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GOG 184

A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study

Date of Publication:

January 1, 2009

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/19108877/
Hypothesis:

Does the addition of paclitaxel to doxorubicin/cisplatin improve survival in women with advanced stage endometrial cancer after optimal surgery and RT?

Control Arm(s):

TAH/BSO, +/- lymphadenectomy (≤2cm residual)EBRT 5040cGy +/- IVRTdoxorubicin 45mg/m2 day 1cisplatin 50mg/m2 day 1q21 days x6 cycles

Experimental Arm(s):

TAH/BSO, +/- lymphadenectomy (≤2cm residual)EBRT 5040cGy +/- IVRTdoxorubicin 45mg/m2 day 1cisplatin 50mg/m2 day 1paclitaxel 160mg/m2 over 3hrs day 2q21 days x6 cycles

Primary End Point:

PFS

Inclusion Criteria:

stage III endometrial cancer, pelvis limited disease - adnexa, uterine serosa, +LN, +washings, or vaginaany histology

Exclusion Criteria:

residual disease >2cm

Results:

doxo/cis (n=270) vs doxo/cis/paclitaxel (n=282):18% serous or clear cell histology~80% received all 6 cycles in both armstoxicity more frequent and severe in experimental arm (hematologic, neuropathy)3yr PFS: 62% vs 64% (NS)

Conclusions:

Addition of paclitaxel to doxorubicin/cisplatin did not improve PFS in women with advanced stage endometrial cancer treated with optimal surgery and RT

Reviewer:
Olga T Filippova