Health-related quality of life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer

Purpose/Objective(s) Chemoradiotherapy (CRT) for patients with LAPC provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measures during CRT have not been widely reported. This paper reports HRQL data from the SCALOP trial, including validation of the QLQ-PAN26 tool in CRT. Methods and Materials Patients with locally advanced, inoperable, non-metastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable/responding disease were randomised to a further cycle of GEMCAP followed by capecitabine or gemcitabine based CRT. HRQL was assessed with the EORTC QLQ-C30 and PAN26. Results 114 patients from 28 UK centres were registered and 74 patients randomized. There was improvement in the majority of the HRQL scales during induction chemotherapy. Significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance, however where they did, they favoured capecitabine. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity Conclusions Although there is deterioration in HRQL following CRT this resolves within 3 weeks. HRQL data support the use of capecitabine over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool to use in patients receiving CRT