Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

Zamagni, Alice; Buwenge, M.; Macchia, G.; Siepe, G.; Cilla, Savino; Cellini, Francesco; Arcelli, A.; Farina, E.; Deodato, Francesco; Cammelli, S.; Morganti, Alessio Giuseppe

doi:10.21873/anticanres.13699

Cited by 8 publications

(12 citation statements)

References 19 publications

(21 reference statements)

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“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement). Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO).…”

Section: Resultsmentioning

confidence: 99%

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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ImportanceApproximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications.ObjectiveTo investigate the use and reporting of PROs in clinical trials of palliative radiotherapy.Evidence ReviewThis preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines.FindingsAmong 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score.Conclusions and RelevanceIn this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

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Section: Resultsmentioning

confidence: 99%

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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“…: direct infiltration, primary pancreatic; H&N; Lymph-node infiltrating surrounding structures, etc.) QP6a Thomson [ 6 ] H&N : If restricted RT department resources single fraction could be used: 8 Gy/1fx8Gy H&N : If restricted RT department resources: 20 Gy/5fx4Gy • Symptomatic benefit and chance of cure are two of the top three factors determining which patients should start RT within 1–3 wks A = 70% [SA = 30%] D = 30% [SD = 0%] • Do not postpone RT initiation of HNSCC radiotherapy by more than 4–6 wks • If Covid + pt delay RT until clinical recover • Use a more hypofractionated schedule if restricted RT department resources QP6b Combs [ 15 ] H&N : – – A = 60% [SA = 20%] D = 40% [SD = 10%] 14 Gy/4fx 3.5 Gy BID (repeated Q 4 weeks interval × 2 times) [QUAD SHOT- RTOG 8502 [ 26 , 27 ]] QP6c Hahn et al [ 63 ] H&N + Gyn + Melanoma : – – A = 80% [SA = 40%] D = 20% [SD = 0%] • 8 Gy/1fx8Gy • 18–24/3fx6-8 Gy Q 0–7-(21 if needed) [ 25 , 29 , 36 ] QP6d Tchelebi [ 7 ] • Pain by primary Esophageal + HCC : 6–8/1fx6-8 Gy – – A = 80% [SA = 20%] D = 20% [SD = 0%] • Pain by primary Pancreas : 8–10/1fx8-10 Gy …”

Section: Resultsmentioning

confidence: 99%

“…: direct infiltration, primary pancreatic; H&N; Lymph-node infiltrating surrounding structures, etc.) QP6f AIRO Pall H&N : H&N Preferable for alternative: BID options (Sharon, QUAD Shot) can be considered balancing pt and department’s logistic, being suitable for hospitalized pt but not limited to those only A = 100% [SA = 83%] D = 0% [SD = 0%] • 20 Gy/5fx4Gy • 20 Gy/4fx5GyBID [SHARON project [ 28 ]] • 14 Gy/4fx 3.5 Gy BID (repeated Q4 weeks interval × 2 times) [QUAD SHOT- RTOG 8502 [ 26 , 27 ] Secondary alternative option: • 8 Gy/1fx8Gy • 24/3fx8Gy Q 0–7-21 (weekly) [ 25 , 29 , 36 ] • 18/3fx6Gy Q 0–7-21 (weekly) QP6g AIRO Pall Pain by primary Gyn + Melanoma + Esophageal + HCC + Pancreas + SCLC/NSCLC: o Gyn + Melanoma : – A = 92% [SA = 33%] D = 8% [SD = 0%] • 8 Gy/1fx8Gy • 24/3fx8Gy Q 0–7-21 • 18/3fx6Gy Q 0–7-21 o Gyn 18 Gy/4fx4.5GyBID [SHARON project [ 30 ]] o SCLC/NSCLC [IAEA [ 37 ]]: • 16 Gy/2fx 8 Gy (1 week apart) o Pancreas 10 Gy/1fx10Gy P7 Other than Pain symptoms NOT associated to Bone Mets (e.g. : obstruction, etc.)…”

Section: Resultsmentioning

confidence: 99%

“…: obstruction, etc.) QP7k AIRO Pall H&N : H&N Preferable for alternative: • BID options (Sharon, QUAD Shot) can be considered balancing pt and department’s logistic, being suitable for hospitalized pt but not limited to those only A = 100% [SA = 67%] D = 0% [SD = 0%] • 20 Gy/5fx4Gy • 20 Gy/4fx5GyBID [SHARON project [ 28 ]] • 14 Gy/4fx 3.5 Gy BID (repeated Q4 weeks interval × 2 times) [QUAD SHOT- RTOG 8502 [ 26 , 27 ]] Secondary alternative option: • 8 Gy/1fx8Gy • 24/3fx8Gy Q 0–7-21 (weekly) [ 25 , 29 , 36 ] • 18/3fx6Gy Q 0–7-21 (weekly) • 30 Gy/6fx6Gy (2 fx/week) [HYPO trial [ 38 ]] QP7l AIRO Pall Gyn + Melanoma : • Gyn + Melanoma : 24 Gy/3fx8Gy Q 0–7-21 – A = 92% [SA = 42%] D = 8% [SD = 0%] • 8 Gy/1fx8Gy • Gyn 18 Gy/4fx4.5GyBID [SHARON project [ 30 ]] QP7m AIRO Pall Esophageal dysphagia : • 12 Gy/4fx3GyBID [SHARON project [ 23 ]] • BID option can be considered balancing pt and department’s logistic, being suitable for hospitalized pt but not limited to those only A = 100% [SA = 67%] D = 0% [SD = 0%] • 20 Gy/5fx4Gy • Consider either esophageal stent or percutaneous endoscopic gastrostomy (PEG) tube placement QP7n AIRO Pall …”

