Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer

Abstract

Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.

Methods and materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).

Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with 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 favored capecitabine therapy. 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 for use in patients receiving CRT.

Fig. 1

Flow diagram. Abbreviations: CAP_CRT = capecitabine-based chemoradiation therapy (CRT); GEMCAP = gemcitabine plus capecitabine; GEM-CRT = gemcitabine-based CRT.

Fig. 2

Changes in mean HRQL scores following induction chemotherapy (between week 0 and week 17) with 95% confidence intervals. Negative score indicates deterioration in both function and symptom scales. Abbreviations: GQOL = Global Quality of Life Scale; HRQL = health-related quality of life.

Fig. 3

Changes in mean HRQL scores following chemoradiation (week 17 to later time points) with 95% confidence intervals. (a) QLQ-C30. (b) QLQ-PAN26. Negative score indicates deterioration in both functional and symptom scales.

Fig. 4

Changes in selected mean HRQL scores by treatment arm with 95% confidence intervals. (a) Cognitive functioning (high score indicates better QoL). (b) Fatigue (low score indicates better QoL). (c) Bloating (low score indicates better QoL). (d) Dry mouth (low score indicates better QoL). (e) Body image (low score indicates better QoL). (f) Future health concerns (low score indicates better QoL).