Induction with Docetaxel, Cisplatin, and 5-FU provides survival benefits beyond 5 years in head and neck cancer
Author: Chris Berrie
Induction with docetaxel, cisplatin, and 5-fluorouracil (5-FU) provides sustained significant survival advantages beyond 5 years compared with cisplatin and 5-FU in patients with locally advanced squamous cell cancer of the head and neck.
Jochen Lorch, MD, Head and Neck Oncology Programme, Dana Farber Cancer Institute, Harvard University, Boston, Massachusetts, presented a 5-year follow-up analysis of the multicentre, randomised, open-label, phase 3 Cisplatin and Fluorouracil Alone or With Docetaxel in Head and Neck Cancer (TAX 324) at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO).
The benefits of docetaxel in combination with cisplatin and 5-fluorouracil (TPF) was shown in the original TAX 324 and TAX 323 studies. Results of the follow-up were presented here on September 22.
TAX 324 included 501 patients with measurable, nonmetastatic stages III and IV squamous cell carcinoma of the head and neck, with a primary tumour location in the oral cavity, oropharynx, larynx or hypopharynx, and unresectable disease. A World Health Organization (WHO) performance status (PS) of 0/1 and no prior chemotherapy or radiotherapy were also specified.
Patients were randomised to induction therapy of TPF (n = 255) or cisplatin plus 5-fluorouracil (PF) on days 1 to 4, every 3 weeks for 3 cycles (n = 246). The induction treatments were followed by chemoradiotherapy with carboplatin area under the curve (AUC) 1.5, weekly and daily radiotherapy (5 days/week).
In the original study, there was a significant 13% improvement (62% vs 49%) in 3-year overall survival (OS) with TPF over PF (P = .006), with median survivals of 71 months versus 30 months.
The current 5-year, long-term follow-up included 440 patients (88%), and showed a significant 10% improvement (52% vs 42%) for TPF over PF (P = .014), with median survivals of 71 months versus 35 months.
According to disease site subgroups here, the median survivals showed, respectively: oropharynx, not reached versus 65 months (P = .045); hypopharynx, 32 versus 20 months (P = .29); larynx, 58 versus 25 months (P = .29); and oral cavity, 37 versus 14 months (P = .70).
However, as Dr. Lorch noted for laryngeal and hypopharyngeal tumours, “If these patients recur, there is a surgical salvage option.” Thus for progression-free survival rather than overall survival, there was indeed a significant benefit for these patients (P = .0365).
According to tumour staging, the beneficial trend for TPF over PF for stage III at 3 years (71 vs 51 months; P = .07) was lost at 5 years (90 vs 65 months; P = .26). In contrast, the main benefit was for stage IV at both 3 years (59 vs 25 months; P = .02) and 5 years (59 vs 25; P = .03).
For toxicity, Dr. Lorch noted that there were no significant differences at 3 years and at 5 years.
1. Funding for this study was provided by Sanofi-Aventis.
2. Presentation tile: Long-Term (Five-Year) Results of TAX324: A Phase III Trial of Sequential Therapy Comparing TPF With PF in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck. Abstract 8502