Perhaps the most unexpected clinical trial result in lung cancer over the past 5 years was the finding in the large Southwest Oncology Group (SWOG) 0023 trial that randomized several hundred patients to maintenance therapy with either the oral EGFR inhibitor Iressa (gefitinib) or a placebo after chemo/radiation concurrently and then consolidation taxotere (docetaxel).

What we are striving for in cancer care today is personalized medicine. So, if a patient with newly diagnosed NSCLC has an activating epidermal growth factor receptor (EGFR) mutation, we give that patient Tarceva (erlotinib), a tyrosine kinase inhibitor (TKI). Right? Well, yes -- but it doesn’t always work (the response rate is in the 70-75% range). Why not? We’re not sure, but it would be nice to learn why we don't see near a 100% response rate among patients with EGFR mutations, so that we can know to recommend other alternatives.

When most oncologists think about the EGFR inhibitor tarceva (erlotinib), they think of the uncommon but very memorable patient who has a spectacular response within a few weeks of starting it, then continues to do well on it for a year or more. These patients are most commonly never-smokers, often Asian, and almost invariably have an adenocarcinoma. In contrast, many oncologists perceive there to be little to no value in giving tarceva to patients with squamous tumors, and many don’t even bother to offer it to these patients.

As more and more oncologists become aware of the importance of testing for at least the EGFR mutation in tumor, and soon, perhaps, in blood, it seems likely that more patients will have their first systemic treatment for advanced non-small cell lung cancer (NSCLC) be an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), usually Tarceva (erlotinib), until Iressa (gefitinib) is re-approved (perhaps).

Dr.

In the same issue of the New England Journal of Medicine that contained the IPASS trial results, Dr. Rosell and colleagues reported results of their effort to institute large-scale EGFR mutation testing in lung cancer patients in Spain, who then received erlotinib (Tarceva).

Shortly after ASCO 2009, Dr. Pennell provided the highlights of the early report of the SATURN trial, conducted primarily in Europe, that randomized patients to maintenance tarceva (erlotinib) or placebo after four cycles of first line chemotherapy. The early report described a modest but statistically significant improvement in progression-free survival (PFS), but overall survival (OS) wasn't reported at ASCO.

Over the past several months the topic of so-called maintenance therapy in advanced NSCLC has been one of the most timely and controversy questions in lung cancer. We've had posts here covering a trial testing immediate vs.

At ASCO a little over a month ago we learned the preliminary results of the SATURN trial that compared "maintenance" Tarceva (erlotinib), the oral EGFR inhibitor, to an oral placebo in patients who showed no progression after four cycles of first line chemotherapy.

Last week we discussed SATURN, the first of 2 recently presented trials testing the role of maintenance Tarceva (erlotinib) in advanced NSCLC patients. Today I will discuss the ATLAS trial, the last of the 4 major maintenance therapy trials (along with immediate versus delayed Taxotere (docetaxel) and maintenance Alimta (pemetrexed)).