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Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial

Randomized Controlled Trial

Affiliations

• ¹ Indiana University Melvin and Bren Simon Cancer Center, 980 West Walnut St, Suite C528, Indianapolis, IN 46202, USA. ploehrer@iupui.edu

• PMID: 21969502
• PMCID: PMC3525836
• DOI: 10.1200/JCO.2011.34.8904

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Randomized Controlled Trial

Patrick J Loehrer Sr et al. J Clin Oncol. 2011.

• ¹ Indiana University Melvin and Bren Simon Cancer Center, 980 West Walnut St, Suite C528, Indianapolis, IN 46202, USA. ploehrer@iupui.edu

• PMID: 21969502
• PMCID: PMC3525836
• DOI: 10.1200/JCO.2011.34.8904

Item in Clipboard

Purpose: The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer.

Patients and methods: Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m(2)/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed.

Results: Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test).

Conclusion: This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

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Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Progression-free survival. GEM, gemcitabine; RT,…

Progression-free survival. GEM, gemcitabine; RT, radiation therapy.

Progression-free survival. GEM, gemcitabine; RT, radiation therapy.

Overall survival. GEM, gemcitabine; RT,…

Overall survival. GEM, gemcitabine; RT, radiation therapy.

Overall survival. GEM, gemcitabine; RT, radiation therapy.

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