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S76

A B S T R A C T S

can be collected during routine follow up and help determine

the impact of treatment toxicity on patients’ reported quality

of life following radical treatment for prostate cancer.

The purpose of this study was to explore the effect of age

on patient reported quality of life following radical prostate

radiotherapy using the EPIC-CP tool.

Objectives:

The purpose of this study is to explore the

effect of age on late (

3 months post radiotherapy) patient

reported quality of life following radical prostate radiotherapy

using the EPIC-CP.

Methods:

All men who received radical prostate radio-

therapy with intensity-modulated radiation therapy (IMRT)

for localized prostate cancer between 2011 and 2015 at

University College London Hospital were identified. Baseline

demographics, disease specific parameters and treatment

details were collected. EPIC-CP questionnaires were distri-

buted to all men on this database attending follow up at

University College London Hospital between January and

May 2016. The EPIC-CP was self-administered and assessed

urinary and bowel symptoms and erectile function. Urinary,

bowel and sexual function domains and overall EPIC-CP score

were analyzed according to age.

Results:

One hundred and three complete questionnaires

were analysed; 3 patients had incomplete questionnaires and

were excluded. All patients had completed radiotherapy at

least 3 months previously. The median age was 70 (50-85). The

majority of patients (83/100) had high risk disease according

to D’Amico risk stratification. Radiotherapy treatment was

as follows: external beam radiotherapy to prostate and

seminal vesicles 83/100; external beam radiotherapy to

prostate, seminal vesicles and pelvic lymph nodes with HDR

brachytherapy boost 22/100; prostate bed 17/100.

The mean overall and domain specific EPIC-CP scores for all

patients and age specific subgroups are presented in Table 1.

Conclusion:

In our patient population we found no

statistically significant difference in patient reported toxicity

outcomes according to age following radical prostate

radiotherapy. This may indicate reasonable tolerance of

prostate radiotherapy in the elderly. To investigate further we

recommend ongoing prospective collection of quality of life

data at baseline and at follow up intervals after radiotherapy.

Disclosure of interest:

A. Nuhoglu Savas: None declared,

L. Sellers: None declared, A. Al-Abdullah: None declared, R.

Ramiswami: None declared, R. Davda Grant/Research Support

from: Astellas, Jansen andTakeda, Paid Instructor for: Astellas,

A. Mitra: None declared, H. Payne Grant/Research Support

from: received honoraria for advisory boards or lectures or

travel expenses to attend medical meetings from Janssen,

Astellas, Sanofi, Sandoz, Astra Zeneca, Takeda, Ipsen, Bayer

and Ferring

Keywords:

EPIC-CP, patient reported outcomes, prostate,

bladder, kidney, genitourinary cancers, radiotherapy

P068

HOWTO ADDRESS THE HETEROGENEITY IN THE DESIGN OF

PHASE II CLINICAL TRIALS IN GERIATRIC ONCOLOGY?

B. Cabarrou

1,

*, E. Leconte

2

, L. Mourey

3

, P. Sfumato

4

, L. Balardy

5

,

C. Bellera

6,7

, J.-P. Delord

3

, J.-M. Boher

4

, T. Filleron

1

1

Department of Biostatistics, Insititut Claudius Regaud - IUCT-O,

2

TSE-R, Université Toulouse 1 Capitole,

3

Department of Oncology,

Insititut Claudius Regaud - IUCT-O, Toulouse,

4

Department of

Biostatistics, Institut Paoli Calmettes, Marseille,

5

Department of

Oncology, CHU, Toulouse,

6

Elderly and Cancer Platform - French

League Against Cancer,

7

Department of Biostatistics, Institut

Bergonié - Comprehensive Cancer Center, Bordeaux, France

Introduction:

With the overall aging population and the

increased incidence of cancer, incidence of cancer in

75 years

patients is greater than 30%. However, this heterogeneous

population is often excluded from clinical trials and the

lack of prospective data makes difficult the management of

these patients. Many publications highlight the importance

to conduct clinical trials in this population (Pallis, 2011).

As classical single-arm phase II designs (Fleming, 1982;

Simon, 1989) do not take into account the heterogeneity,

elderly specific phase II clinical trials are very uncommon

and generally conducted in specific groups defined by

geriatric criteria which increases the number of patients to

be included and thus reduces the feasibility. Several designs

have been proposed in the literature to address the patients’

heterogeneity in phase II trials for target therapy. In practice,

these adaptive designs remain unknown from the clinicians

and are rarely applied in geriatric oncology.

Objectives:

The main objective of this work is to

present phase II clinical trials designs that take into

account the heterogeneity of the population and to make

recommendations on the methodology to be used in phase II

clinical trials in geriatric oncology.

Methods:

Alternative methods have been proposed in

the literature to deal with stratification in phase II clinical

trials and identification of the best target population will be

presented and compared to classical designs (one study in

each specific subset of patients). Characteristics of adaptive

and classical designs will be illustrated through theoretical or

real examples of elderly specific phase II clinical trials.

Results:

Depending on the hypotheses of the study, the use

of adaptive designs could reduce the sample size compared

to classical designs. For example, assume an elderly specific

clinical trial designed as two parallel single-arm phase II

studies, one including patients with G8

14 and the other

including patients with G8

14. Uninterested feasibility rate is

fixed at 20% in each group and desired feasibility rates are

fixed at 35% and 45% in G8

14 and G8

14 groups, respectively.

Using a two-stage optimal Simon design for each group with

=2.5% (overall

=5%) and power=85%, a maximum of 129

patients have to be included. Under the same hypotheses,

a maximum of 103 patients have to be included using the

adaptive design proposed by Parashar (Parashar, 2016) which

allow the possibility to enrol patients of both groups (G8

14 or

G8

14) in the same study. Stopping rules at interim and final

analysis are presented in Figure 1.