Mortality rate with irinotecan/cisplatin plus concomitant radiation therapy in patients with locally advanced esophageal squamous cell carcinoma
e15560 Background: The cisplatin/irinotecan doublet plus concomitant radiation therapy has been tested in phase II studies as a non-infusional alternative for the treatment of locally advanced esophageal squamous cell carcinoma (ESCC), showing good antitumoral activity and acceptable safety profile. Here, we describe our institutional experience with this combination, specially regarding its toxicity profile. Methods: A series of 26 patients with locally advanced, unresectable ESCC patients treated at our institution between September/2006-January/2008 is reported. Treatment consisted of cisplatin 30 mg/m2 and irinotecan 65 mg/m2 on weeks 1, 2, 4, 5, 8, 9, 11 and 12, and radiation therapy (50,4 Gy, 1,8 Gy/day) on weeks 8–12. Study endpoints were tumor response rate (RECIST), safety profile (CTCAE v3), overall and one year survival. Results: The mean age of patients was 61 years, with stage III disease in 88% of cases and performance status (ECOG) 0–1 in 90% of them. Twenty patients (77%) were available for response, with complete response, partial response/stable disease and progressive disease seen in 40%, 45% in 15% of cases, respectively. With a median follow up of 20 months, the overall survival was 9,2 months and the one-year survival 34,6%. All patients were evaluable for toxicity, with severe (grade 3–4) nausea/vomiting, diarrhea, neutropenia and thrombocytopenia documented in 45%, 33%, 18% and 13% of cases, respectively. Notably, treatment related deaths were observed in 5 cases (19%), mainly due to infectious complications, which led to the closured of this protocol due to excessive toxicity. Conclusions: In spite of its promising antitumor activity, this treatment regimen cannot be recommended for routine use due to its unacceptable treatment-related mortality. No significant financial relationships to disclose.