9121 Amrubicin monotherapy in patients with extensive disease small cell lung cancer (ED-SCLC) refractory to first-line platinum-based chemotherapy: final results of a phase 2 trial

Abstract

The EORTC 08062 phase II randomised trial investigated the activity and safety of single agent amrubicin, cisplatin combined with amrubicin, and cisplatin combined with etoposide as first line treatment in extensive disease (ED) small cell lung cancer (SCLC).Eligible patients with previously untreated ED-SCLC, WHO performance status (PS) 0–2 and measurable disease were randomised to 3 weekly cycles of either amrubicin alone 45 mg/m2 i.v. day(d) 1–3 (A), cisplatin 60 mg/m2 i.v. d1 and amrubicin 40 mg/m2 i.v. d1–3 (PA), or cisplatin 75 mg/m2 i.v. d1 and etoposide 100 mg/m2 d1, d2–3 i.v./po (PE). The primary end-point was overall response rate (ORR) as assessed by local investigators (RECIST1.0 criteria). Secondary end-points were treatment toxicity, progression-free survival and overall survival.The number of randomised/eligible patients who started treatment was 33/28 in A, 33/30 in PA and 33/30 in PE, respectively. Grade (G) ⩾3 haematological toxicity in A, PA and PE was neutropenia (73%, 73%, 69%); thrombocytopenia (17%, 15%, 9.4%), anaemia (10%, 15%, 3.1%) and febrile neutropenia (13%, 18%, 6%). Early deaths, including treatment related, occurred in 1, 3 and 3 patients in A, PA and PE arms, respectively. Cardiac toxicity did not differ among the 3 arms. Out of 88 eligible patients who started treatment, ORR was 61%, (90% 1-sided confidence intervals [CI] 47–100%), 77% (CI 64–100%) and 63%, (CI 50–100%) for A, PA and PE respectively.All regimens were active and PA met the criteria for further investigation, despite slightly higher haematological toxicity.