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Including docetaxel to radiation improves outcomes for sufferers with domestically superior head and neck squamous cell carcinoma who aren’t capable of obtain cisplatin, in response to analysis printed within the Journal of Scientific Oncology.
Researchers discovered that docetaxel improved each disease-free survival (DFS) and general survival (OS) on this affected person group.
The researchers performed a part 2/3 trial of 356 sufferers with domestically superior head and neck squamous cell carcinoma. Sufferers have been randomly assigned to obtain radiation alone (n=176) or radiation together with docetaxel (n=180).
Proceed Studying
Baseline traits have been comparable between the remedy arms. The median age was 63 years within the radiation-alone arm and 61 years within the docetaxel arm (general vary, 23-83 years). Most sufferers have been males (85% within the radiation-alone arm and 81.8% within the docetaxel arm).
There have been 109 sufferers within the radiation-alone arm and 108 within the docetaxel arm who acquired definitive radiation (70 Gy; 2 Gy per fraction, 5 days per week over 7 weeks). There have been 67 sufferers within the radiation-alone arm and 72 within the docetaxel arm who acquired adjuvant radiation (60 Gy; 2 Gy per fraction, 5 days per week over 6 weeks).
Sufferers within the docetaxel arm acquired the drug at 15 mg/m2 as soon as weekly in 500 mL of regular saline intravenously over 1 hour. The primary dose was given inside 5 days of sufferers beginning radiation.
At a median follow-up of 32.4 months, there was a big enchancment in DFS amongst sufferers who acquired docetaxel. The two-year DFS price was 30.3% within the radiation-alone arm and 42% within the docetaxel arm. The unadjusted hazard ratio (HR) for DFS was 0.673 (95% CI, 0.521-0.868; P =.002), and the adjusted HR was 0.631 (95% CI, 0.486-0.818; P <.001).
There was a big enchancment in OS with docetaxel as nicely. The median OS was 15.3 months within the radiation-alone arm and 25.5 months within the docetaxel arm. The two-year OS price was 41.7% and 50.8%, respectively. The unadjusted HR for OS was 0.747 (95% CI, 0.569-0.980; P =.035), and the adjusted HR was 0.694 (95% CI, 0.527-0.915; P <.001).
Grade 3 or larger antagonistic occasions have been extra frequent within the docetaxel arm than within the radiation-alone arm (81.6% and 58%, respectively; P =.001). The commonest grade 3-5 antagonistic occasions (within the docetaxel and radiation-alone arms, respectively) have been mucositis (49.7% vs 22.2%), odynophagia (52.5% vs 33.5%), and dysphagia (49.7% vs 33%).
“Docetaxel can be utilized as a radiosensitizer alongside radiation remedy in cisplatin-ineligible sufferers,” JCO Affiliate Editor Maura L. Gillison, MD, PhD, wrote in a touch upon this analysis. “This examine gives, to our information, the primary evidence-based information for the usage of concurrent chemotherapy in cisplatin-ineligible sufferers.”
Disclosures: Some examine authors declared affiliations with biotech, pharmaceutical, and/or machine corporations. Please see the unique reference for a full listing of authors’ disclosures.
Reference
Patil VM, Noronha V, Menon N, et al. Outcomes of part III randomized trial to be used of docetaxel as a radiosensitizer in sufferers with head and neck most cancers, unsuitable for cisplatin-based chemoradiation. J Clin Oncol. Printed on-line January 27, 2023. doi:10.1200/JCO.22.00980
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