This chapter should be cited as follows:
Shen L, Shi T, Glob Libr Women's Med
ISSN: 1756-2228; DOI 10.3843/GLOWM.422013

The Continuous Textbook of Women’s Medicine Series – Gynecology Module

Volume 13

Gynecological cancer

Volume Editors: Professor Hextan Ngan, Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong
Professor Karen Chan, Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong

Chapter

Maintenance Therapy after Primary Treatment of Ovarian Cancer

First published: May 2026

AUTHOR(S)

Lina Shen

Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China

Tingyan Shi

Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China

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INTRODUCTION

The treatment landscape for newly diagnosed advanced ovarian cancer has undergone a profound transformation with the advent of effective maintenance therapy. On completion of primary cytoreductive surgery and platinum-based chemotherapy, assessment of treatment response is crucial for determining the appropriate subsequent therapy. For patients who had Stage-I disease and have no signs of new disease, observation with follow-up is recommended. For patients with Stage-II–IV disease, the option of further therapy depends on the effectiveness of the previous treatment. For patients who achieved complete remission (CR, defined as no definitive evidence of disease) or partial remission (PR, defined as at least a 30% decrease in the sum of the diameters of all specifically measured ‘target’ lesions, taking the baseline sum as reference), a biomarker-driven, personalized approach to first-line maintenance treatment can be considered. The options for maintenance therapy in the first-line setting include angiogenesis inhibitor (bevacizumab) and poly(ADP-ribose) polymerase (PARP) inhibitors (olaparib, niraparib, rucaparib and fuzuloparib). Meanwhile, several clinical trials are investigating the benefit of anti-programmed cell death protein 1 (PD-1) and anti–programmed death-ligand 1 (PD-L1) antibodies in advanced ovarian cancer.

BEVACIZUMAB

Vascular endothelial growth factor is a key promoter of angiogenesis and disease progression in epithelial ovarian cancer. Bevacizumab, a humanized antivascular endothelial growth factor monoclonal antibody, has been investigated in two Phase-III trials, GOG-0218¹^,² and ICON7,³^,⁴ on survival in women with Stage-II–IV disease.

GOG-0218 trial

In GOG-0218, patients with newly diagnosed Stage-III (incompletely resectable) or Stage-IV epithelial ovarian cancer who had undergone debulking surgery were randomly assigned to one of three groups. The control group was chemotherapy with placebo added in cycles 2–22; bevacizumab-initiation group was chemotherapy with bevacizumab (15 mg/kg of body weight) added in cycles 2–6 and placebo added in cycles 7–22. Bevacizumab-throughout group was chemotherapy with bevacizumab added in cycles 2–22. Overall, 1873 patients were enrolled in this double-blind, placebo-controlled, Phase-III trial. The results demonstrated that patients with bevacizumab-throughout treatment had a 4-month improvement in median progression-free survival (PFS) compared with the control treatment (14.1 vs 10.3 months, hazard ratio (HR) 0.717; 95% CI, 0.625–0.824, P < 0.001).¹ After long-term follow-up (102.9 months), overall survival (OS) was not significantly different across the three groups (relative to control group, for bevacizumab-initiation group, HR was 1.06, 95% CI, 0.94–1.20; for bevacizumab-throughout group, HR was 0.96, 95% CI, 0.85–1.09). Interestingly, for patients with Stage-IV disease, OS for bevacizumab-throughout group was 42.8 vs 32.6 months for the control group (HR 0.75; 95% CI 0.59–0.95).² The discordant outcomes have been attributed to crossover post progression, availability of new agent and potential prognostic or predictive factors, including ascites formation and BRCA1/2 status. Thus, testing for BRCA1/2 mutations and homologous recombination deficiency (HRD) is essential.

