This transcript has been edited for clarity.
This is Dr. Morley Markman of the American Cancer Treatment Center. I would like to talk about a very interesting paper recently published in Journal of Clinical Oncologyentitled, “Overall Survival with Maintenance Olaparib at Seven-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and BRCA Mutations: The SOLO1/GOG 3004 Trial.”
I think many of you are familiar with the results of SOLO1 researchAppeared in New England Journal Medicine many years ago. has demonstrated a very impressive value of Olaparib Short-term maintenance therapy reporting progression-free survival and overall survival in patients with advanced disease ovarian cancer — again, used in maintenance — BRCA mutation.
However, this particular paper, with a seven-year follow-up, begins to address a very important issue.
This was a randomized, double-blind, placebo-controlled study.Newly diagnosed advanced ovarian cancer with documented clinical response BRCA Germline or somatic mutations were randomized to olaparib maintenance upon completion of platinum-based chemotherapy or placebo.
Placebo or olaparib can be continued for up to 2 years. Some patients, with the investigator’s consent, had a chance of 2 years or more, but essentially he was her 2-year maintenance therapy with olaparib or placebo.
This issue of long-term follow-up survival was addressed in this paper. The median duration of treatment with olaparib in this trial was 24.6 months, as expected, compared to his 13.9 months on placebo. The median follow-up for this patient population was 88 months, which exceeds his 7 years.
The total sample size was 260 patients treated with olaparib and 131 patients treated with placebo. In conclusion, at 7 years of follow-up, 46.5% of his olaparib-treated patients were alive compared to 67% of them. of patients receiving placebo treatment. Again, this was a maintenance phase. Essentially, the absolute number of surviving patients receiving olaparib was 20% greater than those receiving placebo.
Put another way, at this particular time point, 7 years of follow-up, 45.3% of patients who received olaparib were alive and did not receive any further treatment regimens. In other words, they were alive and on follow-up without receiving another anti-cancer treatment.
Thus, 45.3% (nearly half) of patients receiving olaparib did not receive further treatment, compared to 20.6% of patients receiving placebo who were alive and did not receive further treatment. was not That is, patients who received placebo treatment were half as likely to remain. [alive] without further treatment. Nearly half of patients treated with olaparib did not receive further treatment at 7 years of follow-up.
Additionally, and very importantly, this study showed with long-term follow-up that there was a very low risk of myelodysplastic syndrome or acute leukemia that has been a concern for PARP inhibitors. There were no new primaries or safety concerns at this long-term follow-up.
This study, SOLO1, emphasized this point. Long-term follow-up survival data demonstrated the value of olaparib maintenance after initial response to platinum-based chemotherapy. BRCA mutation. There is no doubt that this patient population is of great value.
If you are interested in this topic and the management of ovarian cancer, or if you are a patient or family member interested in this specific question, please refer to this very important study. Journal of Clinical Oncology. Thank you for your attention.
Maurie Markman, MD, is president of the Medical and Scientific Division at the Cancer Treatment Centers of America in Philadelphia. He has over 20 years of experience in cancer treatment and research in gynecologic oncology.
