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Richard J Gralla

Publications and source records attributed to Richard J Gralla.

17 recordsLinked to original sources
PubMed2006

American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006.

PURPOSE: To update the 1999 American Society of Clinical Oncology guideline for antiemetics in oncology. UPDATE METHODOLOGY: The Update Committee completed a review and analysis of data published from 1998 thru February 2006. The literature review focused on published randomized controlled trials, and systematic reviews and meta-analyses of published phase II and phase III randomized controlled trials. RECOMMENDATIONS: The three-drug combination of a 5-hydroxytryptamine-3 (5-HT(3)) serotonin receptor antagonist, dexamethasone, and aprepitant is recommended before chemotherapy of high emetic risk. For persons receiving chemotherapy of high emetic risk, there is no group of patients for whom agents of lower therapeutic index are appropriate first-choice antiemetics. These agents should be reserved for patients intolerant of or refractory to 5-HT3 serotonin receptor antagonists, neurokinin-1 receptor antagonists, and dexamethasone. The three-drug combination of a 5-HT3 receptor serotonin antagonist, dexamethasone, and aprepitant is recommended for patients receiving an anthracycline and cyclophosphamide. For patients receiving other chemotherapy of moderate emetic risk, the Update Committee continues to recommend the two-drug combination of a 5-HT3 receptor serotonin antagonist and dexamethasone. In all patients receiving cisplatin and all other agents of high emetic risk, the two-drug combination of dexamethasone and aprepitant is recommended for the prevention of delayed emesis. The Update Committee no longer recommends the combination of a 5-HT3 serotonin receptor antagonist and dexamethasone for the prevention of delayed emesis after chemotherapeutic agents of high emetic risk. CONCLUSION The Update Committee recommends that clinicians administer antiemetics while considering patients' emetic risk categories and other characteristics.

Antiemetics↗
PubMed2005

Antiemetic efficacy of the neurokinin-1 antagonist, aprepitant, plus a 5HT3 antagonist and a corticosteroid in patients receiving anthracyclines or cyclophosphamide in addition to high-dose cisplatin: analysis of combined data from two Phase III randomized clinical trials.

BACKGROUND: The tendency of chemotherapeutic regimens to cause vomiting is dependent on the individual drugs in the regimen. The authors analyzed data combined from 2 Phase III trials to assess the effect of the neurokinin-1 (NK(1)) antagonist aprepitant combined with a 5HT(3) antagonist plus a corticosteroid in a subpopulation receiving > 1 emetogenic chemotherapeutic agent. METHODS: In the current study, 1043 cisplatin-naive patients (42% were women) receiving cisplatin-based (> or = 70 mg/m(2)) chemotherapy were assigned randomly to a control regimen (ondansetron [O] 32 mg intravenously and dexamethasone [D] 20 mg orally on Day 1; D 8 mg twice daily on Days 2-4) or an aprepitant (A) regimen (A 125 mg orally plus O 32 mg and D 12 mg on Day 1; A 80 mg and D 8 mg once daily on Days 2-3; and D 8 mg on Day 4). Randomization was stratified for use of concomitant chemotherapy and female gender. The primary end point was complete response (no vomiting and no rescue therapy) on Days 1-5 (0-120 hours). Data were analyzed by a modified intent-to-treat approach, and logistic regression was used to make treatment comparisons among patients receiving the most frequently coadministered emetogenic concomitant chemotherapy (Hesketh level > or = 3). RESULTS: Among the approximately 13% of patients (n = 81 for A; n = 80 for control) who received additional emetogenic chemotherapy (doxorubicin or cyclophosphamide), the aprepitant regimen provided a 33 percentage-point improvement in the complete response rate compared with the control regimen. Among the general population, the advantage with aprepitant was 20 percentage points. CONCLUSIONS: The current analysis of > 1000 patients from 2 large randomized trials showed that in the subpopulation at increased risk of chemotherapy-induced nausea and vomiting due to concomitant emetogenic chemotherapy, the addition of aprepitant to standard antiemetics improved protection to an even greater extent than in the general study population.

Adrenal Cortex Hormones↗
PubMed2005

Measuring quality of life in patients with pleural mesothelioma using a modified version of the Lung Cancer Symptom Scale (LCSS): psychometric properties of the LCSS-Meso.

