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managed in a multidisciplinary (MD) setting since they have multiple therapeutic
and observational options, depending on the risk class. The PC Programme was
established in 2004 as a translational project. A MD team with urologists, radiation
oncologists, medical oncologists, psychologists, palliative care experts, uropathologists
and radiologists was built, diagnostic and therapeutic guidelines were shared and
adopted, a MD clinic was started in March 2005 organized in: Friday clinic:
urologist, radiation oncologist and psychologist (medical oncologist on demand)
examine PC patients synchronously Monday case discussion (CC) to share the cases,
check quality and application of guidelines, discuss problematic cases on observation
and complex cases seen monodisciplinarily The MD team became multiprofessional
by including a project manager, a secretary, a data manager and a nurse. Results
2760 MD clinics from March 2005 to March 2012. The organizational model was
modified to better the service. Considering the % of low risk PC patients referring to
the MD clinic (61% in 2009) and on active surveillance protocols (342 patients in
Feb 2012), we increased resources to better manage this sub-population. The % of
advanced and metastatic PC patients (5% in 2011) induced to organize the lists
according to the risk class (medical oncologist on demand). Efficacy of the MD clinic
is demonstrated in the drug therapies prescribed outside our Institution and
terminated by the MD team (11%). Efficacy of the CC is demonstrated in the % of
indications formulated in the MD clinics, changed in the following CC (6%)
resulting from quality checks of our own performance.
Conclusions: The MD approach is proving successful. Strategies are agreed on, cases
managed multidisciplinarily, critical issues shared. Psychologists help evaluate
education-related and cultural factors in patients’ decisions. The CC discussion is
fundamental to learn the MD working, create a shared know how and approach the
patient as a subject of care rather than disease to cure. Thanks to Pro ADAMO and
Fond. Monzino for the support
Disclosure: All authors have declared no conflicts of interest.
960 CABAZITAXEL EARLY ACCESS PROGRAM (EAP) - CANADIAN
INTERIM Results: SAFETY, QOL, AND UTILITY VALUES IN
METASTATIC CASTRATION RESISTANT PROSTATE CANCER
(MCRPC)
S.S. Sridhar 1 , E. Winquist 2 , S. Hubay 3 , C. St.-Laurent Thibault 4 , H. Assi 5 ,
S. Berry 6 , E. Levesque 7 , N. Aucoin 8 , P. Czaykowski 9 , F. Saad 10
1 Medical Oncology, Princess Margaret Hospital, Toronto, ON, CANADA,
2 Medical Oncology, University of Western OntarioLondon Regional Cancer
Center, London, ON, CANADA, 3 Medical Oncology, Grand River Regional
Cancer Centre, Kitchener, ON, CANADA, 4 Oncology, Sanofi Inc. Canada,
Montreal, QC, CANADA, 5 Medical Oncology, The Moncton Hospital, Moncton,
NB, CANADA, 6 Medical Oncology, Odette Cancer Centre, Toronto, CANADA,
7 Medical Oncology, CHUQ-L’Hotel-Dieu de Quebec, Quebec City, QC,
CANADA, 8 Medical Oncology, Cité-de-la-Santé Hospital, Laval, QC, CANADA,
9 Medical Oncology, Cancer Care Manitoba, Winnipeg, MB, CANADA, 10 Surgery,
CHUM, Notre-Dame Hospital, Montreal, QC, CANADA
Background: Cabazitaxel/Prednisone (CbzP) improves survival in docetaxel resistant
mCRPC. Canadian investigators collected safety and QoL data for patients (pts)
participating in a global single-arm multicenter EAP.
Methods: Between May 2011 and Feb 2012, 61 evaluable pts were enrolled at 9
centers. Safety and QoL data were collected at baseline and at each cycle. QoL was
assessed using the FACT-P and its subscales, EQ 5D-3L, and ESAS questionnaires.
Utility values were derived from the EQ 5D-3L. Present pain intensity (PPI) and
analgesic scores were assessed using the McGill-Melzack questionnaire. The change
from baseline QoL in individual patients was analyzed.
Results: At the time of analysis, baseline characteristics and safety data were available
for the first 33 pts. Median age was 65; 94% were ECOG 0/1; 85% had bone
metastases; and 76% had progressed within 3 months of prior docetaxel. Over half
(56%) received at least 5 cycles of CbzP. Main grade 3+ toxicities were anemia 3%,
leukopenia 3%, and febrile neutropenia 3% (prophylactic and therapeutic G-CSF use
was permitted). Incidence of diarrhea (all grades) was 52%, and grade 3+ diarrhea
was 3%. No treatment related deaths were reported. Preliminary analyses showed
stable QoL and derived utility values over time. A pain subscale of FACT-P, showed
improvements in the first 4 cycles; PPI scores improved despite stable analgesic use.
Conclusions: In this EAP, reflecting routine clinical practice, the main toxicities of
CbzP were similar to the TROPIC trial (neutropenia and diarrhea) emphasizing the
need for close toxicity monitoring. Preliminary QoL and PPI data support a palliative
benefit of CbzP not reported in TROPIC. Updated data with all evaluable pts and
percentages of pts meeting important response thresholds will be presented.
