Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study
Creators: name: Özgüroğlu, Mustafa
name: Goldman, Jonathan W.
name: Chen, Yuanbin
name: Garassino, Marina Chiara
name: Medic, Nenad
name: Mann, Helen
name: Chugh, Priti
name: Dalvi, Tapashi
name: Paz-Ares, Luis
Publisher: name: Taylor & Francis
Year: 2025
Subjects: subject: Medicine
subject: Pharmacology
subject: Biotechnology
subject: Immunology
subject: FOS: Clinical medicine
subject: Developmental Biology
subject: Cancer

description: 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). 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. 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. www.clinicaltrials.gov identifier is NCT03043872. What is this article about? The CASPIAN clinical study, for patients with small-cell lung cancer (SCLC) that has spread beyond a single area (extensive-stage SCLC; ES-SCLC) who had not received any previous treatment, showed that patients treated with durvalumab plus chemotherapy had a better chance of living longer than patients treated with chemotherapy alone. Treatment for ES-SCLC causes side effects which add to the cancer-related symptoms that patients commonly experience and can impact quality of life. We investigated how a subset of patients in CASPIAN reported 11 side effects using a validated questionnaire developed by the US National Cancer Institute. Patients completed the questionnaire before starting treatment and at regular intervals during treatment. What were the results? We showed that patients treated with durvalumab plus chemotherapy reported a similar pattern of occurrence, frequency, and severity of side effects as patients treated with chemotherapy alone throughout the first 24 weeks of treatment. A comparable proportion of patients treated with durvalumab plus chemotherapy as of those treated with chemotherapy alone reported each side effect at any visit during this treatment period. Patients generally reported that side effects occurred only rarely or occasionally, or when present, as mild or moderately severe. What do the results mean? These findings give insight into patient experiences of treatment with durvalumab plus chemotherapy and support previously published results that this treatment prolongs the life of patients with ES-SCLC without adversely affecting patients’ perspectives on side effects and quality of life when compared to treatment with chemotherapy alone.