TOPLINE:
Durvalumab therapy after chemoradiotherapy significantly improves overall and progression-free survival in patients with limited-stage small cell lung cancer (SCLC). The median overall survival was 55.9 months for durvalumab vs 33.4 months for placebo.
METHODOLOGY:
- In the ADRIATIC trial, 730 patients with limited-stage SCLC and no disease progression after chemoradiotherapy were randomly assigned to receive durvalumab with or without tremelimumab or placebo as adjuvant therapy.
- Patients received 1500 mg of durvalumab every 4 weeks for up to 24 months, with or without 75 mg of tremelimumab for the first four doses.
- The primary endpoints were overall and progression-free survival, assessed by blinded independent central review.
- The trial was conducted across multiple international sites, with randomization stratified by disease stage and the receipt of prophylactic cranial irradiation.
- Patients were followed for a median duration of 37.2 months for overall survival. The median durations of follow-up for progression-free survival were 27.4 and 27.7 months for those receiving durvalumab and placebo, respectively.
TAKEAWAY:
- Durvalumab therapy led to a median overall survival of 55.9 months compared with 33.4 months for placebo.
- Progression-free survival was significantly longer with durvalumab than with placebo, with a median of 16.6 months vs 9.2 months.
- The incidence of adverse events of grade 3 or 4 was similar between the durvalumab and placebo groups, at 24.4% and 24.2%, respectively.
- Pneumonitis or radiation pneumonitis of grade 3 or 4 occurred in 3.1% and 2.6% of patients receiving durvalumab and placebo, respectively; one patient who received durvalumab group had a grade 5 event.
IN PRACTICE:
An ongoing response at 18 months was seen in 71% and 55% of the patients who received durvalumab and placebo, respectively. “These data support the use of adjuvant durvalumab therapy for 24 months, the period during which patients are at highest risk for relapse,” the authors wrote.
SOURCE:
Ying Cheng, MD, of Jilin Cancer Hospital in Changchun, China, was the first author. The article was published online on September 13, 2024, in The New England Journal of Medicine.
LIMITATIONS:
The study’s limitations included the exclusion of patients with persistent grade 2 or higher toxic effects, which may have limited the generalizability of the findings. Additionally, the underrepresentation of Black patients may have affected the applicability of the results to this demographic. The trial was not powered for subgroup comparisons, so caution is needed when interpreting these results.
DISCLOSURES:
The study was supported by grants from AstraZeneca. Disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Source link : https://www.medscape.com/viewarticle/durvalumab-enhances-survival-after-chemoradiotherapy-limited-2024a1000idc?src=rss
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Publish date : 2024-10-08 12:19:15
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