GOG 182 Study
Evaluation of New Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer: A Phase III Trial of the Gynecologic Cancer InterGroup
Disease site
Ovary
Pubmed link
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
| Results | |
|---|---|
|
Randomised (n) |
4,312 |
|
Completed therapy (%) |
79% |
|
Optimal cytoreduction (%) |
70% |
|
Follow up (years) |
3.7 |
|
Experimental regimens PFS |
Median of 16 |
|
Experimental regimens OS |
Median od 44.1 |
| Microscopic Only (residual disease) | Suboptimal (>1 cm) | Gross-optimal (≤1 cm) | |
|---|---|---|---|
|
Number of patients (n) |
1,044 |
1,319 |
1,949 |
|
PFS (months) |
29 |
13 |
16 |
|
OS (months) |
68 |
33 |
40 |
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