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Among patients with advanced non–small cell lung cancer (NSCLC) treated with Erbitux® (cetuximab) plus chemotherapy, the development of a rash as a side effect may be associated with improved response to treatment. These Phase III clinical trial findings were reported in TheLancet Oncology.

Non–small cell lung cancer accounts for roughly 85% of all lung cancer. In advanced NSCLC, cancer has spread outside the lung; standard therapy for this stage of disease includes chemotherapy. Because of suboptimal survival rates for advanced NSCLC, researchers continue to evaluate novel ways to improve outcomes for patients with this disease.

Erbitux is a targeted therapy that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells, including NSCLC. Erbitux is currently approved for the treatment of selected patients with advanced head and neck cancer or advanced colorectal cancer.

A common side effect of treatment with Erbitux is an acne-like rash. There has been some speculation that the development of this rash may be associated with the clinical benefit of Erbitux.

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Researchers conducted a subgroup analysis of patients from the First-Line in Lung Cancer (FLEX) study, a study comparing Erbitux plus chemotherapy to chemotherapy alone in patients with advanced NSCLC, to determine whether development of an acne-like rash in the first cycle (21 days) of treatment was associated with treatment outcome.

  • Among patients who received Erbitux plus chemotherapy, those who developed a rash during the first cycle of treatment survived longer than those who didn’t develop a rash (15 months versus 8.8 months, respectively).
  • Progression-free survival was also improved among those who developed a rash (5.4 months versus 4.3 months, respectively).
  • When overall survival was evaluated according to cell type (adenocarcinoma, squamous cell carcinoma, and other carcinomas), rash was associated with a significant benefit across all groups.

It appears that patients with advanced NSCLC who develop a rash during the first cycle of treatment with Erbitux plus chemotherapy have an improved survival compared with patients receiving the same treatment who do not develop a rash. If confirmed, these findings may help healthcare providers determine which patients are most likely to benefit from treatment with Erbitux.

Reference: Gatzemeier U, von Pawel J, Vynnychenko I, et al. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. The Lancet Oncology [early online publication]. December 20, 2010.

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