S248
ESTRO 36
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OC-0465 Organ preservation for rectal cancer: the
GRECCAR 2 randomized phase III trial
V. Vendrely
1
, P. Rouanet
2
, J.J. Tuech
3
, H. Mosnier
4
, B.
Lelong
5
, M. Rivoire
6
, J.L. Faucheron
7
, M. Jafari
8
, G.
Portier
9
, B. Meunier
10
, B. Sastre
11
, M. Prudhomme
12
, F.
Marchal
13
, M. Pocard
14
, D. Pezet
15
, A. Rullier
16
, J.
Asselineau
17
, A. Doussau
17
, E. Rullier
1
1
CHU de Bordeaux, Gironde, Pessac, France
2
Institut Regional du Cancer Montpellier, Herault,
Montpellier, France
3
CHU Charles Nicolle, Seine-Maritime, Rouen, France
4
Groupe Hospitalier Diaconesses Croix Saint-Simon,
Paris, Paris, France
5
Département de Chirurgie Oncologique- Institut Paoli
Calmette, Bouches-du-Rhone, Marseille, France
6
Département de Chirurgie Oncologique- Centre Léon
Bérard, Rhone, Lyon, France
7
Service de Chirurgie Digestive- Hôpital A. Michallon,
Isere, Grenoble, France
8
Centre Oscar Lambret, Nord, Lille, France
9
Hopital Purpan - Pavillon Dieulafoy, Haute-Garonne,
Toulouse, France
10
CHU Pontchaillou, Ille-et-Vilaine, Rennes, France
11
CHU Timone, Bouches-du-Rhone, Marseille, France
12
Hôpital Universitaire Carémeau, Gard, Nimes, France
13
Centre Alexis Vautrin, Meurthe-et-Moselle, Nancy,
France
14
Hopital Lariboisiere, Paris, Paris, France
15
CHU Hotel-Dieu, Puy-de-Dome, Clermont-Ferrand,
France
16
CHU de Bordeaux- Hopital Pellegrin, Gironde,
Bordeaux, France
17
CHU de Bordeaux- USMR, Gironde, Bordeaux, France
Purpose or Objective
The objective was to compare local excision (LE) and total
mesorectal excision (TME) in patients with a good response
after radiochemotherapy for low rectal cancer.
Material and Methods
Patients with T2-T3 low rectal carcinoma, maximum size
4 cm, received neoadjuvant radiochemotherapy. Good
clinical responders (residual tumor ≤ 2 cm) were
randomized between LE and TME. In the LE group, a
completion TME was required if ypT2-3. The primary end
point was a composite outcome including death,
recurrence, morbidity and after-effects at 2 years.
Secondary outcomes were pathologic response, 3-year
local recurrence and survival.
Results
A hundred forty eight good clinical responders to
radiochemotherapy were randomized, 3 were excluded
and 145 were analyzed: 74 in the LE group and 71 in the
TME group. In the LE group, 26 patients had a completion
TME. At 2 years, significant events occurred in 56% in the
LE group and 48% in the TME group (p=0.320). In intention-
to-treat analysis, there was no difference between LE and
TME in all components of the composite outcome. Per
protocol analysis showed a lower morbidity
(11%/21%/48%,p=0.001)
and
fewer
after-effects
(17%/29%/62%,p<0.001) according to type of surgery LE,
TME and completion TME. Pathologic results showed a low
rate of positive lymph nodes in ypT0-1 (0%) and ypTx/cN0
(2%). 3-year local recurrence (5%) and overall survival
(92%) were similar between LE and TME groups.
Conclusion
LE is oncologically safe as compared to TME. Globally it is
not superior to TME, due to a high rate of completion TME
that increases morbidity and after-effects. A better
patient selection removing unnecessary completion TME
(ypT2/cN0) will improve the strategy.
OC-0466 Brachytherapy for conservative treatment of
penile carcinoma: prognostic factors and outcome
A. Escande
1
, C. Haie-Meder
1
, R. Mazeron
1
, P. Castelnau-
Marchand
1
, P. Maroun
1
, A. Cavalcanti
2
, F. Marsolat
1
, K.
Doyeux
1
, R. De Crevoisier
3
, F. Martinetti
1
, I. Dumas
1
, E.
Deutsch
1
, C. Chargary
1
1
Gustave Roussy Cancer Campus, Brachytherapy Unit-
Radiation Oncology, Villejuif, France
2
Gustave Roussy Cancer Campus, Department of Surgery,
Villejuif, France
3
Eugene Marquis Cancer Center, Radiation Oncology,
Rennes, France
Purpose or Objective
Penile carcinoma is a very rare disease, for which total
glansectomy is frequently proposed as first intent
treatment. However, functional sequelae of surgery have
prompted to look at organ sparing strategies. Here is
reported the largest experience of brachytherapy as a
conservative approach.
Material and Methods
We examined the outcome of 201 patients treated in our
Institution over 45 years for a histologically confirmed
invasive squamous cell carcinoma of the penile glans, with
emphasis on long-term complications and probability to
achieve organ preservation. All had undergone
circumcision prior to brachytherapy. Low dose rate or
pulse dose rate interstitial brachytherapy was used.
Median dose of brachytherapy was 65 Gy (36.5 to 76 Gy).
Results
With a median follow-up of 10.7 years, local relapses were
reported in 38 patients (18.9%) and 22/29 (75.9%) patients
with local failure only were in complete remission after
salvage surgery or second brachytherapy. At last follow-
up, 18 (12.9%) underwent partial surgery and eight (4%)
total penectomies for relapse. Fifty patients (25%)
presented urethral stenosis requiring at least one
dilatation and 13 (6%) required limited surgeries for
toxicities. A tumour diameter > 4cm and a dose < 62 Gy
correlated with a higher probability of local relapse (p =
0.009 and p = 0.015, respectively). At five years, overall
survival rate and local-failure free survival were 79%
(95%CI: 76–82%) and 82% (95%CI: 79–85%), respectively.
Presence of inguinal lymph node metastasis correlated
with a poorer overall survival (p = 0.02). Neutrophilia at
diagnosis correlated with a higher probability of distant
relapse (p = 0.014). The risk of complication correlated
with the dose, treated volume, and dose rate. At five
years, the probability of surviving while preserving the
penile was 85% (95%CI: 82–88%), taking into account the
need for surgery for complications.
Conclusion
This large institutional experience confirms the high local
control achieved with brachytherapy with the advantage
of organ preservation in selected patients. Most local
relapses are efficiently salvaged by second intent
surgery.
OC-0467 Investigating reporting-and-learning systems
of Irish radiation therapy: Can standards be improved?
K. Dowling
1
, C. Poole
1
, L. Mullaney
1
, S. Barrett
1
1
Trinity College Dublin, Discipline of Radiation Therapy,
Dublin, Ireland
Purpose or Objective
Wide variation exists between event (incidents and near-
misses) reporting-and-learning systems utilised in the field
of radiation oncology. Due to the high potential for error
associated with this field of medicine, evidence-based and
rigorous systems are imperative. The implementation of
such systems facilitates the reactive enhancement of
patient safety following an event. This research study was
undertaken so as to evaluate Irish event reporting-and-
learning procedures and to propose recommendations as
to how the national standard can be improved to the
optimal standards outlined in the literature. The
methodology used to undertake this research was
developed with the aim of ensuring its applicability to