Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project)

Farina, E.; Macchia, G.; Buwenge, M.; Siepe, G.; Zamagni, Alice; Cammelli, S.; Cilla, Savino; Tigeneh, Wondemagegnhu; Woldemariam, Aynalem Abraha; Uddin, Aaliya; Sumon, M.A.; Cellini, Francesco; Deodato, Francesco; Morganti, Alessio Giuseppe

doi:10.1007/s10585-018-9942-6

Cited by 6 publications

(17 citation statements)

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“…In fact, in the previous trials, dose planning and delivery were based on a 3D-conformal technique. 20,[22][23][24] Even if in the preliminary our results seem almost similar to more protracted RT regimens, in fact, we 18 and the 69% rate achieved with accelerated but protracted RT (40 Gy in 2 Gy/fraction, bid). 31 Compared with palliative brachytherapy, our results seem not to be inferior in terms of the dysphagia palliation rate (48%).…”

Section: Discussionmentioning

confidence: 55%

“…It is worth noting that we delivered the SHARON treatment with a lower total dose compared with the ones previously defined as safe in other trials (18)(19)(20). 20,[22][23][24] The reduction in dosage was compelled by a lack of evidence regarding the safety of this regimen using a 2D-RT technique. In fact, in the previous trials, dose planning and delivery were based on a 3D-conformal technique.…”

Section: Discussionmentioning

confidence: 99%

“…These studies could focus on: (1) the evaluation of long-term symptomatic control enrolling larger patients cohorts; (2) the delivery of a higher total dose (eg, 16 Gy) to improve the symptomatic response rate; (3) testing this regimen using 2D-RT in other conditions, such as brain or complicated bone metastases and advanced pelvic, head and neck cancers and thoracic tumors, as already evaluated with 3D-conformal RT. 20,[22][23][24] Currently, a multicentric prospective phase III trial is ongoing to compare the SHARON regimen to a conventional one (30 Gy in 10 fractions). The study will enroll a total number of 98 patients in the 2 arms.…”

Section: Discussionmentioning

confidence: 99%

“…The main treatment-related risk from such a scheme is theoretically represented by a higher incidence of acute toxicity owing to the very short treatment duration. The use of an accelerated hypofractionated bid regimen has been reported in pelvic, 19 head and neck, 20 and brain cancers, 21,22 along with complicated bone metastases 23 and thoracic tumors, 24 with high rates of palliative response and also low toxicity rates in older patients (80 years). 25 Although this schedule has been tested and validated in phase I to II studies planned with 3-dimensional conformal RT, [19][20][21][22][23][24][25] no data on this schedule being delivered using 2-dimensional RT (2D-RT) are available.…”

Section: Introductionmentioning

confidence: 99%

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Short-Course 2-Dimensional Radiation Therapy in the Palliative Treatment of Esophageal Cancer in a Developing Country: A Phase II Study (Sharon Project)

Deressa

Wondemagegnehu

Bogale

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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Section: Discussionmentioning

confidence: 55%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Short-Course 2-Dimensional Radiation Therapy in the Palliative Treatment of Esophageal Cancer in a Developing Country: A Phase II Study (Sharon Project)

Deressa

Wondemagegnehu

Bogale

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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“…: extraosseous disease, impending fracture, pathological fracture); see also “Section E1” A = 100% [SA = 75%] D = 0% [SD = 0%] • 20 Gy/4fx5GyBID [SHARON project [ 22 ]] • BID option can be considered balancing pt and department’s logistic, being suitable for hospitalized pt but not limited to those only Secondary alternative Option: • For extreme clinical settings of extensive bone involvement, or retreatment/ pain refractory to pain killers: caution consider “Half-body RT” (i.e. : lumbar + bony pelvis + femurs—15 Gy/4fx3.75 Gy BID [SHARON project [ 35 ]] • 20 Gy/5fx4Gy P2 Non-painful bone metastasis QP2b AIRO Pall – – • Consider to delay RT or evaluate SBRT (depending if oligometastatic and on the basis of prognostic score and impending fracture risk) A = 100% [SA = 75%] D = 0% [SD = 0%] • Consider RT if impending fracture: if “Yes”, see E1 + P1 + P3 P3 Bone Oligometastases Suitable for SBRT QP3d AIRO Pall SBRT 1–5 fx (BED 50-60 Gy if not compromising spinal cord constraints) Single fraction (16 to 24 Gy) SBRT for Retreatment of Symptomatic MESCC • Apply validated prognostic score before clinical indication A = 100% [SA = 58%] D = 0% [SD = 0%] • Consider SBRT in case of future risk of MESCC or fracture • Alternatively, consider delay or avoid SBRT, and/or non-SBRT RT indications P4 Retreatment of painful bone metastasis QP4b AIRO Pall 8 Gy/1fx8Gy SBRT Single fraction (16 to 24 Gy) SBRT for Retreatment of Symptomatic MESCC • Waiting a minimum of 6 weeks after completion of the initial RT A = 92% [SA = 42%] D = 8% [SD = 0%] • For highly selected clinical settings of extensive bone involvement, or retreatment/ pain refractory to pain kil...…”

Section: Resultsmentioning

confidence: 99%

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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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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Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project)

Cited by 6 publications

References 19 publications

Short-Course 2-Dimensional Radiation Therapy in the Palliative Treatment of Esophageal Cancer in a Developing Country: A Phase II Study (Sharon Project)

Short-Course 2-Dimensional Radiation Therapy in the Palliative Treatment of Esophageal Cancer in a Developing Country: A Phase II Study (Sharon Project)

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

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

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