331
Views
0
CrossRef citations to date
0
Altmetric
Clinical Trial Protocol

Phase III Study with FOLFIRI + Cetuximab Versus FOLFIRI + Cetuximab Followed by Cetuximab Alone in RAS and BRAF WT mCRC

, , , , , , , , , , , , , , , , , , , , , , , & show all
Pages 1339-1346 | Received 01 Nov 2017, Accepted 15 Jan 2018, Published online: 30 May 2018

References

  • Van Cutsem E , KohneCH, HitreEet al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N. Engl. J. Med.360, 1408–1417 (2009).
  • Van Cutsem E , KöhneCH, LángIet al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J. Clin. Oncol.29(15), 2011–2019 (2011).
  • Heinemann V , von WeikersthalLF, DeckerTet al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, Phase 3 trial. Lancet Oncol.15(10), 1065–1075 (2014).
  • Pietrantonio F , PetrelliF, CoinuAet al. Predictive role of BRAF mutations in patients with advanced colorectal cancer receiving cetuximab and panitumumab: a meta-analysis. Eur. J. Cancer51(5), 587–594 (2015).
  • Orlandi A , CalegariA, InnoAet al. BRAF in metastatic colorectal cancer: the future starts now. Pharmacogenomics16(18), 2069–2081 (2015).
  • Loupakis F , CremoliniC, MasiGet al. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N. Engl. J. Med.371(17), 1609–1618 (2014).
  • Stintzing S , ModestDP, RossiusLet al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (FIRE-3): a post-hoc analysis of tumour dynamics in the final RAS wild-type subgroup of this randomised open-label Phase III trial. Lancet Oncol.17(10), 1426–1434 (2016).
  • Price T , KimTW, LiJet al. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized Phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur. J. Cancer68, 51–59 (2016).
  • De Roock W , De VriendtV, NormannoNet al. KRAS, BRAF, PIK3CA, and PTEN mutations: implications for targeted therapies in metastatic colorectal cancer. Lancet Oncol.12, 594–603 (2011).
  • Ciardiello F , NormannoN, MaielloEet al. Clinical activity of FOLFIRI plus cetuximab according to extended gene mutation status by next generation sequencing: findings from the CAPRI-GOIM trial. Ann. Oncol.25(9), 1756–1761 (2014).
  • Eisenhauer EA , TherasseP, BogaertsJet al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer45(2), 228–247 (2009).
  • NCI Common Terminology Criteria for Adverse Events data files ( CTCAE v4.03, minor update2010). http://evs.nci.nih.gov/ftp1/CTCAE/About.html
  • Tops BB , NormannoN, KurthHet al. Development of a semi-conductor sequencing-based panel for genotyping of colon and lung cancer by the Onconetwork consortium. BMC Cancer15, 26 (2015).
  • Van Cutsem E , KöhneCH, LángIet al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J. Clin. Oncol.29(15), 2011–2019 (2011).
  • Van Cutsem E , LenzHJ, KöhneCHet al. Fluorouracil, leucovorin, and irinotecan plus cetuximab treatment and RAS mutations in colorectal cancer. J. Clin. Oncol.33(7), 692–700 (2015).
  • Rothmann M , LiN, ChenG, ChiGY, TempleR, TsouHH. Design and analysis of non-inferiority mortality trials in oncology. Stat. Med.22(2), 239–64 (2003).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.