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)

• Published in: Sarcoma Vol. 2005; no. 3-4; pp. 127 - 132
• Main Authors: Poveda, A., López-Pousa, A., Martín, J., Del Muro, J. García, Bernabé, R., Casado, A., Balañá, C., Sanmartín, O., Menéndez, M. D., Escudero, P., Cruz, J., Belyakova, Elena, Menéndez, D., Buesa, J. M.
• Format: Journal Article
• Language: English
• Published: Hindawi Limiteds 01.01.2005; John Wiley & Sons, Inc; Hindawi Publishing Corporation; Hindawi Limited
• Subjects: Care and treatment; Complications and side effects; Dosage and administration; Doxorubicin; Patient outcomes; Quality of life; Sarcoma; Spain; quality of life; soft tissue sarcomas; Pegylated liposomal doxorubicin
• ISSN: 1357-714X; 1369-1643
• DOI: 10.1080/13577140500287024

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/m^2 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.