Phase II Clinical Trial of Pembrolizumab and Chemotherapy Reveals Distinct Transcriptomic Profiles by Radiologic Response in Metastatic Triple-Negative Breast Cancer
A single arm, phase II trial of carboplatin, nab-paclitaxel, and pembrolizumab (CNP) in metastatic triple-negative breast cancer (mTNBC) was designed to evaluate overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), safety/tolerability, overall survival (OS), and...
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| Veröffentlicht in: | Clinical cancer research 2024-01, Vol.30 (1), p.82-93 |
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| creator | Wilkerson, Avia D Parthasarathy, Prerana Bangalore Stabellini, Nickolas Mitchell, Carley Pavicic, Jr, Paul G Fu, Pingfu Rupani, Amit Husic, Hana Rayman, Patricia A Swaidani, Shadi Abraham, Jame Budd, G Thomas Moore, Halle Al-Hilli, Zahraa Ko, Jennifer S Baar, Joseph Chan, Timothy A Alban, Tyler Diaz-Montero, C Marcela Montero, Alberto J |
| description | A single arm, phase II trial of carboplatin, nab-paclitaxel, and pembrolizumab (CNP) in metastatic triple-negative breast cancer (mTNBC) was designed to evaluate overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), safety/tolerability, overall survival (OS), and identify pathologic and transcriptomic correlates of response to therapy.
Patients with ≤2 prior therapies for metastatic disease were treated with CNP regardless of tumor programmed cell death-ligand 1 status. Core tissue biopsies were obtained prior to treatment initiation. ORR was assessed using a binomial distribution. Survival was analyzed via the Kaplan-Meier method. Bulk RNA sequencing was employed for correlative studies.
Thirty patients were enrolled. The ORR was 48.0%: 2 (7%) complete responses (CR), 11 (41%) partial responses (PR), and 8 (30%) stable disease (SD). The median DOR for patients with CR or PR was 6.4 months [95% confidence interval (CI), 4-8.5 months]. For patients with CR, DOR was >24 months. Overall median PFS and OS were 5.8 (95% CI, 4.7-8.5 months) and 13.4 months (8.9-17.3 months), respectively. We identified unique transcriptomic landscapes associated with each RECIST category of radiographic treatment response. In CR and durable PR, IGHG1 expression was enriched. IGHG1high tumors were associated with improved OS (P = 0.045) and were concurrently enriched with B cells and follicular helper T cells, indicating IGHG1 as a promising marker for lymphocytic infiltration and robust response to chemo-immunotherapy.
Pretreatment tissue sampling in mTNBC treated with CNP reveals transcriptomic signatures that may predict radiographic responses to chemo-immunotherapy. |
| doi_str_mv | 10.1158/1078-0432.CCR-23-1349 |
| format | Article |
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Patients with ≤2 prior therapies for metastatic disease were treated with CNP regardless of tumor programmed cell death-ligand 1 status. Core tissue biopsies were obtained prior to treatment initiation. ORR was assessed using a binomial distribution. Survival was analyzed via the Kaplan-Meier method. Bulk RNA sequencing was employed for correlative studies.
Thirty patients were enrolled. The ORR was 48.0%: 2 (7%) complete responses (CR), 11 (41%) partial responses (PR), and 8 (30%) stable disease (SD). The median DOR for patients with CR or PR was 6.4 months [95% confidence interval (CI), 4-8.5 months]. For patients with CR, DOR was >24 months. Overall median PFS and OS were 5.8 (95% CI, 4.7-8.5 months) and 13.4 months (8.9-17.3 months), respectively. We identified unique transcriptomic landscapes associated with each RECIST category of radiographic treatment response. In CR and durable PR, IGHG1 expression was enriched. IGHG1high tumors were associated with improved OS (P = 0.045) and were concurrently enriched with B cells and follicular helper T cells, indicating IGHG1 as a promising marker for lymphocytic infiltration and robust response to chemo-immunotherapy.
