Response Rate And Toxicity Of Primary Concomitant Radio-Chemotherapy In Locally Advanced Cervical Cancer: Results Of An Open Prospective, Multicenter Phase Ii Study Of The Noggo

5038 Background: To determine the response rate and toxicity of primary concomitant radio-chemotherapy (cRCH) consisting of ifosfamide and carboplatin plus external beam radiotherapy with curative intention in locally advanced primary inoperable stage IIB and IIIB squamous cell cervical cancer (CC). Methods: Patients (pts) with CC from 8 institutions were enrolled. Pts received three cycles of Ifosfamide 1,2 mg/m² (+ Mesna 20%) (d1-3) plus Carboplatin AUC 4 (d1), q21d, and concomitant external beam radiotherapy (50.4 Gy: 1.8 Gy/d). Operability and remission was evaluated by clinical gynecological examination in general anesthesia 4 weeks after 3rd cycle cRCH. If operability was achieved, a radical hysterectomy with pelvic lymphadenectomy was performed within 6 weeks after cRCH. If surgery was not done, because of incomplete remission or preferences, vaginal brachytherapy (BT) (15 Gy: 5 Gy/d) was given additionally. Results: Thirty-nine pts were enrolled from January 2003 through July 2008. Median age was 48 years (range, 30 -73). Distribution of FIGO tumor stage was: IIB: 17, IIIB: 23. Median follow-up was 22 months (range, 1-56). All pts completed cRCH. Grade 3/4 hematologic toxicities (in % of all cycles) were moderate: leucopenia 4.3%, thrombocytopenia 2.6% and anaemia 4.3%. In 8.5%, cycles were delayed because of haematological toxicity. Blood transfusions were given in 23.9%, G-CSF in 35.9%. Grade 3/4 non-hematologic toxicities were seldom (< 6%). Response rate was 89.7% (CR: 35.9%, PR: 53.8%, NC: 5.1%). Operability was achieved in 79.5%. Surgery was performed in 92.8%. Complete histological remission was achieved in 61.5%. Conclusions: cRH is a highly effective and tolerable regimen in CC. Partial remission rate and histological tumour residuals indicate the need for further studies.