ICON7 trial

ICON7 showed similar results to those of GOG-0218, with patients receiving carboplatin/paclitaxel/bevacizumab followed by maintenance bevacizumab showing longer PFS than the control group.³ No significant differences in PFS or OS were seen after longer follow-up. Subgroup analyses identified a high-risk group for which bevacizumab improved both median PFS (10.5 vs 16 months; HR 0.73; 95% CI 0.60–0.93, P = 0.002) and median OS (30.2 vs 39.7 months; P = 0.03).⁴ The high-risk group included patients with either Stage IV, inoperable Stage III or suboptimally debulked (residual disease > 1 cm) Stage III. The result was consistent with those from other exploratory analyses that patients with poorer prognosis may derive the most benefit from bevacizumab. GOG-0218 did not include patients with Stage-I–II disease, while ICON7 included patients with Stage-I–IIA disease only if they were considered high risk because of poor differentiation (high grade) or clear cell histology. As to the types of pathology, patients with mucinous, clear cell and endometrioid type were also included in these trials.

Based on results from the GOG-0218 and ICON7 trials, the National Comprehensive Cancer Network (NCCN) Guidelines include bevacizumab-containing regimens as options for first-line chemotherapy following cytoreductive surgery.⁵ There are no data to support introducing bevacizumab as maintenance therapy if bevacizumab was not included in the initial primary regimens used.

PARP INHIBITORS

Recently, PARP inhibitors have been shown, in several Phase-III double-blind, randomized trials, to be active in patients with newly diagnosed, histologically confirmed, FIGO Stage-III/IV ovarian, Fallopian tube or primary peritoneal cancer who have completed first-line chemotherapy. Olaparib and niraparib have been approved by the FDA in the first-line setting in ovarian cancer.

SOLO-1 trial

The SOLO-1 trial was a Phase-III trial, which randomly assigned patients with newly diagnosed ovarian cancer and a germline or somatic BRCA1/2 mutation in clinical response to platinum-based chemotherapy to maintenance olaparib or placebo for up to 2 years. The results demonstrated that the use of maintenance therapy with olaparib provided a substantial benefit with regard to PFS.⁶ After a median follow-up of 41 months, the risk of disease progression or death was 70% lower with olaparib than with placebo (60% vs 27%; HR 0.30; 95% CI 0.23–0.41; P < 0.001). After a 7-year follow-up, a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS, a secondary endpoint, was observed with maintenance olaparib (HR 0.55; 95% CI, 0.40–0.76; P = 0.0004).⁷ Since the PFS benefit of maintenance olaparib is far greater than that reported for the addition of bevacizumab, single-agent olaparib is a category-1 option for patients with BRCA1/2 mutation who did not have bevacizumab as part of primary therapy, according to the NCCN Guideline. Furthermore, single-agent olaparib maintenance was approved by the FDA in patients with deleterious or suspected deleterious BRCA mutation. The frequency of adverse events that led to dose reduction or discontinuation was relatively low.

PAOLA-1/ENGOT-ov25 trial

The PAOLA-1/ENGOT-ov25 trial evaluated the efficacy of olaparib added to maintenance bevacizumab in patients who have CR or PR after first-line platinum-based chemotherapy plus bevacizumab for advanced disease. This study included both patients with and without BRCA1/2 mutations. The results indicated that the addition of olaparib provided a significant PFS benefit (22.1 months with olaparib plus bevacizumab vs 16.6 months with placebo plus bevacizumab, HR 0.59; 95% CI, 0.49–0.72; P < 0.001), which is substantial in patients with HRD-positive tumors (HR 0.33; 95% CI 0.25–0.45), and those with a BRCA mutation (37.2 vs 17.7 months).⁸ Based on these results, maintenance therapy with bevacizumab plus olaparib is considered a category-1 option for patients with BRCA1/2 mutation who have achieved CR/PR after completing first-line therapy including bevacizumab. For patients with BRCA1/2 wild-type or unknown, olaparib + bevacizumab combination or bevacizumab monotherapy are category-2A maintenance therapy options. Furthermore, in the absence of a BRCA1/2 mutation, HRD status may provide information on the magnitude of benefit of PARP inhibitor therapy.⁸ The updated results confirmed the survival benefit of maintenance olaparib plus bevacizumab for HRD-positive patients regardless of clinical risk of disease progression.⁹ For the FDA indication, maintenance bevacizumab plus olaparib is limited to those with HRD as defined by a deleterious or suspected deleterious BRCA mutation and/or genetic instability, as measured using an FDA-approved companion diagnostic. Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.

