In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin and 5 – fluorouracil – for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck.
On October 18, the US Food and Drug Administration (FDA) gave its approval to the new treatment as well. According to Steven Galson, M.D., director of FDA’s Center for Drug Evaluation and Research, it will “provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients’ survival.”
This drug – label extension of Taxotere (docetaxel) was possible due to the EORTC 24971 phase III, open label randomized trial, involving 358 patients, evaluating the benefit derived from docetaxel - based combination in inoperable locally advanced head and neck cancer.
Patients treated with the regimen prior to surgery or radiation had significantly longer median overall survival compared to a standard treatment of cisplatin and 5-fluorouracil; with a 28 percent risk reduction of the, 18.6 vs 14.5 months (p=0.0128). Patients receiving the docetaxel-based regimen also had a significantly longer time-to-disease progression of 11.4 months, compared with 8.3 months (P=0.015) for the patients receiving standard therapy. These results have been associated to an improvement of the safety profile.
”Very few treatment options are currently available for patients with head and neck cancer”, said Jan B. Vermorken, MD, PhD, Head of Oncology Department, University Hospital Antwerp and Chair of the EORTC Head and Neck Cancer Group and Principal Investigator of the EORTC 24971 study. “EORTC 24971/TAX 323 is the first study to identify a neoadjuvant chemotherapy regimen that extended life for patients with inoperable head and neck cancer; so a European approval may offer physicians another treatment option to manage this disease.”
”This label extension once again exemplifies nicely how the pharmaceutical industry and academic clinical research bring about innovation in cancer research. I am confident that an increase in these partnerships will prove to be extremely fruitful for cancer research in Europe”, adds Françoise Meunier, MD, PhD, Director General of the EORTC.
About the EORTC 24971 Trial
Patients in the trial were randomly assigned to receive one of two treatments. Of the 358 participants, 177 received an infusion of docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 on day one and a five-day continuous infusion of 5-fluorouraci (5-FU) 750 mg/m2 and 181 patients received an infusion of a standard treatment consisting of cisplatin 100 mg/m2 on day one followed by a five-day continuous infusion of 5-fluorouracil (5-FU) 1000 mg/m2/d. Treatment cycles were repeated every three weeks for a total of four cycles. Patients received radiation therapy following chemotherapy within four to seven weeks after completing the last cycle of chemotherapy. Radiation therapy was administered five days a week for seven weeks. Patients receiving the cisplatin and 5-fluorouracil (5 – FU) regimen showed greater grade 3-4 nausea (7/2% vs. 0.6%), vomiting (5.0% vs. 0.6 %) stomatitis (11% vs. 4.0 %) during chemotherapy and more toxic deaths (5.5 vs. 2.3 % of the total number of patients) when compared to the docetaxel-based regimen.
Patients treated with the docetaxel-containing regimen experienced significantly less deterioration of their Global Health Score compared to those treated with the standard regimen. The Performance Status Scale was also significantly in favor of the docetaxel-containing regimen. The head and neck subscales of the Performance Status Scale are designed to measure disturbances of speech and eating. Median time to first deterioration of WHO performance status was longer in the docetaxel-arm with a 30% risk reduction of WHO performance status deterioration (p=0.0158). The EORTC trial was supported by Sanofi-Aventis.
About Head and Neck Cancer
More than 640 000 people worldwide are diagnosed with head and neck cancer every year; and more than 350 000 die from the disease annually. Head and neck cancer is a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, nose, and throat. The term encompasses cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, larynx and lymph nodes in the upper part of the neck.
Nicole Heine | alfa
Ion treatments for cardiac arrhythmia — Non-invasive alternative to catheter-based surgery
20.01.2017 | GSI Helmholtzzentrum für Schwerionenforschung GmbH
Seeking structure with metagenome sequences
20.01.2017 | DOE/Joint Genome Institute
An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales
Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...
Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.
As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...
19.01.2017 | Event News
10.01.2017 | Event News
09.01.2017 | Event News
20.01.2017 | Awards Funding
20.01.2017 | Materials Sciences
20.01.2017 | Life Sciences