Nicolas Girard , Keunchil Park , Se-Hoon Lee , Santiago Viteri , Claudio A. Schioppa , Joris Diels , Mustafa Oguz , Bernardo H. Rodrigues , Nora Rahhali , Jan Sermon , Francesca Ghilotti , Tracy Li , Meena Thayu , Roland E. Knoblauch , Parthiv Mahadevia , Byoung Chul Cho
{"title":"关于接受阿米万他单抗治疗的铂后表皮生长因子受体20外显子插入突变非小细胞肺癌患者病情稳定情况的简要报告：基于CHRYSALIS研究的反应分析","authors":"Nicolas Girard , Keunchil Park , Se-Hoon Lee , Santiago Viteri , Claudio A. Schioppa , Joris Diels , Mustafa Oguz , Bernardo H. Rodrigues , Nora Rahhali , Jan Sermon , Francesca Ghilotti , Tracy Li , Meena Thayu , Roland E. Knoblauch , Parthiv Mahadevia , Byoung Chul Cho","doi":"10.1016/j.ctarc.2024.100832","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Amivantamab, an EGFR-MET bispecific antibody, is the first approved targeted therapy for patients with <em>EGFR</em> Ex20ins NSCLC after prior platinum-based chemotherapy—a population with historically poor outcomes before amivantamab approval. As antitumor activity in single-arm studies typically focuses on responders, the evaluation of outcomes in patients with stable disease (SD) as best response is of clinical interest.</p></div><div><h3>Patients and methods</h3><p>Among 114 patients with post-platinum <em>EGFR</em> Ex20ins NSCLC in CHRYSALIS (NCT02609776; data cutoff: March 30, 2021), response was assessed by blinded independent central review via RECIST v1.1. Patients alive and receiving therapy at 12 weeks were grouped by response at this landmark: partial or complete response (PR+), SD, or progressive disease (PD). Progression-free survival (PFS) and overall survival (OS) by response cohort were determined using the Kaplan-Meier method; hazard ratios (HRs) and 95% confidence intervals (CIs) between response cohorts were calculated using Cox proportional hazards regression.</p></div><div><h3>Results</h3><p>Among patients alive and receiving therapy at 12 weeks (n=107), 42 (39%) had PR+, 52 (49%) had SD, and 13 (12%) had PD. Among patients with PR+ and SD, median PFS was 12.2 and 7.0 months, respectively. A corresponding improvement in OS was observed in patients achieving PR+ (median: not reached; HR vs PD=0.21 [95% CI: 0.08–0.54]) and SD (median: 23.0 months; HR vs PD=0.33 [95% CI: 0.14–0.77]), relative to those with PD (median: 14.0 months).</p></div><div><h3>Conclusion</h3><p>SD was observed in 49% of patients receiving amivantamab, with corresponding increases in OS that dramatically improved the prognoses of this patient population.</p></div>","PeriodicalId":9507,"journal":{"name":"Cancer treatment and research communications","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468294224000443/pdfft?md5=5f37518a464c8ffe36c0b6772e0ef5c3&pid=1-s2.0-S2468294224000443-main.pdf","citationCount":"0","resultStr":"{\"title\":\"A brief report on stable disease among amivantamab-treated patients with post-platinum epidermal growth factor receptor exon 20 insertion–mutated non-small cell lung cancer: A response-based analysis from the CHRYSALIS study\",\"authors\":\"Nicolas Girard , Keunchil Park , Se-Hoon Lee , Santiago Viteri , Claudio A. Schioppa , Joris Diels , Mustafa Oguz , Bernardo H. Rodrigues , Nora Rahhali , Jan Sermon , Francesca Ghilotti , Tracy Li , Meena Thayu , Roland E. Knoblauch , Parthiv Mahadevia , Byoung Chul Cho\",\"doi\":\"10.1016/j.ctarc.2024.100832\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Amivantamab, an EGFR-MET bispecific antibody, is the first approved targeted therapy for patients with <em>EGFR</em> Ex20ins NSCLC after prior platinum-based chemotherapy—a population with historically poor outcomes before amivantamab approval. As antitumor activity in single-arm studies typically focuses on responders, the evaluation of outcomes in patients with stable disease (SD) as best response is of clinical interest.