PRIMA/ENGOT-OV26/GOG-3012 trial

The PRIMA/ENGOT-OV26/GOG-3012 trial included the overall population regardless of BRCA1/2 mutation status. The results demonstrated the PFS benefit of maintenance niraparib in the overall population (13.8 vs 8.2 months; HR 0.62; 95% CI 0.50–0.76; P < 0.001). Among patients who had tumors with HRD, the median PFS was significantly longer in the niraparib group than in the placebo group (21.9 vs 10.4 months; HR 0.43; 95% CI 0.31–0.59; P < 0.001). Patients with BRCA1/2 mutation had the greatest PFS benefit from niraparib compared to placebo (22.1 vs 10.9 months; HR 0.40; 95% CI 0.27–0.62; P < 0.001).¹⁰ Subgroup analyses showed the effect of maintenance niraparib on PFS was significant among patients without a BRCA1/2 mutation (HR 0.71, 95% CI 0.58–0.88). However, OS results were negative for the overall population (HR 1.01; 95% CI 0.84–1.23), HRD patients (HR 0.95; 95% CI 0.70–1.29) and homologous recombination proficient patients (HR 0.93; 95% CI 0.69–1.26).¹¹ Based on the above results, maintenance niraparib is considered a category-1 option for patients with BRCA1/2 mutation who achieved CR/PR after first-line chemotherapy. The most common adverse events of Grade 3 or higher were anemia (31%), thrombocytopenia (28.7%) and neutropenia (12.8%).¹⁰

FZOCUS-1 trial

The FZOCUS-1 trial compared the combination of fuzuloparib and apatinib with fuzuloparib monotherapy as first-line maintenance for advanced ovarian cancer, especially in BRCA-mutated/HRD patients. The median PFS was longer in the combination group than the placebo group (26.9 vs 11.1 months, HR 0.57; 95% CI 0.44–0.75; P < 0.0001), and 29.9 months with fuzuloparib monotherapy vs placebo (HR 0.58; 95% CI, 0.44–0.75; P < 0.0001). PFS benefit was observed regardless of germline BRCA1/2 mutation status. OS data were immature. The outcomes support that both fuzuloparib and combination therapy improved PFS compared with placebo as maintenance therapy for patients who had newly diagnosed advanced ovarian cancer.¹²

VELIA/GOG-3005 trial

The Phase-III VELIA/GOG-3005 study assessed the efficacy of veliparib added to first-line induction chemotherapy and continued as maintenance monotherapy in patients with previously untreated Stage-III or -IV high-grade serous ovarian carcinoma. The enrolled population was different from those in the above trials. Patients who had absence of progression during first-line systemic therapy could be enrolled in this trial. Among the three cohorts (control, veliparib combination only, veliparib throughout), veliparib induction therapy followed by veliparib maintenance led to significantly longer PFS than carboplatin plus paclitaxel induction therapy alone group (23.5 vs 17.3 months, HR 0.68; 95% CI, 0.56–0.83; P < 0.001). Patients with BRCA mutation or HRD achieved a greater PFS benefit from veliparib maintenance therapy (BRCA-mutation cohort: 34.7 months in the veliparib-throughout group vs 22.0 months in the control group, HR 0.44; 95% CI, 0.28–0.68; P < 0.001; in the HRD cohort, 31.9 vs 20.5 months, HR 0.57; 95% CI, 0.43–0.76; P < 0.001). Since the FDA did not approve the indication of veliparib, it was not recommended by NCCN Guidelines. The most common adverse events were anemia, thrombocytopenia, nausea and fatigue.¹³

