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Tax-PF superior to PF as induction therapy in HNSCC
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A taxane, cisplatin and fluorouracil combination significantly improved survival and other outcomes compared with cisplatin and fluorouracil alone in patients with locally advanced head and neck squamous cell carcinoma, according to results of a meta-analysis.
The analysis included five randomized trials that included 1,722 patients with locally advanced HNSCC. Researchers set out to compare the efficacy and toxicity of taxane, cisplatin and fluorouracil (Tax-PF) vs. cisplatin plus fluorouracil (PF) in this patient population.
Median follow-up was 4.9 years.
Researchers observed significant decreases in disease progression (HR=0.78; 95% CI, 0.69-0.87), locoregional failure (HR=0.79; 95% CI, 0.66-0.94) and distant failure (HR=0.63; 95% CI, 0.45-0.89) among patients assigned to Tax-PF.
The HR for mortality was 0.79 (95% CI, 0.70-0.89), also in favor of Tax-PF.
Significant heterogeneity was related to one trial included in the analysis (P=.08), according to researchers. However, after exclusion of that trial, researchers reported no heterogeneity (P=.99). The HR for mortality after exclusion was 0.72 (95% CI, 0.63-0.83) and continued to favor Tax-PF.
Age, gender, performance status, tumor stage or site did not affect treatment outcomes.
“Although induction Tax-PF is superior to PF in terms of OS, PFS and locoregional and distant control, its precise role compared with upfront CRT in the management of locoregionally advanced HNSCC remains to be defined,” the researchers wrote.
David J. Adelstein
Despite the findings, the question about whether Tax-PF followed by chemoradiotherapy is more effective than standard chemoradiotherapy alone remains unproven, Arlene A. Forastiere, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, David J. Adelstein, MD, of Cleveland Clinic’s Taussig Cancer Institute, and Judi Manola, MS, of Dana-Farber Cancer Institute, wrote in an accompanying editorial.
“Perhaps we need to ask whether, in retrospect, this meta-analysis was even necessary,” they wrote. “A meta-analysis of randomized trials is one way to establish Level Ia evidence supporting a clinical observation. But what is the clinical observation? In this case, it is the recognition that taxane, fluorouracil, and cisplatin are a better induction regimen than fluorouracil and cisplatin alone. Given the consistently better response rate for the three-drug regimens seen in the phase 3 trials, this observation was not in doubt.
“What this meta-analysis did not change is the standard of care in HNSCC,” Forastiere, Adelstein and Manola wrote. “Neither the multiple phase 3 trials nor their meta-analysis are able to establish a new treatment standard from a comparison of two nonstandard regimens. This point is made by the authors but merits re-emphasis.”
For more information:
- Blanchard P. J Clin Oncol. 2013;31:2854-2860.
- Forastiere AA. J Clin Oncol. 2013;31:2844-2846.
Disclosure: The researchers report research funding and honoraria from, as well as consultant or advisory roles with, Sanofi-Aventis.