CALGB 80405 PDF

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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Among calbb with KRAS wt untreated advanced or metastatic colorectal cancer, there was no significant difference in overall survival between the addition of cetuximab vs bevacizumab to chemotherapy as initial biologic treatment.

While the original trial found no significant advantage in overall or progression-free survival in patients treated with bevacizumab or cetuximab, this analysis suggests that the relative effectiveness of cetuximab and bevacizumab may differ depending on primary tumor location.

Sign in to access your subscriptions Sign in to your personal account. The last date of follow-up caalgb December 15, These results differ from 2 smaller but contemporary studies that asked a similar question.

The FIRE-3 investigators made an effort to document subsequent treatments and postulated 880405 patients receiving first-line cetuximab treatment would have better overall survival because of a biological advantage when an EGFR inhibitor is followed by bevacizumab. Better chemotherapeutic regimens, patient selection, and changing multidisciplinary management likely contributed to these outcomes as did the exclusion of patients with KRAS mutations.

PubMed Google Scholar Crossref. Cetuximab or bevacizumab was administered prior to cytotoxic chemotherapies: See treatment administration and dose modification summary for details eTable 2 in Supplement 2.

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As of December 15,median follow-up for surviving patients was The consensus molecular subtypes of colorectal cancer. Fifty-eight patients remained alive and disease free on the last data survey. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab.

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 A progression-free survival HR of 0. Sign in to download free article PDFs Sign in to access your subscriptions Sign in to your personal account. Patients without reported deaths were censored at their last known follow-up. Patient and tumor characteristics are presented in Table 1.

From September to Marchpatients were preregistered or registered, and patients 800405 randomized to 1 of 3 treatment groups at study sites. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer.

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Similar trends were observed among patients receiving bevacizumab: The incidence of arterial thrombotic events in each treatment group was monitored throughout the trial. The Southwest Oncology Group partner for the present study oversaw specimen biobanking and the distribution of samples to laboratory investigators. Institutional review board approval was required at all participating centers and all participating patients provided written informed consent. Therapeutic anticoagulation was permitted as long as the patient was therapeutic on a stable dose of anticoagulant.

Response rates were Create a free personal account to access your subscriptions, sign up for alerts, and more. Treatment for the acneiform skin reaction was at the discretion of the treating physician. Within each treatment group, the hypothesis that the arterial thrombotic event rate was 0.

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Key Points Those with left-sided tumors had longer median overall survival Patients were excluded if they had undergone major surgery within the last 4 weeks or clgb surgery within the last 2 weeks. Drs Venook and Niedzwiecki had calyb access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Patients who received any subsequent treatment could have changed chemotherapy and either crossed over to or continued with bevacizumab beyond tumor progression. However, there was cagb significant difference in overall survival between panitumumab and bevacizumab Patients experiencing oxaliplatin or other infusion reactions were not rechallenged with treatment.

In this patient population, those with left-sided tumors had longer median overall survival Trying to understand differing results of FIRE-3 and Purchase access Subscribe to JN Learning for one year. All randomized patients with confirmed KRAS wt tumors were evaluated.

Sign in to save your search Sign in to your personal account. Fluorouracil became the only cytotoxic drug indicated for colorectal cancer in the s 1 when the adoption of continuous infusion of this agent was found to have improved the median overall survival from 12 to 15 months. Toxicity and response criteria of the Eastern Cooperative Oncology Group.

Disease assessment was done by the treating investigator and was not blinded. The median overall survival was