Comparative analyses of paclitaxel/carboplatin with cisplatin/5-fluorouracil-based chemoradiation in locally advanced inoperable upper and middle third esophageal cancer: A randomized prospective pilot study.

Introduction: Chemoradiation therapy (CRT) remains the treatment of choice for inoperable locally advanced esophageal cancer (LAEC). Several CRT regimens are existent in esophageal cancer, but definitive conclusions are lacking. We performed a pilot study to compare treatment outcome, survival, and toxicities in inoperable upper and middle third esophageal cancer patients undergoing CRT using either paclitaxel/carboplatin or cisplatin/5FU based regimen.

Methods: Patients were randomised in two arms (arm A and arm B). In Arm A, taxane-based (Paclitaxel+carboplatin) and in arm B non-taxane-based (cisplatin+5FU) doublet chemotherapy drugs were given concurrently with external beam radiation therapy (EBRT). EBRT in two phases up to a total dose of 54 Gy/27#@2Gy/# was given. Response was subsequently assessed using Response evaluation criteria in solid tumors (RECIST v1.1) and toxicities utilizing Common Terminology Criteria for Adverse Events (CTCAE v 4.0).

Result: The overall response rate (ORR) in the taxane-based group was higher than the non-taxane-based group, but was not significantly different (p=0.851). Regarding hematological toxicities, anaemia and reduced cell counts were more in the taxane group compared to the non-taxane group while non-hematological toxicities were comparable. Similarly, better survival with late toxicities were seen with taxane-based arm when compared to non-taxane-based arm, though it was not statistically significant.

Conclusion: Our pilot analysis highlights the fact that paclitaxel/carboplatin CRT shows better response, survival, and comparable toxicities when compared to cisplatin/5FU, though statistically nonsignificant. Further randomised prospective trials with large sample size are warranted.