Evaluation of New Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer: A Phase III Trial of the Gynecologic Cancer InterGroup (GOG 182)

Disease site

Ovary

Publication month/year

March 2009

Study question

Does incorporation of an additional cytotoxic agent improve overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma who receive CP (carboplatin and paclitaxel)?

Type of study

Randomised controlled trial (RCT)

Interventions compared

Standard treatment vs. Treatment regimens 

Three experimental arms (Intervention)
  • Treatment arm II; CPG (CP + gemcitabine)
  • Treatment arm III; CPD (CP + doxorubicin)
  • Treatment arm IV; CT-CP (carboplatin + topotecan then CP)
  • Treatment arm V; CG-CP (carboplatin + gemcitabine then CP)
Control arm

Treatment arm I; CP (carboplatin and paclitaxel)

Primary outcome
  • Overall survival (OS)
  • Progression-free survival (PFS)
Secondary outcome
  • Toxicity
Inclusion criteria
  • Histological diagnosis of advanced-stage epithelial ovarian carcinoma (EOC) or primary peritoneal carcinoma (PPC)
  • FIGO stage (III or IV)
  • Optimal (≤ 1 cm) or suboptimal residual disease
  • GOG performance status of ≤ 2
Exclusion criteria
  • Patients with tumors of low malignant potential
  • Patients with carcinosarcoma or nonepithelial tumors
Results
Other results
  • None of the experimental regimens reduced the PFS event rate at least 7% relative to the reference arm
  • Increased hematologic toxicity in the triplet regimens
  • Increased thrombocytopenia in regimens with gemcitabine.
Conclusions

Addition of a third cytotoxic agent provided no benefit in PFS or OS after optimal or suboptimal cytoreduction

Study limitations
  • Each regimen was limited by practical management of toxicity in the setting of a cooperative group
  • The number and diversity of new agents
Reviewer name