Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: A Phase II Study (SHARON Project)

Abstract

Aim: To define safety and efficacy of a palliative, short-course accelerated radiation therapy for symptomatic locally advanced primary pelvic cancer. Materials and Methods: A phase II trial was planned based on the minimax Simon's twostage design. A total of 18 Gy in 4.5 Gy/fraction administered twice a day was delivered (SHARON). Pain and quality of life were recorded according to the Visual Analogue self-assessment and the cancer linear analog scales (CLAS), respectively. Results: Twenty-five patients were enrolled in the study. The most frequent baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%). The overall palliative response rate was 96.0%, with a median palliative duration of 6 months. An improvement of quality-oflife indices (well-being, fatigue, and ability to perform daily activities) was noted in 64.0%, 36.0%, and 48.0% of patients, respectively. Conclusion: The SHARON regimen was well tolerated and effective in the palliative treatment of patients with locally advanced pelvic cancer. Based on these results, a multicentric prospective phase III trial is ongoing to compare this regimen with traditional 2-week radiotherapy treatment. Symptoms such as pain, bleeding, intestinal/urinary occlusion, nausea, and vomiting can deeply affect the quality of life (QoL) of patients with locally advanced pelvic cancers (1-5). Moreover, for symptomatic patients with metastatic disease or severe comorbidities, radical treatments are generally contraindicated. Palliative radiotherapy (RT) can be an effective option to control symptoms and consequently improve patient QoL (6). Short-course RT regimens have several advantages in the palliative setting: i) Reduced discomfort for patients, ii) reduced delay of systemic treatment when indicated, iii) reduced delay until hospice admission, and iv) reduced costs for the health system. These advantages are particularly interesting in lesser resourced settings with long waiting lists for RT (7). Our group previously reported the results of hypofractionated-accelerated RT (delivered in four fractions on 2 consecutive days) in different palliative settings: complicated bone metastases, brain metastases, head and neck cancer, thoracic tumors, and elderly patients (8-13). The treatment was well tolerated and effective in terms of symptom relief. A potential risk while using a hypo-fractionated regimen is the development of long-term radiation-related side-effects 4237 This article is freely accessible online.

Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease

“…In pelvic cancer, the impact of palliative treatments on QoL is poorly studied. A recent pilot data set from 25 patients treated with radiotherapy where the baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%) showed that the improvement in well-being was 64% and in ability to perform daily activities 48% [33], which mirrors the emotional and physical functioning metrics in our patient cohort.…”

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

“…Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials 20,26,28,30,[34][35][36][37]42,48,53,[56][57][58][61][62][63]66,70,74,75,77,79,83,85,93,94,97,103,[108][109][110]113,115,117,118,124,125,127,128,130,133,134,137 (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 24,25,27,29,[31][32][33]…”

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

“…[ 26 ], or the bis-in-die (BID) schedules advised by both the “Quad Shot RTOG 8502–QUAD SHOT” report created by Spanos et al . [ 27 , 28 ] and the “Sharon project” for multiple palliative settings [ 31 ], can be highly useful. Moreover, our NORMALITY model suggests and offers forms to facilitate the enhancement of preliminary teleconsultations before the first clinical visits of the patients (Figs.…”