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Volume 9, Issue 3-4, Pages 127-132

Phase II Clinical Trial With Pegylated Liposomal Doxorubicin (CAELYX®/Doxil®) and Quality of Life Evaluation (EORTC QLQ-C30) in Adult Patients With Advanced Soft Tissue Sarcomas: A study of the Spanish Group for Research in Sarcomas (GEIS)

1Instituto Valenciano de Oncología, Valencia, Spain
2Hospital de San Pau, Barcelona, Spain
3Hospital Son Dureta, Palma de Mallorca, Spain
4Instituto Catalán de Oncología, Barcelona, Spain
5Hospital Virgen del Rocío, Sevilla, Spain
6Hospital San Carlos, Madrid, Spain
7Hospital Germán Trías y Pujol, Badalona, Spain
8Hospital Provincial de Conxo, Santiago de Compostela, Spain
9Hospital Clínico, Zaragoza, Spain
10Hospital Universitario de Canarias, La Laguna, Spain
11Biostatician, Instituto Universitario de Oncología del Principado de Asturias (IUOPA), Spain
12Data Manager, Hospital de San Pau, Barcelona, Spain
13Servicio de Oncología Médica, Hospital Central de Asturias (IUOPA), Julián Clavería s/n, Oviedo 33005 , Spain

Received 8 April 2005; Revised 5 July 2005; Accepted 22 July 2005

Copyright © 2005 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: Pegylated liposomal doxorubicin (PLD), a formulation with pharmacokinetic differences with respect to doxorubicin (DXR), might benefit patients with advanced soft tissue sarcoma (STS) pretreated with DXR.

Patients and methods: Patients with measurable and progressive STS received PLD at 35 mg/m2 every 3 weeks. Quality of life before and during treatment was assessed with EORTC QLQ-C30.

Results: Twenty-eight patients, 22 DXR-pretreated, were given 140 cycles (median 3, range 1–18). Activity in 27 patients (5 GIST): one complete and one partial remission (both non-GIST and without prior DXR), 12 stabilizations and 13 progressions (response rate 7.4%, 95% CI: 0–17%). Grade 3 toxicity: palmar-plantar erythrodysesthesia (19% of patients), stomatitis (4%) or cutaneous (4%). Neutropenia grade≥3 was detected in 16% of patients. Median relative dose intensity was 95%. Progression-free rate at 3 and 6 months was, respectively, 48 and 22%, median progression-free survival 5.8 months and median overall survival 8.7 months. QLQ-C30 at baseline and at weeks 6–11 in 23 and 13 patients, respectively, showed good reliability and validity. Quality of life did not seem to worsen during therapy.

Conclusions: PLD did not induce objective remissions in 22 STS patients pretreated with DXR, but progression-free rate figures support the use of this agent in patients who have not progressed under a DXR-containing regimen. The toxicity observed was comparable to that of other PLD schedules.