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Cetuximab Adds Improvement in Triple Negative Cancer

VBCC - Other
Charles Bankhead

Milan—Women with so-called triple-negative breast cancer had a 2-fold improvement in response rate and significant improvement in progression-free survival (PFS) when the targeted agent cetuximab was added to cisplatin chemotherapy, according to a study reported at the European Society for Medical Oncology Congress.

The combination had an overall response rate of 20% compared with 10.3% in patients treated with cisplatin alone. Although this difference failed to break the prespecified response threshold of 20% required for statistical significance, patients and clinicians should nonetheless find the results encouraging, said senior author Jose Baselga, MD, PhD, Associate Director of the cancer center at Massachusetts General Hospital in Boston.

“It is a positive study because we saw a doubling of the response,” said Dr Baselga. “More importantly, we observed a hazard ratio of 0.67—a 33% improvement—in progression-free survival.”

New Target for Therapy

The study provided the first evidence that epidermal growth factor receptor (EGFR) represents a legitimate therapeutic target in triple-negative breast cancer, a subgroup of patients who are negative for estrogen and progesterone receptor and for HER2. No standard therapy exists for these patients, who have worse outcomes compared with other patient subgroups.

The findings came from a multicenter, randomized clinical trial involving 173 patients with triple-negative breast cancer. All patients received cisplatin and were randomized 2:1 to cetuximab or placebo. Cetuximab therapy started with a 400-mg/m2loading dose, followed by 250 mg/m2weekly.  Patients in both arms received cisplatin at a dose of 75 mg/m2every 3 weeks for a maximum of 6 cycles. Although the study did not meet the primary end point (P = .11), patients in the cetuximab group had a statistically significant 2.2-month improvement in the secondary end point of PFS (3.7 vs 1.5 months; P = .032).

The study did not yield any new safety issues. The most common grade 3-4 treatment-related adverse events occurred more frequently with cetuximab, including acneiform rash (14% vs 0%), neutropenia (9.6% vs 5.3%), fatigue (8.8% vs 7.0%), and dyspnea (6.1% vs 1.8%).

“I am convinced that cetuximab or another anti-EGFR agent has a role in triple-negative breast cancer,” said Dr Baselga. “We have to design appropriate trials, but EGFR is a target that needs to be studied.”

Conflicting Opinion on Utility

Invited discussant Eric Winer, MD, Director of Breast Oncology at the Dana-Farber Cancer Institute in Boston, offered a more tempered assessment of the trial results.

“The results are consistent with prior studies suggesting some limited activity of cetuximab, in combination with chemotherapy, in patients with triple-negative breast cancer,” said Dr Winer.

“This regimen is not ready for use outside of a clinical trial,” he added. “There seems to be a small patient subset that appears to derive benefit from the addition of cetuximab, but additional studies are needed to identify the patients most likely to respond.”

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Last modified: May 28, 2014
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