In a nutshell
This trial evaluated the safety and effectiveness of the drug lapatinib (Tykerb) when used in combination with other chemotherapeutic drugs to treat women with metastatic HER2 positive breast cancer.
This study concluded that lapatinib combined with vinorelbine or gemcitabine were effective in these patients.
Some background
Lapatinib is a drug used to treat women with HER2 positive (dependent on the human epidermal growth factor receptor 2 for growth) breast cancer that is metastatic (spread to other areas of the body). Lapatinib works by blocking the action of HER2. It is often given with the chemotherapy agent capecitabine (Xeloda). Whether lapatinib can work effectively and safely in combination with other chemotherapeutic drugs still remains unclear.
Methods & findings
The current trial examined the effects of lapatinib when given with the chemotherapeutic drugs, vinorelbine (Navelbine) and gemcitabine (Gemzar). The trial included 141 patients with metastatic HER2 positive breast cancer. The patients had disease progression despite previous taxane therapy (a type of chemotherapy). 50 patients received lapatinib with capecitabine (LC), 45 received lapatinib with vinorelbine (LV) and 45 received lapatinib with gemcitabine (LG). Patients were treated for six to seven 21-day cycles.
The overall response rates (observable response such as tumor shrinkage) were 49% for the LC group, 56% for the LV group, and 41% for the LG group. Average time to disease progression was not significantly different for the three groups (7 to 9 months).
The most common side effect in the LC group was hand-foot syndrome (18% of patients, redness or swelling on the hands or feet). Low levels of white blood cells were the most commone side effect in the LV group (36% of patients) and the LG group (47% of patients).
These results showed that lapatinib in combination with vinorelbine or gemcitabine are effective in patients with metastatic HER2 positive breast cancer. No new safety issues were found in the patients receiving the combination treatments.
The bottom line
The trial concluded that lapatinib with vinorelbine or lapatinib with gemcitabine are active drug combinations that can be used to treat women with metastatic HER2 positive breast cancer.
The fine print
The number of women in each treatment group was low. A larger number of women in the treatment groups would have allowed the researchers to explore the findings further.
What’s next?
Discuss the benefits and risks of combination therapy with your doctor.
Published By :
Clinical Breast Cancer
Date :
Nov 10, 2015
