1. Fernando De Vita Oncologia Medica Seconda Università di Napoli
Esperienza real life A multicenter experience of Nab-paclitaxel plus Gemcitabine as first-line therapy in mPC: efficacy and safety results in clinical practice
Fernando De Vita
Oncologia Medica
Seconda Università di Napoli

2. Esperienza real life – I linea Inclusion criteria
46 pts with mPC who received Nab-paclitaxel and Gemcitabine between January 2012 and December 2014 were selected as the subjects of this study according to the following criteria:
histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
ECOG PS ≤ 2
age ≥ 18
adequate major organ functions
no previous CT; gemcitabine in the adjuvant setting was allowed if the treatment was completed at least 6 months before
written informed consent

3. Esperienza real life – I linea Treatment schedule
Nab-paclitaxel/Gemcitabine
Nab-paclitaxel 125 MG/M2 D1,8,15
Gemcitabine MG/M2 D1,8,15
every 4 weeks

4. Esperienza real life – I linea Endpoints
The purposes of the present study were to evaluate the effectiveness of NAB-P/GEM regimen in an unselected population of patients with metastatic PC and to identify the prognostic factors influencing outcome
Endpoints
Overall Response Rate (ORR)
Progression Free Survival (PFS)
Overall Survival (OS)
Toxicity
Prognostic factors analysis
The data on the patient background characteristics, adverse events, treatment compliance, treatment response, progression-free survival (PFS) and overall survival (OS) were collected retrospectively from the medical records

5. Esperienza real life – I linea Pretreatment evaluation
*CT scan of the chest and abdomen/pelvis
Blood count, serum chemistry and tumor markers (*CA 19-9)
ECG and echocardiogram with evaluation of ventricular function
*tumor response evaluated every 8 weeks by CT scan and CA 19-9

6. Patients characteristics (1)
Esperienza real life – I linea Baseline characteristichs
Patients characteristics (1)
PTS 46
AGE (range)
>70
63 (41-77)
11 (23.9%)
SEX M F
22 (47%)
24 (63%)
PS (ECOG) 1 2
21 (45.6%)
15 (32.6%)
10 (21.7%)
PANCREATIC PRIMARY LOCATION
HEAD
BODY/TAIL
28 (61%)
18 (39%)

7. Patients characteristics (2)
Esperienza real life – I linea Baseline characteristichs
Patients characteristics (2)
SITE OF METASTASIS
Lung
Liver
Peritoneum
Bone
9 (19.5%)
32 (69.5%)
6 (13%)
1 (2%)
No OF METASTATIC SITES 1
≥ 2
31 (67%)
15 (33%)
BILIARY STENT
11 (24%)
MEDIAN CA19.9 U/I (range)
469 ( )
PREVIOUS SURGERY
11 (24%)
PREVIOUS ADJUVANT GEMCITABINE
10 (22%)

8. Esperienza real life – I linea Cross trial comparison
comparison between poor PTS characteristics
CHARACTERISTIC
MPACT
Our experience
ECOG 2 (%) 8
21.7
AGE >70 (%) 10
23.9
BILIARY STENT (%) 19 24
PREVIOUS ADJUVANT CT (%) 22
HEAD 44 61
PERITONEUM 4 13

9. Esperienza real life – I linea Overall Response Rate (ORR)RC
2 (4.3%) RP
14 (30.4%)
16 (34.7%) SD
17 (36.9%)
DCR
33 (71.7%) PD
13 (28.2%)
*CA19.9 ≥ 50% reduction
20 (43.4%)
*correlation between CA19.9 decrease ≥ 50% from baseline and tumor response (Pearson correlation 0.581, Sig. 2 tails )

10. Esperienza real life – I linea Progression Free Survival (PFS)
PFS, months (update data January 2015)
PFS, months
Median
Range
(95% CI)
6.9
(3-14)

