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Bending the Curve Trial by Trial
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GOG-0252

Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study

Phase 3N = 1,560NCT00951496

Population
Women with newly diagnosed advanced epithelial ovarian, fallopian tube or peritoneal carcinoma; designed for optimally resected (1 cm or less) disease
Design
Randomised trial of two intraperitoneal regimens against an intravenous reference, all with bevacizumab 15 mg/kg intravenously every 3 weeks in cycles 2 to 22. Six cycles of intravenous weekly paclitaxel 80 mg/m2 with intravenous carboplatin AUC 6, or weekly paclitaxel with intraperitoneal carboplatin AUC 6, or every-3-week intravenous paclitaxel 135 mg/m2 over 3 hours on day 1 with intraperitoneal cisplatin 75 mg/m2 on day 2 and intraperitoneal paclitaxel 60 mg/m2 on day 8. 1560 participants were enrolled with 84.8 months of follow-up.
Primary endpoint
PFS
Arms
  • IV paclitaxel weekly plus IV carboplatin, with bevacizumab (control): Paclitaxel 80 mg/m2 weekly plus carboplatin AUC 6 intravenously for six cycles, plus bevacizumab 15 mg/kg every 3 weeks in cycles 2 to 22
  • IV paclitaxel weekly plus IP carboplatin, with bevacizumab (experimental): Paclitaxel 80 mg/m2 weekly intravenously plus carboplatin AUC 6 intraperitoneally for six cycles, plus bevacizumab 15 mg/kg every 3 weeks in cycles 2 to 22
  • IV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumab (experimental): Paclitaxel 135 mg/m2 intravenously over 3 hours on day 1, cisplatin 75 mg/m2 intraperitoneally on day 2, paclitaxel 60 mg/m2 intraperitoneally on day 8, every 3 weeks for six cycles, plus bevacizumab 15 mg/kg every 3 weeks in cycles 2 to 22
People
Walker JL, NRG Oncology/Gynecologic Oncology Group
Δ median PFS+2.5 monthsΔ median PFS+1.8 monthsΔ median PFS+2.9 monthsΔ median OS+3.4 monthsΔ median OS+6 monthsPFSHR 0.925 (95% CI 0.802–1.070)
Show the numbers
Results reported for GOG-0252
EndpointAnalysisIV paclitaxel weekly plus IP carboplatin, with bevacizumab / IV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumabIV paclitaxel weekly plus IV carboplatin, with bevacizumabEffect
PFSAll enrolled participants (N=1560)primaryWalker 2019median 27.4 monthsmedian 24.9 monthsThe abstract gives no hazard ratio or p-value; the conclusion states that PFS was not significantly increased with either IP regimen. Follow-up 84.8 months.
PFSStage II/III with residual disease of 1 cm or less (subgroup of 1,380 patients)exploratoryWalker 2019median 28.7 monthsmedian 26.9 monthsSubgroup of 1380 patients as defined in the abstract; no hazard ratio or p-value in the abstract.
PFSStage II/III with no residual disease (subgroup)exploratoryWalker 2019median 38.8 monthsmedian 35.9 monthsSubgroup; the abstract does not say it was prespecified and gives no hazard ratio or p-value. The IP cisplatin median is 35.5 months in the abstract and 36.5 months in the full-text Results, so it is not recorded.
OSAll enrolled participants (N=1560)primaryWalker 2019median 78.9 monthsmedian 75.5 monthsThe abstract gives no hazard ratio or p-value for overall survival.
OSStage II/III with no gross residual disease (subgroup)exploratoryWalker 2019median 104.8 monthsmedian 98.8 monthsThe IP cisplatin arm median was 'not reached' in the abstract and cannot be entered as a number. Subgroup; no hazard ratio or p-value in the abstract.
PFSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.925 (95% CI 0.802–1.070)Hazard of progression or death vs IV carboplatin; the text states no statistically significant difference. Not in the abstract.
PFSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.977 (95% CI 0.847–1.130)Hazard of progression or death vs IV carboplatin; the text states no statistically significant difference. Not in the abstract.
OSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.949 (95% CI 0.799–1.128)Hazard of death vs IV carboplatin, described in the text as similar; 49% of participants alive at median follow-up 84.8 months. Not in the abstract.
OSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 1.050 (95% CI 0.884–1.240)Hazard of death vs IV carboplatin, described in the text as similar. Not in the abstract.
Results reported for GOG-0252
EndpointAnalysisIV paclitaxel weekly plus IP carboplatin, with bevacizumab / IV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumabIV paclitaxel weekly plus IV carboplatin, with bevacizumabEffect
PFSAll enrolled participants (N=1560)primaryWalker 2019median 27.4 monthsmedian 24.9 monthsThe abstract gives no hazard ratio or p-value; the conclusion states that PFS was not significantly increased with either IP regimen. Follow-up 84.8 months.
PFSStage II/III with residual disease of 1 cm or less (subgroup of 1,380 patients)exploratoryWalker 2019median 28.7 monthsmedian 26.9 monthsSubgroup of 1380 patients as defined in the abstract; no hazard ratio or p-value in the abstract.
PFSStage II/III with no residual disease (subgroup)exploratoryWalker 2019median 38.8 monthsmedian 35.9 monthsSubgroup; the abstract does not say it was prespecified and gives no hazard ratio or p-value. The IP cisplatin median is 35.5 months in the abstract and 36.5 months in the full-text Results, so it is not recorded.
OSAll enrolled participants (N=1560)primaryWalker 2019median 78.9 monthsmedian 75.5 monthsThe abstract gives no hazard ratio or p-value for overall survival.
OSStage II/III with no gross residual disease (subgroup)exploratoryWalker 2019median 104.8 monthsmedian 98.8 monthsThe IP cisplatin arm median was 'not reached' in the abstract and cannot be entered as a number. Subgroup; no hazard ratio or p-value in the abstract.
PFSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.925 (95% CI 0.802–1.070)Hazard of progression or death vs IV carboplatin; the text states no statistically significant difference. Not in the abstract.
PFSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.977 (95% CI 0.847–1.130)Hazard of progression or death vs IV carboplatin; the text states no statistically significant difference. Not in the abstract.
OSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 0.949 (95% CI 0.799–1.128)Hazard of death vs IV carboplatin, described in the text as similar; 49% of participants alive at median follow-up 84.8 months. Not in the abstract.
OSITT (all 1,560 randomly assigned participants)primaryWalker 2019——HR 1.050 (95% CI 0.884–1.240)Hazard of death vs IV carboplatin, described in the text as similar. Not in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.9250.802–1.07
PFS0.9770.847–1.13
OS0.9490.799–1.128
OS1.050.884–1.24
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • IV paclitaxel weekly plus IV carboplatin, with bevacizumab (control)
  • IV paclitaxel weekly plus IP carboplatin, with bevacizumab (experimental)
  • IV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsIV paclitaxel weekly plus IV carboplatin, with bevacizumabIV paclitaxel weekly plus IP carboplatin, with bevacizumabIV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumab
0100.0%100.0%100.0%
1762.3%65.0%63.8%
3438.8%42.3%40.7%
5124.2%27.5%25.9%
6914.6%17.5%16.1%
Illustrative — modelled from reported values, not trial data. PFS, exploratory.
0%25%50%75%100%0204060Months (modelled)
  • IV paclitaxel weekly plus IV carboplatin, with bevacizumab (control)
  • IV paclitaxel weekly plus IP carboplatin, with bevacizumab (experimental)
  • IV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsIV paclitaxel weekly plus IV carboplatin, with bevacizumabIV paclitaxel weekly plus IP carboplatin, with bevacizumabIV paclitaxel, IP cisplatin and IP paclitaxel, with bevacizumab
0100.0%100.0%100.0%
1862.9%64.7%63.8%
3639.5%41.9%40.8%
5424.9%27.1%26.0%
7215.6%17.6%16.6%
Primary publication: Walker JL, Brady MF, Wenzel L, Fleming GF, Huang HQ, DiSilvestro PA, et al. Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2019;37(16):1380-1390. PubMedDOI

Appears in

Sources

  1. Walker JL, Brady MF, Wenzel L, Fleming GF, Huang HQ, DiSilvestro PA, et al. Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2019;37(16):1380-1390.

    PubMedDOI