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A B S T R A C T S
S51
P027
FINAL RESULTS OF GERICO 10 GETUG P03 TRIAL
EVALUATING FEASIBILITY OF DOCETAXEL IN VULNERABLE
OR FRAIL ELDERLY (75+) PATIENTS WITH METASTATIC
CASTRATION RESISTANT PROSTATE CANCER
M. Loic
1,
*, I. Latorzeff
2
, N. Houede
3
, J. Meunier
4
, F. Priou
5
,
G.-M. Gwenaëlle
6
, E. Carola
7
, C. Orsini
8
, T. Filleron
9
1
Medical Oncology, Institut Claudius Regaud - IUCT-Oncopole,
2
Radiotherapy, Clinique Pasteur, Toulouse,
3
Medical Oncology,
CHU, Nîmes,
4
Medical Oncology, CHR, Orléans,
5
Medical Oncology,
CH Vendée, La Roche sur Yon,
6
Medical Oncology, Institut Paoli
Calmette, Marseille,
7
Medical Oncology, CH, Senlis,
8
R&D Unicancer,
Paris,
9
Methodologist, Institut Claudius Regaud - IUCT-Oncopole,
Toulouse, France
Introduction:
Prostate cancer (PC) in the elderly is a major
issue for medical community because of epidemiologic and
demographic data.
Treatment of metastatic castration resistant PC (mCRPC)
has evolved with new hormonal therapies but chemotherapy
remains a key treatment for this disease.
Benefit of chemotherapy is independent of age in pivotal
study by Tannock (cut-off:69) in a highly selected population.
But data, especially geriatric data, are lacking to determine
which patient should not receive Docetaxel because off
anticipated toxicity.
Objectives:
Our study aims to evaluate prospectively the
feasibility of a chemotherapy with Docetaxel/Prednisone
administered every 3 weeks in patients 75+, evaluated by
comprehensive geriatric assessment, belonging to group 2
“vulnerable” or to group 3 “frail” of the classification proposed
in 2010 by the International Society of Geriatric Oncology
(SIOG) [1].
Methods:
Chemotherapy with Docetaxel/Prednisone
was administered every 3 weeks (arm A: 60 mg/m² C1 then
70 mg/m² for subsequent cycles if tolerance is good) or weekly
(arm B: 35mg/m² J1J8 with Day 1 = Day 21) in patients 75+,
evaluated by comprehensive geriatric assessment, belonging
to group 2 “vulnerable” or to group 3 “frail” (SIOG 2010).
Feasibility is defined as the possibility for a patient to
receive 6 cycles of chemotherapy without fulfilling the criteria
for withdrawal from study defined “a priori” by GERICO group:
- stop or delay chemotherapy
2 weeks
- necessity to reduce chemotherapy dose
25%
- febrileneutropeniaorNCI CTCgrade III non-haematological
toxicity (except alopecia)
- loss of autonomy (Activity of Daily Living (ADL) decrease
2 points) leads to geriatric criterion
The trials is a double randomized phase II based on a
Simon’s optimum two stages design for each strata defined
according to the SIOG criteria (
= 5%, 1-
= 90%, p0 = 0.70 and
p1 = 0.90).
A pharmacokinetic/pharmacodynamic study is associated
to our project, based on a method of population pharmaco-
kinetics, trying to highlight clinical, geriatric and biological
parameters as predictors of haematological tolerance. A
pharmacogenetic study of PXR (pregnane X receptor or nuclear
receptor NR1I2) but also other enzyme systems (such as
CYP3A4 and CYP3A5) will be associated with pharmacokinetic
investigations.
Results:
From dec 2010 until Aug 2012 21 centers have
included 66 patients, 45 and 21 in groups 2 and 3 respectively
based on investigators evaluation. All allocations were
reviewed by a steering committee.
Enrolment in group 3 was prematurely closed in OCT 2012
on the recommendation of a safety committee. In group 2,
planned interim analysis was performed after inclusion of
30 pts. (ARM A/B n=15/15). 11pts (73,3%; 95%CI=[44,9;92,2])
in arm A and 10 pts (66,6%;95%CI [38,4;88,2] didn’t meet the
predefined criteria.
Conclusion:
According to the criteria of our study, defined
a priori
, Docetaxel weekly or every 3 weeks is not feasible in
patients 75+ with mCRPC classified in groups 2 or 3 of SIOG
2010 recommendations.
In our opinion, m CRPC pts 75+ should not receive
chemotherapy without prior geriatric screening (G8) ±geriatric
assessment ± geriatric intervention.
These results confirm the central role of geriatric assess-
ment in mCRPC elderly patients.
Full geriatric description of the population and all
secondary end points will be presented at the meeting.
Reference
:
[1] Droz JP. BJU Int. 2010 Aug;106(4):462-9
Disclosure of interest:
M. Loic Grant/Research Support
from: GSK, Consultant for: Sanofi Astellas Janssen Roche Pfizer
Novartis Ipsen, I. Latorzeff: None declared, N. HOUEDE: None
declared, J. Meunier: None declared, F. Priou: None declared,
G.-M. Gwenaëlle: None declared, E. Carola: None declared, C.
Orsini: None declared, T. Filleron: None declared
Keywords:
Castration resistant, Chemotherapy, frail,
metastatic, prostate
P028
UNRESECTABLE AND METASTATIC PANCREATIC
ADENOCARCINOMA IN THE ELDERLY: A 10-YEAR
SINGLE-CENTER EXPERIENCE
M. Langlois
1,
*, A. Beaudoin
1
, F. Lemay
1
1
University of Sherbrooke, Sherbrooke, Canada
Introduction:
Pancreatic adenocarcinoma is the fourth
leading cause of cancer deaths in Canada and mainly
affects individuals older than 60 years of age. Pancreatic
cancer follows a relatively silent clinical course and is
more often diagnosed at an advanced stage, thereby ruling
out the possibility of cure. When faced with a diagnosis of
unresectable pancreatic adenocarcinoma, patients may be
offered palliative chemotherapy. Unfortunately, a paucity
of data exists regarding the use, efficacy and safety profile
of chemotherapeutic agents in the elderly population with
pancreatic cancer. With an aging population, clinicians
are bound to be faced with oncologic decisions regarding
treatment of those under-represented elderly patients with
pancreatic adenocarcinoma. It is therefore imperative to