Y Wu1, M M Amonkar2, B H Sherrill3, J O'Shaughnessy4, C Ellis2, J Baselga5, K L Blackwell6, H J Burstein7. 1. Biometrics Department, Research Triangle Institute Health Solutions, Research Triangle Park. Electronic address: ywu@rti.org. 2. Global Health Outcomes, Oncology, GlaxoSmithKline, Collegeville. 3. Biometrics Department, Research Triangle Institute Health Solutions, Research Triangle Park. 4. Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, USA. 5. Medical Oncology Service, Vall d'Hebron University Hospital, Barcelona, Spain. 6. Duke University Medical Center, Durham. 7. Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.
Abstract
BACKGROUND:Progression-free survival (PFS) was significantly longer for the lapatinib plus trastuzumab (L+T) arm than for L alone in a phase III, randomized, open-label study of women with human epidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting. This analysis focused on impact of treatments on health-related quality of life (HRQOL). METHODS:HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Changes from baseline and time to deterioration were analyzed in the intent-to-treat population. RESULTS: Differences between the treatment arms in adjusted mean change from baseline favored the L+T arm, ranging from 0.0 to 4.1 (FACT-B), 1.0-4.0 [Functional Assessment of Cancer Therapy-General (FACT-G)], and 0.5-2.7 (Trial Outcome Index). Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037). Similar results were found in a sensitivity analysis that included HRQOL records up to patient withdrawal from original randomized treatment. The longer time to HRQOL deterioration in the L+T arm was not statistically significant (FACT-B hazard ratio, 0.82; 95% confidence interval 0.56-1.20). CONCLUSION: The addition of lapatinib to trastuzumab prolonged PFS while improving or maintaining near-term HRQOL, suggesting a meaningful clinical benefit to patients.
RCT Entities:
BACKGROUND: Progression-free survival (PFS) was significantly longer for the lapatinib plus trastuzumab (L+T) arm than for L alone in a phase III, randomized, open-label study of women with humanepidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting. This analysis focused on impact of treatments on health-related quality of life (HRQOL). METHODS: HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Changes from baseline and time to deterioration were analyzed in the intent-to-treat population. RESULTS: Differences between the treatment arms in adjusted mean change from baseline favored the L+T arm, ranging from 0.0 to 4.1 (FACT-B), 1.0-4.0 [Functional Assessment of Cancer Therapy-General (FACT-G)], and 0.5-2.7 (Trial Outcome Index). Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037). Similar results were found in a sensitivity analysis that included HRQOL records up to patient withdrawal from original randomized treatment. The longer time to HRQOL deterioration in the L+T arm was not statistically significant (FACT-B hazard ratio, 0.82; 95% confidence interval 0.56-1.20). CONCLUSION: The addition of lapatinib to trastuzumab prolonged PFS while improving or maintaining near-term HRQOL, suggesting a meaningful clinical benefit to patients.
Authors: T Shiroiwa; T Fukuda; K Shimozuma; M Mouri; Y Hagiwara; H Doihara; H Akabane; M Kashiwaba; T Watanabe; Y Ohashi; H Mukai Journal: Qual Life Res Date: 2016-08-12 Impact factor: 4.147