Download - Portec trial ppt
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PORTEC TRIALDR SAILENDRA NARAYAN PARIDASENIOR RESIDENTDEPT.OF RADIOTHERAPYMAULANA AZAD MEDICAL COLLEGE
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• The Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) trial (1990-1997) was among the first to randomly compare pelvic external-beam radiotherapy(EBRT) to no additional treatment (NAT).• Between 1990 and 1997, 715 patients• Pelvic external-beam radiotherapy (EBRT) or
no additional treatment (NAT)• Median follow-up was 13.3 years.
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ELIGIBILITY CRITERIAINCLUSION CRITERIA• Women of any age with a WHO performance score 0 to 2• Endometrial adenocarcinoma stage I, grade 1 with deep (50%)
myometrial invasion; grade 2 with any invasion; or grade 3 with superficial (50%) invasion were eligible.
EXCLUSION CRITERIA• History of invasive cancer(except for basal cell carcinoma of
the skin)• Previously received chemotherapy,hormonal therapy, or
radiotherapy.• The interval between surgery and radiotherapy had to be less
than 8 weeks.INFORMED CONSENT WAS OBTAINED FROM ALL PATIENTS.
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• PRIMARY ENDPOINTSLocoregional recurrence and overall survival.
• SECONDARY ENDPOINTSTreatment morbidity and survival after relapse.
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• Surgery consisted of total extrafascial hysterectomy and bilateral salpingo-oophorectomy without lymphadenectomy (only biopsy of any suspicious lymph nodes)
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RADIOTHERAPY TECHNIQUE
• Pelvic EBRT was administered with the target volume including Parametrial tissuesProximal two thirds of the vagina Lymphatic drainage regions along the internal iliac
vessels up to the promontory.• The superior field border was at the L5-S1 disc. • Total dose was 46 Gy with 2 Gy daily fractions,5 fractions
per week,23#.• The median energy used was 10 MV photons.• The radiotherapy technique consisted of anteroposterior-
posteroanterior fields in 101 patients, a four-field box technique in 177 patients, and a three-field technique in 61 patients.
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FOLLOW UP• Patients were followed in their regional
hospitals at least until 7 years after treatment.• LRRs were defined as vaginal and/or pelvic
recurrences. • Distant failures included para-aortic lymph
node metastases; abdominal relapses; liver, lung, and bone metastases; and diffuse metastatic disease.• All statistical analyses were performed by
using SPSS version 17.0
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• The risk factors identified weregrade 3age 60 years or olderdeep myometrial invasion.
• Patients with at least two of these three risk factors were designated high intermediate risk (HIR).• Patients with HIR features had a 20% risk
of locoregional recurrence (LRR) after NAT, which was reduced to 5% with EBRT.
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RESULTSFIFTEEN-YEAR OUTCOMES• The outcome analysis was done on data
frozen on March 1, 2009.• Of the 714 evaluable patients, 48
patients were lost to follow-up (41 of them were lost after5 years of follow-up).• Median follow-up for patients alive was
13.3 years (range, 2.8 to 18.5 years).
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LRRS AT 15 YEARS
• 5.8% - EBRT Group• 15.5% - NAT Group
• Among 50 LRRS in the NAT arm, 37 (74%) were located in the vagina.
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OS RATE AT 15 YEARS• 52% - EBRT Group• 60% - NAT Group• P=0.14
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TOXICITY PROFILE
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URINARY SYMPTOMS• Compared with patients in the NAT arm, patients
treated with EBRT reported significantly higher levels of urinary urgency (P=0.001), and of urinary incontinence, a higher need to remain close to the toilet,and more limitations in daily activities due to bladder symptoms.
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BOWEL SYMPTOMS• Patients treated with EBRT reported increased levels of
diarrhea, fecal leakage, and more limitations in daily activities due to bowel symptoms(P=0.006).
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• There were no significant differences in vaginal symptoms, body image, lymphedema, lower back pain, or menopausal symptoms between the groups.
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CONCLUSION• PORTEC-1 trial (1990-1997) was among the first to
randomly compare pelvic external beam radiotherapy(EBRT) to no additional treatment (NAT).
• It showed that EBRT provides a highly significant improvement of local control but without a survival advantage.
• It was concluded that in view of the absence of survival benefit, EBRT would be justified only for patients at relatively high risk of recurrence.
• Pelvic EBRT for Endometrial carcinoma is associated with long-term urinary and bowel symptoms, leading to lower physical functioning, even 15 years after treatment.
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LIMITATIONS• Impact of low-grade toxicity on HRQL
are lacking in these trials, and follow-up of reported toxicity generally does not exceed 5 years.• Conformal techniques are not used.
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• Randomised trial undertaken in 19 Dutch radiation oncology centres
• 427 patients with stage I or IIA endometrial carcinoma with features of high-intermediate risk were randomly assigned by a computer-generated system.
• The primary endpoint was vaginal recurrence.• Secondary endpoints were
locoregional recurrence (pelvic or vaginal, or both)distant metastasesoverall and disease-free survivaltreatment-related toxic effects and quality of life
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• The randomised PORTEC-2 trial was started to investigate whether VBT would be equally effective as EBRT in reduction of vaginal recurrence, with fewer treatment related toxic effects and improved quality of life.
