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Table 1 Summary of clinical trial results of PLD in sarcoma

From: Long-term cure of soft tissue sarcoma with pegylated-liposomal doxorubicin after doxorubicin and ifosfamide failure

Study Disease Dosing regimen Organizer/sponsor # of patients Responses and toxicities References
Phase 2 STS (many patients had poor prognostic features, including low-grade tumors PLD 50 mg/m2 every 4 weeks   13 None
Treatment responses possibly affected by poor prognostic features
Garcia et al. [13]
Phase 2 Advanced and/or metastatic STS
Patients were previously treated with an anthracycline-based chemotherapy
PLD 30–50 mg/m2 every 3 weeks   25 3 PRs, 4 minor responses, and 17 patients with SD Toma et al. [22]
Phase 2 randomized Advanced STS, with a high proportion of gastrointestinal stromal tumors PLD 50 mg/m2 every 4 weeks
Doxorubicin 75 mg/m2 every 3 weeks
EORTC Soft Tissue and Bone Sarcoma Group 94 (50 PLD, 44 doxorubicin) PLD had equivalent activity as doxorubicin with an improved toxicity profile, including lower incidence of myelosuppression and alopecia. However, a higher incidence of palmar-plantar erythrodysesthesia was noted in the cohort receiving PLD Judson et al. [6]
Phase 2 Previously treated sarcomas or sarcomas considered unresponsive to chemotherapy PLD 55 mg/m2 with subsequent dose adjustment   47 3 CR or PR and 15 clinical benefit
Treatment was generally well tolerated, and mucositis and hand-foot syndrome were the dose-limiting toxicities
Skubitz [10]
Phase 2 Advanced leiomyosarcoma of the uterus PLD 50 mg/m2 every 4 weeks   31 CR in 1, PR in 4, and SE in 10 patients Sutton et al. [21]
Retrospective analysis Metastatic STS Initial PLD 40–60 mg/m2 every 4 weeks   11 PR in 6 with extended time to progression, SD in 2, and PD in 3
(One patient was progression free for 60 months after receiving seven cycles of PLD)
Grenader et al. [14]