This article is more than 5 years old. Information may no longer be current.
Addition of lapatinib to paclitaxel extended survival in women with HER-2 breast cancer
Click Here to Manage Email Alerts
The addition of lapatinib to paclitaxel conferred significant improvements in OS among patients with newly diagnosed, HER-2–positive metastatic breast cancer, according to phase 3 study results.
In the randomized, double blind study, all 444 patients received 80 mg/m2 paclitaxel weekly. Researchers randomly assigned half to receive 1,500 mg lapatinib (Tykerb, GlaxoSmithKline) daily or placebo.
OS served as the primary outcome measure. Secondary outcome measures included PFS, overall response rate and safety.
Researchers reported a significant improvement in median OS among patients assigned to lapatinib (27.8 months vs. 20.5 months; HR=0.74; 95% CI, 0.58-0.94).
“This improvement in OS was noted despite the fact that [67% of patients] randomly assigned to placebo plus paclitaxel subsequently received lapatinib monotherapy at the time of progressive disease,” the researchers wrote.
Median PFS was 9.7 months in the lapatinib arm compared with 6.5 months in the placebo arm (HR=0.52; 95% CI, 0.42-0.64).
The researchers also reported significant improvements in overall response rate in patients assigned to lapatinib (69% vs. 50%; P<.001).
Adverse events included grade 3 and grade 4 diarrhea and neutropenia. No fatal events occurred in patients assigned to the lapatinib plus paclitaxel.
The investigators, therefore, recommend this combination treatment, particularly when trastuzumab (Herceptin, Genentech) is not an option.
“Our study is not establishing a new standard, but it provides a new option,” Zhongzhen Guan, MD, of the internal medicine department of oncology at Sun Yat-Sen Medical University Cancer Center in Guangzhou, China, told HemOnc Today. “When our study was going on, there was no head-to-head comparison study between trastuzumab and lapatinib. However, at last year’s ASCO meeting, data were reported on the MA 31 study, which compared trastuzumab/paclitaxel with lapatinib/paclitaxel and suggested trastuzumab had a better PFS (HR=1.33; P=.01) but no significant difference in OS (HR=1.1; P=.62). I believe multiple available options are beneficial in clinical patient care.”
For more information:
Zhongzhen Guan, MD, can be reached at guanzhzh@mail.sysu.edu.cn.
Disclosure: The researchers report employment relationships, stock ownership and research funding from GlaxoSmithKline.
Collapse
Click Here to Manage Email Alerts