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)

[摘要] Background:Pegylated liposomal doxorubicin (PLD), a formulation with pharmacokinetic differences with respectto 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/m2every 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 and13 progressions (response rate 7.4%, 95% CI: 0–17%). Grade 3 toxicity: palmar-plantar erythrodysesthesia (19% ofpatients), stomatitis (4%) or cutaneous (4%). Neutropenia grade≥3 was detected in 16% of patients. Median relativedose intensity was 95%. Progression-free rate at 3 and 6 months was, respectively, 48 and 22%, median progression-freesurvival 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-freerate 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.

[学科分类] 肿瘤学