4.1 Article

Observational, prospective, phase 4 study in patients with first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with cetuximab and platinum-based therapy: DIRECT

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CANCER REPORTS
卷 5, 期 2, 页码 -

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WILEY
DOI: 10.1002/cnr2.1467

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5-fluorouracil; carboplatin; cetuximab; cisplatin; head and neck neoplasms; palliative care

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资金

  1. Merck Sante SAS, Lyon, France
  2. Merck KGaA

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The study evaluated the relative dose intensity of cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and found that first-line cetuximab plus platinum-based therapy was a feasible and beneficial treatment option in the real-world setting.
Background Cetuximab plus platinum-based therapy (PBT) followed by cetuximab maintenance until progression (EXTREME) is a guideline-recommended first-line treatment option in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). DIRECT (Dose Intensity RElative to CeTuximab) was the first phase 4 observational study evaluating EXTREME administration in the real-world setting. Aims The primary aim of this study was to assess the relative dose intensity of cetuximab in patients with R/M SCCHN treated with first-line cetuximab according to the EXTREME regimen. Methods and results Patients were >= 18 years old and eligible to receive cetuximab/PBT. Primary endpoint was cetuximab relative dose intensity (RDI). Of prospectively enrolled patients (n = 157), 119 received >= 1 cycle of EXTREME. Practices differing from the EXTREME trial were 5-fluorouracil omission (14%), maintenance cetuximab given every other week (54%), prior cetuximab, disease-free interval <6 months. 64% of patients reached cetuximab RDI >= 80%; mean cetuximab RDI was 88%. 46% of patients received maintenance cetuximab (mean RDI, 91%). Median progression-free survival and overall survival were 4.5 and 9.4 months. No new/unexpected safety findings were observed. Conclusions The DIRECT study showed that first-line cetuximab plus PBT was a feasible, beneficial first-line treatment regimen in patients with R/M SCCHN in the real-world setting.

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