Publication: 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
Issued Date
2011-05-01
Resource Type
ISSN
15277755
0732183X
0732183X
Other identifier(s)
2-s2.0-79955582400
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Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Clinical Oncology. Vol.29, No.13 (2011), 1678-1685
Suggested Citation
Alfonso Dueñas-González, Juan J. Zarbá, Firuza Patel, Juan C. Alcedo, Semir Beslija, Luis Casanova, Pittayapoom Pattaranutaporn, Shahid Hameed, Julie M. Blair, Helen Barraclough 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. Journal of Clinical Oncology. Vol.29, No.13 (2011), 1678-1685. doi:10.1200/JCO.2009.25.9663 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/11562
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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
Other Contributor(s)
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.
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.
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.