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MSKCC

NAPOLI-1

1

nal-IRI+5-FU/LV

(n = 56)

nal-IRI+5-FU/LV

(n = 117)

Toxicities

Any grade (%) Grade 3/4 (%)

Any grade (%)

Grade 3/4 (%)

Nausea

33 (59)

2 (4)

60 (51)

9 (8)

Vomiting

18 (32)

2 (4)

61 (52)

13 (11)

Diarrhoea

35 (63)

1 (2)

69 (59)

15 (13)

Fatigue

45 (80)

1 (2)

47 (40)

16 (14)

Anorexia

32 (57)

0 (0)

52 (44)

5 (4)

Neutropenia

16 (29)

1 (2)

46 (39)

32 (27)

Anaemia

50 (89)

10 (18)

44 (38)

11 (9)

Single centre experience: AEs, dosing, dose reductions and

treatment sequencing

AE, Adverse event; MSKCC, Memorial Sloan-Kettering Cancer

centre

Glassman DC, et al. J Clin Oncol 2018;

36 (suppl 4S): 471 (and poster)

Dose reductions

n = 18

n (%)

1

15 (83)

2

3 (17)

Reason attributed for dose reduction

Fatigue

8 (44)

Diarrhea

8 (44)

Nausea

2 (11)

Neutropenia

2 (11)

Anorexia

2 (11)

Abdominal cramping

1 (6)

Ageusia

1 (6)

Not defined

1 (6)

Starting dose

nal-IRI (mg/m

2

)

n = 56

%

≤50

23 (41)

55

9 (16)

60

7 (13)

70

17 (30)

Treatment sequencing

FOLF(IRIN)OX ↔ gemcitabine+(nab-paclitaxel)

à

nal-IRI+5-FU/LV

26 (46)

Gemcitabine+nab-paclitaxel

à

nal-IRI+5-FU/LV

25 (45)

Gemcitabine+nab-paclitaxel

à

Gemcitabine/capecitabine

à

nal-IRI+5-FU/LV

3 (5)

Other

2 (4)