caa a22 4500 397563787 CHVBK 20180308164822.0 cr unu---uuuuu 161202e19960501xx s 000 0 eng 10.1093/jnci/88.9.583 doi (NATIONALLICENCE)oxford-10.1093/jnci/88.9.583 Five-Year Update of a Randomized Trial of Alternating Radiotherapy and Chemotherapy Compared With Radiotherapy Alone in Treatment of Unresectable Squamous Cell Carcinoma of the Head and Neck [Elektronische Daten] [Marco Merlano, Marco Benasso, Renzo Corvò, Riccardo Rosso, Vito Vitale, Fulvia Blengio, Gianmauro Numico, Giovanni Margarino, Luigina Bonelli, Leonardo Santi] Background: In 1992, we reported the first analysis of a randomized trial comparing alternating radiotherapy and chemotherapy with radiotherapy alone in the treatment of squamous cell carcinoma of the head and neck. The results of that 3-year analysis indicated that the combined treatment had superior efficacy. Purpose: After an additional 2 years of follow-up, we again compared the efficacy of the two treatment regimens, with attention paid to differences in overall survival, progression-free survival, and locoregional relapse-free survival. Methods: One hundred fifty-seven patients with untreated, unresectable squamous cell carcinoma of the head and neck were randomly assigned to receive either chemotherapy (four courses of cisplatin [20 mg/m2] and fluorouracil [200 mg/m2], given daily for 5 consecutive days during weeks 1, 4, 7, and 10) plus radiotherapy (three courses of 20 Gy each, given in fractions of 2 Gy per day during weeks 2-3, 5-6, and 8-9) or radiotherapy alone (70 Gy total dose, given in fractions of 2 Gy per day, 5 days per week). Eighty patients received the combined therapy, and 77 were treated with radiotherapy alone. Responses, failures, and toxic effects associated with the two treatment regimens were compared. Overall survival, progression-free survival, and locoregional relapse-free survival were calculated according to the Kaplan-Meier method; the logrank test was used to compare survival parameters between the two patient groups. Reported P values are two-sided. Results: As reported previously, toxic effects associated with the combined therapy included both chemotherapy- and radiotherapy-related effects; however, the incidence and severity of mucositis were nearly identical among patients in the two treatment arms. The combined treatment was associated with a statistically significant increase in the frequency of complete response (i.e., the disappearance of clinically detectable disease for at least 4 weeks) (43% for the combined-treatment group compared with 22% for the radiotherapy-only group; P =.037, chi-squared test). Five-year estimates of overall survival in the combined-treatment group compared with the radiotherapy-only group were 24% (95% confidence interval [CI] = 14%-40%) and 10% (95% CI = 4%-24%), respectively (P =.01, logrank test). The estimates of progression-free survival at 5 years in the combined-treatment group compared with the radiotherapy-only group were 21% (95% CI = 11%-37%) and 9% (95% CI = 3%-22%), respectively (P =.008, logrank test). Finally, the 5-year estimates of locoregional relapse-free survival were 64% (95% CI = 36%-84%) in the combined-treatment group and 32% (95% CI = 10%-65%) in the radiotherapy-only group (P =.038, logrank test). Conclusions and Implications: The superiority of alternating chemotherapy and radiotherapy over radiotherapy alone in treating unresectable squamous cell carcinoma of the head and neck seen at 3 years was confirmed at 5 years. However, additional trials must be conducted before considering the combined approach as standard therapy. [J Natl Cancer Inst 1996; 88: 583-9] © Oxford University Press REPORTS nationallicence Merlano Marco Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut Benasso Marco Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut Corvò Renzo Department of Radiation Oncology, National Institute for Cancer Research Genoa, Italy aut Rosso Riccardo Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut Vitale Vito Department of Radiation Oncology, National Institute for Cancer Research Genoa, Italy aut Blengio Fulvia Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut Numico Gianmauro Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut Margarino Giovanni Department of Surgical Oncology, National Institute for Cancer Research Genoa, Italy aut Bonelli Luigina Department of Biostatistics, National Institute for Cancer Research Genoa, Italy aut Santi Leonardo National Institute for Cancer Research Genoa, Italy aut JNCI: Journal of the National Cancer Institute Oxford University Press 88/9(1996-05-01), 583-589 0027-8874 88:9<583 1996 88 jnci https://doi.org/10.1093/jnci/88.9.583 text/html Onlinezugriff via DOI 1 other jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jnci/88.9.583 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Merlano Marco Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Benasso Marco Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Corvò Renzo Department of Radiation Oncology, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Rosso Riccardo Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Vitale Vito Department of Radiation Oncology, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Blengio Fulvia Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Numico Gianmauro Department of Medical Oncology 1, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Margarino Giovanni Department of Surgical Oncology, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Bonelli Luigina Department of Biostatistics, National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 700 1- Santi Leonardo National Institute for Cancer Research Genoa, Italy aut NATIONALLICENCE 773 0- JNCI: Journal of the National Cancer Institute Oxford University Press 88/9(1996-05-01), 583-589 0027-8874 88:9<583 1996 88 jnci Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford