Assessment of Quality of Life, Tumour Control and Adverse Effects Observed in Patients Treated with Palliative Radiotherapy for Unresectable Gallbladder Cancer: A Prospective Interventional Study

Abstract

Introduction: Treating advanced Gallbladder Cancer (GBC) poses a substantial therapeutic challenge. Palliative chemotherapy is the primary treatment for patients with unresectable tumours. The effectiveness of this treatment in extending lifespan is limited, usually quantified in a few months, and its accompanying harmful effects can significantly impair overall well-being. As a viable alternative, palliative radiation offers the benefits of shorter treatment duration and a potentially lower risk of harmful side-effects. Its potential in the treatment of advanced GBC has not been fully explored, and the existing medical literature on this topic is scarce. However, the promising aspects of palliative Radiotherapy (RT) suggest a hopeful future for its application in treating unresectable GBC. Aim: To evaluate the Quality of Life (QoL), treatment-related toxicities and tumour response to palliative RT in unresectable GBC. Materials and Methods: A single-arm prospective interventional study was conducted in the Department of Radiation Oncology Outpatient Department (OPD), Sarojini Naidu Medical College, Agra, Uttar Pradesh, India, from September 2022 to May 2024. The present study included all patients with unresectable advanced GBC reported to OPD. Patients who had been previously treated or had ascites or duodenal infiltration were excluded. Twenty-four patients were recruited to receive RT alone (30 Gy in 10 fractions, D1-D10 over two weeks, five fractions per week). Treatment planning was Computed Tomography (CT) scan-guided. Quality of life assessment was based on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and BIL-21 questionnaires, and the Analysis of Variance (ANOVA) test was applied to compare variables. Tumour response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and a paired t-test was applied to compare pre and post-treatment values. Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5) was used to monitor toxicity. Descriptive statistics were used to examine patient demographics, baseline characteristics, treatment details and toxicity profiles. Results: Initially, 24 patients were enrolled in the present study, out of which four defaulted before treatment began. The mean age was 49.48±5.2 years. There was a female predominance, with 17 (70.8%) female patients and 7 (29.2%) male patients. The most common stage of the disease was stage IV A, affecting 16 (66.6%) of the patients. The overall QoL score pretreatment was 37.50±21.54, the mid-treatment score was 45.85±11.18, and the post-treatment score was 54.65±16.11. The scores showed improvement but were not statistically significant. A combined tumour response (complete+partial) was achieved in 10 (50%) patients. Treatment-related toxicities were within tolerable limits, with two patients developing cholangitis grade 2. Conclusion: Improvement was observed in the QoL score. Adverse effects were minimal, with a tumour response observed in 50% of patients. Hence, palliative RT showed promising results with the advantage of a short treatment time. However, a study with a larger sample size in different institutes is needed for a clearer picture.

Keywords

• palliative treatment
• radiation therapy
• tumour response
• treatment-related toxicities