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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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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.

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Get free access to newly published articles. Disease assessment was done by the treating investigator and was not blinded. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. Baseline characteristics were comparable between patients with and without expanded RAS results. Of patients, The trial was designed to target a hazard ratio HR of 0.

From September to Marchpatients were preregistered or registered, and patients were randomized to 1 of 3 treatment groups at study sites. Continuation of bevacizumab after first progression in metastatic colorectal cancer ML As of December 15,median follow-up for surviving patients was Overall survival was Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment.

Patients experiencing oxaliplatin or other infusion reactions were not rechallenged with treatment. Sign in to access your subscriptions Sign in to your personal account. Initially, enrolled patients could consent to the biomarker companion study Cancer and Leukemia Group B and submit a specimen for EGFR status evaluation.

This eligibility change increased the proportion of study patients who might benefit from cetuximab but also improved the prognosis for the entire group by eliminating patients with negatively prognostic RAS mutations.

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Also, patients in this study likely had lower tumor burden compared with patients who participated in earlier studies as a result of better imaging at diagnosis as well as the coincidental detection of small cancers when patients undergo diagnostic imaging for other indications.

Design, Setting, and Participants: A retrospective analysis from a large, federally funded clinical trial calgv that the location of the primary tumor within the colon predicts survival and may help inform optimal treatment selection for patients with metastatic colorectal cancer. This information was collected post hoc through chart review and has been suggested to influence outcome as a biologic surrogate. The majority of patients also had access to both cetuximab and bevacizumab at progression because each biologic therapy was commercially available.

Median overall survival was No significant interactions were observed for sex HR for interaction, 0.

Create a free personal account to download free article PDFs, sign up for alerts, and more. The chemotherapy by biologic interaction HR for overall survival was 1.

The last date of follow-up was December 15, The median progression-free survival was J Natl Cancer Inst.

Vose, MD, MBA, FASCOremarked, “This is the largest study to date of tumor location in colorectal cancer, and it strongly cslgb that this unexpected factor could answer some long-standing questions about why certain patients do better than others.

A progression-free survival HR of 0. These results differ from 2 smaller but contemporary studies that asked a similar question. Treatment for the acneiform skin reaction was at the discretion of the treating physician. Thereafter, patients were randomized calbb No significant differences were observed for either overall survival or progression-free survival in the primary analysis cohort.

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A Randomized Clinical Trial. Patients with KRAS mutant tumors were excluded from analysis but were given the option to continue 8040 the study treatment. Dr Mulkerin reports receiving institutional research grant support from the NCI cooperative group funding.

The last date of follow-up was December 15, Combining biologic calgn antibodies with chemotherapeutic cytotoxic drugs provides clinical benefit to patients with advanced or metastatic colorectal cancer, but the optimal choice of the initial biologic therapy in previously untreated patients is unknown. Presented June 25, As of December 15,median follow-up for surviving patients was This also contributed to the survival results.

Create a free personal account to download free article PDFs, sign up for alerts, customize your interests, and more. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: Following the amendment restricting eligibility to patients with KRAS wt tumors, patients consented to be tested for KRAS and agreed to submit 2 archival paraffin-embedded tumor tissue sections and 1 histology reference slide or 1 paraffin-embedded tumor block to the Southwest Oncology Group Solid Tumor Specimen Repository.

Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer.

Sign in to make a comment Sign in to your personal account. Data were released by the Alliance Data and Safety Monitoring Board in January after the 11th interim analysis concluded with high probability that neither treatment group could meet the preplanned goal of a 5.

Conversely, among patients with left-sided tumors, treatment with cetuximab was associated with longer overall survival than bevacizumab 36 vs