Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1)
Abstract 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 LA...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-11-01
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| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.3330 |
| _version_ | 1818555432067661824 |
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| author | Alessandra Arcelli Milly Buwenge Gabriella Macchia Federica Bertini Alessandra Guido Francesco Deodato Savino Cilla Valerio Scotti Maria Elena Rosetto Igor Djan Salvatore Parisi Gian Carlo Mattiucci Francesco Cellini Michele Fiore Pierluigi Bonomo Liliana Belgioia Rita Marina Niespolo Pietro Gabriele Mariacristina Di Marco Nicola Simoni Renzo Mazzarotto Alessio Giuseppe Morganti the AIRO (Italian Association of Radiation Oncology and Clinical Oncology) Gastrointestinal Study Group |
| author_facet | Alessandra Arcelli Milly Buwenge Gabriella Macchia Federica Bertini Alessandra Guido Francesco Deodato Savino Cilla Valerio Scotti Maria Elena Rosetto Igor Djan Salvatore Parisi Gian Carlo Mattiucci Francesco Cellini Michele Fiore Pierluigi Bonomo Liliana Belgioia Rita Marina Niespolo Pietro Gabriele Mariacristina Di Marco Nicola Simoni Renzo Mazzarotto Alessio Giuseppe Morganti the AIRO (Italian Association of Radiation Oncology and Clinical Oncology) Gastrointestinal Study Group |
| author_sort | Alessandra Arcelli |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-12T09:53:23Z |
| format | Article |
| id | doaj.art-c7c3e13702e6444dbeaf6adfa8586e35 |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-12-12T09:53:23Z |
| publishDate | 2020-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-c7c3e13702e6444dbeaf6adfa8586e352022-12-22T00:28:13ZengWileyCancer Medicine2045-76342020-11-019217879788710.1002/cam4.3330Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1)Alessandra Arcelli0Milly Buwenge1Gabriella Macchia2Federica Bertini3Alessandra Guido4Francesco Deodato5Savino Cilla6Valerio Scotti7Maria Elena Rosetto8Igor Djan9Salvatore Parisi10Gian Carlo Mattiucci11Francesco Cellini12Michele Fiore13Pierluigi Bonomo14Liliana Belgioia15Rita Marina Niespolo16Pietro Gabriele17Mariacristina Di Marco18Nicola Simoni19Renzo Mazzarotto20Alessio Giuseppe Morganti21the AIRO (Italian Association of Radiation Oncology and Clinical Oncology) Gastrointestinal Study GroupRadiation Oncology Center Department of Experimental, Diagnostic and Specialty Medicine – DIMES University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyRadiation Oncology Center Department of Experimental, Diagnostic and Specialty Medicine – DIMES University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyRadiotherapy Unit Gemelli Molise Hospital Campobasso ItalyRadiation Oncology Center Department of Experimental, Diagnostic and Specialty Medicine – DIMES University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyRadiation Oncology Center Department of Experimental, Diagnostic and Specialty Medicine – DIMES University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyRadiotherapy Unit Gemelli Molise Hospital Campobasso ItalyMedical Physics Unit Gemelli Molise Hospital Campobasso ItalySan Rossore Private Hospital Pisa ItalyRadiotherapy Unit Belcolle Hospital Viterbo ItalyInstitute of Oncology Vojvodina Sremska Kamenica, Medical Faculty University of Novi Sad Novi Sad SerbiaUnit of Radiation Therapy IRCCS “Casa Sollievo della Sofferenza” San Giovanni Rotondo San Giovanni Rotondo ItalyUOC Radioterapia Oncologica Dipartimento di Diagnostica per Immagini Radioterapia Oncologica ed Ematologia Fondazione Policlinico Universitario "A. Gemelli" IRCCS Rome ItalyUOC Radioterapia Oncologica Dipartimento di Diagnostica per Immagini Radioterapia Oncologica ed Ematologia Fondazione Policlinico Universitario "A. Gemelli" IRCCS Rome ItalyRadiation Oncology Campus Bio‐Medico University Rome ItalyRadiation Oncology Azienda Ospedaliero‐Universitaria Careggi Florence ItalyDepartment of Radiotherapy Policlinico San Martino University of Genoa Genoa ItalyRadiotherapy Unit Azienda Ospedaliera San Gerardo Monza ItalyRadiation Therapy Candiolo Cancer Institute – FPO IRCCS Candiolo Candiolo ItalyOncology Unit Department of Experimental Diagnostic and Specialty Medicine – DIMES, University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyDepartment of Radiotherapy Azienda Ospedaliera Universitaria Integrata Verona ItalyDepartment of Radiotherapy Azienda Ospedaliera Universitaria Integrata Verona ItalyRadiation Oncology Center Department of Experimental, Diagnostic and Specialty Medicine – DIMES University of Bologna S. Orsola‐Malpighi Hospital Bologna ItalyAbstract 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.https://doi.org/10.1002/cam4.3330conventionally fractionated radiotherapypancreatic cancerradiation therapystereotactic body radiotherapy |
| spellingShingle | Alessandra Arcelli Milly Buwenge Gabriella Macchia Federica Bertini Alessandra Guido Francesco Deodato Savino Cilla Valerio Scotti Maria Elena Rosetto Igor Djan Salvatore Parisi Gian Carlo Mattiucci Francesco Cellini Michele Fiore Pierluigi Bonomo Liliana Belgioia Rita Marina Niespolo Pietro Gabriele Mariacristina Di Marco Nicola Simoni Renzo Mazzarotto Alessio Giuseppe Morganti the AIRO (Italian Association of Radiation Oncology and Clinical Oncology) Gastrointestinal Study Group Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) Cancer Medicine conventionally fractionated radiotherapy pancreatic cancer radiation therapy stereotactic body radiotherapy |
| title | Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) |
| title_full | Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) |
| title_fullStr | Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) |
| title_full_unstemmed | Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) |
| title_short | Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case‐control study (PAULA‐1) |
| title_sort | stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer a multicenter case control study paula 1 |
| topic | conventionally fractionated radiotherapy pancreatic cancer radiation therapy stereotactic body radiotherapy |
| url | https://doi.org/10.1002/cam4.3330 |
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