- Email: [email protected]
PO-0680: SBRT for locally advanced pancreatic cancer (LAPC): a retrospective multi-institutional experience
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11]. This checklist consists of minimum criteria that cancer clinical trials should incorporate to provide reliable HRQoL outcomes. The 11 items are categorized into conceptual, measurement, methodology and interpretation domains. All included studies were scored for adherence to the checklist. Each item that met the criteria received 1 point with a maximum of 11 points. Outcomes range from ‘probably robust’ (8 – 11) to ‘very limited’ (0 – 4). Results From 2005-2015, out of 225 publications reviewed, 16 LANSCLC clinical trials (represented in 25 articles) incorporated HRQoL endpoints. Radiotherapy was evaluated, in combination with surgery, systemic therapy or with medication aiming to reduce adverse radiotherapy effects, and impact on HRQoL was assessed. None of the studies had a methodological quality below 4 (‘very limited’). The average quality score of HRQoL reporting in all studies was 7.875, with 13 studies considered to be of high quality (‘probably robust’), versus 3 studies of average quality (‘limited robust’). No studies fulfilled all criteria. Particularly, details on a priori hypothesis (n=16) and details on missing data (n=9) were missing. Additionally, clinical significance rather than simple statistical significance was often unaddressed (n=13). Conclusion Qualitative reporting of HRQoL outcomes in scientific articles is a crucial aspect to adequately interpret HRQoL results, with the aim to facilitate daily clinical decision making and support therapy policies. In this review, only the minority of clinical trials fulfilled the minimum criteria for adequate HRQoL reporting. Due to the limited methodological quality and especially the fact that certain crucial aspects of HRQoL data reporting are lacking in the studies, good interpretation of HRQoL data remains difficult. Poster: Clinical track: Upper GI (oesophagus, stomach, pancreas, liver) PO-0679 Role of Chemoradiation Therapy as an Initial Treatment for Esophageal Carcinoma: A Meta-Analysis M. MA1, X.S. Gao1, X. Gu1 1 Peking University First Hospital, Radiation Oncology, Beijing, China Purpose or Objective This study was aimed to compare the therapeutic efficacy of definitive chemoradiotherapy(dCRT) and esophagectomy as initial treatment for resectable oesophageal cancer by meta-analysis. Material and Methods Databases of Pubmed and Web of Science were systematically searched to identify relevant studies. Combined odds ratio(OR) and 95% confidential interval (CI) were computed to assess the comparison effects. Results A total of thirteen studies (2 RCTs and 11 non-RCTs) with 2071 patients were identified, consisting of the dCRT arm (n=869) and surgery arm (n=1202). There was no statistically significant benefit on 1-year (OR 1.23, 0.67 to 2.24; P=0.50), 3-year (OR 1.022, 0.795 to 1.312; P=0.87) and 5-year overall survival (OR 1.05, 0.82 to 1.35; P = 0.68) for surgery compared with dCRT(Fig.A). As for diseasefree survival (DFS). dCRT is relatively inferior than surgery in short term result (OR for 3-year PFS: 1.37, 1.03 to 1.82; p=0.03) but is equivocal with surgery in long-term result (OR for 5-year PFS: 1.06, 0.79 to 1.42; p=0.70). Additionally, patients with positive lymph node could benefit on 5-year OS from dCRT (OR 0.238, 0.079 to 0.717; P=0.011)(Fig.B). Subgroup analysis for Asian and North American patients indidates that surgery is superior on 2-
year OS as compared with dCRT among North American patients(Fig.C). OR of 2-year OS for Asian patients and North American patients were 1.001, (95% CI 0.693 to 1.446; P=0.996) and 1.552, (95% CI 1.035 to 2.238; P=0.033), repectively. Furthermore, we analysed 5 studies consisting a total of 1202 patients which focused on stage I esophageal cancer, no statistically difference was found between dCRT and surgery on 2-year OS (OR 1.279, 0.704 to 2.35; p=0.419)(Fig.D).
