Aim: To determine the maximum tolerated dose (MTD) of a short-course accelerated radiotherapy and its feasibility for symptomatic palliation of advanced head and neck cancer or head and neck metastases from any primary site. Patients and Methods: A phase I trial in four dose-escalation steps was planned: total dose ranged between 14 and 20 Gy in a total of four fractions administered twice a day. The dose-limiting toxicity (DLT) was determined as grade 3 or more toxicity occurring during treatment. The MTD obtained was used to plan a phase II trial. Results: A total of 48 patients were treated. In the phase I trial, the 20 Gy dose level was determined to be the MTD. In the phase II trial, the palliative response rate was 82.7%, with a median duration of palliation of 3 months. Conclusion: Short-course accelerated radiotherapy was well tolerated and effective for palliation. These findings may help design future prospective randomized studies.
Farina, E., Capuccini, J., Macchia, G., Caravatta, L., Nguyen, N. P., Cammelli, S., Farioli, A., Rambaldi, G. Z., Cilla, S., Wondemagegnhu, T., Uddin, A. F. M. K., Sumon, M. A., Genovesi, D., Buwenge, M., Cellini, F., Valentini, V., Deodato, F., Morganti, A. G., Phase I-II study of short-course accelerated radiotherapy (SHARON) for palliation in head and neck cancer, <<ANTICANCER RESEARCH>>, 2018; 38 (4): 2409-2414. [doi:10.21873/anticanres.12491] [http://hdl.handle.net/10807/149074]
Phase I-II study of short-course accelerated radiotherapy (SHARON) for palliation in head and neck cancer
Cellini, Francesco;Valentini, Vincenzo;Deodato, Francesco;
2018
Abstract
Aim: To determine the maximum tolerated dose (MTD) of a short-course accelerated radiotherapy and its feasibility for symptomatic palliation of advanced head and neck cancer or head and neck metastases from any primary site. Patients and Methods: A phase I trial in four dose-escalation steps was planned: total dose ranged between 14 and 20 Gy in a total of four fractions administered twice a day. The dose-limiting toxicity (DLT) was determined as grade 3 or more toxicity occurring during treatment. The MTD obtained was used to plan a phase II trial. Results: A total of 48 patients were treated. In the phase I trial, the 20 Gy dose level was determined to be the MTD. In the phase II trial, the palliative response rate was 82.7%, with a median duration of palliation of 3 months. Conclusion: Short-course accelerated radiotherapy was well tolerated and effective for palliation. These findings may help design future prospective randomized studies.
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