P-054. Preoperative concurrent Paclitaxel, Carboplatin and radiotherapy in stage III/IV resectable cancer of the oropharynx and oral cavity: Results of a multicenter phase-II study

Aims: Taxol and carboplatin have both demonstrated excellent radiosensitization through two mechanisms, namely cell blockage in G2-M phase and inhibition of DNA repair, respectively. A prospective Phase II trial was initiated using Paclitaxel and carboplatin (CBDCA) with concurrent conventional fractionated external beam radiotherapy as preoperative regimen. Methods: From May 1998 to October 2000 53 patients received five cycles of weekly Paclitaxel (40 mg/m²), CBDCA (AUC of 1.5) with conventional radiotherapy (40 Gy). Three to four weeks after chemoradiotherapy resection of the tumor with neck dissection was performed. Results: The patient characteristics were as follows: men 44, women nine; median age 57 years (range 31-76 years); Stage III 11, Stage IV 42. Site: oropharynx 12, oral cavity 41. One patient was excluded for protocol violation; one treatment-related death (1.8%) occurred. Fifty-one patients were evaluable for toxicity and response. The clinical response of the primary tumor was as follows: complete response (CR) 31/51 (61%); partial response (PR) 20/51 (39%). CTC grade 2 or 3 mucositis occurred in all 53 patients. Predominant hematological toxicity was leukopenia CTC grade 3 (33%), grade 4 (10%), thrombocytopenia CTC grade 3 (14%) and hemoglobin CTC grade 3 (14%). Mean follow-up was 10.6 months (95% C.I. 8.4-12.8; range 1-27 months,). One- and 2-year-overall survival were 83%. Conclusion: Concurrent Paclitaxel, carboplatin and radiotherapy as preoperative treatment is highly effective and resulted in excellent clinical and pathological responses. Close monitoring of patients and adequate supportive therapy is strongly recommended. Mucositis was the most common and significant morbidity.