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palliative care
1422O EFFICACY AND SAFETY OF A TWO DRUG-COMBINATION
REGIMEN FOR CANCER-RELATED CACHEXIA IN THE
CLINICAL PRACTICE
C. Madeddu 1 , A. Macciò 2 , M.C. Cau 1 , M. Dessi’ 1 , F. Panzone 1 , R. Serpe 1 ,
G. Antoni 1 , G. Mantovani 1
1 Department of Medical Oncology, University of Cagliari, Cagliari, ITALY,
2 Department of Obstetrics and Gynecology, Sirai Hospital, Carbonia, ITALY
Background and aims: To test the safety and efficacy of a two-drug combination
(including nutraceuticals, i.e. antioxidants) with carnitine + celecoxib for the
treatment of cancer-related anorexia/cachexia syndrome (CACS) in the clinical
practice. Primary endpoints: safety, increase of lean body mass (LBM) and
improvement of quality of life. Secondary endpoints: increase of physical
performance (tested by grip strength and 6-min walk test, 6MWT) and decrease of
inflammation (assessed by serum levels of IL-6 and Glasgow prognostic score, GPS).
Patients and methods: Outpatients with advanced cancer at different sites with
CACS (i.e. loss of body weight >5% of the pre-illness or ideal weight in the last
3 months) were eligible to receive: L-carnitine 4 g/day + Celecoxib 300 mg/day. All
patients received as basic treatment polyphenols 300 mg/day, lipoic acid 300 mg/day,
carbocysteine 2.7 g/day, Vitamin E, A, C, all orally. Treatment duration was
4 months.
Results: From June 2011 to April 2012, 50 patients with advanced cancer (all stage
IV) at different sites were enrolled: 40 completed the treatment and were evaluable
(mean age 63.8 ± 9.6, range 32-81 years). Results showed a significant increase of
LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) from
baseline as well as physical performance assessed by 6MWT. Quality of life (assessed
by EORTC-QLQ-C30 and EQ-5D) also improved significantly. ECOG PS and GPS
decreased significantly. The treatment was safe, no grade 3–4 toxicities occurred and
no patient had to discontinue the treatment due to severe adverse events.
Conclusions: The results of the present study confirm the efficacy and safety of the
two-drug combination regimen previously shown in a randomized clinical trial
(Madeddu et al, Clinical Nutrition 31:176-182, 2012). Therefore, this simple, feasible,
effective, safe, with favorable cost-benefit profile, two-drug approach could be
suggested in the clinical practice as a treatment for CACS.
Disclosure: All authors have declared no conflicts of interest.
1423O REAL-TIME ELECTRONIC MONITORING OF
PATIENT-REPORTED SYMPTOMS AND SYNDROMES (PRS):
E-MOSAIC, A MULTICENTER PHASE III STUDY (SAKK 95/06)
D. Blum 1 , D. Koeberle 2 , R. von Moos 3 , K. Ribi 4 , S. Aebi 5 , D.C. Betticher 6 ,
S. Hayoz 7 , J. Nadig 8 , S. Mauri 9 , F. Strasser 10
1 Department of Cancer Research and Molecular Medicine, European Palliative
Care Research Center Clinical, Trondheim, NORWAY, 2 Dept. Oncology/
Hematology, Kantonsspital St. Gallen, St. Gallen, SWITZERLAND, 3 Medizinische
Onkologie und H, Cantonal Hospital Graub, Chur, SWITZERLAND, 4 IBCSG,
IBCSG, Berne, SWITZERLAND, 5 Medizinische Onkologie, Luzerner
Kantonsspital, Luzern, SWITZERLAND, 6 Oncology, Hospital Fribourg, Fribourg,
SWITZERLAND, 7 Sakk, SAKK, Berne, SWITZERLAND, 8 Oncology, Oncology
Buelach, Buelach, SWITZERLAND, 9 Oncologia, IOSI Oncology Institute of
Southern SwitzerlandOspedale Regionale di Lugano, Sede Italiano, Viganello,
SWITZERLAND, 10 Oncology and Palliative Medecine, Kantonsspital St. Gallen,
St. Gallen, SWITZERLAND
Background: In incurable cancer patients (pts) chemotherapy (CTx) may be used by
oncologists (ONC) to alleviate PRSS. We assessed if E-MOSAIC influences global
quality of life (G-QOL) and patient care.
