BACKGROUND:Single-agent gemcitabine (GEM) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer. However, recently, several studies reported encouraging activity and good tolerability for some combination regimens. Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM, oxaliplatin (L-OHP), and capecitabine (CAP), this randomized phase II study compared the activity and safety of the combination GEM, L-OHP, and CAP (GEMOXEL) versus GEM alone, in patients with metastatic pancreatic cancer. MATERIALS AND METHODS: The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m(2) as a 30-min intravenous infusion on days 1, 8, 15, 22, L-OHP 100 mg/m(2) i.v. on day 2, and CAP 1,500 mg/m(2)/day in two divided doses on days 1-14, every 21 days (one cycle). In both treatment groups, GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks, and thereafter, GEM was continued on days 1, 8, 15, every 28 days. Chemotherapy was administered until disease progression or unacceptable toxicity. RESULTS:Sixty-seven patients were enrolled in the study. Thirty-four were randomly assigned to GEMOXEL and 33 to GEM. At 4 months, disease control rate was 79.4% with GEMOXEL versus 45.4 % with GEM (p = 0.004). The median progression-free survival was 6.8 months (95% CI 5.3-7.3 months) in GEMOXEL arm and 3.7 months (95% CI 2.9-4.7 months) in GEM arm (p < 0.001). The median OS was 11.9 months (95% CI 10.6-12.9 months) in GEMOXEL arm and 7.1 months (95% CI 5.5-9.1 months) in GEM arm (p < 0.001). Hematologic and non-hematologic toxicity was more severe with combination chemotherapy, yet still tolerable. No grade 4 adverse events were observed with either regimen. CONCLUSION: GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer.
RCT Entities:
BACKGROUND: Single-agent gemcitabine (GEM) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer. However, recently, several studies reported encouraging activity and good tolerability for some combination regimens. Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM, oxaliplatin (L-OHP), and capecitabine (CAP), this randomized phase II study compared the activity and safety of the combination GEM, L-OHP, and CAP (GEMOXEL) versus GEM alone, in patients with metastatic pancreatic cancer. MATERIALS AND METHODS: The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m(2) as a 30-min intravenous infusion on days 1, 8, 15, 22, L-OHP 100 mg/m(2) i.v. on day 2, and CAP 1,500 mg/m(2)/day in two divided doses on days 1-14, every 21 days (one cycle). In both treatment groups, GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks, and thereafter, GEM was continued on days 1, 8, 15, every 28 days. Chemotherapy was administered until disease progression or unacceptable toxicity. RESULTS: Sixty-seven patients were enrolled in the study. Thirty-four were randomly assigned to GEMOXEL and 33 to GEM. At 4 months, disease control rate was 79.4% with GEMOXEL versus 45.4 % with GEM (p = 0.004). The median progression-free survival was 6.8 months (95% CI 5.3-7.3 months) in GEMOXEL arm and 3.7 months (95% CI 2.9-4.7 months) in GEM arm (p < 0.001). The median OS was 11.9 months (95% CI 10.6-12.9 months) in GEMOXEL arm and 7.1 months (95% CI 5.5-9.1 months) in GEM arm (p < 0.001). Hematologic and non-hematologic toxicity was more severe with combination chemotherapy, yet still tolerable. No grade 4 adverse events were observed with either regimen. CONCLUSION:GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer.
Authors: Werner Scheithauer; Gabriela Kornek; Gerald Prager; Nadja Stranzl; Friedrich Laengle; Martin Schindl; Josef Friedl; Julia Klech; Sabine Roethlin; Christoph Zielinski Journal: J Gastrointest Oncol Date: 2016-04
Authors: Karen Legler; Charlotte Hauser; Jan-Hendrik Egberts; Anna Willms; Carola Heneweer; Susann Boretius; Christoph Röcken; Claus-Christian Glüer; Thomas Becker; Michael Kluge; Oliver Hill; Christian Gieffers; Harald Fricke; Holger Kalthoff; Johannes Lemke; Anna Trauzold Journal: Cell Death Dis Date: 2018-05-01 Impact factor: 8.469
Authors: Pablo Sala Elarre; Esther Oyaga-Iriarte; Kenneth H Yu; Vicky Baudin; Leire Arbea Moreno; Omar Carranza; Ana Chopitea Ortega; Mariano Ponz-Sarvise; Luis D Mejías Sosa; Fernando Rotellar Sastre; Blanca Larrea Leoz; Yohana Iragorri Barberena; Jose C Subtil Iñigo; Alberto Benito Boíllos; Fernando Pardo; Javier Rodríguez Rodríguez Journal: Cancers (Basel) Date: 2019-04-30 Impact factor: 6.639