MITO 37 is a multicenter retrospective Italian study aiming at correlating Ki67 expression with a clinical outcome following platinum treatment and PARPi maintenance. Clinical data were collected from all patients with high grade serous or endometroid BRCA WT ovarian cancer treated with niraparib or rucaparib maintenance between 2010–2021. The study has been approved by the ethical committee of participating Institutions. We collected data from 15 Italian Centers. See Table S1 .
Eligible patients were at least 18 years of age and had platinum-sensitive (defined as PFI ≥ 6 months) relapsed cancer of the ovary, peritoneum, or fallopian tube (collectively defined as ovarian cancer), with disease progression after at least 1 line of chemotherapy. All patients had high-grade serous or endometrioid tumors that were classified at diagnosis according to the FIGO staging criteria. Before the start of PARPi, all the patients had received four to six cycles of platinum-based chemotherapy, which had resulted in a complete response (CR) or partial response (PR), according to investigator assessment. Patients receiving treatment within clinical trials were not eligible. All patients had been tested for BRCA1/2 germline and/or somatic mutations and resulted WT.
The primary endpoint was to determine, in a real-world setting, the overall response rate (ORR) to platinum-based chemotherapy and to PARPi according to the Ki67 value expressed as %. Patients were divided into 2 groups (low and high) using the median value as the cut-off (see below).
The secondary endpoints were to describe progression free survival (PFS) and OS comparing subgroups based on the Ki67 value.
PFS was defined as the time from the first day of niraparib or rucaparib administration to the date of objective disease progression on imaging according to the response evaluation criteria in solid tumors (RECIST), version 1.1, or death from any cause. Patients who did not experience progression disease (PD) were censored on the date of the last follow-up visit. OS was defined from the first day of niraparib or rucaparib administration to death for any cause or the last follow up visit. The median follow-up (FU) was calculated according to the reverse Kaplan–Meier formula. PFS and OS were calculated according to the Kaplan–Meier formula, and groups were compared by log-rank test.
Within 8 weeks after completion of the last dose of platinum-based chemotherapy, patients were assigned to receive oral niraparib or rucaparib as per clinical practice choice (according to previous toxicities, comorbidities, and patients’ choice) in 28-day cycles.
All the patients started rucaparib at a fixed dose of 600 mg twice daily, while patients starting niraparib were assigned a full dose of 300 mg daily or an individualized dose of 200 mg daily according to platelets count and weight (a 200 mg daily dose was assigned in case of a baseline body weight of less than 77 kg, a platelet count of less than 150,000/mm3, or both) [34 (link)].
The data cut-off for the analysis was 30 April 2022.
Eligible patients were at least 18 years of age and had platinum-sensitive (defined as PFI ≥ 6 months) relapsed cancer of the ovary, peritoneum, or fallopian tube (collectively defined as ovarian cancer), with disease progression after at least 1 line of chemotherapy. All patients had high-grade serous or endometrioid tumors that were classified at diagnosis according to the FIGO staging criteria. Before the start of PARPi, all the patients had received four to six cycles of platinum-based chemotherapy, which had resulted in a complete response (CR) or partial response (PR), according to investigator assessment. Patients receiving treatment within clinical trials were not eligible. All patients had been tested for BRCA1/2 germline and/or somatic mutations and resulted WT.
The primary endpoint was to determine, in a real-world setting, the overall response rate (ORR) to platinum-based chemotherapy and to PARPi according to the Ki67 value expressed as %. Patients were divided into 2 groups (low and high) using the median value as the cut-off (see below).
The secondary endpoints were to describe progression free survival (PFS) and OS comparing subgroups based on the Ki67 value.
PFS was defined as the time from the first day of niraparib or rucaparib administration to the date of objective disease progression on imaging according to the response evaluation criteria in solid tumors (RECIST), version 1.1, or death from any cause. Patients who did not experience progression disease (PD) were censored on the date of the last follow-up visit. OS was defined from the first day of niraparib or rucaparib administration to death for any cause or the last follow up visit. The median follow-up (FU) was calculated according to the reverse Kaplan–Meier formula. PFS and OS were calculated according to the Kaplan–Meier formula, and groups were compared by log-rank test.
Within 8 weeks after completion of the last dose of platinum-based chemotherapy, patients were assigned to receive oral niraparib or rucaparib as per clinical practice choice (according to previous toxicities, comorbidities, and patients’ choice) in 28-day cycles.
All the patients started rucaparib at a fixed dose of 600 mg twice daily, while patients starting niraparib were assigned a full dose of 300 mg daily or an individualized dose of 200 mg daily according to platelets count and weight (a 200 mg daily dose was assigned in case of a baseline body weight of less than 77 kg, a platelet count of less than 150,000/mm3, or both) [34 (link)].
The data cut-off for the analysis was 30 April 2022.
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