Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared with cetuximab and bevacizumab alone in irinotecan-refractory colorectal cancer: The BOND-2 study Journal Article
| Authors: | Saltz, L. B.; Lenz, H. J.; Kindler, H. L.; Hochster, H. S.; Wadler, S.; Hoff, P. M.; Kemeny, N. E.; Hollywood, E. M.; Gonen, M.; Quinones, M.; Morse, M.; Chen, H. X. |
| Article Title: | Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared with cetuximab and bevacizumab alone in irinotecan-refractory colorectal cancer: The BOND-2 study |
| Abstract: | Purpose: We evaluated the safety and efficacy of concurrent administration of two monoclonal antibodies, cetuximab and bevacizumab, in patients with metastatic colorectal cancer. Patients and Methods: This was a randomized phase II study in patients with irinotecan-refractory colorectal cancer. All patients were naïve to both bevacizumab and cetuximab. Patients in arm A received irinotecan at the same dose and schedule as last received before study entry, plus cetuximab 400 mg/m2 loading dose, then weekly cetuximab 250 mg/m2, plus bevacizumab 5 mg/kg administered every other week. Patients in arm B received the same cetuximab and bevacizumab as those in arm A but without irinotecan. Results: Forty-three patients received cetuximab, bevacizumab, and irinotecan (CBI) and 40 patients received cetuximab and bevacizumab alone (CB). Toxicities were as would have been expected from the single agents. For the CBI arm, time to tumor progression (TTP) was 7.3 months and the response rate was 37%; for the CB arm, TTP was 4.9 months and the response rate was 20%. The overall survival for the CBI arm was 14.5 months and the overall survival for the CB-alone arm was 11.4 months. Conclusion: Cetuximab and bevacizumab can be administered concurrently, with a toxicity pattern that seems to be similar to that which would be expected from the two agents alone. This combination plus irinotecan also seems to be feasible. The activity seen with the addition of bevacizumab to cetuximab, or to cetuximab plus irinotecan, seems to be favorable when compared with historical controls of cetuximab or cetuximab/irinotecan in patients who are naïve to bevacizumab. © 2007 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; overall survival; clinical trial; fatigue; neutropenia; bevacizumab; cancer combination chemotherapy; cancer growth; diarrhea; drug efficacy; drug safety; cancer patient; colorectal cancer; cancer immunotherapy; metastasis; controlled clinical trial; drug eruption; phase 2 clinical trial; nausea; randomized controlled trial; antineoplastic combined chemotherapy protocols; camptothecin; cetuximab; cancer resistance; irinotecan; drug hypersensitivity; loading drug dose; colorectal neoplasms; drug induced headache; survival time; antibodies, monoclonal; narcotic analgesic agent; feasibility study; disease progression; acne; neoplasm metastasis; intermethod comparison; paronychia |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 25 |
| Issue: | 29 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2007-10-10 |
| Start Page: | 4557 |
| End Page: | 4561 |
| Language: | English |
| DOI: | 10.1200/jco.2007.12.0949 |
| PUBMED: | 17876013 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 201" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus" |
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