Capecitabine Ineffective in Elderly Early Breast Cancer Patients

The gist: A recent study found that elderly patients with early-stage, moderate- to high-risk breast cancer don’t benefit from the addition of the drug capecitabine to their post-surgery treatment with the drug ibandronate.

“The use of adjuvant capecitabine in elderly patients with moderate- to high-risk early breast cancer resulted in no improvement in disease-free survival, according to a study presented at the 2014 San Antonio Breast Cancer Symposium.

“The phase III ICE study tested ibandronate, a bisphosphonate, with or without capecitabine in women aged 65 years or older.

“ ‘At 3 years there was no difference in invasive disease-free survival between the treatment arms,’ said study presenter, Gunter von Minckwitz, MD, chairman of the German Breast Group and a professor of gynecology at University of Frankfurt, Germany. ‘After 5 years, the curves seem to slightly separate, but after the curves cross, showing no statistically significant difference.’ ”


Neratinib Plus Capecitabine Shows Activity in HER2-Positive Metastatic Breast Cancer

The gist: A recent clinical trial tested a new breast cancer treatment in volunteer patients. The treatment combines a new drug called neratinib with the chemotherapy drug capecitabine. The trial found promising results for patients who had HER2-positive metastatic breast cancer and who had already been treated with trastuzumab (Herceptin) and taxanes. Some of the patients had also had prior treatment with the drug lapatinib (Tykerb). Patients interested in this treatment can now enroll in a new phase III clinical trial.

“Neratinib is an irreversible pan-tyrosine kinase inhibitor with activity against HER1, HER2, and HER4. In a phase I/II trial reported in the Journal of Clinical Oncology, Saura et al found that the combination of neratinib and capecitabine exhibited high activity in patients with trastuzumab (Herceptin)- and taxane-pretreated HER2-positive metastatic breast cancer, including those with prior treatment with the dual HER1/HER2 kinase inhibitor lapatinib (Tykerb)…

“In the phase I dose-escalation phase in 33 patients, the maximum tolerated dose of the combined regimen was found to be neratinib at 240 mg once a day continuously and capecitabine at 1,500 mg/m2 twice a day on days 1 and 14 every 21 days. No dose-limiting toxicity was observed at this level; dose-limiting toxicities at higher doses of neratinib or capecitabine included diarrhea, increased liver enzymes, and asthenia…

“In the phase II portion, 72 patients, including 7 with prior lapatinib treatment, received the maximum tolerated dose of the combination. The overall response rate in 65 patients with no prior lapatinib was 64% (95% confidence interval [CI] = 51%–76%), including complete response in 12%. In the 7 patients with prior lapatinib treatment, the response rate was 57% (95% CI = 18%–90%), including complete response in 1 patient (14%).

“Stable disease ≥ 24 weeks was achieved in an additional 8% and 14% of patients. Median progression-free survival was 40.3 weeks (95% CI = 30.3–66.0 weeks) and 35.9 weeks (95% CI = 18.9–60.1 weeks).”