FLOX regimen (5-FU, folinic acid, oxaliplatin) and FLIRI regimen (5-FU, folinic acid, irinotecan) as first-line treatment in metastatic and locally advanced gastric cancer: A randomized phase II study.
Nils GlenjenKatrin HammerlingIngunn HatlevollR SmålandPetra Weber HaugeGeir Egil EideHalfdan SørbyeOlav DahlGunilla Frykholm
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71 Background: The Norwegian Gastrointestinal Cancer Group (NGICG) conducted a phase II randomized study comparing the efficacy and safety of FLOX and FLIRI as first line treatment in metastatic or locally advanced gastric cancer. At progression or unacceptable drug related toxicity, a crossover to the other treatment arm should be done, if second line chemotherapy was indicated. Methods: 66 patients from 6 treatment centers in Norway were randomized to FLOX (oxaliplatin 85 mg/m 2 on day 1, bolus 5-FU 500 mg/m 2 and FA 60 mg/m 2 on day 1 and 2, or FLIRI (irinotecan 180 mg/m 2 on day 1, bolus 5-FU 500 mg/m 2 and FA 60 mg/m 2 on day 1 and 2). Both treatments were repeated every second week. The primary endpoint was response rate (RR) and time to progression (TTP). Secondary endpoints were overall survival (OS) and safety data. Results: At the present time data from 63 patients are available for analysis. First-line treatment: FLOX (n = 32) versus (v.) FLIRI (n = 31): Complete response (CR) n = 0 in both arms, partial response (PR) n = 16 v. 9, stable disease (SD) n = 12 v. 13, progressive disease (PD) n = 3 v. 6, not assessable for evaluation n = 1 v. 3 patients. RR was 50 % in the FLOX arm v. 29 % in the FLIRI arm, p = not significant (n.s), Pearson Chi-Square test. Median TTP was 5 months (95 % CI 2.2-7.8) v. 4 months (95 % CI 2.2-5.8), p = n.s, median OS was 11 months (95 % CI 9.2-12.8 ) v. 10 months (95 % CI 5.7-14.3), p = n.s, Log Rank test. Patient characteristics were well balanced. Febrile neutropenia was present among 10 % of the patients in the FLOX arm versus 7 % in the FLIRI arm. Second line treatment: 30 patients received second line treatment with FLOX or FLIRI. Data regarding RR, TTP, OS and safety will be updated in December 2011. Conclusions: The FLOX and FLIRI regimens are well tolerated among patients with locally advanced and metastatic gastric cancer. As first line treatment the FLOX regime had a higher RR of 50% v. 29% for the FLIRI regime, longer TTP; 5 v. 4 months and longer OS 11 v. 10 months, but the difference did not reach statistical significance.Keywords:
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Objectives To evaluate the efficacy and toxicity of home made oxaliplatin plus fluoriouracil, and folinic acid combination therapy in the treatment of colorectal carcinoma.Methods twenty-six cases received oxaliplatin 130mg/m 2,d1;folinic acid 200mg/m 2,d 1-d 5 and fluoriouracil 300mg/m 2,d 1-d 5.The regiment was repeated every 21 days.Results There were Dukes' A 1 case, Dukes'B 7 cases, and Dukes'C+D 18 cases; the overall response rate was 61.5%. The advanced' response rate was 44.4%. The major toxic reactions were nausea, vomiting and peripheral neurotioxixity.Conclusions Oxaliplatin plus fluoriouracil and folinic acid combination therapy is positively effective and cheap in colorectal carcinoma. The toxicity is mild to moderate and reversible.
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This study was designed to asses the inhibition of tumor growth by oxaliplatin combined with UFT and folinic acid (FA). Growth inhibition was studied in nude mice transplanted with human colorectal HT29 tumor cell xenografts and treated for 28 days with oral UFT (20 mg/kg/day) and FA (4 mg/kg/day), i.p. oxaliplatin (10 mg/kg on day 1) or a combination of oxaliplatin, UFT and FA, or else not treated (controls). Tumor surface area and weight were recorded twice a week, and mice were sacrificed at day 28. Two separate experiments were performed for each group of 25 mice. At day 28, mean tumor weights (g) were 2.89±0.22 (controls), 2.03±0.14 (oxaliplatin), 2.02±0.21 (UFT/FA) and 1.23±0.17 (oxaliplatin+UFT/FA). For the three treatment groups, tumor weight decreases were 30.1% (p<0.05), 29.9% (p<0.05) and 57.5% (p<0.001), respectively. Combined treatment (UFT/FA+oxaliplatin) reduced tumor weight by 39% compared to oxaliplatin alone (p<0.05) or UFT/FA (p<0.05). These results demonstrate the synergistic effect of the combination of oxaliplatin, UFT and FA in this HT29 cell xenograft model, and warrant further investigations in patients with metastatic colorectal cancer.
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Although several evidences have demonstrated a synergistic activity of 5-fluorouracil with irinotecan and oxaliplatin, thus explaining the use of this drug combination in the first-line treatment of advanced colorectal cancer, the need for the reintroduction of 5-FU in the second-line setting is more questionable.We retrospectively evaluated the outcome of patients developing progressive disease while on an infusional 5-FU-based front-line chemotherapy and subsequently treated with one of the four following chemotherapy regimens: irinotecan, oxaliplatin and irinotecan or oxaliplatin both combined with the de Gramont schedule (LV5-FU2).225 patients (137 males and 88 females), were eligible for analysis. Second-line chemotherapy consisted of irinotecan in 79 patients (35%, group A), oxaliplatin in 47 patients (21%, group B), irinotecan with LV5-FU2 in 53 patients (24%, group C) and oxaliplatin with LV5-FU2 in the remaining 46 cases (20%, group D). The response rate to second-line chemotherapy was obtained in 6/79 patients (8%) in group A, in 4/47 patients (9%) in group B, in 11/53 patients (21%) in group C and in 10/46 patients (22%) in group D (p = 0.04).These data suggest that reintroduction of 5-FU could increase irinotecan and oxaliplatin activity in patients progressing during a 5-FU-based first-line chemotherapy.
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Efficacy of three chemotherapy regimens was studied in 99 patients with metastatic colorectal cancer. Patients receiving oxaliplatin plus capecitabine combination demonstrated better immediate and follow-up results than those receiving oxaliplatin + fluorouracil + folinic acid or fluorouracil + folinic acid regimens. Overall response and 2-year survival rates were 45.5±8.6%and19.1%respectivelyinoxaliplatinpluscapecit-8.6% and 19.1% respectively in oxaliplatin plus capecitabine group versus 40.6±8.7and16.3%respectivelyinthefluorouracil+folinicacidgroup.Differencesin.7 and 16.3% respectively in the fluorouracil + folinic acid group. Differences in survival rates between groups with vs without oxaliplatin were statistically significant (p
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