دورية أكاديمية
Cetuximab and Irinotecan With or Without Bevacizumab in Refractory Metastatic Colorectal Cancer: BOND-3, an ACCRU Network Randomized Clinical Trial.
| العنوان: | Cetuximab and Irinotecan With or Without Bevacizumab in Refractory Metastatic Colorectal Cancer: BOND-3, an ACCRU Network Randomized Clinical Trial. |
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| المؤلفون: | Lipsyc-Sharf M; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Ou FS; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA., Yurgelun MB; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Rubinson DA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Schrag D; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Dakhil SR; Cancer Center of Kansas, Wichita, KS, USA., Stella PJ; St. Joseph Mercy Hospital, Ypsilanti, MI, USA., Weckstein DJ; New Hampshire Oncology Hematology, Hooksett, NH, USA., Wender DB; June E. Nylen Cancer Center, Sioux City, IA, USA., Faggen M; Dana-Farber at South Shore Hospital, South Weymouth, MA, USA., Zemla TJ; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA., Heying EN; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA., Schuetz SR; University of Vermont Larner College of Medicine, Burlington, VT, USA., Noble S; ACCRU, Mayo Clinic, Rochester, MN, USA., Meyerhardt JA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., Bekaii-Saab T; Mayo Clinic Cancer Center, Phoenix, AZ, USA., Fuchs CS; Yale Cancer Center, New Haven, CT, USA.; Genentech, South San Francisco, CA, USA., Ng K; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. |
| المصدر: | The oncologist [Oncologist] 2022 Apr 05; Vol. 27 (4), pp. 292-298. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols*/adverse effects , Colorectal Neoplasms*/pathology, Bevacizumab/adverse effects ; Camptothecin/adverse effects ; Cetuximab/adverse effects ; Fluorouracil ; Humans ; Irinotecan/therapeutic use |
| مستخلص: | Background: Combination irinotecan and cetuximab is approved for irinotecan-refractory metastatic colorectal cancer (mCRC). It is unknown if adding bevacizumab improves outcomes. Patients and Methods: In this multicenter, randomized, double-blind, placebo-controlled phase II trial, patients with irinotecan-refractory RAS-wildtype mCRC and no prior anti-EGFR therapy were randomized to cetuximab 500 mg/m2, bevacizumab 5 mg/kg, and irinotecan 180 mg/m2 (or previously tolerated dose) (CBI) versus cetuximab, irinotecan, and placebo (CI) every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and adverse events (AEs). Results: The study closed early after the accrual of 36 out of a planned 120 patients due to changes in funding. Nineteen patients were randomized to CBI and 17 to CI. Baseline characteristics were similar between arms. Median PFS was 9.7 versus 5.5 months for CBI and CI, respectively (1-sided log-rank P = .38; adjusted hazard ratio [HR] = 0.64; 95% confidence interval [CI], 0.25-1.66). Median OS was 19.7 versus 10.2 months for CBI and CI (1-sided log-rank P = .02; adjusted HR = 0.41; 95% CI, 0.15-1.09). ORR was 36.8% for CBI versus 11.8% for CI (P = .13). Grade 3 or higher AEs occurred in 47% of patients receiving CBI versus 35% for CI (P = .46). Conclusion: In this prematurely discontinued trial, there was no significant difference in the primary endpoint of PFS between CBI and CI. There was a statistically significant improvement in OS in favor of CBI compared with CI. Further investigation of CBI for the treatment of irinotecan-refractory mCRC is warranted.Clinical Trial Registration: NCT02292758. (© The Author(s) 2022. Published by Oxford University Press.) |
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| فهرسة مساهمة: | Keywords: bevacizumab; cetuximab; colorectal neoplasm; irinotecan |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02292758 |
| المشرفين على المادة: | 2S9ZZM9Q9V (Bevacizumab) 7673326042 (Irinotecan) PQX0D8J21J (Cetuximab) U3P01618RT (Fluorouracil) XT3Z54Z28A (Camptothecin) |
| تواريخ الأحداث: | Date Created: 20220405 Date Completed: 20220407 Latest Revision: 20220629 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC8982431 |
| DOI: | 10.1093/oncolo/oyab025 |
| PMID: | 35380713 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1549-490X |
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| DOI: | 10.1093/oncolo/oyab025 |