nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial

Figures & data

Table 1 Baseline characteristics of the Western European cohort

Characteristic	nab-P + Gem (n=38)	Gem (n=38)	All patients in Western Europe (n=76)	ITT population (N=861)*
Age, median (range), years	59.5 (37–77)	66.0 (42–80)	63.0 (37–80)	63.0 (27–88)
≥65 years, %	29	61	45	42
Male, %	53	39	46	58
KPS, %
90–100	74	82	78	60
70–80	24	18	21	40
Primary tumor location, %
Head	39	27a	33	43
Body	47	49a	48	31
Tail	13	24a	19	25
Site(s) of metastasis, %
Liver	87	84	86	84
Lung	24	45	34	39
No of metastatic sites, %
1	8	8	8	6
2	53	47	50	47
≥3	39	45	42	46
Previous Whipple, %	0	5	3	7
Biliary stent, %	8	8	8	17

Notes:

a Evaluable n=37.

* From N Engl J Med, Von Hoff DD, Ervin T, Arena FP, et al, Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine, 69, 1691–1703. Copyright © (2013) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.⁸

Abbreviations: Gem, gemcitabine; ITT, intention-to-treat; KPS, Karnofsky performance status; nab-P, nab-paclitaxel.

Figure 1 Overall survival in the Western European cohort.

Abbreviations: CI, confidence interval; Gem, gemcitabine; HR, hazard ratio; mo, month; nab-P, nab-paclitaxel.

Table 2 Second-line therapy in the treated population of the Western European cohort

Regimen, n (%)	nab-P + Gem (n=39)	Gem (n=36)
Any second-line therapy	20 (51)	22 (61)
Fluoropyrimidine containing	19 (95)	19 (86)
FOLFOX/OFF	5 (25)	5 (23)
FOLFIRINOX	1 (5)	2 (9)
Other than fluoropyrimidine containing	1 (5)	3 (14)

Abbreviations: FOLFIRINOX, 5-fluorouracil, folinic acid (leucovorin), irinotecan, and oxaliplatin; FOLFOX, folinic acid (leucovorin), fluorouracil, and oxaliplatin; Gem, gemcitabine; nab-P, nab-paclitaxel; OFF, oxaliplatin, folinic acid, and 5-fluorouracil.

Table 3 Safety in the treated population of the Western European cohort

Safety, n (%)	nab-P + Gem (n=39)a	Gem (n=36)
Patients with ≥1 AE leading to death	2 (5)	2 (6)
Grade ≥3 hematologic AEs in >10% of patients in either armb	(n=37)
Neutropenia	17 (46)	12 (33)
Leukopenia	13 (35)	7 (19)
Anemia	8 (22)	0
Thrombocytopenia	5 (14)	1 (3)
Grade ≥3 nonhematologic AEs in >10% of patients in either armc
Asthenia	8 (21)	2 (6)
Peripheral neuropathyd	5 (13)	1 (3)
Alopecia	4 (10)	0

Notes:

a One patient was randomized to the Gem-only arm but received nab-paclitaxel plus gemcitabine;

b Assessment of the event was made on the basis of laboratory values;

c Assessment of the event was made on the basis of investigator assessment of treatment-related AEs;

d Peripheral neuropathy was reported on the basis of groupings of preferred terms, defined by standardized queries in the Medical Dictionary for Regulatory Activities.

Abbreviations: AE, adverse event; Gem, gemcitabine; nab-P, nab-paclitaxel.

Von HoffDDErvinTArenaFPIncreased survival in pancreatic cancer with nab-paclitaxel plus gemcitabineN Engl J Med2013369181691170324131140

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