At long last, and after years of planning, a new large phase III randomized clinical trial is getting underway to determine whether adding avastin to chemotherapy as post-operative (adjuvant) treatment for early stage NSCLC provides added benefit compared to chemotherapy alone.

In my last post I covered much of the controversy about whether patients with stage IIIA, N2-node positive NSCLC should be treated with induction therapy (chemotherapy or chemo/radiation) followed by surgery, or an alternative approach of chemo along with radiation delivered at a definitive dose (curative, not just the supplemental, lower doses used in induction therapy).

It's over, and I won (did you doubt me?).

I'm heading off today to Hawaii (Maui), which I must hasten to add is for a conference, the Eighth International Lung Cancer Congress, not just a vacation, although working in Hawaii often seems better than time off at home. The meeting not only includes a lot of good lectures and debates, but it gives us the opportunity to actually discuss the importance and implications of the trials that were just presented a few weeks before at ASCO.

One of the central ideas in management of advanced NSCLC is that many two-drug chemo combinations have been compared and show essentially superimposable results, as I described in a prior post.

As I described in prior post, prophylactic cranial irradiation (PCI) is established as a treatment approach for patients with LD-SCLC who have had a complete or "good partial" response to chemo and radiation. Some physicians also recommend PCI for patients with ED-SCLC who have experienced a very good response, since about 10% of the patients on the PCI trials that led to our current recommendations had ED-SCLC.

One of the more intriguing presentations at ASCO this year was the one in which a novel vaccine against a protein called MAGE-A3 was tested in patients who underwent surgery and then received the vaccine post-operatively. What is MAGE-A3? It's a nearly tumor-specific antigen, which means that it's a protein seen almost exclusively on cancer cells, including lung cancer, head & neck, bladder, and melanomas.

As described in one of my first posts, Avastin was approved by the US FDA for the first line treatment of advanced NSCLC in patients with non-squamous cancers, no history of coughing up blood, and no brain metastases, based on the positive trial ECOG 4599 (abstract here) that demonstrated a survival benefit for carbo/taxol/a

I had previously mentioned in prior posts that there have been a few studies in advanced NSCLC that indicate that about 4 cycles provides as much treatment benefit as continuing first-line chemo until progression. I also noted that the ECOG 4599 trial (abstract here) gave up to 6 cycles of chemo (with carbo/taxol) and avastin, followed by avastin alone as a maintenance therapy until progression of the cancer.

While post-operative chemotherapy has emerged as the standard treatment for patients with stage II and resected IIIA NSCLCC, and some patients with stage IB disease, trials conducted over the past few years are providing information about the option of treating with initial chemotherapy before surgery. A couple of trials were presented at ASCO this year that did not demonstrate a significant survival benefit of pre-operative chemo compared with no treatment.