295 Capecitabine plus irinotecan (CAPIRI) vs capecitabine plus oxaliplatin (CAPOX) as first-line therapy of advanced colorectal cancer (ACRC): updated results of a randomized phase II trial

Grothey, Axel; Jordan, Kim; Kellner, O.; Constantin, Carolina; Dietrich, Georg; Kroening, Hendrik; Mantovani, Luisa; Schlichting, C.; Forstbauer, Helmut; Schmoll, H.-J.

doi:10.1016/s1359-6349(03)90328-4

Cited by 35 publications

(28 citation statements)

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“…The ORRs for capecitabine/irinotecan and capecitabine/oxaliplatin were 37 and 49.3%, and PFS 8.2 and 6.6 months, respectively (Grothey et al, 2003). A European phase II study of 43 patients evaluating capecitabine combined with oxaliplatin demonstrated an impressive ORR of 55% (95% CI 45 -65) and median time to disease progression (PFS) of 7.4 months; however, there was one treatment-related death and 11% grade 3/4 sensory neuropathy (Tabernero et al, 2002).…”

Section: Discussionmentioning

confidence: 96%

Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

Cunningham

Price³

et al. 2004

Br J Cancer

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This study was designed to assess the safety and efficacy of capecitabine and mitomycin C (MMC) in previously untreated patients with advanced colorectal cancer (CRC). Patients received capecitabine 2500 mg m 2 day 1, orally divided in two doses of 1250 mg m À2 in the morning and evening for 14 days every 21 days and MMC 7 mg m À2 (maximum total dose 14 mg) as an intravenous bolus every 6 weeks for a total of four courses. The median age was 70 years (range 24 -85) and the majority of patients (86.9%) were of performance status 1/2. The most common metastatic site was liver. In all, 84 patients were assessable for response. The overall response rate was 38% (95% CI: 27.7 -49.3) and a further 33.3% of patients achieved stable disease over 12 weeks. There was good symptom resolution ranging from 64 to 86%. Grade 3/4 toxicity was as follows: hand -foot syndrome 19.7%; diarrhoea 10%; neutropenia 2.4%; infection 2.3%. Capecitabine and MMC have shown encouraging activity with a favourable toxicity profile, a convenient administration schedule, and could be considered for patients deemed unsuitable for oxaliplatin and irinotecan combinations.

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Section: Discussionmentioning

confidence: 96%

Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

Cunningham

Price³

et al. 2004

Br J Cancer

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“…FOLFOX or XELOX) show that most doublets are equally effective with respect to RR, median TTP and median OS (e.g. Grothey et al, 2003;Tournigand et al, 2004;Cassidy et al, 2006;Kubicka et al, 2006), however, only in studies in which identical fluoropyrimidenes were used .…”

Section: First-line Combination Chemotherapymentioning

confidence: 99%

Current role of antibody therapy in patients with metastatic colorectal cancer

2007

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“…A similar combination, with oxaliplatin 120 mg/m 2 on day 1 and capecitabine 2,500 mg/ m 2 days 1-14, obtained a 44% response rate, and a median survival time of 20 months; however, occurrence of gradȩ 3 diarrhea was seen in 28% of patients (Zeuli et al 2003). Furthermore, a phase II randomized study assessed the addition of oxaliplatin 70 mg/m 2 (CAPOX) or irinotecan 80 mg/m 2 (CAPIRI) on days 1 and 8 to capecitabine 2,000 mg/m 2 given for 2 weeks, reporting a 50.7% response rate with the CAPOX regimen (Grothey et al 2003). In a Swiss phase II study, 26 pretreated and 43 chemonaive patients received oxaliplatin 130 mg/m 2 and capecitabine 2,500 mg/m 2 on day 1-14 every 3 weeks.…”

Section: Introductionmentioning

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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295 Capecitabine plus irinotecan (CAPIRI) vs capecitabine plus oxaliplatin (CAPOX) as first-line therapy of advanced colorectal cancer (ACRC): updated results of a randomized phase II trial

Cited by 35 publications

References 0 publications

Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

Current role of antibody therapy in patients with metastatic colorectal cancer

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

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