Neratinib-based therapy in patients with metastatic HER2-positive breast cancer from Asia.

To evaluate the safety and efficacy of neratinib-based therapy in Asian patients with HER2-positive metastatic breast cancer (MBC). We performed a pooled analysis of seven early-phase studies of neratinib given either as monotherapy or in combination with chemotherapeutic agents or trastuzumab in patients with advanced solid tumors. A total of 793 patients with HER2-positive MBC were included in the efficacy analysis (Asia: 271 patients; other regions: 522 patients).

Isoniazid vs. rifampin for latent tuberculosis infection in jail inmates: toxicity and adherence.

This open-label randomized trial compared isoniazid (9 months) to rifampin (4 months) on toxicity and completion in a jailed population with latent tuberculosis infection. Rifampin resulted in fewer elevated liver function tests (risk ratio [RR] 0.39, 95% confidence interval [CI] [0.

Multisite analytic performance studies of a real-time polymerase chain reaction assay for the detection of BRAF V600E mutations in formalin-fixed, paraffin-embedded tissue specimens of malignant melanoma.

Context: A polymerase chain reaction-based companion diagnostic (cobas 4800 BRAF V600 Mutation Test) was recently approved by the US Food and Drug Administration to select patients with BRAF-mutant metastatic melanoma for treatment with the BRAF inhibitor vemurafenib.

Objectives: (1) To compare the analytic performance of the cobas test to Sanger sequencing by using screening specimens from phase II and phase III trials of vemurafenib, and (2) to assess the reproducibility of the cobas test at different testing sites.

Design: Specimens from 477 patients were used to determine positive and negative percent agreements between the cobas test and Sanger sequencing for detecting V600E (1799T>A) mutations.