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Dr. Jack West is a medical oncologist and thoracic oncology specialist who is the Founder and previously served as President & CEO, currently a member of the Board of Directors of the Global Resource for Advancing Cancer Education (GRACE)


Oral Topotecan FDA Approved in US for Second Line SCLC
Howard (Jack) West, MD

This bit of news slipped under the radar for the past six weeks, but oral topotecan was approved by the FDA for the treatment of SCLC that has recurred at least 45 days after the last chemotherapy had been given. I'm a little embarrassed to say that I hadn't noted this, but it really got very little airplay. Part of it is that topotecan was already available and approved for recurrent SCLC in its IV form. But as you can review in my summary post about it, the prior FDA approved form of topotecan, as a regimen given IV for five days in a row each 3 week cycle, makes for a rather inconvenient approach for many patients. Giving IV topotecan on a weekly schedule is a feasible alternative, but it hasn't been as well studied as a five consecutive day schedule. While IV and oral topotecan have been shown to have the same activity overall, it was actually the oral topotecan formulation that was recently shown to have a significant survival benefit compared with supportive care alone for recurrent SCLC. I described that in the post referenced above, in which I also said that while oral topotecan wasn't approved yet, it likely would be soon. It should be routinely available in 2008.

I'll also mention that oral topotecan happens to have been studied in second-line NSCLC as well. In a trial that randomized over 800 patients with previously treated advanced NSCLC to either IV taxotere on day 1 (the first FDA-approved second line NSCLC treatment) or oral topotecan for five days every 21 days (abstract here), Ramlau and colleagues reported that oral topotecan produced a similar but borderline significantly inferior overall survival rate. This is illustrated in the figure below, where the curves are close, but taxotere is always on top by a small margin:

Ramlau PO topo

(Click on image to enlarge)

While oral topotecan appeared perhaps just a shade inferior in activity, it was actually rated overall a little worse in quality of life in this study as well. Measured side effects were pretty comparable overall.

So for previously treated NSCLC, while topotecan is a consideration, and the oral form has been pretty well studied in this setting, there's no reason to recommend it over taxotere. And you may also recall that the majority of US oncologists now favor alimta over taxotere as a second line chemo, because the two were found to have stunningly similar activity overall, and most oncologists have found alimta to be the easier treatment for a majority of patients. And with tarceva as another very reasonable option for previously treated NSCLC patients, taxotere is already getting squeezed down the rankings for many patients, leaving oral topotecan as a possibility, but pretty low on the list.

Still, that's not to say that it can't have a place in the discussion. I have a few patients who have received multiple lines of therapy and are still feeling well and doing well overall. So sometimes it's still helpful to have one more option with some evidence of activity (oral topotecan had a 5% response rate, the same as IV taxotere, in the head to head trial noted above), even when it wouldn't be at the top of the list. And the oral formulation makes it easier for most patients.

Next I'll cover vinflunine, another tested chemo drug that may find its way into lung cancer treatment.

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