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Annals of Oncology<br />
1425P PAIN MANAGEMENT IN EIGHT ITALIAN ONCOLOGICAL<br />
CARE CENTRES<br />
S. Barni 1 , K.F. Borgonovo 1 , F. Di Costanzo 2 , F. Cognetti 3 , G. Bernardo 4 ,<br />
C. Boni 5 , B. Agostara 6 , P. Pronzato 7 , G. Colucci 8 , M. Mammucari 9<br />
1 Medical Oncology Division, Azienda Ospedaliera Treviglio-Caravaggio, Treviglio,<br />
ITALY, 2 Medical Oncology Unit, Azienda Ospedaliero Universitaria Careggi,<br />
Firenze, ITALY, 3 Division Medical Oncology A, Istituto Regina Elena, Roma, ITALY,<br />
4 Oncologia Medica 2, Fondazione S. Maugeri IRCCS, Pavia, ITALY, 5 Oncology<br />
Dept., Arcispedale S. Maria NuovaDivisione di Oncologia, Reggio Emilia, ITALY,<br />
6 Oncology Division, A.O. Civico Palermo, Palermo, ITALY, 7 Oncologia Medica A,<br />
IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro,<br />
Genova, ITALY, 8 Oncology Division, Istituto Tumori Ospedale Oncologico, Bari,<br />
ITALY, 9 RMF, RMF, Roma, ITALY<br />
Introduction: Management of oncologic patients is different between treating<br />
centers, and in particular management of pain. We decided to perform a<br />
retrospective study to explore different approaches to oncological painful patients<br />
(pts) in different Italian Cancer Units.<br />
Materials and methods: We evaluated in 8 Italian cancer hospitals all consecutive<br />
pts during 5 days in order to investigate level of pain in <strong>the</strong> previous 7 days and in<br />
<strong>the</strong> following two weeks from <strong>the</strong> basal visit. Patients and oncologists filled up a<br />
questionnaire (type of pain, intensity, site of pain, and analgesic <strong>the</strong>rapy).<br />
Results: 265 pts were enrolled, 59% female and 41% male; median age 61.5. 88% of<br />
pts had ECOG PS 0-1; 72.8% of pts reported metastatic disease and 86.4% were<br />
under chemo<strong>the</strong>rapy treatment. Pain measured with VAS (Visual Analogic Scale) at<br />
baseline was 2.9. Pain was somatic in 32.4%, visceral in 12.5% visceral, 13.9%<br />
neuropathic, 41.2% mixed. The current analgesic <strong>the</strong>rapy at baseline had been<br />
prescribed by oncologist in 38.2%, by o<strong>the</strong>r specialist in 42.1%, by family doctor in<br />
18.5% and by o<strong>the</strong>r doctor in 1.1%. The basal analgesic treatment was confirmed in<br />
57.3%, adjusted in 34%, and changed in 8.6%. At baseline we detected NSAIDS in<br />
69.4% pts, weak opioids in 34% of pts; strong opioids in 38.9%, and 27.7% of pts also<br />
had adjuvants (24.5% pregabalin, 57.1% steroids, 18.4% o<strong>the</strong>r drugs). At first weekly<br />
follow-up (216 pts) <strong>the</strong> intensity of pain was 2.6 (VAS). The analgesic <strong>the</strong>rapy was<br />
confirmed in 72.2% and adjusted in 27.8%. New drugs prescribed at first follow-up<br />
were NSAIDS in 43.3%, weak opioids in 21.7%, strong opioids in 86.7%, adjuvants in<br />
55%. At second weekly follow-up (131 pts): 80.9% of <strong>the</strong>rapies were confirmed and<br />
19.1% adjusted. 90.3% <strong>the</strong>rapies of 72 pts coming to third follow-up were confirmed.<br />
In 85.7% of <strong>the</strong> adjusted <strong>the</strong>rapies an adjuvant was prescribed.<br />
Conclusions: Our data suggest two important comments. First, we observed a poor<br />
utilization of adjuvants by physicians in oncologic patients, especially when <strong>the</strong>rapies<br />
are not prescribed by oncologists. Second, our data confirmed <strong>the</strong> need for a close<br />
follow-up to improve analgesic <strong>the</strong>rapy.<br />
Disclosure: All authors have declared no conflicts of interest.<br />
1426P PAIN PALLIATION OF BONE METASTASES USING<br />
MAGNETIC RESONANCE GUIDED FOCUSED ULTRASOUND -<br />
MULTI-CENTER MULTI-TRIAL RESULTS<br />
R. Catane 1 , D. Gianfelice 2 , M. Kawasaki 3 , D. Iozeffi 4 , S. Kanyev 5 , A. Napoli 6 ,<br />
P. Ghanouni 7 ,G.Lo 8 , Y. Inbar 9 , L. Shay Levi 10<br />
1 Division of Oncology, Chaim Sheba Medical Center, Ramat Gan, ISRAEL,<br />