Disclosure: S.S. Sridhar: Dr. Sridhar has served on the advisory board for and is
involved in research projects with Sanofi Aventis Canada. E. Winquist: Dr Winquist
has received travel funding and consultant’s honoraria from Sanofi Canada. He is
involved in research projects with Sanofi Canada. C. St.-Laurent Thibault: Catherine
Saint-Laurent Thibault is an employee of Sanofi Canada Inc. H. Assi: Membership
on an Advisory board, S. Berry: Membership on an advisory board, N. Aucoin:
Membership on an advisory board, F. Saad: Dr Fred Saad sits on the advisory board
Annals of Oncology
for Sanofi Aventis Canada and has received consultant\\’s honoraria from Sanofi
Canada. He is involved in research projects with Sanofi Canada. All other authors
have declared no conflicts of interest.
961 UPDATED ANALYSIS OF A COMBINATION HERBAL
SUPPLEMENT TRIAL IN BIOCHEMICALLY RECURRENT
PROSTATE CANCER
J. Pinski 1 , T.B. Dorff 1 ,D.Hawes 1 , D. Tsao-Wei 1 , D.I. Quinn 1 , A. Goldkorn 1 ,
G. Liskovsky 1 , N. Vogelzang 2 , S. Groshen 3 ,L.Ji 1
1 USC Norris Comprehensive Cancer Center, University of Southern California,
Keck School of Medicine, Los Angeles, CA, UNITED STATES OF AMERICA,
2 Oncology, US Oncology Nevada, Las Vegas, NV, UNITED STATES OF
AMERICA, 3 Biostatistics, USC Norris Comprehensive Cancer Center,
Los Angeles, CA, UNITED STATES OF AMERICA
Background: After curative local therapy, thousands of men will experience rising
PSA as an early indicator of recurrent prostate cancer. For these men no standard of
care exists, and concern over serious side effects of androgen deprivation (ADT)
makes delaying ADT common. We tested Prostate Health Cocktail (PHC), which
contains vitamins D & E, saw palmetto, lycopene, green tea and soy extracts, in this
population, to see whether it could induce PSA declines.
Methods: Eligible men had a rising PSA with doubling time (DT) between 3 and 36
months, with no evidence of metastases on CT and bone scan. Treatment included
PHC 3 capsules PO daily for 4 week cycles for a maximum of 1 year. PSA was
repeated after 1 cycle and then every 2 cycles thereafter with imaging only as
clinically indicated; the primary endpoint was PSA decline at 12 weeks. PSA
progression was defined as 25% increase above baseline/nadir and absolute increase
of 5 ng/mL or return to baseline. Circulating tumor cells (CTCs) were measured at
baseline and after 3 cycles using parylene membrane filters.
Results: A total of 36 patients were enrolled as of January 31, 2012; 3 were
retrospectively classified as ineligible and were excluded from all analyses except for
toxicity. The median age was 67 (range 54-85) and baseline PSA was 2.9 ng/mL
(1.1-53.2). The median number of cycles was 8 (1-13). Stable PSA was the best
response for 25/27 men assessable at 12 weeks (93%) and 11/33 men (33%) had a
PSA decline (1.1%-49.0% decrease). There was no significant change in testosterone
or DHT during treatment. Circulating tumor cells were detected in some of the
subjects. One patient had grade 3 transaminitis in the setting of alcohol
consumption, otherwise the toxicities were limited to grade 1 or 2 and related to the
gastrointestinal and metabolic/laboratory systems.
Conclusion: PHC demonstrated activity in men with biochemical recurrence,
resulting in PSA declines in about a third of cases, and was not associated with
changes in serum androgens or significant toxicities. For the first time, we are
reporting that circulating tumor cells can be detected in men with biochemical
recurrence using filter technology.
Disclosure: J. Pinski: I am a co-owner of OncoNatural Solutions Inc, the company
which produces the Prostate Heath Coctail (PHC). All other authors have declared
no conflicts of interest.
962TiP CABAZITAXEL PLUS PREDNISONE (CBZP) IN METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL (D):
EFFICACY AND SAFETY RESULTS FROM EARLY-ACCESS
PROGRAM (EAP) SINGLE SITE EXPERIENCE
P. Rescigno 1 ,C.D’Aniello 1 , P. Federico 1 , L. Puglia 1 , A. Petremolo 1 ,
C. Cavaliere 1 , C. Buonerba 1 , S. De Placido 2 , G. Di Lorenzo 1
1 Genitourinary Cancer Section and Rare-cancer Center, University Federico II,
Naples, ITALY, 2 Medical Oncology Department, University Federico II, Naples,
ITALY
Background: In the phase 3 TROPIC trial, mCRPC pts previously treated with D
had a significant survival and clinical benefit with CbzP, a new tubulin-binding
taxane, compared with mitoxantrone plus prednisone. The clinical benefits observed
supported a global EAP, allowing pts with mCRPC to have access to Cbz prior to its
commercial availability and providing safety and efficacy data in the real life
population. We report the safety and efficacy results of 32 consecutive pts treated
with CbzP in a single Italian centre.
Methods: Pts recruited from a single centre between March and December 2011
received Cbz 25mg/m2 IV q21 and prednisone 10 mg daily until disease progression,
unacceptable toxicity, physician/pt decision or death. Biochemical and Tumour
response were assessed before cycle 6 and 12. Pain response was assessed in
symptomatic Pts before each cycle.
Results: 32 pts were analyzed; median age was 67 years (≥ 75 years, 18%); 68.8% of
pts had one previous D regimen and 31.2% ≥ 2 regimens, 93.8% had ECOG PS 0-1;
Median number of CbzP cycles was 8; 43.7% had pain at treatment initiation with a
median PSA value of 85 ng/mL. All pts had bone mets, 68% had visceral disease
ix316 | Abstracts Volume 23 | Supplement 9 | September 2012