Comparison of capecitabine plus oxaliplatin (CAPOX) vs paclitaxel plus carboplatin (PC) as chemotherapy in definitive chemo-radiotherapy (CRT) in carcinoma esophagus: A prospective study from a tertiary cancer center in north India.

e16100 Background: Definitive chemo-radiotherapy (dCRT) is standard of treatment for unresectable, non-metastatic esophageal cancers. Both CapOx and PC are standard chemotherapy partner with CRT. CapOx or FOLFOX has been compared with cisplatin/5FU (PF), concurrent with radiotherapy and CapOx has shown to be non-inferior to PF. As there is no prospective study of direct comparison of CapOx with PC in dCRT, we conducted a small prospective study to compare the efficacy, toxicities & QoL parameters. Methods: 50 patients of non-metastatic esophageal cancer (ineligible for surgery or those who refused surgery), adenocarcinoma or Squamous cell carcinoma (SqCC), age > 18 years, ECOG PS 0-2, were randomized 1:1 to either CapOx (arm 1, Oxaliplatin 50 mg/m 2 and Capecitabine 625 mg/m 2 PO twice a day for 5 days a week) or PC (arm 2, Paclitaxel 50 mg/m 2 and Carboplatin AUC-2 weekly), both for 5 weeks, concurrent with radiotherapy 50.4 to 54.0 Gy by IMRT technique. Co-primary end points were to compare response rates (RR) and toxicities while secondary end points were progression free survival (PFS), overall survival (OS) and QoL parameters (EORTC QLQ-C30). Results: Mean age of study population was 56.76 years (range 34 to 72), males 62 % & females 38 %, tumor site distribution was U1/3 14%, M1/3 64% and L1/3 22 %. Most of the patient had T3 stage (96% vs 92%) while N stage distribution was N0 (28% vs 56 %), N1 (52% vs 36%). Stage distribution was stage II (24% vs 48%), stage III (72% vs 44%) and IVa (4% vs 8%). Most of the patients were SqCC (92% v 100%). Mean radiation dose delivered was 53.4 Gy vs 52.9 Gy. Overall response rates were 76% vs 96% [CR 60% vs 68% (p = 0.55), PR 16% vs 28 % and PD 24% vs 4 % (p = 0.041)]. Hematological toxicities were mostly grade 1 & 2 and not significantly different in 2 arms. Non-hematological toxicity of grade 3 were esophagitis (40% vs 32%, p = 0.196) and odynophagia (36% vs 24%, p = 0.165). Hand foot syndrome was seen only in CapeOx arm (Gr 1- 32%, gr2-56%, gr3-8%). Pre- & post- treatment Weight change was not significant in 2 arms (p = 0.087). After median follow up of 8 months, Median PFS was 12 months vs 10 months (p = 0.611) and median OS was 13 month vs 12 month (p = 0.867). There was no significant difference in QoL parameters at all time points but social functioning was better in PC arm (p = 0.013) and fatigue was less in PC arm (p = 0.05). PC arm also had significantly better global health scale (p = 0.025). Conclusions: There were more disease progression in CapOx arm but both arms did not show significant differences in survival outcome. There were non-significant differences in toxicities and QoL parameters except social function and global health scale which were in favour of PC arm. Both regimes are effective and safe but small sample size and short follow up are the limitations of this study.