One of the successful examples of incorporating patient-reported outcome (PRO) measures into an important clinical trial was in the NCI-Canada study BR.21 (abstract here). This study assigned patients to either tarceva or placebo in a 2:1 randomization to the active drug:

In my last post I described a new study that will be randomizing previously treated advanced NSCLC patients with a current or prior smoking history to receive either tarceva or a new chemotherapy called pralatrexate. Now it’s time to provide a little background on this new agent.

I've described in a prior post and many of my comments here how tarceva and iressa, oral targeted therapies against EGFR, have been pretty consistently impressive in never-smokers. Not infallibly great, but these agents have shown high response rates in the 25-50% range for never-smokers, and have also been pretty favorable for remote and minimal smokers.

There's a website called Adjuvant! Online, developed by oncologist Peter Ravdin, that is best known for its use after surgery for breast cancer in assessing the value of post-operative chemo. Because I don't really treat breast cancer, I haven't spent time on the website, but I do know that it's a valued resource among practicing oncologists who care for patients with breast cancer.

The antibody to the epidermal growth factor receptor erbitux (cetuximab) (introductory post here) has been used as an effective treatment for colon and also head and neck cancer for several years, but its role in lung cancer has yet to be defined.

Although I've previously written about the question about optimal duration of therapy for first-line chemotherapy in advanced NSCLC (post here), these conclusions have been based on a limited number of trials. One study randomized patients to three or six cycles of rather old chemo and found no significant differences (abstract here).

While there is a lot of variability in the clinical behavior of bronchioloalveolar carcinoma (BAC), there are some commonly observed findings that are now leading lung cancer experts to consider it as a distinct clinical entity worthy of special consideration for management. Among the important areas for potentially special clinical management is in surgical management of early stage disease.

Rashes from EGFR inhibitors: we like to see them, because we know that many trials have shown that skin toxicity on drugs like tarceva is associated with better survival (see prior post), but the fact is that sometimes a rash is more than an inconvenience and can really make people miserable, or at least pretty unhappy, as described in the comments and questions from a discussion forum thread today.

As I described in my prior post, the marker ERCC1 (excision-repair cross complementing group 1) is a prognostic variable that is associated with a more favorable survival in patients who aren't treated with chemo after surgery for early stage NSCLC. But this marker also appears to be predictive of resistance to cisplatin and a worse survival in patients treated with platinum-based chemo after surgery.

Although I’ve described this concept in a few posts over the past year, it’s time for me to dedicate some real discussion to the concept of individualizing treatment with the ERCC1 marker. ERCC1 stands for excision repair cross-complementing group 1, and it helps repair damage to DNA.