Health-related quality of life (QOL) assessment is a key component in patient assessment and the development of therapies for malignant pleural mesothelioma. However, no mesothelioma-specific instrument was available. The Lung Cancer Symptom Scale (LCSS), a site-specific instrument used to assess QOL in patients with lung cancer, was identified as an instrument that could be appropriate. A modified nine-item patient-reported and six-item observer-reported LCSS was incorporated into two clinical trials of pemetrexed in patients with pleural mesothelioma. Basic psychometric properties of feasibility, reliability, and validity were tested. Properties were stable or enhanced by deletion of the hemoptysis item. Feasibility was demonstrated with a high completion rate of 90% by 512 patients. Reliability was acceptable, with good internal consistency for the eight-item measure (alpha coefficient=0.86) and reasonably good for the five-item observer measure (alpha coefficient=0.66); there was also good stability for the patient measure using test-retest (r=0.87). Content validity was supported by a literature review and patient self-report of presenting symptoms (>90% of patients had three or more symptoms). Construct validity was well supported by finding better scores in the higher performance status groups and greater symptom improvement in patients with tumor response, good concordance with the LCSS conceptual model and good explanation of variance for summation items, and a high degree of convergence between the patient and observer forms (r=0.57). Criterion-related validity was supported by predicting survival time, time to progression, and tumor response rate; all three summary items and the total LCSS-Meso score were statistically significant predictors (p<0.005). The LCSS-Meso is a feasible, reliable, and valid instrument to assess health-related QOL in patients with pleural mesothelioma. One item, hemoptysis, was dropped from the original LCSS based on these findings.

Adult↗
PubMed2005

Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy.

PURPOSE: This is the first study in which the NK(1)-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. PATIENTS AND METHODS: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide +/- doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) [DOSAGE ERROR CORRECTED] or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. RESULTS: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. CONCLUSION: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

Adult↗
PubMed2005

The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: Pooled data from 2 randomised, double-blind, placebo controlled trials.

In this work, data from two phase III studies were pooled to further evaluate the NK(1) antagonist aprepitant for prevention of cisplatin induced nausea and vomiting. One thousand and forty three patients receiving cisplatin (> or = 70 mg/m2) were randomised to receive either a control regimen (32 mg intravenous ondansetron [O] and 20 mg oral dexamethasone [D] on day 1; 8 mg D twice daily on days 2-4) or an aprepitant (A) regimen (125 mg A plus 32 mg O and 12 mg D on day 1, 80 mg A and 8 mg D once daily on days 2-3, and 8 mg D on day 4). The primary endpoint was no emesis and no rescue therapy. Potential correlations between acute and delayed emesis were assessed, as were frequency of emetic episodes by time interval and effects on nausea and quality of life as measured by the functional living index emesis (FLIE) questionnaire. In the aprepitant group, there was statistically significantly less nausea over the study period as well as higher functioning on the FLIE questionnaire in both the nausea and vomiting domains. Patients without acute emesis were more likely to have no emesis in the delayed phase. Compared with control, the aprepitant regimen improved prevention of delayed emesis by 16% points in patients without acute emesis, and by 17% points in patients with acute emesis. Among patients who did not have complete response, the frequency of emesis at various intervals over 5 days was consistently lower in patients receiving aprepitant. Analyses of this combined Phase III population further characterized the clinical profile of the aprepitant regimen, showing that delayed emesis is correlated with, but not entirely dependent on, the presence of acute emesis, and that aprepitant has a favorable effect against nausea throughout 5 days postchemotherapy. In addition, even among patients who had emesis or needed rescue therapy, aprepitant was associated with a lower frequency of these events compared with the control regimen.

Acute Disease↗
PubMed2004

Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--an update.

Development of effective antiemetic therapy depends upon an understanding of both the antiemetic agents and the emetogenic challenges these agents are designed to address. New potential antiemetic agents should be studied in an orderly manner, proceeding from phase I to phase II open-label trials and then to randomized double-blind phase III trials comparing new agents and regimens to best standard therapy. Use of placebos in place of antiemetic therapy against highly or moderately emetogenic chemotherapy is unacceptable. Nausea and vomiting should be evaluated separately and for both the acute and delayed periods. Defining the emetogenicity of new antineoplastic agents is a challenge, since such data are often not reliably recorded during early drug development. A four-level classification system is proposed for emetogenicity of intravenous antineoplastic agents. A separate four-level classification system for emetogenicity of oral antineoplastic agents, which are often given over an extended period of time, is also proposed.

Antiemetics↗
PubMed2004

Delayed emesis: moderately emetogenic chemotherapy.

