Several trials have recently opened up for never-smokers with any lung adenocarcinoma or those with BAC (or adeno/BAC mix, invasive adenocarcinoma with BAC features) with any smoking status. Both of these groups have only recently gained recognition as likely being a distinct clinical entity with a different natural history (clinical behavior outside of treatment) and pattern of responsiveness to treatments that is different from other types of lung cancer.

The decision about pursuing post-operative treatment is often difficult and requires carefully weighing the risks of treatment with potentially challenging and even dangerous chemotherapy against the potential to eradicate micrometastases and actually lead some people to be cured who otherwise wouldn't be. It's important to remember that some people are already cured, while others won't be cured even with treatment.

While there are good reasons to not pursue chemo after surgery for stage I NSCLC, there are several factors that argue at least for strong consideration of adjuvant chemotherapy for higher risk patients. Because stage IB generally has a less favorable prognosis than stage IA, it's not suprising that the debate about which patients should or should not be receiving post-op chemo has centered more on the stage IB population, which have much more commonly been included in trials testing the value of adjuvant chemotherapy.

Over the last several years, chemo for resected early stage NSCLC has become a standard of care, but while it's pretty widely accepted for stage II and IIIA patients after surgery, the role for chemo is much more debatable for stage I patients. I'll try to explain why, starting with the downside, and then turn to some of the reasons to consider it.

In addition to a direct comparison of iressa to chemo in the second line setting for advanced NSCLC (see recent post on INTEREST trial), as conducted with the INTEREST trial I described in a recent post, a very similar comparison of Iressa to chemo was also performed in another setting where single-agent chemo is also the treatment of choice. Specifically, the INVITE trial evaluated iressa vs.

In a post several months ago, I described the results of a trial from Japan, designated V-15-32, that directly compared Iressa to Taxotere as a second line therapy. Although overall comparable, the study showed that Japanese patients receiving Iressa had a higher response rate, but despite that had a lower median and one year survival.

In my recent post on the JMDB trial that randomized patients between cisplatin/alimta and cisplatin gemcitabine in first line treatment of advanced NSCLC, the take home conclusions were that overall efficacy was very similar, with the cis/alimta arm looking a little better in several side effect parameters, most notably a less significant decline in blood counts and lower risk for fevers with a low white blood cell count.

In my last post, I noted that the FLEX trial of cisplatin/navelbine with or without the EGFR monoclonal antibody erbitux was reported to be positive, demonstrating a significant survival benefit.

Merck KgAA, the company developing cetuximab/Erbitux, the monoclonal antibody against EGFR, reviewed here) outside of the US, has announced that their pivotal FLEX trial (for First-Line Trial for patients with EGFR-Expressing Advanced NSCLC) is positive, demonstrating a signficant improvement in overall survival, as indicated