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The treatment of ovarian cancer is a globally recognized problem
Mystery 1: Clarify the purpose of the research and only answer one question at a time
Mystery 1: Clarify the purpose of the research and only answer one question at a timeThe purpose of clinical research is to make clear, concise, precise, scientifically effective, quantitative, and easy to transform into hypothetical statements about a series of medical problems
Before PARP inhibitors were used in the maintenance treatment of ovarian cancer, some scholars tried to use secondary tumor cytoreductive surgery in patients with recurrent ovarian cancer to reduce tumor lesions, creating conditions for subsequent treatment
This study actually contains two clinical questions:
1.
A clinical study containing two research purposes is bound to cause many confounding factors.
In contrast, the purpose of clinical research related to PARP inhibitors is very clear: Study19, SOLO-2 and OPINION evaluate the efficacy and safety of oral olaparib vs.
Mystery 2: Take down the core beneficiaries first, and then expand the indications
Mystery 2: Take down the core beneficiaries first, and then expand the indicationsThe "synthetic lethal" effect of PARP inhibitors is inseparable from BRCA gene mutations
Figure 1.
After determining that PARP inhibitors can benefit the core beneficiary population-BRCA-mutated ovarian cancer patients, follow-up studies have carried out a series of clinical trials for the first-line population as a whole, and want to further expand the indications for the first-line maintenance treatment of PARP inhibitors
Mystery 3: For advanced disease, choose the correct endpoint
Mystery 3: For advanced disease, choose the correct endpointAs a phase III clinical trial, the end point is usually OS, but sometimes PFS can also be used as the end point, especially in the research of first-line new drugs
The inconsistency of benefits between PFS and OS in clinical studies of advanced ovarian cancer may be due to crossover after progression, the emergence of new drugs, potential prognostic or predictive indicators such as combined ascites, BRCA1/2 and CD31 status
All in all, only good design can have high-quality research
【references】
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Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
[J].
New England Journal of Medicine, 2018.
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2020 ESMO Abs 811MO
