The Patient Perspective on Clinical Trials from MK

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Because progress against ovarian cancer has been slow, many patient advocates believe that clinical trials hold the key to improving treatment outcomes for patients today. Ovarian cancer survivor and Clearity patient MK believes she is living proof of the value of clinical trial options in ovarian cancer treatment.

After her diagnosis with Stage IIIc ovarian cancer in 2007, MK went through standard of care treatments and then a maintenance program. “I was sick for a year and a half [with those treatments]. Then three months later, I had golf ball-sized tumors.”
After doing research on clinical trial options, MK was interested to participate in a clinical trial testing olaparib, a parp inhibitor, as maintenance therapy, but she needed to be in remission in order to be eligible for the trial. MK had her tumor profiled through Clearity and was successful getting into remission with the combination of carboplatin and doxil and she was able to enroll in the clinical trial in December of 2009.

MK has remained in remission after starting the olaparib trial but in December of 2011, AstraZeneca, the sponsor of the clinical trial, announced that it would not advance olaparib into Phase III development for the maintenance treatment of serous ovarian cancer. The company made its decision after reviewing data from an interim analysis which indicated that “the previously reported progression-free survival benefit is unlikely to translate into an overall survival benefit.” MK was surprised given that she had been in remission for two years when her previous remission was only 3 months. This is unusual for women that have progressed quickly after ending their primary treatment.

Interestingly, in December of 2011, The Clearity Foundation began testing tumor DNA for a broad panel of mutations and translocations at Foundation Medicine in Cambridge, MA. MK consented to have her tumor DNA tested and discovered that her tumor DNA contained a novel BRCA2 mutation (read below about the types of BRCA mutations). This may explain why she responded so well while on study and others did not. Fortunately, AstraZeneca continues to make the pills available for women that remain on the study so MK is still taking her 16 pills per day.

Terminating the clinical trial that MK was enrolled in was very disappointing in light of her 2+ years in remission. Why had MK responded and others had not? Scientific and clinical evidence indicates that tumors with BRCA mutations respond especially well to PARP inhibitors. Even though the study was stopped, Clearity believes that the other women that remain in remission should be tested for both kinds of BRCA mutations. If more women are like MK, more women might benefit and the clinical trials may have a higher probability for success if PARP inhibitors are studies in this subset of tumors.

MK feels strongly that new approaches must be tried because so little has been offered to ovarian cancer patients. She worked very hard to get into the olaparib trial, including advocating for the best treatment choice and changing doctors. It’s no wonder she would like to see other patients have the same opportunity to benefit from olaparib, especially those with BRCA mutations.

About BRCA Mutations

Many women know that there are two BRCA genes; BRCA1 and BRCA2. Some women are born with BRCA mutations. These are called germ line mutations and the tests for these are conducted by Myriad Genetics by drawing a tube of blood. Being born with a BRCA1 or BRCA2 mutation is very serious because it significantly increases the likelihood of getting certain kinds of cancer such as breast and ovarian. If you have a BRCA mutation, consult an oncologist that specializes in this. MK had this test performed and no mutations were detected. MK was not born with a BRCA mutation.

There is another way that women with ovarian cancer can have a BRCA mutation. Some tumors spontaneously develop mutations in BRCA1 or BRCA2 even if you are not born with them. These are called somatic mutations and the tests are conducted by isolating DNA from tumor cells. Several laboratories can perform these tests. The Clearity Foundation had MK’s tumor DNA test at Foundation Medicine and she was found to have a somatic BRCA2 mutation.