A multicenter, open‐label, single‐arm study of anamorelin (ONO‐7643) in advanced gastrointestinal cancer patients with cancer cachexia

Summary Plasma 5-hydroxytryptamine (serotonin), tryptophan and neopterin levels were measured in patients with depressive cancer cachexia and in healthy controls during the same time period. Patients with advanced cancers had significantly raised neopterin, a marker of endogenous gamma-interferon (IFN-γ) production, but decreased serotonin and tryptophan levels. IFN-γ induces a high level of indoleamine dioxvgenase (IDO), a tryptophan degrading enzyme, which in turn increases metabolism along the tryptophan- nicotinic acid pathway, resulting in decreased synthesis of serotonin. These results suggest that persistent immune activation occur in patients with cancer cachexia, resulting in disorders involving tryptophan metabolism.

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Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol04-i07/682 ◽

2019 ◽

Vol 4 (07) ◽

Author(s):

Edit Nadasi ◽

Gellert Cseh

Keyword(s):

Clinical Trial ◽

Cancer Patients ◽

Study Protocol ◽

Negative Energy ◽

Malignant Diseases ◽

Open Label ◽

Multicentre Clinical Trial ◽

Patients With Cancer ◽

Extra Energy ◽

Oral Nutritional Supplements

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

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The right immune-modulation at the right time: thymosin α1 for prevention of severe COVID-19 in cancer patients

Future Oncology ◽

10.2217/fon-2020-0754 ◽

2021 ◽

Author(s):

Melissa Bersanelli ◽

Diana Giannarelli ◽

Alessandro Leonetti ◽

Sebastiano Buti ◽

Marcello Tiseo ◽

...

Keyword(s):

Cancer Patients ◽

Immune Modulation ◽

Randomized Study ◽

Open Label ◽

Thymosin Α1 ◽

Patients With Cancer ◽

Incurable Disease ◽

Start Up ◽

Open Label Phase ◽

The Right

We presented the rationale for the use of thymosin α1 as prophylaxis of severe COVID-19 in cancer patients undergoing active treatment, constituting the background for the PROTHYMOS study, a prospective, multicenter, open-label, Phase II randomized study, currently in its start-up phase (Eudract no. 2020-006020-13). We aim to offer new hope for this incurable disease, especially to frail patient population, such as patients with cancer. The hypothesis of an effective prophylactic approach to COVID-19 would have immediate clinical relevance, especially given the lack of curative approaches. Moreover, in the ‘COVID-19 vaccine race era’ both clinical and biological results coming from the PROTHYMOS trials could even support the rationale for future combinatorial approaches, trying to rise vaccine efficacy in frail individuals.

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Epoetin Alfa Therapy Increases Hemoglobin Levels and Improves Quality of Life in Patients With Cancer-Related Anemia Who Are Not Receiving Chemotherapy and Patients With Anemia Who Are Receiving Chemotherapy

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.21.4126 ◽

2001 ◽

Vol 19 (21) ◽

pp. 4126-4134 ◽

Cited By ~ 120

Author(s):

