Phase II Clinical Trial With Pegylated Liposomal Doxorubicin (CAELYX(R)/Doxil(R)) 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).
Phase II Clinical Trial With Pegylated Liposomal Doxorubicin (CAELYX(R)/Doxil(R)) 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).
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作者：
Poveda A;López-Pousa A;Martín J;Del Muro JG;Bernabé R;Casado A;Balañá C;Sanmartín O;Menéndez MD;Escudero P;Cruz J;Belyakova E;Menéndez D;Buesa JM
背景：聚乙二醇化阿霉素脂质体(PLD)是一种与阿霉素(DXR)有药代动力学差异的制剂，可能有利于接受DXR治疗的晚期软组织肉瘤(STS)患者。患者和方法：可测量和进行性STS的患者接受PLD，每3周一次，每次35 mg/2。用EORTC QLQ-C30评定治疗前和治疗中的生活质量。结果：28例患者，22例DXR前治疗，共接受140个周期(中位数3，范围1-18)。活动期27例(5例GIST)：1例完全缓解，1例部分缓解(包括非GIST和既往无DXR)，12例稳定，13例进展(有效率7.4%，95%CI：0~17%)。3级毒性：掌底红肿(19%)、口腔炎(4%)或皮肤(4%)。16%的患者出现≥3级中性粒细胞减少。中位相对剂量强度为95%。术后3个月和6个月的无进展率分别为48%和22%，中位无进展生存期为5.8个月，中位总生存期为8.7个月。QLQ-C30在基线和6-11周分别有23例和13例患者表现出良好的信度和效度。在治疗期间，生活质量似乎并没有恶化。结论：在接受DXR治疗的22名STS患者中，PLD没有诱导客观缓解，但无进展率数据支持在含有DXR的方案下没有进展的患者中使用这种药物。观察到的毒性与其他PLD方案相似。
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/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.