Outcome of the nonrandomized patients in the FFCD 9102 trial: Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus

Abstract

4555 Background: For locally advanced thoracic oesophageal cancers, the FFCD 9102 trial have demonstrated that for responders chemoradiation only was equivalent to chemoradiation followed by surgery in term of overall survival. What about nonrandomized patients (Bedenne L et al. J Clin Oncol 2007;25:1160–8)? Methods: Out of 451 patients, 192 were not randomized because of no objective response or improved dysphagia, contraindication to either surgery or continuation of chemo-radiation, patient’s refusal, death or no further treatment. Results: At the end of the induction chemo-radiation, there was no difference between randomized and non-randomized patients in term of age, tumor height and diameter, doses of chemotherapy or radiotherapy. However, weight loss, body surface and Spitzer QoL Index were significantly different. Duration of follow-up was identical: 47.3 months vs 48.1 months (NS). Overall survival was significantly lower in non-randomized patients: median survival 11.5 months (SE = 1.09 months) vs 18.9 months (SE = 1.03 months) in randomized patients (HR = 1.40 [95%CI, 1.13 to 1.74], p = 0.0024). In the non-randomized group 112 patients were operated on, among them 80 had R0 resection (42%). For all patients operated on median survival was 17.3 months (SE = 0.65 months) versus 6.1 months (SE = 0.46 months) in non-operated patients (p < 0.0001), and was not different from survival of the randomized ones (p = 0.58). Conclusions: Surgery is a valuable option for patients non responding to a planned exclusive chemoradiation therapy. No significant financial relationships to disclose.