I. Quirt ◽

C. Robeson ◽

C. Y. Lau ◽

M. Kovacs ◽

S. Burdette-Radoux ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Eastern Cooperative Oncology Group ◽

Epoetin Alfa ◽

Open Label ◽

Open Label Study ◽

Patients With Cancer ◽

Cancer Related Anemia ◽

Linear Analog Scale Assessment

PURPOSE: To evaluate efficacy, safety, and quality of life (QOL) changes with epoetin alfa therapy for anemia in patients with nonmyeloid malignancies.PATIENTS AND METHODS: Anemic cancer patients were enrolled onto this prospective, open-label study from 34 centers across Canada. The trial had two cohorts: patients who were and were not receiving chemotherapy during the 16-week study. All patients initially received epoetin alfa 150 IU/kg subcutaneously three times per week. The dose was doubled after 4 weeks for patients who did not experience sufficient response.RESULTS: Of the 183 patients enrolled in the nonchemotherapy cohort, statistically significant and clinically relevant improvements in QOL were observed with epoetin alfa therapy using both the FACT-An questionnaire and linear analog scale assessment. Hemoglobin levels increased significantly (P < .001; mean increase 2.5 g/dL from baseline to end of study) and these increases were positively correlated with improved QOL and change in Eastern Cooperative Oncology Group (ECOG) scores. There was a significant reduction in the percentage of patients who required blood transfusions. The 218 patients in the chemotherapy cohort also experienced significant improvements in QOL, decreased transfusion use, and increased hemoglobin levels that correlated with QOL improvements and change in ECOG scores. Epoetin alfa was well-tolerated in both cohorts.CONCLUSION: Epoetin alfa administered to patients with cancer-related anemia for up to 16 weeks resulted in significantly improved QOL, increased hemoglobin levels, and decreased transfusion use. These benefits were observed in cancer patients who were not receiving chemotherapy as well as those who were.

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Weight loss, appetite loss and food intake in cancer patients with cancer cachexia: Three peas in a pod? – analysis from a multicenter cross sectional study

Acta Oncologica ◽

10.3109/0284186x.2013.823239 ◽

2013 ◽

Vol 53 (4) ◽

pp. 539-546 ◽

Cited By ~ 39

Author(s):

Tora S. Solheim ◽

David Blum ◽

Peter M. Fayers ◽

Marianne J. Hjermstad ◽

Guro B. Stene ◽

...

Keyword(s):

Weight Loss ◽

Food Intake ◽

Cancer Patients ◽

Cancer Cachexia ◽

Cross Sectional Study ◽

Sectional Study ◽

Appetite Loss ◽

Cross Sectional ◽

Patients With Cancer ◽

Pod Analysis

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Early Results Suggest That Epoetin Alfa 60,000 U Every 2 Weeks Improves Hemoglobin in Patients with Cancer Not Receiving Chemotherapy or Radiotherapy.

Blood ◽

10.1182/blood.v104.11.4222.4222 ◽

2004 ◽

Vol 104 (11) ◽

pp. 4222-4222

Author(s):

Daniel Shasha ◽

David H. Henry ◽

Denise Williams

Keyword(s):

Cancer Patients ◽

Study Drug ◽

Epoetin Alfa ◽

Open Label ◽

Vascular Events ◽

Patients With Cancer ◽

Early Results ◽

Transfusion Requirements ◽

Intent To Treat ◽

To Receive

Abstract Epoetin alfa has been shown to increase hemoglobin (Hb), decrease transfusion requirements, and improve quality of life (QOL) in patients receiving chemotherapy (CT) and/or radiotherapy (RT). However, the efficacy of epoetin alfa in cancer patients receiving neither CT nor RT is not as well characterized, particularly at doses less frequent than 3 times weekly. The objective of this open-label, nonrandomized, multicenter pilot study was to evaluate epoetin alfa 60,000 U subcutaneously (SC) every 2 weeks (Q2W) in 50 anemic patients with cancer who were not receiving CT or RT. The primary efficacy endpoint is the proportion of patients achieving a hematopoietic response (HR; Hb increase ≥2 g/dL from baseline and/or Hb increase to ≥12 g/dL at any scheduled visit) independent of transfusion within 28 days. Patients with histologically confirmed nonmyeloid malignancy, Hb ≤11 g/dL, and who had not received CT in the previous 8 weeks or RT in the previous 4 weeks were enrolled. Patients were permitted to receive hormonal therapy, androgen deprivation therapy, and/or immunotherapy. Patients were to receive epoetin alfa 60,000 U SC Q2W, with escalation to 80,000 U Q2W after 4 weeks if Hb increased ≤1 g/dL. Dose will be titrated to maintain Hb ≤13 g/dL; all patients were to receive oral ferrous sulfate 325 mg daily. Patients will be treated for up to 12 weeks, with a 4-week follow-up after last dose of study drug. As of July 2004, 18 patients are evaluable for efficacy (modified intent-to-treat, ie, all enrolled patients who received ≥1 dose of study drug and had ≥1 postbaseline Hb or transfusion evaluation) and 18 for safety (all enrolled patients who received ≥1 dose of study drug). Mean age was 74.4 ± 8.7 yrs, mean baseline Hb was 10.0 ± 1.0 g/dL (n=18), and 7/18 were men. Of these patients, 7 completed 4 weeks, 3 completed 8 weeks, and 1 completed 12 weeks on study. The HR of these patients was assessed regardless of how many weeks of study they completed at the time of this interim analysis; HR was 44.4%. Hb increased 1.4 ± 0.7 g/dL (n=11) after 4 weeks and 1.2 ± 1.4 g/dL (n=4) after 8 weeks of treatment. Adverse events were limited to 1 patient, who experienced back pain and epistaxis. No patients died during the study, and no thrombotic vascular events were reported. Early results of this study suggest that epoetin alfa 60,000-80,000 U SC given every other week is well tolerated and appears to effectively increase Hb in anemic cancer patients not receiving CT or RT. The study is currently ongoing.

