S110
ESTRO 35 2016
_____________________________________________________________________________________________________
Conclusion:
Based on the current results, analyzed on the
current dataset, we have shown that the logistic regression
model (separate model for every time point) may perform
better than models trying to cover the complete follow-up
period. This may be due to the optimization capabilities,
when training a new model for every follow-up time point,
but might be susceptible for overfitting. From a clinical
perspective, this could be plausible as the influence of
variables (e.g. (neo-)adjuvant chemotherapy) may vary
during the follow-up period and targeted outcome and could
show how clinical and/or treatment decisions have influence
on the patient outcome over time. Future work also involves
handling of missing values, which is a major concern when
merging trial datasets.
OC-0243
Randomised
trial
on
preoperative
platin-based
Radiochemotherapy in rectal cancer: 10-years analysis
M. Gambacorta
1
Catholic University, Radiation Oncology - Gemelli ART,
Rome, Italy
1
, F. Cellini
1
, M. Colangione
1
, M. Lupattelli
2
, V.
Lancellotta
2
, D. Genovesi
3
, M. Cosimelli
4
, V. Picardi
5
, M.
Osti
6
, M. Portaluri
7
, F. Tramacere
7
, E. Maranzano
8
, G.
Mantello
9
, V. Valentini
1
2
Università degli Studi di Perugia, Dipartimento di
Radioterapia, Perugia, Italy
3
Università Gabriele D'annunzio, Dipartimento di
Radioterapia, Chieti, Italy
4
Istituto Regina Elena, Dipartimento di Chirurgia, Roma,
Italy
5
Centro Alta Tecnologia, Dipartimento di Radioterapia,
Campobasso, Italy
6
Università La Sapienza - Ospedale S. Andrea, Dipartimento
di Radioterapia, Roma, Italy
7
Ospedale Civile, Dipartimento di Radioterapia, Brindisi,
Italy
8
Ospedale Civile, Dipartimento di Radioterapia, Terni, Italy
9
Azienda Ospedaliero-Universitaria Ospedali Riuniti-
Università Politecnica delle Marche, Dipartimento di
Radioterapia, Ancona, Italy
Purpose or Objective:
To investigate long term outcome and
predictors between two schedules of platin based
preoperative radiochemotherapy (RTCT)
Material and Methods:
Patients with rectal adenoca, MRI
based stage cT3N0-N2, were randomized into two arms:
1) PLAFUR: RT= 50.4 Gy; Concurrent chemotherapy (CT)=
CDDP 60 mg m2 (days 1-29) + 5FU continuous infusion in 96 h
(days 1-4 and 29-32)
2) TOMOX-RT: RT=50.4 Gy; CT= Tomudex 3 mg / m2 +
oxaliplatin 130 mg / m2 (days 1, 19 and 38).
Restaging at 6-8 weeks after the end of RTCT, followed by
surgery in 1-2 weeks.
Adjuvant CT was recommended in ypN1-2.
Local control (LC), metastases-free survival (MFS), disease-
free survival (DFS) and overall survival (OS) were analyzed.
Predictive endpoints of clinical outcome were tested by
univariate and multivariate analysis. The investigated
variables were: (i) patients (age, sex), (ii) therapy (RTCT
schedule, adjuvant CT, surgery type, colostomy), (iii) tumor
related (cT, cN, ypT, ycN, TRG grade, site of primary T).
Results:
From 2002 to 2005, 164 patients were enrolled (M: F
= 104: 60); 83 were randomized to PLAFUR and 81 to TOMOX-
RT. The median follow-up was 120.2 months (5.8-152.5).
The 10-years rates of the efficacy endpoints, per arm, were
as follows: LC: PLAFUR= 89.2% , TOMOX-RT= 96.3%
(p=0.0757); MFS: PLAFUR= 81.9% , TOMOX-RT= 81.5%
(p=0.987) ; DFS: PLAFUR= 78.3% , TOMOX-RT= 77.8%
(p=0.982); OS: PLAFUR =50%, TOMOX-RT= 50% (p=0.918)
TOMOX-RT showed a non-significantly higher rate of ypT0
compared to PLAFUR: 35.8% vs 24.1% (p = 0.102),
respectively.
Sphincter-saving surgery procedure was applied in: PLAFUR=
87.9%, TOMOX-RT= 86.4%.
Grade 3-4 acute toxicity occurred in: 7.1% in the PLAFUR arm
vs 16.4% in the TOMOX-RT arm.
Confirmed predictors of outcome were found:
- For LC: at univariate analisys= ypT; ypN, TRG Grade; at
multivariate analysis= TRG Grade (p = 0.0126)
- For MFS: at univariate analisys= age ypT, ypN and TRG
Grade; at multivariate analysis= TRG Grade (p = 0.0255)
- For DFS: at univariate analisys= age ypT, ypN and TRG
Grade; at multivariate analysis= TRG Grade (p = 0.0224)
- For OS: at univariate analisys= age ypT, ypN and TRG Grade;
at multivariate analysis= no predictor was significantly
associated.
Conclusion:
The TOMOX-RT schedule allowed higher non-
significant local control, and comparable clinical outcome to
the compared schedule. Moreover the ypT downstaging was
significantly improved. Acute toxicity was comparable
between arms.
The TRG Grade was a good independent variable predicting
LC, MFS and DFS, but not OS.
OC-0244
Similar quality of life after short-course radiation versus
chemoradiation in rectal cancer patients
A.M. Couwenberg
1
UMC Utrecht, Radiotherapy, Utrecht, The Netherlands
1
, J.P.M. Burbach
1
, M. Van Vulpen
1
, M.P.W.
Intven
1
, O. Reerink
2
, W.M.U. Van Grevenstein
3
, M. Koopman
4
,
H.M. Verkooijen
5
2
Isala, Radiotherapy, Zwolle, The Netherlands
3
UMC Utrecht, Surgery, Utrecht, The Netherlands
4
UMC Utrecht, Oncology, Utrecht, The Netherlands
5
UMC Utrecht, Imaging, Utrecht, The Netherlands
Purpose or Objective:
A majority of patients with rectal
cancer is treated with neoadjuvant radiotherapy, with or
without chemotherapy. If after chemoradiation (CRT)
patients show a good clinical response, organ-preserving
strategies are increasingly being offered. To increase the
amount of patients with a good clinical response, it has been
proposed to replace short-course radiotherapy (SCRT) by
CRT. However, intensified treatment may affect patients’
quality of life (QoL). This study aims to compare self-
reported QoL between routinely treated rectal cancer
patients receiving SCRT versus CRT before, during and after
treatment.
Material and Methods:
This multicenter prospective cohort
study includes rectal cancer patients of all stages referred
for radiotherapy between February 2013 and May 2015. QoL
was assessed by EORTC-C30 and -CR29 questionnaires at
baseline, 3, 6 and 12 months. For each patient, a propensity
score (PS) for receiving CRT was calculated and used for
restriction and adjustment. Changes in QoL over time were
analyzed by mixed models between patients receiving CRT
and SCRT, and additionally compared to a normative age-
matched Dutch population.
Results:
After PS based restriction, 191 of 208 eligible
patients were included, of which 69 underwent SCRT and 122
CRT. Patients undergoing CRT were younger (62.2 vs. 68.0
year), had more mesorectal fascia invasion (66.6% vs. 27.9%),