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Table 2 Safety and efficacy profiles of the included studies for MBC

From: A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer

Author+Year Study Design Sample Size (N) Treatment Line Nab-paclitaxel Monotherapy Regimen Treatment Related Adverse Events (TRAEs) Efficacy Outcomes
Neutropenia (%) Leukopenia (%) Neuropathy (%) Fatigue (%) ORR (%) CBR (%) Median PFS (Months) Median OS (Months)
All grades 3/4 grade All grades 3/4 grade All grades 3/4 grade All grades 3/4 grade
Ibrahim NK 2005 [24] Phase II Multicenter 63 Mixed 300 mg/m2 q3w 9 51 91 24 64 11 40 13 48    14.8
39 First 300 mg/m2 q3w          64    
24 Further 300 mg/m2 q3w          21    
Gradishar WJ 2005 [19] Phase III RCT Multicenter 229 Mixed 260 mg/m2 q3w   30   7   10   7 33    15.2
97 First 260 mg/m2 q3w          42    
132 Further 260 mg/m2 q3w          27    13.2
Blum JL 2007 [6] Phase II Multicenter 106 Further 100 mg/m2 qw 3/4 49 18 62 19 25 8 37 5 14 26 3 9.2
75 Further 125 mg/m2 qw 3/4 64 34 66 36 51 19 45 12 16 37 3.5 9.1
Guan ZZ 2009 [17] Phase II RCT Multicenter 104 Further 260 mg/m2 q3w 69 42 64 24 76 7 17   54 71 7.6 17.8
Mirtsching B 2011 [29] Phase II Multicenter 72 First 125 mg/m2 qw 3/4 14 11 11 1.4 54 8.3 58 6.9 42.2 68.8 14.5 29
Gradishar WJ 2009/2012 [15, 16] Phase II RCT Multicenter 76 First 100 mg/m2 qw 3/4 80 25    58 9 34 0 63 83 7.5 22.2
74 First 150 mg/m2 qw 3/4 92 44    68 22 47 4 74 91 14.6 33.8
76 First 300 mg/m2 q3w 93 44    73 21 36 5 46 72 10.9 27.7
Brezden B 2016 [4] Phase II Multicenter 47 First 100 mg/m2 qw 3/4 14.9 9    46.8 0 70   30 51 6 20.9
76 First 100 mg/m2 qw 3/4 17.1 9    57.9 0 72   28 57 6.7 20
Ranade AA 2013 [36] Phase II RCT Multicenter 55 Mixed 220 mg/m2 q3w   28     1.5    40 67   
53 Mixed 300 mg/m2 q3w   38     17    40 72   
Palumbo R 2015 [35] Phase II Multicenter 52 Further 260 mg/m2 q3w 77 21.2 88.5 25 48.1 5.8 27 0 48.1 76.9 8.9  
Fabi A 2015 [14] Phase II Single center 42 Further Mixed 95 70 95 25 80 12 72 13 23.8 50 4.6  
32 Further 125 mg/m2 qw 3/4          28.1 50   
10 Further 260 mg/m2 q3w          10 50   
Hurria A 2015 [21] Phase II Multicenter 39 Mixed 100 mg/m2 qw 3/4 26 3 36 5 8 0 31 5 31 69 5.7 19.4
Andres FT 2015 [1] Phase II RCT Multicenter 21 Mixed 100 mg/m2 qw 3/4 38 14    48 5 54 10 38 52 3.7  
Jain MM 2016 [25] Phase III RCT Multicenter 58 Mixed 260 mg/m2 q3w 33 21 28 16 60 17 36 7 43 75 7.9  
Yamamoto S 2017 [42] Phase II Multicenter 35 Mixed 180 mg/m2 q3w   46     0    23 51 6.5 44.7
Tamura K 2017 [39] Phase II RCT Multicenter 98 First 150 mg/m2 qw 3/4 97 78 96 58 88 22 33 1 61.2 96.9 11.2 42.4
Bernardo A 2017 [5] Cohort 209 Further Mixed 9.4 3    29.9 2.1 27.4 1.7 32.1 57.7   18
68 Further 125 mg/m2 qw 3/4 8.7 1.1    17.4 2.2 12 1.1 31.5 54.3   16.9
121 Further 260 mg/m2 q3w 9.9 4.2    38 2.1 37.3 2.1 32.4 59.9   18
Gennari A 2018 [18] Phase II RCT Multicenter 83 First 150 mg/m2 q2w 55.4 21.7    69.5 8   48.2 47 65.1 7.9 25.8
86 First 100 mg/m2 qw 3/4 68.6 27.9    73.2 5.8   46.5 54.7 68.6 9 26.2
86 First 75 mg/m2 qw 72.2 24.4    70 5.8   10.5 44.7 60.5 8.5 25.5
Marschner N 2018 [32] Cohort Multicenter 697 Mixed Mixed   4   7.5 39.6 4.3 20.8 1.3 37.2 68.3 5.9 15.6
491 Mixed ≤150 mg/m2 qw          39.1 68.8 6 16.3
194 Mixed 220-260 mg/m2 q3w          33 67.5 5.7 15.1
Hurria A 2019 [23] Phase II Multicenter 40 Mixed 100 mg/m2 qw 3/4 44 11 18 3 10 5 55 5 35 75 6.5 21.2
Ciruelos E 2019 [7] Phase II RCT Multicenter 16 First 100 mg/m2 qw 3/4 37.5 0 50.1 6.3 81.3 0 43.9 6.3 37.5    
14 First 150 mg/m2 q2w 18.8 0 25.1 6.3 62.6 0 87.6 0 12.5    
16 First 150 mg/m2 qw 3/4 64.2 50 50 28.6 78.6 35.7 64.3 14.3 42.9    
Hara F 2019 [22] Phase II RCT Multicenter 48 Mixed 180 mg/m2 q3w 50 14.6 60.4 14.6 81.3 8.3 70.8 0 37.8   6.8  
45 Mixed 220 mg/m2 q3w 73.3 37.7 77.8 26.6 84.4 8.9 77.8 0 44.1   7.3  
47 Mixed 260 mg/m2 q3w 57.4 25.4 66 19.1 91.5 31.9 80.9 2.1 48.7   6.7  
Schmid P 2020 [38] Phase III RCT Multicenter 449 First 100 mg/m2 qw 3/4 15 8.2    23 2.7 44 3 45.9 72.4 5.5 18.7