Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.
Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.
- 2013
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).
English
0923-7534
*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, Biological
Washington Cancer Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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).
English
0923-7534
*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, Biological
Washington Cancer Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't