11. Esperienza real life – I linea PFS: univariate analysis
VARIABLE P
ECOG (PS 0-1 vs 2)
0.043
AGE (<70 vs > 70)
0.989
SEX (M vs F)
0.126
Tumor Site (Head vs Other)
0.116
Bilirubin (> ULN vs < ULN)
0.05
Byliary Stent (No vs Yes)
0.365
Liver Metastasis (No vs Yes)
0.119
Multiple Metastasis (No vs Yes)
0.794
Basal Ca 19.9 (> 59ULN vs ≤ 59ULN)
0.741
Ca 19.9 Response (<50% vs >50%)
0.006
NLR ( <5 vs >5)
0.011

12. Esperienza real life – I linea PFS according NLR
Median
(95% CI)
Range
<5
8.0
>5
3.0
Log Rank test:
P: 0.005

13. Esperienza real life – I linea PFS according CA 19.9 response
Median
(95% CI)
Range
Response
<50%
4.0
>50%
9.0

14. MULTIVARIATE ANALYSIS
Esperienza real life – I linea PFS: multivariate analysis
MULTIVARIATE ANALYSIS
VARIABLE P
ECOG
0.125
CA 19.9 response
0.006
NLR
0.002
Bilirubin
0.444

15. Esperienza real life – I linea Overall survival
OS, months
Median
Range
(95% CI)
10.5
7.8-13
OS, months (update data January 2015)
3 (7.3 %)
13 (31.7%)
3 (7.3%)

16. Esperienza real life – I linea OS: univariate analysis
VARIABLE P
ECOG (PS 0-1 vs 2)
0.02
AGE (<70 vs > 70)
0.56
SEX (M vs F)
0.23
Tumor Site (Head vs Other)
0.22
Bilirubin (> ULN vs < ULN)
0.12
Byliary Stent (No vs Yes)
0.77
Liver Metastasis (No vs Yes)
0.24
Multiple Metastasis (No vs Yes)
0.82
Basal Ca 19.9 (> 59ULN vs ≤ 59ULN)
0.25
Ca 19.9 Response (<50% vs >50%)
0.04
NLR ( <5 vs >5)
0.001

17. Esperienza real life – I linea OS according NLR
Median
(95% CI)
Range
<5
12.0
>5
7.0
Log Rank test, P:

18. MULTIVARIATE ANALYSIS
Esperienza real life – I linea OS: multivariate analysis
MULTIVARIATE ANALYSIS
VARIABLE P
ECOG
0.03
CA 19.9 response
0.15
NLR
0.002

19. Esperienza real life – I linea Second-line CT

20. Esperienza real life – I linea Treatment exposure
Total number of cycles: 273
Median number of cycles: 6 (range 1 – 14)

21. Esperienza real life – I linea ToxicityAE
nab-P + Gem
(n = 46)
Grade 3 hematologic AE, no (%)
Anemia
7 (15.2%)
Neutropenia
12 (26%)
Thrombocytopenia
8 (17.3%)
Grade 3 non hematologic AE, no (%)
Fatigue
Peripheral neuropathy
6 (13%)
Diarrhea
7 (15%)
Nausea
6 (13%)

22. Esperienza real life – I linea Conclusions
Our results indicate that Nab-P + Gem is an effective treatment with the potential for long-term survivors also in the clinical practice including elderly and poor PS pts
Availability of Nab-P + Gem as an effective first-line may conceivably allow maintenance of a better PS, thus increasing the chance of exposing pts to subsequent treatment lines, with consequent benefit in terms of OS
This study provides safety data similar to those of the pivotal MPACT phase III trial
Exploratory analyses suggest that PS and NLR are independent predictor of OS

23. Esperienza real life – I linea
Oncologia Medica
Seconda Università di Napoli
Jole Ventriglia
Angelica Petrillo
Alessio Fabozzi
Ospedale Sacro Cuore di Gesù - Benevento
Antonio Febbraro
Guido Giordano
La realta' e' determinata non da quello che gli scienziati o chiunque altro dice o crede ma da quello che le prove ci rivelano.
Alan Hale 

24. Esperienza real life – I linea Background
“In the era of biologic and molecularly targeted agents, the success of nab-paclitaxel in recalcitrant pancreatic cancer is a timely reminder of the importance and relevance of pharmacology and novel drug delivery technology in the development of anticancer drugs.”