gms | German Medical Science

Background: Organ preservation with multimodality treatment in advanced laryngeal and hypopharyngeal cancer is coming up as an attractive alternative for total laryngectomy in Germany. A prospective multicenter phase II trial was performed to evaluate the effect of induction chemotherapy (ICHT) with paclitaxel/cisplatin followed by accelerated-hyperfarctionated (concomitant boost) radiotherapy (RT) in responders on larynx preservation, tumor control, survival and salvage surgery in patients with larynx/hypopharynx carcinoma eligible for total laryngectomy (TL) or TL plus partial pharyngectomy (TLPP).

Patients and Methods: 71 patients (40 larynx, 87,5% St.III,IV; 31 hypopharynx, 93,6% St. III,IV) eligible for TL or TLPP were enrolled onto a prospective multicenter study and treated with ICHT (200 mg/m(2) paclitaxel, 100 mg/m(2) cisplatin; day 1, 22) according to the DeLOS-protocol. Participating centers were the Universities of Würzburg, Hamburg, Heidelberg, Halle, Düsseldorf, Marburg, Tübingen, Köln, Homburg and medical centres of Kassel, Karlsruhe, Nordhausen. Patients with complete or partial tumor response proceeded to RT (69.9 Gy in 5.5 weeks). Non-responders received a TL/TLPP followed by postoperative RT (56-70 Gy in 51/2 to 7 weeks).

Results: The response rate to ICHT for larynx cancer was 70% (7,5% complete, 62,5% partial response) and for hypopharynx cancer was 84,3% (6,9% complete, 77,4 partial response). Overall survival after 24 months was 71,6% (95%-KI: 59.9% - 83.3%), laryngectomy-free survival after 24 months was 54.3% (95%-KI: 42.1% - 66.6%). Laryngectomy was indicated in 15 non-responders after ICHT. Five of the 15 non-responders refused the laryngectomy. Two of the five received RT instead and had no evidence of disease 2 years after RT. Late toxicity was tolerable (dysphagia III,IV lent soma: 1,8%) and salvage surgery without major complications.

Conclusion: In a large portion of patients eligible for TL or TLPP the larynx could be preserved after ICHT with paclitaxel/cisplatin followed by accelerated-hyperfractionated RT. Because of the relatively high proportion of non-responders after ICHT refusing the indicated laryngectomy, the role of ICHT to select patients for surgical or organ preservation therapy has to be questioned.