6th ICHNO Abstract Book

12 / 79

6th ICHNO page 13
6th ICHNO Conference
International Conference on innovative approaches in Head and Neck Oncology
16 – 18 March 2017
Barcelona, Spain
__________________________________________________________________________________________
7AO Alessandria, Oncologia, Alessandria, Italy
8INT Milano, Oncology, Milano, Italy
9AO città della Salute Torino, Oncology, Torino, Italy
10ASL3 genova, Oncology, Genova, Italy
11ASO Santa Croce e Carle, Oncologia Ufficio Trials,
CUNEO, Italy
12ASO Santa Croce e Carle, Oncology, Cuneo, Italy
Purpose/Objective
On January 2010 We started a randomized multicenter
phase III study comparing chemoradiation (Aldestein RTOG
regimen) (CRT) versus induction chemotherapy followed
by bioradiation (RT +Cetuximab). The main objective of
the trial is Overall Survival and secondary end points are
Response Rate (RR), Progression Free survival (PFS) role of
Biomolecular prognostic factors (EGFR,HPV) and Toxicities
Material/Methods
Naïve patients with locally advanced head and neck
squamous cell carcinoma (HNSCC), histological proven, of
the oral cavity larynx hypopharynx oropharynx stage III or
IV are eligible. Additional requirement for enrolment
included adequate bone marrow function, renal function,
hepatic function and age higher than 18 yr old.
Treatment consisted of: Arm A Taxotere 75 mg/mq and
Cisplatin 75 mg/mq day 1, 5FU c.i. 750mg/mq 96h, every
3 weeks for 3 times and Cetuximab loading dose 400
mg/mq followed by weekly 250mg/mq with a standard
Radiotherapy program equivalent daily dose 2Gy up to 70
Gy; Arm B Cisplatin 100 mg/mq day 1,22,43 concurrent
with the same RT scheduling.
Statistic: 278 pts twill be accrued. Primary end-point is
OS; secondary end-points include PFS, LRC, Complete
response rate, toxicity and metastasis free survival.
Results
276/278 pts were enrolled up to now. Accrual will be
stopped on December 2016 and the final analyses will be
provided by April 2018.
Preliminary toxicity data on 170 pts previously presented
(ESMO 2015) were as follows: (85 and 85 on Arm A and B).
M/F were 70/15 and 66/19 in Arm A and B respectively.
Toxicities are reported as the worst grade observed during
the treatment. Haematological toxicities G3 + G4 in Arm
A and B were: leukopenia 8 and 6; neutropenia: 18 and 7;
anaemia: 2 and 3 ; thrombocytopenia were 0 and 1
respectively in arm A and arm B. Stomatitis G3/4 were
28/4 and 23/1. Weight loss G1/2/3 weight loss was
25/10/2 and 25/ 12/2 in arm A and in Arm B respectively.
Radio-dermatitis G 3/4 was 14/1 and 3/0 in Arm A and B.
Dysphagia G2/3 was reported in 16/11 and 10/15 patients
at first post treatment clinical evaluation. 2 patients (1 in
Arm A and 1 in Arm B) developed Renal toxicity.
Final results on patients’ population and toxicity will be
presented at the ICHNO meeting.
Conclusion
The study will finish accrual in few weeks. Data from
comparison of these two arms will be presented.
OC-020 Sarcopenia predicts chemotherapy dose-
limiting toxicity in patients with head and neck cancer
S.I. Bril1, A.W. Wendrich2, J.E. Swartz2, I. Wegner2, A. De
Graeff 3, E.J. Smid4, R. De Bree1, A.J. Pothen1
1UMC Utrecht, Head and Neck Surgical Oncology,
Utrecht, The Netherlands
2UMC Utrecht, Otorhinolaryngology - Head and Neck
Surgery, Utrecht, The Netherlands
3UMC Utrecht, Medical Oncology, Utrecht, The
Netherlands
4UMC Utrecht, Radiotherapy, Utrecht, The Netherlands
Purpose or Objective
Low skeletal muscle mass or sarcopenia is emerging as an
adverse prognostic factor for chemotherapy dose limiting
toxicity (CLDT) and overall survival (OS) in cancer
patients. In contrast to other cancers, sarcopenia has not
yet been researched as a prognostic factor in head and
neck cancer. We recently published a novel method for
accurate and easy measurement of skeletal muscle mass
in head and neck cancer patients. Using this method, we
aimed to determine the prognostic impact of sarcopenia
on CDLT and OS in patients with locally advanced head and
neck squamous cell carcinoma (LA-HNSCC) treated with
primary radiochemotherapy (RCT).
Material and Methods
All patients diagnosed with LA-HNSCC and treated with
primary RCT between January 2007 and December 2011 in
the University Medical Center Utrecht, the Netherlands,
were included in this study. Clinical variables were
retrospectively retrieved. Skeletal muscle mass was
measured at the level of the third cervical vertebra (C3)
using pre-therapy CT scans and controlled for height
(cm2/m 2). A cut-off point for sarcopenia was determined
using optimum stratification. We performed multivariate
analysis to determine prognostic factors for CDLT and OS.
Results
112 patients were included in this study. 34 (30.4%)
experienced CDLT. The optimal cut-off value for defining
sarcopenia as a predictor of CDLT was ≤43.2 cm2/m2.
Using this cut-off, 61 patients were sarcopenic (54.5%).
Sarcopenic patients experienced significantly more CDLT
than non-sarcopenic patients (44.3% versus 13.7%, p <
0.000). In multivariate analysis, an increase in skeletal
muscle mass was associated with lower odds of CDLT (OR
0.93, 95% CI: 0.88–0.98). OS did not differ significantly
between sarcopenic and non-sarcopenic (45.1 versus 49.0
months, p = 0.189). Patients who experienced CDLT had a
significantly lower OS than patients who did not (36.6
versus 54.2 months, p = 0.038).
Conclusion
Sarcopenia is an independent predictor of CDLT in LA-
HNSCC patients treated with primary RCT. OS did not
differ significantly between sarcopenic and non-
sarcopenic patients, but patients with CDLT had a
significantly lower OS. Pre-therapeutic assessment of
skeletal muscle mass can help identifying patients at risk
of CDLT. In the future, routine skeletal muscle mass
assessment may allow for personalized cancer care
regarding optimal chemotherapy dose and early
supportive care interventions.