2 Vascular/interventional Radiology, University Health Network, Toronto, CANADA,<br />
3 Orthopaedic Surgery, Kochi Medical School, Kochi, JAPAN, 4 Radiology, Rostov<br />
State Scientific Research Institute of Oncology, Rostov-on-Don, RUSSIAN<br />
FEDERATION, 5 Radiology, N.N. Petrov Institute of Oncology, Saint Petersburg,<br />
RUSSIAN FEDERATION, 6 Radiology, Sapienza University of Rome, Rome, ITALY,<br />
7 Radiology, Stanford University, Stanford, CA, UNITED STATES OF AMERICA,<br />
8 Radiology, Hong Kong Sanatorium & Hospital, Happy Valley, HONG KONG,<br />
9 Radiology, Chaim Sheba Medical Center, Ramat Gan, ISRAEL, 10 Application,<br />
InSightec, Tirat Carmel, ISRAEL<br />
Introduction: Magnetic Resonance guided Focused Ultrasound (MRgFUS) is a<br />
non-invasive, non-ionizing treatment for <strong>the</strong>rmal ablation of tumors. The technology<br />
uses high intensity focused ultrasound ablation combined with continuous MR<br />
imaging to denervate pain. Precise targeting of <strong>the</strong> lesion and real time monitoring<br />
of tissue temperature rise are cornerstones of <strong>the</strong> technique. We present here results<br />
of multiple multi-center studies evaluating <strong>the</strong> safety and effectiveness of MRgFUS<br />
for painful bone metastases.<br />
Methods: 93 patients with painful bone metastases underwent MRgFUS in 14<br />
medical centers worldwide. Treated lesions had to be remote from nervous structures<br />
or joints. Effectiveness of pain palliation was evaluated with a standardized 11-point<br />
pain rating scale (0-no pain/10-worst pain) and by monitoring changes in<br />
pain-relieving medication. A reduction of 2 points or more was considered a<br />
significant response. Safety events were recorded and evaluated by severity. Results of<br />
31 patients treated in initial safety studies were previously reported by Liberman et al<br />
(Ann Surg Oncol. 2009 Jan; 16(1):140-6).<br />
Results: 107 procedures were performed, targeting 96 lesions in 93 patients. 3<br />
patients were treated twice targeting a different lesion; ano<strong>the</strong>r 11 patients underwent<br />
a second treatment due to large lesions. Patients were followed-up for a period of 3<br />
months. Pain response was relatively rapid: within 3 days, on average, <strong>the</strong> clinical<br />
endpoint was met and maintained. Pain scores averaged 6.9 pre-treatment, decreased<br />
to 4.5 within 3 days post-treatment, to 3.3 at one month post-treatment, and fur<strong>the</strong>r<br />
decreased to 2.6 at three month follow-up. There were no serious adverse events<br />
related to <strong>the</strong> treatment. 2 patients had mild skin ery<strong>the</strong>ma following <strong>the</strong> treatment<br />
and 5 patients (5%) had pain progression. Our updated results are similar to early<br />
reports.<br />
Conclusions: The presented results clearly show that MRgFUS can provide a quick,<br />
effective and safe palliative <strong>the</strong>rapy for patients suffering from painful bone<br />
metastases. Current results are consistent with initial reported results. Randomized<br />
trials are being conducted in patients as a first line treatment of painful bone<br />
metastases vs. radiation <strong>the</strong>rapy and in patients who failed radiation <strong>the</strong>rapy vs.<br />
sham.<br />
Disclosure: L. Shay Levi: I work in InSightec as <strong>the</strong> global bone applications<br />
specialist. InSightec is <strong>the</strong> company sponsered <strong>the</strong>se clinical trials.All o<strong>the</strong>r authors<br />
have declared no conflicts of interest.<br />
1427P CURCUMA LONGA EXTRACT IS EFFECTIVE IN IMPROVING<br />
INFLAMMATORY STATUS AND REDOX BALANCE IN<br />
PATIENTS WITH CANCER-RELATED CACHEXIA AND<br />
OXIDATIVE STRESS<br />
G. Mantovani 1 , C. Madeddu 1 , F. Panzone 1 , M.C. Cau 1 , G. Antoni 1 ,F.Leo 1 ,<br />
A. Maccio’ 1 , R. Serpe 2<br />
1 Department of Medical Oncology, University of Cagliari, Cagliari, ITALY, 2 Parco<br />
Scientifico e Tecnologico della Sardegna, Nutrisearch SRL, Cagliari, ITALY<br />
