Adjuvant Sequential Chemo-Radiation Therapy In High-Risk Endometrial Cancer: Results Of A Prospective, Multicenter Phase Ii Study Of The Noggo.

5109 Background: To determine the toxicity, tolerability and quality of life (QoL) of adjuvant CT with sequential RT in patients (pts) with high-risk endometrial cancer (hrec). Methods: Pts with hrec from 8 institutions were enrolled. All pts underwent abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic (100%) and paraaortic (77%) lymphadenectomy and surgical staging. Pts received four cycles of Paclitaxel 175 mg/m² (P) and Carboplatin AUC5 (C) (d1, q21d), subsequent external pelvic radiation therapy (45 Gy: 1.8 Gy/d) and vaginal brachytherapy (15 Gy: 3x 5 Gy). QoL was assessed using the EORTC-QLQ-C30 questionnaire. Primary endpoints: tolerability, toxicity and QoL. Secondary endpoint: progression-free survival (PFS). Results: Thirty-five pts were enrolled from December 2004 through May 2008. Median follow-up was 21 months (range, 3-24 months). Most of the pts (n=30) had an endometroid histology. Distribution of tumor stage (FIGO 2006) was: Ic:9, IIa:2, IIb:5, IIIa:3 and IIIc:16. All pts received 4 cycles of P and C. All pts completed RT. Grade 3/4 hematologic toxicities (in % of all cycles) were mild: leucopenia 6.6%, granulocytopenia 5.9%. Three cycles were delayed because of leucopenia. Darbepoetin alfa was given in 5.1%, G-CSF in 2.9%, blood transfusions in 2.9%. Grade 3/4 non-hematologic toxicities were seldom (< 3%). Only, alopecia occurred in 44.8%. No overall change in QoL occurred during treatment. Median Global Health Score was 50%. 2-year progression-free survival was 77.1%. Conclusions: Adjuvant combination CT with P+C and sequential RT is well tolerated and a feasible regimen in pts with hrec.