Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.

Aim: In the phase III CASPIAN study, first-line durvalumab plus platinum-etoposide (EP) improved survival compared with EP in patients with extensive-stage small-cell lung cancer. We report an exploratory analysis of patient-reported adverse events (AEs).

Methods: Of 537 patients randomized to durvalumab + EP or EP arms, 164 were asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) for AEs at baseline, every 3 weeks (q3w) during EP, then q4w until disease progression, then post-progression on day 28, 2 months, and q8w until second progression/death. Presence/absence, frequency, or severity of 11 selected AEs were examined during the first 24 weeks of treatment, alongside interference with usual/daily activities for five AEs.

Results and conclusions: A minority of patients reported the examined AEs before starting treatment, from 3-5% who reported hand-foot syndrome, up to 34-41% for dry mouth. AE rates were generally comparable with baseline and the patterns of AEs reported by patients over time were similar in both treatment arms. Most patients indicated that reported AEs occurred rarely/occasionally and were mild/moderate in severity. These PRO-CTCAE data complement the clinician-reported AEs and give insight into patients' experience of treatment.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT03043872.