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Durvalumab in combination with chemoradiotherapy for patients with unresectable stage III non-small-cell lung cancer: Results from the phase 1 CLOVER study

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dc.contributor.author조병철-
dc.date.accessioned2024-10-04T02:43:53Z-
dc.date.available2024-10-04T02:43:53Z-
dc.date.issued2024-04-
dc.identifier.issn0169-5002-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/200576-
dc.description.abstractIntroduction: For patients with unresectable, stage III non-small-cell lung cancer (NSCLC), current standard of care is concurrent chemoradiotherapy (cCRT) followed by consolidation durvalumab. However, earlier initiation of durvalumab simultaneously with cCRT may increase antitumor activity relative to initiation after cCRT. The phase 1 CLOVER study (NCT03509012) evaluated durvalumab combined with cCRT in patients with advanced solid tumors; we report findings from the NSCLC cohort. Methods: CLOVER comprised a dose-limiting toxicity (DLT) assessment part, followed by an expansion part. In the NSCLC cohort, patients with previously untreated, unresectable, stage III NSCLC were enrolled in three treatment arms: durvalumab every 4 weeks (Q4W) + cisplatin + etoposide + radiotherapy (Arm 1); durvalumab Q4W + carboplatin + paclitaxel + radiotherapy (Arm 2); or durvalumab Q4W + carboplatin or cisplatin + pemetrexed + radiotherapy (non-squamous histology only; Arm 3). Patients received durvalumab until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. Results: Sixty-four patients were enrolled: 21, 22, and 21 in Arms 1, 2, and 3, respectively. One patient in Arm 1 had DLT (grade 3 aspartate aminotransferase increase and grade 4 alanine aminotransferase increase); no DLTs were observed in Arms 2 or 3. Grade 3/4 adverse events occurred in 76.6 % of patients overall; the most common were neutropenia (51.6 %), leukopenia (20.3 %), and anemia (17.2 %). In a post-hoc analysis, 7.8 % of patients had grade 3 pneumonitis/radiation pneumonitis (grouped term) events. Overall, the objective response rate was 60.9 % (95 % confidence interval [CI], 47.9–72.9); median duration of response was 15.8 months (95 % CI, 9.0–not estimable [NE]). Median progression-free survival was 13.4 months (95 % CI, 8.8–20.1) and median overall survival was not reached (95 % CI, 21.9–NE). Conclusion: Durvalumab in combination with cCRT was well tolerated, with a manageable safety profile and showed encouraging antitumor activity in patients with unresectable, stage III NSCLC.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier Scientific Publishers-
dc.relation.isPartOfLUNG CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAntibodies, Monoclonal*-
dc.subject.MESHCarboplatin-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / drug therapy-
dc.subject.MESHChemoradiotherapy / methods-
dc.subject.MESHCisplatin / therapeutic use-
dc.subject.MESHHumans-
dc.subject.MESHLung Neoplasms* / drug therapy-
dc.subject.MESHNeoplasm Staging-
dc.subject.MESHPaclitaxel-
dc.titleDurvalumab in combination with chemoradiotherapy for patients with unresectable stage III non-small-cell lung cancer: Results from the phase 1 CLOVER study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorDong-Wan Kim-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorKrishna Pachipala-
dc.contributor.googleauthorSang-We Kim-
dc.contributor.googleauthorChih-Liang Wang-
dc.contributor.googleauthorGee-Chen Chang-
dc.contributor.googleauthorMyung-Ju Ahn-
dc.contributor.googleauthorRosa Alvarez-
dc.contributor.googleauthorChao-Hua Chiu-
dc.contributor.googleauthorJosé Trigo-
dc.contributor.googleauthorAnna Estival-
dc.contributor.googleauthorSana D Karam-
dc.contributor.googleauthorCathy O'Brien-
dc.contributor.googleauthorHema Gowda-
dc.contributor.googleauthorHaiyi Jiang-
dc.contributor.googleauthorJulie E Bauman-
dc.identifier.doi38471416-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ02174-
dc.identifier.eissn1872-8332-
dc.identifier.pmid10.1016/j.lungcan.2024.107530-
dc.subject.keywordConcurrent chemoradiotherapy-
dc.subject.keywordDurvalumab-
dc.subject.keywordPhase 1 study-
dc.subject.keywordStage III NSCLC-
dc.subject.keywordUnresectable-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume190-
dc.citation.startPage107530-
dc.identifier.bibliographicCitationLUNG CANCER, Vol.190 : 107530, 2024-04-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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