Conclusion In summary, therapeutic effects of dCRT as the initial treatment is similar to that of surgery on long-term survivals and it remains equivalent with surgical resection for patients with stage I esophageal cancer. Patients with positive lymph node may benefit from dCRT. More randomized trials are needed to confirm our results. PO-0680 SBRT for locally advanced pancreatic cancer (LAPC): a retrospective multi-institutional experience G. Macchia1, A. Arcelli2, A.G. Morganti2, F. Bertini2, A. Guido2, L. Fuccio3, F. Dalla Torre1, S. Cilla4, V. Scotti5, M.E. Rosetto6, I. Djan7, S. Parisi8, G.C. Mattiucci9, V. Valentini9, M. Fiore10, P. Bonomo11, A. Bacigalupo12, R.M. Niespolo13, P. Gabriele14, F. Deodato1 1 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Radiotherapy Unit, Campobasso, Italy 2 University of Bologna, Radiation Oncology CenterDepartment of Experimental- Diagnostic and Specialty Medicine - DIMES, Bologna, Italy 3 University of Bologna, Department of Medical and Surgical Sciences - DIMEC, Bologna, Italy 4 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Medical Physic Unit, Campobasso, Italy 5 Radiosurgery Center Malzoni, Radiosurgery Center, Agropoli, Italy 6 Ospedale Belcolle, Radiotherapy Unit, Viterbo, Italy 7 Medical Faculty- University of Novi Sad, Institute of Oncology Vojvodina- Sremska Kamenica, Serbia, Serbia 8 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, Radiotherapy Unit, Foggia, Italy 9 Policlinico Universitario “A. Gemelli”- Università Cattolica del Sacro Cuore, Department of Radiotherapy, Rome, Italy 10 Università Campus Biomedico, Department of Radiotherapy, Rome, Italy 11 Azienda Ospedaliero Universitaria Careggi AOUC, Dpartment of Radiotherapy, Firenze, Italy 12 IRCCS AOU San Martino– IST, Department of Radiotherapy, Genova, Italy 13 Azienda Ospedaliera San Gerardo, Radiotherapy Unit, Monza, Italy 14 Fondazione del Piemonte per l'Oncologia FPO- IRCCS Candiolo, Department of Radiotherapy, Torino, Italy
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Purpose or Objective Pancreatic carcinoma is projected to become the 2^ leading cause of cancer mortality by 2030. At diagnosis, 30% of patients (pts) present with LAPC involving adjacent structures such as blood vessels, not usually removed because of risk of postoperative complications. Patients with LAPC have an intermediate prognosis between resectable and metastatic pts (median OS ranging from 5 to 11 months). LAPC cause significant pain, obstruction, and other morbidity due to direct extension of the primary tumor. Currently, a treatment option for LAPC is radiochemotherapy (RCT). SBRT is one emerging technique for treatment of LAPC, used by specialized centers to deliver a higher biologically effective dose of precisely targeted radiation in a short course of therapy. Conformity and rapid dose fall-off associated with SBRT offer the potential for dose escalation. We retrospectively review the experience of 5 different centers treating LAPC with SBRT. Material and Methods We included 41 pts with LAPC, undergoing SBRT +/chemotherapy (CT) with multiagent CT regimens. Exclusion criteria were metastatic disease and radical surgical treatment. Only palliative surgery was admitted. Median dose and median fractionation dose for SBRT were 25 Gy (range: 4-45) and 6 Gy (range: 4-22), respectively. Toxicity was evaluated by CTCAE.4 scale. Overall survival (OS) was estimated and compared by Kaplan-Meier and log-rank methods, respectively. Results We analyzed 41 pts (M/F: 21/20; median age: 71, range: 36-89). Median, 6 months, 1-year, and 2-year OS were: 15 months (range 13.5-16.4), 87.6%, 73.9%, 20.1%, respectively. At univariate analysis a better prognosis was recorded for pts with tumor located at the tail (p= 0.046), with a histologic grade 2 tumor (p<0.001), treated with adjuvant CT (p=0.036). There was a trend for improved OS in pts with cT3 tumor stage (p=0.085), and in pts treated with biliary stent (p=0.066). Nodal stage was not significantly related to OS. Incidence of gastrointestinal (GI) G1-G2 acute toxicity was 40%. Only one case of G3 GI acute toxicity (4%) and only one of G3 GI late toxicity (4.5%) were registered.
Conclusion Fractionated SBRT +/- CT results in tolerable acute and minimal late GI toxicity and warrants OS comparable to current standard treatment (RCT). Future studies should incorporate SBRT with more aggressive multiagent CT to optimize pts outcomes.
