Encouraging Pathological Complete Response Rate from Neoadjuvant Chemotherapy with Albumin-Bound Paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Esophageal Squamous Carcinoma: Preliminary Outcome of a Retrospective Study

Abstract

Objective

To evaluate the efficacy and safety of neoadjuvant chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine for locally advanced esophageal squamous cell carcinoma (ESCC).

Methods

The data of thirty-one patients with locally advanced ESCC (cT1-2N+M0, cT3-4aNanyM0) received preoperative chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine (referred as APCC regimen) were retrospectively analysed. The primary endpoint was pathological complete response (pCR) rate.

Results

The median number of chemotherapy cycles with APCC regimen every 3 weeks were 4 (range: 1–6), which was completed by 23 patients. The clinical efficacy of 30 patients was evaluated and all showed reduction of tumours in varying degrees. Five patients received radiotherapy following chemotherapy. Four patients could not receive surgery due to COVID-19 pandemic. Of the 24 patients who underwent surgery, 3 received radiotherapy following chemotherapy, the resection rate of R0 was 95.8%, 9 cases (37.5%) showed pCR and 16 cases (66.7%) showed major pathological response (MPR). Postoperative pathology of 15 cases (62.5%) were stage I (ypT0-2N0M0). Of the 21 patients who underwent surgery after neoadjuvant chemotherapy alone, 8 (38.1%) had pCR and 15 (71.4%) had MPR. The most common grade 3/4 adverse events of chemotherapy included neutropenia (35.5%) and leukopenia (9.7%). Grade 2 postoperative complications occurred in 3 (12.5%) patients.

Conclusion

The preliminary results of this study suggest that preoperative chemotherapy with the triplet regimen of albumin-bound paclitaxel, cisplatin and capecitabine for patients with locally advanced ESCC revealed significant tumour downstage and encouraging pCR rate, with well-tolerable toxicities. The role of this regimen warrants further investigation.

Keywords:

• albumin-bound paclitaxel
• cisplatin
• capecitabine
• esophageal squamous cell carcinoma
• neoadjuvant chemotherapy
• pathological complete response

Ethics Approval

The study protocol was reviewed and approved by the Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences (approval No: 20/381-2577). This study is a retrospective non-intervention study, which does not interfere with the routine diagnosis and treatment, does not affect any medical rights and interests of patients, and does not increase the risk of patients. The results of the study will be published in the form of statistical analysis without any identifiable patient information. Most of the patients in this study have completed the treatment and cannot obtain their informed consent objectively. Based on the above reasons. We have applied to the Ethics Committee for exemption from the informed consent of all patients in this study and have been approved.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare no conflict of interest.