Health-related quality of life in patients receiving first-line eribulin mesylate with or without trastuzumab for locally recurrent or metastatic breast cancer

Autor: Linda T. Vahdat, Erhan Berrak, Sharon Wilks, Yaohua He, Shannon Puhalla, Joyce O'Shaughnessy, Kristi McIntyre, Lee S. Schwartzberg
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Cancer Research
Health-related quality of life
chemistry.chemical_compound
0302 clinical medicine
Trastuzumab
Surveys and Questionnaires
Antineoplastic Combined Chemotherapy Protocols
Neoplasm Metastasis
media_common
Aged
80 and over
Ketones
Middle Aged
Metastatic breast cancer
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Treatment Outcome
Tolerability
030220 oncology & carcinogenesis
Female
Research Article
medicine.drug
Eribulin
Adult
Eribulin Mesylate
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Breast Neoplasms
lcsh:RC254-282
03 medical and health sciences
Breast cancer
Internal medicine
Genetics
medicine
Humans
media_common.cataloged_instance
European union
Furans
Adverse effect
Aged
business.industry
medicine.disease
Survival Analysis
030104 developmental biology
chemistry
Quality of Life
First-line therapy
Neoplasm Recurrence
Local
business
Zdroj: BMC Cancer, Vol 19, Iss 1, Pp 1-10 (2019)
BMC Cancer
ISSN: 1471-2407
Popis: Background Eribulin mesylate is a nontaxane microtubule dynamics inhibitor approved for second-line (European Union) or third-line (United States) treatment of metastatic breast cancer. Two phase 2 single trials, evaluating first-line eribulin as monotherapy (Study 206; NCT01268150) or in combination with trastuzumab (Study 208; NCT01269346) in locally recurrent or metastatic breast cancer, demonstrated objective response rates of 28.6 and 71.2%, respectively. Median progression-free survival was 6.8 and 11.6 months, respectively. Tolerability profiles were similar to those from previous studies. This secondary analysis was conducted to assess health-related quality of life (HRQoL) in both phase 2 trials. Methods Patients received eribulin mesylate 1.4 mg/m2 intravenously on days 1 and 8 of each 21-day cycle. Patients in Study 208 also received intravenous trastuzumab on day 1 of each cycle (8 mg/kg in cycle 1, then 6 mg/kg). HRQoL was assessed by the European Organization for Research and Treatment of Cancer Quality-of-Life (QLQ-C30) assessment tool and the Quality-of-Life Questionnaire for Breast Cancer (QLQ-BR23) at baseline and cycles 2, 4, and 6. Results for clinically meaningful changes were based on previously published minimum important differences. Results Of the 108 patients (56 in Study 206 and 52 in Study 208) treated, 57 and 87%, respectively, completed 6 cycles. Completion rates for both questionnaires were 94 and 98%, respectively, at cycle 6. Most patients had stable/improved HRQoL scores with some exceptions; for example, more patients experienced a worsening in cognitive functioning and systemic therapy side effects than experienced improvement. Mean QLQ-C30 symptom scores correlated with corresponding adverse event rates for nausea/vomiting, dyspnea, appetite loss, constipation, and diarrhea in Study 206 and for fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, and diarrhea in Study 208. Conclusions First-line eribulin ± trastuzumab therapy did not lead to deterioration of overall HRQoL in most patients, with more than 60% of patients having stable/improved global health status/quality-of-life scores. Eribulin has been demonstrated to be comparable with other chemotherapy agents with an acceptable safety profile. Therefore, further evaluation is warranted to determine whether eribulin ± trastuzumab therapy may be a potential option for first-line treatment in some patients with metastatic breast cancer who were recently treated in the neoadjuvant setting. Trial registration NCT01268150 (December 29, 2010), NCT01269346 (January 4, 2011) Electronic supplementary material The online version of this article (10.1186/s12885-019-5674-5) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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