Poster 112, Sprache: EnglischKüttner, Christian/Eckardt, André/Rades, D./Wildfang, Ingeborg/Hofele, Christof/Dammer, Ralf
Objective: Based on documented excellent radiosensitization effects, a prospective phase II trial was initiated using paclitaxel (P) and carboplatin (C) with concurrent conventional fractionated radiotherapy followed by surgery of the primary tumor and regional neck nodes.
Methods: From 6/98 - 8/99 twenty-eight patients (pts) received 5 cycles of weekly P (40mg/m2), C (AUC 1.5) with conventional radiotherapy 40Gy. Surgery was performed within 3-4-weeks after chemoradiation.
Results: Pts characteristics: 23 males, 5 females, mean age 54 (range 40-71); stage III 6, stage IV 22. Site: oropharynx 6, oral cavity 22. Twenty-seven pts were evaluable for toxicity and response. One early death was reported due to septic neutropenia. Clinical response was as follows: CR (14/27 52%); PR (13/27 48%). Twenty-three pts were evaluable for pathologic response after surgical resection. Pathological response was as follows: pCR (10/23 44%); pPR(13/23 56%). CTC grade 2 or 3 mucosistis occured in all pts. Hematologic toxicity was as follows: hemoglobin CTC grade 3 (14%), leukocytes CTC grade 1 (24%), grade 3 (33%), grade 4 (10%), thrombocytes CTC grade 2 (10%), grade 3(14%).
Conclusions: Concurrent P/C and radiotherapy resulted in excellent clinical and pathological response rates in advanced stage disease. Mucositis was the most common and significant toxicity.
Schlagwörter: Paclitaxel, Carboplatin, phase-II-clinical-trial, head and neck cancer, squamous cell carcinoma, chemotherapy, radiotherapy, Dösak