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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
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2024-10-04T02:43:53Z | - |
dc.date.available | 2024-10-04T02:43:53Z | - |
dc.date.issued | 2024-04 | - |
dc.identifier.issn | 0169-5002 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/200576 | - |
dc.description.abstract | Introduction: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier Scientific Publishers | - |
dc.relation.isPartOf | LUNG CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal* | - |
dc.subject.MESH | Carboplatin | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Chemoradiotherapy / methods | - |
dc.subject.MESH | Cisplatin / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Neoplasm Staging | - |
dc.subject.MESH | Paclitaxel | - |
dc.title | Durvalumab in combination with chemoradiotherapy for patients with unresectable stage III non-small-cell lung cancer: Results from the phase 1 CLOVER study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Krishna Pachipala | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Chih-Liang Wang | - |
dc.contributor.googleauthor | Gee-Chen Chang | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Rosa Alvarez | - |
dc.contributor.googleauthor | Chao-Hua Chiu | - |
dc.contributor.googleauthor | José Trigo | - |
dc.contributor.googleauthor | Anna Estival | - |
dc.contributor.googleauthor | Sana D Karam | - |
dc.contributor.googleauthor | Cathy O'Brien | - |
dc.contributor.googleauthor | Hema Gowda | - |
dc.contributor.googleauthor | Haiyi Jiang | - |
dc.contributor.googleauthor | Julie E Bauman | - |
dc.identifier.doi | 38471416 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02174 | - |
dc.identifier.eissn | 1872-8332 | - |
dc.identifier.pmid | 10.1016/j.lungcan.2024.107530 | - |
dc.subject.keyword | Concurrent chemoradiotherapy | - |
dc.subject.keyword | Durvalumab | - |
dc.subject.keyword | Phase 1 study | - |
dc.subject.keyword | Stage III NSCLC | - |
dc.subject.keyword | Unresectable | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 190 | - |
dc.citation.startPage | 107530 | - |
dc.identifier.bibliographicCitation | LUNG CANCER, Vol.190 : 107530, 2024-04 | - |
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