Patient Summary: Randomized phase III trial comparing induction chemotherapy using cisplatin (P) fluorouracil (F) with or without docetaxel (T) for organ preservation in hypopharynx and larynx cancer. Preliminary results of GORTEC 2000-01
Randomized phase III trial comparing induction chemotherapy using cisplatin (P) fluorouracil (F) with or without docetaxel (T) for organ preservation in hypopharynx and larynx cancer. Preliminary results of GORTEC 2000-01
Chemotherapy followed by radiation treatment (RT) provides a potential for laryngeal preservation in patients with locally advanced laryngeal and hypopharyngeal cancer. Cisplatin and 5-FU is the standard regimen in locally advanced head & neck cancer, and data have suggested to the addition of docetaxel may improve the likelihood of preserving laryngeal function. 220 patients with larynx or hypopharynx primary sites, T3-T4 tumors or T2 tumors not suitable for partial laryngectomy, were randomized to cisplatin/5-FU (PF) or cisplatin/5-FU/docetaxel (TPF). After chemotherapy, patients who did not respond underwent total laryngectomy, and those who did respond received radiation therapy.
As for side effects, hair loss and neutropenia were more common in the TPF arm; mucositis and neutropenic fever were more common in the PF arm. 81.2% of patients in the TPF arm versus 67.4% of patients in the PF arm received the total prescribed doses. The TPF arm resulted in more patients being offered laryngeal preservation (80.0% versus 57.6%), and at three years, more patients in the TPF arm still had a functioning larynx (73% vs. 63%). There was not a statistically significant survival advantage in the TPF arm, but the results are leaning towards this, and we may see a survival advantage with increased follow-up. Nevertheless, TPF appears to be the standard of care as an induction regimen in head & neck cancer.