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Ovarian Cancer

Designed for students and trainees, this section summarizes high-impact ovarian cancer trials from frontline therapy to maintenance and recurrence. Learn what shaped today’s treatment strategies in a clear, organized format.

🧪 GOG-111 Trial
  • Trial Name / Acronym
    GOG-111
  • Publication Details
  • Title: Phase III trial of cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in stage III and IV ovarian cancer patients
  • Journal: New England Journal of Medicine (NEJM)
  • Year: 1996
  • DOI: 10.1056/NEJM199601043340101
  • Patient Population
    Previously untreated women with suboptimal stage III or stage IV epithelial ovarian cancer.
  • Intervention / Control
  • Experimental arm: Paclitaxel + Cisplatin
  • Control arm: Cyclophosphamide + Cisplatin
  • Key Findings / Outcomes
  • Paclitaxel + cisplatin significantly improved median overall survival (38 months vs 24 months) and progression-free survival.
  • Established paclitaxel and platinum as the new standard of care for advanced ovarian cancer.
  • Impact / Significance
    Pivotal trial that transformed first-line chemotherapy for advanced ovarian cancer to include taxanes in combination with platinum agents.
  • Trial Name / Acronym
    ICON3
  • Publication Details
  • Title: “Paclitaxel plus Carboplatin versus Standard Chemotherapy with or without Paclitaxel in Women with Ovarian Cancer: the ICON3 Randomised Trial”
  • Journal: The Lancet
  • Year: 2002
  • DOI: 10.1016/S0140-6736(02)08993-2
  • Study Design
  • Phase III, randomized, open-label, multicenter trial
  • Three-arm comparison
  • Patient Population
  • 2,010 women with newly diagnosed ovarian cancer (any stage)
  • Mix of low- and high-risk patients, post-surgical cytoreduction
  • Number of Patients
  • Total: 2,010
  • Carboplatin alone
  • Paclitaxel + carboplatin
  • CAP (cyclophosphamide, doxorubicin, cisplatin)
  • Interventions Compared
  • Paclitaxel + carboplatin vs carboplatin alone vs CAP
  • All administered every 3 weeks for 6 cycles
  • Primary and Secondary Endpoints
  • Primary: Overall Survival (OS)
  • Secondary: Progression-Free Survival (PFS), toxicity
  • Key Findings
  • No significant OS difference between the arms
  • Paclitaxel-based regimens had similar efficacy to older CAP regimen
  • Fewer side effects with carboplatin-only arm
  • Impact on Clinical Practice
  • Validated carboplatin-based regimens as frontline standard
  • Provided reassurance about single-agent carboplatin in appropriate patients
  • Trial Sponsor / Group
  • Sponsor: Medical Research Council (MRC) and International Collaborative Ovarian Neoplasm (ICON) Group
  • Trial Name / Acronym
    GOG-0218
  • Publication Details
  • Title: “Bevacizumab Combined with Chemotherapy for Advanced Epithelial Ovarian Cancer”
  • Journal: NEJM
  • Year: 2011
  • DOI: 10.1056/NEJMoa1007207
  • Study Design
  • Phase III, double-blind, placebo-controlled, multicenter
  • Three-arm design: chemo ± bevacizumab
  • Patient Population
  • 1,873 women with Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • After primary surgery
  • Number of Patients
  • Total: 1,873
    • Chemo alone
    • Chemo + bevacizumab during chemo
    • Chemo + bevacizumab during and after chemo (maintenance)
  • Interventions Compared
  • Paclitaxel + carboplatin ± bevacizumab (15 mg/kg q3w)
  • Bevacizumab given either during chemo only or during and after (up to 15 months total)
  • Primary and Secondary Endpoints
  • Primary: PFS
  • Secondary: OS, safety, QoL
  • Key Findings
  • Median PFS: 14.1 months (maintenance arm) vs 10.3 months (chemo only)
