GRACE :: Lung Cancer

First-line treatment

Dr West

Is it Time for EGFR Mutation Testing? Confessions of a Newly Convinced, Former Clinical Selector

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Those who have followed my writings over time will know that I haven’t been inclined to adopt a reflexive strategy of ordering molecular testing without good evidence that having this information will improve outcomes. Testing tumors for EGFR mutations is advocated by a vocal minority of lung cancer experts in Boston and New York City, but this hasn’t been advocated by the broader lung cancer community yet, or adopted as routine clinical practice. Although I’ve felt that we’ll have enough evidence to support broad use of molecular variables to individualize treatment for lung cancer patients in the next few years, I haven’t felt that they have a role yet, but I’ve now seen some results that I believe are enough for me to change that conclusion.

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Dr West

Carbo/Alimta: Poised to Become a Popular First Line Doublet in NSCLC

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With last week’s FDA approval of alimta in the first line setting for NSCLC, we’re likely to see a lot of alimta (pemetrexed) use shift from the second and third line setting to first line. Alimta’s been a very popular choice for previously treated patients, based on issues like the relatively convenient schedule of a ten minute infusion one day every three weeks, no hair loss, and typically less of a drop in blood counts than seen with some other regimens. In the last year, we’ve seen a growing amount of data using it in combination with either cisplatin or carboplatin in the first line setting. While the official approval of alimta was with cisplatin and only in patients with non-squamous cancers (see prior post), I suspect that it’ll be the carbo/alimta combination that really makes an impact. Historically, US-based oncologists and their patients have preferred carboplatin for it’s easier side effect profile and greater convenience (cisplatin is usually given with loads of fluids to protect the kidneys, leading to long days in the outpatient infusion center or an overnight hospitalization stay). And based on the responses I saw on a recent audience response system for a case-based lung cancer meeting this weekend, the greater interest will again be with carboplatin instead of cisplatin.

So what data do we have to support this combination in lung cancer? Early safety and efficacy studies were done in Italy (article here) and at MD Anderson Cancer Center in Houston (article here) and were certainly encouraging. A friend of mine at MD Anderson, Dr. Ralph Zinner, led their trial and raved about how well tolerated the regimen was, with some patients continuing without progression for 8 or 10 or even more cycles. With a median overall survival of over 13 months, these results were favorable (we expect most trials from MD Anderson to exceed the numbers seen for trials around the country, due to selection bias in the population who come there), but a special appeal was the tolerability of the regimen.

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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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