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ONCAlert | Upfront Therapy for mRCC

Durvalumab Following Chemoradiotherapy and Surgery

Targeted Oncology
Published Online:1:37 PM, Fri February 15, 2019

Mark A. Socinski, MD: One of the questions that the PACIFIC trial raises is that if you have this clinically impressive and statistically significant survival advantage for the use of durvalumab after chemoradiotherapy in unresectable patients, would you expect the same benefit in patients who have resectable stage I, II, or III disease and have undergone surgery?

Those trials are ongoing. In my practice, I would not recommend it until we have some randomized data that [show] that there is an advantage to it. Again, I think we realize that patients who undergo surgery tend to be fit. The goal of surgery is to cure those patients. We know that adjuvant chemotherapy plays a role. I am cautiously optimistic that we may see positive data in this setting. It makes sense to me. But in terms of a routine clinical practice today, in the absence of randomized data from a phase III trial, I would personally not recommend the use of it in the surgical adjuvant setting. I would encourage clinicians to put patients on clinical trials that are evaluating this at this particular time.

You know we talked before about the issue of pneumonitis and oftentimes if you’re doing CT scans on patients within 6 weeks of completing chemoradiation to prove that they don’t have disease progression because you want to use durvalumab, in a fair number of patients, you are going to see changes on the CT scan that look like radiation pneumonitis. If the patient is asymptomatic, then that would be a kind of a grade 1 radiation pneumonitis. It’s an expected finding at that particular time. If the patient is asymptomatic it would not deter me from recommending durvalumab in this setting. Again, I mentioned before that there was a slight increase of about 10% in grade 1 or 2 pneumonitis as a result of durvalumab but no increase in the rate of grade 3 or 4 pneumonitis as a result of using durvalumab versus placebo. So asymptomatic grade 1 pneumonitis would not deter me from using a checkpoint inhibitor in that setting.

Transcript edited for clarity.

Mark A. Socinski, MD: One of the questions that the PACIFIC trial raises is that if you have this clinically impressive and statistically significant survival advantage for the use of durvalumab after chemoradiotherapy in unresectable patients, would you expect the same benefit in patients who have resectable stage I, II, or III disease and have undergone surgery?

Those trials are ongoing. In my practice, I would not recommend it until we have some randomized data that [show] that there is an advantage to it. Again, I think we realize that patients who undergo surgery tend to be fit. The goal of surgery is to cure those patients. We know that adjuvant chemotherapy plays a role. I am cautiously optimistic that we may see positive data in this setting. It makes sense to me. But in terms of a routine clinical practice today, in the absence of randomized data from a phase III trial, I would personally not recommend the use of it in the surgical adjuvant setting. I would encourage clinicians to put patients on clinical trials that are evaluating this at this particular time.

You know we talked before about the issue of pneumonitis and oftentimes if you’re doing CT scans on patients within 6 weeks of completing chemoradiation to prove that they don’t have disease progression because you want to use durvalumab, in a fair number of patients, you are going to see changes on the CT scan that look like radiation pneumonitis. If the patient is asymptomatic, then that would be a kind of a grade 1 radiation pneumonitis. It’s an expected finding at that particular time. If the patient is asymptomatic it would not deter me from recommending durvalumab in this setting. Again, I mentioned before that there was a slight increase of about 10% in grade 1 or 2 pneumonitis as a result of durvalumab but no increase in the rate of grade 3 or 4 pneumonitis as a result of using durvalumab versus placebo. So asymptomatic grade 1 pneumonitis would not deter me from using a checkpoint inhibitor in that setting.

Transcript edited for clarity.
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