Lapatinib plus capecitabine versus capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment
- 701 Downloads
The randomized phase III trial EGF100151 demonstrated that the combination of lapatinib plus capecitabine (L + C) significantly improved time to progression (TTP) compared with capecitabine alone (C) in heavily pretreated patients with HER2+ (ErbB2+) advanced or metastatic breast cancer. This analysis assessed the effects of study treatments on quality of life (QOL) among patients in EGF100151. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL (EQ-5D) questionnaires. Patients completed questionnaires during efficacy and safety assessment visits (i.e., at screening visit, every 6 weeks for the first 24 weeks, every 12 weeks thereafter, and at discontinuation of study treatment). Primary analyses compared the treatment groups based on change from baseline QOL. Exploratory analyses compared proportion of patients achieving minimum important differences (MID) in QOL scores and the relationship between QOL and tumor status. Quality of life for patients in both treatment groups was maintained during 24 weeks of follow-up. Adjusted mean changes from baseline in all QOL scores for the L + C arm were comparable to those for the C arm. The between-group differences ranged from 0.7 to 2.2 (FACT-B total) and 0.3 to 1.8 (EQ-5D visual analog scale) and were consistently in favor of the L + C arm, although not statistically significant. Patients with an objective tumor response or stable disease showed clinically meaningful differences in QOL scores compared to patients with progressive disease. A greater proportion of patients receiving L + C versus C achieved the MID for all five QOL scores, although differences were not statistically significant. The addition of lapatinib to capecitabine significantly increases TTP without any evidence of a deleterious effect on patients’ QOL, confirming its clinical benefit in this heavily pretreated patient population with advanced HER2+ breast cancer that has progressed on trastuzumab therapy.
KeywordsHER2 Breast cancer Lapatinib Quality of life
We thank the patients who participated in the study and their families; the medical, nursing, and research staff at the study centers; the independent data and safety monitoring committee; and the monitors, clinical operations staff, data managers, statisticians, and programmers at GlaxoSmithKline. The EGF100151 study and the QOL analysis based on this study and reported in this paper were funded by GlaxoSmithKline. Financial support for medical editorial assistance was provided by GlaxoSmithKline. We also thank Bret A. Wing, PhD, ProEd Communications, Inc.®, for his medical editorial assistance with this manuscript.
- 17.Cameron D, Casey M, Press M et al (2008) A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 112:533–543. doi: 10.1007/s10549-007-9885-0 PubMedCrossRefGoogle Scholar
- 19.Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer Institute of the United States, national cancer institute of Canada. J Natl Cancer Inst 92:205–216. doi: 10.1093/jnci/92.3.205 PubMedCrossRefGoogle Scholar
- 26.Bottomley A, Biganzoli L, Cufer T et al (2004) Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: European organization for research and treatment of cancer breast cancer group, investigational drug branch for breast cancer and the new drug development group study. J Clin Oncol 22:2576–2586. doi: 10.1200/JCO.2004.02.037 PubMedCrossRefGoogle Scholar
- 27.Kloke O, Klaassen U, Oberhoff C et al (1999) Maintenance treatment with medroxyprogesterone acetate in patients with advanced breast cancer responding to chemotherapy: results of a randomized trial. Essen Breast Cancer Study Group. Breast Cancer Res Treat 55:51–59. doi: 10.1023/A:1006169012544 PubMedCrossRefGoogle Scholar
- 29.Kramer JA, Curran D, Piccart M et al (2000) Randomised trial of paclitaxel versus doxorubicin as first-line chemotherapy for advanced breast cancer: quality of life evaluation using the EORTC QLQ-C30 and the Rotterdam symptom checklist. Eur J Cancer 36:1488–1497. doi: 10.1016/S0959-8049(00)00134-9 PubMedCrossRefGoogle Scholar