  • OS: no significant difference overall
  • Greater benefit in patients with stage IV or residual disease
  • Impact on Clinical Practice
  • Introduced bevacizumab into the frontline treatment paradigm
  • Paved the way for maintenance strategies with biologics
  • Trial Sponsor / Group
  • Sponsor: Gynecologic Oncology Group (GOG), Genentech
  • Trial Name / Acronym
    SOLO-1 (Study 42)
  • Publication Details
  • Title: Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation
  • Journal: New England Journal of Medicine (NEJM)
  • Year: 2018
  • DOI: 10.1056/NEJMoa1810858
  • Patient Population
    Women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer and germline or somatic BRCA mutation who had a complete or partial response to platinum-based chemotherapy.
  • Intervention / Control
  • Experimental arm: Maintenance olaparib (PARP inhibitor)
  • Control arm: Placebo
  • Key Findings / Outcomes
  • At 3 years, 60% of patients receiving olaparib were progression-free vs 27% on placebo.
  • Median PFS not reached in the olaparib group vs 13.8 months in placebo.
  • Impact / Significance
    First trial to show substantial benefit of PARP inhibitor maintenance in frontline setting, changing the standard of care for BRCA-mutated advanced ovarian cancer.
  • Trial Name / Acronym
    ICON7
  • Publication Details
  • Title: “Bevacizumab Combined with Chemotherapy in Ovarian Cancer”
  • Journal: NEJM
  • Year: 2011
  • DOI: 10.1056/NEJMoa1103799
  • Study Design
  • Phase III, open-label, randomized
  • Similar to GOG-218 but used lower-dose bevacizumab
  • Patient Population
  • 1,528 women with newly diagnosed high-risk early-stage or advanced epithelial ovarian cancer
  • Post-surgical cytoreduction
  • Number of Patients
  • Total: 1,528
  • Chemo alone: 764
  • Chemo + bevacizumab (7.5 mg/kg): 764
  • Interventions Compared
  • Carboplatin + paclitaxel ± bevacizumab (during chemo and 12 cycles maintenance)
  • Primary and Secondary Endpoints
  • Primary: PFS
  • Secondary: OS, safety
  • Key Findings
  • Modest overall PFS benefit
  • Subgroup analysis: greatest PFS and OS benefit in high-risk patients
  • No significant OS improvement in overall population
  • Impact on Clinical Practice
  • Helped refine bevacizumab use to high-risk subsets
  • Added support to maintenance strategies in front-line therapy
  • Trial Sponsor / Group
  • Sponsor: ICON/MRC (UK)
  • Trial Name / Acronym
    PRIMA (ENGOT-OV26)
  • Publication Details
  • Title: “Niraparib Maintenance Therapy in Patients with Advanced Ovarian Cancer”
  • Journal: New England Journal of Medicine (NEJM)
  • Year: 2019
  • DOI: 10.1056/NEJMoa1910962
  • Study Design
  • Phase III, double-blind, randomized, placebo-controlled
  • Maintenance PARP inhibition after frontline platinum response
  • Patient Population
  • 733 women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer
  • Complete or partial response to platinum chemotherapy
  • Enriched for high-risk (residual disease or stage IV)
  • Number of Patients
  • Total: 733
    • Niraparib: 487
    • Placebo: 246
  • Interventions Compared
  • Niraparib (individualized dosing: 200 or 300 mg daily) vs placebo
  • Given as maintenance for up to 3 years
  • Primary and Secondary Endpoints
  • Primary: PFS in homologous recombination deficient (HRD+) population
  • Secondary: PFS in overall population, OS (immature), safety
  • Key Findings
  • HRD+ PFS: 21.9 vs 10.4 months (HR 0.43)
  • Overall population PFS: 13.8 vs 8.2 months (HR 0.62)
  • Benefit extended to BRCA– and HRD– subsets, though less pronounced
  • Impact on Clinical Practice
