Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy (RT) in patients with locally advanced esophageal cancer: Final results of the multicenter phase ll trial SAKK 75/02

Abstract

4550 Background: The purpose was to investigate the efficacy, toxicity and feasibility of preoperative docetaxel-cisplatin together with RT in a 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 ×5 docetaxel 20mg/m2 and cisplatin 25mg/m2 with concomitant 45 Gy RT in 25 fractions; surgery 3–8 weeks after RT. Simons two stage design was used. Primary endpoint was histopathological response rate according to Mandard (Cancer 1994). Results: 66 pts, 56 males, were included from 11 institutions; median age 61y (35–70y); AC 53%; SCC 46%; 9 pts (14%) had no resection (4 progressive disease, 4 medical reasons, 1 patient's refusal). Of 57 (86%) operated pts, 53 pts (93%) had RO-resection, 6 pts died due to complications after surgery (3 after > 30 days). Four pts needed a feeding tube before start of treatment and 2 during treatment. The most frequent grade 3/4 toxicity of chemoradiotherapy was Dysphagia in 21%. 32 pts (48% of all included pts) achieved complete or nearly complete histopathological remission (TRG 1 or 2), 19 SCC (64% of SCC) and 13 AC (34% of AC). After a median follow up of 29 months (CI: 24–32), median time to progression or death was 22.5 months (CI: 14.0–28.3). Median overall survival was 39.7 months (lower CI: 27.0). 27 pts (40%) are still alive and without residual or recurrent disease. Conclusions: This trimodality treatment shows encouraging antineoplastic activity with 48% histopathological responders, the survival data compares favorable with other trials and it is feasible in a community-based multicenter setting. In most cases, the insertion of feeding tubes during therapy was not necessary due to the induction chemotherapy. No significant financial relationships to disclose.