Lapatinib plus capecitabine versus capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment

Abstract

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.

Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial

“…Оценка связи между КЖ и ответом опухоли на лечение у больных онкологическими заболеваниями разной локали-зации, например раком молочной железы и почечно-кле-точным раком, изучалась в ряде клинических исследований [23,21,19,20,7]. Было показано, что у пациентов с медлен-ным прогрессированием опухолевого заболевания, продол-жающих лечение, КЖ стабильное или снижается медленнее, чем у пациентов с быстрым прогрессированием.…”

Health state utility values in breast and prostate cancer measured using EQ-5D: a systematic review of the literature

“…[10][11][12][13] The study that reported the highest value (0.75) also estimated a value of 0.51 for patients receiving palliative care, thus indicating that individuals with terminal disease were not included in the cohort with mBC. 10 The lowest value (0.55) was reported in a study of patients receiving palliative care.…”

“…14 • A single study followed up patients receiving treatment for mBC and showed little change from baseline after 6 months of treatment with either capecitabine alone or capecitabine with lapatinib. 13 …”

Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: an economic analysis from the Brazilian public health care perspective

“…Inputs and their sources are presented in Table 1. 14,18,[20][21][22][23][24][25] Two clinical studies formed the body of evidence to support the current cost-effectiveness analysis. Those were the EGF100151 and GBG 26/BIG 3-05 clinical trials, which demonstrated the clinical benefits of adding HER2-targeted therapy with lapatinib or trastuzumab to capecitabine monotherapy in patients with MBC who had progressed while receiving trastuzumab.…”

“…24 Estimated decrements in utility associated with progression were 32% (0.22 in absolute terms) using data from a study of societal preferences for different stages of MBC. 25 …”