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GOG 122

Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma

Date of Publication:

January 1, 2006

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/16330675/
Hypothesis:

Does whole abdominal irradiation improves PFS compared to cytotoxic chemotherapy for advanced endometrial carcinoma?

Control Arm(s):

Doxorubicin 60mg/m2

Cisplatin 50mg/m2

q3 weeks x 7 cycles

8th cycle Cisplatin only

Experimental Arm(s):

Whole abdominal irradiation (3000cGy followed by pelvic boost 1500cGy)

Primary End Point:

PFS

Inclusion Criteria:

Stage III and IV endometrial carcinoma of any histology

TAH/BSO, LN optional

Residual tumor ≤2cm

Exclusion Criteria:

Recurrent disease

Liver, lung, or hematogenous mets

Inguinal node involvement

Prior pelvic or abdominal radiation or prior chemotherapy

Results:

Whole Abdominal Radiation vs. Doxorubicin/Cisplatin:

median f/u: 74 mos

5yr PFS: 38% vs 50% (SS)

5yr OS: 42% vs 55% (SS)

Tumor recurrence: 54% vs 50%

Pelvic recurrence: 13% vs 18%

Abdominal recurrence: 16% vs 14%

Extra-abd/liver recurrence: 22% vs 18%

G3/4 Leukopenia: 4% vs 62%

G3/4 Neutropenia: <1 vs 85%

G3/4 Thrombocytopenia: 2% vs 21%

G3/4 GI toxicity: 13 vs 20%

Conclusions:

Chemotherapy significantly improves PFS compared to whole abdominal irradiation in patients with advanced endometrial carcinoma, although chemotherapy is associated with more frequent and more severe adverse treatment effects.

Reviewer:
Anna Kuan-Celarier, OTF