Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: Results of Eastern Cooperative Oncology Group study E2399

Purpose Taxane- based concurrent chemoradiotherapy ( CCR) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation. This phase II multi- institutional trial evaluates taxane- based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx ( OP) cancer patients. Patients and Methods Eligibility required resectable stage T2N+, or T3-T4N0-3M0 biopsy- proven squamous carcinoma, age at least 18 years, PS 0 to 2, good organ function, and no prior chemotherapy or radiation. Treatment was induction paclitaxel 175 mg/m(2) and carboplatin area under the concentration-time curve ( AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m(2) every 7 days with 70 Gy if no evidence of tumor progression. Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin (< 14 gm/dL men, < 13 gm/dL women). The primary end point was organ preservation ( freedom from primary site salvage surgery or primary tumor recurrence). Results One hundred five of 111 patients ( 36 larynx, 69 OP) were eligible. Median follow- up was 36.7 months. Ninety- four percent received full- dose radiotherapy and 91% received at least five cycles of concurrent paclitaxel. No patient progressed while receiving chemotherapy. Organ preservation was 81% at 2 years after completion of therapy ( larynx 74%, OP 84%). Thirteen patients required primary-site salvage surgery ( seven larynx, six OP), and six of these have progressed and died ( three larynx, three OP). Thirteen patients developed distant metastases ( seven larynx, six OP; P =.02) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease. Two- year survival is 76% ( 63% larynx v 83% OP). Conclusion A high organ preservation rate was obtained with this regimen for OP but not for larynx patients. Toxicity was low, and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy.