A randomized, double-blind, placebo (P) controlled, multicenter phase III trial to evaluate the efficacy and safety of adding bevacizumab (B) to erlotinib (E) and gemcitabine (G) in patients (pts) with metastatic pancreatic cancer

Vervenne, Walter L.; Bennouna, Jaafar; Humblet, Yves; Gill, Stan; Moore, Malcolm J.; Laethem, J. Van; Shang, Aijing; Cosaert, Jan; Verslype, Chris; Cutsem, Éric Van

doi:10.1200/jco.2008.26.15_suppl.4507

Cited by 40 publications

(15 citation statements)

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“…Differences in the distribution of prognostic factors purportedly accounted for differences in treatment efficacy between this trial and the phase II trial that supported investigation of bevacizumab in a randomized study (17). In contrast, preliminary data from a subsequent phase III trial of gemcitabine and erlotinib, with or without bevacizumab, in patients with metastatic pancreatic cancer, showed a significant improvement in PFS (4.1 vs. 3.6 months; hazard ratio [HR] = 0.73; p = 0.0002) but not in OS (7.1 vs. 6.0 months; HR = 0.89; p = 0.2087) in the bevacizumab-containing arm (13).…”

Section: Discussionmentioning

confidence: 94%

“…Use of the antivascular endothelial growth factor (VEGF) antibody bevacizumab in combination with chemotherapeutic agents has improved clinical outcomes in advanced or metastatic colorectal (9,10), lung (11), and breast cancers (12) and has recently demonstrated a significant improvement in progression-free survival (PFS) when used in combination with gemcitabine and erlotinib in a phase III trial of patients with metastatic pancreatic cancer (13).…”

Section: Introductionmentioning

confidence: 99%

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Phase II Trial of Full-Dose Gemcitabine and Bevacizumab in Combination With Attenuated Three-Dimensional Conformal Radiotherapy in Patients With Localized Pancreatic Cancer

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Mulcahy

Rademaker

et al. 2011

International Journal of Radiation Oncology*Biology*Physics

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Phase II Trial of Full-Dose Gemcitabine and Bevacizumab in Combination With Attenuated Three-Dimensional Conformal Radiotherapy in Patients With Localized Pancreatic Cancer

Small

Mulcahy

Rademaker

et al. 2011

International Journal of Radiation Oncology*Biology*Physics

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“…This trial also failed in its attempt to show an increase in OS. -In the AViTA study [86], the randomisation was not really between gemcitabine vs. a pair of drugs including gemcitabine, but rather between a pair with gemcitabine (gemcitabine-erlotinib-placebo) vs. a trio of drugs including gemcitabine (gemcitabineerlotinib-bevacizumab). This study included 607 patients and a statistically significant increase was found in terms of the progression-free survival (PFS) in the arm with bevacizumab (median DFS of 3.6 months in the placebo arm vs. 4.6 months in the bevacizumab arm, HR=0.73; 95% CI: 0.61 0.86; p=0.0002).…”

Section: Locally Advanced and Metastatic Diseasementioning

confidence: 99%

Consensus on the treatment of pancreatic cancer in Spain

et al. 2009

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Pancreatic cancer (PC) represents one of the greatest oncological challenges of our century, due to its high mortality and incidence. A group of Spanish experts in PC treatment reviewed data available on different therapeutic combinations and established consensus on what would be the best strategy in PC management, depending on the stage of the disease. Surgery with complete resection may produce 5-year survival rates of 18-24%, but definitive control is still precarious. In the absence of consensus, the best evidence suggests that adjuvant chemotherapy with gemcitabine for 6 months using the CONKO-001 regime is the treatment of choice after resection of PC for patients with acceptable functional status. This group recommends chemoradiotherapy (CT-RT) in patients with factors for poor loco-regional prognosis. However, chemotherapy is an option for the treatment of locally advanced PC in patients with good general status and in the absence of metastatic disease the recommended treatment is CT-RT followed by gemcitabine-based chemotherapy. A period of chemotherapy followed by consolidation CT-RT may be appropriate, as it allows selection of patients with locally advanced disease who may benefit most from combined treatment. Erlotinib combined with gemcitabine shows significant survival improvement in PC and must be considered an option in the first-line treatment of advanced and metastatic PC. The gemcitabine-erlotinib combination is proposed as the standard treatment for metastatic PC in patients with PS=/>2. In patients with PS<2, gemcitabine-erlotinib is recommended as the first-line treatment option, supported by a maximum degree of evidence, without ruling out other options, such as gemcitabine-oxaliplatin, gemcitabine-capecitabine or gemcitabine alone.

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“…In einer weiteren Phase-III-Studie wurde 607 Patienten Gemcitabin und Erlotinib mit und ohne zusätzliche Gabe von Bevacizumab verabreicht. Ein signifikanter Überlebensvorteil für die Dreierkombination aus Gemcitabin, Erlotinib und Bevacizumab konnte nicht nachgewiesen werden, wenngleich das krankheitsfreie Überleben statistisch signifikant verbessert wurde (3,6 vs. 4,6 Monate, p=0,0002) [44].…”

Section: Zielgerichtete Therapie Gegen Vegfunclassified