2023 World Conference on Lung Cancer (Posters)-P2.14. A Phase II Study of Sintilimab Combined with Concurrent Chemoradiotherapy in Patients with Limited-Stage Small Cell Lung Cancer:SINCE-01 Trial

P2.14. A Phase II Study of Sintilimab Combined with Concurrent Chemoradiotherapy in Patients with Limited-Stage Small Cell Lung Cancer:SINCE-01 Trial - PDF(Abstract)

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This study, titled "A Phase II Study of Sintilimab Combined with Concurrent Chemoradiotherapy in Patients with Limited-Stage Small Cell Lung Cancer: SINCE-01 Trial", aimed to investigate the effectiveness and safety of combining sintilimab with concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer (LD-SCLC). LD-SCLC patients typically experience local recurrence or distant metastasis within a year of treatment, with a median progression-free survival (PFS) of only 12 months. <br /><br />The study, conducted from November 2020 to August 2021, enrolled 20 patients with LD-SCLC. The patients received sintilimab combined with concurrent chemoradiotherapy, consisting of etoposide and carboplatin chemotherapy along with three-dimensional conformal or intensity-modulated radiotherapy. Prophylactic cranial irradiation was recommended for patients who showed complete or partial response after chemoradiotherapy.<br /><br />As of March 2023, with a median follow-up time of 24 months, neither PFS nor overall survival (OS) had been reached. The 12-month and 24-month PFS rates were 75% and 59.1%, respectively. The 12-month and 24-month OS rates were 90% and 69.3%, respectively. The objective response rate (ORR) was 95%, with 6 cases of complete response, 13 cases of partial response, and 1 case of stable disease. The disease control rate was 100%. The median duration of response was not reached. <br /><br />The study reported a manageable safety profile, with most adverse events (AEs) being of grade 1-2 severity. Three grade AEs were recorded, including leukopenia, neutropenia, and thrombocytopenia. The incidence of immune-related adverse events was 35%, with pneumonia, liver function damage, hyperglycemia, and hypothyroidism being the main issues. No grade 3 immune-related AEs were observed, and no AEs resulted in drug discontinuation or death.<br /><br />Overall, the study showed promising results for the combination of sintilimab and concurrent chemoradiotherapy in LD-SCLC patients. However, long-term efficacy is still being monitored.

Asset Subtitle

Wei Huang

Meta Tag

Speaker Wei Huang

Topic SCLC & Neuroendocrine Tumors: First Line Therapy

Keywords

Phase II Study

Sintilimab

Concurrent Chemoradiotherapy

Limited-Stage Small Cell Lung Cancer

LD-SCLC

Effectiveness

Safety

Progression-Free Survival

Overall Survival

Objective Response Rate