PO-0681 SBRT VS standard chemoradiation in locally advanced pancreatic cancer (LAPC): a case-control study A. Arcelli1, F. Bertini1, A.G. Morganti1, A. Guido1, L. Fuccio2, F. Deodato3, S. Cilla4, F. Dalla Torre3, V. Scotti5, E.M. Rosetto6, I. Djan7, S. Parisi8, G.C. Mattiucci9, V. Valentini9, M. Fiore10, P. Bonomo11, A. Bacigalupo12, R.M. Niespolo13, P. Gabriele14, G. Macchia3 1 University of Bologna, Radiation Oncology CenterDepartment of Experimental- Diagnostic and Specialty Medicine - DIMES, Bologna, Italy 2 University of Bologna, Department of Medical and Surgical Sciences - DIMEC, Bologna, Italy 3 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Radiotherapy Unit, Campobasso, Italy 4 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Medical Physic Unit, Campobasso, Italy 5 Radiosurgery Center Malzoni, Radiosurgery Center, Agropoli, Italy 6 Ospedale Belcolle, Radiotherapy Unit, Viterbo, Italy 7 Medical Faculty- University of Novi Sad, Institute of Oncology Vojvodina- Sremska Kamenica, Serbia, Serbia 8 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, Radiotherapy Unit, Foggia, Italy 9 Policlinico Universitario “A. Gemelli”- Università Cattolica del Sacro Cuore, Department of Radiotherapy, Rome, Italy 10 Università Campus Biomedico, Department of Radiotherapy, Rome, Italy 11 Azienda Ospedaliero Universitaria Careggi AOUC, Department of Radiotherapy, Firenze, Italy 12 IRCCS AOU San Martino– IST, Department of Radiotherapy, Genova, Italy 13 Azienda Ospedaliera San Gerardo, Radiotherapy Unit, Monza, Italy 14 Fondazione del Piemonte per l'Oncologia FPO- IRCCS Candiolo, Department of Radiotherapy, Torino, Italy Purpose or Objective In the last decades a treatment option for LAPC has been represented by chemoradiation (CRT), however SBRT is considered an emerging option for these patients (pts). Unfortunately, comparison between these two treatment techniques, in terms of toxicity and pts outcome, are lacking. Therefore, aim of this multicentric study is to compare toxicity and outcome between two cohorts of pts treated with SBRT or CRT. Material and Methods A case-control study was performed. Forty-two patients were enrolled (M/F: 25/17; median age: 68.5; range: 3689). Pts in the two groups were matched according to: age
11]. This checklist consists of minimum criteria that cancer clinical trials should incorporate to provide reliable HRQoL outcomes. The 11 items are categorized into conceptual, measurement, methodology and interpretation domains. All included studies were scored for adherence to the checklist. Each item that met the criteria received 1 point with a maximum of 11 points. Outcomes range from ‘probably robust’ (8 – 11) to ‘very limited’ (0 – 4). Results From 2005-2015, out of 225 publications reviewed, 16 LANSCLC clinical trials (represented in 25 articles) incorporated HRQoL endpoints. Radiotherapy was evaluated, in combination with surgery, systemic therapy or with medication aiming to reduce adverse radiotherapy effects, and impact on HRQoL was assessed. None of the studies had a methodological quality below 4 (‘very limited’). The average quality score of HRQoL reporting in all studies was 7.875, with 13 studies considered to be of high quality (‘probably robust’), versus 3 studies of average quality (‘limited robust’). No studies fulfilled all criteria. Particularly, details on a priori hypothesis (n=16) and details on missing data (n=9) were missing. Additionally, clinical significance rather than simple statistical significance was often unaddressed (n=13). Conclusion Qualitative reporting of HRQoL outcomes in scientific articles is a crucial aspect to adequately interpret HRQoL results, with the aim to facilitate daily clinical decision making and support therapy policies. In this review, only the minority of clinical trials fulfilled the minimum criteria for adequate HRQoL reporting. Due to the limited methodological quality and especially the fact that certain crucial aspects of HRQoL data reporting are lacking in the studies, good interpretation of HRQoL data remains difficult. Poster: Clinical track: Upper GI (oesophagus, stomach, pancreas, liver) PO-0679 Role of Chemoradiation Therapy as an Initial Treatment for Esophageal Carcinoma: A Meta-Analysis M. MA1, X.S. Gao1, X. Gu1 