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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

Open access
Dueñas-González, Alfonso, Zarbá, Juan J., Patel, Firuza, Alcedo, Juan C., Beslija, Semir, Casanova, Luis, Pattaranutaporn, Pittayapoom, Hameed, Shahid, Blair, Julie M., Barraclough, Helen, Orlando, Mauro·2011·Journal of Clinical Oncology

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.

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Metadata

Authors
Dueñas-González, A., Zarbá, J. J., Patel, F., Alcedo, J. C., Beslija, S., Casanova, L., Pattaranutaporn, P., Hameed, S., Blair, J. M., Barraclough, H., & Orlando, M.
Venue
Journal of Clinical Oncology
Published
2011-05-01
Volume
29
Issue
13
Pages
1678-1685
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2104360894
Cited by
484
References
19
FWCI
45.22
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1200/jco.2009.25.9663
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Dueñas-González, A., Zarbá, J. J., Patel, F., Alcedo, J. C., Beslija, S., Casanova, L., Pattaranutaporn, P., Hameed, S., Blair, J. M., Barraclough, H., & Orlando, M. (2011). 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. https://doi.org/10.1200/jco.2009.25.9663

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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