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Journal of Clinical Oncology, Vol 15, 2403-2413, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

Improvements in survival and clinical benefit with gemcitabine as first- line therapy for patients with advanced pancreas cancer: a randomized trial

HA Burris 3rd, MJ Moore, J Andersen, MR Green, ML Rothenberg, MR Modiano, MC Cripps, RK Portenoy, AM Storniolo, P Tarassoff, R Nelson, FA Dorr, CD Stephens and DD Von Hoff
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA.

PURPOSE: Most patients with advanced pancreas cancer experience pain and must limit their daily activities because of tumor-related symptoms. To date, no treatment has had a significant impact on the disease. In early studies with gemcitabine, patients with pancreas cancer experienced an improvement in disease-related symptoms. Based on those findings, a definitive trial was performed to assess the effectiveness of gemcitabine in patients with newly diagnosed advanced pancreas cancer. PATIENTS AND METHODS: One hundred twenty-six patients with advanced symptomatic pancreas cancer completed a lead-in period to characterize and stabilize pain and were randomized to receive either gemcitabine 1,000 mg/m2 weekly x 7 followed by 1 week of rest, then weekly x 3 every 4 weeks thereafter (63 patients), or to fluorouracil (5-FU) 600 mg/m2 once weekly (63 patients). The primary efficacy measure was clinical benefit response, which was a composite of measurements of pain (analgesic consumption and pain intensity), Karnofsky performance status, and weight. Clinical benefit required a sustained (> or = 4 weeks) improvement in at least one parameter without worsening in any others. Other measures of efficacy included response rate, time to progressive disease, and survival. RESULTS: Clinical benefit response was experienced by 23.8% of gemcitabine- treated patients compared with 4.8% of 5-FU-treated patients (P = .0022). The median survival durations were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients, respectively (P = .0025). The survival rate at 12 months was 18% for gemcitabine patients and 2% for 5-FU patients. Treatment was well tolerated. CONCLUSION: This study demonstrates that gemcitabine is more effective than 5-FU in alleviation of some disease-related symptoms in patients with advanced, symptomatic pancreas cancer. Gemcitabine also confers a modest survival advantage over treatment with 5-FU.
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Past and Future of Pancreas Cancer: Are We Ready to Move Forward Together?
J. Clin. Oncol., July 20, 2008; 26(21): 3478 - 3480.
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G. R. Varadhachary, R. A. Wolff, C. H. Crane, C. C. Sun, J. E. Lee, P. W.T. Pisters, J.-N. Vauthey, E. Abdalla, H. Wang, G. A. Staerkel, et al.
Preoperative Gemcitabine and Cisplatin Followed by Gemcitabine-Based Chemoradiation for Resectable Adenocarcinoma of the Pancreatic Head
J. Clin. Oncol., July 20, 2008; 26(21): 3487 - 3495.
[Abstract] [Full Text] [PDF]

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 JCOHome page
D. B. Evans, G. R. Varadhachary, C. H. Crane, C. C. Sun, J. E. Lee, P. W.T. Pisters, J.-N. Vauthey, H. Wang, K. R. Cleary, G. A. Staerkel, et al.
Preoperative Gemcitabine-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreatic Head
J. Clin. Oncol., July 20, 2008; 26(21): 3496 - 3502.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
N. Dhillon, B. B. Aggarwal, R. A. Newman, R. A. Wolff, A. B. Kunnumakkara, J. L. Abbruzzese, C. S. Ng, V. Badmaev, and R. Kurzrock
Phase II Trial of Curcumin in Patients with Advanced Pancreatic Cancer
Clin. Cancer Res., July 15, 2008; 14(14): 4491 - 4499.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
Y. J. Chua and J. R. Zalcberg
Pancreatic cancer--is the wall crumbling?
Ann. Onc., July 1, 2008; 19(7): 1224 - 1230.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
R. R. McWilliams, W. R. Bamlet, J. M. Cunningham, E. L. Goode, M. de Andrade, L. A. Boardman, and G. M. Petersen
Polymorphisms in DNA Repair Genes, Smoking, and Pancreatic Adenocarcinoma Risk
Cancer Res., June 15, 2008; 68(12): 4928 - 4935.
[Abstract] [Full Text] [PDF]