1 Peking University First Hospital, Radiation Oncology, Beijing, China Purpose or Objective This study was aimed to compare the therapeutic efficacy of definitive chemoradiotherapy(dCRT) and esophagectomy as initial treatment for resectable oesophageal cancer by meta-analysis. Material and Methods Databases of Pubmed and Web of Science were systematically searched to identify relevant studies. Combined odds ratio(OR) and 95% confidential interval (CI) were computed to assess the comparison effects. Results A total of thirteen studies (2 RCTs and 11 non-RCTs) with 2071 patients were identified, consisting of the dCRT arm (n=869) and surgery arm (n=1202). There was no statistically significant benefit on 1-year (OR 1.23, 0.67 to 2.24; P=0.50), 3-year (OR 1.022, 0.795 to 1.312; P=0.87) and 5-year overall survival (OR 1.05, 0.82 to 1.35; P = 0.68) for surgery compared with dCRT(Fig.A). As for diseasefree survival (DFS). dCRT is relatively inferior than surgery in short term result (OR for 3-year PFS: 1.37, 1.03 to 1.82; p=0.03) but is equivocal with surgery in long-term result (OR for 5-year PFS: 1.06, 0.79 to 1.42; p=0.70). Additionally, patients with positive lymph node could benefit on 5-year OS from dCRT (OR 0.238, 0.079 to 0.717; P=0.011)(Fig.B). Subgroup analysis for Asian and North American patients indidates that surgery is superior on 2-
year OS as compared with dCRT among North American patients(Fig.C). OR of 2-year OS for Asian patients and North American patients were 1.001, (95% CI 0.693 to 1.446; P=0.996) and 1.552, (95% CI 1.035 to 2.238; P=0.033), repectively. Furthermore, we analysed 5 studies consisting a total of 1202 patients which focused on stage I esophageal cancer, no statistically difference was found between dCRT and surgery on 2-year OS (OR 1.279, 0.704 to 2.35; p=0.419)(Fig.D).
Conclusion In summary, therapeutic effects of dCRT as the initial treatment is similar to that of surgery on long-term survivals and it remains equivalent with surgical resection for patients with stage I esophageal cancer. Patients with positive lymph node may benefit from dCRT. More randomized trials are needed to confirm our results. PO-0680 SBRT for locally advanced pancreatic cancer (LAPC): a retrospective multi-institutional experience G. Macchia1, A. Arcelli2, A.G. Morganti2, F. Bertini2, A. Guido2, L. Fuccio3, F. Dalla Torre1, S. Cilla4, V. Scotti5, M.E. Rosetto6, I. Djan7, S. Parisi8, G.C. Mattiucci9, V. Valentini9, M. Fiore10, P. Bonomo11, A. Bacigalupo12, R.M. Niespolo13, P. Gabriele14, F. Deodato1 1 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Radiotherapy Unit, Campobasso, Italy 2 University of Bologna, Radiation Oncology CenterDepartment of Experimental- Diagnostic and Specialty Medicine - DIMES, Bologna, Italy 3 University of Bologna, Department of Medical and Surgical Sciences - DIMEC, Bologna, Italy 4 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Medical Physic Unit, Campobasso, Italy 5 Radiosurgery Center Malzoni, Radiosurgery Center, Agropoli, Italy 6 Ospedale Belcolle, Radiotherapy Unit, Viterbo, Italy 7 Medical Faculty- University of Novi Sad, Institute of Oncology Vojvodina- Sremska Kamenica, Serbia, Serbia 8 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, Radiotherapy Unit, Foggia, Italy 9 Policlinico Universitario “A. Gemelli”- Università Cattolica del Sacro Cuore, Department of Radiotherapy, Rome, Italy 10 Università Campus Biomedico, Department of Radiotherapy, Rome, Italy 11 Azienda Ospedaliero Universitaria Careggi AOUC, Dpartment of Radiotherapy, Firenze, Italy 12 IRCCS AOU San Martino– IST, Department of Radiotherapy, Genova, Italy 13 Azienda Ospedaliera San Gerardo, Radiotherapy Unit, Monza, Italy 14 Fondazione del Piemonte per l'Oncologia FPO- IRCCS Candiolo, Department of Radiotherapy, Torino, Italy
