drug therapy for cancer cachexia j. arends (de) · drug therapy for cancer cachexia j. arends (de)...
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ESPEN Congress Geneva 2014LLL LIVE COURSE: NUTRITIONAL SUPPORT IN CANCER
Drug therapy for cancer cachexiaJ. Arends (DE)
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ESPEN LLL CourseNutritional Support in Cancer Patients
Jann Arends
PHARMACOLOGIC THERAPY
Dept. Medical OncologyTumor Biology Center at Freiburg University
Module 26.4
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Targets forpharmacologic therapy
anorexiaGI dysfunctioncatabolismsystemic inflammation
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Pharmacologic Topics
Appetite stimulationGI modulation
Anticatabolic/anabolic agents
Anti-inflammatory agents
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CorticosteroidsProgestinsCannabinoidsGhrelinCyproheptadineBranched-chain amino acidsHerbal medicine, bitters
Appetite stimulation
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effectivity typical dose
Hydrocortisone 1Prednisolone, methylprednisolone 5 20 mgDexamethasone 20 4 mg
Systematic review: 6 RCT (n=647; duration 4d to 8w):Stimulation of appetite, anti-emetic, increase well-beingEffects disappear after 4 weeks !
Side-effects: myopathyosteoporosis
immune suppressionedema
insulin resistanceGI ulcers
Corticosteroids
Yavuszen T et al. J Clin Oncol 2005LoE=I
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typical dose
Megestrolacetate (MA) 160-1600 mgMedroxyprogesterone acetate (MPA) 300-1200 mg
Stimulation of appetite Increase in body weight, but no increase in LBMImprove QoL
Side-effects: thromboembolism (5%)impotence in malesvaginal spotting or bleedinghypertension, hyperglycemiaedemaadrenal insufficiency
Progestins
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progestins worse progestins better
Progestins: Effect on weight in patientswith cancer cachexia (11 RCT)
Maltoni et al. Ann Oncol 2001
compared to placebo
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Cochrane metaanalysis 2005
31 RCT (n=4123) MA vs PLAC: app +, WT +
Metaanalysis 200830 RCT (n=4430) MA vs PLAC app +, WT +
survival ∅, QoL ∅
Berenstein EG et al. Cochrane Database Syst Rev 2005Lesniak W et al. Pol Arch Med Wewn 2008LoE=I
Not approved for cancer anorexia
Progestins
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Marijuana stimulates appetite
- Marijuana extracts- Delta-9-tetrahydrocannabinol = THC / Dronabinol
Stimulation of appetite with 5-20 mg Effects on mood, nausea, pain
Use regulated by narcotics law
Side-effects: dizzinessslurred speech
Cannabinoids
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Appetite improved
Weight increased
Quality of life improved
C
M
D
Dronabinol (D) vs megestrolacetate (M) vs combination (C)in patients with cancer cachexia (4 wk)
Jatoi A et al. J Clin Oncol 2002
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RCT (n=164 cancer cachexia) 6 weeks:
cannabis extract (5 mg THC)vs THC (5 mg)vs placebo: app ∅, QoL ∅
Strasser F et al. J Clin Oncol 2009
Cannabinoids
Unfortunately: no dose escalation allowed
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Anamorelin, oral GH secretagogue receptor agonist2012: RCT 12 w: WT +, grip strength +2013: RCT 3 d: WT +
Ghrelin and Analogues
Lundholm K et al Cancer 2010Garcia J et al. Supp Care Cancer 2012 + 2013LoE=I experimental agent
Ghrelin, peptide hormone of gastric mucosa2004: RCT (n=7) 3 h: food intake +2008: RCT (n=21) 1 h: app ∅2010: RCT (n=15) 10 d: app +, food +, WT-loss -2010: RCT (n=31) 8 w: fat loss -
Neary NM et al. J Clin Endocrinol Metab 2004Holst B et al. Br J Cancer 2008
Adachi S et al. Gastroenterol 2010
