Christhardt Köhler1, Alexander Mustea2, Simone Marnitz3, Achim Schneider4, Vito Chiantera5, Uwe Ulrich6, Jens-Peter Scharf7, Peter Martus8, Marcelo Andrade Vieira9, Audrey Tsunoda10. 1. Department of Advanced Operative and Oncologic Gynecology, Asklepios Hospital, Hamburg, Germany. 2. Department of Gynecology and Obstetrics, University Hospital, Greifswald, Germany. 3. Department of Radiology-Oncology, Charité-Universitätsmedizin, Berlin, Germany. 4. Institute for Cytology and Dysplasia, Fürstenberg-Carree, Berlin, Germany. 5. Department of Gynecologic Oncology, Universita Cattolica del Sacro Coure, Campobasso, Italy. 6. Department of Gynecology and Obstetrics, Martin-Luther-Krankenhaus, Berlin, Germany. 7. Department of Gynecology, Sana-Klinik, Berlin, Germany. 8. Institute for Clinical Epidemiology and Applied Biostatistics, Eberhard-Karls-Universität Tübingen, Tübingen, Germany. 9. Department of Gynecologic Oncology, Hospital de Cancer de Barretos, São Paulo, Brazil. 10. Department of Gynecologic Oncology, Hospital de Cancer de Barretos, São Paulo, Brazil. Electronic address: atsunoda@gmail.com.
Abstract
OBJECTIVE: The International Federation of Gynecology and Obstetrics (FIGO) staging for cervical cancer is based on clinical examination. Previous studies have demonstrated significant upstaging with surgical staging. However, no randomized trial has ever shown a survival benefit when radiation combined with chemoradiation (RCTX) is modified according to surgical staging. The objective of the study was to evaluate the feasibility and outcomes of surgical staging prior to radical RCTX treatment among patients with locally advanced cervical cancer in the setting of a larger, prospective, randomized study (the Uterus-11 study of the German Gynecologic Oncology Group). STUDY DESIGN:Between 2009 and 2013, 255 patients with advanced cervical cancer (FIGO IIB-IVA) were randomized to surgical staging and RCTX (arm A) or RCTX (arm B). RCTX in both arms included pelvic external beam radiotherapy with weekly cisplatin at 40 mg/m(2) and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases. RESULTS:One hundred thirty patients were randomized to surgical staging; 121 were eligible for this analysis. The mean patient age was 47.2 years, and the mean body mass index was 26.2 kg/m(2); the FIGO stages were IIB, IIIA, IIIB, and IVA in 85 (70.2%), 4 (3.3%), 29 (24%), and 3 (2.5%) patients, respectively. Arm A and arm B were similar with respect to Karnofsky performance status, histology, comorbidities, and lymphovascular space involvement. The surgical approach was transperitoneal laparoscopy in nearly all patients (93.4%), with no operative mortality. One patient (0.8%) had a conversion to laparotomy; 2 patients had more than 500 mL blood loss; the early postoperative complication rate was 7.3%. A mean of 19 pelvic and 17 paraaortic nodes were removed, with means of 2.4 and 1.3 positive nodes, respectively. RCTX began between 7 and 21 days after surgery. Operative staging led to upstaging in 40 of 121 (33%). CONCLUSION: Surgical staging in patients with locally advanced cervical cancer is safe and does not delay primary RCTX in a randomized study.
RCT Entities:
OBJECTIVE: The International Federation of Gynecology and Obstetrics (FIGO) staging for cervical cancer is based on clinical examination. Previous studies have demonstrated significant upstaging with surgical staging. However, no randomized trial has ever shown a survival benefit when radiation combined with chemoradiation (RCTX) is modified according to surgical staging. The objective of the study was to evaluate the feasibility and outcomes of surgical staging prior to radical RCTX treatment among patients with locally advanced cervical cancer in the setting of a larger, prospective, randomized study (the Uterus-11 study of the German Gynecologic Oncology Group). STUDY DESIGN: Between 2009 and 2013, 255 patients with advanced cervical cancer (FIGO IIB-IVA) were randomized to surgical staging and RCTX (arm A) or RCTX (arm B). RCTX in both arms included pelvic external beam radiotherapy with weekly cisplatin at 40 mg/m(2) and brachytherapy. Extended-field radiation was performed in cases of confirmed paraaortic metastases. RESULTS: One hundred thirty patients were randomized to surgical staging; 121 were eligible for this analysis. The mean patient age was 47.2 years, and the mean body mass index was 26.2 kg/m(2); the FIGO stages were IIB, IIIA, IIIB, and IVA in 85 (70.2%), 4 (3.3%), 29 (24%), and 3 (2.5%) patients, respectively. Arm A and arm B were similar with respect to Karnofsky performance status, histology, comorbidities, and lymphovascular space involvement. The surgical approach was transperitoneal laparoscopy in nearly all patients (93.4%), with no operative mortality. One patient (0.8%) had a conversion to laparotomy; 2 patients had more than 500 mL blood loss; the early postoperative complication rate was 7.3%. A mean of 19 pelvic and 17 paraaortic nodes were removed, with means of 2.4 and 1.3 positive nodes, respectively. RCTX began between 7 and 21 days after surgery. Operative staging led to upstaging in 40 of 121 (33%). CONCLUSION: Surgical staging in patients with locally advanced cervical cancer is safe and does not delay primary RCTX in a randomized study.
Authors: Lucas Gomes Sapienza; Maria José Leite Gomes; Vinicius Fernando Calsavara; Mario M Leitao; Glauco Baiocchi Journal: Gynecol Oncol Date: 2016-11-28 Impact factor: 5.482