Cited 16 times in
Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial
DC Field | Value | Language |
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dc.contributor.author | 김민환 | - |
dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2023-03-21T07:27:21Z | - |
dc.date.available | 2023-03-21T07:27:21Z | - |
dc.date.issued | 2022-09 | - |
dc.identifier.issn | 2374-2437 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193387 | - |
dc.description.abstract | Importance: Addition of immune checkpoint inhibitors to anti-ERBB2 treatment has shown synergistic efficacy in preclinical studies and is thus worth investigating as a neoadjuvant treatment to maximize efficacy and to minimize toxic effects. Objective: To determine if neoadjuvant atezolizumab, docetaxel, trastuzumab, and pertuzumab therapy for ERBB2-positive early breast cancer warrants continuation to the next phase. Design, setting, and participants: This nonrandomized, open label, multicenter, phase 2 trial was conducted by the Korean Cancer Study Group and enrolled patients across 6 institutions in Korea from May 2019 to May 2020. Eligible patients were diagnosed with ERBB2-positive breast cancer (primary tumor size >2 cm or pathologically confirmed lymph node-positive cancer, without distant metastases) with a clinical stage of II or III. Interventions: Patients received 6 cycles of neoadjuvant pertuzumab (840 mg at first cycle, 420 mg during subsequent cycles), atezolizumab (1200 mg), docetaxel (75 mg/m2), and trastuzumab (600 mg via subcutaneous injection) every 3 weeks, followed by surgery. Patients with pathologic complete response (pCR) received 12 cycles of adjuvant atezolizumab, trastuzumab, and pertuzumab every 3 weeks after surgery. Patients without pCR were treated with 14 cycles of atezolizumab, 1200 mg, plus trastuzumab emtansine, 3.6 mg/kg, every 3 weeks. Main outcomes and measures: The primary end point was pCR rate, which was defined as the absence of invasive cancer cells in the primary tumor and regional lymph nodes (ypT0/isN0). Secondary end points included clinical objective response rate, 3-year event-free survival rate according to pCR achievement, disease-free survival, overall survival, toxic effects, and quality-of-life outcomes. Results: A total of 67 women (median [range] age, 52 [33-74] years) were enrolled. Hormone receptor expression was positive in 32 (48%) patients. Curative surgery was performed in 65 patients because 2 patients showed disease progression during neoadjuvant treatment and their tumors became unresectable. The overall pCR rate was 61% (41 of 67 patients). The pCR rate was higher in hormone receptor-negative disease vs hormone receptor-positive disease (27 of 35 [77%] patients vs 14 of 32 [44%] patients) and in programmed cell death 1-positive expression vs programmed cell death 1-negative expression (13 of 13 [100%] patients vs 28 of 53 [53%] patients). Grade 3 and 4 neutropenia and febrile neutropenia occurred in 8 (12%) patients and 5 (8%) patients, respectively. Grade 3 and 4 immune-related adverse events occurred in only 4 patients (grade 3 skin rash, encephalitis, hepatitis, and fever). No treatment-related death occurred during the neoadjuvant phase. Conclusions and relevance: In this nonrandomized clinical trial, treatment with the neoadjuvant atezolizumab, docetaxel, trastuzumab, and pertuzumab regimen in patients with stage II or III ERBB2-positive breast cancer appears to have had an acceptable pCR rate and modest toxic effects. Further investigation of this immunotherapy combination in ERBB2-positive early breast cancer is warranted. Trial registration: ClinicalTrials.gov Identifier: NCT03881878. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Medical Association | - |
dc.relation.isPartOf | JAMA ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Ado-Trastuzumab Emtansine | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Breast Neoplasms* / pathology | - |
dc.subject.MESH | Docetaxel / adverse effects | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Hormones / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immune Checkpoint Inhibitors | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoadjuvant Therapy* / adverse effects | - |
dc.subject.MESH | Receptor, ErbB-2 / metabolism | - |
dc.subject.MESH | Trastuzumab | - |
dc.title | Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hee Kyung Ahn | - |
dc.contributor.googleauthor | Sung Hoon Sim | - |
dc.contributor.googleauthor | Koung Jin Suh | - |
dc.contributor.googleauthor | Min Hwan Kim | - |
dc.contributor.googleauthor | Jae Ho Jeong | - |
dc.contributor.googleauthor | Ji-Yeon Kim | - |
dc.contributor.googleauthor | Dae-Won Lee | - |
dc.contributor.googleauthor | Jin-Hee Ahn | - |
dc.contributor.googleauthor | Heejung Chae | - |
dc.contributor.googleauthor | Kyung-Hun Lee | - |
dc.contributor.googleauthor | Jee Hyun Kim | - |
dc.contributor.googleauthor | Keun Seok Lee | - |
dc.contributor.googleauthor | Joo Hyuk Sohn | - |
dc.contributor.googleauthor | Yoon-La Choi | - |
dc.contributor.googleauthor | Seock-Ah Im | - |
dc.contributor.googleauthor | Kyung Hae Jung | - |
dc.contributor.googleauthor | Yeon Hee Park | - |
dc.identifier.doi | 10.1001/jamaoncol.2022.2310 | - |
dc.contributor.localId | A00482 | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J02919 | - |
dc.identifier.eissn | 2374-2445 | - |
dc.identifier.pmid | 35797012 | - |
dc.contributor.alternativeName | Kim, Min Hwan | - |
dc.contributor.affiliatedAuthor | 김민환 | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 8 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1271 | - |
dc.citation.endPage | 1277 | - |
dc.identifier.bibliographicCitation | JAMA ONCOLOGY, Vol.8(9) : 1271-1277, 2022-09 | - |
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