ATHENA-MONO/GOG-3020/ENGOT-ov45 trial

The ATHENA-MONO/GOG-3020/ENGOT-ov45 assessed the survival benefit of maintenance therapy with rucaparib monotherapy following standard treatment for ovarian cancer in the first-line setting. Rucaparib monotherapy is effective as first-line maintenance, conferring significant benefit vs placebo in patients with advanced ovarian cancer (20.2 vs 9.2 months; HR 0.52; 95% CI, 0.40–0.68; P < 0.0001). In the subgroup of HRD-positive patients, the PFS benefit was greater (28.7 vs 11.3 months; HR 0.47; 95% CI, 0.31–0.72; P = 0.0004).¹⁴ For a group generally associated with poorer PFS and OS outcomes, i.e. the HRD-negative population, rucaparib was associated with improved investigator-assessed PFS compared to placebo (12.1 vs 9.1 months; HR 0.65; 95% CI 0.45–0.95).¹⁴ The most common ≥ Grade-3 adverse events were anemia and neutropenia.

Hematologic adverse events were the most common high-grade events (Grade ≥3). Furthermore, PARP inhibitors were associated with higher rates of several common non-hematologic adverse events, such as fatigue/asthenia, nausea and vomiting. There were no statistically significant differences between treatment arms in the health-related QoL metrics evaluated in the abovementioned trials for PARP inhibitors.

IMMUNOTHERAPY

We identified four trials investigating the effectiveness of immunotherapy in first-line therapy in advanced ovarian cancer: FIRST, DUO-O, KEYLYNK-001 and ATHENA. Results of these trials will determine whether PARP inhibitors and PD-(L)1 inhibitor combination with or without bevacizumab can improve patient outcomes. The ATHENA-COMBO/GOG-3020/ENGOT-OV45 trial assessed the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)–blocking monoclonal antibody) vs rucaparib alone in women with newly diagnosed ovarian, Fallopian tube or peritoneal cancer. The results demonstrated that nivolumab did not improve PFS compared with rucaparib maintenance in ovarian cancer (15.0 vs 20.2 months; HR 1.29; 95% CI, 1.08–1.53), with no benefit observed in subgroup analyses of patients with HRD or PD-1 expression ≥ 1%. OS data are not mature.¹⁵ The results of FIRST, DUO-O and KEYLYNK-001 have not yet been released.

SUMMARY

Principal discrepancies in maintenance therapy recommendations between the FDA and NCCN Guidelines are summarized in Table 1 and the key characteristics of the main trials informing these recommendations are provided in Table 2. Whether patients with advanced ovarian cancer can benefit from maintenance therapy depends on the success of the first-line chemotherapy and surgery. For patients who are at high risk of disease progression, bevacizumab prolongs survival. The survival benefit of PARP inhibitors for patients with newly diagnosed advanced ovarian cancer who achieve CR/PR after frontline chemotherapy, especially for those with BRCA1/2 mutation, is supported by several randomized trials. Clinical HRD testing is recommended for those patients without germline BRCA1/2 mutations, as HRD test status may provide information on the magnitude of benefit of PARP inhibitor maintenance therapy in these patients.

Key discrepancies in maintenance therapy recommendations between the FDA and NCCN Guidelines.

Maintenance regimen	FDA-approved	NCCN Guidelines
Bevacizumab	Stage-III–IV disease	Stage-II–IV disease
Singe-agent bevacizumab	Not restricted based on BRCA1/2 mutation status	Limited to patients without a BRCA1/2 mutation
Olaparib + bevacizumab combination	Does not specify that patients must have received prior bevacizumab; restricted to patients with BRCA1/2 mutations or genomic instability	Restricted to patients who received prior bevacizumab; regardless of homologous recombination deficiency status
Niraparib	Not restricted by BRCA1/2 mutation status or prior bevacizumab use	For patients who received bevacizumab as part of primary therapy, niraparib is a maintenance option only for those with BRCA1/2 mutation

Summary of key clinical trials.

