Real World Data for Combination Strategies With Chemotherapy and Immunotherapy in ES-SCLC

Transcript:

Taofeek K. Owonikoko, MD, PhD: It's important to recognize, as we're looking at data, these are really well-selected rarefied patient subgroups that went on the clinical trials. And we always ask ourselves, how relevant would this data be to our day-to-day regular patient walking into our clinic, where you are now going through the detailed eligibility criteria that were required by the protocol? I think in that regard, there are now, at least, whether in abstract from a full publication, several publications showing that in the real-world, patients treated with this regimen, not in the context of a defined rigorous clinical trial. Some people use flat iron data, other people use institutional or registry data. I think we could all be confident now that even in patients who would otherwise not be considered protocol eligible but treated in the real world, the benefit of adding immunotherapy to chemotherapy was comparable to what you would find in patients who are enrolled on the trial. Now, the other thing is, Dr Sands mentioned this before in terms of the number of cycles of treatment to be given. As we all remember from the CASPIAN trial [NCT03043872], the control arm on chemotherapy alone was actually allowed to get up to 6 cycles. We know some of our colleagues, I don't do that, but I'm aware of some of our colleagues who, with the usual practice of wanting to give as many cycles as possible of chemotherapy that's working before they stop. They will actually continue to give 6 cycles of chemotherapy along with immunotherapy before they switch to a maintenance setting. So, for those who want to do that, I generally would not recommend it. The question we always ask is, is it safe? And now we do have some phase 3B type trial showing that if we were to give 6 cycles of chemotherapy along with immunotherapy, the benefit is not there. You don't get any super-duper overall survival advantage, but you do get a little bit more toxicity. So, I think we have to follow the original design of the trial of 4 cycles of chemoimmunotherapy, followed by immunotherapy maintenance. And then the other group that I want to mention in the context of equitable access to drugs and treatment is the elderly patient. A lot of us self-select who can get treatment and who cannot. And at times, that numerical value of, “oh, this is an 80-year-old,” or “this is a 75-year-old,” can influence the type of treatment options that we discuss with those patients. Now we have real-world data showing patients older than 65 compared to those younger than 65, they benefit just as well with this regimen. So, I think it's also important for our audience to be aware of this real-world data that really should make us comfortable to offer this type of regimen to our older patients if they are otherwise eligible for this regimen.

Transcript edited for clarity.