Section: Resultsmentioning

confidence: 99%

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Palliative radiotherapy indications during the COVID-19 pandemic and in future complex logistic settings: the NORMALITY model

et al. 2021

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Introduction The COVID-19 pandemic has challenged healthcare systems worldwide over the last few months, and it continues to do so. Although some restrictions are being removed, it is not certain when the pandemic is going to be definitively over. Pandemics can be seen as a highly complex logistic scenario. From this perspective, some of the indications provided for palliative radiotherapy (PRT) during the COVID-19 pandemic could be maintained in the future in settings that limit the possibility of patients achieving symptom relief by radiotherapy. This paper has two aims: (1) to provide a summary of the indications for PRT during the COVID-19 pandemic; since some indications can differ slightly, and to avoid any possible contradictions, an expert panel composed of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) and the Palliative Care and Supportive Therapies Working Group (AIRO-palliative) voted by consensus on the summary; (2) to introduce a clinical care model for PRT [endorsed by AIRO and by a spontaneous Italian collaborative network for PRT named “La Rete del Sollievo” (“The Net of Relief”)]. The proposed model, denoted “No cOmpRoMise on quality of life by pALliative radiotherapy” (NORMALITY), is based on an AIRO-palliative consensus-based list of clinical indications for PRT and on practical suggestions regarding the management of patients potentially suitable for PRT but dealing with highly complex logistics scenarios (similar to the ongoing logistics limits due to COVID-19). Material and Methods First, a summary of the available literature guidelines for PRT published during the COVID-19 pandemic was prepared. A systematic literature search based on the PRISMA approach was performed to retrieve the available literature reporting guideline indications fully or partially focused on PRT. Tables reporting each addressed clinical presentation and respective literature indications were prepared and distributed into two main groups: palliative emergencies and palliative non-emergencies. These summaries were voted in by consensus by selected members of the AIRO and AIRO-palliative panels. Second, based on the summary for palliative indications during the COVID-19 pandemic, a clinical care model to facilitate recruitment and delivery of PRT to patients in complex logistic scenarios was proposed. The summary tables were critically integrated and shuffled according to clinical presentations and then voted on in a second consensus round. Along with the adapted guideline indications, some methods of performing the first triage of patients and facilitating a teleconsultation preliminary to the first in-person visit were developed. Results After the revision of 161 documents, 13 papers were selected for analysis. From the papers, 19 clinical presentation items were collected; in total, 61 question items were extracted and voted on (i.e., for each presentation, more than one indication was provided from the literature). Two tables summarizing the PRT indications during the COVID-19 pandemic available from the literature (PRT COVID-19 summary tables) were developed: palliative emergencies and palliative non-emergencies. The consensus of the vote by the AIRO panel for the PRT COVID-19 summary was reached. The PRT COVID-19 summary tables for palliative emergencies and palliative non-emergencies were adapted for clinical presentations possibly associated with patients in complex clinical scenarios other than the COVID-19 pandemic. The two new indication tables (i.e., “Normality model of PRT indications”) for both palliative emergencies and palliative non-emergencies were voted on in a second consensus round. The consensus rate was reached and strong. Written forms facilitating two levels of teleconsultation (triage and remote visits) were also developed, both in English and in Italian, to evaluate the patients for possible indications for PRT before scheduling clinical visits. Conclusion We provide a comprehensive summary of the literature guideline indications for PRT during COVID-19 pandemic. We also propose a clinical care model including clinical indications and written forms facilitating two levels of teleconsultation (triage and remote visits) to evaluate the patients for indications of PRT before scheduling clinical visits. The normality model could facilitate the provision of PRT to patients in future complex logistic scenarios.

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“…The experimentation of the SHARON scheme began with a phase I study on brain metastases (11), followed by subsequent trials and analyses (12)(13)(14)(15)(16)(17)(18)(19)(20). In particular, the SHARON schedule was extensively analyzed in multiple settings for symptomatic clinical presentations: brain metastases, thoracic, esophageal, pelvic, and "head and neck" lesions, and complicated bone metastases.…”

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A “SHort course Accelerated RadiatiON therapy” (SHARON) During and Beyond the COVID-19 Pandemic

et al. 2022

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Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

Cited by 8 publications

References 19 publications

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Palliative radiotherapy indications during the COVID-19 pandemic and in future complex logistic settings: the NORMALITY model

A “SHort course Accelerated RadiatiON therapy” (SHARON) During and Beyond the COVID-19 Pandemic

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