R Hitt1, L Iglesias2, A López-Pousa3, A Berrocal-Jaime4, J J Grau5, C García-Girón6, J Martínez-Trufero7, M Guix8,9, J Lambea-Sorrosal10, E Del Barco-Morillo11,12, X León-Vintró13, A J Cunquero-Tomas4, N Baste5, A Ocaña11,12, J J Cruz-Hernández11,12. 1. Medical Oncology Department, Hospital Universitario Severo Ochoa, Avda. de Orellana, s/n, 28911, Leganés (Madrid), Spain. rhitt@telefonica.net. 2. Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain. 3. Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Calalunya, Spain. 4. Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain. 5. Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain. 6. Medical Oncology Department, Hospital Universitario de Burgos, Castilla y León, Spain. 7. Medical Oncology Department, Hospital Universitario Miguel Servet, Aragón, Spain. 8. Medical Oncology Department, Hospital del Mar, Barcelona, Spain. 9. Cancer Research Program (CIBERONC), Institut Mar d Investigacions Mèdiques (IMM), Barcelona, Spain. 10. Medical Oncology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain. 11. Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain. 12. Institute for Biomedical Research of Salamanca (IBSAL), Castilla y León, Spain. 13. ENT Department, Hospital de la Santa Creu i Sant Pau, Catalunya, Spain.
Abstract
BACKGROUND: Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients. MATERIALS AND METHODS: Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with eitherdocetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial. RESULTS: In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8-34.4), 26.2 (95% CI, 18.2-36.6) and 25.4 months (95% CI, 17.4-36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx-hypopharynx primary tumors treated withIC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes. CONCLUSION: After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx-hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team. ClinicalTrials.gov identifier NCT00261703.
RCT Entities:
BACKGROUND: Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients. MATERIALS AND METHODS: Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial. RESULTS: In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8-34.4), 26.2 (95% CI, 18.2-36.6) and 25.4 months (95% CI, 17.4-36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx-hypopharynx primary tumors treated with IC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes. CONCLUSION: After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx-hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team. ClinicalTrials.gov identifier NCT00261703.
Entities:
Keywords:
Chemoradiotherapy; Head and neck cancer; Induction chemotherapy; Unresectable
Authors: M G Ghi; A Paccagnella; D Ferrari; P Foa; D Alterio; C Codecà; F Nolè; E Verri; R Orecchia; F Morelli; S Parisi; C Mastromauro; C A Mione; C Rossetto; M Polsinelli; H Koussis; L Loreggian; A Bonetti; F Campostrini; G Azzarello; C D'Ambrosio; F Bertoni; C Casanova; E Emiliani; M Guaraldi; F Bunkheila; P Bidoli; R M Niespolo; A Gava; E Massa; A Frattegiani; F Valduga; G Pieri; T Cipani; D Da Corte; F Chiappa; E Rulli Journal: Ann Oncol Date: 2017-09-01 Impact factor: 32.976
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Authors: Benjamin Lacas; Alexandra Carmel; Cécile Landais; Stuart J Wong; Lisa Licitra; Jeffrey S Tobias; Barbara Burtness; Maria Grazia Ghi; Ezra E W Cohen; Cai Grau; Gregory Wolf; Ricardo Hitt; Renzo Corvò; Volker Budach; Shaleen Kumar; Sarbani Ghosh Laskar; Jean-Jacques Mazeron; Lai-Ping Zhong; Werner Dobrowsky; Pirus Ghadjar; Carlo Fallai; Branko Zakotnik; Atul Sharma; René-Jean Bensadoun; Maria Grazia Ruo Redda; Séverine Racadot; George Fountzilas; David Brizel; Paolo Rovea; Athanassios Argiris; Zoltán Takácsi Nagy; Ju-Whei Lee; Catherine Fortpied; Jonathan Harris; Jean Bourhis; Anne Aupérin; Pierre Blanchard; Jean-Pierre Pignon Journal: Radiother Oncol Date: 2021-01-27 Impact factor: 6.280