The US Oncology expert reported that secondary surgical cytoreduction may not lead to improved outcomes in women platinum-sensitive, recurrent ovarian cancer.
Secondary surgical cytoreduction may not lead to improved outcomes in women platinum-sensitive, recurrent ovarian cancer, according to Robert L. Coleman, MD.
At the 2020 ASCO Virtual Program, he discussed study results from the NRG Oncology/Gynecologic Oncology Group (GOG) study – a phase 3 randomized controlled trial of secondary surgical cytoreduction followed by platinum-based combination chemotherapy, with or without bevacizumab (Avastin) in platinum-sensitive, recurrent ovarian cancer.
In an interview with CancerNetwork, Coleman, chief scientific officer of US Oncology Network, discussed the findings of the trial, and why they were surprising.
I’d say that almost everybody believes that surgery is better. So, the surprising aspect of this trial is that we found that it wasn't. So that and again, the primary end point of the trial is overall survival. And that's a really important concept to understand. We felt, since all of these patients are essentially incurable at recurrence and this intervention has a potential negative, we really want to make sure that it was actually going to be making patients live longer. So, the trial was designed with that primary intent.
Now, what's happened in the process and the timeframe during which the trial was actually enrolled was that all of our medical therapies kept getting better, 1 of which was actually approved by our own trial, in that bevacizumab (Avastin) added to chemotherapy was better than chemotherapy without bevacizumab. That was not in question. That’s been reproduced multiple times over.
So during the context of answering the surgical question, the field had moved, and then in more recent times, it's been moving again, because now we have PARP inhibitors. And so our array of treatment that we would use in the adjuvant setting is now affecting what the impact is of the surgery. Right? So it's a 1-2 punch. It's not like we're doing surgery and nothing. We're doing surgery and something, and the something has morphed. So, when this trial was started in 2007, we had no bevacizumab and we had no PARP. But now we have both. And now we've even got data to suggest that both may be an improvement.
So again, the field had changed during the context of trial. And so the surprising aspect that we saw was that there was no benefit. So that was the kind of major thing. It wasn't that it was just like negative, it was very negative because we actually released the data early. because the data safety monitoring committee felt that it was important to let patients know that continuing to not know the answer to this question was potentially a disservice.
Fortunately, when we updated the data for the publication, which added another almost 2 years to the follow up, we were able to demonstrate that indeed, that was the case there was no benefit. In fact, it looked like there was actually a little bit of an advantage to be on the non-surgical arm, again, which took everybody by surprise.