| Title |
5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study
|
|---|---|
| Published in |
Cancer Management and Research, June 2015
|
| DOI | 10.2147/cmar.s61408 |
| Pubmed ID | |
| Authors |
J Randolph Hecht, Edith P Mitchell, Takayuki Yoshino, Manfred Welslau, Xun Lin, Edna Chow Maneval, Jolanda Paolini, Maria Jose Lechuga, Albrecht Kretzschmar |
| Abstract |
Sunitinib is an oral inhibitor of tyrosine kinase receptors implicated in tumor proliferation, angiogenesis, and metastasis. In this randomized, multicenter, open-label Phase IIb study, sunitinib plus mFOLFOX6 (oxaliplatin plus leucovorin plus 5-fluorouracil) was compared with bevacizumab plus mFOLFOX6 as first-line therapy in patients with metastatic colorectal cancer. Patients were stratified by performance status, baseline lactate dehydrogenase level, and prior adjuvant treatment, and randomized 1:1 to receive sunitinib 37.5 mg/day for 4 weeks on and 2 weeks off plus mFOLFOX6 every 2 weeks or bevacizumab 5 mg/kg every 2 weeks plus mFOLFOX6 every 2 weeks. The primary endpoint was progression-free survival. Secondary endpoints included objective response rate, overall survival, safety, and quality of life. Enrollment was closed early following accrual of 191 patients, based on an interim analysis showing an inferior trend in the primary progression-free survival efficacy endpoint for sunitinib. Ninety-six patients were randomized to sunitinib plus mFOLFOX6 and 95 to bevacizumab plus mFOLFOX6. Median progression-free survival was 9.3 months and 15.4 months, respectively, but the objective response rate was similar between the study arms. Median overall survival was 23.7 months and 34.1 months, respectively. Dose reductions and interruptions were more common with sunitinib. Hematologic toxicity was more common in the sunitinib arm. While the results of the sunitinib arm are comparable with those of previously reported FOLFOX combinations, the sunitinib-based combination was associated with more toxicity than that observed with bevacizumab and mFOLFOX6. The bevacizumab arm had an unexpectedly good outcome, and was much better than that seen in the Phase III trials. Combination therapy with sunitinib plus mFOLFOX6 is not recommended for patients with metastatic colorectal cancer. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Canada | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 39 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 39 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 5 | 13% |
| Student > Bachelor | 5 | 13% |
| Student > Doctoral Student | 3 | 8% |
| Student > Ph. D. Student | 2 | 5% |
| Student > Master | 2 | 5% |
| Other | 5 | 13% |
| Unknown | 17 | 44% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 11 | 28% |
| Nursing and Health Professions | 5 | 13% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 8% |
| Agricultural and Biological Sciences | 2 | 5% |
| Psychology | 1 | 3% |
| Other | 1 | 3% |
| Unknown | 16 | 41% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 17 June 2015.
All research outputs
#20,656,820
of 25,374,647 outputs
Outputs from Cancer Management and Research
#1,128
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#206,513
of 281,411 outputs
Outputs of similar age from Cancer Management and Research
#11
of 11 outputs
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