Methods: In this prospective, cluster (ONC) randomized trial pts with defined PRSS
starting a new line of palliative CTx with expected response rate ≤ 20% completed a
mobile computer-based (E-MOSAIC) assessment (Edmonton Symptom [SYM]
Assessment Scale, ≤3 additional SYM, nutritional intake, body weight, Karnofsky
Score, medications for main PRSS) before 6 consecutive weekly visits. Eligible ONC
Annals of Oncology 23 (Supplement 9): ix462–ix468, 2012
doi:10.1093/annonc/mds411
received (Intervention [IA]) or not (control [CA]) the cumulative computer printout
of their pts results. Primary endpoint (PE) was the difference (Δ) between baseline
(BL) and week 6 in G-QOL (EORTC-QLQ-C30, #29&30). Sample size per arm was
84 pts from 20 ONC for 80% power to detect a 10 point Δ, significance level 5%. A
planned interim analysis with 100 pts showed many for the PE non-evaluable pts:
sample size was increased to 264 pts. Due to clustering, a mixed effects model
adjusting for BL G-QOL and other preselected covariates was used. Secondary EP
included SYM Distress (∑ 10 VAS, 0–10), pts-perceived ONC compassion
(∑ 5 VAS, 0–100) and communication, coping, treatment burden and SYM
management by nurse report.
Results: In 8 centers, 84 ONC treated 264 pts (median 66y; overall survival IA 6.3,
CA 5.4 mts) with various tumors. 102 pts (IA: 55; CA: 47) had uninterrupted (> 4/6
visits, same ONC) pat-ONC sequences, required for PE. The between-arm Δ of PE
was 6.8 (p = 0.11) in favor of the IA. In a sensitivity analysis with ONC treating ≥2
pts (IA: 50; CA 39 pts) it was 9.0 (p = 0.07). BL G-QOL was the most influential
factor (p < 0.01). Intention to treat analysis revealed improvement in SYM Distress
(Δ BL-last study visit: IA -4.9 vs. CA 2.0, p= 0.003), compassion (Δ BL-week 6: IA:
18.9 vs. CA: 4.3), communication, treatment burden and coping in favor of the IA.
More pts with high SYM had ONC management.
Conclusion: Our intervention of real-time monitoring of PRSS, delivered to
oncologist, clearly improved SYM distress with a trend to better SYM management,
communication and Qol.Further development is warranted.
Disclosure: All authors have declared no conflicts of interest.
1424P COMPARISON OF 8GY SINGLE FRACTION RADIOTHERAPY
VERSUS 20GY IN FIVE FRACTIONS OR 30GY IN 10
FRACTIONS FOR THE TREATMENT OF METASTATIC
BONE PAIN
B. El Hawwari, A. Telfah
Department of Hemato- Oncology, King Hussein medical Center, Amman,
JORDAN
Introduction: In 1974 the Radiation Therapy Oncology Group (RTOG) initiated a
randomized clinical trial comparing various dose-fractionation schedules in the
palliation of cancer metastatic to bone. The trial was closed in February of 1980 and
results have been published in 1982, with the conclusion that: “low-dose short
schedules are as effective as more aggressive protracted programs. Since that time,
different radiotherapy schedules had been employed for palliation of bone metastasis:
40 Gy in 20 fractions, 30 Gy in 10 fractions and single fractions of 8 Gy, 6 Gy or 4
Gy. Several randomized prospective trials and meta-analyses have been reported
showing the same results in pain relief when comparing single doses vs protracted
treatments.
Objectives: The aim of this study was to compare the most common fractionation
used in oncology to treat bone metastases which are 8Gy single fraction, 20Gy in five
fractions and 30Gy in 10 fractions.
Method: A total dose of 120 patients who is known to have stage VI cancer with
bone metastasis at King Hussein Medical Center between January 2007 and
December 2009, were allocated to receive either 8Gy single fraction, 20Gy in five
fractions or 30Gy in 10 fractions for the treatment of their pain. Patient recorded
pain severity and analgesic requirements on questionnaire which was filled by the
main investigator before treatment, at 2 weeks and at 1,2,3,4,5,6,8,10, and 12 months
after radiotherapy. Pain relief was the primary endpoint of treatment benefit.
Results: There was no difference in the time to first improvement in pain, time to
complete pain relief or in time to first increase in pain at any time up to 12 months
after randomization, nor in the class of analgesic used. Retreatment was twice as
common after 8Gy than after multifraction radiotherapy, although retreatment for
residual or recurrent pain did not reflect a difference between the three groups in the
probability of pain relief.
Conclusion: A single fraction of 8 Gy when used for the treatment of bone
metastasis is as safe and effective as a multifraction regimen for the palliation of
metastatic bone pain for at least 12 months. This may make it suitable alternative to
the multifraction radiotherapy regimens. Keywords: Bone metastases; Radiotherapy;
Pain relief; Palliation
Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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