PROs Support Safety of Durvalumab Plus Platinum/Etoposide in ES-SCLC

Results from the trial revealed that at baseline, a minority of patients reported AEs, ranging from 4% to 34% of the durvalumab/EP arm and 3% to 41% of the EP alone arm.

Patient-reported outcomes (PROs) for adverse effects (AEs) showed that durvalumab plus platinum/etoposide (EP) did not negatively impact quality of life vs EP alone in patients with extensive-stage small cell lung cancer (ES-SCLC), according to self-reported data from the phase 3 CASPIAN trial (NCT03043872) published in Future Oncology.

Results from the trial revealed that at baseline, a minority of patients reported AEs, ranging from 4% to 34% of the durvalumab/EP arm and 3% to 41% of the EP alone arm. During individual timepoints throughout treatment, the proportions of patients reporting AEs were generally comparable to baseline in both arms, with some variability observed. Furthermore, the proportion of patients reporting an AE of any frequency or severity during the initial 24 weeks of treatment varied across 11 AEs examined on study, with rash reported the least in 30% of the durvalumab/EP arm and 24% of the EP arm, and dry mouth reported the most in 76% of both arms.

Additional data showed that the proportion of patients experiencing “mild” or worse dizziness increased from 16% at baseline to 40% at cycle 5 in the durvalumab/EP arm, whereas in the EP alone arm, the proportions were similar at each period. Furthermore, the proportion of patients reporting “mild” or worse itching increased from 13% at baseline to 34% in cycle 6 in the durvalumab/EP arm and from 12% at baseline to 42% at cycle 8 in the EP arm.

“[I]n this assessment of patient-reported AE data from patients in the [phase 3] CASPIAN study, the 11 selected AEs examined during the first 24 weeks of treatment were generally reported by a minority of patients at each timepoint, mostly with rare or occasional frequency or mild-to-moderate severity,” Mustafa Özgüroğlu, MD, professor of Oncology at Istanbul University-Cerrahpasa, wrote in the publication with study coinvestigators. “Reporting rates and patterns for all selected AEs were broadly similar in the durvalumab plus EP and EP arms. These results complement the clinician-assessed safety profile observed in the CASPIAN study and give insight into the patients’ experience of treatment.”

The open-label, multicenter, phase 3 CASPIAN trial enrolled patients aged 18 years and older (20 years and older in Japan) with ES-SCLC and randomly assigned them 1:1:1 to receive durvalumab plus EP, durvalumab and tremelimumab (Imjudo) plus EP, or EP alone. Random assignment was stratified by platinum therapy with carboplatin or cisplatin.

Among patients assigned to receive durvalumab plus EP (n = 83) or EP alone (n = 81), the median age was 65.0 years (range, 40-82) vs 63.0 years (range, 46-82) in the respective arms. A total of 75.9% of the durvalumab plus EP arm vs 76.5% of the EP alone arm were White, 61.4% vs 54.3% had a WHO performance status of 1, and 88.0% vs 92.6% had American Joint Committee on Cancer stage IV disease at diagnosis. The top study countries included Spain (24.1% vs 30.9%), the US (30.1% vs 22.2%), Japan (21.7% vs 19.8%), Germany (13.3% vs 9.9%), and Austria (4.8% vs 16.0%).

The primary end point of the study was overall survival. Secondary end points included progression-free survival, objective response rate, safety, and tolerability. The assessment of AEs was undertaken through patient self-reporting using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The PRO-CTCAE consists of a library of 124 items across 78 symptomatic AEs commonly observed in oncology clinical trials and written in accessible language. In the CASPIAN analysis, 11 AEs were selected from the PRO-CTCAE item library as being the most relevant to patients with ES-SCLC and the treatment they received following internal discussion by the study sponsor.

Reference

Özgüroğlu M, Goldman JW, Chen Y, et al. Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study. Future Oncol. 2025;21(12):1511-1523. doi:10.1080/14796694.2025.2491297