Download the ESMO 2012 Abstract Book - Oxford Journals

Novartis and unrestricted research grants from Amgen and Roche, D. Patrick:
Research funding from Amgen Inc., D.H. Henry: Advisory board member, served on
the speakers bureau, and received research funding from Amgen Inc., V. Hirsh:
Advisory board member for Amgen Inc., A. Feng: Employed by and owns stock/
stock options in Amgen Inc., Z. Cong: Employed by and owns stock/stock options in
Amgen Inc., A. Braun: Employed by and owns stock/stock options in Amgen Inc.,
All other authors have declared no conflicts of interest.
1581P A RANDOMIZED PHASE II TRIAL COMPARING STANDARD
PAIN CONTROL WITH OR WITHOUT GABAPENTIN FOR THE
TREATMENT OF PAIN RELATED TO RADIATION-INDUCED
MUCOSITIS IN HEAD AND NECK CANCER
T. Kataoka 1 , N. Kiyota 2 , T. Shimada 2 , M. Toyoda 2 , Y. Fujiwara 2 , K. Nibu 3 ,
T. Komori 4 , R. Sasaki 5 , T. Mukohara 2 and H. Minami 2
1 Division of Oral and Maxillofacial Surgery, Shizuoka Cancer Center, Shizuoka,
JAPAN, 2 Medical Oncology and Hematology, Kobe University Hospital, Kobe,
JAPAN, 3 Otolaryngology and Head and Neck Surgery, Kobe University Hospital,
Kobe, JAPAN, 4 Oral and Maxillofacial Surgery, Kobe University Hospital, Kobe,
JAPAN, 5 Radiation Oncology, Kobe University Hospital, Kobe, JAPAN
Background: Radiation-induced mucositis (RIM) in chemoradiation (CRT) for
head and neck cancer (HNC) causes severe pain and worsens CRT
compliance and outcome. Following retrospective reports that gabapentin
might improve RIM-associated pain during CRT, we conducted a randomized
phase II trial to analyze the safety and efficacy of gabapentin for
RIM-associated pain.
Methods: HNC patients (pts) receiving CRT were randomized to receive standard
pain control (SPC) or SPC plus gabapentin (SPC + G). Pts in the SPC arm received
acetaminophen and opioids as analgesic, while those in the SPC + G arm received
gabapentin in addition to SPC. Gabapentin maintained at dose of 900 mg/day till 4
weeks after CRT. The prescribed RT dose was 66-70 Gy/33-35Fr. Concurrent
chemotherapy consisted of a three-week cycle of cisplatin. Primary endpoint was
maximum VAS score during CRT. Secondary endpoints were total dose of opioids,
change in QOL (EORTC QLQ-C30 and EORTC QLQ-HN 35) from base line to 4
weeks after CRT, and adverse events.
Results: From Apr 2010 to Oct 2011, 22 eligible pts were randomly assigned to
receive SPC (n = 11) or SPC + G (n = 11). All pts were Stage III or IV. Twelve were
treated in a locally advanced setting and 10 in a postoperative setting. No statistically
significant differences were seen in median maximum VAS scores between arms (47
in SPC vs. 74 in SPC + G; p = 0.517). Median total dose of opioids at maximum VAS
and total dose of opioids at 4 weeks after CRT did not statistically differ but
appeared higher in the SPC + G arm (215 mg vs. 745.3 mg; p = 0.880, 1260 mg vs.
1537.5 mg; p = 0.9438). QOL analysis showed significantly worse scores in the SPC +
G arm for weight gain (p = 0.005). Adverse events related to gabapentin were
manageable. One-year survival rate in both arms was equivalent.
Conclusions: This is the first prospective randomized trial to analyze the safety and
efficacy of gabapentin for RIM-associated pain. While survival data was equivalent in
both arms, gabapentin may have detrimental effects for RIM and further
investigation is warranted.
Disclosure: N. Kiyota: an advisory board member on proper usage of cetuximab for
head and neck cancer in Japan (Merck Serono) All other authors have declared no
conflicts of interest.
1582P PAIN AND BOWEL FUNCTION EVOLUTION, IN CANCER
PATIENTS TREATED WITH STRONG OPIOIDS AT THE FIRST
TIME THAT THEY REPORT MODERATE-SEVERE PAIN. C2
STUDY
I. López Calderero 1 , L. Zugazabeitia Olabarria 2 , M.Á. Nuñez Viejo 3 , J.M.
García Bueno 4 , E. Blanco Campanario 5 , J. Contreras Martínez 6 ,M.
López Mata 7 , J.L. Marti Ciriquian 8 , D. Isla Casado 9 and M. Provencio Pulla 10
1 Radio-Oncology Service, Hospital Virgen del Rocío, Sevilla, SPAIN, 2 Oncology
Service, Hospital Povisa, S.A, Vigo, SPAIN, 3 Oncology Service, Hospital Santa
María Nai, Ourense, SPAIN, 4 Oncology Service, Hospital General de Albacete,
Albacete, SPAIN, 5 Oncology Service, Hospital Infanta Cristina, Badajoz, SPAIN,
6 Radio-Oncology Service, Complejo Hospitalario Regional Carlos Haya, Málaga,
SPAIN, 7 Radio-Oncology Service, Hospital Clínico Universitario Lozano Blesa,
Zaragoza, SPAIN, 8 Oncology Service, Hospital General Universitario de Alicante,
Alicante, SPAIN, 9 Oncology Service, Hospital Clínico Universitario Lozano Blesa,
Zaragoza, SPAIN, 10 Oncology Service, Hospital Universitario Puerta de Hierro de
Majadahonda, Madrid, SPAIN
Introduction and objectives: Opioids remain the cornerstone of analgesic treatment
for cancer patients, but gastrointestinal side effects have a great impact on their
quality of life. The aim of this analysis was to evaluate the use of strong opioids in
Annals of Oncology
these patients, and if oxycodone/naloxone combination provides benefits in terms of
analgesia, without compromising bowel function.
Material and methodology: Interim analysis of an observational multicentre study,
in which patients reporting moderate-severe pain, at 1 st time in the oncology
services, were treated following investigator criteria. We present results of the patients
treated with strong opioids during 1 month (N= 298).
Results: Baseline characteristics: 65% male, mean ± SD age: 66 ± 13 years (27% ≥ 75
years old), ECOG 1: 54%; receiving chemotherapy 64% and radiotherapy 41%. Main
location of the primary tumor: lung (28%), colon/rectum (12%), head and neck
(11%). Metastatic cancer: 79%; 67% of patients reported pain secondary to
metastases. Comparison between patients treated with oxycodone/naloxone (n= 217)
with those treated with other strong opioids (n= 81) showed a good pain control in
both groups (NRS0-10-2.7 and -2.2 points respectively, p = 0,08). It was confirmed a
significant improvement of bowel function (