Patient-Reported Outcomes Evaluating the Impact of Hypo-Fractionated Palliative Quadshot Radiotherapy and Concurrent CDDP Treatment on Health-Related Quality of Life in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Abstract

In locally advanced squamous cell carcinoma of the head and neck (LAHNSCC), the main goal of treatment remains survival while improving quality of life (QOL). In recent decades, there has been a paradigm shift in the measurement of clinical outcomes in patients diagnosed with cancer, focusing on the patient perspective by incorporating patient-reported outcomes (PROs). The primary objective of this study was to evaluate the improvement in quality of life with the use of cyclic hypo-fractionated palliative QUAD SHOT radiotherapy (RT) with concurrent cisplatin (CDDP) in previously untreated patients with incurable LAHNSCC. In this prospective interventional phase- II study, 60 patients with locally advanced squamous cell carcinoma of the head and neck, majority stage IVB, ECOG PS ≤ 3, were treated with QUAD SHOT RT (14 Gy/4 fractions/2 days - BD with 6-hour interval and concurrent CDDP at 6 mg/m2. This treatment was repeated at 4-week intervals for 2 additional cycles if tumor progression did not occur. Serial changes in HR -QoL were assessed using EORTC QLQ C-30 and H&N-35) at 4 different time points. Statistical methods such as the Wilcoxon signed-rank test and Friedman test were used to compare QoL values at different time points with Bonferroni correction for multiple comparisons to control for type I errors. The median global health score (GHS) at baseline was 41.667, with an initial increase in score at 4 weeks (50.00) and at 8 weeks (54.167) that did not continue at 12 weeks (41.667). Symptoms related to toxicities (speech, social contact, sticky saliva, dry mouth, senses in H&N 35) were lower after 4 weeks. Application of the Friedman test for four time points revealed significant improvement in role function at 4 weeks, which remained constant at 8 weeks but was not sustained at 12 weeks. Comparison of HN-35 symptom scores between the four time points showed improvement in symptoms such as pain, swallowing, and mouth opening at 4 and 8 weeks. The mean QLQ C30 summary score for these patients improved at four weeks but did not remain constant at 8 and 12 weeks. Our study showed significant improvement in quality-of-life parameters and reduction in symptom burden at 4 and 8 weeks due to disease control and symptom palliation by QUADSHOT CTRT, while quality-of-life scores worsened and symptom scores were not maintained at 12 weeks due to disease progression and occurrence of acute toxicities. This phase II study may serve as the basis for designing a phase III randomized control trial to compare quality of life changes with QUADSHOT CTRT and other palliative CTRT regimens.