Strategies for assessing and managing the adverse events of sorafenib and other targeted therapies in the treatment of renal cell and hepatocellular carcinoma: Recommendations from a European nursing task group

Edmonds, Kim; Hull, Diana; Spencer-Shaw, Andrea; Koldenhof, J.J.; Chrysou, Maria; Boers–Doets, Christine B.; Molassiotis, Alex

doi:10.1016/j.ejon.2011.05.001

Cited by 36 publications

(38 citation statements)

References 75 publications

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“…For patients with sub-optimally controlled hypertension, treatment-induced hypertension could be controlled through increasing the dose of current medication or adding new medication. Pretreatment evaluation of risk factors of cardiovascular diseases, such as peripheral vascular disease, diabetes mellitus, cardiac conditions and renal disease is essential since patients with these risk factors may require close monitoring and the aggressive management of cardiovascular events during treatment (27). In addition, clinicians should to check whether patients have received hypertension-inducing agents such as hormones or steroids, which may complicate the management of axitinib-induced hypertension (28).…”

Section: Sternberg 2010 ---------------------------------------------mentioning

confidence: 99%

Therapeutic effects and associated adverse events of multikinase inhibitors in metastatic renal cell carcinoma: A meta-analysis

Tan

Long²,

Chen

2015

Experimental and Therapeutic Medicine

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Abstract. This study aimed to compare the therapeutic effects and adverse events of the multikinase inhibitors sorafenib, sunitinib, pazopanib and axitinib in advanced renal cell carcienal cell carcinoma (RCC). A meta-analysis of randomized controlled trials was performed to assess the effects of multikinase inhibitors among patients with advanced RCC. The data of median progression-free survival (PFS), median overall survival (OS), progressive disease rate (PDR), objective response rate (ORR) and grade 3/4 adverse events were extracted to assess therapeutic effects and toxicity, respectively. It was found that multikinase inhibitors are more effective in extending PFS [hazard ratio (HR)= 0.58; 95% confidence interval (CI): 0.45-0.74; P<0.0001), controlling tumor progression [relative risk (RR)=0.67; 95% CI: 0.55-0.83; P=0.0002) and ORR (RR=2.93; 95% CI: 1.40-6.14; P=0.004) compared with placebo or interferon-α. Patients treated with multikinase inhibitors had significantly higher rates of grade 3 or 4 hypertension (RR=6.00; 95% CI: 3.36-10.69; P<0.00001), diarrhea (RR=5.84; 95% CI: 3.06-11.16; P<0.00001), nausea (RR=2.30; 95% CI: 1.16-4.54; P=0.02), vomiting (RR=1.84; 95% CI: 1.00-3.41; P=0.05) and hand-foot skin reaction (RR=11.78; 95% P<0.00001). Multikinase inhibitors can significantly control disease progress and improve the ORR. However, they are also associated with a higher risk of grade 3 and 4 hypertension and gastrointestinal events. Proper management of these events is necessary to improve patient quality of life.

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Section: Sternberg 2010 ---------------------------------------------mentioning

confidence: 99%

Therapeutic effects and associated adverse events of multikinase inhibitors in metastatic renal cell carcinoma: A meta-analysis

Tan

Long²,

Chen

2015

Experimental and Therapeutic Medicine

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“…However, the stomatitis induced by this therapeutic family is more of a diffuse mucosal hypersensitivity/dysesthesia [25], in some cases associated with moderate erythema [28] or painful inflammation of the oral mucosa (including burning mouth, discomfort induced by hot or spicy foods) [25]. Such symptoms appear quite rapidly in the first weeks of treatment [28,140] and gradually disappear [21,25]. In some cases, well-limited ulcerations of the nonkeratinized mucosa were also noted (Fig.…”

Section: Stomatitismentioning

confidence: 99%

Oral mucosal changes induced by anticancer targeted therapies and immune checkpoint inhibitors

