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OlympiA trial results (Olaparib)

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    Posted: Aug 26 2021 at 11:53am

Behind the Breakthroughs: A Promising New Therapy for High-Risk Breast Cancers

Dr. Susan Domchek breaks down results from the game-changing OlympiA trial

Among the biggest headlines out of this year’s American Society of Clinical Oncology annual meeting were the results from the phase III OlympiA trial involving more than 1,800 patients with early-stage HER2-negative breast cancer who had a high risk of recurrence and carried inherited mutations in the BRCA1 and 2 genes.

OlympiA researchers (including several BCRF investigators) reported that patients who received the PARP inhibitor olaparib (Lynparza®) after standard-of-care treatment experienced a significant reduction in local recurrence, metastatic recurrence, and death compared to the placebo. The results of this trial could have wide-ranging implications, especially for people diagnosed with triple-negative breast cancer—a form of the disease that lacks many targeted treatments and is most common in BRCA1 and 2 gene mutation carriers. . .

. . .

What did the OlympiA trial find?

OlympiA enrolled individuals who had BRCA1 or 2 mutations, and those that were at high risk for their cancer coming back. There were individuals with triple-negative breast cancer whose tumors were over two centimeters or had positive lymph nodes, as well as individuals who had had preoperative chemotherapy and had cancer left. There were people with ER-positive tumors that had either four positive lymph nodes or quite a bit of cancer left after chemotherapy. These women and men were randomly assigned either olaparib or a placebo pill after their regular treatment. There were more than 1,800 patients in this trial, which is a testament to the power of collaborative and international research, and BCRF investigators from all over were part of it.

What was amazing is that the women and men who received olaparib were much less likely to get their cancer back, including outside their breast (metastatic disease). This is a really big advance. We don’t yet have data to show that it makes people live longer, but that’s just because we haven’t had long enough follow-up time. It is trending in that direction. The other important thing is quality of life. We saw that although there are side effects with olaparib, individuals’ quality of life was really pretty good. And lastly, there were no big changes in other areas. For instance, we don’t see, at least at this point, an excess risk of leukemia or other cancers. This really is a game-changer for individuals who have BRCA1 or 2 mutations and have high-risk, early-stage cancers.

Is this available to patients now? What’s next?

At the current time, there is not FDA approval for the use of olaparib in this adjuvant [after treatment] setting. That is planned. But this is different from the question of if you can give the drug at this point. Off-label use occurs in oncology. So far, even though my numbers are small, I have been able to have insurance cover this drug, and I do think that the data are compelling enough that oncologists should be trying.

I want to be clear though that this drug is not for everyone. Even BRCA1 and 2 mutation carriers can have very early-stage cancers or estrogen receptor–positive cancers that are small and lymph node–negative. This drug does have side effects, so not everybody—and not every BRCA1 and 2 mutation carrier—should get this medication. We need to be thoughtful about weighing risks and benefits. But the group that was included in the trial—those particularly high-risk patients—yes, I think that they should get the medication.

Does this study change how we think about genetic testing?

Everybody who has triple-negative breast cancer should get genetic testing. And the reason why is that 85 percent of the time, BRCA1 mutation–related breast cancers are triple-negative. Individuals with triple-negative breast cancer are much more likely to have a BRCA1, BRCA2, or PALB2 mutation. And even though PALB2 wasn’t directly tested in this study, these drugs likely work in those cases as well.

Estrogen receptor (ER)–positive cancers are different, and I want to be clear that if you are a 70-year-old woman with a lymph node–negative, ER-positive cancer, olaparib is probably not a good addition, whether you have a BRCA1 or 2 mutation or not. A 70-year-old woman with an ER-positive tumor who is not of Jewish descent and has no family history is exceedingly unlikely to have BRCA1 or 2 mutations. We’re not going to be giving olaparib to everybody. But individuals with very high-risk ER-positive breast cancers might get genetic testing to determine the therapeutic benefit of olaparib. . .

To read the entire article:

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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