A Paccagnella1, M G Ghi2, L Loreggian3, A Buffoli4, H Koussis5, C A Mione6, A Bonetti7, F Campostrini8, G Gardani9, A Ardizzoia10, D Dondi11, M Guaraldi12, R Cavallo13, L Tomio14, A Gava15. 1. Department of Medical Oncology, Venezia. Electronic address: adriano.paccagnella@ulss12.ve.it. 2. Department of Medical Oncology, Venezia. 3. Department of Radiotherapy, Istituto Oncologico Veneto, Istituto di Ricerca e Cura a Carattere Scientifico, Padova. 4. Department of Radiotherapy, Azienda Ospedaliera Universitaria, Udine. 5. Department of Medical Oncology, Istituto Oncologico Veneto, IRCCS, Padova. 6. Department of Radiotherapy, Ospedale SS. Giovanni e Paolo, Venezia. 7. Department of Medical Oncology, Ospedale Mater Salutis, Legnago. 8. Department of Radiotherapy, Ospedale Mater Salutis, Legnago. 9. Department of Radiotherapy, S. Gerardo Hospital, Monza. 10. Department of Medical Oncology, S. Gerardo Hospital, Monza. 11. Sanofi-Aventis, Milano. 12. Department of Medical Oncology, S. Orsola-Malpighi Hospital, Bologna. 13. Department of Medical Oncology, P. Cosma Hospital, Camposampiero, Padova. 14. Department of Radiotherapy, S. Chiara Hospital, Trento. 15. Department of Radiotherapy, Ospedale Ca' Foncello, Treviso, Italy.
Abstract
BACKGROUND:Concomitant chemoradiotherapy (CT/RT) is the standard treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). We evaluated the efficacy of induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone. PATIENTS AND METHODS: Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one, were randomly assigned to receive CT/RT alone (arm A: two cycles of cisplatin 20 mg/m(2), days1-4, plus5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy) or three cycles of TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT. The primary end point was the rate of radiologic complete response (CR) at 6-8 weeks after the end of CT/RT. RESULTS:A total of 101 patients were randomly allocated to the study (51 arm A; 50 arm B). CR rates were 21.2% (arm A) versus 50% (arm B). Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B). Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms. CONCLUSION: Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility.
RCT Entities:
BACKGROUND: Concomitant chemoradiotherapy (CT/RT) is the standard treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). We evaluated the efficacy of induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone. PATIENTS AND METHODS: Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one, were randomly assigned to receive CT/RT alone (arm A: two cycles of cisplatin 20 mg/m(2), days1-4, plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy) or three cycles of TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT. The primary end point was the rate of radiologic complete response (CR) at 6-8 weeks after the end of CT/RT. RESULTS: A total of 101 patients were randomly allocated to the study (51 arm A; 50 arm B). CR rates were 21.2% (arm A) versus 50% (arm B). Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B). Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms. CONCLUSION: Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility.
Authors: Douglas Adkins; Jessica Ley; Kathryn Trinkaus; Wade Thorstad; James Lewis; Tanya Wildes; Barry A Siegel; Farrokh Dehdashti; Hiram Gay; Paul Mehan; Brian Nussenbaum Journal: Cancer Date: 2012-09-18 Impact factor: 6.860