Background: Curcumin (diferuloylmethane) is <strong>the</strong> biologically active compound of<br />
Turmeric (Curcuma Longa) and has long been used in traditional Asian medicine to<br />
treat diseases ranging from heartburn to arthritis: it is thought to have antioxidant<br />
and antinflammatory properties.<br />
Aim: To assess <strong>the</strong> antioxidant and antinflammatory properties of a curcumin extract<br />
in advanced cachectic cancer patients.<br />
Methods: From September 2011 to March <strong>2012</strong>, 15 cachectic patients (M 7/F 8; age<br />
range 55–85 y) with cancer at different sites were enrolled, all stage IV. Twenty-one<br />
age/sex matched healthy controls were studied. All enrolled patients had<br />
inflammation and oxidative stress (high blood levels of proinflammatory cytokine<br />
Interleukin-6 (IL-6), high levels of blood C-reactive protein (CRP), high levels of<br />
ROS, low levels of blood antioxidant enzymes GPx and SOD and low levels of total<br />
blood antioxidant status, TAS, compared to controls. Patients were administered 4<br />
tablets (2 g/day, equivalent to 400 mg/day of active curcuminoids extract, Meriva,<br />
Indena, Milan, Italy). Treatment duration was 4 weeks.<br />
Results: A significant reduction of ROS levels ( 510 ± 120 vs 390 ± 186 Fort U)<br />
and a significant improvement of circulating levels of GPx (5630 ± 1189 vs 6590 ±<br />
2390 U/l) as well as a significant improvement of TAS (0.61 ± 0.23 vs 0.69 ± 0.4<br />
mmol Trolox eq.) was observed after treatment. The inflammatory marker CRP<br />
decreased significantly (38.12 ± 28.4 vs 20.24 ± 17.37 mg/dl), no significant decrease<br />
of serum IL-6 (25.58 ± 23.67 vs. 19.9 ± 16.8) was observed. No patient was withdrawn<br />
from <strong>the</strong> study and <strong>the</strong> treatment was safe and well tolerated.<br />
Conclusions: Curcumin extract added to <strong>the</strong> normal diet was able to significantly<br />
improve inflammatory status and counteract key parameters of oxidative stress, such<br />
as ROS, GPx and TAS. Curcumin antinflammatory-antioxidant activity could be<br />
useful in a multi-targeted combined pharmaco-nutritional approach to treat<br />
cancer-cachexia. Dr. Roberto Serpe was supported by grant CRP1_296 from <strong>the</strong><br />
Regione Autonoma della Sardegna by PO Sardegna FSE 2007-2013 (L.R.7/2007)<br />
titled”Promotion of scientific and technological research in Sardinia”, Italy<br />
Disclosure: All authors have declared no conflicts of interest.<br />
1428P APPLICATION OF KM-CART (ADVANCED CELL-FREE AND<br />
CONCENTRATED ASCITES REINFUSION THERAPY)<br />
TREATMENT TO PATIENTS WITH CANCEROUS ASCITES<br />
K. Matsusaki, K. Ohta, A. Yoshizawa, S. Goto<br />
Ascites Treatment Center, Japanese CART Study Group, Tokyo, JAPAN<br />
Purpose: The purpose of our study was to demonstrate <strong>the</strong> utility of KM-CART<br />
<strong>the</strong>rapy in <strong>the</strong> care of patients with refractory ascites. We also report one colon<br />
cancer case treated with a dendritic cell vaccine that was prepared utilizing <strong>the</strong> high<br />
yield number of autologous carcinoma cells collected in KM-CART processing.<br />
Patients with refractory ascites can suffer severe bloating and/or respiratory<br />
discomfort disrupting both <strong>the</strong>ir activities of daily living (ADL) and terminating<br />
<strong>the</strong>ir anticancer <strong>the</strong>rapy. We developed a novel KM-CART system for cancerous<br />
ascites using original CART system approved by <strong>the</strong> Ministry of Health, Labor and<br />
Welfare. KM-CART consists of ex vivo double filtration processing of autologous<br />
ascites fluid to prepare: (1) a protein (albumin and globulins) concentrate fraction<br />
suitable for intravenous fluid <strong>the</strong>rapy back to <strong>the</strong> donor patient intravenously, and<br />
(2) a cell concentrate suitable for research for anticancer drug sensitivity and<br />
immuno<strong>the</strong>rapy.<br />
Volume 23 | Supplement 9 | September <strong>2012</strong> doi:10.1093/annonc/mds411 | ix463