Bejarano, P.

de Lima Lopes, G.

Easey, M.

Gomez, C.

Hosein, P.

Macintyre, J.

Merchan, J.

Pastorini, V.

Reis, I.

Rocha-Lima, C.

EJC Supplements

de Lima Lopes, G

Hosein, P

Gomez, C

Pastorini, V

Macintyre, J

Easey, M

Reis, I

Merchan, J

Bejarano, P

Rocha-Lima, C

University of Miami: Scholarship Miami

European Journal of Cancer Supplements

OP2 Nab-paclitaxel in the treatment of advanced pancreatic cancer refractory to gemcitabine – Final results of a phase 2 trial

Elsevier - Publisher Connector 

OP2 Nab-paclitaxel in the treatment of advanced pancreatic cancer refractory to gemcitabine – Final results of a phase 2 trial 

2011 Asian Oncology Summit
OP1 ADHERENCE TO 6-MONTH ORAL ALPHA LIPOIC ACID
FOR PREVENTION OF PLATINUM-INDUCED POLYNEUROPATHY
Y. Guo *, J.L. Palmer, A. Forman, L. Ho, S. Tummala, M. Fisch.
University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
Background: Peripheral neuropathy induced by platinum-con-
taining chemotherapy causes pain, and frequently becomes a
dose-limiting factor for cancer treatment. The neurotoxicity
appears to be irreversible; therefore prevention of neuropathy is
necessary. Our aim was to determine whether a-lipoic acid
(ALA, thioctic acid) can prevent peripheral neuropathy for
patients receiving platinum.
Methods: Adult patients were randomised to receive either
600 mg ALA or placebo three times a day for 24 weeks. Neuropa-
thy was measured by the FACT/GOG-NTX score, and pain was
measured by the brief pain inventory (BPI).
Findings: Of the 243 patients randomised, 96 completed treat-
ment for 24 weeks. At baseline, the ALA (n = 122) and placebo
(n = 121) groups were comparable for age (58 ± 11 and 60 ± 11
years; p = 0.26), gender (51% and 49% male; p = 0.85), prior plati-
num exposure (p > 0.99), FACT/GOG-NTX score, and BPI score.
At 24 weeks, only 43 evaluable patients remained in the ALA
group, and 53 evaluable patients in the placebo group. The
drop-out rate was 65% for the ALA group and 56% for placebo
(p = 0.17). Reasons for drop-out were: withdrew consent (57 of
147, 39%), refused to take medication or non-compliant (35 of
147, 24%), lost to follow-up (2 of 147, 3%), death (2 of 147, 1%),
change of chemotherapy regimen (8 of 147, 5%), physician deci-
sion (8 of 147, 5%), adverse effects (4 of 147, 3%), or other (31 of
147, 21%).
Interpretation: Intensive schedules of oral agents may
be particularly challenging in the symptom-prevention set-
ting. Strategies to gauge the pre-enrolment risk of non-
adherence, and to monitor adherence, are worthy of further
exploration.
Funding: YG and MF are supported in part by the National
Institutes of Health.
The authors declared no conflicts of interest.
doi:10.1016/j.ejcsup.2011.02.002
OP2 NAB-PACLITAXEL IN THE TREATMENT OF ADVANCED
PANCREATIC CANCER REFRACTORY TO GEMCITABINE – FINAL
RESULTS OF A PHASE 2 TRIAL
G. de Lima Lopes a,*, P. Hosein b, C. Gomez b, V. Pastorini b,
J. Macintyre b, M. Easey b, I. Reis b, J. Merchan b, P. Bejarano b,
C. Rocha-Lima b. a Johns Hopkins Singapore International Medical
Centre, Republic of Singapore. b University of Miami, Miami, FL, USA
Background: There are few treatment options for patients with
advanced pancreatic cancer who do not respond to gemcitabine.
Expression of secreted protein acidic and rich in cysteine (SPARC)
might be a predictive marker of activity for nanoparticle albumin-
bound (Nab)-paclitaxel (Nab-P). We aimed to assess the feasibility
and efficacy of Nab-P in gemcitabine-refractory individuals, and
the use of SPARC as a predictive factor.
Methods: In this phase 2 trial, patients with advanced pancre-
atic cancer refractory to gemcitabine andwith ECOG performance
status (PS) 0–2, received Nab-P 100 mg/m2 on days 1, 8, and 15 of a
28-day cycle. The primary endpoint was 6-month overall survival
(OS). Secondary endpoints were response rate (by RECIST criteria),
progression-free survival (PFS), safety and toxicity profile, and
SPARC expression.
Findings: 19 eligible patients accrued. The median age was 61
years, nine patients were male, 18 had stage IV disease, and 15
had a PS of 0–1. 6-month OS was 58% (95% CI 33–76%), median
OS was 7.3 months (2.8–13.3), and median PFS was 1.6 months
(1.5–3.4). One patient had a partial response (PR) and six had sta-
ble disease (SD; three of which lasted longer than 6months). After
two cycles, the median CA 19-9 level decreased by 52% in patients
who had SD or PR, versus 18% in patients with PD. Non-haemato-
logical toxicities were generally mild, with grade 1 or 2 nausea in
63% of patients, anorexia in 47%, hypocalcaemia in 37%, and
vomiting in 26%. Grade 3 or 4 neutropenia, neutropenic fever,
and anaemia occurred in 32%, 11%, and 11% of patients, respec-
tively. There were no cases of grade 3 or 4 neuropathy. SPARC
expression did not correlate with clinical outcomes.
Interpretation: Nab-P is active in pancreatic cancer refractory to
gemcitabine. A randomised phase 3 trial is ongoing to confirm the
efficacy of Nab-P in pancreatic cancer, and the usefulness of
SPARC as a predictor of its activity.
Funding: Abraxis Inc.
All authors receive research funding from Abraxis Inc, manu-
facturer of Nab-P.
doi:10.1016/j.ejcsup.2011.02.003
doi:10.1016/S1359-6349(11)00002-4
E J C S U P P L E M E N T S 9 ( 2 0 1 1 ) 1 –2 3
ava i lab le a t www.sc iencedi rec t . com
journal homepage: www.ejconl ine.com


G. de Lima Lopes

P. Hosein

C. Gomez

V. Pastorini

J. Macintyre

M. Easey

I. Reis

J. Merchan

P. Bejarano

C. Rocha-Lima

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OP2 Nab-paclitaxel in the treatment of advanced pancreatic cancer refractory to gemcitabine – Final results of a phase 2 trial

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