Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: A randomised placebo-controlled trial

Beller, Elaine; Tattersall, Martin H. N.; Lumley, Thomas; Levi, John A.; Dalley, D.; Olver, I.; Page, J.; Abdi, Ehtesham; Wynne, Christopher; Friedlander, Michael; Boadle, David; Wheeler, Helen; Margrie, S.; Simes, R. John

doi:10.1023/a:1008291825695

Cited by 78 publications

(51 citation statements)

References 11 publications

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“…Synthetic progestagens, MA and MPA, are currently the only approved drugs for CACS in Europe; their mechanism of action may be partly related to glucocorticoid activity and the ability to downregulate the synthesis of proinflammatory cytokines [40] and to increase food intake by neuropeptide Y release [41]. To date, Ͼ15 randomized, controlled studies in weight-losing cancer patients have demonstrated that MPA and MA significantly improve appetite, food intake, body weight, and sometimes nausea and emesis, whereas in most trials, no definite improvement in global QoL was observed [42][43][44][45][46]. The weight gain observed with progestagens consists mainly of water and fat mass [47], having virtually no influence on LBM and functional activity [48].…”

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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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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“…Synthetic progestogens, MA/MPA, are currently the only approved drugs for CACS in Europe. Several randomized studies in mixed groups of weight-losing patients with cancer have suggested that MA/ MPA improves appetite and stabilizes weight to an extent greater than placebo [4,[46][47][48][49]. The ω-3 polyunsaturated fatty acids (EPA and docosahexaenoic acid) have been shown to inhibit the production of proinflammatory cytokines and thereby to act positively on cancer cachexia.…”

Section: Combined Approachmentioning

confidence: 99%

Cancer cachexia: medical management

Mantovani

Madeddu

2009

Support Care Cancer

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To date, despite several years of co-ordinated efforts in basic and clinical research, practice guidelines for the prevention and treatment of cancer-related muscle wasting are lacking, mainly because of the multifactorial pathogenesis of the syndrome. From all the data presented, one can speculate that one single therapy may not be completely successful in the treatment of cachexia. From this point of view, treatments involving different combinations are more likely to be successful.

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“…Several randomized studies in mixed groups of weight-losing patients with cancer have suggested that MA/ MPA improves appetite and stabilizes weight to an extent greater than placebo. [446–49] The ω-3 polyunsaturated fatty acids (EPA and docosahexaenoic acid) have been shown to inhibit the production of proinflammatory cytokines and thereby to act positively on cancer cachexia. In experimental tumor models, EPA has demonstrated antitumor and anticachectic effects.…”

Section: Introductionmentioning

confidence: 99%

Treatment of cachexia in oncology

Tazi

Errihani

2010

Indian J Palliat Care

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Cachexia is a complex metabolic syndrome associated with many chronic or end-stage diseases, especially cancer, and is characterized by loss of muscle with or without loss of fat mass. The management of cachexia is a complex challenge that should address the different causes underlying this clinical event with an integrated or multimodal treatment approach targeting the different factors involved in its pathophysiology. The purpose of this article was to review the current medical treatment of cancer-related cachexia, in particular focusing on combination therapy and ongoing research. Among the treatments proposed in the literature for cancer-related cachexia, some proved to be ineffective, namely, cyproheptadine, hydrazine, metoclopramide, and pentoxifylline. Among effective treatments, progestagens are currently considered the best available treatment option for cancer-related cachexia, and they are the only drugs approved in Europe. Drugs with a strong rationale that have failed or have not shown univocal results in clinical trials so far include eicosapentaenoic acid, cannabinoids, bortezomib, and anti-TNF-alpha MoAb. Several emerging drugs have shown promising results but are still under clinical investigation (thalidomide, selective cox-2 inhibitors, ghrelin mimetics, insulin, oxandrolone, and olanzapine). To date, despite several years of coordinated efforts in basic and clinical research, practice guidelines for the prevention and treatment of cancer-related muscle wasting are lacking, mainly because of the multifactorial pathogenesis of the syndrome. From all the data presented, one can speculate that one single therapy may not be completely successful in the treatment of cachexia. From this point of view, treatments involving different combinations are more likely to be successful.

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Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: A randomised placebo-controlled trial

Abstract: Megestrol acetate given at 480 mg/day is useful palliation in patients with endocrine-insensitive advanced cancer. It improves appetite, mood and overall quality of life in these patients, although not through a direct effect on nutritional status.

Cited by 78 publications

References 11 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

Cancer cachexia: medical management

Treatment of cachexia in oncology

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