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.
|Published (Last):||12 October 2004|
|PDF File Size:||12.4 Mb|
|ePub File Size:||4.72 Mb|
|Price:||Free* [*Free Regsitration Required]|
Eligible patients had pathology-documented untreated locally advanced or metastatic colorectal cancer, although measurable disease tumor that could be quantified was not require. However, overall survival favored cetuximab by 3. Therefore, the sequencing theory promulgated by FIRE-3 caglb is not addressed. At randomization, the primary physician indicated whether the treatment goal was palliative or potentially curative.
The chemotherapy by biologic interaction HR for overall survival was 1. Patient and tumor characteristics are presented in Table 1.
Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. Fluorouracil became the only cytotoxic drug indicated for colorectal cancer in the s 1 when the caogb of continuous infusion of this agent was found to have improved the median overall survival from 12 to 15 months. James Cancer Hospital, Columbus.
Meeting Library | Meeting Library
All randomized patients with confirmed KRAS wt tumors were evaluated. A progression-free survival HR of 0. Thus, these analyses should be considered exploratory. Similar trends were observed among patients receiving bevacizumab: Capgb assessment was done by the treating investigator and was not blinded.
Dr Meyerhardt reports receiving personal fees from Genentech.
Because treatment holidays were used more commonly during the course of the study and 84005 collection of the details of treatment drugs and schedules, aclgb and complications has been challenging, it is difficult to infer the effects of subsequent management decisions.
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. This study has several limitations.
No significant difference in day mortality was observed 1. Overall survival was The last date of follow-up was December 15, 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.
Furthermore, the variances in management preferences across the world can have important effects on overall survival. Patients were excluded if they had undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks.
Hazard ratio and P value for the RAS analysis are adjusted for prior adjuvant therapy, prior radiotherapy, protocol chemotherapy, and randomization before or after the amendment restricting eligibility to KRAS wild type tumor KRAS is defined as exon 2 codons 12, 13; exon 4, codons; exon 3 codons 59, 61 or NRAS: Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: From November to September patients were randomized 1: The Southwest Oncology Group partner for the present study oversaw specimen biobanking and the distribution of samples to laboratory investigators.
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. Patients experiencing oxaliplatin or other infusion reactions were not rechallenged with treatment.
PubMed Google Scholar Crossref. Patients in that treatment group were removed from the study, received treatment at the discretion of their physician, and were followed up per protocol.
The majority of patients also had access to both cetuximab and bevacizumab at progression because each biologic cakgb was commercially available. Treatment assignments were generated according to randomly permuted blocks within strata.
As of December 15,median follow-up for surviving patients was N Engl J Med.