RADIOTHERAPY  COMBINED  WITH  ANDROGEN DEPRIVATION  (ADT)  vs  ADT  IN CLINICALLY  LOCALLY  ADVANCED...
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RADIOTHERAPY COMBINED WITH ANDROGEN DEPRIVATION (ADT) vs ADT IN CLINICALLY LOCALLY ADVANCED PROSTATE CANCER. A prospective randomized trial N. Mottet, M Peneau, JJ Mazeron, V Molinié and P Richaud. Disclosures. N. Mottet: Advisor and paid consultant for Takeda

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RADIOTHERAPY COMBINED WITH ANDROGEN DEPRIVATION (ADT) vs ADT IN CLINICALLY LOCALLY ADVANCED PROSTATE CANCER

A prospective randomized trial

N. Mottet, M Peneau,JJ Mazeron, V Molinié and P Richaud


Disclosures
Disclosures vs ADT IN CLINICALLY LOCALLY ADVANCED PROSTATE CANCER

N. Mottet: Advisor and paid consultant for Takeda

Received compensations for lectures and clinical trials

Protocol fully funded by Takeda France

Protocol independently written from the company

Data monitoring and statistical analysis performed by Mapi

An IDMC committee had full access to all data


Background

Radiotherapy with prolonged ADT: superior to radiotherapy alone [EORTC 22863, 22961, RTOG 8531, 9202]

ADT: sometimes used alone in locally advanced PCa.

However - Combined modality superior to ADT (NSAA) [Widmark Lancet 2009]

- No data available with an LHRH agonist

Rational for a randomized trial: 3 years ADT ± Radiotherapy.

BACKGROUND


Study protocol

STUDY POPULATION alone

Age < 80, Karnofsky over 70

Prostate Cancer histologically confirmed

T3/T4 or pT3 ( biopsy) N0/M0

Never treated except TURP for obstructive syndrome

PRIMARY ENDPOINT

5 years overall Progression free survival: biological and clinical

Expected benefit: 15% at 5 years

SECONDARY CRITERIA

Survival (Overall and specific)

Quality of life (QLQ-c30 and QLQ-PR25)

Tolerance to treatment (SOMALENT)

STUDY PROTOCOL


Study design
STUDY DESIGN alone

R1 – M0b < 90 days

Treatment period : 3 years (ADT)

(1 visit / 6 months)

Without treatment

period : 2 years

(1 visit / 6 months)

Post protocol

follow-up

R1

R2

2 months

M6

M12

M18

M24

M30

V

V

V

V

M36

3,5

5

4,5

4

M0b

randomization

M0a

Selection

M36

V

V

M6

M12

M18

M24

M30

V

V

3,5

5

4,5

4

Centralized PSA (Hybritech) / 6 months Acute toxicity RTOG: M6


Treatment

ADT alone : Leuprorelin SR 11.25 mg SC / 3 months + Flutamide 750 mg / day, Month 1

Radiotherapy : Total dose 70 ± 4 Gy. 35 fractions (±2) Pelvis (4 fields technique) 48 ± 2 Gy Prostate boost: 3D conformal

Standardized planning

OF NOTE

  • Radiotherapy quality control: independent committee validated each treatment

  • Independent Data monitoring committee

TREATMENT


Population

Randomised patients alone

N=264

ADT group

N=131

Combined group

N=133

ITT Population

N=263

ADT group

N=130

Combined group

N=133

PP Population

N=237

ADT group

N=128

Combined group

N=109

POPULATION

Planed number of patients = 256

Included patients

N=273

40 French sites

From March 2000 to December 2008 LVLP

Inclusion: 2000 – 2003

Data base locked: 07/2009

Median follow up: 67 months


PATIENTS alone


% patients alone

Years

ADT group

Combined group

RESULTS 1

5 years overall PFS (ASTRO definition)

ADT group

Combined group

ADT group

Combined group

Median PFS:7.7 vs 1.7 years p < 0.0001


RESULTS 2 alone

5 years overall PFS (Phoenix definition)

ADT group

Combined group

% patients

Years

ADT group

Combined group

Median PFS: 6.96 vs 3.46 years p = 0.0005


Pfs and baseline psa phoenix definition
PFS AND BASELINE PSA alone (Phoenix definition )

100%

90%

80%

70%

60%

50%

% patients

40%

30%

p=0.001

20%

RR : 5.22 [3.05; 8.95]; p=0.0011

p = 0.0053

10%

0%

1

2

3

4

5

Baseline PSA<20 ng/ml: ADT group combined group

Baseline 20<PSA<50 ng/ml: ADT group combined group

Baseline PSA>=50 ng/ml: ADT group combined group


Clinical pfs itt population
CLINICAL PFS alone ITT population

ADT group

Combined group

% patients

Years

ADT group

Combined group

88.7% vs 62.3% p < 0.001


Loco regional pfs itt population
LOCO-REGIONAL PFS alone ITT population

ADT group

Combined group

% patients

RR : 3.7 [1.9; 7.4] p<0.0002

Years

ADT group

Combined group

90.3% vs 70.77% p < 0.0002


METASTATIC PFS alone ITT population

ADT group

Combined group

% patients

Years

ADT group

Combined group

97% vs 89.23%p = 0.0183


Overall survival itt population
OVERALL SURVIVAL alone ITT population

ADT group

Combined group

% patients

Years

ADT group

Combined group

At 5 years: 71.5% vs 71.4% p = 0.7882


SPECIFIC SURVIVAL alone ITT population

ADT group

Combined group

% patients

% patients

Years

Years

ADT group

Combined group

At 5 years: 93.2% vs 86.1% p = 0.11


Summary
SUMMARY alone

In patients with locally advanced PCa, addition of local radiotherapy to 3 years of LHRH significantly reduces the progression risk (biological, clinical, metastatic).

The benefit appears to be related mainly to improved loco-regional control.

A prolonged follow up is needed to see a potential survival impact


Conclusion
CONCLUSION alone

This reduction of disease progression confirms that radiotherapy combined with ADT should be one standard for patients with a locally advanced disease and a significant life expectancy.


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