European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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The results of many clinical trials on empirical therapy in febrile, neutropenic cancer patients cannot be readily transferred to the clinical practice, because the methodology is often flawed and definitions, study endpoints and eligibility criteria differ from trial to trial. This article critically reviews some issues related to the design and implementation of randomised clinical trials of empirical antibiotic therapy in cancer patients. Within the definition of phase III clinical trials, two approaches co-exist, based on the trial's specific aims: the "explanatory" approach and the "pragmatic" approach. ⋯ Information related to fever and signs of infection, age, underlying disease, neutropenia and concomitant administration of other antibiotics are crucial entry criteria that need to be clearly discussed and defined. Finally, the evaluation of toxicity is problematic in this patient population, due to the existence of a number of toxigenic factors, including the underlying disease, the type of infectious complication, the administration of chemotherapy and radiotherapy and the use of parental nutrition. All these effects tend to overlap, thus impairing the investigator's ability to detect specific drug-related side-effects.
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Comparative Study
Comparison of methods for the estimation of carboplatin pharmacokinetics in paediatric cancer patients.
The antitumour and toxic effects of platinum drugs, in particular carboplatin, have been related to their plasma concentration and this has led to the concept of a target area under the plasma concentration-time curve (AUC) for carboplatin dosing. A formula based on renal function has been successfully applied to carboplatin dosing in adults and modified versions have also been proposed for paediatric patients. In order to monitor carboplatin AUC with maximum efficiency and minimum patient inconvenience, limited sampling strategies are desirable. ⋯ A technique, developed in adult patients, for estimating AUC from a measurement of 24 h total plasma platinum was comparable to estimates based on renal function, but was less reliable. The estimation of carboplatin AUC can be performed using only one or two plasma samples and Bayesian analysis. This approach is less biased and more precise than methods based on surface area, renal function or total platinum at 24 h postdose, but is probably best used in combination with dosing based on renal function.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of granisetron alone and granisetron plus hydroxyzine hydrochloride for prophylactic treatment of emesis induced by cisplatin chemotherapy.
The efficacy and safety of granisetron alone (group G) and granisetron plus hydroxyzine hydrochloride (group G/H) as prophylactic therapy for acute and delayed nausea and vomiting were evaluated in an open trial in head and neck cancer patients undergoing chemotherapy with cisplatin. The severity of nausea was significantly reduced on days 1 and 4 in patients receiving combination therapy, but the frequency of vomiting was not significantly different between the two groups. The only side-effect observed was headache in 1 patient from group G, and no drug-related laboratory test abnormalities were observed. These results suggest that the anti-emetic efficacy of granisetron can be augmented by hydroxyzine hydrochloride.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The effect of blood transfusions on survival after surgery for colorectal cancer.
The immunosuppressive effect of allogeneic blood transfusions can be associated with a poor prognosis for cancer patients. Predeposit autologous blood transfusions could be a solution to overcome this putative deleterious effect. We performed a randomised clinical study to compare the effects of autologous with allogeneic blood transfusions in colorectal cancer patients. ⋯ This association of transfusions with recurrent disease was only the case for local recurrences, whereas the incidence of distant metastases was unaffected. We conclude that the use of a predeposit autologous blood transfusion programme does not improve the prognosis in colorectal cancer patients. The negative association between blood transfusions and cancer recurrence is only true for local recurrences, which suggests that not the blood transfusions themselves but rather the circumstances necessitating them are the real predictors of prognosis.