Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.

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Citation: Annals of Oncology. 24(10):2630-5, 2013 Oct.PMID: 23868905Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | *Breast Neoplasms/dt [Drug Therapy] | *Taxoids/tu [Therapeutic Use] | Antibodies, Monoclonal, Humanized/ae [Adverse Effects] | Antineoplastic Agents/ae [Adverse Effects] | Antineoplastic Agents/tu [Therapeutic Use] | Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | Breast Neoplasms/mo [Mortality] | Disease-Free Survival | Double-Blind Method | Female | Humans | Neoplasm Metastasis/dt [Drug Therapy] | Placebos/ad [Administration & Dosage] | Quality of Life | Questionnaires | Receptor, erbB-2/me [Metabolism] | Survival | Taxoids/ae [Adverse Effects] | Treatment Outcome | Tumor Markers, BiologicalYear: 2013Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0923-7534
Name of journal: Annals of oncology : official journal of the European Society for Medical Oncology / ESMOAbstract: BACKGROUND: The phase III CLEOPATRA study demonstrated that combining pertuzumab with trastuzumab plus docetaxel significantly improves progression-free and overall survival in previously untreated HER2-positive metastatic breast cancer. Here, we report health-related quality-of-life (HRQoL) results from CLEOPATRA.CONCLUSIONS: Combining pertuzumab with trastuzumab and docetaxel had no adverse impact on HRQoL and may prolong time to worsening of breast cancer-specific symptoms.PATIENTS AND METHODS: Participants were randomly assigned to pertuzumab or placebo, each given with trastuzumab plus docetaxel every 3 weeks. Pertuzumab and trastuzumab were administered until progression and six or more docetaxel cycles were recommended. Time from randomization to a > 5-point decrease in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was analyzed as a prespecified secondary end point. A post hoc exploratory analysis investigated time to > 2-point deterioration in Breast Cancer Subscale (BCS) score.RESULTS: Time to > 5-point decline in TOI-PFB did not differ significantly between the pertuzumab and placebo arms [hazard ratio (HR), 0.97; P = 0.7161]. The median times to TOI-PFB deterioration were 18.4 and 18.3 weeks, respectively (approximately six cycles). The mean TOI-PFB declined slightly until week 18 and recovered thereafter. Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).All authors: Baselga J, Clark E, Cortes J, Im SA, Im YH, Knott A, Pivot X, Ross G, Swain SMFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-08-21
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 23868905 Available 23868905

Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1999 - 2006

BACKGROUND: The phase III CLEOPATRA study demonstrated that combining pertuzumab with trastuzumab plus docetaxel significantly improves progression-free and overall survival in previously untreated HER2-positive metastatic breast cancer. Here, we report health-related quality-of-life (HRQoL) results from CLEOPATRA.

CONCLUSIONS: Combining pertuzumab with trastuzumab and docetaxel had no adverse impact on HRQoL and may prolong time to worsening of breast cancer-specific symptoms.

PATIENTS AND METHODS: Participants were randomly assigned to pertuzumab or placebo, each given with trastuzumab plus docetaxel every 3 weeks. Pertuzumab and trastuzumab were administered until progression and six or more docetaxel cycles were recommended. Time from randomization to a > 5-point decrease in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was analyzed as a prespecified secondary end point. A post hoc exploratory analysis investigated time to > 2-point deterioration in Breast Cancer Subscale (BCS) score.

RESULTS: Time to > 5-point decline in TOI-PFB did not differ significantly between the pertuzumab and placebo arms [hazard ratio (HR), 0.97; P = 0.7161]. The median times to TOI-PFB deterioration were 18.4 and 18.3 weeks, respectively (approximately six cycles). The mean TOI-PFB declined slightly until week 18 and recovered thereafter. Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).

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