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Article: Neratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens

TitleNeratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens
Authors
KeywordsNeratinib
Metastatic breast cancer
Health-related quality of life
HER2-positive
Issue Date2021
PublisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6806
Citation
Breast Cancer Research and Treatment, 2021, Epub on 2021-04-28 How to Cite?
AbstractPurpose: To characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. Methods: In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan–Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. Results: Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63–1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32–2.23]). Conclusion: In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.
DescriptionHybrid open access
Persistent Identifierhttp://hdl.handle.net/10722/299790
ISSN
2020 Impact Factor: 4.872
2020 SCImago Journal Rankings: 1.908
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorMoy, B-
dc.contributor.authorOliveira, M-
dc.contributor.authorSaura, C-
dc.contributor.authorGradishar, W-
dc.contributor.authorKim, SB-
dc.contributor.authorBrufsky, A-
dc.contributor.authorHurvitz, SA-
dc.contributor.authorRyvo, L-
dc.contributor.authorFagnani, D-
dc.contributor.authorKalmadi, S-
dc.contributor.authorSilverman, P-
dc.contributor.authorDelaloge, S-
dc.contributor.authorAlarcon, J-
dc.contributor.authorKwong, A-
dc.contributor.authorKeyvanjah, K-
dc.contributor.authorLee, KS-
dc.contributor.authorAng, PCS-
dc.contributor.authorOw, SGW-
dc.contributor.authorChu, SC-
dc.contributor.authorBryce, R-
dc.contributor.authorBebchuk, J-
dc.contributor.authorZhang, B-
dc.contributor.authorOestreicher, N-
dc.contributor.authorBose, R-
dc.contributor.authorChan, N-
dc.date.accessioned2021-05-26T03:29:06Z-
dc.date.available2021-05-26T03:29:06Z-
dc.date.issued2021-
dc.identifier.citationBreast Cancer Research and Treatment, 2021, Epub on 2021-04-28-
dc.identifier.issn0167-6806-
dc.identifier.urihttp://hdl.handle.net/10722/299790-
dc.descriptionHybrid open access-
dc.description.abstractPurpose: To characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. Methods: In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan–Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. Results: Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63–1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32–2.23]). Conclusion: In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.-
dc.languageeng-
dc.publisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6806-
dc.relation.ispartofBreast Cancer Research and Treatment-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectNeratinib-
dc.subjectMetastatic breast cancer-
dc.subjectHealth-related quality of life-
dc.subjectHER2-positive-
dc.titleNeratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1007/s10549-021-06217-4-
dc.identifier.pmid33909203-
dc.identifier.scopuseid_2-s2.0-85105406543-
dc.identifier.hkuros322530-
dc.identifier.volumeEpub on 2021-04-28-
dc.identifier.isiWOS:000645182300002-
dc.publisher.placeUnited States-

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