Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case-control study (PAULA-1).
Autor: | Arcelli A; Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy., Buwenge M; Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy., Macchia G; Radiotherapy Unit, Gemelli Molise Hospital, Campobasso, Italy., Bertini F; Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy., Guido A; Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy., Deodato F; Radiotherapy Unit, Gemelli Molise Hospital, Campobasso, Italy.; Istituto di Radiologia, Università Cattolica del Sacro Cuore, Rome, Italy., Cilla S; Medical Physics Unit, Gemelli Molise Hospital, Campobasso, Italy., Scotti V; San Rossore Private Hospital, Pisa, Italy., Rosetto ME; Radiotherapy Unit, Belcolle Hospital, Viterbo, Italy., Djan I; Institute of Oncology Vojvodina, Sremska Kamenica, Medical Faculty, University of Novi Sad, Novi Sad, Serbia., Parisi S; Unit of Radiation Therapy, IRCCS 'Casa Sollievo della Sofferenza' San Giovanni Rotondo, San Giovanni Rotondo, Italy., Mattiucci GC; UOC Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy., Cellini F; UOC Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy., Fiore M; Radiation Oncology, Campus Bio-Medico University, Rome, Italy., Bonomo P; Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy., Belgioia L; Department of Radiotherapy, Policlinico San Martino, University of Genoa, Genoa, Italy., Niespolo RM; Radiotherapy Unit, Azienda Ospedaliera San Gerardo, Monza, Italy., Gabriele P; Radiation Therapy, Candiolo Cancer Institute - FPO, IRCCS Candiolo, Candiolo, Italy., Di Marco M; Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy., Simoni N; Department of Radiotherapy, Azienda Ospedaliera Universitaria Integrata, Verona, Italy., Mazzarotto R; Department of Radiotherapy, Azienda Ospedaliera Universitaria Integrata, Verona, Italy., Morganti AG; Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. |
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Jazyk: | angličtina |
Zdroj: | Cancer medicine [Cancer Med] 2020 Nov; Vol. 9 (21), pp. 7879-7887. Date of Electronic Publication: 2020 Sep 10. |
DOI: | 10.1002/cam4.3330 |
Abstrakt: | Conventionally fractionated chemoradiation (CRT) or chemotherapy (CHT) are considered as standard options in locally advanced pancreatic cancer (LAPC) while stereotactic body radiotherapy (SBRT) is an emerging treatment in this setting. The aim of this study was to compare two cohorts of LAPC patients treated with SBRT ± CHT vs CRT ± CHT in terms of local control (LC), distant metastases-free survival (DMFS), progression-free survival (PFS), overall survival (OS), and toxicity. Eighty patients were included. Patients in the two cohorts were matched according to: age ≤/>65 years, tumor diameter (two cut-offs: ≥3.0 and ≥3.9 cm), clinical tumor stage and clinical nodal stage, neoadjuvant CHT, and adjuvant CHT. Median prescribed total dose was 30.0 Gy (range: 18.0-37.5) and 54.0 Gy (18.0-63.0) in SBRT and CRT cohorts, respectively. Toxicity was evaluated by CTCAE v4.0 scale. Survival curves were calculated by Kaplan-Meier method. For hypothesis testing an equivalence and a non-inferiority test was calculated. No statistically significant differences in terms of acute and late toxicity, DMFS, PFS, and OS were recorded among the two cohorts. Median, 1-, and 2-year LC was: 16.0 months, 53.1%, and 40.5% in the CRT cohort and 22.0 months, 80.4%, and 49.8% in the SBRT cohort, respectively (P: .017). A statistically non-inferiority significance was recorded in terms of OS between CRT and SBRT (P = .031). Patients treated with SBRT showed higher LC rate and similar OS compared to CRT. Therefore, the design of confirmatory randomized studies comparing SBRT and CRT seems justified. (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.) |
Databáze: | MEDLINE |
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