Hossein Borghaei, DO, MS:Every clinical trial obviously is designed to resemble the patient population we see in the clinics, but I think we have to keep in mind that the patient population that enters a clinical trial is a little bit different from some of the patients we might see in our offices. I think if you look at the presentation of the casea 72-year-old with heavy smoking history, some hypertension, hyperlipidemia, but otherwise fully functional with considerable weight loss, 17-pound weight loss—I think I have to say that the patient probably resembles very closely the cohort of patients that entered the PACIFIC study. Based on patient characteristics, obviously when you look at the case and read about it, it appears to be very close to the patient population that entered the PACIFIC trial. So I don’t think I have any issue with this particular patient being treated following the PACIFIC study. I think I’m very comfortable using that data as they apply to this patient.
Let’s review what the PACIFIC trial really does represent. This is a very well-conducted international study. A large number of patients participated. They were randomized to standard of care, which was concurrent chemotherapy radiation, followed basically by observation versus concurrent chemotherapy radiation, followed by 1 year of durvalumab given once every other week. I’ll be discussing the results shortly. So the duration of therapy, as far as I’m concerned, is dictated by the results of the study. We obtained the best PFS [progression-free survival] and overall survival data in PACIFIC for patients who followed the protocol as written. So if my patients can actually tolerate the regimen without adverse effects or toxicities, then my preference is to use durvalumab exactly as they did in the PACIFIC study, using it every other week for a duration of a year, simply because I really don’t have any additional data as to whether the continued treatment is efficacious or more toxic or not. So I try to use it for a year.
Infections are completely different. Obviously, infections require active antibiotic therapy, depending on how sick the individual is, and maybe hospitalization. So I think we have standard guidelines for the management of infections. As for infusion reactions, again, I haven’t seen a lot of infusion reactions with durvalumab so far. But again, we have institutional guidelines for management of infusion reactions that are something as simple as perhaps some acetaminophen before the administration of the next drug, to this patient can never be exposed to this drug again just because they had such a severe infusion reaction. Most of the biologics that we use, antibodies that we use for the management of patients with oncologic issues, can potentially lead to infusion reactions. Obviously, we get infusion reactions to agents like paclitaxel, so allergic reactions like that. So the management is sort of guided by institutional guidelines. Again, if the patient is severely symptomaticfluids, H1 blockers, H2 blockers… All of those are sort of our standard armamentarium to use for someone who is having a real, either allergic reaction or infusion-related reaction.
Transcript edited for clarity.
Case: A 72-Year-Old Female With Stage IIIB NSCLC