Clinical Situation: Maintenance After First-line Treatment

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

Maintenance after first-line therapy: Treatment to prevent relapse after complete response to 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 III Bevacizumab, Carboplatin, Paclitaxel 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+Bev w/ Bev maint vs CarboPt+Bev vs CarboPt:

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*

v. 6/2018
Angiogenesis Inhibitors: VEGF NCT00483782 III Bevacizumab, Carboplatin, Paclitaxel 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+Bev w/ Bev maint vs CarboPt:

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)

v. 4/2018
*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
Drugs in NCCN Guidelines
Chemotherapy NCT00003120 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

v. 7/2017
Angiogenesis Inhibitors: VEGFR/PDGFR NCT00866697 III Pazopanib A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Improved PFS, but no OS benefit with pazopanib maintenance

Paz vs Placebo:

PFS: 17.9 vs 12.3 months*
OS: 59.1 vs 64.0 months

v. 6/2018
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

v. 6/2017
DNA Damage Repair Pathway Inhibitors:PARP NCT01844986 III Olaparib 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

v. 10/2018
Anti-hormone 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: NR vs 13.2 months*
Patients w/o residual disease: NR vs 20.8 months
Patients w/ residual disease: 21.6 vs 8.8 months*

v. 6/2018
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 vs 16.0/12.6 months

v. 2/2017
*Statistically significant result

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