ASCO, ITT, KRAS-WT primary OS results: CALGB failed to meet its primary endpoint of OS Cetuximab is not superior to Avastin in 1L KRAS-WT. CALGB/SWOG Phase III trial of FOLFIRI or mFOLFOX6 with bevacizumab or cetuximab for patients with expanded RAS analyses in. CALGB/SWOG Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab.
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Secondary objectives included progression-free survival and overall response rate, site-reported confirmed or unconfirmed complete or partial response. Our website uses cookies to enhance your experience. As of December 15,median follow-up for surviving patients was KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab.
Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: This information was collected post hoc through chart review and has been suggested to influence outcome as a biologic surrogate.
Individual patient data analysis of progression-free survival versus overall survival as a first-line end point for metastatic colorectal cancer in modern randomized trials: The Cancer and Leukemia B and Southwest Oncology Group trial was designed in collaboration with the National Cancer Institute NCI and was started in September to compare various combinations of chemotherapies and biologic therapies as first-line treatment of advanced and metastatic colorectal cancer: The last date of follow-up was December 15, It is also an important reminder, in this exciting era of precision medicine, that genomics is not the only source of insight into how cancers should be studied and treated.
Boundaries were truncated at 2. This is speculative, however, because the collection of subsequent treatment details across calfb of sites in North America is extremely difficult and the details of such data would be open to questioning no matter the resources put into such an effort. These findings persisted cqlgb exclusion of patients with aclgb RAS mutations.
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Presented June 1, Purchase access Subscribe to the journal. Better chemotherapeutic regimens, patient selection, 880405 changing multidisciplinary management likely contributed to these outcomes as did the exclusion of patients with KRAS mutations.
The majority of patients also had access to both cetuximab and bevacizumab at progression because each biologic therapy was commercially available. Results are reported for 1 the primary 2-group comparison between cetuximab and bevacizumab; 2 the comparison of cetuximab vs bevacizumab in an expanded RAS subset described above; and 3 the chemotherapy subgroups. From November to September patients were randomized 1: Response rates were Up to 6 months of prior adjuvant treatment had to have concluded at least 12 months before recurrence.
Disease assessment was done by the treating investigator and was not blinded. Following the amendment restricting eligibility to patients with KRAS wt tumors, patients consented to be tested for KRAS and calggb to submit 2 archival paraffin-embedded tumor tissue sections and 1 histology reference slide or 1 paraffin-embedded tumor block to the Southwest Capgb Group Solid Tumor Specimen Repository.
Researchers are in the process of examining the molecular biology that presumably underlies these findings. Dr Mulkerin reports receiving institutional research grant support from the NCI cooperative group funding.
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Patients in that treatment group were removed from the study, received treatment at the discretion of their physician, and were followed up per protocol. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. A progression-free survival HR of 0. N Engl J Med. Patients received routine supportive care at the discretion of the treating physician.
From September to Marchpatients were preregistered or registered, and patients were randomized to 1 of 3 treatment falgb at study sites.
Main Outcomes and Measures: Baseline characteristics were comparable between patients with and without expanded RAS results. The chemotherapy by biologic interaction HR for overall survival was 1. Conflict of Interest Disclosures: After 10 years and additional amendments a revised 2-group trial cetuximab vs bevacizumab with chemotherapy regimens completed patient enrollment and follow-up see eTable 1 in Supplement 2.
No significant differences were observed for either overall survival or progression-free survival in the primary analysis cohort.
Critical revision of the manuscript for important intellectual content: To determine if the addition of cetuximab vs bevacizumab to the combination of leucovorin, fluorouracil, and oxaliplatin mFOLFOX6 regimen or the combination of leucovorin, fluorouracil, and irinotecan FOLFIRI regimen is superior as first-line therapy in advanced or metastatic KRAS wild-type wt colorectal cancer.
Treatment for the acneiform skin reaction was at the discretion of the treating physician.
For the progression-free survival end point, patients alive without documented tumor progression were censored for progression at the most recent disease assessment. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer.
Median overall survival was Toxicity and response criteria of the Eastern Cooperative Oncology Group. Based on these factors, patients and primary outcome events were needed. Initially, enrolled patients could consent to the biomarker companion study Cancer and Leukemia Group B and submit a specimen for EGFR 800405 evaluation. At falgb, the primary physician indicated whether the treatment goal was palliative or potentially curative.
Cetuximab or bevacizumab was administered prior to cytotoxic chemotherapies: Because the trial was initiated before KRAS mutation status was known to be an important factor in the use of cetuximab, a smaller population of patients had KRAS mutations an additional Fifty-eight patients remained alive and disease free on the last data survey.
The primary statistical analyses were 2-sided tests of superiority comparing cetuximab vs bevacizumab with regard to the primary and main secondary outcomes among patients whose tumors were determined to be KRAS wt exon 2, codons 12,13 by Southwest Oncology Group review using intention-to-treat analyses.
Create a personal account to register for email alerts with links to free full-text articles. Patients were stratified for statistical analysis by the time of enrollment either before or after the KRAS amendment.