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Download the ESMO 2012 Abstract Book - Oxford Journals

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1609P PHYSICAL ACTIVITY (PA) AND PHYSICAL FITNESS (PF) IN<br />

LYMPHOMA PATIENTS BEFORE DURING AND AFTER<br />

CHEMOTHERAPY (PAFILP): A PROSPECTIVE<br />

OBSERVATIONAL PILOT-STUDY<br />

P. Wolter 1 , N. Vermaete 2 , D. Dierickx 3 , A. Janssens 3 , P. Schöffski 1 , G. Verhoef 3<br />

and R. Gosselink 2<br />

1 Department of General Medical Oncology, University Hospitals Leuven, Leuven,<br />

BELGIUM, 2 Department of Rehabilitation Sciences, KU Leuven, Leuven,<br />

BELGIUM, 3 Department of Hematology, University Hospitals, Leuven, BELGIUM<br />

Background: We performed a prospective longitudinal single-center pilot study to<br />

investigate physical activity (PA) and physical fitness (PF) in Hodgkin Lymphoma<br />

(HL) and Non-Hodgkin-Lymphoma (NHL) patients before, during and after<br />

first-line systemic chemo<strong>the</strong>rapy. Fur<strong>the</strong>r aims were to correlate different patient-,<br />

disease-, and treatment-related factors with <strong>the</strong> possible decline or increase of PA<br />

and PF and to identify patients at risk of developing a significant decline in PA and<br />

PF who might be candidates for an individualized exercise training program.<br />

Methods: PA was assessed with an activity monitor (Dynaport MiniMod McRoberts,<br />

The Hague, The Ne<strong>the</strong>rlands), PF by incremental cycle ergometry and by a 6 minute<br />

walking test (6MWD). Isometric quadriceps strength was measured using a Cybex II<br />

dynamometer (Lumex, Bay Shore, United States). Pulmonary function tests,<br />

electrocardiogram, echocardiography, blood pressure measurements were routinely<br />

performed.<br />

Results: The pilot study involved a total of 22 lymphoma patients (♂: 19, ♀: 3,<br />

median age 57 years, NHL: 14, HL: 8) from 10/2010 to 01/<strong>2012</strong>. At baseline PA,<br />

6MWD, maximal inspiratory pressure, quadriceps strenght, diffusion capacity at<br />

pulmonary function tests were significantly lower than predicted. In contrast, forced<br />

expiratory volume in one second (FEV1), forced vital capacity (FVC), maximal<br />

oxygen consumption (VO2max), maximal expiratory force and hand grip force were<br />

not significantly different. We observed a broad variation in <strong>the</strong> different test results<br />

between patients at baseline. After 2-3 cycles of chemo<strong>the</strong>rapy we did not identify a<br />

significant decrease in PA, whereas VO2max decreased significantly after 2-3 cycles<br />

but recovered after completion of chemo<strong>the</strong>rapy (6-8 cycles). Importantly, a huge<br />

interpatient variability could be observed at all different time points.<br />

Conclusions: Preliminary results of <strong>the</strong> PAFILP pilot study suggest that levels of PA<br />

and PF probably evolve very differently between lymphoma patients. The study is<br />

ongoing to identify possible risk factors predictive for decline in PA and PF. Such a<br />

screening tool would allow us to identify early in <strong>the</strong> course of treatment patients at<br />

risk of developing a significant decline in PA and PF who might benefit from an<br />

individualized exercise training program.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

1610P SURVEY OF OUTPATIENT CANCER CHEMOTHERAPY:<br />

OCCURRENCE OF SIDE EFFECTS AND REASONS FOR<br />

DISCONTINUATION OR DELAY<br />

H. Kushihara 1 , K. Kawada 2 , T. Kushihara 3 , N. Hamajima 4 , M. Amano 4 , K. Ooji 4 ,<br />

K. Honda 2 , F. Nomura 2 , Y. Ikeda 1 and K. Mori 1<br />

1 Pharmacy, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, JAPAN,<br />

2 Medical Oncology, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya,<br />

JAPAN, 3 Pharmacy, Japanese Red Cross Nagoya First Hospital, Nagoya,<br />

JAPAN, 4 Nursing, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya,<br />

JAPAN<br />

Background: In cancer chemo<strong>the</strong>rapy, patients have various side effects. In general, if<br />

patients’ quality of life is negatively affected (e.g., toxicity of grade 3 or higher), <strong>the</strong><br />

treatment will be discontinued. On <strong>the</strong> o<strong>the</strong>r hand, if symptoms are mild or<br />

