A phase III randomized study comparing the effects of oxandrolone (Ox) and megestrol acetate (Meg) on lean body mass (LBM), weight (wt) and quality of life (QOL) in patients with solid tumors and weight loss receiving chemotherapy

Lesser, Glenn J.; Case, Douglas; McQuellon, Richard P.; Choksi, J. K.; Sanders, GL; Rosdhal, R.; Shaw, Edward G.

doi:10.1200/jco.2008.26.15_suppl.9513

Cited by 20 publications

(18 citation statements)

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“…We obviously did not include agents or treatments that were developed for their anticachectic potential later on, such as insulin treatment [67], oxandrolone [68], and olanzapine [69].…”

Section: Discussionmentioning

confidence: 99%

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

et al. 2010

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Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia-lean body mass (LBM), resting energy expenditure (REE), and fatigue-and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines.Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months.Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. The Oncologist 2010;15:200 -211

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“…We obviously did not include agents or treatments that were developed for their anticachectic potential later on, such as insulin treatment [67], oxandrolone [68], and olanzapine [69].…”

Section: Discussionmentioning

confidence: 99%

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

et al. 2010

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“…This study showed that patients treated with oxandrolone experienced an increase in lean body mass, a reduction in fat mass, and fewer self-reported anorectic symptoms 31. The side effects of these agents include elevated transaminase levels (especially with nandrolone), decreased high-density lipoprotein levels, interactions with oral anticoagulants, oral hypoglycemics, and adrenal steroids, and hypogonadism (with decreased systemic testosterone levels).…”

Section: Treatment Of Cacsmentioning

confidence: 90%

Drugs in development for treatment of patients with cancer-related anorexia and cachexia syndrome

Mantovani¹,

Madeddu²,

Macciò³

2013

DDDT

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Cancer-related anorexia and cachexia syndrome (CACS) is a complex multifactorial condition, with loss of lean body mass, chronic inflammation, severe metabolic derangements, reduced food intake, reduced physical activity, and poor quality of life as key symptoms. Cachexia recognizes different phases or stages, moving from precachexia through overt cachexia to advanced or refractory cachexia. The purpose of this review is to describe currently effective approaches for the treatment of cachexia, moving forward to drugs and treatments already shown to be effective but needing further clinical trials to confirm their efficacy. We then introduce novel promising investigational drugs and approaches which, based on a strong rationale from the most recent data on the molecular targets/pathways driving the pathophysiology of cachexia, need to be tested either in currently ongoing or appropriate future clinical trials to confirm their clinical potential. Although different drugs and treatments have been tested, we can speculate that a single therapy may not be completely successful. Indeed, considering the complex clinical picture and the multifactorial pathogenesis of CACS, we believe that its clinical management requires a multidisciplinary and multitargeted approach. In our opinion, appropriate treatment for cachexia should target the following conditions: inflammatory status, oxidative stress, nutritional disorders, muscle catabolism, immunosuppression, quality of life, and above all, fatigue. A comprehensive list of the most interesting and effective multitargeted treatments is reported and discussed, with the aim of suggesting the most promising with regard to clinical outcome. A critical issue is that of testing therapies at the earliest stages of cachexia, possibly at the precachexia stage, with the aim of preventing or delaying the development of overt cachexia and thereby obtaining the best possible clinical outcome for patients.

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“…Hence, randomized controlled trials are warranted. that patients treated with oxandrolone experienced an increase in LBM, a reduction in fat mass and reduced self-reported anorectic symptoms [9 ]. However, these preliminary results should be considered with caution.…”

Section: Ghrelin Mimetics With Orexigenic and Anabolic Activitymentioning

confidence: 67%

“…A new formulation of marine fatty acids with more than 50% of phospholipid-bound fatty acids EPA and docosahexaenoic acid was investigated [9 ]. Thirty-one cancer patients with weight loss received marine phospholipids (1.5 g/day) as soft gel capsules for 6 weeks.…”

Section: Marine Phospholipidsmentioning

confidence: 99%

An update on promising agents for the treatment of cancer cachexia

Madeddu

Mantovani

2009

Current Opinion in Supportive &Amp; Palliative Care

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A number of promising new agents are currently being developed but are not as yet regarded as standard of care. They include: selective COX-2 inhibitors, ghrelin mimetics, oxandrolone, selective androgen receptor modulators (ostarine), olanzapine, anti-IL-6 antibody and an innovative approach of multitargeted combined treatment. The data reported seem to suggest that the most effective treatment for cancer cachexia may be a combination regimen rather than single-agent treatments. This is in keeping with the general consensus that cancer cachexia is a multifactorial process and, hence, a potentially effective approach should be multimodal.

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A phase III randomized study comparing the effects of oxandrolone (Ox) and megestrol acetate (Meg) on lean body mass (LBM), weight (wt) and quality of life (QOL) in patients with solid tumors and weight loss receiving chemotherapy

Cited by 20 publications

References 0 publications

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

Drugs in development for treatment of patients with cancer-related anorexia and cachexia syndrome

An update on promising agents for the treatment of cancer cachexia

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