Study of efficacy and tolerability of paclitaxel and carboplatin as a concurrent chemotherapeutic radiation sensitizer regimen in patients of esophageal cancer: Prospective observational study from tertiary center in northern India.

Abstract

e16526 Background: Neo-adjuvant chemotherapy followed by surgery is the standard of care in non metastatic oesophageal cancers. After the overall survival benefit observed in Cross trial, Paclitaxel and Carboplatin based neo-adjuvant chemoradiation has become the preferred treatment modality. There is paucity of data of its efficacy and tolerability in Indian patients. So this prospective study was done to assess the same. Methods: We enrolled 64 patients aged 18-75 years with histologically confirmed, potentially resectable squamous-cell carcinoma of the esophagus or esophagogastric junction from Aug 2017 to Jan 2019. On days 1, 8, 15, 22, and 29, carboplatin AUC 2 and paclitaxel 50 mg/m2 intravenously and a total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy each by external-beam radiation. Pathological complete response rate, Clinical response based on PET-CT scan and tolerability of paclitaxel and carboplatin as a concurrent chemotherapeutic radiation sensitizer regimen was studied. Results: 23 out 64 patients underwent surgery while others were either lost to follow up or they refused for surgery. Of these 23, 87.5% could complete all 5 planned cycles of chemotherapy. Complete pathological response was found in 73.9% patients. Statistically significant correlation was found between pathological and PET-CT based response (p-0.044). 4 patients showed distant progression on PET-CT based evaluation after neoadjuvant chemo radiotherapy before surgery. The most common major hematologic toxic effects were leukopenia (14%) and neutropenia (12.5%). Febrile neutropenia and grade 3 anemia was observed 2 and 4 patients respectively. The most common major non-hematologic toxic effects were vomiting (4.6%), nausea (3.1%), bronchoesophageal fistula(3.1%). Post operative mortality was seen in 1(4.3%) patient. Grade 3 pulmonary complications, atrial fibrillation and anastomotic leak was observed in 1 patient each. Conclusions: Concurrent chemoradiotherpy with weekly paclitaxel and caboplatin is well tolerated in Indian patients. High complete resection rate and PCR rate can be achieved with this regime with manageable adverse effect profile. Response evaluation with PET-CT after completion of preoperative therapy has correlation with pathological complete response.