By David Douglas
NEW YORK (Reuters Health) – Adding lapatinib to paclitaxel provided significant benefits to women with newly diagnosed HER2-positive metastatic breast cancer in a recent study.
The randomized trial, in which women received paclitaxel with or without lapatinib, “is not establishing a new standard, but provides another option in treating HER-2 positive breast cancer patients,” Dr. Zhongzhen Guan told Reuters Health by email. “I believe multiple options can be beneficial in clinical patient care.”
“At least at the present time,” Dr. Guan added, this approach is likely to be particularly beneficial in situations where trastuzumab is not readily available.
Dr. Guan of Sun Yat-Sen Medical University Cancer Center, Guangzhou, China, and colleagues reported their findings March 18 online in the Journal of Clinical Oncology. Altogether they treated 444 patients with paclitaxel plus lapatinib or placebo.
Combining paclitaxel with trastuzumab has helped such patients, but this new trial was conducted “in clinical environments in which trastuzumab was not widely accessible,” the authors said.
The combination therapy group had significantly longer median overall survival (27.8 vs 20.5 months) and progression-free survival (9.7 vs 6.5 months) and a higher overall response rate (69% vs 50%).
More patients experienced serious adverse events with lapatinib (30% vs 14%). Four percent of the lapatinib patients had febrile neutropenia compared to less than 1% of the placebo patients. However, there were no fatal adverse events in the lapatinib group.
The researchers conclude that “lapatinib combined with paclitaxel offers a significant and clinically meaningful survival advantage over paclitaxel alone.”
The study was supported by GlaxoSmithKline, which markets lapatinib as Tykerb.
SOURCE: Randomized Trial of Lapatinib Versus Placebo Added to Paclitaxel in the Treatment of Human Epidermal Growth Factor Receptor 2–Overexpressing Metastatic Breast Cancer
J Clin Oncol 2013.