moderate (e.g., toxicity of grade 2 or lower), <strong>the</strong> treatment will be continued with<br />

supportive <strong>the</strong>rapy. Patients with mild or moderate side effects must tolerate such<br />

adverse effects for a prolonged period. Therefore, to continue chemo<strong>the</strong>rapy safety, it<br />

is very important to understand <strong>the</strong> extent of symptoms and to provide suitable<br />

supportive care as required. We conducted a survey of outpatient cancer<br />

chemo<strong>the</strong>rapy.<br />

Methods: We retrospectively investigated <strong>the</strong> characteristics of side effects and <strong>the</strong><br />

reasons for discontinuation or delay of chemo<strong>the</strong>rapy between July 2009 and March<br />

2011 at Nagoya Daiichi Red Cross Hospital in Japan.<br />

Result: Data on 924 patients (8221 cases) were analyzed. The following data are<br />

presented in <strong>the</strong> order of grade 2 and grade 3 or higher. Nonhematologic toxicities<br />

were constipation (32.0, 0.7%), fatigue (21.3, 2.7%), anorexia (17.0, 0.6%), neuropathy<br />

(15.3, 1.4%), nausea (14.4, 0.6%), pain (13.7, 1.0%), vomiting (7.5, 0.6%), diarrhea<br />

(6.3, 0.2%), dysgeusia (6.0, − %), oral mucositis (4.1, 0.1%), and nail changes (3.6,<br />

0.1%). Hematologic toxicities were neutropenia (16.3, 19.1%), thrombocytopenia (4.1,<br />

2.1%), and anemia (26.1, 7.0%). Nonhematologic toxicities Grade 2 or lower had a<br />

high average incidence of 44.6%. Chemo<strong>the</strong>rapy was discontinued in 1341 patients<br />

(16.3%). The reasons for discontinuation or delay were laboratory abnormalities<br />

(35.4%), chief complaints of patients (34.0%), and o<strong>the</strong>rs (30.1%).<br />

Conclusion: In patients with grade 3 or higher toxicity, appropriate care was<br />

provided, including dose reduction or discontinuation of treatment. In patients with<br />

grade 2 or lower toxicity, treatment tended to be continued. Our results showed that<br />

a large proportion of patients tolerate mild or moderate side effects that do not lead<br />

to discontinuation or delay of treatment. It is necessary to evaluate <strong>the</strong> extent of<br />

symptoms and to provide supportive care from an early stage.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

1611P IMPROVING PATIENT ADHERENCE BY USING THE<br />

FLOWCHART TYPE LEAFLET<br />

Annals of Oncology<br />

S. Suzuki 1 , M. Yoshida 1 , Y. Yajima 2 , T. Kobayashi 2 , S. Kobayashi 1 , T. Enokida 2 ,<br />

H. Ishiki 2 , K. Endo 3 , K. Izumi 1 and M. Tahara 4<br />

1 Pharmacy, National Cancer Center Hospital East, Kashiwa, JAPAN, 2 Head and<br />

Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa,<br />

JAPAN, 3 Drug Safety Management, Meiji Pharmaceutical University, Tokyo,<br />

JAPAN, 4 Endoscopy & Gi Oncology, National Cancer Center Hospital East,<br />

Kashiwa, JAPAN<br />

Background: Most information sheets cover <strong>the</strong> schedule of chemo<strong>the</strong>rapy sessions<br />

and <strong>the</strong> adverse reactions of <strong>the</strong> respective drugs. However, <strong>the</strong> leaflets do not<br />

provide enough information instructing <strong>the</strong>m how to take <strong>the</strong>ir supportive<br />

medications while at home for patients that have adverse drug reactions. We have<br />

developed a flowchart type leaflet to help improve <strong>the</strong> patients’ adherence. The<br />

flowchart consisted of yes/no questions to guide how to take supportive medicine for<br />

adverse drug reactions or when patients should call to a hospital.<br />

Objective: This study was designed to evaluate <strong>the</strong> benefits associated with <strong>the</strong><br />

flowchart type leaflet (FC). [Subjects and methods] Subjects include head and neck<br />

cancer inpatients who received induction chemo<strong>the</strong>rapy, TPF (docetaxel, cisplatin,<br />

and 5FU) or TPS (docetaxel, cisplatin, and S-1), from September 2009 to April <strong>2012</strong>.<br />

Group A used FC while Group B did not use FC in <strong>the</strong>ir chemo<strong>the</strong>rapy. A<br />

retrospective study was performed using patient records. The endpoints of this study<br />

were: (1) To determine <strong>the</strong> emergency hospital admissions/visits, (2) To determine<br />

