RTP On Demand: Current and Future Role of PARP Inhibitors in the Management of Ovarian Cancer (Video Program) - Video 9A 55-year-old woman undergoes optimal cytoreductive surgery, receives multiple lines of chemotherapy and then receives olaparib on a clinical trial
4:29 minutes.
TRANSCRIPTION:
DR LOVE: This lady now has had, it looks like, several lines of chemotherapy. She’s had surgery. She’s got progressive disease. What was her clinical condition when she went on this trial? DR MATULONIS: She was actually in very good shape. She had a great performance status. It was zero. And because of the CA-125 biomarker being very sensitive and specific for picking up recurrence, it had been slowly rising. And the minute it had started to go up, had done a CAT scan, saw a perisplenic metastasis, probably, then followed it up a few weeks later and documented that there was actually growth of this splenic, perisplenic metastasis. DR LOVE: That was the only lesion that was imaged? DR MATULONIS: That was her predominant RECIST image. That's right. She had some low-level peritoneal disease, but certainly not enough to give her significant ascites. DR LOVE: So she, as you said, got randomized to olaparib alone. What happened? DR MATULONIS: She went on the dose that is now FDA approved. And that’s 400 milligrams twice daily of using the capsule form. And she has done well. She’s been in remission now for — she started the trial, I believe, in 2011. DR LOVE: Wow! DR MATULONIS: But she did have some anemia. She presented with increasing fatigue. And we kind of watched that over a period of a few months. She got to actually Grade 3 anemia and then made that decision that she was tired. It was that level of anemia was impacting her life negatively, and then brought her from 400 twice daily down to 200 twice daily, which we know from Study 12, Stan Kaye’s trial that looked at 400 twice daily/200 twice daily versus pegylated liposomal doxorubicin, that those 2 doses of olaparib are pretty comparable. You may miss a few patients in the lower dose, but that’s certainly an acceptable dose to drop down to. DR LOVE: And what happened to the lesion, the perisplenic lesion? DR MATULONIS: It’s now gone. I mean, her scans have a complete response. DR LOVE: And what about her CA-125? DR MATULONIS: It’s been 5, 5-6. It’s been totally low and stable. DR LOVE: Did you consider, and do you sometimes in patients who are responding who become anemic from olaparib, transfusion? DR MATULONIS: I think she did get a transfusion when she had that Grade 3 symptomatic anemia. And that was really — that episode of transfusion and then the patient, herself, really feeling fatigued — she’s a skier. She’s very active. She works full-time. So that level of anemia was definitely impacting her quality of life negatively. And she’s done subsequently very well. I mean, that was a very early dose reduction, I think, 4 to 5 months into the original dosing of olaparib. She’s been really doing quite well since then. DR LOVE: Any GI side effects? DR MATULONIS: No. She has not, surprisingly. I mean, I know that in women who take olaparib, or any PARP inhibitor for that matter, one of the class effects has been gastrointestinal toxicities: Some nausea, dyspepsia, anorexia, occasional vomiting and some lower GI effects, which is diarrhea, but it’s mostly upper GI effects. But remarkably, she has not had any of those. DR LOVE: Do you typically start preemptively with antinausea medications, et cetera, when you start olaparib, or you wait and see what happens? DR MATULONIS: I will counsel patients that that is a possible side effect, certainly focusing on GI toxicities, and then hem toxicities. But most of the time they will have a prescription for antiemetics at home and, if they don’t, I can write one for them. But I would not — I don’t preemptively give them antinausea medicines to take, no. DR LOVE: So she’s right now having no tolerability issues with the treatment? DR MATULONIS: She’s having no tolerability issues with the treatment. That’s correct. |