BACKGROUND: The present study evaluated the efficacy and safety of oxaliplatin, UFT, and leucovorin in metastatic gastric cancer. METHODS: Patients received intravenous oxaliplatin 130 mg/m(2) on day 1, followed by oral UFT capsules (350 mg/m(2) per day) and leucovorin tablets (90 mg/day), every 8 h, for 14 days, in a 3-week cycle. RESULTS: Twenty-three patients (61% with > or = 2 metastatic sites), median age of 60 years (range, 39-69 years) were entered. Based on intention-to-treat analysis, one complete response and seven partial responses were found, resulting in an overall response rate (RR) of 35% (95% confidence interval [CI], 16-54), a median time to progression of 4 months (95% CI, 0.5-7.5), and a median overall survival (OS) of 8 months (95% CI, 4.5-11.5). The 1-year survival rate was 26%. Three patients did not complete the first course of 2 weeks; 1 died suddenly on day 16 with fatal lung embolism; 1 had rapid progressive disease and 1 experienced gastric hemorrhage on day 15 - both these patients withdrew. In the 20 patients assessable for toxicity no grade 4 toxicity occurred, grade 3 toxicity consisted of anemia in 1, diarrhea in 2, and neurotoxicity in 3 patients. No hand-foot syndrome (HFS) occurred. CONCLUSION: Oxaliplatin is an effective drug in gastric cancer, but, as previously reported, its feasibility in combination with capecitabine is hampered due to combined hand-foot-based toxicity. The present phase II study of a combination of oxaliplatin with UFT and leucovorin appears to have efficacy and tolerability comparable to two other drug regimens used in gastric cancer, without the HFS problem.
BACKGROUND: The present study evaluated the efficacy and safety of oxaliplatin, UFT, and leucovorin in metastatic gastric cancer. METHODS:Patients received intravenous oxaliplatin 130 mg/m(2) on day 1, followed by oral UFT capsules (350 mg/m(2) per day) and leucovorin tablets (90 mg/day), every 8 h, for 14 days, in a 3-week cycle. RESULTS: Twenty-three patients (61% with > or = 2 metastatic sites), median age of 60 years (range, 39-69 years) were entered. Based on intention-to-treat analysis, one complete response and seven partial responses were found, resulting in an overall response rate (RR) of 35% (95% confidence interval [CI], 16-54), a median time to progression of 4 months (95% CI, 0.5-7.5), and a median overall survival (OS) of 8 months (95% CI, 4.5-11.5). The 1-year survival rate was 26%. Three patients did not complete the first course of 2 weeks; 1 died suddenly on day 16 with fatal lung embolism; 1 had rapid progressive disease and 1 experienced gastric hemorrhage on day 15 - both these patients withdrew. In the 20 patients assessable for toxicity no grade 4 toxicity occurred, grade 3 toxicity consisted of anemia in 1, diarrhea in 2, and neurotoxicity in 3 patients. No hand-foot syndrome (HFS) occurred. CONCLUSION:Oxaliplatin is an effective drug in gastric cancer, but, as previously reported, its feasibility in combination with capecitabine is hampered due to combined hand-foot-based toxicity. The present phase II study of a combination of oxaliplatin with UFT and leucovorin appears to have efficacy and tolerability comparable to two other drug regimens used in gastric cancer, without the HFS problem.
Authors: Barry C Lembersky; H Samuel Wieand; Nicholas J Petrelli; Michael J O'Connell; Linda H Colangelo; Roy E Smith; Thomas E Seay; Jeffrey K Giguere; M Ernest Marshall; Andrew D Jacobs; Lauren K Colman; Atilla Soran; Greg Yothers; Norman Wolmark Journal: J Clin Oncol Date: 2006-05-01 Impact factor: 44.544
Authors: Anna D Wagner; Wilfried Grothe; Johannes Haerting; Gerhard Kleber; Axel Grothey; Wolfgang E Fleig Journal: J Clin Oncol Date: 2006-06-20 Impact factor: 44.544
Authors: Jacek A Kopec; Greg Yothers; Patricia A Ganz; Stephanie R Land; Reena S Cecchini; H Samuel Wieand; Barry C Lembersky; Norman Wolmark Journal: J Clin Oncol Date: 2007-02-01 Impact factor: 44.544
Authors: R Pazdur; Y Lassere; V Rhodes; J A Ajani; S M Sugarman; Y Z Patt; D V Jones; A B Markowitz; J L Abbruzzese; B Bready Journal: J Clin Oncol Date: 1994-11 Impact factor: 44.544
Authors: David Cunningham; Naureen Starling; Sheela Rao; Timothy Iveson; Marianne Nicolson; Fareeda Coxon; Gary Middleton; Francis Daniel; Jacqueline Oates; Andrew Richard Norman Journal: N Engl J Med Date: 2008-01-03 Impact factor: 91.245
Authors: Y Chao; C P Li; T Y Chao; W C Su; R K Hsieh; M F Wu; K H Yeh; W Y Kao; L T Chen; A L Cheng Journal: Br J Cancer Date: 2006-06-27 Impact factor: 7.640