Aim: To define safety and efficacy of a palliative, short-course accelerated radiation therapy for symptomatic locally advanced primary pelvic cancer. Materials and Methods: A phase II trial was planned based on the minimax Simon’s two-stage design. A total of 18 Gy in 4.5 Gy/fraction administered twice a day was delivered (SHARON). Pain and quality of life were recorded according to the Visual Analogue self-assessment and the cancer linear analog scales (CLAS), respectively. Results: Twenty-five patients were enrolled in the study. The most frequent baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%). The overall palliative response rate was 96.0%, with a median palliative duration of 6 months. An improvement of quality-of-life indices (well-being, fatigue, and ability to perform daily activities) was noted in 64.0%, 36.0%, and 48.0% of patients, respectively. Conclusion: The SHARON regimen was well tolerated and effective in the palliative treatment of patients with locally advanced pelvic cancer. Based on these results, a multicentric prospective phase III trial is ongoing to compare this regimen with traditional 2-week radiotherapy treatment.

Farina, E., Macchia, G., Siepe, G., Zamagni, A., Buwenge, M., Scirocco, E., Cellini, F., Deressa, B. T., Tigeneh, W., Uddin, K. A. F. M., Sumon, M. A., Caravatta, L., Genovesi, D., Mauro, F. A., Cammelli, S., Cilla, S., Morganti, A. G., Deodato, F., Palliative short-course radiotherapy in advanced pelvic cancer: A phase II study (SHARON project), <<ANTICANCER RESEARCH>>, 2019; 39 (8): 4237-4242. [doi:10.21873/anticanres.13585] [http://hdl.handle.net/10807/203506]

Palliative short-course radiotherapy in advanced pelvic cancer: A phase II study (SHARON project)

Macchia, G.;Cellini, F.;Cilla, S.;Morganti, A. G.;Deodato, F.
2019

Abstract

Aim: To define safety and efficacy of a palliative, short-course accelerated radiation therapy for symptomatic locally advanced primary pelvic cancer. Materials and Methods: A phase II trial was planned based on the minimax Simon’s two-stage design. A total of 18 Gy in 4.5 Gy/fraction administered twice a day was delivered (SHARON). Pain and quality of life were recorded according to the Visual Analogue self-assessment and the cancer linear analog scales (CLAS), respectively. Results: Twenty-five patients were enrolled in the study. The most frequent baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%). The overall palliative response rate was 96.0%, with a median palliative duration of 6 months. An improvement of quality-of-life indices (well-being, fatigue, and ability to perform daily activities) was noted in 64.0%, 36.0%, and 48.0% of patients, respectively. Conclusion: The SHARON regimen was well tolerated and effective in the palliative treatment of patients with locally advanced pelvic cancer. Based on these results, a multicentric prospective phase III trial is ongoing to compare this regimen with traditional 2-week radiotherapy treatment.
Inglese
Farina, E., Macchia, G., Siepe, G., Zamagni, A., Buwenge, M., Scirocco, E., Cellini, F., Deressa, B. T., Tigeneh, W., Uddin, K. A. F. M., Sumon, M. A., Caravatta, L., Genovesi, D., Mauro, F. A., Cammelli, S., Cilla, S., Morganti, A. G., Deodato, F., Palliative short-course radiotherapy in advanced pelvic cancer: A phase II study (SHARON project), <<ANTICANCER RESEARCH>>, 2019; 39 (8): 4237-4242. [doi:10.21873/anticanres.13585] [http://hdl.handle.net/10807/203506]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/203506
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