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J. D. Fowler, J. A. Brown, K. A. Johnson, and Z. Suo
Kinetic Investigation of the Inhibitory Effect of Gemcitabine on DNA Polymerization Catalyzed by Human Mitochondrial DNA Polymerase
J. Biol. Chem., May 30, 2008; 283(22): 15339 - 15348.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. Heinrich, B. C. Pestalozzi, M. Schafer, A. Weber, P. Bauerfeind, A. Knuth, and P.-A. Clavien
Prospective Phase II Trial of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin for Resectable Adenocarcinoma of the Pancreatic Head
J. Clin. Oncol., May 20, 2008; 26(15): 2526 - 2531.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
J. Nieto, M. L. Grossbard, and P. Kozuch
Metastatic Pancreatic Cancer 2008: Is the Glass Less Empty?
Oncologist, May 1, 2008; 13(5): 562 - 576.
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 Jpn J Clin OncolHome page
K. Miyanishi, H. Ishiwatari, T. Hayashi, M. Takahashi, Y. Kawano, K. Takada, H. Ihara, T. Okuda, K. Takanashi, S. Takahashi, et al.
A Phase I Trial of Arterial Infusion Chemotherapy with Gemcitabine and 5-Fluorouracil for Unresectable Advanced Pancreatic Cancer after Vascular Supply Distribution via Superselective Embolization
Jpn. J. Clin. Oncol., April 1, 2008; 38(4): 268 - 274.
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 Clin. Cancer Res.Home page
T. Okazaki, L. Jiao, P. Chang, D. B. Evans, J. L. Abbruzzese, and D. Li
Single-Nucleotide Polymorphisms of DNA Damage Response Genes Are Associated with Overall Survival in Patients with Pancreatic Cancer
Clin. Cancer Res., April 1, 2008; 14(7): 2042 - 2048.
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 The OncologistHome page
A. F. Hezel and A. X. Zhu
Systemic Therapy for Biliary Tract Cancers
Oncologist, April 1, 2008; 13(4): 415 - 423.
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 JAMAHome page
W. F. Regine, K. A. Winter, R. A. Abrams, H. Safran, J. P. Hoffman, A. Konski, A. B. Benson, J. S. Macdonald, M. R. Kudrimoti, M. L. Fromm, et al.
Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial
JAMA, March 5, 2008; 299(9): 1019 - 1026.
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J. L. Abbruzzese
Adjuvant Therapy for Surgically Resected Pancreatic Adenocarcinoma
JAMA, March 5, 2008; 299(9): 1066 - 1067.
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 Jpn J Clin OncolHome page
A. Maeda, N. Boku, A. Fukutomi, S. Kondo, T. Kinoshita, M. Nagino, and K. Uesaka
Randomized Phase III Trial of Adjuvant Chemotherapy with Gemcitabine versus S-1 in Patients with Resected Pancreatic Cancer: Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC-01)
Jpn. J. Clin. Oncol., March 1, 2008; 38(3): 227 - 229.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
B. Laquente, C. Lacasa, M. M. Ginesta, O. Casanovas, A. Figueras, M. Galan, I. G. Ribas, J. R. Germa, G. Capella, and F. Vinals
Antiangiogenic effect of gemcitabine following metronomic administration in a pancreas cancer model
Mol. Cancer Ther., March 1, 2008; 7(3): 638 - 647.
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 Clin. Cancer Res.Home page
M. P. Kim and G. E. Gallick
Gemcitabine Resistance in Pancreatic Cancer: Picking the Key Players
Clin. Cancer Res., March 1, 2008; 14(5): 1284 - 1285.
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 Clin. Cancer Res.Home page
D. Laheru, E. Lutz, J. Burke, B. Biedrzycki, S. Solt, B. Onners, I. Tartakovsky, J. Nemunaitis, D. Le, E. Sugar, et al.
Allogeneic Granulocyte Macrophage Colony-Stimulating Factor-Secreting Tumor Immunotherapy Alone or in Sequence with Cyclophosphamide for Metastatic Pancreatic Cancer: A Pilot Study of Safety, Feasibility, and Immune Activation
Clin. Cancer Res., March 1, 2008; 14(5): 1455 - 1463.
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 The OncologistHome page
H. Burris III and C. Rocha-Lima
New Therapeutic Directions for Advanced Pancreatic Cancer: Targeting the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways
Oncologist, March 1, 2008; 13(3): 289 - 298.
[Abstract] [Full Text] [PDF]