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Anamorelin
Garcia JM et al. Supp Care Cancer 2013
App +Food intake ØGH +IGF-1 +IGFBP3 +
hyperglycemia (2)nausea (1)dizziness (1)
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Cyproheptadine5-HT2-antagonist: RCT adults: ∅
RCT children: WT +
Branched-chain amino acids (BCAA)RCT (n=28 pre-surgery) 7d: app +RCT (n=84 HCC) 1 year: QoL +
Herbal medicine, bittersno controlled studies
Other appetite stimulants
Kardinal CG et al. Cancer 1990Couluris M et al. J Pediatr Hematol Oncol 2008
Cangiano C et al. J Natl Cancer Inst 1996Poon RT et al. Aliment Pharmacol Ther 2004
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AntiemeticsPsychotropic drugsAnalgesics
Prokinetic agentsInhibitors of GI motilityProton pump inhibitorsParasympathomimetics
GI modulationand supportive agents
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CorticosteroidsProgestagensCannabinoidsNon-steroidal anti-inflammatory drugs (NSAID)N-3 fatty acidsAnti-cytokinesMelatoninAntioxidants
Anti-inflammatory agents
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CorticosteroidsProgestagensCannabinoidsNon-steroidal anti-inflammatory drugs (NSAID)N-3 fatty acidsAnti-cytokinesMelatoninAntioxidants
Anti-inflammatory agents
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Indomethacin, ibuprofen, celecoxib, etc.
Side-effects: GI ulcerskidney failureetc.
NSAID
PUFA ProstanoidsCOX‐1COX‐2
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Lundholm K et al. Cancer Res 1994
NSAID
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Systematic review: 13 studies (6 controlled studies)
studies are smallsuboptimal designmany studies without comparator
in 11/13: stabilization or improvement of WT or LBM
„NSAIDs may improve weight in cancer patients..“„Evidence is too frail to recommend..“
NSAID in cancer cachexia
Solheim T et al. Acta Oncol 2012Not approved for cancer anorexia
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N-6PUFA
Prostanoids2 and 4 series
N-3PUFA
Prostanoids3 and 5 series
COX
pro-inflammatory
anti- / less inflammatory
Arachidonic acid
Eicosapentaenoic acid
Side effects: dyspepsia, nauseaprolonged bleeding time
Long chain fatty acids
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Cochrane systematic reviewon 5 RCT: insufficient data
but: poor complianceonly short trials
Systematic review Colomer et al.on 17 clinical trials: >1.5 g/d app +, WT +, QoL +
but: not based on RCTs
LoE=II Dewey A et al. Cochrane Database Syst Rev 2007Colomer R et al. Br J Nutr 2007
N-3 Fatty acids
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2010 RCT, double-blind; n=40 NSCLC stage III2 pack ONS ± (2 g EPA + 0.9 g DHA) for 5 w
WT+, FFM+, REE -, intake +
LoE=I van der Meij et al., J Nutr 2010Murphy et al., Cancer 2011
N-3 Fatty acids in NSCLC
2011 “free-choice-study”, n=40 NSCLC stage IIIstd (n=24) vs fish oil (n=16) = 2.2 g EPA
during ..1st-line CHT WT -2.3 vs +0.5, +muscle 29 vs 69%
1st year CHT RR 26 vs 60%, survival 39 vs 60%
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Open label study / free choicen=46 NSCLC: N=31 „Standard-of-care“
N=15 fish oil: 2.5 g (EPA+DHA) per day as capsule or oilChemother: different regimensDuration: 1 year
Results Control Fish oil
Response rate = CR + PR 26% 60%
CR + PR + stable disease 42% 80%
Dose limiting toxicity no difference
1-Year survival 39% 60%
ONS with fish oil in NSCLC
Murphy et al., Cancer 2011
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Anti-cytokinesInfliximab RCT (n=89) 8 w: ∅Etanercept RCT (n=63) 3 m: ∅Pentoxifylline RCT (n=70) 8 w: ∅Thalidomide RCT (n=37) 10 d: app +
CT (n=10) 2 w: WT +RCT (n=33) 4 w: WT +
Clarithromycin CT (n=66) 3 m: WT +
