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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%),