The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.
Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study
Abstract
Purpose: This phase III study compared the safety and efficacy of the following three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer: irinotecan plus infusional fluorouracil (FU)/leucovorin (LV) (FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI). Patients and Methods: A total of 430 previously untreated metastatic colorectal cancer patients were randomly assigned to receive FOLFIRI (n = 144), mIFL (n = 141), or CapeIRI (n = 145). Patients were concurrently randomly assigned to a double-blind treatment with celecoxib or placebo. After a protocol amendment, an additional 117 patients were randomly assigned to either FOLFIRI plus bevacizumab (FOLFIRI+Bev; n = 57) or mILF plus bevacizumab (mIFL+Bev; n = 60), whereas the CapeIRI arm was discontinued. The primary study end point was progression-free survival (PFS), with secondary end points of overall survival (OS), response rate, and toxicity. Results: Median PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (P = .004 for the comparison with FOLFIRI), and 5.8 months for CapeIRI (P = .015). Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (P = .09), and 18.9 months for CapeIRI (P = .27). CapeIRI was associated with higher rates of severe vomiting, diarrhea, and dehydration. After the amendment to add bevacizumab, the median survival time has not yet been reached for FOLFIRI+Bev and was 19.2 months for mIFL+Bev (P = .007). FOLFIRI+Bev was associated with a higher rate of ≥ grade 3 hypertension than mIFL+Bev. Conclusion: FOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe. An infusional schedule of FU should be the preferred irinotecan-based regimen in first-line metastatic colorectal cancer.
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Cites
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Cited by
ESMO consensus guidelines for the management of patients with metastatic colorectal cancer
Van Cutsem, E., Cervantes, A., Adam, R., Sobrero, A., Van Krieken, J. H., Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw235 · Cited by 3,421
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“(1) Patients appropriate for intensive therapy (a) When the patient has become refractory or intolerant to the first-line therapy, including OX • FOLFIRI [62] + Bmab [85] ▪ FOLFIRI + Rmab [86] • IRIS (note 6) [87] + Bmab • IRI [88] + Bmab • FOLFIRI (or IRI) + Cmab/Pmab [88, 89] (b) When the patient has become refracto…”
InfluentialHashiguchi, Y., Muro, K., Saito, Y., Ito, Y., Ajioka, Y., Hamaguchi, T., Hasegawa, K., Hotta, K., Ishida, H., Ishiguro, M., et al. (2020) · International Journal of Clinical Oncology · doi:10.1007/s10147-019-01485-z · Cited by 1,922
Cervantes, A., Adam, R., Roselló, S., Arnold, D., Normanno, N., Taïeb, J., Seligmann, J., De Baere, T., Osterlund, P., Yoshino, T., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2022.10.003 · Cited by 1,796
Breast Cancer, Version 4.2017, NCCN Clinical Practice Guidelines in Oncology
Gradishar, W. J., Anderson, B. O., Balassanian, R., Blair, S. L., Burstein, H. J., Cyr, A., Elias, A. D., Farrar, W. B., Forero, A., Giordano, S. H., et al. (2018) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2018.0012 · Cited by 1,609
Metadata
- Authors
- Fuchs, C. S., Marshall, J., Mitchell, E., Wierzbicki, R., Ganju, V., Jeffery, M., Schulz, J., Richards, D., Soufi-Mahjoubi, R., Wang, B., & Barrueco, J.
- Venue
- Journal of Clinical Oncology
- Published
- 2007-10-20
- Volume
- 25
- Issue
- 30
- Pages
- 4779-4786
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2132545630
- Cited by
- 851
- References
- 17
- FWCI
- 31.54
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study. https://app.cochat.ai/papers/10.1200/jco.2007.11.3357
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- Fuchs, C. S., Marshall, J., Mitchell, E., Wierzbicki, R., Ganju, V., Jeffery, M., Schulz, J., Richards, D., Soufi-Mahjoubi, R., Wang, B., & Barrueco, J. (2007). Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.11.3357
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