142P Phase IIIb study of durvalumab plus platinum–etoposide in first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): Treatment patterns of chemotherapy combination phase with durvalumab

Abstract

Most patients (Pts) with small-cell lung cancer (SCLC) have extensive-stage (ES) disease at diagnosis, and poor prognosis. First-line durvalumab (D) plus platinum–etoposide (EP) significantly improved overall survival in pts with ES-SCLC versus control group in CASPIAN study. CANTABRICO will assess safety and effectiveness of D plus EP in a real world ES-SCLC population. CANTABRICO is a phase IIIb, single arm, multicentre study (NCT04712903). Eligible Pts were ≥18 years old with treatment naive ES-SCLC, ECOG PS 0-2, with at least one measurable lesion. D (1500 mg) was concurrently administered with first-line cisplatin (CPT) or carboplatin (CP) d1 plus ET d1-3 every 3 weeks for 4 to 6 cycles (limited to 4 cycles in CASPIAN), and every 4 weeks thereafter until progressive disease or unacceptable toxicity. Between December 2020 and April 2021 101 Pts from 35 sites in Spain were included. At data cut-off (October 22nd 2021) all pts had finished chemotherapy. 56% of Pts were ≥ 65 years old, 67% were men, 94% had ECOG 0-1. 35%, 31% and 11% of Pts had liver, bone or brain metastases, respectively. 98% were current or former smokers and 10% had limited stage diagnosis. 85% of Pts completed ≥ 4 cycles, 41% ≥ 5 cycles and 32% 6 cycles of EP. Most Pts (89%) received CP-ET. Approximately half of the Pts had EP dose delays and a quarter dose reductions. Most frequent reason for EP dose delay/reduction were hematological toxicity (53%/63%). D was interrupted in 5 Pts due to nephritis (2), liver toxicity, rash and skin reaction. Seven Pts discontinued EP due to adverse events (6/7 before cycle 5): 1 respiratory infection; 1 kidney function impairment, atrial flutter, congestive heart failure and hypoxemia; 1 pneumonitis; 1 neutropenia; 1 thrombopenia, anemia and herpes zoster; 1 respiratory insufficiency and 1 thrombocytopenia, neutropenia and anemia. CANTABRICO showed that increasing number of EP didn't have a detrimental effect as more than 40% were able to receive more than 4 cycles (32% 6 cycles), with only 1 Pt discontinued after cycle 5 due to toxicity. Most common AEs leading to treatment modification were hematological and due to EP.