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Randomized phase 3 trial of amrubicin versus topotecan as second-line treatment for small cell lung cancer (SCLC)

J von Pawel, R Jotte, DR Spigel, MA Socinski, MER O'Brien, E Paschold, J Mezger, M Steins, L Bosquée, J Bubis, K Nackaerts, JM Trigo, P Clingan, W Schuette, P Lorigan, M Reck, M Domine, F Shepherd, R McNally, M Renschler · Pneumologie · 2012 · Heft 02

Dokument
867641
CareLit-ID
Jahr
2012
Publikation
PDF
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Metadaten
DOI
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Bibliografische Angaben

Zeitschrift
Pneumologie
Autor:innen
J von Pawel, R Jotte, DR Spigel, MA Socinski, MER O'Brien, E Paschold, J Mezger, M Steins, L Bosquée, J Bubis, K Nackaerts, JM Trigo, P Clingan, W Schuette, P Lorigan, M Reck, M Domine, F Shepherd, R McNally, M Renschler
Ausgabe
Heft 02 / 2012
Seiten
–
Erschienen: 2012-02-23 00:00:00
ISSN
0934-8387
DOI
10.1055/s-0032-1302561

Zusammenfassung

Aims: Amrubicin, a 3rd gen. anthracycline and potent topoisomerase II inhibitor, has shown activity in SCLC. ACT-1 compared the safety and efficacy of amr vs. topo for 2nd line treatment of SCLC. Methods: 637 pts were random. 2:1 amr 40mg/m2 IV d 1–3 (n=424) vs. topo 1.5mg/m2 IV d 1–5 (n=213) with proph. WBC growth factors and antibiotics required in last 1/3 of trial. Endpoints: OS (primary), RR, PFS, and safety. Subgroup analyses used protocol-defined definitions: refract. pts had PD as best response to 1st line therapy or progressed

Schlagworte

Pneumologie