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Purpose or Objective Pancreatic carcinoma is projected to become the 2^ leading cause of cancer mortality by 2030. At diagnosis, 30% of patients (pts) present with LAPC involving adjacent structures such as blood vessels, not usually removed because of risk of postoperative complications. Patients with LAPC have an intermediate prognosis between resectable and metastatic pts (median OS ranging from 5 to 11 months). LAPC cause significant pain, obstruction, and other morbidity due to direct extension of the primary tumor. Currently, a treatment option for LAPC is radiochemotherapy (RCT). SBRT is one emerging technique for treatment of LAPC, used by specialized centers to deliver a higher biologically effective dose of precisely targeted radiation in a short course of therapy. Conformity and rapid dose fall-off associated with SBRT offer the potential for dose escalation. We retrospectively review the experience of 5 different centers treating LAPC with SBRT. Material and Methods We included 41 pts with LAPC, undergoing SBRT +/chemotherapy (CT) with multiagent CT regimens. Exclusion criteria were metastatic disease and radical surgical treatment. Only palliative surgery was admitted. Median dose and median fractionation dose for SBRT were 25 Gy (range: 4-45) and 6 Gy (range: 4-22), respectively. Toxicity was evaluated by CTCAE.4 scale. Overall survival (OS) was estimated and compared by Kaplan-Meier and log-rank methods, respectively. Results We analyzed 41 pts (M/F: 21/20; median age: 71, range: 36-89). Median, 6 months, 1-year, and 2-year OS were: 15 months (range 13.5-16.4), 87.6%, 73.9%, 20.1%, respectively. At univariate analysis a better prognosis was recorded for pts with tumor located at the tail (p= 0.046), with a histologic grade 2 tumor (p<0.001), treated with adjuvant CT (p=0.036). There was a trend for improved OS in pts with cT3 tumor stage (p=0.085), and in pts treated with biliary stent (p=0.066). Nodal stage was not significantly related to OS. Incidence of gastrointestinal (GI) G1-G2 acute toxicity was 40%. Only one case of G3 GI acute toxicity (4%) and only one of G3 GI late toxicity (4.5%) were registered.
Conclusion Fractionated SBRT +/- CT results in tolerable acute and minimal late GI toxicity and warrants OS comparable to current standard treatment (RCT). Future studies should incorporate SBRT with more aggressive multiagent CT to optimize pts outcomes.
PO-0681 SBRT VS standard chemoradiation in locally advanced pancreatic cancer (LAPC): a case-control study A. Arcelli1, F. Bertini1, A.G. Morganti1, A. Guido1, L. Fuccio2, F. Deodato3, S. Cilla4, F. Dalla Torre3, V. Scotti5, E.M. Rosetto6, I. Djan7, S. Parisi8, G.C. Mattiucci9, V. Valentini9, M. Fiore10, P. Bonomo11, A. Bacigalupo12, R.M. Niespolo13, P. Gabriele14, G. Macchia3 1 University of Bologna, Radiation Oncology CenterDepartment of Experimental- Diagnostic and Specialty Medicine - DIMES, Bologna, Italy 2 University of Bologna, Department of Medical and Surgical Sciences - DIMEC, Bologna, Italy 3 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Radiotherapy Unit, Campobasso, Italy 4 Fondazione di Ricerca e Cura “Giovanni Paolo II”, Medical Physic Unit, Campobasso, Italy 5 Radiosurgery Center Malzoni, Radiosurgery Center, Agropoli, Italy 6 Ospedale Belcolle, Radiotherapy Unit, Viterbo, Italy 7 Medical Faculty- University of Novi Sad, Institute of Oncology Vojvodina- Sremska Kamenica, Serbia, Serbia 8 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, Radiotherapy Unit, Foggia, Italy 9 Policlinico Universitario “A. Gemelli”- Università Cattolica del Sacro Cuore, Department of Radiotherapy, Rome, Italy 10 Università Campus Biomedico, Department of Radiotherapy, Rome, Italy 11 Azienda Ospedaliero Universitaria Careggi AOUC, Department of Radiotherapy, Firenze, Italy 12 IRCCS AOU San Martino– IST, Department of Radiotherapy, Genova, Italy 13 Azienda Ospedaliera San Gerardo, Radiotherapy Unit, Monza, Italy 14 Fondazione del Piemonte per l'Oncologia FPO- IRCCS Candiolo, Department of Radiotherapy, Torino, Italy Purpose or Objective In the last decades a treatment option for LAPC has been represented by chemoradiation (CRT), however SBRT is considered an emerging option for these patients (pts). Unfortunately, comparison between these two treatment techniques, in terms of toxicity and pts outcome, are lacking. Therefore, aim of this multicentric study is to compare toxicity and outcome between two cohorts of pts treated with SBRT or CRT. Material and Methods A case-control study was performed. Forty-two patients were enrolled (M/F: 25/17; median age: 68.5; range: 3689). Pts in the two groups were matched according to: age