Skip to content
Bending the Curve Trial by Trial
?

GOG-122

Whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma (Gynecologic Oncology Group study 122)

Phase 3N = 422NCT00002493

Population
Stage III or IV endometrial carcinoma with a maximum of 2 cm of postoperative residual disease; 396 of 422 entered patients assessable
Design
Randomised phase 3 trial of whole-abdominal irradiation (WAI; 30 Gy in 20 fractions with a 15-Gy boost) versus doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 every 3 weeks for seven cycles followed by one cycle of cisplatin (AP). 422 patients entered; 396 were assessable (202 WAI, 194 AP). Median age 63 years; 50% had endometrioid tumours. Median follow-up 74 months. The abstract does not designate a control arm; the control and experimental roles below follow the order of the comparison and are a data-model convention, not a statement by the authors.
Arms
  • Whole-abdominal irradiation (control, n = 202): Whole-abdominal irradiation 30 Gy in 20 fractions with a 15-Gy boost
  • Doxorubicin and cisplatin (experimental, n = 194): Doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 every 3 weeks for seven cycles, followed by one cycle of cisplatin
People
Randall ME, Gynecologic Oncology Group
PFSHR 0.71 (95% CI 0.55–0.91)Δ 60-month PFS+12 pointsOSHR 0.68 (95% CI 0.52–0.89)Δ 60-month OS+13 pointsΔ Deaths probably related to treatment+2 points
Show the numbers
Results reported for GOG-122
EndpointAnalysisDoxorubicin and cisplatinWhole-abdominal irradiationEffect
PFSAssessable patients (396)Progression-free survival; hazard ratio for progression adjusted for stage. The 60-month figures are the percentages predicted to be alive and disease free, adjusting for stageprimarymedian follow-up 74 monthsRandall 200650% at 5 y38% at 5 yHR 0.71 (95% CI 0.55–0.91)P<.01Hazard ratio for progression adjusted for stage, favouring doxorubicin-cisplatin. 396 of 422 patients entered were assessable (202 whole-abdominal irradiation, 194 doxorubicin-cisplatin).
OSAssessable patients (396)Overall survival; death hazard ratio adjusted for stage. The 60-month figures are the percentages predicted to be alive, adjusting for stageprimarymedian follow-up 74 monthsRandall 200655% at 5 y42% at 5 yHR 0.68 (95% CI 0.52–0.89)P<.01Stage-adjusted death hazard ratio favouring doxorubicin-cisplatin.
Deaths probably related to treatmentAssessable patients (396)Deaths to which treatment probably contributedprimaryRandall 20064%2%Five patients with whole-abdominal irradiation and eight with doxorubicin-cisplatin. The abstract also reports greater acute toxicity with doxorubicin-cisplatin.
Results reported for GOG-122
EndpointAnalysisDoxorubicin and cisplatinWhole-abdominal irradiationEffect
PFSAssessable patients (396)Progression-free survival; hazard ratio for progression adjusted for stage. The 60-month figures are the percentages predicted to be alive and disease free, adjusting for stageprimarymedian follow-up 74 monthsRandall 200650% at 5 y38% at 5 yHR 0.71 (95% CI 0.55–0.91)P<.01Hazard ratio for progression adjusted for stage, favouring doxorubicin-cisplatin. 396 of 422 patients entered were assessable (202 whole-abdominal irradiation, 194 doxorubicin-cisplatin).
OSAssessable patients (396)Overall survival; death hazard ratio adjusted for stage. The 60-month figures are the percentages predicted to be alive, adjusting for stageprimarymedian follow-up 74 monthsRandall 200655% at 5 y42% at 5 yHR 0.68 (95% CI 0.52–0.89)P<.01Stage-adjusted death hazard ratio favouring doxorubicin-cisplatin.
Deaths probably related to treatmentAssessable patients (396)Deaths to which treatment probably contributedprimaryRandall 20064%2%Five patients with whole-abdominal irradiation and eight with doxorubicin-cisplatin. The abstract also reports greater acute toxicity with doxorubicin-cisplatin.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.710.55–0.91
OS0.680.52–0.89
Primary publication: Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, et al. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006;24(1):36-44. PubMedDOI

Appears in

Sources

  1. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, et al. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006;24(1):36-44.

    PubMedDOI