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First-line treatment

Dr West

Cisplatin/Alimta Receives FDA Approval for First Line Advanced NSCLC, Non-Squamous Only

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Yesterday, as described in a press release, the FDA approved the regimen of cisplatin and alimta as a first line therapy for advanced NSCLC, based on the positive results from a trial called “JMDB” by the sponsor company (Eli Lilly). I described the highlights in a prior post, also recently published (abstract here). It compared cisplatin/gemcitabine to cisplatin/alimta (pemetrexed) in 1725 patients with previously untreated advanced NSCLC and found that the overall efficacy was the same between the two regimens, with a little more favorable side effect profile on the alimta arm. That wasn’t the interesting part.

The part that generated interest within the lung cancer community was the fact that the different main subtypes of NSCLC (tumor histology) did better with one chemo regimen or the other. Patients with squamous NSCLC did better on cisplatin/gemcitabine, while the patients with adenocarcinoma or large cell NSCLC did better on cisplatin/alimta, as shown in both the survival curves and the table below:

JMDB OS (click to enlarge)

JMDB histology table

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Dr West

Survival Results Presented for European AVAiL Trial of Chemo/Avastin: All Arms with Median Survival Beyond a Year

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Last week, updated information on the AVAiL (AVAstin in Lung cancer) trial (see prior post) of cisplatin/gemcitabine with either placebo or a low or higher (full) dose of avastin was presented in a meeting in Stockholm. We had previously heard that this trial was positive for a significant improvement in progression-free survival for both the lower and higher doses of avastin with cis/gemcitabine, but there was no overall survival benefit compared with chemo and placebo.

The presentation last week shed some light on the subject. The highlight of the presentation, or at least the spin, was that all three groups had an unprecedented median overall survival of over 13 months. It was actually 13.4 months for the group receiving chemo with avastin at the standard (high) dose of 15 mg/kg IV every 3 weeks, 13.6 months at the avastin dose of 7.5 mg/kg IV every 3 weeks, and 13.1 months in the placebo arm.

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Dr West

Selection of Patients by EGFR Mutations: A Powerful Predictor, but How Much Does it Really Add?

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Another lung cancer trial that received a good deal of attention at the recent European Society for Medical Oncology (ESMO) conference in Stockholm this past week was conducted by the Spanish Lung Cancer Group and led by Dr. Rafael Rosell, who is chief of medical oncology at Catalan Institute of Oncology in Barcelona and one of the true international greats in the field who has made important contributions for a couple of decades now. His leading interest these days is in refining treatment plans based on molecular characteristics of lung tumors, and this particular study focuses on how patients who have been selected based on EGFR activating mutations do when they receive EGFR inhibitors. We have a pretty good hint of this from several smaller studies that have already been conducted around the world:

EGFR TKI ph2 trials  in mutation pos pts (click to enlarge)

So while these are smallish trials, the largest being 127 patients who actually had a mutation, they all show response rates in the 55-82% range, and the median time to progression is 9-12 months (with some going far beyond).

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Dr West

US-Based Erbitux Trial Shows Favorable Survival Trend, But Not Significant Benefit

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Imclone put out a press release yesterday that the previously described, US-based BMS-099 trial of carboplatin-taxane (either taxol (paclitaxel) or taxotere (docetaxel), investigator’s discretion) with or without the EGFR monoclonal antibody erbitux (ceteuximab) has failed to demonstrate a statistically significant improvement in overall survival. Just over a year ago, we first learned that this trial did not meet its primary endpoint (see prior post): I thought this bode very poorly for the future of erbitux in lung cancer. Shortly thereafter, though, Imclone put out a press release that the European FLEX trial of cisplatin/navelbine (vinorelbine) with or without erbitux (see prior post), although we had to wait nearly nine months to get more information. The results of the FLEX trial were ultimately presented at the Plenary Session of ASCO 2008 (summary post here), showing a statistically significant improvement in survival from the addition of erbitux to this chemo regimen, but with an improvement in median survival of only just over a month, many people are left wondering whether this difference is truly clinically significant, especially factoring in the added side effects, weekly ongoing treatment, and expense.

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Dr West

What I Really Do: First Line Treatment for Avastin Ineligible Patients

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As I mentioned in another post, one of the first branch points in the decision tree about what I recommend as treatment for fit patients with previously untreated advanced NSCLC is the question of eligibility for avastin. Although I do routinely recommend avastin for eligible patients, they aren’t the majority; instead, I would estimate that population ineligible for avastin due to squamous histology, brain metastases (especially now that we routinely look for them with a head MRI), coughing blood, or other factors account for about 60% of my patients.

As I’ve described previously (prior post here), the available evidence is pretty definitive that the vast majority of platinum-based doublets are remarkably similar in their overall activity. There is a little evidence that cisplatin in a little bit more active (see prior post for details), but most oncologists feel that it’s clearly more challenging in terms of side effects, so carboplatin doublets are far more commonly used, including by me. I’ve historically favored the doublet of carbo/gemcitabine for many patients, because the main side effects are decreases in blood counts with usually very little hair loss, nausea/vomiting, and many other unpleasant side effects. I generally favor regimens that have mostly “paper toxicities” that you tell the patient about, compared with ones that the patient experiences and tells you about. But I’ve used several different carbo-based doublet regimens.

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