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W. Small Jr, J. Berlin, G. M. Freedman, T. Lawrence, M. S. Talamonti, M. F. Mulcahy, A. B. Chakravarthy, A. A. Konski, M. M. Zalupski, P. A. Philip, et al.
Full-Dose Gemcitabine With Concurrent Radiation Therapy in Patients With Nonmetastatic Pancreatic Cancer: A Multicenter Phase II Trial
J. Clin. Oncol., February 20, 2008; 26(6): 942 - 947.
[Abstract] [Full Text] [PDF]

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 Journal of Pharmacy PracticeHome page
A. A. Garcia
Small Molecules: Big Changes in the Cancer Treatment Paradigm
Journal of Pharmacy Practice, February 1, 2008; 21(1): 17 - 35.
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 Ann OncolHome page
S. Boeck, T. Hoehler, G. Seipelt, R. Mahlberg, A. Wein, A. Hochhaus, H.-P. Boeck, B. Schmid, E. Kettner, M. Stauch, et al.
Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer
Ann. Onc., February 1, 2008; 19(2): 340 - 347.
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C. M. Booth and I. Tannock
Reflections on Medical Oncology: 25 Years of Clinical Trials Where Have We Come and Where Are We Going?
J. Clin. Oncol., January 1, 2008; 26(1): 6 - 8.
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 Ann OncolHome page
A. Duffy, J. Kortmansky, G. K. Schwartz, M. Capanu, S. Puleio, B. Minsky, L. Saltz, D. P. Kelsen, and E. M. O'Reilly
A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma
Ann. Onc., January 1, 2008; 19(1): 86 - 91.
[Abstract] [Full Text] [PDF]

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 GutHome page
S A Khan, A Miras, M Pelling, and S D Taylor-Robinson
Cholangiocarcinoma and its management
Gut, December 1, 2007; 56(12): 1755 - 1756.
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 Molecular Cancer TherapeuticsHome page
L. C. DeRosier, S. M. Vickers, K. R. Zinn, Z. Huang, W. Wang, W. E. Grizzle, J. Sellers, C. R. Stockard Jr., T. Zhou, P. G. Oliver, et al.
TRA-8 anti-DR5 monoclonal antibody and gemcitabine induce apoptosis and inhibit radiologically validated orthotopic pancreatic tumor growth
Mol. Cancer Ther., December 1, 2007; 6(12): 3198 - 3207.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
F. Joly, J. Vardy, M. Pintilie, and I. F. Tannock
Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer
Ann. Onc., December 1, 2007; 18(12): 1935 - 1942.
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 Clin. Cancer Res.Home page
R. Hassan, V. C. Broaddus, S. Wilson, D. J. Liewehr, and J. Zhang
Anti Mesothelin Immunotoxin SS1P in Combination with Gemcitabine Results in Increased Activity against Mesothelin-Expressing Tumor Xenografts
Clin. Cancer Res., December 1, 2007; 13(23): 7166 - 7171.
[Abstract] [Full Text] [PDF]


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