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.

Despite the fact that a very significant proportion of the "real world" patients have considerable medical problems such as markedly decreased lung function (pretty common with many years of smoking), weight loss (5 or 10% of body weight is usually considered a problem), or otherwise are not able to be very active.

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

Let's move to combinations of velcade with other anti-cancer agents. My friend, Dr.Angela Davies from the University of California at Davis, led a single-arm phase II trial conducted by the Southwest Oncology Group, SWOG 0339, that evaluated the combination of velcade with gemcitabine and carboplatin (abstract here).

I've recently received some questions about the advantages and disadvantages of maintenance Avastin as a single agent for patients after completion of 6 cycles of first line chemo and avastin together for avastin-eligible patients. While this is generally considered to be a standard of care, many oncologists question whether it should be done. It's worth looking at how that standard came about and the strength of the evidence for it.