Trial	Setting	Key findings	Outcomes	Comments
GOG-0218¹^,²	Addition of bevacizumab to first-line chemotherapy and as maintenance therapy in patients with: Stage III incompletely resected disease (≤1 cm: 34%; > 1 cm: 40%) or Stage IV disease (26%) Residual disease (R0/≤ 1 cm/> 1 cm: 5%/41%/54%) Histology: 85% serous Tumor grade 3 : 73%	Incorporation of bevacizumab during chemotherapy and for up to 10 months as maintenance prolonged PFS by approximately 4 months, with no OS benefit	PFS: 14.1 months (TC/bev–bev) vs 11.2 months (TC/bev–placebo) vs 10.3 months (TC–placebo) OS: 39.7 months (TC/bev–bev) vs 38.7 months (TC/bev–placebo) vs 39.3 months (TC–placebo)	Bevacizumab improved PFS, but not OS in the study population.
ICON7³^,⁴	Addition of bevacizumab to first-line chemotherapy and as maintenance therapy in patients with: High-risk early-stage disease (Stage I–IIA clear cell or Grade 3; Stage IIB–IV) Residual disease (R0/≤ 1 cm/> 1 cm: 48%/24%/26%) Cancer type: 69% serous Tumor grade 3 : 72%	Bevacizumab did not improve PFS or OS in the overall population but prolonged survival in the high-risk subgroup	High-risk subgroup: PFS: 16.0 months (with bevacizumab) vs 10.5 months (without bevacizumab) OS: 39.7 months (with bevacizumab) vs 30.2 months (without bevacizumab)	Bevacizumab improved PFS and OS in patients with high-risk disease (Stage-IV disease; inoperable Stage-III disease; or suboptimally debulked Stage-III disease (> 1 cm)).
SOLO-1⁶^,⁷	Addition of maintenance therapy olaparib to patients with newly diagnosed ovarian cancer with germline or somatic BRCA1/2 mutation following clinical response to platinum-based chemotherapy	Olaparib provided substantial PFS benefit and clinically meaningful OS improvement	PFS: HR 0.30; 95% CI 0.23–0.41; P < 0.001 (risk of progression or death 70% lower vs placebo) OS: HR 0.55; 95% CI 0.40–0.76; P = 0.0004	Olaparib maintenance prolongs PFS and improves OS for patients with BRCA1/2 mutation
PAOLA-1/ ENGOT-ov25⁸^,⁹	Maintenance olaparib + bevacizumab in patients with advanced ovarian cancer receiving first-line standard therapy	Addition of olaparib to bevacizumab significantly improved PFS	PFS: 22.1 vs 16.6 months; HR 0.59; 95% CI 0.49–0.72; P < 0.001. In HRD-positive tumors without BRCA mutation: HR 0.33; 95% CI 0.25–0.45	Olaparib + bevacizumab improves PFS in the first-line setting, especially in HRD-positive tumors
PRIMA/ ENGOT-OV26/ GOG-3012¹⁰^,¹¹	Addition of niraparib maintenance to patients with newly diagnosed advanced ovarian cancer following response to first-line platinum-based chemotherapy	Niraparib improved PFS overall and in HRD-positive tumors	PFS: Overall population 13.8 vs 8.2 months; HR 0.62; 95% CI 0.50–0.76; P < 0.001 HRD-positive: 21.9 vs 10.4 months; HR 0.43; 95% CI 0.31–0.59; P < 0.001 OS: Overall population (HR 1.01; 95% CI 0.84–1.23), HRD patients (HR 0.95; 95% CI 0.70–1.29), HRP patients (HR 0.93, 95% CI 0.69–1.26)	Maintenance niraparib improved PFS, especially in HRD-positive patients
FZOCUS-1¹²	Combination of fuzuloparib and apatinib with fuzuloparib monotherapy as first-line maintenance for advanced ovarian cancer, especially in BRCA-mutated/HRD patients	Fuzuloparib improved PFS; OS data immature.	PFS: Combination 26.9 vs 11.1 months; HR 0.57; 95% CI 0.44–0.75; P < 0.0001 Monotherapy 29.9 vs placebo; HR 0.58; 95% CI 0.44–0.75; P < 0.0001	Both fuzuloparib monotherapy and combination therapy improved PFS
VELIA/ GOG-3005¹³	Addition of veliparib to the first-line induction chemotherapy and continued as maintenance monotherapy in patients with previously untreated Stage-III or -IV high-grade serous ovarian carcinoma	Veliparib improved PFS	PFS: Overall population 23.5 vs 17.3 months; HR 0.68; 95% CI 0.56–0.83; P < 0.001 BRCA-mutation: 34.7 vs 22.0 months; HR 0.44; 95% CI 0.28–0.68; P < 0.001 HRD-positive: 31.9 vs 20.5 months; HR 0.57; 95% CI 0.43–0.76; P < 0.001	Veliparib improved PFS, especially in BRCA-mutated or HRD-positive patients
ATHENA-MONO/ GOG-3020/ ENGOT-ov45¹⁴^,¹⁶	Maintenance therapy with rucaparib monotherapy following standard treatment for ovarian cancer in the frontline setting	Rucaparib monotherapy improved PFS	PFS: Overall population 20.2 vs 9.2 months; HR 0.52; 95% CI 0.40–0.68; P < 0.0001 HRD-positive: 28.7 vs 11.3 months; HR 0.47; 95% CI 0.31–0.72; P = 0.0004 HRD-negative: 12.1 vs 9.1 months; HR 0.65; 95% CI 0.45–0.95	Rucaparib monotherapy is effective as first-line maintenance
ATHENA-COMBO¹⁵^,¹⁶	Rucaparib ± nivolumab in frontline maintenance in ovarian cancer	Addition of nivolumab to rucaparib did not improve outcomes	PFS: 15.0 vs 20.2 months; HR 1.29; 95% CI 1.08–1.53	Addition of nivolumab to rucaparib did not improve PFS in the frontline setting compared to rucaparib maintenance alone and was associated with increased toxicity

