Effect of endurance for adverse drug reactions on the preference for aggressive treatments in cancer patients

2014 ◽  
Vol 23 (4) ◽  
pp. 1091-1097 ◽  
Author(s):  
Naomi Iihara ◽  
Takayuki Nishio ◽  
Tetsuko Goda ◽  
Hideaki Anzai ◽  
Masatoshi Kagawa ◽  
...  
2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.


2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Megan L. Steele ◽  
Jan Axtner ◽  
Antje Happe ◽  
Matthias Kröz ◽  
Harald Matthes ◽  
...  

Background.In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany.Methods.A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated.Results.Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies.Conclusion.The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.


2017 ◽  
Vol 9 (4) ◽  
pp. 593-597 ◽  
Author(s):  
Sapan Kumar Behera ◽  
Chenchu Reddy Kishtapati ◽  
Vikneswaran Gunaseelan ◽  
Biswajit Dubashi ◽  
Adithan Chandrasekaran ◽  
...  

2020 ◽  
Vol 95 (2) ◽  
pp. 104-113
Author(s):  
Hae-Soo Jeon ◽  
Hee-Kyoo Kim ◽  
Gil-Soon Choi

Background/Aims: Although the number of domestic adverse drug reactions (ADRs) reported in Korea is rapidly increasing, the analysis of ADRs in cancer patients remains limited. We sought to investigate the clinical features of ADRs in cancer patients.Methods: ADR data were collected from a spontaneous reporting system at single university hospital, between July 2010 and June 2015. ADR cases assessed to be “unlikely” or “unclassifiable” as per the criteria of the World Health Organization-Uppsala Monitoring Center were excluded. Additional medical information was retrospectively collected from chart reviews, and clinical features of ADRs were analyzed.Results: In total, 1,455 cases were reported. Of these, 822 ADRs (52.1%) were observed in cancer patients. The mean age of cancer patients was 60.8 years (range, 17–90 years), and 45.9% were male. The most prevalent clinical features were gastrointestinal abnormalities (32.6%), such as nausea and vomiting, followed by skin (28.5%) and neurologic manifestations (26.0%). Fifty-one (6.2%) and 296 cases (36.0%) were classified as severe and moderate, respectively. The most common causative agents were parenteral nutrition (PN) supplements (40.4%), followed by antibiotics (17.8%), analgesics (16.7%), iodinated contrast media (ICM, 10.6%), and vitamins (3.9%). Antineoplastic agents were responsible for 2.9% of cases. PN supplements were commonly associated with severe reactions.Conclusion: Although it is well known that antibiotics, ICM, and analgesics induce ADRs, PN supplements, vitamins, and antineoplastic agents should also be considered as common causes of ADRs in cancer patients. Further investigation and monitoring to determine the causality associated with these agents is required.


2016 ◽  
pp. 1445-1464
Author(s):  
Kevin Yi-Lwern Yap

Pharmaco-cybernetics is an upcoming interdisciplinary field that supports our use of medicines and drugs through the combined use of computational technologies and techniques with human-computer-environment interactions to reduce or prevent drug-related problems. The advent of pharmaco-cybernetics has led to the development of various software, tools, and Internet applications that can be used by healthcare practitioners to deliver optimum pharmaceutical care and health-related outcomes. Patients are becoming more informed through health information on the Internet, which empowers them to better participate in the management of their own conditions. Focusing on patients with cancer, this chapter describes the use of a pharmaco-cybernetics approach to identify clinically relevant predictors of two debilitating adverse drug reactions, which are a cause of patient safety – chemotherapy-induced nausea and vomiting and febrile neutropenia. The early identification of such clinical predictors enables clinicians to prevent or reduce the occurrence of adverse drug reactions in cancer patients undergoing chemotherapy through appropriate management strategies. The computational methods used in this approach involve two unsupervised machine-learning techniques – principal component and multiple correspondence analyses. Using two case examples, this chapter shows the potential of machine-learning techniques for identifying patients who are at greater risks of these adverse drug reactions, thus enhancing patient safety. This chapter also aims to increase the awareness among healthcare professionals and clinician-scientists about the usefulness of such techniques in clinical patient populations, so that these can be considered as part of clinical care pathways to enhance patient safety and effectively manage cancer patients on chemotherapy.


Author(s):  
Kevin Yi-Lwern Yap

Pharmaco-cybernetics is an upcoming interdisciplinary field that supports our use of medicines and drugs through the combined use of computational technologies and techniques with human-computer-environment interactions to reduce or prevent drug-related problems. The advent of pharmaco-cybernetics has led to the development of various software, tools, and Internet applications that can be used by healthcare practitioners to deliver optimum pharmaceutical care and health-related outcomes. Patients are becoming more informed through health information on the Internet, which empowers them to better participate in the management of their own conditions. Focusing on patients with cancer, this chapter describes the use of a pharmaco-cybernetics approach to identify clinically relevant predictors of two debilitating adverse drug reactions, which are a cause of patient safety – chemotherapy-induced nausea and vomiting and febrile neutropenia. The early identification of such clinical predictors enables clinicians to prevent or reduce the occurrence of adverse drug reactions in cancer patients undergoing chemotherapy through appropriate management strategies. The computational methods used in this approach involve two unsupervised machine-learning techniques – principal component and multiple correspondence analyses. Using two case examples, this chapter shows the potential of machine-learning techniques for identifying patients who are at greater risks of these adverse drug reactions, thus enhancing patient safety. This chapter also aims to increase the awareness among healthcare professionals and clinician-scientists about the usefulness of such techniques in clinical patient populations, so that these can be considered as part of clinical care pathways to enhance patient safety and effectively manage cancer patients on chemotherapy.


Author(s):  
Katsuhito Hori ◽  
Kayoko Kubota ◽  
Yasuhiko Mimura ◽  
Isao Adachi ◽  
Junichi Kawakami

Author(s):  
Li-Ju Chen ◽  
Thi Ngoc Mai Nguyen ◽  
Dana Clarissa Laetsch ◽  
Jenny Chang-Claude ◽  
Michael Hoffmeister ◽  
...  

Abstract Background Evidence about the clinical relevance of appropriate co-medication among older colorectal cancer (CRC) patients is sparse. Methods A cohort study was conducted with 3,239 CRC patients aged 65 years and older. To assess co-medication quality, we calculated the total Fit fOR The Aged (FORTA) score and its sub-scores for medication overuse, underuse, and potentially inappropriate medication use. Multivariable Cox proportional hazards or logistic regression models were performed to evaluate the association of co-medication quality with up to 5-year overall survival, CRC-specific survival, and chemotherapy-related adverse drug reactions (ADRs). Results Overall, 3,239 and 1,209 participants were included in analyses on survival and ADRs, respectively. The hazard ratios [95%-confidence intervals] for the total FORTA score ≥ 7 vs. 0-1 points were 1.83 [1.40-2.40] and 1.76 [1.22-2.52] for up to 5-year overall and CRC-specific survival, respectively. Worse up to 5-year OS and CSS was also evident for FORTA sub-scores for PIM use and overuse whereas no association was observed for underuse. Although results for the total FORTA and potentially inappropriate medication score were much stronger among patients receiving chemotherapy, no significant associations with chemotherapy-related ADRs were observed. Moreover, associations were particularly strong among men and rectal cancer patients as compared to women and colon cancer patients. Conclusions Poor total co-medication quality was significantly associated with worse up to 5-year overall and CRC-specific survival. Randomized controlled trials are needed to test whether improved cancer co-medication management in older CRC patients prolongs survival.


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