First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
환자: extensive-stage SCLC (ES-SCLC) who received first-line tislelizumab plus chemotherapy experienced significant improvements in overall survival (OS; HR = 0
I · Intervention 중재 / 시술
first-line tislelizumab plus chemotherapy experienced significant improvements in overall survival (OS; HR = 0
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Tislelizumab plus chemotherapy was tolerable, with no new safety signals identified. [CLINICAL TRIAL INFORMATION] ClinicalTrials.gov Identifier: NCT04005716.
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[INTRODUCTION] In the final analysis of the randomized, phase 3 RATIONALE-312 trial (data cutoff: April 19, 2023), patients with extensive-stage SCLC (ES-SCLC) who received first-line tislelizumab plu
- 표본수 (n) 227
- p-value p = 0.004
- 95% CI 0.61-0.93
- HR 0.75
APA
Fan Y, Zhao Y, et al. (2026). First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial.. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 103655. https://doi.org/10.1016/j.jtho.2026.103655
MLA
Fan Y, et al.. "First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial.." Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2026, pp. 103655.
PMID
41796863 ↗
Abstract 한글 요약
[INTRODUCTION] In the final analysis of the randomized, phase 3 RATIONALE-312 trial (data cutoff: April 19, 2023), patients with extensive-stage SCLC (ES-SCLC) who received first-line tislelizumab plus chemotherapy experienced significant improvements in overall survival (OS; HR = 0.75 [95% CI: 0.61-0.93]; one-sided p = 0.004) and tolerable toxicity compared with placebo plus chemotherapy. We report long-term follow-up (data cutoff: December 29, 2023) data.
[METHODS] Adults with previously untreated ES-SCLC were randomized 1:1 to four induction cycles of intravenous tislelizumab 200 mg or placebo once every 3 weeks plus investigator's choice of chemotherapy (intravenous carboplatin or cisplatin plus etoposide), followed by tislelizumab or placebo maintenance. The primary end point was OS.
[RESULTS] With a median survival follow-up of 39.8 and 36.4 months in the tislelizumab (n = 227) and placebo (n = 230) arms, respectively, OS benefit in the intent-to-treat population was sustained compared with final analysis (median OS: 15.5 versus 13.5 mo, respectively; HR = 0.78; 95% CI: 0.63-0.95). Exploratory analyses found a consistent OS improvement favoring tislelizumab over placebo across programmed death-ligand 1 expression subgroups. The most frequently reported treatment-related adverse events in the tislelizumab and placebo arms were alopecia (78.4% versus 79.5%), anemia (76.7% versus 78.6%), and neutropenia (68.7% versus 70.3%).
[CONCLUSIONS] Long-term follow-up data from RATIONALE-312 reported that patients with ES-SCLC treated with first-line tislelizumab plus chemotherapy had clinically meaningful and sustained improvements in OS compared with placebo plus chemotherapy in the intent-to-treat and programmed death-ligand 1-assessable populations. Tislelizumab plus chemotherapy was tolerable, with no new safety signals identified.
[CLINICAL TRIAL INFORMATION] ClinicalTrials.gov Identifier: NCT04005716.
[METHODS] Adults with previously untreated ES-SCLC were randomized 1:1 to four induction cycles of intravenous tislelizumab 200 mg or placebo once every 3 weeks plus investigator's choice of chemotherapy (intravenous carboplatin or cisplatin plus etoposide), followed by tislelizumab or placebo maintenance. The primary end point was OS.
[RESULTS] With a median survival follow-up of 39.8 and 36.4 months in the tislelizumab (n = 227) and placebo (n = 230) arms, respectively, OS benefit in the intent-to-treat population was sustained compared with final analysis (median OS: 15.5 versus 13.5 mo, respectively; HR = 0.78; 95% CI: 0.63-0.95). Exploratory analyses found a consistent OS improvement favoring tislelizumab over placebo across programmed death-ligand 1 expression subgroups. The most frequently reported treatment-related adverse events in the tislelizumab and placebo arms were alopecia (78.4% versus 79.5%), anemia (76.7% versus 78.6%), and neutropenia (68.7% versus 70.3%).
[CONCLUSIONS] Long-term follow-up data from RATIONALE-312 reported that patients with ES-SCLC treated with first-line tislelizumab plus chemotherapy had clinically meaningful and sustained improvements in OS compared with placebo plus chemotherapy in the intent-to-treat and programmed death-ligand 1-assessable populations. Tislelizumab plus chemotherapy was tolerable, with no new safety signals identified.
[CLINICAL TRIAL INFORMATION] ClinicalTrials.gov Identifier: NCT04005716.
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