<strong>the</strong> nonadherence, (3) To determine <strong>the</strong> telephone calls from patients.<br />

Results: There were 49 patients and a total of 139 chemo<strong>the</strong>rapy sessions in group A<br />

while <strong>the</strong>re were 60 patients and a total of 163 chemo<strong>the</strong>rapy sessions in group B with<br />

no significant differences in age, performance status, and <strong>the</strong>ir chemo<strong>the</strong>rapy regimen.<br />

The results are: (1) Incidence of emergency hospital admission was significantly lower<br />

in group A compared to group B. (Group A v.s. Group B: 1% v.s. 10%, p < 0.01) (2)<br />

The nonadherence rate in supportive medication for adverse drug reactions due to<br />

chemo<strong>the</strong>rapy was significantly lower in group A than group B (Group A v.s. Group<br />

B: 5% v.s. 23%, p < 0.01). (3) Telephone call rates were statistically significant in group<br />

A (16%, total 30 calls) compared to group B (7%, total 11 calls) in each chemo<strong>the</strong>rapy<br />

regimen. Of <strong>the</strong> 30 telephone calls in group A, 24 calls (80%) were in a situation<br />

where patients needed to call a hospital and 5 calls (45%) in group B.<br />

Conclusions: The FC could contribute to reducing emergency hospital admissions to<br />

prevent nonadherence and encourage patients’ judgments in chemo<strong>the</strong>rapy.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

1612P BREAKTHROUGH PAIN (BTP) IN OPIOID-TOLERANT<br />

CANCER PATIENTS: A PAN-EUROPEAN OPEN-LABEL<br />

MULTICENTRE STUDY WITH FENTANYL BUCCAL TABLET<br />

(FBT)<br />

S. Mercadante 1 , A. Davies 2 , J. Jarosz 3 , U.R. Kleeberg 4 ,T.O’Brien 5 , P. Poulain 6<br />

and H. Schneid 7<br />

1 Anes<strong>the</strong>sia and Intensive Care Unit & Pain Relief and Palliative Care Unit, La<br />

Maddacena Cancer Center, Palermo, ITALY, 2 Palliative Medicine, Royal Surrey<br />

County Hospital NHS Foundation Trust, Guildford, UNITED KINGDOM, 3 Palliative<br />

Medicine Unit, SCMCC and Institute of Oncology, Warsaw, POLAND,<br />

4 Hematology and Medical Oncology, H, Hamburg, GERMANY, 5 Palliative<br />

Medicine, Marymount Hospice, Cork, IRELAND, 6 Palliative Unit, Polyclinique de<br />

l’Ormeau, Tarbes, FRANCE, 7 Medical Affairs EU, Teva Pharmaceutical,<br />

Maisons-Alfort, FRANCE<br />

BTP, a transitory exacerbation of pain that occurs on a background of o<strong>the</strong>rwise<br />

controlled persistent pain, is a common problem in cancer patients. FBT is indicated<br />

for <strong>the</strong> treatment of BTP in adults with cancer already receiving maintenance opioid<br />

<strong>the</strong>rapy for chronic cancer pain and should be titrated to an effective dose that<br />

provides adequate analgesia and minimises undesirable events. In this study, patients<br />

entered a screening period and were randomized during an open-label titration<br />

period to a starting FBT dose of 100 µg (group A) or 200 µg (group B) to identify<br />

<strong>the</strong> FBT effective dose and <strong>the</strong>n treated in an open-label period (for 8 BTP episodes).<br />

Patients’ inclusion followed <strong>the</strong> FBT label. 442 patients were screened from 135<br />

European sites (7 countries) and 330 were enrolled into <strong>the</strong> titration period [group A<br />

(156); group B (174)]. Cancer history of <strong>the</strong> patients: breast (20.3%), lung (14.2%),<br />

colon/rectum (12.1%), o<strong>the</strong>r (24.5%). The most frequent extent of <strong>the</strong> disease was<br />

bone metastasis and local disease, for 45.8% and 40.6% of patients, respectively. 312<br />

(94.5%) received at least one dose of study drug during <strong>the</strong> titration period [group A<br />

(145; 92.9%); group B (167; 96.0%). The effective dose rate (primary outcome) was<br />

75.2% in <strong>the</strong> group A compared to 81.4% in <strong>the</strong> group B with non-inferiority<br />

ix518 | <strong>Abstract</strong>s Volume 23 | Supplement 9 | September <strong>2012</strong>

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