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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The trial was designed to target a hazard ratio HR of 0. Patients were stratified for statistical analysis by the time of enrollment either before or after the KRAS amendment. Neither of these studies mandated subsequent treatment choices although Calgv had recommended specific second-line treatments per protocol.
Accessed May 26, Patients received routine supportive care at the discretion of the treating physician. Thirty-one patients died while receiving the protocol therapy: A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. Vose, MD, MBA, FASCOremarked, “This is the largest study to date of tumor location in colorectal cancer, and it strongly suggets that this unexpected factor could answer some long-standing questions about why certain patients do better than others.
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.
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Cetuximab or bevacizumab was administered prior to cytotoxic chemotherapies: Due to the large number of enrollment sites, this variable was not considered in the analysis. Up to 6 months of prior adjuvant treatment had to have concluded at least 12 months before recurrence. Ethnicity was not considered other than descriptively. Treatment assignments were generated according to randomly permuted 880405 within strata.
Initially, enrolled patients could consent to the biomarker companion study Cancer and Leukemia Group B and submit a specimen calgn EGFR status evaluation. The primary end point of overall survival was defined as time of study entry until death.
Patients were excluded if they had undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks. Median overall survival was Because treatment holidays were used more commonly during the course of the study and because collection of the details of treatment drugs and schedules, dosing and complications has been challenging, it is difficult to infer the effects of subsequent management decisions.
This cooperative research group performed critical aspects of the present study: 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.
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.
Only patients with confirmed KRAS wt were included in this primary analysis. Response rates were The patients randomized after and the patients registered before the KRAS amendment was implemented comprise the final primary analysis cohort Figure 1. The Kaplan-Meier method was used to estimate overall and progression-free survival. Secondary end points included response rate site-reported confirmed or unconfirmed complete or partial response by RECIST [Response Evaluation Criteria in Solid Tumors] and progression-free survival measured from study entry until first documented progression or death.
This also contributed to the survival results.
Among patients who received cetuximab, patients with left-sided tumors lived 36 months, whereas those with right-sided tumors lived 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 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: In this patient clagb, those with left-sided tumors had longer median overall survival The content is solely the responsibility of the authors and does not necessarily represent clagb official views of the National Institutes of Health.
Overall survival was Irinotecan combined with fluorouracil compared with fluorouracil czlgb as first-line treatment for metastatic colorectal cancer: Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. Analyses are based on clinical data and patient follow-up as of December 15, Eligible patients had pathology-documented untreated locally advanced or metastatic colorectal cancer, although measurable disease tumor that could be quantified was not require.
Create a free personal account to calgh your subscriptions, sign up for alerts, cqlgb more. Among patients who received cetuximab, patients with left-sided tumors lived 36 months, while those with right-sided tumors lived Create a free personal account to make a comment, download free article PDFs, ccalgb up for cwlgb and more. Patients with a significant bleeding event within 6 months of enrollment or a gastrointestinal perforation within 12 months of enrollment were excluded unless the perforated bowel segment had been resected.