Article and Video CATEGORIES

Cancer Journey

Search By

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
Author
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.

Next Previous link

Previous PostNext Post

Related Content

Image
Lung Cancer OncTalk 2023
Video
At our live event, Lung Cancer OncTalk 2023, Dr. Jeff Yang, discusses different surgical procedures used to treat early-stage lung cancer and different approaches to removing cancerous tissue from the lung. 
Image
Lung Cancer OncTalk 2023
Video
At our live event, Lung Cancer OncTalk 2023, Dr. Millie Das, discusses different Studies and Trials for NSCLC. Dr. Das specializes in the treatment of thoracic malignancies. She sees and treats patients both at the Stanford Cancer Center and at the Palo Alto VA Hospital. She is the Chief of Oncology at the Palo Alto VA and is an active member of the VA National Lung Cancer Working Group and Lung Cancer Precision Oncology Program. Learn more about Dr. Das here.
Image
The Importance of Early Detection 2023
Video
Drs. Meredith McKean, Dr. Doug Micalizzi and patient advocate and lung cancer survivor, Ivy Elkins, discuss the importance of early detection and treatment across cancer types, including skin, lung, and breast. To watch the complete playlist click here.

Forum Discussions

Hi Blaze,

 

As much as I hate to say it, Welcome back Blaze.  It sounds like you're otherwise feeling good and enjoying life which is a wonderful place to be. ...

Waiting for my appointment with oncologist this morning. Thank you for the response. It helps. <3

It sounds like you’re thinking of this in a very appropriate way. Specifically, it sounds like the growth of the nodule is rather modest, though keep in mind that the change...

Hi and welcome to GRACE.  I'm sorry your mom is having this difficulty.  An indwelling catheter is used when the pleura space continually fills and the catheter is always there to...

Hi Oaktowngrrl,  Welcome to Grace.  I'm so sorry you're going through this.

 

 Finding a reputable dedicated thoracic surgeon for lung surgery might be difficult, as it is a complex and...

Recent Comments

JOIN THE CONVERSATION
Could you
By Maeve785 on
It sounds like you’re…
By Dr West on
Thank you Janine
By blaze100 on
Hi Blaze,

 

As much as I…
By JanineT GRACE … on