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Impact of Second-Line Approval of Liposomal Irinotecan

Insights From: Fadi Braiteh, MD, University of Nevada School of Medicine; John L. Marshall, MD, Georgetown University Hospital ; Kenneth H. Yu, MD, Memorial Sloan Kettering Cancer Center
Published: Tuesday, Mar 20, 2018



Transcript: 

John L. Marshall, MD: The new approval of Onivyde really shifts our thinking in patients with metastatic disease. It gives us legitimate second-line data that say we have improved outcomes and improved benefits. This really enables a legitimate discussion on lines of therapy with patients. You don’t have to give everything in a FOLFIRINOX regimen, right from the beginning. You can pace yourself. Remember, it’s not curative therapy. While we do want to get responses and control of the disease, we also want quality of life. We want good performance status, and we want patients to go on and live their lives as they’re being treated. This opens up that opportunity.

Kenneth H. Yu, MD: The approval of nanoliposomal irinotecan was really a big step forward. Up until that point, we didn’t have an FDA-approved drug for use in the second-line setting or after the failure of gemcitabine-based chemotherapy. After the drug was approved, we (Memorial Sloan Kettering Cancer Center) were very interested in understanding the experience—in terms of real-life settings. So, we conducted a study and presented some of that research at ASCO’s 2018 Gastrointestinal Cancers Symposium. Hopefully, we’ll publish our results, for the wider public, downstream.

The bottom line is, at our institution, our experience was very similar to what was seen in the NAPOLI-1 study: reasonable progression-free survival and overall survival in patients receiving nanoliposomal irinotecan. Toxicities were all very well within the limits of what we were expecting to see.

We also treated a lot of patients with lower doses. With dose reductions, it did not seem to negatively impact the outcomes for our patients. The bottom line, what we saw, which was also encouraging, was that patients who received nanoliposomal irinotecan in earlier lines of therapy seemed to benefit more. The most encouraging thing that we found was that by sequencing treatments—starting with treatments like gemcitabine and nab-paclitaxel, followed by nanoliposomal irinotecan—patients actually lived for a very long time with their advanced pancreatic cancer, probably as long as we’ve seen in any other studies that have been published. So, our experience has been very encouraging, and we hope to share more details about that experience in a publication soon.

John L. Marshall, MD: When we think about who should get the new therapies, first you have to be in a second-line setting. You typically have to have seen gemcitabine-based therapy in the frontline setting. And, typically, you also should be 5-FU–naïve. So, you’ve never seen a 5-FU–based regimen. That’s the sweet spot patient. They still have a decent performance status. They are doing OK. They are able to tolerate chemotherapy. Because this is the infusion pump, there are some side effects. We can’t get away from that. But you want a decent performance status patient who has normal liver function, or pretty normal liver function. This is important with these kinds of drugs. You probably would do this in somebody who’s got good help at home. I worry about patients who don’t have a strong caregiver or partner to support them. I don’t necessarily worry because they’re so sick. However, the whole pump thing and everything else can be a little complicated. It’s nice to have an extra set of ears and an extra set of hands around. So, if you have all of those pieces in place, which is common for a lot of patients with pancreas cancer, then I think that is ideal.

Transcript Edited for Clarity 
 
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Transcript: 

John L. Marshall, MD: The new approval of Onivyde really shifts our thinking in patients with metastatic disease. It gives us legitimate second-line data that say we have improved outcomes and improved benefits. This really enables a legitimate discussion on lines of therapy with patients. You don’t have to give everything in a FOLFIRINOX regimen, right from the beginning. You can pace yourself. Remember, it’s not curative therapy. While we do want to get responses and control of the disease, we also want quality of life. We want good performance status, and we want patients to go on and live their lives as they’re being treated. This opens up that opportunity.

Kenneth H. Yu, MD: The approval of nanoliposomal irinotecan was really a big step forward. Up until that point, we didn’t have an FDA-approved drug for use in the second-line setting or after the failure of gemcitabine-based chemotherapy. After the drug was approved, we (Memorial Sloan Kettering Cancer Center) were very interested in understanding the experience—in terms of real-life settings. So, we conducted a study and presented some of that research at ASCO’s 2018 Gastrointestinal Cancers Symposium. Hopefully, we’ll publish our results, for the wider public, downstream.

The bottom line is, at our institution, our experience was very similar to what was seen in the NAPOLI-1 study: reasonable progression-free survival and overall survival in patients receiving nanoliposomal irinotecan. Toxicities were all very well within the limits of what we were expecting to see.

We also treated a lot of patients with lower doses. With dose reductions, it did not seem to negatively impact the outcomes for our patients. The bottom line, what we saw, which was also encouraging, was that patients who received nanoliposomal irinotecan in earlier lines of therapy seemed to benefit more. The most encouraging thing that we found was that by sequencing treatments—starting with treatments like gemcitabine and nab-paclitaxel, followed by nanoliposomal irinotecan—patients actually lived for a very long time with their advanced pancreatic cancer, probably as long as we’ve seen in any other studies that have been published. So, our experience has been very encouraging, and we hope to share more details about that experience in a publication soon.

John L. Marshall, MD: When we think about who should get the new therapies, first you have to be in a second-line setting. You typically have to have seen gemcitabine-based therapy in the frontline setting. And, typically, you also should be 5-FU–naïve. So, you’ve never seen a 5-FU–based regimen. That’s the sweet spot patient. They still have a decent performance status. They are doing OK. They are able to tolerate chemotherapy. Because this is the infusion pump, there are some side effects. We can’t get away from that. But you want a decent performance status patient who has normal liver function, or pretty normal liver function. This is important with these kinds of drugs. You probably would do this in somebody who’s got good help at home. I worry about patients who don’t have a strong caregiver or partner to support them. I don’t necessarily worry because they’re so sick. However, the whole pump thing and everything else can be a little complicated. It’s nice to have an extra set of ears and an extra set of hands around. So, if you have all of those pieces in place, which is common for a lot of patients with pancreas cancer, then I think that is ideal.

Transcript Edited for Clarity 
 
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