Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer – EORTC 08062

• Published in: European journal of cancer (1990) Vol. 47; no. 15; pp. 2322 - 2330
• Main Authors: O’Brien, Mary E.R, Konopa, Krzystof, Lorigan, Paul, Bosquee, Lionel, Marshall, Ernest, Bustin, Frederique, Margerit, Sabine, Fink, Christian, Stigt, Jos A, Dingemans, Anne Marie C, Hasan, Baktiar, Van Meerbeeck, Jan, Baas, Paul
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.10.2011; Elsevier
• Subjects: Adult; Aged; Amrubicin; Anthracyclines - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Cisplatin - administration & dosage; Disease-Free Survival; Etoposide - administration & dosage; Europe; Female; Hematology, Oncology and Palliative Medicine; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Small cell lung cancer; Survival; Survival Analysis; Survival Rate; Time Factors; Toxicity; Treatment Outcome; Tumors; Europe; Amrubicin; Small cell lung cancer; Toxicity; Survival; Antineoplastic agent; Lung cancer; Bonchopulmonary small cell carcinoma; Podophyllotoxin derivatives; Randomization; Isomerases; Cancerology; Phase II trial; Bronchus disease; Antimitotic; Platinum II Complexes; Human; DNA topoisomerase (ATP-hydrolysing); Lung disease; Drug combination; Enzyme; Respiratory disease; Enzyme inhibitor; Etoposide; Topoisomerase II inhibitor; Malignant tumor; Cisplatin; First line treatment; Alkylating agent; Clinical stage; Anthracyclins; Comparative study; Cancer; European Organization for Research and Treatment of Cancer
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2011.05.020

Abstract Purpose 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). Patients and methods 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. Results 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. Conclusion All regimens were active and PA met the criteria for further investigation, despite slightly higher haematological toxicity.