Helmut Oettle1, Hanno Riess2, Jens M Stieler2, Gerhard Heil2, Ingo Schwaner2, Jörg Seraphin2, Martin Görner2, Matthias Mölle2, Tim F Greten2, Volker Lakner2, Sven Bischoff2, Marianne Sinn2, Bernd Dörken2, Uwe Pelzer2. 1. Helmut Oettle, Hanno Riess, Jens M. Stieler, Sven Bischoff, Marianne Sinn, Bernd Dörken, and Uwe Pelzer, Charitě Universitätsmedizin; Ingo Schwaner, Clinical Center, Berlin; Helmut Oettle, Clinical Center, Friedrichschafen; Gerhard Heil, Clinical Center, Lüdenscheid; Jörg Seraphin, Clinical Center, Northeim; Martin Görner, Clinical Center, Bielefeld; Matthias Mölle, Clinical Center, Dresden; Tim F. Greten, Hannover Medical School, Hannover; and Volker Lakner, Clinical Center, Rostock, Germany. helmut.oettle@charite.de. 2. Helmut Oettle, Hanno Riess, Jens M. Stieler, Sven Bischoff, Marianne Sinn, Bernd Dörken, and Uwe Pelzer, Charitě Universitätsmedizin; Ingo Schwaner, Clinical Center, Berlin; Helmut Oettle, Clinical Center, Friedrichschafen; Gerhard Heil, Clinical Center, Lüdenscheid; Jörg Seraphin, Clinical Center, Northeim; Martin Görner, Clinical Center, Bielefeld; Matthias Mölle, Clinical Center, Dresden; Tim F. Greten, Hannover Medical School, Hannover; and Volker Lakner, Clinical Center, Rostock, Germany.
Abstract
PURPOSE: To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy. PATIENTS AND METHODS: A randomized, open-label, phase III study was conducted in 16 institutions throughout Germany. Recruitment ran from January 2004 until May 2007, and the last follow-up concluded in December 2012. Overall, 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil (FF) or oxaliplatin and FF (OFF). Patients were stratified according to the presence of metastases, duration of first-line therapy, and Karnofsky performance status. RESULTS: Median follow-up was 54.1 months, and 160 patients were eligible for the primary analysis. The median overall survival in the OFF group (5.9 months; 95% CI, 4.1 to 7.4) versus the FF group (3.3 months; 95% CI, 2.7 to 4.0) was significantly improved (hazard ratio [HR], 0.66; 95% CI, 0.48 to 0.91; log-rank P = .010). Time to progression with OFF (2.9 months; 95% CI, 2.4 to 3.2) versus FF (2.0 months; 95% CI, 1.6 to 2.3) was significantly extended also (HR, 0.68; 95% CI, 0.50 to 0.94; log-rank P = .019). Rates of adverse events were similar between treatment arms, with the exception of grades 1 to 2 neurotoxicity, which were reported in 29 patients (38.2%) and six patients (7.1%) in the OFF and FF groups, respectively (P < .001). CONCLUSION: Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer.
RCT Entities:
PURPOSE: To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy. PATIENTS AND METHODS: A randomized, open-label, phase III study was conducted in 16 institutions throughout Germany. Recruitment ran from January 2004 until May 2007, and the last follow-up concluded in December 2012. Overall, 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil (FF) or oxaliplatin and FF (OFF). Patients were stratified according to the presence of metastases, duration of first-line therapy, and Karnofsky performance status. RESULTS: Median follow-up was 54.1 months, and 160 patients were eligible for the primary analysis. The median overall survival in the OFF group (5.9 months; 95% CI, 4.1 to 7.4) versus the FF group (3.3 months; 95% CI, 2.7 to 4.0) was significantly improved (hazard ratio [HR], 0.66; 95% CI, 0.48 to 0.91; log-rank P = .010). Time to progression with OFF (2.9 months; 95% CI, 2.4 to 3.2) versus FF (2.0 months; 95% CI, 1.6 to 2.3) was significantly extended also (HR, 0.68; 95% CI, 0.50 to 0.94; log-rank P = .019). Rates of adverse events were similar between treatment arms, with the exception of grades 1 to 2 neurotoxicity, which were reported in 29 patients (38.2%) and six patients (7.1%) in the OFF and FF groups, respectively (P < .001). CONCLUSION: Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer.
Authors: Davendra P S Sohal; Erin B Kennedy; Alok Khorana; Mehmet S Copur; Christopher H Crane; Ignacio Garrido-Laguna; Smitha Krishnamurthi; Cassadie Moravek; Eileen M O'Reilly; Philip A Philip; Ramesh K Ramanathan; Joseph T Ruggiero; Manish A Shah; Susan Urba; Hope E Uronis; Michelle W Lau; Daniel Laheru Journal: J Clin Oncol Date: 2018-05-23 Impact factor: 44.544
Authors: Davendra P S Sohal; Pamela B Mangu; Alok A Khorana; Manish A Shah; Philip A Philip; Eileen M O'Reilly; Hope E Uronis; Ramesh K Ramanathan; Christopher H Crane; Anitra Engebretson; Joseph T Ruggiero; Mehmet S Copur; Michelle Lau; Susan Urba; Daniel Laheru Journal: J Clin Oncol Date: 2016-05-31 Impact factor: 44.544
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Authors: Andrew H Ko; Tanios Bekaii-Saab; Jessica Van Ziffle; Olga M Mirzoeva; Nancy M Joseph; AmirAli Talasaz; Peter Kuhn; Margaret A Tempero; Eric A Collisson; R Kate Kelley; Alan P Venook; Elizabeth Dito; Anna Ong; Sharvina Ziyeh; Ryan Courtin; Regina Linetskaya; Sanaa Tahiri; W Michael Korn Journal: Clin Cancer Res Date: 2015-08-06 Impact factor: 12.531