H&N cancer
EXTREME trial, Cis/5FU +/- Cetuximab | 2008 | Head & Neck |
CHECKMATE 141, nivo vs chemo in 2nd line | 2016 | Head & Neck |
Gem/Cis/IMRT vs | 2019 | Head & Neck |
KEYNOTE-048 | 2019 | Head & Neck |
KEYNOTE-040 trial | 2019 | Head & Neck |
MACH-NC mena-analysis | 2021 | Head & Neck |
JUPITER 02 | 2021 | Head & Neck |
Javelin Head and Neck 100 | 2021 | Head & Neck |
GORTEC 2000-01 trial, TPF vs PF | 2015 | Head & Neck - Larynx |
Cisplantin q3wk vs q1wk by Tata Memorial | 2018 | Head & Neck - Larynx |
SELECT trial, Lenvatinib 2nd line | 2015 | Thyroid cancer |
EXTREME trial, Cis/5FU +/- Cetuximab
Vermorken J et al, NEJM, 2008, PMID: 18784101
Head & Neck
Background: phase III RCT included 442 patients with previously untreated recurrent or metastatic squamous-cell carcinoma of the head and neck. Exclusion: surgery or RTx <4wk, previous chemo (unless it was part of multimodal treatment for locally advanced disease >6mo ago), nasopharyngeal carcinoma.
Arm A: cisplatin 100 mg/m2 D1 (or carboplatin AUC 5 D1) and 5FU 1000 mg/m2 for 4 days q21d x6cycles
Arm B: cisplatin (or carboplatin) and 5FU PLUS Cetuximab 400 mg/m2 as 1-h infusion x6 cycles
Primary endpoint: Overall Survival
Secondary endpoints: PFS, ORR x 4 weeks, disease control etc.
mOS: 7.4mo vs 10.1 mo, arm A vs arm B respectively, HR 0.80, 95% CI 0.64-0.99; P=.04
mPFS: 3.3mo vs 5.6mo, HR 0.54, 95%CI 0.43-0.67; P<.001
Main adverse events: Sepsis 1 vs 9 cases, P=0.02, arm A vs B respectively, hypomagnesemia (3 vs 11 cases,P=0.05). Grade 3 skin reactions 9%, infusion reactions: grade 3 (n=4) and grade 4 (n=2) in patients receiving cetuximab.
Conclusions: addition of cetuximab to platinum–fluorouracil chemotherapy improved OS in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck when given as first-line treatment
Summarized by Richard White, DO