  • Broadened use of niraparib to patients regardless of BRCA status
  • Supported routine HRD testing
  • Trial Sponsor / Group
  • Sponsor: Tesaro (now GSK) and ENGOT
  • Trial Name / Acronym
    PAOLA-1
  • Publication Details
  • Title: “Olaparib plus Bevacizumab as Maintenance Therapy in Ovarian Cancer”
  • Journal: NEJM
  • Year: 2019
  • DOI: 10.1056/NEJMoa1911361
  • Study Design
  • Phase III, randomized, double-blind
  • Evaluated combining PARP inhibitor with anti-angiogenic agent in maintenance
  • Patient Population
  • 806 women with newly diagnosed stage III/IV ovarian cancer
  • Completed platinum-based chemo with bevacizumab
  • Regardless of BRCA/HRD status
  • Number of Patients
  • Total: 806
    • Olaparib + bevacizumab: 537
    • Bevacizumab + placebo: 269
  • Interventions Compared
  • Maintenance: Olaparib 300 mg BID + bevacizumab vs bevacizumab alone
  • Duration: Olaparib for up to 2 years
  • Primary and Secondary Endpoints
  • Primary: PFS
  • Secondary: OS (immature), safety
  • Key Findings
  • HRD+ PFS: 37.2 vs 17.7 months (HR 0.33)
  • No PFS benefit in HRD– patients
  • Adverse events higher in combination group but manageable
  • Impact on Clinical Practice
  • Supported synergistic use of PARP + anti-VEGF in HRD+ disease
  • Reinforced importance of HRD testing beyond BRCA
  • Trial Sponsor / Group
  • Sponsor: AstraZeneca and ENGOT
  • Trial Name / Acronym
    NOVA (ENGOT-OV16)
  • Publication Details
  • Title: “Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer”
  • Journal: NEJM
  • Year: 2016
  • DOI: 10.1056/NEJMoa1611310
  • Study Design
  • Phase III, randomized, double-blind
  • Two independent cohorts: BRCA-mutated and BRCA wild-type
  • Patient Population
  • 553 patients with platinum-sensitive recurrent ovarian cancer
  • Prior response to platinum therapy
  • Number of Patients
  • Total: 553
    • Niraparib: 367
    • Placebo: 186
  • Interventions Compared
  • Niraparib 300 mg daily vs placebo
  • Continued until progression or unacceptable toxicity
  • Primary and Secondary Endpoints
  • Primary: PFS in BRCA-mutated and non-mutated cohorts
  • Secondary: OS, safety
  • Key Findings
  • PFS BRCA+: 21.0 vs 5.5 months
  • PFS BRCA– HRD+: 12.9 vs 3.8 months
  • PFS BRCA– HRD–: 9.3 vs 3.9 months
  • Benefit seen across all subgroups
  • Impact on Clinical Practice
  • First PARP inhibitor shown to benefit non-BRCA patients
  • Expanded indication for niraparib maintenance therapy
  • Trial Sponsor / Group
  • Sponsor: Tesaro (GSK), ENGOT
  • Trial Name / Acronym
    ARIEL3
  • Publication Details
  • Title: “Rucaparib Maintenance Treatment for Recurrent Ovarian Carcinoma after Response to Platinum Therapy”
  • Journal: The Lancet
  • Year: 2017
  • DOI: 10.1016/S0140-6736(17)32440-6
  • Study Design
  • Phase III, randomized, double-blind
  • Stratified by BRCA and HRD status
  • Patient Population
  • 564 women with platinum-sensitive recurrent ovarian cancer
  • Complete/partial response to platinum therapy
  • Number of Patients
  • Total: 564
    • Rucaparib: 375
    • Placebo: 189
  • Interventions Compared
  • Rucaparib 600 mg BID vs placebo
  • Maintenance until progression or toxicity
  • Primary and Secondary Endpoints
  • Primary: PFS in BRCA+, HRD+, and ITT populations
  • Secondary: OS (immature), safety
  • Key Findings
  • PFS BRCA+: 16.6 vs 5.4 months
  • PFS HRD+: 13.6 vs 5.4 months
  • PFS ITT: 10.8 vs 5.4 months
  • Most common AE: nausea, fatigue, anemia
  • Impact on Clinical Practice
  • Led to FDA approval of rucaparib as maintenance in platinum-sensitive recurrence
  • Supported use across HRD+ and BRCA– cohorts
  • Trial Sponsor / Group

