Pre-operative chemo-radiotherapy followed by surgery compared to surgery alone in patients with stage II and III esophageal cancer

ABSTRACT

Current primary treatment options for esophageal cancer are surgery only or concomitant chemo-radiotherapy [CRT] and the long-term survival of patients with locally-advanced disease is rare. Pre-operative concomitant CRT seems to be beneficial, mostly in patients who achieve a complete pathologic response [pCR] after CRT. In this study the efficiency and toxicity of pre-operative CRT in patients with locally-advanced esophageal cancer was analyzed as well as the influence of CRT on the survival. Thirty patients with stages II and III esophageal cancer were randomly assigned to surgery alone and another 30 patients were assigned to surgery after 80 mg/m[2] cisplatin on day 1, 800 mg/m[2] fluorouracil on days 1 - 4, with concurrent radiotherapy of 45 Gy given in 22 fractions over 4.5 weeks. The primary end-point was progression-free survival and the secondary end-points were overall survival, tumor response, toxic effects, patterns of failure and quality of life. Progression-free survival and overall survival did not differ between both groups [PFT P=0.16, Median survival P=0.34]. The chemo-radiotherapy and surgery group had more complete resections with clear margins than did the surgery alone group [24 of 30 [80%] versus 14 of 30 [47%], P= 0.001], and had fewer positive lymph nodes [11 of 30 [37%] versus 20 of 30 [67%], P= 0.012]. Neo-adjuvant chemo-radiation [NCRT] followed by surgery is associated with a small non-statistically significant improvement in the overall survival. Whether this benefit is sufficient to warrant the considerable expense and risk associated with NCRT should be the subject of further larger randomized trials