Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer

Abstract

Objective:

EGF103009 (ClinicalTrials.gov identifier: NCT00105950) was a phase 2, open-label, multicenter study that showed lapatinib monotherapy to be clinically active in women with relapsed or refractory HER2+ (ErbB2+) inflammatory breast cancer that progressed following prior therapy with anthracyclines, taxanes, and trastuzumab. The objective of the present study was to assess the impact of lapatinib on quality of life (QOL) and pain symptoms in these patients.

Research design and methods:

QOL and pain assessments were added during a study amendment and hence only 33 of 126 HER2+ patients were available for baseline assessment. QOL and pain were assessed using the EORTC QLQ-C30 and Brief Pain Inventory–Short Form (BPI-SF) questionnaires, respectively. Both questionnaires were completed at baseline and every 4 weeks thereafter. Change from baseline in QOL and pain scores were summarized by visit. In a post hoc analysis, scores were compared between patients with different clinical response status.

Results:

Over 60% of the 33 HER2+ patients with the baseline assessments completed the first three postbaseline assessments (week 4, n = 26; week 8, n = 21; week 12, n = 20). At week 8, improvement from baseline in mean EORTC QLQ-C30 scores was observed for global QOL (delta = 14.5; 95% CI: 4.0, 25.0), role functioning (delta = 15; 95% CI: 0.9, 29.1), social functioning (delta = 14.9; 95% CI: −0.5, 30.3), and physical functioning subscales (delta = 9.0; 95% CI: 1.2, 16.8). All symptom scales (except diarrhea) improved from baseline at most scheduled visits during the 20-week follow-up period. Mean scores for all four BPI-SF summary pain scores at week 8 suggested improvement in pain severity and pain interference. Clinical responders had improved scores on most aspects of QOL, compared with declining scores among nonresponders to treatment.

Conclusions:

The QOL improvement among the small number of patients with QOL data indicates that lapatinib monotherapy may improve level of functioning/QOL and provide relief from symptoms, including pain, in the short term. These QOL benefits add to the clinical improvement associated with lapatinib therapy in heavily pretreated patients with an aggressive form of breast cancer.

Trial registration: ClinicalTrials.gov identifier: NCT00105950.

Key words::

• HER2+
• Inflammatory breast cancer
• Lapatinib
• Quality of life

Transparency

Declaration of funding

The EGF103009 study and analyses reported in this paper were funded by GlaxoSmithKline. Two employees from GlaxoSmithKline participated with other coauthors in the interpretation of analysis results and in manuscript writing/review.

Declaration of financial/other relationships

B.K. reports no conflicts of interest related to this article. M.A. and V.S. are employees of GlaxoSmithKline and hold stock in GlaxoSmithKline. Y.W., B.S., P.V., and T.B. serve as consultants to GlaxoSmithKline. S.J. has received honoraria from GlaxoSmithKline. S.J. and T.B. have received research funding from GlaxoSmithKline. Peer reviewers may receive honoraria from CMRO for their review work. The peer reviewers have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors 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 authors would also like to thank Michelle DeSilvio for her valuable assistance.

Presented in part at the 2008 San Antonio Breast Cancer Symposium (SABCS) 10–14 December 2008, San Antonio, TX, USA.

Notes

*Tykerb/Tyverb are the registered trade names of GlaxoSmithKline, RTP, NC, USA.

†Xeloda is the registered trade name of Roche, Nutley, NJ, USA.