M Frikha1, A Auperin2, Y Tao3, F Elloumi4, N Toumi4, P Blanchard3, P Lang5, S Sun6, S Racadot7, J Thariat8, M Alfonsi9, C Tuchais10, A Cornely2, A Moussa2, J Guigay8, J Daoud11, J Bourhis12. 1. Medical Oncology Department, Sfax University Hospital, Sfax, Tunisia. 2. Department of Statistics, Gustave-Roussy, Villejuif, France. 3. Department of Radiation Oncology, Gustave-Roussy, Villejuif, France. 4. Radiation Oncology Department, Sfax University Hospital, Sfax, Tunisia. 5. Radiation Oncology Department, Pitié Salpetrière, Paris, France. 6. Radiation Oncology Department, Centre Hospitalier Montbeliard, Montbeliard, France. 7. Radiation Oncology Department, Centre L. Bérard, Lyon, France. 8. Department of Oncology, Centre A. Lacassagne, Nice, France. 9. Radiation Oncology Department, Clinique St Catherine, Avignon, France. 10. Radiation Oncology Department, Centre C. Papin, Angers, France. 11. Radiation Oncology Department, Sfax University Hospital, Sfax, Tunisia. Electronic address: jameldaoud@gmail.com. 12. Department of Radiation Oncology, Gustave-Roussy, Villejuif, France; Radiation Oncology Department, CHUV, Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.
Abstract
Background: Concomitant chemotherapy (CT)-radiotherapy (RT) is a standard of care in locally advanced nasopharyngeal carcinoma (NPC) and a role for induction CT is not established. Methods: Patients with locally advanced NPC, WHO type 2 or 3, were randomized to induction TPF plus concomitant cisplatin-RT or concomitant cisplatin-RT alone. The TPF regimen consisted of three cycles of Docetaxel 75 mg/m2 day 1; cisplatin 75 mg/m2 day 1; 5FU 750 mg/m2/day days 1-5. RT consisted of 70 Gy in 7 weeks plus concomitant cisplatin 40 mg/m2 weekly. Results:A total of 83 patients were included in the study. Demographics and tumour characteristics were well balanced between both arms. Most of the patients (95%) in the TPF arm received three cycles of induction CT. The rate of grade 3-4 toxicity and the compliance (NCI-CTCAE v3) during cisplatin-RT were not different between both arms. With a median follow-up of 43.1 months, the 3-year PFS rate was 73.9% in the TPF arm versus 57.2% in the reference arm [hazard ratio (HR) = 0.44; 95% confidence interval (CI): 0.20-0.97, P = 0.042]. Similarly the 3 years overall survival rate was 86.3% in the TPF arm versus 68.9% in the reference arm (HR = 0.40; 95% CI: 0.15-1.04, P = 0.05). Conclusion: In conclusion, several important aspects can be emphasized: the compliance to induction TPF was good and TPF did not compromise the tolerance of the concomitant RT-cisplatin phase. The improved PFS and overall survival rates needs to be confirmed by further trials.
RCT Entities:
Background: Concomitant chemotherapy (CT)-radiotherapy (RT) is a standard of care in locally advanced nasopharyngeal carcinoma (NPC) and a role for induction CT is not established. Methods:Patients with locally advanced NPC, WHO type 2 or 3, were randomized to induction TPF plus concomitant cisplatin-RT or concomitant cisplatin-RT alone. The TPF regimen consisted of three cycles of Docetaxel 75 mg/m2 day 1; cisplatin 75 mg/m2 day 1; 5FU 750 mg/m2/day days 1-5. RT consisted of 70 Gy in 7 weeks plus concomitant cisplatin 40 mg/m2 weekly. Results: A total of 83 patients were included in the study. Demographics and tumour characteristics were well balanced between both arms. Most of the patients (95%) in the TPF arm received three cycles of induction CT. The rate of grade 3-4 toxicity and the compliance (NCI-CTCAE v3) during cisplatin-RT were not different between both arms. With a median follow-up of 43.1 months, the 3-year PFS rate was 73.9% in the TPF arm versus 57.2% in the reference arm [hazard ratio (HR) = 0.44; 95% confidence interval (CI): 0.20-0.97, P = 0.042]. Similarly the 3 years overall survival rate was 86.3% in the TPF arm versus 68.9% in the reference arm (HR = 0.40; 95% CI: 0.15-1.04, P = 0.05). Conclusion: In conclusion, several important aspects can be emphasized: the compliance to induction TPF was good and TPF did not compromise the tolerance of the concomitant RT-cisplatin phase. The improved PFS and overall survival rates needs to be confirmed by further trials.
Authors: Carlos Rodriguez-Galindo; Mark D Krailo; Matthew J Krasin; Li Huang; M Beth McCarville; John Hicks; Farzana Pashankar; Alberto S Pappo Journal: J Clin Oncol Date: 2019-09-25 Impact factor: 44.544
Authors: Kenneth C W Wong; Edwin P Hui; Kwok-Wai Lo; Wai Kei Jacky Lam; David Johnson; Lili Li; Qian Tao; Kwan Chee Allen Chan; Ka-Fai To; Ann D King; Brigette B Y Ma; Anthony T C Chan Journal: Nat Rev Clin Oncol Date: 2021-06-30 Impact factor: 66.675