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. 2023 Jun;11(2):245-261.
doi: 10.1007/s40487-023-00227-6. Epub 2023 Apr 4.

Real-World Outcomes Following First-Line Treatment in Patients with Advanced Ovarian Cancer with Multiple Risk Factors for Disease Progression who Received Maintenance Therapy or Active Surveillance

Dana Chase  1 , Jessica Perhanidis  2 , Divya Gupta  3 , Linda Kalilani  4 , Amanda Golembesky  4 , Antonio González-Martín  5   6   7
Affiliations

Real-World Outcomes Following First-Line Treatment in Patients with Advanced Ovarian Cancer with Multiple Risk Factors for Disease Progression who Received Maintenance Therapy or Active Surveillance

Dana Chase et al. Oncol Ther. 2023 Jun.

Abstract

Introduction: We evaluated real-world outcomes in patients with advanced ovarian cancer (AOC) based on their cumulative risk profile and maintenance therapy (MT) status following first-line (1L) treatment.

Methods: This retrospective observational study of a nationwide electronic health record-derived de-identified database included adult patients diagnosed with stage III/IV OC from January 1, 2011 to February 28, 2021, who received 1L therapy and had ≥ 12 weeks of follow-up after the index date (end of 1L therapy). Patients were grouped according to whether they received MT or active surveillance (AS) following 1L treatment and by the cumulative number of risk factors (RF) present (stage IV disease; no surgery/treated with neoadjuvant therapy and interval debulking surgery; had postoperative visible residual disease; and had BRCA wild-type disease/unknown BRCA status). Time to next treatment (TTNT) and overall survival (OS) were assessed with a cloning and inverse probability of censoring (IPC)-weighted Kaplan-Meier method.

Results: Among 1920 patients, 22.2% received MT and 77.8% received AS. Median IPC-weighted TTNT and OS were 13.3 months (95% CI 11.7-15.8) and 39.1 months (95% CI 32.5-48.6) in the MT cohort, respectively, and 8.6 months (95% CI 8.0-9.5) and 38.4 months (95% CI 36.4-41.0) in the AS cohort, respectively. Almost all patients had ≥ 1 RF (MT 95.3%; AS 96.7%). Median IPC-weighted TTNT was shorter among patients with more RF in both cohorts (MT: 1 RF, 19.3 months, 95% CI 13.5-37.8; 2 RF, 17.2 months, 95% CI 12.8-20.2; 3 RF, 11.0 months, 95% CI 8.2-13.8; 4 RF, 7.0 months, 95% CI 6.2-8.8; AS: 1 RF, 17.7 months, 95% CI 13.5-22.3; 2 RF, 10.2 months, 95% CI 9.1-11.5; 3 RF, 6.5 months, 95% CI 5.8-7.4; 4 RF, 4.1 months, 95% CI 3.5-4.5).

Conclusion: Regardless of RF number, MT was associated with longer TTNT in real-world patients with AOC.

Keywords: Electronic health records; Maintenance therapy; Ovarian cancer; Risk factors.

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Conflict of interest statement

Dana Chase reports speakers’ bureau fees and/or advisory roles from, AstraZeneca, Clovis, Genentech/Roche, and GSK and consulting fees from GSK, AstraZeneca, Clovis, and Genentech/Roche. Jessica Perhanidis is a current employee of GSK and reports financial interest (stock) in Boston Scientific and GSK. Linda Kalilani and Amanda Golembesky are current employees of GSK. Divya Gupta was an employee of GSK at the time the analysis was conducted, and is currently affiliated with Mersana Therapeutics, Inc, Cambridge, MA, USA. Antonio González-Martín reports honoraria as advisor from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, HederaDx, ImmunoGen, Merck Sharp & Dohme, MacroGenics, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, Sutro; honoraria as speaker for AstraZeneca, Clovis, GSK, PharmaMar, Roche; institutional funding (GEICO) for clinical research from Roche and GSK; and non-remunerated activities as chair in GEICO and ENGOT (for the period 2018–2020).

Figures

Fig. 1
Fig. 1
Patient attrition chart for the selection of patients with advanced ovarian cancer who received first-line platinum-based chemotherapy prior to cloning and IPC weighting. aPatients who underwent debulking surgery and were missing either the surgical date or postoperative residual disease status were excluded. bPatients with incomplete medical history within 90 days of diagnosis or debulking surgery (no visit or non-cancelled medication order within 90 days of diagnosis or debulking surgery) were excluded. cPatients who received maintenance treatment within 120 days of the end of first-line therapy (index date). dPatients who did not receive maintenance treatment within 120 days of the end of first-line therapy (index date). 1L, first-line; 2L, second-line; IPC, inverse probability of censoring; PARP, poly(ADP-ribose) polymerase
Fig. 2
Fig. 2
Percentage of patients by cumulative number of high-risk factors prior to cloning. The percentage of patients by cumulative number of high-risk factors present in the a maintenance therapy cohort and b active surveillance cohort. Patients who did not undergo debulking surgery were assumed to have visible residual disease
Fig. 3
Fig. 3
Kaplan–Meier survival curves for TTNT and OS based on IPC-weighted cloning (N = 1920). Kaplan–Meier estimated a TTNT and b OS using IPC-weighted cloning method. IPC, inverse probability of censoring; TTNT, time to next treatment; OS, overall survival
Fig. 4
Fig. 4
IPC-weighted Kaplan–Meier survival curves for TTNT and OS by risk category (N = 1920). Kaplan–Meier estimated TTNT and OS by cohort and cumulative number of high-risk factors using IPC-weighted cloning method. IPC-weighted TTNT in a patients who received maintenance therapy and b patients who were treated with active surveillance. IPC-weighted OS in c patients who received maintenance therapy and d patients who were treated with active surveillance. Patients who did not undergo debulking surgery were assumed to have visible residual disease. IPC, inverse probability of censoring; OS, overall survival; TTNT, time to next treatment
Fig. 4
Fig. 4
IPC-weighted Kaplan–Meier survival curves for TTNT and OS by risk category (N = 1920). Kaplan–Meier estimated TTNT and OS by cohort and cumulative number of high-risk factors using IPC-weighted cloning method. IPC-weighted TTNT in a patients who received maintenance therapy and b patients who were treated with active surveillance. IPC-weighted OS in c patients who received maintenance therapy and d patients who were treated with active surveillance. Patients who did not undergo debulking surgery were assumed to have visible residual disease. IPC, inverse probability of censoring; OS, overall survival; TTNT, time to next treatment
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