Advanced Ovarian Cancer: Recent Advances and Unmet Needs - Episode 3
Transcript:Bradley J. Monk, MD: Let’s transition, now, to treatment. I’d like to begin by talking about frontline treatment, and surgery is still an important modality. All patients undergo a debulking operation, either in the beginning or after 3 cycles of chemotherapy. What we call interval debulking. There was a surgery paper called “The LION Study.” Do you want to tell us about the LION study?
Katie Moore, MD: This is a really interesting study. I was so pleased to see surgery studies at the 2017 ASCO Annual Meeting, I just have to say that. The LION study basically took patients who are undergoing primary cytoreductions. It was a randomized phase III trial. It was done at centers with a demonstrated commitment to aggressive upfront cytoreduction—so they had, importantly, a big effort to get to no gross residual disease—and they randomized patients into 2 groups. One group was the patients who were able to completely cytoreduce and had visibly normal lymph nodes. So, for that group, they debulked them. They did a big lymphadenectomy, with lots of lymph nodes—40 lymph nodes. It was not like a sampling.
And the other group, in the same scenario, got down to no gross residual, visibly negative lymph nodes—they left them. Patients who had big lymph nodes, or who they couldn’t reduce, fell out of the analysis. And the reason they did this is that there was a prior study, about a decade ago, saying that lymph nodes didn’t matter. But as with every surgical trial, there have been questions about how much effort you put into the surgery. So, these guys put the effort in.
Bradley J. Monk, MD: In the past, 50% of those grossly normal lymph nodes had cancer in them. So, clearly, getting a bigger knife is going to be good, right?
Katie Moore, MD: We’ve seen the same here. They found positive lymph nodes.
Bradley J. Monk, MD: How could cutting cancer out be bad?
Katie Moore, MD: But it didn’t help, and that’s the surprising thing. The discussant, Ritu Salani, made a great point. This belief we all have that there are these sanctuary sites, and we’re leaving tumor—why would you leave tumor? It didn’t matter. So, I think that changed. A lot of us sat up there and said, “Alright.”
Robert L. Coleman, MD: But Kate, don’t you agree that the previous study had all those criticisms? It was a good study. I actually believed it. It showed that there’s this...
Matthew A. Powell, MD: Benefit.
Robert L. Coleman, MD: Because, remember, we had this dogma. We fully stage patients because we don’t want to miss patients who have really metastatic disease. There’s this dogma that’s there. So, they do the study, and then they criticize it for all the things that they put into the LION trial, which was really nice. They picked the right surgeons, and they picked the right setting.
Bradley J. Monk, MD: They still had a 12% reoperation rate. They hurt people.
Robert L. Coleman, MD: But the thing is, it was like you had your believers, and they said, “Listen, we’ll show you.”
Bradley J. Monk, MD: And then they had the people who were right.
Gottfried E. Konecny, MD: Rob, I applaud them for this very carefully conducted study. Would you change your practice now, based on what you heard with the data in these 600 patients? That for a patient who you’ve optimally debulked—you cannot feel any lymph node pathology—you would still go forward, now, and do a lymph node dissection?
Robert L. Coleman, MD: No, I wouldn’t.
Matthew A. Powell, MD: And you wouldn’t before?
Gottfried E. Konecny, MD: Just bulky nodes.
Robert L. Coleman, MD: We would look for bulky nodes, right, but in the absence of that? Nick Spirtos and others have shown, for a long time, that there was this very high rate, and they said, “It’s there, so you should take it out.”
Katie Moore, MD: Right.
Bradley J. Monk, MD: It’s tough for the patient. She might say, “Well, what about my nodes?” So, I didn’t biopsy them. Why not?
Gottfried E. Konecny, MD: And you would continue to do it with bulky nodes?
Bradley J. Monk, MD: Yes, absolutely.
Katie Moore, MD: That gets you to no gross residual disease, which we know is a good prognostic factor. But I think there are a lot of believers, and you go for it. Why on earth would you do a big surgery, splenectomy, and all these things and leave the nodes?
Bradley J. Monk, MD: Yes. Now we know.
Katie Moore, MD: It did have toxicities, but not much.
Bradley J. Monk, MD: Twelve percent reoperation.
Katie Moore, MD: But you see that in big series.
Matthew A. Powell, MD: This is relaparotomy, though. That’s really high.
Katie Moore, MD: Otherwise, their toxicities were fairly reasonable for the aggressive surgery.
Matthew A. Powell, MD: The only other thing I don’t know is, were they doing routine CAT scans for the patients and monitoring them? In the Italian study, most of the recurrences were nodal, so the PFS difference was what drove the differences. If you didn’t have any standardization of follow-up, which I’m not sure about in this study, it could completely bias the ascertainment of when these patients recur. So, I think we still need to wait on the final manuscript.
Katie Moore, MD: The overall, right? Because the median outcome is survival.
Matthew A. Powell, MD: My practice will still be bulky nodes only.
Transcript Edited for Clarity