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Title: Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix
Authors: Alfonso Dueñas-González
Juan J. Zarbá
Firuza Patel
Juan C. Alcedo
Semir Beslija
Luis Casanova
Pittayapoom Pattaranutaporn
Shahid Hameed
Julie M. Blair
Helen Barraclough
Universidad Nacional Autonoma de Mexico
Medical Center
Eli Lilly Interamerica
Postgraduate Institute of Medical Education and Research
National Institute of Oncology
University of Sarajevo
Instituto Nacional de Enfermedades Neoplsicas
Mahidol University
Shaukat Khanum Memorial Cancer Hospital and Research Centre
Eli Lilly Australia Pty Ltd.
Keywords: Biochemistry, Genetics and Molecular Biology;Medicine
Issue Date: 1-May-2011
Citation: Journal of Clinical Oncology. Vol.29, No.13 (2011), 1678-1685
Abstract: Purpose: To determine whether addition of gemcitabine to concurrent cisplatin chemoradiotherapy and as adjuvant chemotherapy with cisplatin improves progression-free survival (PFS) at 3 years compared with current standard of care in locally advanced cervical cancer. Patients and Methods: Eligible chemotherapy- and radiotherapy-naive patients with stage IIB to IVA disease and Karnofsky performance score ≥ 70 were randomly assigned to arm A (cisplatin 40 mg/m 2 and gemcitabine 125 mg/m 2 weekly for 6 weeks with concurrent external-beam radiotherapy [XRT] 50.4 Gy in 28 fractions, followed by brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two adjuvant 21-day cycles of cisplatin, 50 mg/m 2 on day 1, plus gemcitabine, 1,000 mg/m 2 on days 1 and 8) or to arm B (cisplatin and concurrent XRT followed by BCT only; dosing same as for arm A). Results: Between May 2002 and March 2004, 515 patients were enrolled (arm A, n = 259; arm B, n = 256). PFS at 3 years was significantly improved in arm A versus arm B (74.4% v 65.0%, respectively; P = .029), as were overall PFS (log-rank P = .0227; hazard ratio [HR], 0.68; 95% CI, 0.49 to 0.95), overall survival (log-rank P = .0224; HR, 0.68; 95% CI, 0.49 to 0.95), and time to progressive disease (log-rank P = .0012; HR, 0.54; 95% CI, 0.37 to 0.79). Grade 3 and 4 toxicities were more frequent in arm A than in arm B (86.5% v 46.3%, respectively; P < .001), including two deaths possibly related to treatment toxicity in arm A. Conclusion: Gemcitabine plus cisplatin chemoradiotherapy followed by BCT and adjuvant gemcitabine/cisplatin chemotherapy improved survival outcomes with increased but clinically manageable toxicity when compared with standard treatment. © 2011 by American Society of Clinical Oncology.
ISSN: 15277755
Appears in Collections:Scopus 2011-2015

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