“Linac Based SBRT for Low-intermediate Risk Prostate ...
Transcript of “Linac Based SBRT for Low-intermediate Risk Prostate ...
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“Linac Based SBRT for Low-intermediate Risk Prostate Cancer in 5 Fractions: Preliminary Report of a Phase II
Study with FFF Delivery” FILIPPO ALONGI MD
Radiation Oncology & Radiosurgery Istituto Clinico Humanitas
Rozzano-Milan
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2012
SBRT and (Extreme) Hypofractionation
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Humanitas Protocol: FEATURES
SBRT 7Gy x5
(alternative days)
FFF beams (RapidArc Technique
on TrueBeam)
SpaceOAR (optionally)
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Is α/β ratio really low in prostate cancer?
2012
in press
..in 5,069pts
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BACKGROUND: Hypofractionation and therapeutic Ratio
Ritter et al Cancer J 2009
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Humanitas Protocol :Treatment Schedule
NTD2 OK for controlling low and intermediate risk disease and late tox
OK
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TRUE BEAM: Beams profiles
6FFF 6X
10X 10FFF
Unflattened Beam and SBRT
J. Hrbacek et al. IJRBPO 2011
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2012
2012
….SBRT delivered High dose per fractions (25 Gy) by means of FFF resulted to be fasible with shorter treatment time
Unflattened Beam and SBRT: our experience
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Humanitas Protocol: end points
Acute-Late Toxicity
SECONDARY
Late toxicity
Outcome
PRIMARY:
Technical feasibility
Acute toxicity
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Between January 2012 and January 2013 :40 patients for low and intermediate risk were recruited in the phase II study.
In all 40 patients: • CT/MRI was utilized for simulation procedure
• Dose prescription was: 35 Gy in 5 fractions on prostate +/-seminal vesicles (based on Roach Formula risk for seminal vesiscles)
• CTVàPTV margin was in 5 all direction and 3 posteriorly
• Delivery was performed by TrueBeam with FFF beams (RapidArc Technique)
• Daily CBCT was performed.
MATERIAL AND METHODS
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• Age ≤ 80 years
• WHO performance status ≤ 2.
• Histologically proven prostate adenocarcinoma àAny case where prophylactic lymph node irradiation is not required (risk of microscopic involvement ≤ 15%)
• PSA ≤ 20 ng/ml.
• T1-T2 (localized)-stage
• No pathologic lymph nodes at CT/ MR and NO distant metastases
• No previous prostate surgery other than TURP
• No malignant tumors in the previous 5 years
• IPSS 0-7
• Combined HT according to risk factors.
• Informed consent
Humanitas Protocol:Inclusion Criteria
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CT
MRI
IMAGING and TARGET DEFINITION
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PLANNING-CONSTRAINTS
RECTUM
V 18 Gy ≤ 35% V28 Gy ≤ 10% V32 Gy ≤ 5% V35 Gy ≤ 5% D1%≤ 35 Gy
BLADDER D1%≤ 35 Gy
*Target coverage was required to be: V95%>99% on CTV (95% on PTV)
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PLANNING – LOW RISK
35 Gy in 5 fractions 2 arcs with 10 FFF beams 1077+1076 MU BOT=120 sec
T1, iPSA 6, GS 3+3 Red=Prostate target Brown=rectum Green=bladder Yellow=penile bulb
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35 Gy in 5 fractions 2 arcs with 10 FFF beams 1076+1094 MU BOT=121sec
PLANNING – INTERMEDIATE RISK T2, iPSA 8, GS 3+4
Red=Prostate target Brown=rectum Green=bladder Yellow=penile bulb
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PROSTATE ON TRUE BEAM STx NOVALIS EXAC TRAC MATCHING
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DAILY TREATMENT VERIFICATION
Online registration and matching
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MRI T2 Image
SpaceOAR
CT Image
SPACEOAR IN HUMANITAS SBRT PROTOCOL CASE 1
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SPACEOAR IN SBRT PROTOCOL
SpaceOAR
Rectum
PTV
Bladder
3D reconstruction of PTV and OAR
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SPACEOAR IN HUMANITAS SBRT PROTOCOL
Dose distribution Isodose 50%
with SpaceOAR Dose Distribution
Isodose 50%
Anterior Rectal wall
CASE 5
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SPACEOAR IN SBRT PROTOCOL
DVH COMPARISON
Rectum
Rectum with SpaceOAR
CTVs PTVs
CASE 5
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Humanitas Protocol: PRELIMINARY RESULTS
Acute-Late Toxicity
PRIMARY:
Technical feasibility
Acute toxicity
The first 40 patients analysis
Published on June 2013
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PATIENTS CHARACTERISTICS (60 pts):
N. of patients 60 Recruitment Feb 2012-August
2013 Median Age [year] 70 [56, 80] Median Initial PSA [ng/mL] 6.45 [0.50, 17] Median Gleason Score 6 [6, 7] NCCN Low Risk Class 35 NCCN Intermediate Risk Class 25 Median F-UP [days] 297 [30-532] N. of patients with SpaceOAR ™ 13
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PRELIMINARY RESULTS (60 pts):
0
10
20
30
40
50
GURECTUM
GU 17 23 0 20RECTUM 11 5 0 44
G1 G2 G3 G0
• Dose: 35 Gy in 5 fractions
• Median follow-up: 297 days
• SpaceOAR: 13 pts
Acute Toxicity
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PRELIMINARY RESULTS
0510152025303540
GURECTUM
GU 3 2 0 35RECTUM 3 0 0 37
G1 G2 G3 G0
Late toxicity (>6 months) was evaluable in 40/60 trial patients.
Late Toxicity
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PRELIMINARY RESULTS
Urinary
QoL: EPIC QUESTIONNAIRE
Bowel
0 10 20 30 40 50 60 70 80 90 100
before RT end RT 3 months 0 10 20 30 40 50 60 70 80
Rel
ativ
e sc
ore
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CONCLUSIONS
• In summary, our early findings suggest that LINAC based SBRT FFF treatment for prostate cancer in 5 fractions is feasible, fast and well tolerated in acute setting.
• No cases of biochemical recurrence were found. However, longer follow-up is needed for definitive assessment of late toxicity and clinical outcome
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LOCALIZED PROSTATE CANCER
Robotic and traditional SURGERY
Brachytherapy Conventional EBRT
SBRT
SBRT: A NEW EFFECTIVE AND NON INVASIVE OPTION FOR LOCALIZED CANCER?