Melatonin RCT (n=86) 3 m: WT-loss -systematic review: survival +
Antioxidants no high-quality controlled studies
Other anti-inflamm. agents
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Insulin and insulin sensitivity modulatorsGrowth hormone, secretagogues, IGF-1Anabolic androgenic steroids and SARMsProteasome inhibitorsß-receptor modulatorsß-hydroxy ß-methylbutyrate and amino acidsHydrazine sufateAdenosine triphosphate (ATP)
Anticatabolic agents
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Central anabolic hormoneinhibits proteolysis, stimulates protein synthesis
RCT (n=338) 0.1 U/kg/d s.c. Fat +, survival +
Metformin: stimulates AMPK, improves insulin sensitivity
RCT (n=8 burn pats.) 7 d protein synthesis +hyperglycemia -
Insulin and sensitizers
Lundholm K et al. Clin Cancer Res 2007Gore DC et al. Ann Surg 2005LoE=I
Not approved for cancer anorexia
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Growth hormone (GH)decrease fat, increase muscle mass, increase bone density, improve immune and sexual functions
Does GH stimulate tumor growth?GH in ICU patients increased mortality !
Insulin-like growth factor (IGF-1)Does IGF-1 stimulate tumor growth?
Growth Hormone, IGF-1
Ghrelin GH IGF‐1
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Burney BO et al. JCEM 2012
Testosterone in cachexia
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Nandrolone RCT (n=37) 4 w WT (+)Fluoxymesterone RCT (n=475) 4 w app +, WT (+)Oxandrolone RCT (n=155) 12 w WT ∅, LBM +
less effective than corticosteroids/progestinsdepression, thromboembolism, virilizing effects, hypertension etc.
Anabolic androgenicsteroids / SARMs
Chlebowski RT et al. Cancer 1986Loprinzi CL et al. J Clin Oncol 1999Dobs et al., Lancet Oncology 2013
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Nandrolone RCT (n=37) 4 w WT (+)Fluoxymesterone RCT (n=475) 4 w app +, WT (+)Oxandrolone RCT (n=155) 12 w WT ∅, LBM +
less effective than corticosteroids/progestinsdepression, thromboembolism, virilizing effects, hypertension etc.
Anabolic androgenicsteroids / SARMs
Chlebowski RT et al. Cancer 1986Loprinzi CL et al. J Clin Oncol 1999Dobs et al., Lancet Oncology 2013
Selective androgen response modifiersEnobosarm Phase 2b trial (n=100; 3m) LBM+, muscle str.+
Ph3 trial in NSCLC NCT 01355484
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Enobosarm: Change in LBM
Dobs et al., Lancet Oncology 2013
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Enobosarm: Stair climb time and power
Dobs et al., Lancet Oncology 2013
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Interleukin-6 antibody
BMS945429 in NSCLC symptoms-, fatigue-, LBM+
Selumetinib in CCC 84% gain muscle
Myostatin antibody
LY2495655 in Pa-Ca + GEM (Ph2)
BYM338 in Pa-Ca (Ph2)
MC4R - Melanocortin-4 receptor antagonists
Interleukin 15 agonists
New agents
Bayliss et al. Exp Opin Biol Ther 2011Prado et al., Br J Cancer 2012Dallmann R et al., JSCM 2011
Stofkova A 2012
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● To improve appetite, relieve psychological distress and chronic pain
● Optimize gastrointestinal function and relieve nausea
● To stimulate appetite, corticosteroids and progestins are best established; both have unwanted side-effects that need to be considered
● Anti-cancer treatment may improve metabolism and decrease inflammation
● Anti-inflammatory agents, like NSAIDs and N-3 fatty acids may be used to counteract chronic inflammatory states in cancer patients
● Hunger-inducing peptides like ghrelin and MC4R antagonists, anabolic-androgenic agents and antibodies against myostatin and IL6 are being investigated as potential anticachectic agent
● All anticachectic agents should be accompanied by exercise training
Key Messages