Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy in patients with locally advanced esophageal cancer: A prospective, multicenter phase ll trial of the Swiss Group for Clinical Cancer Research

Abstract

4562 Background: The role of preoperative therapy in patients (pts) with locally advanced esophageal cancer remains unclear. Non-randomized and randomized studies were often performed in single and highly specialized centers. The purpose of this study was to investigate 1) the efficacy and toxicity of preoperative docetaxel-cisplatin together with radiation therapy (RT) 2) the feasibility of a complex preoperative strategy in a community-based multicenter setting. Methods: Eligibility criteria: resectable, locally advanced (uT3 or uN1, T4 if deemed resectable) squamous cell carcinoma (SCC) or adenocarcinoma (AC) of the thoracic esophagus or gastroesophageal junction (Siewert type l); staged by EUS, CT and PET scan; age 18–70y; PS <2; normal organ functions. Treatment: 2 cycles of docetaxel 75mg/m2 and cisplatin 75mg/m2 q3w, followed by weekly x5 docetaxel 20mg/m2 and cisplatin 25mg/m2 with concomitant 45 Gy RT in 25 fractions; surgery 3- 8 weeks after RT. A two stage-design was used with two primary endpoints: 1) efficacy (TRG : tumor regression grade ); 2) feasibility (successful completion of entire therapy and being alive 30 days after surgery). Results: 66 pts, 56 males, were included from 11 institutions; median age 61y (35–70y); AC 53%; SCC 46%; 53 pts (80%) completed the preoperative therapy, underwent resection and were alive 30 days after surgery; 10 pts (15%) had no resection (4 progressive disease, 4 medical reasons, 2 patient’s refusal). Of 56 (85%) pts who had surgery, 51 pts had RO-resection (91%), 5 pts (9%) died due to complications after surgery (3 after > 30 days). Conclusion: Our trimodality treatment shows encouraging antineoplastic activity with 57% histopathological responders (TRG1 and 2) and acceptable feasibility in a community-based multicenter setting. [Table: see text] No significant financial relationships to disclose.