</p></div><div><h3>Patients and methods</h3><p>Among 114 patients with post-platinum <em>EGFR</em> Ex20ins NSCLC in CHRYSALIS (NCT02609776; data cutoff: March 30, 2021), response was assessed by blinded independent central review via RECIST v1.1. Patients alive and receiving therapy at 12 weeks were grouped by response at this landmark: partial or complete response (PR+), SD, or progressive disease (PD). Progression-free survival (PFS) and overall survival (OS) by response cohort were determined using the Kaplan-Meier method; hazard ratios (HRs) and 95% confidence intervals (CIs) between response cohorts were calculated using Cox proportional hazards regression.</p></div><div><h3>Results</h3><p>Among patients alive and receiving therapy at 12 weeks (n=107), 42 (39%) had PR+, 52 (49%) had SD, and 13 (12%) had PD. Among patients with PR+ and SD, median PFS was 12.2 and 7.0 months, respectively. 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A brief report on stable disease among amivantamab-treated patients with post-platinum epidermal growth factor receptor exon 20 insertion–mutated non-small cell lung cancer: A response-based analysis from the CHRYSALIS study
Background
Amivantamab, an EGFR-MET bispecific antibody, is the first approved targeted therapy for patients with EGFR Ex20ins NSCLC after prior platinum-based chemotherapy—a population with historically poor outcomes before amivantamab approval. As antitumor activity in single-arm studies typically focuses on responders, the evaluation of outcomes in patients with stable disease (SD) as best response is of clinical interest.
Patients and methods
Among 114 patients with post-platinum EGFR Ex20ins NSCLC in CHRYSALIS (NCT02609776; data cutoff: March 30, 2021), response was assessed by blinded independent central review via RECIST v1.1. Patients alive and receiving therapy at 12 weeks were grouped by response at this landmark: partial or complete response (PR+), SD, or progressive disease (PD). Progression-free survival (PFS) and overall survival (OS) by response cohort were determined using the Kaplan-Meier method; hazard ratios (HRs) and 95% confidence intervals (CIs) between response cohorts were calculated using Cox proportional hazards regression.
Results
Among patients alive and receiving therapy at 12 weeks (n=107), 42 (39%) had PR+, 52 (49%) had SD, and 13 (12%) had PD. Among patients with PR+ and SD, median PFS was 12.2 and 7.0 months, respectively. A corresponding improvement in OS was observed in patients achieving PR+ (median: not reached; HR vs PD=0.21 [95% CI: 0.08–0.54]) and SD (median: 23.0 months; HR vs PD=0.33 [95% CI: 0.14–0.77]), relative to those with PD (median: 14.0 months).
Conclusion
SD was observed in 49% of patients receiving amivantamab, with corresponding increases in OS that dramatically improved the prognoses of this patient population.
期刊介绍：
Cancer Treatment and Research Communications is an international peer-reviewed publication dedicated to providing comprehensive basic, translational, and clinical oncology research. The journal is devoted to articles on detection, diagnosis, prevention, policy, and treatment of cancer and provides a global forum for the nurturing and development of future generations of oncology scientists. Cancer Treatment and Research Communications publishes comprehensive reviews and original studies describing various aspects of basic through clinical research of all tumor types. The journal also accepts clinical studies in oncology, with an emphasis on prospective early phase clinical trials. Specific areas of interest include basic, translational, and clinical research and mechanistic approaches; cancer biology; molecular carcinogenesis; genetics and genomics; stem cell and developmental biology; immunology; molecular and cellular oncology; systems biology; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; cancer policy; and integration of various approaches. Our mission is to be the premier source of relevant information through promoting excellence in research and facilitating the timely translation of that science to health care and clinical practice.
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