Source: www.medscape.com
Author: Maurie Markman, MD

Hello. I am Dr. Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I wanted to briefly discuss with you a very interesting paper[1] that appeared online in The Lancet Oncology on December 20th, 2010, and will be in print soon.

The paper was entitled “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.” This was a very interesting subgroup analysis — a retrospective analysis. What the group of investigators attempted to look at was the impact on a patient who received cetuximab and developed a rash compared with individuals who received cetuximab and did not develop a rash. And, of course, the other control group here would be the patients who received chemotherapy without cetuximab.

What this retrospective analysis demonstrated was that overall survival in patients who received combination chemotherapy plus cetuximab and who developed a rash was significantly longer in all of the subtypes of non-small cell lung cancer that were looked at (including squamous and adenocarcinoma), compared with chemotherapy alone or chemotherapy plus cetuximab and no development of a rash.

These data, which are quite provocative and need to be confirmed by others, suggest that the development of a rash may be a reasonable clinical biomarker of the potential impact of this targeted agent on cancer. That is, the development of a rash suggests that there is going to be an effect on the target within the cancer. In the absence of a rash, perhaps either something needs to be done in terms of dosing or perhaps there is indication that this drug is not going to be effective on the cancer.

I encourage you to read this paper. Clearly, these data need to be confirmed by other reports, but this was a large study that looked at over 1000 patients and 290 developed a first-cycle rash. I think it provides very provocative information suggesting that perhaps the development of a rash is a good biomarker for an indication, at least in non-small cell lung cancer, that cetuximab is going to have an effect on the cancer.

Source:
1. 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 of analysis data from the FLEX phase 3 study. Lancet Oncol. 2011;12:30-37. Abstract