Clinical Situation: Maintenance After First-line Treatment

First-line treatment with/without extended (maintenance) treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

Overall Survival (months)

The length of time where half the patients in the study are still alive

No Prior Therapies

Maintenance after first-line therapy: Treatment to prevent relapse after complete response to therapy

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

Overall Survival (months)

The length of time where half the patients in the study are still alive

1 Prior Therapy

First-line treatment with/without extended (maintenance) treatment

For more detailed information, please click on the clinical trial ID number.

Drug Class Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Standard of Care Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00262847; GOG-218 III Bevacizumab, Carboplatin, Paclitaxel Prescribing Information A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (GOG218)

Improved PFS with addition of bevacizumab to carboplatin+paclitaxel in high risk patients, particularly those with ascites

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:

All:
PFS: 14.1 vs 11.2 vs 10.3 months*
OS: 43.3 vs 40.8 vs 41.1 months
With ascites:
PFS: 15.2 vs 10.3 months*
OS: 43.3 vs 39.9 months*

pub 2015; abs Jun 2018

Angiogenesis Inhibitors: VEGF NCT00483782; ICON7 III Bevacizumab, Carboplatin, Paclitaxel Prescribing Information ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

Improved PFS and OS with addition of bevacizumab to carboplatin+paclitaxel in high risk patients

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:

All:
PFS: 19.9 vs 17.5 months
OS: 45.5 vs 44.6 months (restricted mean survival)
High risk:
PFS: 16.0 vs 10.5 months*
OS: 39.3 vs 34.5 months* (restricted mean survival)

pub 2011; 2015

Angiogenesis Inhibitors: VEGF NCT00951496; GOG-252 III Bevacizumab, Carboplatin, Cisplatin, Paclitaxel A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Compared to the IV reference arm, PFS was not significantly increased with either IP regimen

IV CarboPt+Pac+Bev w/ Bev maint vs IP CarboPt+Pac+Bev w/ Bev maint vs IP CisPt+Pac+Bev w/ Bev maint:

PFS: 24.9 vs 27.4 vs 26.2 months
OS: 75.5 vs 78.9 vs 72.9 months

pub 2019

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP NCT02470585; VELIA III Carboplatin, Paclitaxel, Veliparib A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Veliparib added to chemotherapy and continued as maintenance significantly extended PFS in all newly diagnosed patients

CarboPt+Pac+Vel w/Vel maint vs CarboPt+Pac+Vel vs CarboPt+Pac:

BRCA MUT:
PFS: 34.7 vs 21.1 vs 22.0 months*
HRD-pos (incl. BRCA MUT):
PFS: 31.9 vs 18.1 vs 20.5 months*
All patients:
PFS: 23.5 vs 15.2 vs 17.3 months*

pub 2019

Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR IRCT2016- 022726788N1 II Carboplatin, Metformin, Paclitaxel Evaluation of the clinical efficacy of adding metformin to chemotherapy regimen for patients with ovarian cancers

Improved RFS with addition of metformin to carboplatin+paclitaxel in stage I-III patients

CarboPt+Pac+Met vs CarboPt+Pac:

RFS: 48.0 vs 25.7 months

pub 2018

*Statistically significant result

Maintenance after first-line therapy: Treatment to prevent relapse after complete response to therapy

For more detailed information, please click on the clinical trial ID number.

Drug Class Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Standard of Care Targeted Drugs
DNA Damage Repair Pathway Inhibitors: PARP NCT01844986; SOLO-1 III Olaparib Prescribing Information A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1)

Considerably improved PFS for BRCA MUT patients with olaparib maintenance treatment

Ola maint vs Placebo:

PFS: Not Reached vs 14.1 months*

pub 2018

Drugs in NCCN Guidelines
Chemotherapy NCT00003120; GOG-178 III Paclitaxel Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (GOG-178)

Improved PFS with 12 cycles of paclitaxel, no OS difference

12 cycles Pac vs 3 cycles Pac:

PFS: 28 vs 21 months*
OS: 53 vs 48 months

pub 2003; 2009

Drugs in Clinical Development
Chemotherapy NCT00108745 III Paclitaxel, Paclitaxel Poliglumex A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Improved PFS with paclitaxel poliglumex or paclitaxel maintenance treatment, but no OS difference

Pac Poliglu vs Pac vs Placebo:

PFS: 16.3 vs 18.9 vs 13.4 months*
OS: 60 vs 51.3 vs 54.8 months

abs Mar 2017

DNA Damage Repair Pathway Inhibitors: PARP NCT02477644: PAOLA III Bevacizumab, Carboplatin, Olaparib, Paclitaxel Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

Dual maintenance therapy with olaparib and bevacizumab significantly improves PFS compared with bevacizumab maintenance alone

Ola vs Placebo:

All patients:
PFS: 22.1 vs 16.6 months*
BRCA MUT:
PFS: 37.2 vs 21.7 months*
HRD-pos (incl BRCA MUT):
PFS: 37.2 vs 17.1 months*

abs Oct 2019

DNA Damage Repair Pathway Inhibitors: PARP NCT02655016; PRIMA III Niraparib A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Considerably improved PFS for all patients that received niraparib maintenance treatment

Nir maint vs Placebo:

All patients:
PFS: 13.8 vs 8.2 month*
HRD-positive:
PFS: 21.9 vs 10.4 months*

pub 2019

Hormonal Therapy: Aromatase Letrozole University Hospital Basel Single-site Letrozole Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients

Promising activity with minimal toxicity of letrozole maintenance in ER-positive patients

Let vs Placebo:

All patients:
RFS: Not Reached vs 13.2 months*

Patients w/o residual disease:
RFS: Not Reached vs 20.8 months

Patients w/ residual disease:
RFS: 21.6 (n=7) vs 8.8 (n=6) months*

pub 2018

Hormonal Therapy: Aromatase Retrospective Study: Hormonal Maintenance in LGSC II Anastrozole, Letrozole, Tamoxifen Retrospective analysis of Hormonal Maintenance Therapy for Patients With LGS Ovarian Cancer

Significantly longer PFS with hormonal maintenance therapy (HMT) vs. observation (OBS) in Low Grade Serous OC patients

HMT vs OBS:

PFS: 64.9 vs 26.4 months
OS: 115.7 vs 102.7 months

pub 2017

Hormonal Therapy: Anti-Estrogens Retrospective Study: Hormonal Maintenance in LGSC II Anastrozole, Letrozole, Tamoxifen Retrospective analysis of Hormonal Maintenance Therapy for Patients With LGS Ovarian Cancer

Significantly longer PFS with hormonal maintenance therapy (HMT) vs. observation (OBS) in Low Grade Serous OC patients

HMT vs OBS:

PFS: 64.9 vs 26.4 months
OS: 115.7 vs 102.7 months

pub 2017

Immunotherapy: Vaccine NCT01309230 II Gemogenovatucel-T Open Label Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer

FANG vaccine shows encouraging anti-tumor activity and increased RFS with remarkable safety

FANG vs Placebo:

RFS (from time of procurement, mean/median):
27.5/20.1 (n=31) vs 16.0/12.6 (n=11) months

pub 2016

*Statistically significant result

< Return to Clinical Situation

< Return to Clinical Trial Results Homepage