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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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. Conversely, among patients with left-sided tumors, treatment with cetuximab was associated with longer overall survival than bevacizumab 36 vs No Difference, but Not the Same. Second, this study only mandated first-line treatment with patients who at any time went more than 28 days without treatment being removed from study.
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Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. Institutional review board approval was required at all participating centers and all participating patients provided written informed consent. 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.
Create a free personal account to access your subscriptions, sign up for alerts, and more. Patients received routine supportive care at the discretion of the treating physician.
At randomization, the primary physician indicated whether the treatment goal was palliative or potentially curative. Among patients 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.
For a longer-form examination of these data, click here. Colorectal cancer is the second leading cause of cancer death in North America.
Should Oncologists Recommend Cannabis? The consensus molecular subtypes of colorectal cancer. Response rates were not significantly different, The Kaplan-Meier method was used to estimate overall and progression-free survival.
Patients enrolled and consented to the companion study whose tumor was KRAS wt and who received single antibody treatment were included in the primary cohort.
Sign in to save your search Sign in to your personal account. James Cancer Hospital, Columbus. Patients experiencing oxaliplatin or other infusion reactions were not rechallenged with treatment.
Tick marks on the curves denote the last known follow-up time for patients with no death date reported. Among patients with right-sided tumors, treatment with bevacizumab was associated with longer survival than that seen with cetuximab From September to Marchpatients were preregistered or registered, and patients were randomized to 1 of 3 treatment groups at study sites. Among patients who received cetuximab, patients with left-sided tumors lived 36 months, whereas those with right-sided tumors lived Assuming no adverse reactions, subsequent infusions were administered over 30 to 60 minutes every other week.
Treatment for the acneiform skin reaction was at the discretion of the treating physician. An additional secondary end point was day mortality assessed as the proportion of patients dying due to any cause within 60 days of beginning protocol therapy.
Thirty-one patients died while receiving the protocol therapy: The hazard ratio and P value are adjusted for prior adjuvant therapy, prior radiotherapy, protocol chemotherapy, and randomization before and after the amendment restricting eligibility to the KRAS wild-type tumor. This randomized clinical trial compares the effects of fruquintinib, a vascular endothelial growth factor receptor Calg inhibitor, vs calgbb on overall survival among patients with metastatic colorectal cancer whose disease progressed on treatment or who could not tolerate standard treatment because of toxic effects.
Get free access to newly published articles Create a clagb account or sign in to: For the primary analysis, researchers identified data from patients with right-sided primary tumors and patients with left-sided primary tumors. In addition, some patients may have benefitted from subsequent experimental or off-label treatments.
PubMed Google Scholar Crossref. A progression-free survival HR of 0. 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.
Cetuximab, a chimerized monoclonal antibody to the epidermal growth factor receptor EGFRwas approved in combination with irinotecan or alone following irinotecan failure for patients with advanced or metastatic colorectal cancer whose tumors expressed EGFR. Create a free personal account to download free article PDFs, sign up for alerts, and more. Disease assessment was done by the treating investigator and was not blinded. 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: However, overall survival favored cetuximab by 3.
Patients who received any subsequent treatment could have changed chemotherapy and either crossed over to or continued with bevacizumab beyond tumor progression. Main Outcomes and Measures: The primary end point was overall survival. Get free access to newly published articles. The incidence of arterial thrombotic events in each treatment group was monitored throughout the trial.
Furthermore, the variances in management preferences across the world can have important effects on overall survival.
The combination of chemotherapy and surgery rendered patients disease free; median overall survival for the bevacizumab group was Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. A retrospective analysis from a large, federally funded clinical trial finds 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.