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)

 

SATURN Survival Results: What Can We Say About "Maintenance" Tarceva?
Please Note: While this is Still Excellent Background Info, New Treatments Have Emerged Since this Original Post
Author
Howard (Jack) West, MD

Shortly after ASCO 2009, Dr. Pennell provided the highlights of the early report of the SATURN trial, conducted primarily in Europe, that randomized patients to maintenance tarceva (erlotinib) or placebo after four cycles of first line chemotherapy. The early report described a modest but statistically significant improvement in progression-free survival (PFS), but overall survival (OS) wasn't reported at ASCO. Frankly, the modestly favorable results in terms of PFS were overshadowed at ASCO by the maintenance therapy trial with alimta (pemetrexed), which showed a significant improvement in both PFS and OS. One of the more interesting presentations with new data at the World Conference on Lung Cancer in San Francisco a few weeks ago was an update of the SATURN trial results that included OS results. It revealed a significant improvement in OS, with a difference in median OS of one month (11 vs. 12 months, measured from the time of randomization, so patients had generally received about three months of treatment before then). The survival curves are shown below: saturn-os-curves

This was statistically significant, and the curves separate meaningfully, but I would say not as impressively as in the maintenance alimta trial. With a three month OS benefit overall and a 5 month improvement vs. placebo in patients with a non-squamous NSCLC tumor, the alimta trial captured the attention of far more people in the lung cancer world. However, one major shortcoming of the alimta trial is that only 19% of the patients on the placebo arm received alimta at the time of progression, and only about half of patients ever got any treatment we'd consider to be particularly effective second line therapy for lung cancer. Because of this, critics are right in saying that the alimta trial really isn't an ideal trial for testing the timing of alimta as maintenance as much as the difference between all patients on one arm getting alimta, vs. only 19% on the other arm. That's not exactly a fair test. This shortcoming in the alimta trial leaves an area for the SATURN trial to do better, but unfortunately it makes the same mistake. The presentation didn't give any understandable details of which agents people received after they progressed on the trial, but only 21% on the placebo arm ever got an EGFR inhibitor like tarceva. So this trial repeats the same mistake of testing the value of tarceva for everyone vs. tarceva for one fifth of the patients, and despite that handicap in favor of the immediate tarceva arm, the results aren't especially impressive. One other interesting point was that there wasn't a survival benefit on the maintenance tarceva arm in the patients with an EGFR mutation, the group of patients in whom you'd most expect to see a major difference favoring tarceva over placebo. In fact, there was a HUGE difference in PFS for tarceva in EGFR mutation patients, but that was erased when looking at overall survival. Why? Because the doctors were able to learn who had a mutation, and these patients essentially always received an EGFR inhibitor later. Apparently, these patients ended up doing just as well if they received tarceva after they progressed -- so no penalty for getting it as second line treatment instead of a maintenance therapy. And a clear example that if both patient groups actually get the same treatment, timing may not matter. My view of this trial is that while it's supportive of the idea that the benefit of maintenance or second line treatments can be very real, but all of these "maintenance" trials are greatly flawed in not really testing the timing of treatment as much as the difference between all patients getting an effective treatment vs. only some patients getting an effective treatment. And I must say that it really saddens me that only about 20% of patients in Europe are getting these therapies that we know improve survival in previously treated patients. The practice patterns in the US show that patients are more likely to get these treatments, but far too many patients are still missing out on them, some because they're followed off of all treatment and progress too much to safely receive more later. They therefore effectively missing a good opportunity to do better, and to me this group of patients is the strongest argument for shifting treatments earlier, whether that's chemo or tarceva.

Next Previous link

Previous PostNext Post

Related Content

Image
Trial data ASCO 2024
Video
In this video series from ASCO 2024, Drs. Aakash Desai and Fauwzi Abu Rous discuss trial dates and clinical data as presented at the 2024 ASCO. To watch the complete playlist, click here.         
Image
Bladder Cancer Video Library 2024
Video
Dr. Petros Grivas discusses intravesical treatment for patients with nonmuscle invasive, or early-stage, bladder cancer, the importance of participating in clinical trials for bladder cancer, combination therapy options for patients with metastatic or incurable bladder cancer, and the importance of family history of cancer and discussing that history with your doctor.
Image
Case Based Panel
Video
The panel discusses treatment options for a patient diagnosed with EGFR Exon 19 Deletion NSCLC and examines data from the Laura Trial, a patient with a smoking history and diagnosis of small cell lung cancer, and how the Adriatic Study factors into decisions, and a patient with NSCLC adenocarcinoma, and a EGFR Exon 21 L858R Alteration, and how data from the Flaura 2 Trial can impact treatment decisions.

Forum Discussions

Hi elysianfields and welcome to Grace.  I'm sorry to hear about your father's progression. 

 

Unfortunately, lepto remains a difficult area to treat.  Recently FDA approved the combo Lazertinib and Amivantamab...

Hello Janine, thank you for your reply.

Do you happen to know whether it's common practice or if it's worth taking lazertinib without amivantamab? From all the articles I've come across...

Hi elysianfields,

 

That's not a question we can answer. It depends on the individual's health. I've linked the study comparing intravenous vs. IV infusions of the doublet lazertinib and amivantamab...

Recent Comments

JOIN THE CONVERSATION
I could not find any info on…
By JanineT GRACE … on
Hi elysianfields,

 

That's…
By JanineT GRACE … on
Hello Janine, thank you for…
By elysianfields on
EGFR
By happybluesun on