Patient-Reported AEs in ES-SCLC Treated With Durvalumab Plus EP or EP Alone

According to the CASPIAN phase 3 study, D+EP is now the gold standard for treating ES-SCLC worldwide. Standard adverse event (AE) reporting in oncology trials was supplemented by creating the Patient-Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) document. This is the first time the PRO-CTCAE tool has been piloted in SCLC research, and researchers detailed the symptomatic AEs that patients reported experiencing while using PRO-CTCAE in the CASPIAN study. Patients with ES-SCLC who were treatment-naive (WHO PS 0/1) were randomly assigned to receive either 4 cycles of D+EP q3w followed by maintenance D q4w until progressive disease (PD) or up to 6 cycles of EP q3w. Patients were asked to complete the PRO-CTCAE on an electronic device at baseline, every 3 weeks during EP (in both arms), every 4 weeks until PD, every 28 days after PD, every 2 months after PD, and every 8 weeks until the second progression or death as part of exploratory analyses when validated local language versions were available (in English, German, Japanese, or Spanish). Eleven AEs were selected based on their potential relevance to patients with ES-SCLC, and their presence, frequency, or severity was evaluated throughout the first 24 weeks of treatment.

Of the 537 points randomly assigned to D+EP and EP in CASPIAN, 164 (31%) were asked to fill out the PRO-CTCAE (D+EP: 83; EP: 81). Patients in the D+EP arm were more likely to complete the PRO-CTCAE at baseline (84%) than those in the EP arm (81%). Both groups attained more than 60% compliance rates through cycle 32 for D+EP and cycle 6 for EP, respectively. While some patients in each group did report these AEs before starting treatment, only a minority did so across the board (range D+EP vs EP: 4% vs 3% for the hand-foot syndrome to 34% vs 41% for dry mouth) except for itchy skin, which increased from 13% at baseline to a peak of 34% at cycle 6 in the D+EP arm and 12% at baseline to a peak of 42% at cycle 8 in the EP arm, and dizziness, which increased from 16% at baseline to a peak of 40% at cycle 5 in the D+EP arm. While rates were maintained vs baseline in the EP arm, AE rates were generally maintained in both arms up to 24 weeks after starting treatment. Patients who had these AEs said they were mostly mild or moderate in frequency and intensity. Patients’ self-reports in CASPIAN revealed that the 11 AEs investigated in the first 24 weeks of treatment were experienced by a small percentage of patients, were mild to moderate in intensity, and occurred infrequently. Both the D+EP and EP groups saw a similar rate and pattern of AEs throughout time. These findings supplement the CASPIAN safety profile and provide valuable information on how patients felt during their care.

Source:https://meetings.asco.org/abstracts-presentations/209798

Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03043872

Mustafa Özgüroğlu, Jonathan W. Goldman, Yuanbin Chen, Marina Chiara Garassino, Nenad Medic, Helen Mann, Priti Chugh, Tapashi Dalvi, Luis G. Paz-Ares/Adverse events self-reported by patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with durvalumab (D) plus platinum-etoposide (EP) or EP in the CASPIAN study/J Clin Oncol 40, 2022 (suppl 16; abstr 8571) DOI10.1200/JCO.2022.40.16_suppl.8571