Capecitabine plus oxaliplatin (xelox) versus protracted 5-fluorouracil venous infusion plus oxaliplatin (pvifox) as first-line treatment in advanced colorectal cancer: A GOAM phase II randomised study (FOCA trial)

Martoni, Andrea; Pinto, Carmine; Fabio, Francesca Di; Lelli, G.; Llimpe, F. L. Rojas; Gentile, Anna Lisa; Mutri, V.; Ballardini, Pierluigi; Giaquinta, S.; Piana, E

doi:10.1016/j.ejca.2006.08.034

Cited by 40 publications

(33 citation statements)

References 38 publications

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“…The activity was similar (response rate, 43.5 vs. 48.2%; median progression-free survival, 9 vs. 7 months). However, the XELOX regimen caused less severe diarrhea (8 vs. 13%), and stomatitis (13 vs. 29%) (Martoni et al 2006).…”

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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“…Two of the ten trials Kohne et al 2008) included other treatment arms, in addition to the two arms considered for the meta-analysis. In combination settings, capecitabine dose was 1,000 mg/m 2 .bid d 1-11 in one trial (Comella et al 2009), 1,000 mg/m 2 .bid d 1-14 in six trials Diaz-Rubio et al 2007;Kohne et al 2008;Martoni et al 2006;Porschen et al 2007;Rothenberg et al 2008), and 1,000 mg/m 2 .bid d 2-15 in one trial (Skof et al 2009). …”

Section: Selection Of the Trialsmentioning

confidence: 98%

“…1), ten eligible trials Comella et al 2009;Diaz-Rubio et al 2007;Hoff et al 2001;Kohne et al 2008;Martoni et al 2006;Porschen et al 2007;Rothenberg et al 2008;Skof et al 2009;Van Cutsem et al 2001) were identified, and the respective electronic databases were obtained for all of them. The quality scores of the RCTs were assessed according to the Jadad scale (Jadad et al 1996) and ranged from 2 to 4 (5-point scale), with a mean of 3.3.…”

Section: Selection Of the Trialsmentioning

confidence: 99%

Capecitabine-based chemotherapy for metastatic colorectal cancer

Wei

Fan²,

et al. 2010

J Cancer Res Clin Oncol

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“…Capecitabine in combination with oxaliplatin (the CapeOX or XELOX regimens) is considered one of the standard chemotherapy regimens in the treatment of metastatic colorectal cancer (mCRC), having efficacy similar to that of regimens based on continuous infusions of 5-fluorouracil (5-FU) combined with oxaliplatin, as evaluated in several phase III studies [1][2][3][4][5] and in a recent meta-analysis [6].…”

Section: Introductionmentioning

confidence: 99%

First-Line XELOX Plus Bevacizumab Followed by XELOX Plus Bevacizumab or Single-Agent Bevacizumab as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: The Phase III MACRO TTD Study

Dı́az-Rubio¹,

et al. 2012

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The Oncologist 2012;17:15-25 www.TheOncologist.com Patients and Methods. Patients were randomly assigned to receive six cycles of bevacizumab, capecitabine, and oxaliplatin every 3 weeks followed by XELOX plus bevacizumab or bevacizumab alone until progression. The primary endpoint was the progression-free survival (PFS) interval; secondary endpoints were the overall survival (OS) time, objective response rate (RR), time to response, duration of response, and safety.Results. The intent-to-treat population comprised 480 patients (XELOX plus bevacizumab, n ‫؍‬ 239; bevacizumab, n ‫؍‬ 241); there were no significant differences in baseline characteristics. The median follow-up was 29.0 months (range, 0 -53.2 months). There were no statistically significant differences in the median PFS or OS times or in the RR between the two arms. The most common grade 3 or 4 toxicities in the XELOX plus bevacizumab versus bevacizumab arms were diarrhea, hand-foot syndrome, and neuropathy. Conclusion. Although the noninferiority of bevacizumab versus XELOX plus bevacizumab cannot be confirmed, we can reliably exclude a median PFS detriment >3 weeks. This study suggests that maintenance therapy with singleagent bevacizumab may be an appropriate option following induction XELOX plus bevacizumab in mCRC patients. The Oncologist 2012;17:15-25

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Capecitabine plus oxaliplatin (xelox) versus protracted 5-fluorouracil venous infusion plus oxaliplatin (pvifox) as first-line treatment in advanced colorectal cancer: A GOAM phase II randomised study (FOCA trial)

Cited by 40 publications

References 38 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

Capecitabine-based chemotherapy for metastatic colorectal cancer

First-Line XELOX Plus Bevacizumab Followed by XELOX Plus Bevacizumab or Single-Agent Bevacizumab as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: The Phase III MACRO TTD Study

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