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Clinical Trial
. 2017 Nov 16;377(20):1919-1929.
doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

"VSports最新版本" Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer

Scott J Antonia  1 , Augusto Villegas  1 , Davey Daniel  1 , David Vicente  1 , Shuji Murakami  1 , Rina Hui  1 , Takashi Yokoi  1 , Alberto Chiappori  1 , Ki H Lee  1 , Maike de Wit  1 , Byoung C Cho  1 , Maryam Bourhaba  1 , Xavier Quantin  1 , Takaaki Tokito  1 , Tarek Mekhail  1 , David Planchard  1 , Young-Chul Kim  1 , Christos S Karapetis  1 , Sandrine Hiret  1 , Gyula Ostoros  1 , Kaoru Kubota  1 , Jhanelle E Gray  1 , Luis Paz-Ares  1 , Javier de Castro Carpeño  1 , Catherine Wadsworth  1 , Giovanni Melillo  1 , Haiyi Jiang  1 , Yifan Huang  1 , Phillip A Dennis  1 , Mustafa Özgüroğlu  1 ; PACIFIC Investigators
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Free article
Clinical Trial

Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer

Scott J Antonia (VSports注册入口) et al. N Engl J Med. .
Free article

Abstract

Background: Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy) VSports手机版. This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. .

Methods: We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy V体育安卓版. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective response rate, the duration of response, the time to death or distant metastasis, and safety. .

Results: Of 713 patients who underwent randomization, 709 received consolidation therapy (473 received durvalumab and 236 received placebo). The median progression-free survival from randomization was 16. 8 months (95% confidence interval [CI], 13. 0 to 18. 1) with durvalumab versus 5. 6 months (95% CI, 4. 6 to 7. 8) with placebo (stratified hazard ratio for disease progression or death, 0. 52; 95% CI, 0. 42 to 0. 65; P<0. 001); the 12-month progression-free survival rate was 55. 9% versus 35. 3%, and the 18-month progression-free survival rate was 44. 2% versus 27. 0%. The response rate was higher with durvalumab than with placebo (28. 4% vs. 16. 0%; P<0. 001), and the median duration of response was longer (72. 8% vs. 46. 8% of the patients had an ongoing response at 18 months). The median time to death or distant metastasis was longer with durvalumab than with placebo (23 V体育ios版. 2 months vs. 14. 6 months; P<0. 001). Grade 3 or 4 adverse events occurred in 29. 9% of the patients who received durvalumab and 26. 1% of those who received placebo; the most common adverse event of grade 3 or 4 was pneumonia (4. 4% and 3. 8%, respectively). A total of 15. 4% of patients in the durvalumab group and 9. 8% of those in the placebo group discontinued the study drug because of adverse events. .

Conclusions: Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups. (Funded by AstraZeneca; PACIFIC ClinicalTrials. gov number, NCT02125461 . ). VSports最新版本.

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