Antineoplastic dosing in overweight and obese cancer patients: an Associazione Italiana Oncologia Medica (AIOM)/Associazione Medici Diabetologi (AMD)/Società Italiana Endocrinologia (SIE)/Società Italiana Farmacologia (SIF) multidisciplinary consensus position paper

Silvestris, Nicola; Argentiero, Antonella; Natalicchio, Annalisa; D’Oronzo, Stella; Beretta, Giordano D.; Acquati, S.; Adinolfi, Valerio; Bartolo, Paolo Di; Danesi, Romano; Faggiano, Antongiulio; Ferrari, P; Gallo, Marco; Gori, Stefania; Morviducci, Lelio; Russo, Antonio; Tuveri, Enzo; Zatelli, Maria Chiara; Montagnani, Monica; Giorgino, Francesco

doi:10.1016/j.esmoop.2021.100153

Cited by 17 publications

(25 citation statements)

References 121 publications

(153 reference statements)

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“…With regard to overnutrition at diagnosis and survival from childhood cancer, several potential mechanisms have been proposed. There is clinical evidence suggesting that obese patients may have altered pharmacokinetics in the metabolism of chemotherapeutic agents, although prospective trials have not confirmed such variations [ 52 , 53 ]. Overnutrition may also affect both the tumor microenvironment and the microenvironment of the host [ 54 ].…”

Section: Discussionmentioning

confidence: 99%

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature

et al. 2022

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Few studies so far have examined the impact of nutritional status on the survival of children with cancer, with the majority of them focusing on hematological malignancies. We summarized published evidence reporting the association of nutritional status at diagnosis with overall survival (OS), event-free survival (EFS), relapse, and treatment-related toxicity (TRT) in children with cancer. Published studies on children with leukemia, lymphoma, and other solid tumors have shown that both under-nourished and over-nourished children at cancer diagnosis had worse OS and EFS. Particularly, the risk of death and relapse increased by 30–50% among children with leukemia with increased body mass index at diagnosis. Likewise, the risk of TRT was higher among malnourished children with osteosarcoma and Ewing sarcoma. Nutritional status seems to play a crucial role in clinical outcomes of children with cancer, thus providing a significant modifiable prognostic tool in childhood cancer management. Future studies with adequate power and longitudinal design are needed to further evaluate the association of nutritional status with childhood cancer outcomes using a more standardized definition to measure nutritional status in this population. The use of new technologies is expected to shed further light on this understudied area and give room to person-targeted intervention strategies.

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Section: Discussionmentioning

confidence: 99%

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature

et al. 2022

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“…The exploration related to refining the scheme has been carried out in different types of malignant tumors and therapeutic drugs (70,71). Cancer societies have initiated the establishment of consensus and guidelines on the dosage of drugs for specific patient populations, such as the elderly, obese and overweight patients (72,73). This disagrees with our conventional thinking, which involves the use of the body surface area and the bodyweight to calculate the dose of chemotherapy while ignoring the discrepancies noted in the response of different populations to treatment.…”

Section: Discussionmentioning

confidence: 99%

Management of chemotherapy dose intensity for metastatic colorectal cancer (Review)

2022

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Chemotherapy dose intensity is a momentous parameter of antitumor clinical medication. In certain clinical trials, the actual application dose of the chemotherapeutic drugs is frequently different from the prescribed dose. The chemotherapy dose intensity completed in different trials is also variable, which has an impact on the treatment efficacy, disease prognosis and patient safety. When these agents are tested in the population, chemotherapy reduction and delay or failure to complete the planned cycle constantly occur due to age, performance status, adverse reactions and other reasons, resulting in the modification of the chemotherapy dose intensity. The present review analyzed the correlation between the chemotherapy dose intensity and the incidence of adverse reactions, the treatment efficacy and disease prognosis in clinical trials of metastatic colorectal cancer. Moreover, the clinical applications of chemotherapy dose intensity were discussed. Based on individual differences, the present review analyzed the clinical trials that examined the efficacy of the chemotherapy dose intensity in different patient populations. The conclusions suggested that different populations require a specific dose intensity to reduce treatment toxicity without affecting the curative effect. Contents 1. Introduction 2. Three-drug combination chemotherapy regimens 3. Two-drug combination chemotherapy regimens 4. DI of specific populations 5. Conclusion

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“…56 In the context of obesity, fixed dosing can most commonly lead to underdosing, as a 1-size-fits-all approach may not accurately reflect the altered pharmacokinetics of the drug in people with obesity. 56,57 Underdosing can lead to serious lack-ofefficacy health risks.…”

Section: What Is the Role Of The Therapeutic Window Of A Drug For Inf...mentioning

confidence: 99%

Is There a Need for a Dedicated Pharmacokinetic Trial for a Drug in Obese Populations? A Drug Prioritization Decision Tree Framework

Langevin,

Gobburu,

Gopalakrishnan

2023

The Journal of Clinical Pharma

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Obesity is a growing global health concern associated with high comorbidity rates, leading to an increasing number of patients who are obese requiring medication. However, clinical trials often exclude or under‐represent individuals who are obese, creating the need for a methodology to adjust labeling to ensure safe and effective dosing for all patients. To address this, we developed a 2‐part decision tree framework to prioritize drugs for dedicated pharmacokinetic studies in obese subjects. Leveraging current drug knowledge and modeling techniques, the decision tree system predicts expected exposure changes and recommends labeling strategies, allowing stakeholders to prioritize resources toward the drugs most in need. In a case study evaluating 30 drugs from literature across different therapeutic areas, our first decision tree predicted the expected direction of exposure change accurately in 73% of cases. We conclude that this decision tree system offers a valuable tool to advance research in obesity pharmacology and personalize drug development for patients who are obese, ensuring safe and effective medication.

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Antineoplastic dosing in overweight and obese cancer patients: an Associazione Italiana Oncologia Medica (AIOM)/Associazione Medici Diabetologi (AMD)/Società Italiana Endocrinologia (SIE)/Società Italiana Farmacologia (SIF) multidisciplinary consensus position paper

Cited by 17 publications

References 121 publications

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature

Management of chemotherapy dose intensity for metastatic colorectal cancer (Review)

Is There a Need for a Dedicated Pharmacokinetic Trial for a Drug in Obese Populations? A Drug Prioritization Decision Tree Framework

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