Impact of radiation (RT) regimen on palliative procedures (PP) for patients with resectable locally advanced esophageal cancer treated with exclusive chemoradiation (CRT) or preoperative chemoradiation (CRT+S): results from a phase III trial of the Federation Francophone de Cancerologie Digestive (FFCD 9102)
4531 Background: The FFCD 9102 trial demonstrated that CRT is an alternative to CRT+S for responding patients. We investigated the type of PP in the follow-up (FU) period, according to the RT scheme: protracted (P-RT) vs. split course (SC-RT). Methods: Resectable T3 N0–1 M0 thoracic esophageal carcinoma were included. First sequence : 2 cycles of cisplatin and 5-FU (day (d)1 - d22) combined with RT. Two schemes of RT were allowed: P-RT (46 Gy / 4.5 weeks (w), 2 Gy / f) or SC-RT (2 one-week courses of 15 Gy, 3 Gy / f). For CRT, the same chemotherapy was given on d43, d64 and d92 combined with 20 Gy / 2w (P-RT) or 15 Gy / 1w (SC-RT). Responding patients after the first sequence were randomized between CRT and CRT+S. The impact of SC-RT vs. P-RT on PP in the FU period was explored using a Mann-Whitney test. Results: From February 1993 to December 2000, 451 pts were registered and 446 were eligible. P-RT: 161 pts, SC-RT: 285 pts. After a median FU of 47.4 months, 2-year overall survival and local relapse-free survival were for P-RT vs. SC-RT: 37.1% vs. 30.5% (p = 0.25) and 76.7% vs. 56.8% (p = 0.002), respectively. P-RT vs. SC-RT: mean length of hospital stay: 48 d vs. 60.5 d (p= 0.0003). Mean number of dilatation sessions: 0.56 vs. 0.66 (p= 0.43). Mean number of stents: 0.21 vs. 0.34 (p= 0.03). Mean number of any PP: 1.01 vs. 1.50 (p= 0.001). Mean dysphagia grade: 2.99 vs. 3.12 (p= 0.21). In the CRT+S-group, P-RT vs. SC-RT: mean length of hospital stay 55.0d vs. 68.7d (p =0.051). Mean number of dilatation sessions: 0.74 vs. 0.74 (p= 0.77). Mean number of stents: 0.09 vs. 0.18 (p= 0.44). Mean number of PP: 1.00 vs. 1.37 (p= 0.054). In the CRT-group, P-RT vs. SC-RT, mean length of hospital stay: 42.6d vs 54.0d (p= 0.053). Mean number of dilatation sessions : 0.38 vs. 0.67 (p= 0.12). Mean number of stents: 0.31 vs. 0.50 (p= 0.03). Mean number of PP: 0.83 vs. 1.86 (p= 0.0005). Conclusions: Stents, rate of PP and length of hospital stay were significantly increased with SC-RT. Dysphagia score was similar between SC-RT and P-RT at last FU. No significant financial relationships to disclose.