A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer

Oettle, Helmut; Richards, Donald A.; Ramanathan, R. K.; Laethem, Jean Luc Van; Peeters, Marc; Fuchs, Martin; Zimmermann, Annamaria H.; John, William J.; Hoff, D. Von; Arning, M.; Kindler, Hedy L.

doi:10.1093/annonc/mdi309

Cited by 287 publications

(118 citation statements)

References 24 publications

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“…Table 3 summarizes 13 randomized phase III trials that attempted to improve upon the survival outcomes achieved with gemcitabine alone, typically by adding a second cytotoxic agent [20,[31][32][33][34][35][36][37][38][39][40][41][42]. With the exception of the gemcitabine plus capecitabine experimental arm reported by Cunningham et al [35] in abstract form only as of this review, these efforts have failed to identify a gemcitabine-based chemotherapy doublet that has produced significantly better median or 1-year survival outcomes.…”

Section: Phase III Combination Chemotherapy Trialsmentioning

confidence: 99%

Metastatic Pancreatic Cancer 2008: Is the Glass Less Empty?

2008

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Pancreatic cancer is the fourth most common cause of adult cancer death in the U.S. The high mortality rate from pancreatic cancer is a result of the high incidence of metastatic disease at the time of diagnosis, an often fulminant clinical course, and the lack of adequate systemic therapies. Unfortunately, only 5%-25% of patients present with tumors amenable to resection. The median diseasefree survival interval following resection for operable pancreatic cancer is 13.4 months for patients treated with adjuvant gemcitabine and 6.9 months for untreated patients. A much higher percentage of patients present with metastatic disease (40%-45%) or locally advanced disease (40%), and have median survival times of 3-6 months or 8 -12 months, respectively. The frustrating lack of significant clinical advancements in the treatment of metastatic pancreatic cancer remains one of medical oncology's biggest disappointments. The past decade-long frustration has resulted in regulators, investigators, and practicing oncologists gradually lowering their standards/expectations with regard to interpreting clinical trials. Two of the more important examples of this include the approval of gemcitabine plus erlotinib and the use of a progressionfree survival advantage to defend the use of gemcitabine plus oxaliplatin. Given the marginal benefit of systemic antineoplastics, a scholarly review inclusive of other palliative strategies will help oncologists optimize the care of pancreatic cancer patients. This article examines the existing evidence in support of a role for palliative therapy in metastatic pancreatic cancer, describes recent developments with newer chemotherapeutic and molecular-targeted agents, and explores future study designs. The Oncologist 2008;13:562-576

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Section: Phase III Combination Chemotherapy Trialsmentioning

confidence: 99%

Metastatic Pancreatic Cancer 2008: Is the Glass Less Empty?

2008

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“…Trials were undertaken with gemcitabine plus either 5-FU, cisplatin, irinotecan, oxaliplatin, pemetrexed, or exatecan [11][12][13][14][15][16][17]. Disappointingly, while tumor response and time to cancer progression were greater with some of these regimens, no clear survival benefit has been reported.…”

Section: Gemcitabine Combinations For Advanced Diseasementioning

confidence: 99%

New Therapeutic Directions for Advanced Pancreatic Cancer: Targeting the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways

Burris

Rocha-Lima

2008

The Oncologist

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After completing this course, the reader will be able to:1. Evaluate the existing chemotherapeutic options for advanced pancreatic cancer.2. Interpret data from trials of HER-1/EGFR-and VEGFR-targeted agents in advanced pancreatic cancer.3. Take advantage of the potential of biomarkers in selecting optimal molecular-targeted therapies for advanced pancreatic cancer.Access and take the CME test online and receive 1 AMA PRA Category 1 Credit ™ at CME.TheOncologist.com CME CME ABSTRACT

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“…Gemcitabine, a nucleoside analog that inhibits DNA synthesis by blocking DNA polymerase and the M1 binding site of ribonucleotide reductase (RR), is standard of care for advanced pancreatic cancer [2]. Phase III trials of 5-FU, CPT-11, cisplatin, or oxaliplatin with gemcitabine did not improve overall survival (OS) compared to single-agent gemcitabine [3][4][5][6][7]. Although OS improved when combining gemcitabine with erlotinib (6.24 vs. 5.91 months) [8], this gain was minimal and underscores the need for novel treatments for pancreatic cancer.…”

Section: Introductionmentioning

confidence: 99%

A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas

et al. 2008

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A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer

Abstract: Pemetrexed plus gemcitabine therapy did not improve OS. Single-agent gemcitabine remains the standard of care for advanced pancreatic cancer.

Cited by 287 publications

References 24 publications

Metastatic Pancreatic Cancer 2008: Is the Glass Less Empty?

Metastatic Pancreatic Cancer 2008: Is the Glass Less Empty?

New Therapeutic Directions for Advanced Pancreatic Cancer: Targeting the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways

A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas

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