A Prospective Phase II Study of Simultaneous Modulated Accelerated Radiotherapy Concurrently With CDDP/S1 for Esophageal Squamous Cell Carcinoma in the Elderly.

Abstract

BACKGROUND:

To explore the efficacy and toxicity of simultaneous modulated accelerated radiotherapy (SMART) concurrently with cisplatin (CDDP) and S1 (tegafur/gimeracil/oteracil) in elderly patients with esophageal squamous cell carcinoma (ESCC).

METHODS:

This single-arm, phase II study enrolled pathologically confirmed, stage II-IVa ESCC of 70-80 years old and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. Patients received SMART (64 Gy to gross tumor volume and 48 Gy to clinical target volume in 30 fractions) with concurrent CDDP (day 1 of each week) and S1 (days 1-14, 22-35). The primary endpoint was objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS) and toxicities.

RESULTS:

Thirty-seven eligible patients were analyzed with median follow-up of 25.7 months for all and 46.1 months for survivors. The ORR was 88.9%. Patients with baseline weight loss <5% (p=0.050) and nutritional risk index (NRI) ≥105.2 (p=0.023) had better tumor response. Median PFS was 13.8 months with 2-year PFS of 37.5%. Median OS was 27.7 months with 2-year OS of 57.5%. OS was significantly associated with ECOG PS (p=0.005), stage (p=0.014), gross tumor volume (p=0.004), baseline NRI (p=0.036), baseline C-reactive protein (CRP) level (p=0.003) and tumor response (p=0.000). CRP level (p=0.016) and tumor response (p=0.021) were independently prognostic of OS. ≥grade 3 anemia, neutropenia and thrombocytopenia occurred in 2.7%, 10.8% and 13.5% of patients; ≥grade 3 esophagitis and pneumonitis occurred in 18.9% and 2.7% of patient, respectively.

CONCLUSION:

SMART concurrently with CDDP/S1 yielded satisfactory response rate, survival outcome and tolerable treatment-related toxicities in elderly patients with ESCC. Further studies are warranted to validate the results.

• Authors: SuPing Guo, FangJie Liu, Hui Liu, YingJia Wu, XuHui Zhang, WenFeng Ye, GuangYu Luo, QiWen Li, NaiBin Chen, Nan Hu, Bin Wang, Jun Zhang, MaoSheng Lin, HuiXia Feng, Bo Qiu
• Journal: Frontiers in oncology (Front Oncol) Vol. 11 Pg. 760631 ( 2021) ISSN: 2234-943X [Print] Switzerland
• PMID: 34900709 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 Guo, Liu, Liu, Wu, Zhang, Ye, Luo, Li, Chen, Hu, Wang, Zhang, Lin, Feng and Qiu.