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Dr. Jack West is a medical oncologist and thoracic oncology specialist, and Executive Director of Employer Services at the City of Hope Comprehensive Cancer Center in Duarte, CA.

Early Report: SATURN Trial of Maintenance Tarceva Positive for Improvement in Progression-Free Survival
Fri, 11/07/2008 - 15:54
Howard (Jack) West, MD, Associate Clinical Professor, Medical Oncology, Executive Director, Employer Services, Founder, President and CEO of GRACE

Well, it happened again that the first word came from the financial community (report here), as we learned today that a large trial testing the value of maintenance tarceva (erlotinib), the oral EGFR inhibitor, provides a significant improvement in progression-free survival (PFS). In the following slide, I show the design for two similar trials that test the value of tarceva after four cycles of first line treatment of advanced NSCLC.


The first, called the ATLAS trial, is for avastin-eligible patients who would typically receive avastin alone as maintenance therapy after initial chemo/avastin. It randomizes patients to maintenance avastin/tarceva vs. avastin alone. We don't have results from that trial yet. The results we have are from the SATURN trial, which asks a similar question but without the avastin: is there a significant delay in progression if patients who haven't progressed after four cycles of platinum-based standard chemotherapy (and no avastin) receive tarceva as a maintenance therapy, compared with an oral placebo?

The answer we received as that yes, there is a significant benefit for PFS among the 889 enrolled patients, but we don't yet know the absolute magnitude of that benefit or whether it's accompanied by an improvement in overall survival (OS).

This result isn't surprising to me. I had been following this very timely question of whether we should now standardly offer maintenance therapy to patients who aren't progressing after 4-6 cycles of initial treatment. As I highlighted in a recent prior post, I have been impressed that the limited evidence with both taxotere (docetaxel) and alimta (pemetrexed) is quite convincingly positive for a highly significant improvement in PFS and a nearly statistically significant improvement in OS (nearly three months in both of the chemo trials). Moreover, my impression of the overall data out there for these three agents is that they're quite comparable overall in their efficacy in a broad population, although there are certainly a minority of patients who show stunning benefits from EGFR inhibitors, and the clinical benefit with alimta appears to be limited to patients with non-squamous NSCLC. I would have been surprised if a similar trend hadn't been seen with the third drug that we commonly recognize as being active in previously treated patients with advanced NSCLC.

We have yet to learn any details, though next week I'll be attending the largest meeting dedicated to lung cancer this year, in Chicago, so we may see a presentation of this information. With such a large trial, it's possible that the absolute difference in outcomes isn't enough to lead to significant changes in practice, particularly if there is little or no improvement in survival. Thus far, there hasn't been much of a movement toward accepting maintenance chemotherapy after first line treatment yet, and many of the detractors cite the absence of a significant survival benefit as a key reason (I happen to disagree on this point -- see prior post). But the concept of giving patients an oral, generally well-tolerated therapy may be more appealing in the maintenance setting than more standard IV chemotherapy.

I'll certainly add more information about this trial when it becomes available. I'll also be interested to learn from people who have been on both standard chemo and tarceva whether they'd be more amenable to an oral strategy like tarceva, whether they'd be perfectly comfortable continuing on chemo, or whether they'd just really welcome a break from treatment after 3-4 months of initial chemo +/- avastin.

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