Pretreatment tissue sampling in mTNBC treated with CNP reveals transcriptomic signatures that may predict radiographic responses to chemo-immunotherapy.</description><identifier>ISSN: 1078-0432</identifier><identifier>ISSN: 1557-3265</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-23-1349</identifier><identifier>PMID: 37882661</identifier><language>eng</language><publisher>United States</publisher><subject>Antibodies, Monoclonal, Humanized - pharmacology ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Gene Expression Profiling ; Humans ; Progression-Free Survival ; Triple Negative Breast Neoplasms - drug therapy ; Triple Negative Breast Neoplasms - genetics ; Triple Negative Breast Neoplasms - pathology</subject><ispartof>Clinical cancer research, 2024-01, Vol.30 (1), p.82-93</ispartof><rights>2023 The Authors; Published by the American Association for Cancer Research.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-e28ec86965032f56f90db960b4b1f813b68cfea22683f7ab136b723c533d99123</citedby><cites>FETCH-LOGICAL-c356t-e28ec86965032f56f90db960b4b1f813b68cfea22683f7ab136b723c533d99123</cites><orcidid>0000-0002-1128-6185 ; 0000-0003-4016-2197 ; 0000-0002-7696-6608 ; 0000-0003-0629-775X ; 0000-0002-3135-7980 ; 0009-0007-0809-8451 ; 0000-0002-2502-7926 ; 0000-0003-2383-0499 ; 0000-0003-2206-370X ; 0000-0002-7472-9350 ; 0000-0002-6941-4215 ; 0009-0008-5909-7173 ; 0000-0002-8221-8120 ; 0000-0002-2185-9557 ; 0000-0002-5772-3192 ; 0000-0002-3261-140X ; 0000-0002-2334-5218 ; 0009-0006-3831-9481 ; 0000-0002-9265-0283 ; 0009-0002-7702-9656</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,3354,27922,27923</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37882661$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wilkerson, Avia D</creatorcontrib><creatorcontrib>Parthasarathy, Prerana Bangalore</creatorcontrib><creatorcontrib>Stabellini, Nickolas</creatorcontrib><creatorcontrib>Mitchell, Carley</creatorcontrib><creatorcontrib>Pavicic, Jr, Paul G</creatorcontrib><creatorcontrib>Fu, Pingfu</creatorcontrib><creatorcontrib>Rupani, Amit</creatorcontrib><creatorcontrib>Husic, Hana</creatorcontrib><creatorcontrib>Rayman, Patricia A</creatorcontrib><creatorcontrib>Swaidani, Shadi</creatorcontrib><creatorcontrib>Abraham, Jame</creatorcontrib><creatorcontrib>Budd, G Thomas</creatorcontrib><creatorcontrib>Moore, Halle</creatorcontrib><creatorcontrib>Al-Hilli, Zahraa</creatorcontrib><creatorcontrib>Ko, Jennifer S</creatorcontrib><creatorcontrib>Baar, Joseph</creatorcontrib><creatorcontrib>Chan, Timothy A</creatorcontrib><creatorcontrib>Alban, Tyler</creatorcontrib><creatorcontrib>Diaz-Montero, C Marcela</creatorcontrib><creatorcontrib>Montero, Alberto J</creatorcontrib><title>Phase II Clinical Trial of Pembrolizumab and Chemotherapy Reveals Distinct Transcriptomic Profiles by Radiologic Response in Metastatic Triple-Negative Breast Cancer</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>A single arm, phase II trial of carboplatin, nab-paclitaxel, and pembrolizumab (CNP) in metastatic triple-negative breast cancer (mTNBC) was designed to evaluate overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), safety/tolerability, overall survival (OS), and identify pathologic and transcriptomic correlates of response to therapy.
Patients with ≤2 prior therapies for metastatic disease were treated with CNP regardless of tumor programmed cell death-ligand 1 status. Core tissue biopsies were obtained prior to treatment initiation. ORR was assessed using a binomial distribution. Survival was analyzed via the Kaplan-Meier method. Bulk RNA sequencing was employed for correlative studies.
Thirty patients were enrolled. The ORR was 48.0%: 2 (7%) complete responses (CR), 11 (41%) partial responses (PR), and 8 (30%) stable disease (SD). The median DOR for patients with CR or PR was 6.4 months [95% confidence interval (CI), 4-8.5 months]. For patients with CR, DOR was >24 months. Overall median PFS and OS were 5.8 (95% CI, 4.7-8.5 months) and 13.4 months (8.9-17.3 months), respectively. We identified unique transcriptomic landscapes associated with each RECIST category of radiographic treatment response. In CR and durable PR, IGHG1 expression was enriched. IGHG1high tumors were associated with improved OS (P = 0.045) and were concurrently enriched with B cells and follicular helper T cells, indicating IGHG1 as a promising marker for lymphocytic infiltration and robust response to chemo-immunotherapy.
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Patients with ≤2 prior therapies for metastatic disease were treated with CNP regardless of tumor programmed cell death-ligand 1 status. Core tissue biopsies were obtained prior to treatment initiation. ORR was assessed using a binomial distribution. Survival was analyzed via the Kaplan-Meier method. Bulk RNA sequencing was employed for correlative studies.
Thirty patients were enrolled. The ORR was 48.0%: 2 (7%) complete responses (CR), 11 (41%) partial responses (PR), and 8 (30%) stable disease (SD). The median DOR for patients with CR or PR was 6.4 months [95% confidence interval (CI), 4-8.5 months]. For patients with CR, DOR was >24 months. Overall median PFS and OS were 5.8 (95% CI, 4.7-8.5 months) and 13.4 months (8.9-17.3 months), respectively. We identified unique transcriptomic landscapes associated with each RECIST category of radiographic treatment response. In CR and durable PR, IGHG1 expression was enriched. IGHG1high tumors were associated with improved OS (P = 0.045) and were concurrently enriched with B cells and follicular helper T cells, indicating IGHG1 as a promising marker for lymphocytic infiltration and robust response to chemo-immunotherapy.
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| source | MEDLINE; American Association for Cancer Research; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Antibodies, Monoclonal, Humanized - pharmacology Antineoplastic Combined Chemotherapy Protocols - adverse effects Gene Expression Profiling Humans Progression-Free Survival Triple Negative Breast Neoplasms - drug therapy Triple Negative Breast Neoplasms - genetics Triple Negative Breast Neoplasms - pathology |
| title | Phase II Clinical Trial of Pembrolizumab and Chemotherapy Reveals Distinct Transcriptomic Profiles by Radiologic Response in Metastatic Triple-Negative Breast Cancer |
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