Alfonso Dueñas-GonzálezJuan J. ZarbáFiruza PatelJuan C. AlcedoSemir BeslijaLuis CasanovaPittayapoom PattaranutapornShahid HameedJulie M. BlairHelen BarracloughUniversidad Nacional Autonoma de MexicoMedical CenterEli Lilly InteramericaPostgraduate Institute of Medical Education and ResearchNational Institute of OncologyUniversity of SarajevoInstituto Nacional de Enfermedades NeoplsicasMahidol UniversityShaukat Khanum Memorial Cancer Hospital and Research CentreEli Lilly Australia Pty Ltd.2018-05-032018-05-032011-05-01Journal of Clinical Oncology. Vol.29, No.13 (2011), 1678-1685152777550732183X2-s2.0-79955582400https://repository.li.mahidol.ac.th/handle/123456789/11562Purpose: 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.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyMedicineArticleSCOPUS10.1200/JCO.2009.25.9663