e15664 Background: Currently, there is no standard regimen for metastatic or recurrent upper or middle squamous cell esophageal cancer. Multiple agents including Taxanes, Ifosfamide have shown significant single agent efficacy in this subset of patients. We therefore undertook this study to test the first-line combination of TIP regimen (Paclitaxel, Ifosfamide and cisplatinum) in patients with metastatic carcinoma of the esophagus. Methods: This study evaluated the efficacy, tolerability and toxicity profile of the TIP regimen in patients with metastatic or recurrent carcinoma of the upper or middle squamous cell carcinoma of esophagus. Patients received Paclitaxel 135 mg/m2, Ifosfamide 1.3 gm/m2 day1–3, CDDP 75 mg/m2( split in day 1–2). Granulocyte Colony stimulating factors were not administered until the patient had prolonged Gr IV neutropenia or febrile neutropenia. Patients were evaluated after 3 cycles and at completion of treatment. Results: A total of 32 patients were treated with TIP regimen. 24 patients completed a median of 4 cycles of which 21 were evaluable for response assessment. 13 patients achieved a major response of which 5 patients had complete response. The median time to tumor progression was 7 months and the median survival was 13 months (range 2–36 months). The regimen was well tolerated with only 1 patient requiring dose reduction.Febrile Neutropenia occurred in 8 patients, all of whom recovered after treatment with antibiotics. There were no reported events of Gr IV peripheral neuropathy or mucositis. There were no treatment related deaths. In addition to the radiological responses, patients who responded had a significant better quality of life. Conclusions: The combination of Paclitaxel, Ifosfamide and Cisplatinum has significant activity in metastatic or recurrent esophageal cancer. This regimen is well tolerated with a high response rate. The ease of administration, cost effectiveness and suitable safety profile makes it an ideal first line regimen in metastatic esophageal cancer. No significant financial relationships to disclose.
Development and Validation of a Predictive Model for Disease Control (Dc) at First Disease Assessment, Among Patients (Pts) with Metastatic Squamous Cell Esophageal Cancer (Mscc) Treated with First-Line Chemotherapy (Ct)