Table 1 Summary of clinical trial results of PLD in sarcoma

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]