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Apixaban and dalteparin in active malignancy associated venous thromboembolism

Thrombosis and Haemostasis ◽

10.1160/th17-03-0193 ◽

2017 ◽

Vol 117 (10) ◽

pp. 1952-1961 ◽

Cited By ~ 38

Author(s):

Charles Loprinzi ◽

Aneel Ashrani ◽

Juliana Perez Botero ◽

Roberto Leon Ferre ◽

Stanislav Henkin ◽

...

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Major Bleeding ◽

The United States ◽

Limited Data ◽

Open Label ◽

Safety Outcome ◽

Patients With Cancer ◽

Superiority Trial ◽

To Receive

SummaryCurrently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.

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Treatment and secondary prevention of venous thromboembolism in cancer patients

Onkologische Welt ◽

10.1055/s-0038-1630173 ◽

2012 ◽

Vol 03 (03) ◽

pp. 121-125

Author(s):

I. Pabinger ◽

C. Ay

Keyword(s):

Clinical Trials ◽

Venous Thromboembolism ◽

Cancer Patients ◽

Oral Anticoagulants ◽

Factor Xa ◽

New Oral Anticoagulants ◽

Phase Iii ◽

Patients With Cancer ◽

Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

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Thrombosis in Cancer Patients Treated with Hematopoietic Growth Factors - A Meta-Analysis

Thrombosis and Haemostasis ◽

10.1055/s-0038-1650276 ◽

1996 ◽

Vol 75 (02) ◽

pp. 368-371 ◽

Cited By ~ 51

Author(s):

T Barbul ◽

G Finazzi ◽

A Grassi ◽

R Marchioli

Keyword(s):

Cancer Patients ◽

Case Reports ◽

Meta Analysis ◽

Case Series ◽

Hematopoietic Growth Factors ◽

Patients With Cancer ◽

Cytotoxic Treatment ◽

Pertinent Data ◽

Thrombotic Complications ◽

Vascular Occlusions

SummaryHematopoietic colony-stimulating factors (CSFs) are largely used in patients with cancer undergoing cytotoxic treatment to accelerate neutrophil recovery and decrease the incidence of febrile neutropenia. Clinical practice guidelines for their use have been recently established (1), taking into account clinical benefit, but also cost and toxicity. Vascular occlusions have been recently reported among the severe reactions associated with the use of CSFs, in anedoctal case reports (2, 3), consecutive case series (4) and randomized clinical trial (5, 6). However, the role of CSFs in the pathogenesis of thrombotic complications is difficult to ascertain, because pertinent data are scanty and widely distributed over a number of heterogenous investigations. We report here a systematic review of relevant articles, with the aims to estimate the prevalence of thrombosis associated with the use of CSFs and to assess if this rate is significantly higher than that observed in cancer patients not receiving CSFs.

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