This is a prospective study, a study that was run out of the United States through a group called the Gyn Oncology Group or GOG. It’s an expansion actually of a study that had already completed. What we looked at was trying to test different chemotherapy regimens in women who were older than 70, who were just diagnosed with ovarian cancer and were about to embark on getting chemotherapy and/or surgery which are curative treatments for women with ovarian cancer.
The challenge has been in all the other prior studies the amount of women who were older than 70 were very small. Even though 30% of women with ovarian cancer are older than 70, only about 10% of those women were going on clinical trials and so we embarked on a study that restricted enrolment based on age, so you had to be older than 70 to go on to the study.
The first part of the study looked at two chemotherapy regimens, carboplatin and Taxol which is the standard regimen or carboplatin alone. That study completed and what it showed was that most patients completed their treatment as planned. The other thing that it showed was that taking a geriatric measure called IADL or Instrumental Activities of Daily Living predicted both whether patients were going to develop toxicity, dose adjustments, and it even predicted survival.
What we did in this abstract that I am going to be presenting on Saturday is look at a different chemotherapy regimen which is more up-to-date with the standard of care which is the same two chemos, carboplatin and paclitaxel, but giving the paclitaxel in a weekly dose-dense version which has become a standard modality in how we do this chemotherapy.
What were you investigating and what were the results?
What we did, and what we’ll be presenting, is actually looking to see, one, if the carboplatin and weekly Taxol was tolerable. Then we were also looking to see whether there was specific tools that we can do before starting chemotherapy that would predict dose modifications or toxicity. We looked at the Instrumentals of Activities of Daily Living, like was done at the first part of the study, but we added a more comprehensive geriatric assessment and a more comprehensive score, what we called the geriatric risk score, to see if that added more information to help guide doctors and treatment.
Does weekly dosage then increase the risk of resistance?
Not really, we’ve known for quite a long time that giving paclitaxel in smaller doses weekly is more effective. We know this in women with breast cancer and in ovarian cancer there have been two large international studies that have shown that weekly Taxol works better when given with carboplatin so we use that as a standard regimen for all women with ovarian cancer. It’s typically given three weeks in a row without a gap. In this study we were using that knowledge, what we know about all women, and making some modifications to the dose of the Taxol and allowing flexibility in not giving all three weeks of Taxol so the ability to drop the third week in the older patients.
Has there been improved survival?
That’s too early to know: the study just closed. What we’ll be presenting is the toxicity and also the evaluation of these geriatric assessment scores. Overall the regimen was very well tolerated, over two thirds of patients were able to complete all the planned treatment without any dose modification. The Instrumental Activities of Daily Living again predicted toxicity, just like it had in the first two arms of the study. What we didn’t find though was that adding these additional assessment measures to the score didn’t add much as far as determining whether patients would get through all their treatment without modification or develop toxicity.
The one thing I would like to stress is that from what we see in our results is that older women should be offered standard of care treatment and that most women tolerate treatment. Because these are curative treatments even in advanced stages that older women should be for sure offered standard treatment.