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This Week in JAMA: Apr 4, 2012


In JAMA this week, Alberts et al. examine the effect of adding cetuximab to oxaliplatin, fluorouracil, and leucovorin on the survival of patients with resected stage III colon cancer. The team randomly assigned 2,686 patients to receive the standard leucovorin, fluorouracil, and oxaliplatin — or FOLFOX — adjuvant therapy either with or without cetuximab. After a median follow-up of 28 months, the team found no benefit of adding cetuximab. Three-year disease-free survival was 74.6 percent for FOLFOX alone, compared to 71.5 percent with the addition of cetuximab, in patients with wild-type KRAS, and 67.1 percent versus 65 percent in patients with mutated KRAS, the team reports.

In an editorial in JAMA this week, Weill Cornell Medical College's Neil Segal and Memorial Sloan-Kettering Cancer Center's Leonard Saltz write that the anti-tumor activity of a cancer treatment in metastatic disease doesn't predict its efficacy in the adjuvant setting. The colon cancer study done by Alberts et al. shows that enhanced regimens aren't always the best option, even when the drugs are proven to work well in certain cases. "In this context, although the negative results of the N0147 cetuximab trial are still surprising, this pattern has been observed before," Segal and Saltz write. "The inescapable conclusion is that efficacy in the metastatic setting does not reliably predict efficacy in the adjuvant setting."

Also in JAMA this week, a team of researchers from across the US assess the efficacy of adding an annual screening ultrasound or a single screening MRI to mammography for the detection of breast cancer in women with elevated risk for the disease. The team examined 2,809 women with elevated risk and dense breasts with these three screens for two years. They found that the addition of MRI or ultrasound to mammography caught more cancers, but they also raised the rate of false-positive findings.

The Scan

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Novel Brain Cell Organoids Show Promise for Autism Research

University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.