On October 15th there was a press release that, as far as I can tell, went almost entirely unnoticed. News outlets reported that Roche (owner of Genentech, the maker of Avastin (bevacizumab)) reported to OSI Pharmaceuticals (the maker of Tarceva (erlotinib)) the final overall survival results from the ATLAS trial.

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).

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.

In 2008 the SWOG 0023 trial was published, which looked at the question of maintenance Iressa (gefitinib) after definitive chemoradiation in patients with locally advanced (Stage III) NSCLC. The trial randomized patients who had not progressed after completing CRT with concurrent cisplatin and etoposide chemotherapy followed by consolidation Taxotere (docetaxel) to either Iressa or placebo. Patients were then followed until progression or death.

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.

Patients often ask me, "Why are we only doing four cycles of chemotherapy for my lung cancer?" This is a great question and one for which the answer is a moving target, based on recent data incorporating maintenance therapies. A recently published meta-analysis took another look at this question in NSCLC.

For many years, chemotherapy for advanced or metastatic NSCLC had been limited to the use of “doublet” (two-drug) therapy using different combination regimens that were overall found to have very similar outcomes, but with different toxicity (side effect) profiles. Attempts to add a third chemotherapy agent for a triplet regimen, and numerous attempts to add different targeted-therapy agents, had dismal success. Not only did most of the combinations fail to improve on the survival outcomes, they increased the number of side effects compared with doublet chemotherapy alone.

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)).