Trial reportFuture oncology (London, England)2025
Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.
Trial report in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03043872 (A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimIn 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).
methodsOf 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
conclusionsA 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 registrationwww.clinicaltrials.gov identifier is NCT03043872.
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