Patient preference for oral or intravenous chemotherapy: A randomised cross-over trial comparing capecitabine and Nordic fluorouracil/leucovorin in patients with colorectal cancer

Pfeiffer, Per; Mortensen, Jakob; Bjerregaard, Beth; Eckhoff, Lise; Schønnemann, Katrine Rahbek; Sandberg, Erik; Aabo, Kristian; Jakobsen, Anders

doi:10.1016/j.ejca.2006.06.027

Cited by 71 publications

(56 citation statements)

References 20 publications

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“…Some investigators have underlined the patient preference for an oral and/or home therapy, provided that it is equally eVective to an intravenous regimen (Liu et al 1997;Twelves et al 2006); others reported a grater preference for an i.v. regimen, which produced lower acute toxicity (PfeiVer et al 2006). Moreover, some studies have shown that capecitabine is associated with reduced costs compared with i.v.…”

Section: Discussionmentioning

confidence: 99%

Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

Comella

Massidda

Filippelli³

et al. 2008

J Cancer Res Clin Oncol

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Purpose Oxaliplatin combined with either Xuorouracil/ leucovorin (OXAFAFU) or capecitabine (OXXEL) has a demonstrated activity in metastatic colorectal cancer patients. We aimed at comparing these two regimens in terms of response rate (RR), safety, progression-free survival (PFS), and quality of life (QoL) of patients. Methods A total of 322 patients with metastatic colorectal cancer were randomized to receive biweekly: oxaliplatin 100 mg/m 2 i.v. on day 1, capecitabine 1,000 mg/m 2 orally twice daily from day 1 to day 11 (OXXEL); or oxaliplatin 85 mg/m 2 i.v. on day 1; 6S-leucovorin 250 mg/m 2 i.v. and Xuorouracil 850 mg/m 2 i.v. on day 2 (OXAFAFU). Results Eleven complete and 42 partial responses were registered with OXXEL (RR = 34%); six complete and 48 partial responses were obtained with OXAFAFU (RR = 33%) (P = 0.999). Severe adverse events were less frequent (32 vs. 43%) with OXXEL, which also reduced the occurrence of severe neutropenia (10 vs. 27%) and febrile neutropenia (6 vs. 13%), but produced more gastric side eVects (8 vs. 3%) and diarrhea (13 vs. 8%). QoL did not diVer across the two arms. Median PFS was 6.6 months in the OXXEL, and 6.5 months in the OXAFAFU arm (HR = 1.12, P = 0.354). Median overall survival was 16.0 and 17.1 months (HR = 1.01, P = 0.883). Conclusions OXXEL and OXAFAFU regimens were equally active in metastatic colorectal cancer. The choice should be based on patient preference and on pharmacoeconomic evaluations.

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Section: Discussionmentioning

confidence: 99%

Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

Comella

Massidda

Filippelli³

et al. 2008

J Cancer Res Clin Oncol

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“…therapy provided that efficacy is not compromised and that side-effects are not more frequent [41]. In three randomized phase II studies, two of which were cross over studies [40,42], patients expressed a preference for oral treatment with UFT over i.v.…”

Section: Oral Fluoropyrimidinesmentioning

confidence: 99%

The role of UFT in advanced gastric cancer

Aykan

Idelevich

2008

Annals of Oncology

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Background: Advanced gastric cancer has a poor prognosis, with a relative 5-year survival rate of 7%-27%.Chemotherapy, which improves overall survival (OS) and quality of life, is the main treatment option. Although numerous regimens have been investigated, there is no standard treatment. Combination chemotherapy, however, is associated with a significant survival benefit compared with monotherapy and i.v. 5-fluorouracil (5-FU) is one of the most widely used agents. UFT (tegafur-uracil) has similar efficacy to continuous infusion 5-FU with improved tolerability and is more convenient for patients. Design:The efficacy and safety of UFT in the treatment of advanced gastric cancer have been demonstrated in a number of phase II studies.Results: UFT with leucovorin (folinic acid) monotherapy shows overall response rates (ORRs) of 16%-29% and median OS of 5.8 months. Combination of UFT with cisplatin, etoposide, or paclitaxel shows ORRs of 35%-51% and median OS of 8.3-10.1 months. UFT-based three-drug combinations show ORRs of 41%-57% and median OS of 8.6-15 months. UFT-based combinations have a good tolerability profile, particularly a low incidence of myelosuppression, mucositis, and hand-foot syndrome.Conclusion: UFT represents a logical replacement for 5-FU in chemotherapy regimens for the treatment of advanced gastric cancer.

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“…5-FU regimens, with most patients citing the convenience of oral treatment as a reason for this preference Rocha Lima and del Giglio, 2005). However, patient preference is largely driven by tolerability, as shown by a recent study comparing capecitabine with the Nordic 5-FU/LV regimen (Pfeiffer et al, 2006). In that study, i.v.…”

Section: Discussionmentioning

confidence: 99%

Alternating irinotecan with oxaliplatin combined with UFT plus leucovorin (SCOUT) in metastatic colorectal cancer

et al. 2008

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Tegafur -uracil (UFT) plus leucovorin s (LV, folinic acid) with alternating irinotecan and oxaliplatin were effective and well tolerated in patients with metastatic colorectal cancer (mCRC) in a phase I study. This study expanded the maximum tolerated dose group. Patients aged X18 years had histologically confirmed, inoperable, previously untreated, measurable mCRC. Patients received irinotecan 180 mg m À2 on day 1, oxaliplatin 100 mg m À2 on day 15 and UFT 250 mg m À2 plus LV 90 mg on days 1 -21 every 28 days. The phase I/II study comprised 45 patients, 29 at the maximum tolerated dose (MTD). The response rate in 38 evaluable patients was 63% (95% confidence interval (CI): 49 -80). Median time to progression and overall survival were 8.7 months (95% CI: 7.9 -10.4) and 16.8 months (95% CI: 9.6 -25.3), respectively. In the MTD group, one patient had grade 3 leucopaenia; one had grade 3 neutropaenia; three had grade 3 diarrhoea; and one had grade 3 neurotoxicity. No hand -foot syndrome grade 41 was seen. In total, 67% of eligible patients received second-line therapy. UFT plus LV with alternating irinotecan and oxaliplatin is an efficacious first-line treatment for mCRC, with minimal neurotoxicity and hand -foot syndrome.

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Patient preference for oral or intravenous chemotherapy: A randomised cross-over trial comparing capecitabine and Nordic fluorouracil/leucovorin in patients with colorectal cancer

Cited by 71 publications

References 20 publications

Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

The role of UFT in advanced gastric cancer

Alternating irinotecan with oxaliplatin combined with UFT plus leucovorin (SCOUT) in metastatic colorectal cancer

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