A phase II study of a new formulation of nonpegylated liposomal doxorubicin (doxorubicin GP-pharm) as first-line treatment in patients with advanced soft-tissue sarcomas (STS) who are age 65 or older: A GEIS trial.
2011; Lippincott Williams & Wilkins; Volume: 29; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2011.29.15_suppl.10072
ISSN1527-7755
AutoresAntonio López‐Pousa, Binh Bui Nguyen, Xavier García del Muro, Javier Martín‐Broto, Carmen Balañá, Javier Lavernia, José Arnaldo Shiomi da Cruz, Joan Maurel, R. Andrés, Claudia Valverde, J. Fra, Javier Martínez‐Trufero, José A. López-Martín, Isabel Sevilla, Ricardo Cubedo, Jean‐Yves Blay,
Tópico(s)Fungal Infections and Studies
Resumo10072 Background: Doxorubicin remains the standard of care for STS. Its use has been limited due to bone marrow and cardiac toxicity, specially in elderly patients (pts). Doxorubicin GP-Pharm (Sarcodoxome)(DX-GP) is a non-pegylated liposomal formulation containing lipochromane-6. Previous Phase I study suggested activity and a low cardiac toxicity (CTOS 2008) Methods: Multicenter multinational Phase II prospective trial in advanced or metastatic STS pts aged ≥64 yr, to asses efficacy and safety of DX-GP in first line setting. Eligibility: ECOG ≤ 2, measurable disease by RECIST and acceptable hematologic, liver, renal and cardiac function. DX-GP 80 mg/m2 was administered IV over 60 minutes on day 1 every 3 weeks for a maximum of 6 cycles. Troponin, BNP, ECG and MUGA were performed every 2 cycles to evaluate cardiac function. An amendment (2009) expanded inclusion criteria to pts over than 45 years (thus only 4 pts <65 years old have been recruited). Results: From February 2007 to January 2010, 37 pts (13 male and 24 female) were included (12 retroperitoneum/trunk, 8 extremities, 4 uterine, 4 visceral). Median age 74 years (51-87). Non-resectable locally advanced 9, metastatic 28 pts. Nr of cycles: 116, mean 3(1-6). Grade 3/4 toxicities: Neutropenia 23 (62%), Leukopenia 10 (27%), febrile neutropenia 6 (16%), thrombopenia 4 (10%), anemia 2(5%) pts. Non-hematological toxicities were grade 3 asthenia 4 (10%) pts and grade II stomatitis and alopecia among others. 2 pts presented cardiac toxicity grade 1 and grade 5 respectively. Non cumulative cardiac toxicity. One treatment-related death. Efficacy (PR or SD) was seen in 8/26 (30%) evaluable pts. Median PFS was 3 (CI95% 1.9-7.4) months. Median survival time 14.4 (CI95% 6.3-27.1) months. Conclusions: DX-GP is a new liposomal DX that shows acceptable toxicity profile and efficacy at 80 mg/m2 in elderly pts with STS. Studies are needed in younger pts.
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