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Proffered Paper session 2

LBA3 - Safety and efficacy of pembrolizumab combined with paclitaxel and cisplatin as a neoadjuvant treatment for locally advanced resectable (stage III) esophageal squamous cell carcinoma (Keystone-001): interim analysis of a prospective, single-arm, single-center, Phase II trial.

Date

10 Dec 2021

Session

Proffered Paper session 2

Presenters

Xiaobin Shang

Citation

Annals of Oncology (2021) 32 (suppl_7): S1428-S1457. 10.1016/annonc/annonc787

Authors

X. Shang1, C. Zhang1, G. Zhao1, W. Zhang1, L. Liu1, X. Duan1, J. Yue1, Z. Ma1, C. Chen1, B. Meng1, X. Ren2, H. jiang3

Author affiliations

  • 1 Tianjin Medical University Cancer Institute & Hospital, Tianjin/CN
  • 2 Tianjin Medical University Cancer Institute & Hospital, 145000 - Tianjin/CN
  • 3 Tianjin Medical University Cancer Institute & Hospital, 300060 - Tianjin/CN
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Resources

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Abstract LBA3

Background

Neoadjuvant concurrent chemoradiotherapy with surgery is the standard treatment for esophageal squamous cell carcinoma (ESCC) in NCCN guidelines. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot surgery for locally advanced (stage III) ESCC. The purpose is to observe and evaluate the efficacy and safety.

Methods

The enrolled subjects are the locally advanced and resectable (stage Ⅲ,8th, AJCC) ESCC patients, who will receive pembrolizumab (200mg, IV, D1, Q3W for 3 cycles), paclitaxel (135mg/m2, IV, D2, Q3W for 3 cycles) ,and cisplatin (20mg/m2, IV, D2-4, Q3W for 3 cycles), then will undergo Da Vinci robot-assisted McKeown surgery within 4-6 weeks after neoadjuvant treatment. If the pathology result is not a complete response, pembrolizumab alone as adjuvant therapy should be continued for at least 6 cycles with the same usage as before. Primary endpoints: major pathological response (MPR) rate; the safety. Secondary endpoints: pathological complete response (pCR) rate, objective response rate (ORR); 1, 3, 5-years OS and DFS, R0 resection rate and 30-day perioperative complications. Quality of life (EORTC QLQ-C30, OES18) and nutrition assessment (PG-SGA score).

Results

This trial has recruited 42 subjects (50 in plan), of which 29 have finished robot surgery. The results confirm that this new treatment is safe (no adverse events of grade 3 or higher), and did not cause a delay in surgery. Patients' nutritional status and QOL improved significantly. R0 resection rate is 100%, with MPR 21/29 (72.4%), pCR 12/29 (41.4%), and ORR 28/29 (96.6%). No perioperative death has occurred so far.

Conclusion

Pembrolizumab combined with paclitaxel and cisplatin as a neoadjuvant therapy was associated with few side effects, did not delay surgery, and induced a major pathological response in 72.4% of resected ESCC tumors. It may be better than the neoadjuvant concurrent chemoradiation recommended by NCCN guidelines.

Clinical trial identification

NCT 04389177, date of registration: 15 May 2020.

Disclosure

All authors have declared no conflicts of interest.

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