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Table 5 Efficacy of recent clinical trials with liposomal doxorubicin in mono and combination therapy

From: Nanomedicine review: clinical developments in liposomal applications

References

Years

Phase

Disease

LF

n

Dose by cycle

Efficacy

ORR (%)

m-PFS (months)

Banerjee et al. (2018)

2018

II

ROC

PLD

48

40 mg/m2 IV Q4W

15

3.1

Lee et al. (2017)

2017

II

ROC

PLD

40

50 mg/m2

5

5

Monk et al. (2017)

2017

II

ROC

PLD

149

40 mg/m2

21.5

5.2

Marth et al. (2017)

2017

III

ROC

PLD

109

50 mg/m2 Q4W

21

7.2

Lindemann et al. (2017)

2017

III

ROC

PLD

86

40 mg/m2

16.9

12.7

Herzog et al. (2016)

2016

II

ROC

PLD

15

50 mg/m2 IV Q4W

–

–

Lee et al. (2017)

2017

II

ROC

PLD + carboplatin

12

50 mg/m2 + 5 AUC

33.3

13

Sehouli et al. (2016)

2016

III

ROC

PLD + carboplatin

5

30 mg/m2 + 5 AUC

75.1

11

Nagao et al. (2016)

2016

I

ROC

PLD + carboplatin + paclitaxel

7

30 mg/m2 + 60 mg/m2 + 6 AUC

33

12

Landrum et al. (2016)

2016

I

ROC

PLD + carboplatin + veliparib

10

30 mg/m2 + 5 AUC + 50 mg

50

–

Kim et al. (2015)

2016

I

ROC

PLD + carboplatin + farletuzumab

15

30 mg/m2 + 5–6 AUC + 2.5 mg/kg

73.2

10.4b

Runnebaum et al. (2018)

2018

II

ROC

PLD + trabectedin

77

30 mg/m2 + 1.1 mg/m2 IV Q3W

31

6.3

Monk et al. (2017)

2017

II

ROC

PLD + motolimod

148

40 mg/m2 + 30 mg/m2

20.9

4.8

Marth et al. (2017)

2017

III

ROC

PLD + trebananib

114

50 mg/m2 Q4W + 15 mg/kg Q1W

46

7.6

Shoji et al. (2017)

2017

II

ROC

PLD + irinotecan

31

30 mg/m2

32.3

2

Thaker et al. (2017)

2017

I

ROC

PLD + GEN

7

50 mg/m2 + 36 mg/m2

29

4.7

Herzog et al. (2016)

2016

II

ROC

PLD + vintafolide

22

50 mg/m2 IV Q4W + 7.5 mg IV Q2W

–

–

Jehn et al. (2016)

2016

II

MBC

Caelix®

25

25 mg/m2

4.5

1.75a

Harbeck et al. (2016)

2016

III

MBC

PLD

105

150 mg/m2

–

6a

Chang et al. (2018)

2018

II

MBC

PLD + CPM

21

30 mg/m2 Q4–6W + 60 mg/m2 PO daily

21

6.4

Tampaki et al. (2018)

2018

II

BC

PLD + CPM + bevacizumab + paclitaxel

62

30 mg/m2 + 600 mg/m2 + 8 mg/kg + 120 mg/m2 Q2W

95.2

–

Basho et al. (2016)

2016

I

TNBC

PLD + bevacizumab + temsirolimus

24

30 mg/m2 + 15 mg/kg Q3W + 25 mg Q1W IV

21

4

PLD + bevacizumab + everolimus

9

30 mg/m2 + 15 mg/kg Q3W IV + 7.5 mg PO daily

Rocca et al. (2017)

2017

I

BC

PLD + lapatinib

9

30 mg/m2 Q3W + 1500 mg/day on days 1–21

11

5.75a

Coltelli et al. (2017)b

2017

II

BC

Myocet® + CPM + paclitaxel

47

60 mg/m2 + 600 mg/m2 IV Q3W + 80 mg/m2 Q1W

–

–

Orlowski et al. (2016)

2016

III

RMM

PLD + bortezomib

324

30 mg/m2 + 1.3 mg/m2

–

33.0c

Cohen et al. (2018)

2018

II

MM

PLD + pomalidomide + dexamethasone

16

5 mg/m2 + 40 mg IV days 1, 4, 8 and 11 + 4 mg/day for 21 days, 28-day cycle

31

5

Becker et al. (2016)

2016

II

MM

PLD + bortezomib + CPM + dexamethasone

20

30 mg/m2 IV Q4W + 1.6 mg/m2 + 300 mg/m2 + 40 mg three times by cycle

90

–

Voorhees et al. (2017)

2017

I

RMM

PLD + bortezomib + vorinostat

32

30 mg/m2 + 1.3 mg/m2 + escalating dose of vorinostat

65

13.9

Casadei et al. (2018)

2018

I

MHL

PLD

9

60 mg IV Q3W

50

–

Luminari et al. (2017)

2017

II

DLBCL

Myocet® + CPM + vincristine + prednisone + rituximab

49

50 mg/m2 + 750 mg/m2 and 1.4 mg/m2 day 1 + 100 mg days 1–5 + 375 mg/m2 day 3 of each cycle

72

17

Fridrik et al. (2016)

2016

II

DLBCL

Myocet® + CPM + vincristine + prednisolone + rituximab

40

50 mg/m2 + 750 mg/m2 + 1.4 mg/m2 + 40 mg/m2/day for 5 days + 375 mg IV QW3

97.5

–

  1. LF liposomal formulation, ORR objective response rate, m-PFS median progression-free survival, CPM cyclophosphamide, PLD PEGylated liposomal doxorubicin,GEN an IL-12 plasmid formulated with PEG–PEI–cholesterol lipopolymer; Q4W, Q3W, Q2W, Q1W, every 4, 3, 2 and 1 weeks, respectively, AUC areas under curve, ROC recurrent ovarian cancer, MBC metastatic breast cancer, BC breast cancer, TNBC triple-negative breast cancer, RMM relapse or refractory multiple myeloma, MM multiple myeloma, MHL multirelapsed Hodgkin’s lymphoma, DLBCL diffuse large B-cell lymphoma
  2. aTTP, time to progression [the event of interest is only disease progression, while patients who die of other causes are not included (Fiteni et al. 2014)]
  3. bMedian radiologic PFS
  4. cMedian overall survival. The median follow-up for survival was 103 months (8.6 years)