Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib + bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION(NMPA)-approved agent for ovarian cancer patients. In this setting, olaparib mono-maintenance therapy has been implemented among patients with BRCA-wild type tumors in clinical practice in China.
The main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFS rate) We hypothesize that olaparib monotherapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy. The secondary objectives are to evaluate the outcomes of olaparib-based maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy. The exploratory objective is to evaluate the status quo of genetic testing, R0 resection and related outcomes.
Study Type
OBSERVATIONAL
Enrollment
50
Olaparib mono-maintenance therapy in patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer is defined as drug exposure. At least one dose of olaparib tablets monotherapy as maintenance therapy will be required.
1-yr PFS rate
The main objective is to evaluate the outcome of olaparib-based maintenance therapy by proportion of patients alive and progression free at 1 year.
Time frame: 12 months after date of first dose
2-yr PFS rate
The proportion of patients alive and progression free by 2 years by investigator assessed clinical progression
Time frame: 24 months after date of first dose
Median PFS
Median time from date of first dose until disease progression per clinical progression (mPFS) as assessed by the investigator at local site or death due to any cause (if this occurs before disease progression)
Time frame: Median time from date of first dose until disease progression
mTFST
Median Time to First Subsequent Therapy or death
Time frame: Median time from date of first dose to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of treatment or death due to any cause
post-progression treatment after first progression
The proportion of patients receiving each treatment after first progression
Time frame: The proportion of patients receiving each treatment after first progression
Reason for olaparib dose adjustment, dose interruptions, and dose discontinuations
The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations
Time frame: The proportion of olaparib dose adjustment, dose interruptions, and dose discontinuations
Reason for use of concomitant therapy
The proportion of concomitant therapy
Time frame: The proportion of concomitant therapy
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