Vigarios

Epstein

Sibaud

2017

Support Care Cancer

145

136

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Development of biological targeted therapies and immune checkpoint inhibitors has redefined the treatment for many cancers; however, the increasing use of new protocols has led to physicians observing a new spectrum of toxicities. To date, oral adverse events induced by these new anticancer therapies have been mainly reported using nonspecific terminology (Bstomatitis,^Bmucosal inflammation,^Bmucositis^) and remain poorly characterized, with the exception of mammalian target of rapamycin (mTOR) inhibitor-associated stomatitis. Oral toxicities of targeted therapies often display very characteristic features which clearly differ from classic oral injuries observed with cytotoxic chemotherapy and/or radiotherapy. In addition, they frequently affect more than 20% of treated patients and can lead to a significant morbidity or permanent treatment discontinuation. Oral mucosal toxicities described in this review include mTOR inhibitor-associated stomatitis (mIAS); stomatitis, benign migratory glossitis, and osteonecrosis of the jaw associated with multi-targeted kinase inhibitors of the VEGF and PDGF receptors; mucositis induced by EGFR inhibitors (in monotherapy or in combination with head and neck radiotherapy and/or chemotherapy); hyperkeratotic lesions with BRAF inhibitors; pigmentary changes and lichenoid reactions secondary to imatinib; and more recent data on the BOsler-Weber-Rendu-like syndrome^described with the antibody-drug conjugate, TDM-1. Finally, we provide, to our knowledge, the first available structured data on oral toxicities induced by the new recently FDA-and EMA-approved monoclonal antibodies targeting PD-1. Clinical management of these targeted therapy-related oral changes is also discussed.

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“…• Loperamide schedule recommended by a European nurse task group [38]: ū 4 mg followed by 2 mg every 2 h until 2 h after the last bowel movement. ū For patients with long-term diarrhea, 2-4 mg twice daily titrated according to bowel function.…”

Section: Box 2 Recommendations For the Management Of Diarrhea With Smentioning

confidence: 99%

“…To this end, a wide variety of recommendations have been developed by multidisciplinary teams and are available in order to guide physicians in their management of the most common AEs associated with sorafenib [35][36][37][38][39][40][41]. Recommendations for managing HFSR, diarrhea, fatigue, and hypertension are shown in table 6 and Boxes 1-4.table…”

mentioning

confidence: 99%

Refining Sorafenib Therapy: Lessons from Clinical Practice

et al. 2014

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AbstrAct:Understanding the best use of sorafenib is essential in order to maximize clinical benefit in hepatocellular carcinoma. Based on Phase III and noninterventional study data, as well as our extensive experience, we discuss dose modification in order to manage adverse events, disease response evaluation and how to maximize treatment benefit. Sorafenib should be initiated at the approved dose (400 mg twice daily) and reduced/ interrupted as appropriate in order to manage adverse events. Dose modification should be considered before discontinuation. Appropriate tumor response assessment is critical. Focusing on radiologic response may result in premature sorafenib discontinuation; symptomatic progression should also be considered. If second-line therapies or trials are unavailable, continuing sorafenib beyond radiologic progression may provide a clinical benefit. Our recommendations enable the maximization of treatment duration, and hence clinical benefit, for patients. Keywords:• adverse event managementIt is well established that hepatocellular carcinoma (HCC) is a complex and heterogeneous disease that is affected by multiple genetic and epigenetic alterations [1]. In the overwhelming majority of patients, liver cirrhosis -another complex disease in its own right -is superimposed on HCC. As a result, the prognostic range for these patients varies considerably and continues to change for each patient at every time point over the clinical course of their disease. A meta-analysis of 30 clinical trials into which HCC patients were enrolled for palliative treatment reflects this heterogeneity. It demonstrated a high variability in survival among untreated patients and concluded that no single patient characteristic alone could predict outcome [2].The prognosis and treatment options for HCC are generally related to tumor stage and liver function at presentation [3,4]. In the west, approximately 30% of all patients with HCC are diagnosed in

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Strategies for assessing and managing the adverse events of sorafenib and other targeted therapies in the treatment of renal cell and hepatocellular carcinoma: Recommendations from a European nursing task group

Cited by 36 publications

References 75 publications

Therapeutic effects and associated adverse events of multikinase inhibitors in metastatic renal cell carcinoma: A meta-analysis

Therapeutic effects and associated adverse events of multikinase inhibitors in metastatic renal cell carcinoma: A meta-analysis

Oral mucosal changes induced by anticancer targeted therapies and immune checkpoint inhibitors

Refining Sorafenib Therapy: Lessons from Clinical Practice

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