharyngectomy (TLP), radical neck dissection (RND) and postop XRT. Preliminary results were published in 1996; this updated analysis has been carried with a median follow-up of 10 years. Methods: 202 patients (pts) candidates for TLP + RND + XRT were randomly assigned to receive in the surgery arm (arm 1) this treatment or in the ICT arm (arm 2) up to 3 cycles of CDDP (100mg/m2 day 1) and 5FU (1000 mg/m2 days 1–5) followed in case of complete response by XRT or by TPL + RND + XRT in the other cases. The endpoints were survival (OS and PFS) and LP defined as a functional larynx free of disease (larynx in place without tracheotomy, feeding tube or gastrostomy, and without evidence of local disease). Results: this final analysis was carried out on 194 eligible pts (arm 1: 94, arm 2: 100). There were 92 males (98%) in arm 1 and 94 (94%) in arm 2. Stage II, III and IV respectively numbered 6, 51 and 37 in arm 1 and 7, 59 and 34 in arm 2. Postop courses and quality of surgical resections did not differ between both arms (ie. initial surgery in arm 1or surgery after ICT in arm 2) as well as tolerance to XRTwhatever its schedule. Ultimate disease control, including successful salvage surgeries after XRT, was not significantly different between both arms. As of December 2003, 14 % of pts in arm 1 and 17 % of pts in arm 2 were still alive. The hypopharynx SCC evolution was the cause of death in 43 pts in arm 1 and in 41 pts in arm 2. The 5-yr.OS was 33 % in arm 1 and 38 % in arm 2, the 10-yr. OS was respectively 14 % and 13 %. The 5-yr. PFS was 26 % in arm 1 and 32 % in arm 2, the 10-yr. PFS was respectively 8.5 % and 11 %. In arm 2 survival with a functional larynx in place was 22 % at 5 years and 9 % at 10 years. Conclusions: this final analysis has confirmed the preliminary results. This LP strategy provided similar survival curves as compared with conventional treatment and allowed 2/3 of the survivors to retain their larynx. No significant financial relationships to disclose.