bev, bevacizumab; HRD, homologous recombination deficient; HRP, homologous recombination proficient.

PRACTICE RECOMMENDATIONS

First-line maintenance therapy is now standard for patients with newly diagnosed advanced ovarian cancer who achieve a complete or partial response to platinum-based chemotherapy after cytoreductive surgery. Observation only is reserved for Stage-I patients with no evidence of disease.
Maintenance therapy selection is biomarker-driven. Testing for BRCA1/2 mutations and homologous recombination deficiency (HRD) is essential to personalize therapy and predict the magnitude of benefit from PARP inhibitors.
PARP inhibitors are a cornerstone of maintenance, especially for BRCA mutant or HRD-positive patients.
- For patients with a BRCA1/2 mutation, single-agent olaparib (SOLO-1) or niraparib (PRIMA) provides a significant progression-free survival (PFS) benefit and is a category-1 recommendation.
- For patients receiving first-line chemotherapy with bevacizumab, the combination of bevacizumab plus olaparib (PAOLA-1) is a category-1 option for those with a BRCA mutation or HRD-positive tumors.
- For patients without a BRCA mutation, PARP inhibitor monotherapy or combination therapy (PARPi + bevacizumab in HRD-positive) are effective options, with benefit being greatest in the HRD-positive subgroup.
Bevacizumab monotherapy remains an important option, particularly for patients with high-risk disease (Stage IV, inoperable Stage III or suboptimally debulked > 1 cm), where it improves PFS and, in some analyses, overall survival (OS).
The role of immunotherapy (PD-1/PD-L1 inhibitors) in first-line maintenance is not yet established. Current evidence does not support adding nivolumab to PARP inhibitors in this setting, and results from other trials are pending.

CONFLICTS OF INTEREST

The author(s) of this chapter declare that they have no interests that conflict with the contents of the chapter.

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