Weekly cisplatin/irinotecan and radiotherapy (RT) in patients with locally advanced esophageal cancer : multicenter FFCD phase II trial.

4060 Background: A recent phase I have showed that weekly cisplatin, irinotecan and concurrent RT can be administered with moderate toxicity (J Cin Oncol 2003;21:2926-32).,patients (pts) with no prior treatment and esophageal squamous cell carcinoma (SCC) or adenocarcinoma (ADK), stage I to III (AJCC 1983), performance status ≤2, caloric intake >1500 Kcal/d and weight loss<15% were included. Chemotherapy with weekly cisplatin 30 mg/m2 and irinotecan 60 mg/m2 was administered at day 1,8,22,29,43,50,64 and 71. Concurrent RT was delivered weeks 7 to 11 (day 43 to 75) with 50Gy in 25 fractions/5 weeks. Response was assessed by clinical examination, esophageal endoscopy with biopsy, CT scan at weeks 21. Complete response was defined as no tumor detectable on esophagus endoscopy with absence of malignant cells on biopsies and no appearance of distant metastasis on CT scan. In all other cases, the pts were considered as non responders.,from 1/2003 to 12/2003, 43 pts were included, 10 stage I, 19 stage II and 14 stage III (38 SCC, 4 ADK, 1 undifferentiated). Mean age was 59.2 y (range 44-79). 32/43 pts performed treatment as planned with all courses of chemotherapy. All pts were included in analysis.Grade 3 toxicity occurred in 21/43 pts: neutropenia 9, thrombopenia 3, anemia 4, vomiting 1, mucosite 1, diarrhea 1, cardiac failure 2, renal failure 1. Grade 4 toxicity occurred in 7/43 pts: neutropenia 2, febrile neutropenia 1, sepsis during neutropenia 1, diarrhea 1, cardiac failure 1, hepatic failure 1. One toxic death was occurred (diarrhea grade 4). The complete endoscopic response rate with absence of malignant cells on biopsies was 53.5% (CI95%:38.5-68.5%). The one year survival rate will be available at the meeting.,cisplatin-irinotecan-RT is an active treatment for pts with non operable esophageal cancer. Future study with EGFr inhibitor is considered to increase response rate. [Table: see text].