Abstract
BackgroundTo 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).MethodsThis 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.ResultsThirty-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.ConclusionSMART 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.
Highlights
Esophageal cancer is the sixth leading cause of cancer death worldwide [1]
RTOG8501 has established the role of concurrent chemoradiotherapy (CCRT) in locally advanced esophageal cancer, only 23% of the subjects in the clinical trial were over 70 years old [3]
Between July 2015 and June 2018, 42 patients with stage II–IVa esophageal squamous cell carcinoma (ESCC) were enrolled in this study
Summary
30% of patients diagnosed as esophageal cancer are over 70 years’ old [2], so there is an urgent need to optimize the treatment strategy in elderly. RTOG8501 has established the role of concurrent chemoradiotherapy (CCRT) in locally advanced esophageal cancer, only 23% of the subjects in the clinical trial were over 70 years old [3]. Given that the risk of ≥grade 4 side effects was 10% in the concurrent chemoradiotherapy group, significantly higher than that in the radiotherapy alone group, the concurrent treatment mode is more inclined to younger patients with better general conditions. 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)
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