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ePoster Display

1378P - A single-center, prospective, open-label, single-arm trial of sintilimab with paclitaxel and carboplatin as a neoadjuvant therapy for esophageal squamous carcinoma

Date

16 Sep 2021

Session

ePoster Display

Presenters

Zhi Zhang

Citation

Annals of Oncology (2021) 32 (suppl_5): S1040-S1075. 10.1016/annonc/annonc708

Authors

Z. Zhang1, J. Ye2, H. Li2, M. Du2, D. Gu2, J. Zhang3, W. Chen2, C. Xu4, Y. Fang5, J. Zhang6, K. Zhao7, G. Zhou5

Author affiliations

  • 1 Department Of Thoracic Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 2 Department Of Radiotherapy, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 3 Department Of Pathology, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 4 Department Of Respiratory, Children's Hospital Affiliated to Nanjing Medical University, 210009 - Nanjing/CN
  • 5 Department Of Oncology, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 6 Medical Marketing Department, 3D Medicines Inc., 201114 - Shanghai/CN
  • 7 Department Of Radiotherapy, Fudan University Shanghai Cancer Center, 201114 - Shanghai/CN
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Abstract 1378P

Background

Although neoadjuvant chemotherapy has been recommended for resectable ESCC patients, the 5-year overall survival rate was less than 50%. Immune checkpoint inhibitors have been shown to be efficient for advanced ESCC, while few studies focus on the neoadjuvant immunotherapy combined with chemotherapy. Herein, we designed a trial to evaluate the safety and efficacy of Sintilimab combined with paclitaxel and carboplatin for resectable ESCC.

Methods

All patients had treatment-naïve resectable ESCC (stage II-ⅣA) that were confirmed by histopathology. Each patient received 2 cycles of combined therapy with sintilimab (200 mg), paclitaxel (135 mg/m2) and carboplatin (area under the curve = 5). The primary endpoint was the major pathologic response (MPR). Secondary endpoints were disease-free survival (DFS), overall survival (OS), R0 resection rate and safety profile.

Results

Between Oct. 1, 2019, and Apr. 1, 2021, we assessed 45 patients for screening, of whom 40 patients were enrolled. Neoadjuvant therapy was not associated with delays in surgery or increased surgical complications/mortality. The median follow-up was 7.7 months (range 2.0∼21.0 months). The 6-month local RFS and 6-month OS were 92.5% and 97.5%, respectively. Thirty-nine (97.5%) successfully underwent R0 resection. Of the 40 evaluable patients, 19 (47.5%) were MPR, 10 (25.0%) were pathologic complete response (pCR). Imaging evaluation was feasible in all 40 patients. Partial response (PR) was achieved in 33 (82.5%) and stable disease (SD) was observed in 7 (17.5%). The most common treatment-related grade 1-2 adverse events were thrombocytopenia (8, 20.0%), anemia (19, 47.5%), myelosuppression (6, 15.0%), appetite loss (10, 25%), hair loss (12, 30%) and liver dysfunction (3, 7.5%). The most frequent grade 3-4 events were myelosuppression (3, 7.5%), neutropenia (4, 10.0%), thrombocytopenia (1, 2.5%) and severe anemia (1, 2.5%). There was treatment-related deaths.

Conclusions

Neoadjuvant sintilimab plus paclitaxel and carboplatin had manageable treatment-related toxic effects. This regimen induced pCR or MPR in 81.2% of resected tumor, demonstrating its antitumor efficacy in resectable ESCC.

Clinical trial identification

ChiCTR1900026593.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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