Clinical Trial Clarification

Portal Forums Cancer Basics Clinical Trials and Drug Development Clinical Trial Clarification

This topic contains 4 replies, has 3 voices, and was last updated by  sawyer6 3 years, 6 months ago.

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May 16, 2014 at 3:11 pm  #1263833    

sawyer6

I have been looking through the abstracts posted ahead of the ASCO conference at the end of the month and have been wondering what definition is typically used for overall survival. The FDA website (to paraphrase) says that overall survival is from the date at which randomization began. To me this means survival from the date the investigational therapy was started, i.e. if therapy began on 1/1/14 and you lived until 1/1/15 overall survival would be 1 year, even if you might have been diagnosed with disease being studied 10 years previously and had received 5 previous treatments, for example, in those 10 years. Is my understanding correct? Thanks,

Seth


March 2014: 83 y/o dad dx with stage iv squamous cell carcinoma, mets to spine, rib
Initial treatment plan 4-6 rds carbo/taxol
April 2014: dx changed to adenocarcinoma, continue original treatment plan
May 2014: 33% shrinkage of tumor in lung; treatment break after 4th round carbo/taxol
July 2014: Lung stable; growth of spine and rib met; radiation to spine

May 16, 2014 at 4:07 pm  #1263834    
JimC Forum Moderator
JimC Forum Moderator

Hi Seth,

That’s correct. And that’s why you really can’t compare the survival results from one trial to another, because the starting points for each may be quite different, not to mention that the trial cohorts can be very different as well.

JimC
Forum moderator


Jul 2008 Wife Liz (51/never smoker) Dx Stage IV NSCLC EGFR exon 19
4 cycles Carbo/alimta, 65% shrinkage
Tarceva maintenance
Mar 2010 progression, added Alimta, stable
Sep 2010 multiple brain mets, WBR
Oct 2010 large pericardial effusion, tamponade
Jan 2011 progression, start abraxane
Jun 2011-New liver, brain mets, add Tarceva
Oct 2011-Dx Leptomeningeal carcinomatosis; pulsed Tarceva
At rest Nov 4 2011
Since then: http://cancergrace.org/blog/jim-and-lisa

May 16, 2014 at 4:21 pm  #1263835    

sawyer6

Thanks Jim.

Well, that’s encouraging, although I know Dr. West posted previously to proceed with caution when looking at early stage clinical trials as the response rates will likely trend downward as the number of patients enrolled increases. So, that tempers my excitement a bit with some of the numbers I saw.

Best,

Seth


March 2014: 83 y/o dad dx with stage iv squamous cell carcinoma, mets to spine, rib
Initial treatment plan 4-6 rds carbo/taxol
April 2014: dx changed to adenocarcinoma, continue original treatment plan
May 2014: 33% shrinkage of tumor in lung; treatment break after 4th round carbo/taxol
July 2014: Lung stable; growth of spine and rib met; radiation to spine

May 16, 2014 at 7:36 pm  #1263837    
Dr West
Dr West

Yes. The key is to just interpret results relative to comparable patients – within limits. So you can compare overall survival results obtained in various second line NSCLC trials to each other, which is far more appropriate than comparing results of a second line therapy trial to one of first lime treatment. However, some second line trials may enroll more fit, younger patients or more who responded well to first line treatment than another trial, so “cross trial comparisons” must be taken with a grain of salt, since they are not treating the exact same patients under the same conditions.

-Dr. West

May 17, 2014 at 11:19 am  #1263849    

sawyer6

Thanks Dr. West; I will keep that in mind when viewing trial information.


March 2014: 83 y/o dad dx with stage iv squamous cell carcinoma, mets to spine, rib
Initial treatment plan 4-6 rds carbo/taxol
April 2014: dx changed to adenocarcinoma, continue original treatment plan
May 2014: 33% shrinkage of tumor in lung; treatment break after 4th round carbo/taxol
July 2014: Lung stable; growth of spine and rib met; radiation to spine

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