Sponsor: Clovis Oncology

  • Trial Name / Acronym
    GOG-0213
  • Publication Details
  • Title: “Secondary Cytoreduction and Chemotherapy in Recurrent Ovarian Cancer”
  • Journal: NEJM
  • Year: 2019
  • DOI: 10.1056/NEJMoa1902627
  • Study Design
  • Phase III, randomized
  • Surgery + chemo vs chemo alone in recurrent disease
  • Patient Population
  • 485 women with platinum-sensitive recurrent ovarian cancer
  • ECOG 0–1 and resectable disease
  • Number of Patients
  • Total: 485
    • Surgery + chemo: 240
    • Chemo alone: 245
  • Interventions Compared
  • Surgery followed by platinum chemo vs chemo alone
  • Investigator’s choice of chemo allowed
  • Primary and Secondary Endpoints
  • Primary: Overall Survival (OS)
  • Secondary: PFS, surgical morbidity
  • Key Findings
  • Median OS: 50.6 months (surgery) vs 64.7 months (no surgery)
  • No OS benefit, PFS not significantly improved
  • Complications in 9% of surgery group
  • Impact on Clinical Practice
  • Challenged the role of secondary cytoreduction in recurrent disease
  • Shifted emphasis toward patient selection and systemic options
  • Trial Sponsor / Group
  • Sponsor: GOG Foundation, NCI
  • Trial Name / Acronym
    ATHENA-MONO (Part of ATHENA trial program)
  • Publication Details
  • Title: “Rucaparib Maintenance Treatment for Ovarian Cancer after Response to First-line Platinum-Based Chemotherapy”
  • Journal: Journal of Clinical Oncology (JCO)
  • Year: 2022
  • DOI: 10.1200/JCO.21.02754
  • Study Design
  • Phase III, randomized, double-blind
  • Evaluated rucaparib maintenance ± immunotherapy (nivolumab)
  • Patient Population
  • 538 women with newly diagnosed advanced epithelial ovarian cancer
  • Response to platinum-based chemotherapy
  • Number of Patients
  • Total: 538
    • Rucaparib: 185
    • Placebo: 184
    • (Separate arm with nivolumab not reported here)
  • Interventions Compared
  • Rucaparib 600 mg BID vs placebo
  • Maintenance up to 2 years
  • Primary and Secondary Endpoints
  • Primary: Investigator-assessed PFS
  • Secondary: OS (ongoing), safety
  • Key Findings
  • PFS significantly improved with rucaparib
    • HRD+ PFS: 28.7 vs 11.3 months
    • ITT population: 20.2 vs 9.2 months
  • Safety profile consistent with other PARPs
  • Impact on Clinical Practice
  • Reinforced use of rucaparib in frontline maintenance, especially HRD+
  • Expanded future interest in PARP + immunotherapy combinations
  • Trial Sponsor / Group

Sponsor: Clovis Oncology

Table Of Content

  • MOSAIC (2004)

  • NSABP C-07 (2007)

  • QUASAR (2007)

  • IDEA Collaboration (2018)

  • CRYSTAL (2009)

  • OPUS (2008)

  • CALGB/SWOG 80405 (2014)

  • FIRE-3 (2014)

  • NO16966 (2007)

  • KEYNOTE-177 (2020)
  • CheckMate-142 (2017 & 2018)

  • FOCUS (2003)

  • TOMOX / Tournigand (2004)

  • ASCO Rechallenge & Maintenance Studies

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