• The study was undertaken between May 27, 2002, and Sept 25, 2006.
• Clinically suspicious pelvic or pariaortic lymph nodes were removed, but no routine lymphadenectomy was done.
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ELIGIBILITY CRITERIA• Patients with endometrial
adenocarcinoma were eligible for the trial on the basis of the following features of• High-intermediate risk:
Age greater than 60 years Stage 1C grade 1 or 2 disease Stage 1B grade 3 disease
Stage 2A disease,any age (apart from grade 3 with greater than 50% myometrial invasion)
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• HIGH RISK Non endometrioid type carcinomaIC grade 3Stage IIB or higher.
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EXCLUSION CRITERIA• Serous or clear cell carcinoma• Staging lymphadenectomy interval
between surgery and radiotherapy more than 8 weeks• History of previous malignant disease• Previous radiotherapy,hormonal
therapy,or chemotherapy• Previous diagnosis of Crohn’s disease or
ulcerative colitis.
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RADIOTHERAPY TECHNIQUE
• The clinical target volume for EBRT consisted of The proximal half of the vaginaParametrial tissuesInternal and external iliac lymph node region and
the caudal part of the common iliac lymph node chain(up to 1 cm below the level of the promontory)
• The planning target volume consisted of the clinical target volume with a 1 cm three dimensional margin.
• A dose of 46 Gy, with 2 Gy fractions, 5 times per week, was prescribed to the planning target volume.
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• Computerised treatment planning was done with three-dimensional conformal or multiple field techniques• Brachytherapy was delivered with a
vaginal cylinder, with the reference isodose covering the proximal half of the vagina.• The dose was specified at 5mm distance
from the surface of the cylinder.
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BRACHYTHERAPY SCHEDULE
• DOSE FOR HDR 21 Gy in 3 fractions of 7 Gy, 1 week apart
• DOSE FOR LDR30 Gy at 50–70 cGy/h
• DOSE FOR MDR28 Gy at 100 cGy/h in 1 session
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FOLLOW UP• Patients were assessed by their
radiation oncologist 2–4 weeks after completion of radiotherapy.• Follow-up visits to the gynaecologist
and radiation oncologist were planned every 3 months in the first 2years, every 6 months until year 5, and then every year, up to 10 years.
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• All statistical analyses were done with SPSS(version 16.0).• Data were frozen for analysis on May
19, 2009
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• No significant difference in 5-year locoregional recurrence, despite a higher rate of pelvic recurrence after VBT.
• No significant difference in OS and DFS
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• No significant difference in vaginal recurrence
• More pelvic recurrence with VBT than with EBRT
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• NO SIGNIFICANT DIFFERENCE IN LRR AND OS AT 5 YEARS
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TOXIC EFFECTSG.I.TOXICITY• Grade 1 and 2 gastrointestinal (EORTC-RTOG small/large
intestine) toxic effects increased significantly at completion of EBRT compared with VBT (EBRT 53·8%[112/208] vs 12·6% [27/215]).
• This difference decreased with further follow-up and lost statistical significance after 24 months
• For patients assigned to VBT, gastrointestinal toxic effects remained at baseline level.
MUCOSAL TOXICITY• From 6 months onwards, grade 1–2 mucosal atrophy
increased, with significantly more grade 2 atrophy after VBT than after EBRT
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• PORTEC-2 shows that patients at high intermediate risk, about 30% of all patients with endometrial cancer, can be safely treated with vaginal brachytherapy alone, with fewer side effects and improved quality of life.• EBRT will thus be used only for the
15% of patients with high-risk or advanced disease.
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CONCLUSION• VBT is very effective in ensuring local control keeping
to a minimum the risk of vaginal recurrence.• VBT achieves excellent vaginal control and rates of
locoregional recurrence.• Overall survival, and disease-free survival that are
similar to EBRT• Quality of life and gastrointestinal toxic effects are
significantly better with VBT.• VBT should be the adjuvant treatment of choice for
patients with endometrial carcinoma of high intermediate risk.
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LIMITATIONS• Number of patients is low that under powers
the study• Change in grade I and grade II diseases in
central pathological review.44% to 79% in grade I44% to 9% in grade II13% In Retrospect were ineligible for trial
• It did not consider LVSI in risk factors• It underscored the role of pathologists in the
diagnosis of carcinoma endometrium
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PORTEC-3• Randomized Phase III Trial
Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma:PORTEC-3• An international Intergroup trial• Recruitment ended in Dec 31, 2013• Data not yet published.PORTEC-3, CKTO 2006-04, CME P06.031, version
12 April 2012
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PORTEC-4• Postoperative Radiation Therapy
for Endometrial Carcinoma Multicenter Randomised Phase III Trial Comparing Vaginal Brachytherapy (Two Dose Schedules) with Observation after Surgery• A Dutch Gynaecological Oncology
Group trial• Recruitment will continue upto 5
years• Result not yet published
PORTEC-4, KWF-CKS UL2011-5336; CME P11.185; version 1.5.1, 09 May 2013
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THANK YOU
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THE LANCET • Vol 355 • April 22, 2000