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A non-randomized comparison of gemcitabine-based chemoradiation with or without induction chemotherapy for locally advanced squamous cell carcinoma of the head and neck
BMC Cancer, 08/10/09
Specenier PM et al. – A nonrandomized phase III trial reports that the time to distant metastasis (TDM) and overall survival (OS) were longer in the sequential treatment (ST) of induction chemotherapy (IC) followed by CRT without a reduced locoregional control in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
Methods- Study compares the outcome of 2 cohorts of pts with LA-SCCHN treated with:
Chemoradiation (CRT; n=27)- consisted of gemcitabine (GEM) 100 mg/m2 weekly + conventional RT (70 Gy), or - Sequential treatment (ST; n=31)- consisted of the same CRT preceded by platinum-based IC
- Response to IC: complete 8 (26 %), partial 20 (65 %), stable 1, progressive 1, not evaluable 1
- Median f/u of the surviving pts: for CRT 73 mo, for ST 51 mo
- Median TDM: for CRT 23.6 mo, for ST not reached
- Median OS: for CRT 20.2 mo, for ST 40.2 mo
- Cox regression analysis: taking into account age, T and N stage and tumor site, showed a hazard ratio with ST of :
- 1.190 for time to locoregional failure
- 0.162 for TDM, and
- 0.441 for OS
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