Data on the incidence and efficacy of antiemetic prophylaxis against delayed emesis induced by moderately emetogenic chemotherapy are scanty. An overview of the literature has been done that showed the efficacy of dexamethasone in two of three randomized trials. Its optimal dose and duration of administration has not been defined. Only one of four randomized studies showed a statistically significant efficacy of 5-HT(3) antagonists. Finally, only weak evidence has been published on the efficacy of dopamine receptor antagonists.

Antiemetics↗
PubMed2004

Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation.

BACKGROUND: The underpinning conceptual model for the Lung Cancer Symptom Scale (LCSS), an instrument used to assess health-related quality of life in patients with lung cancer, has been described elsewhere. The patient-rated scale of the LCSS was modified slightly for patients with mesothelioma (LCSS-Meso), because no other mesothelioma-specific instrument was available. METHODS: In the current methodologic study, the authors tested the conceptual model for the LCSS-Meso. Chemotherapy-naive patients with unresectable malignant pleural mesothelioma who were participating in two clinical trials of pemetrexed (ALIMTA; Eli Lilly, Indianapolis, IN) completed the scale twice before the start of therapy and once weekly during the trials. Three time points were analyzed: baseline, Day 40, and Day 82. Poisson regression was used to determine the contribution of predictive factors (i.e., symptoms) to the summary items (symptom distress, activity level, and global quality of life). RESULTS: The model was tested in 495 patients who had malignant pleural mesothelioma. More than 85% of patients reported pain, dyspnea, fatigue, and appetite loss. Pain, dyspnea, and fatigue were significant and stable predictors for all summary items; however, pain had a significant effect on global quality of life only through Day 40. Appetite loss was a significant and stable predictor of activity level and global quality of life. The explained variance for the model was 39-55%. CONCLUSIONS: Further support for the content validity of the LCSS-Meso was obtained, as nearly all patients validated that the symptoms described in the scale captured their disease experience. The only exception was the hemoptysis item, which was removed based on the current large normative data set. Support for the construct validity of the LCSS-Meso also was obtained. For both mesothelioma and lung cancer, the majority of factors within the LCSS model are relevant and have the expected amount of variability. These findings support the use of the LCSS as a sensitive instrument for serial measurement during clinical trials involving patients with lung malignancies.

Adult↗
PubMed2004

Quality of life as a clinical trial endpoint: determining the appropriate interval for repeated assessments in patients with advanced lung cancer.

One of the unresolved design issues for clinical trials with quality of life (QOL) as an endpoint is the frequency of measurement in patients with stage III and IV lung cancer. In a retrospective review of clinical trials, the QOL interval varied widely from 1 to 12 weeks during treatment. During follow-up, the interval was generally 2 to 3 months or not at all. The purpose of this methodological study was to determine an appropriate interval for QOL serial measurement based on prospectively collected data. The 20 patients for this study were part of a phase I/I study using combination chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). They were typical of patients in lung cancer clinical trials, with a median age of 67 (interquartile range: 58, 72) years, the majority were male (13, 65%), and a baseline median Karnofsky performance status was 80 (interquartile range: 70%, 90%). The primary instrument, developed in 1985, was the Lung Cancer Symptom Scale (LCSS) patient form, a 9-item self-report and site-specific QOL measure. The method, outcome, and implication of these findings to research are presented for establishing a method for obtaining an appropriate serial measurement interval for QOL during therapy in clinical trials. Based on the findings of this study, an every 3-week QOL assessment for patients with advanced NSCLC provides data similar to more frequent evaluation (94% of data preserved compared to twice-weekly assessment, 95% confidence interval, 86-98%, p=0.05). Less frequent assessment (every 4 or every 6 weeks) retained less than 85% of the data, which is the recommended minimum adequacy rate. Retaining a high percentage of QOL information may lessen the effect of measurement bias due to patient attrition and may give more validity to QOL studies.

Adult↗
PubMed2004

Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: results of a prospective, randomized phase III trial.

PURPOSE AND METHODS: Docetaxel second-line chemotherapy for non-small-cell lung cancer (NSCLC) has previously been shown to improve survival significantly compared with best supportive care (BSC). This multicenter phase III trial prospectively investigated quality of life (QOL) in NSCLC patients treated with either second-line docetaxel or BSC. Patients with stage IIIB/IV NSCLC, performance status < or =2, and adequate biochemistry and hematology were eligible if they had received > or =1 platinum-based chemotherapy regimens. Patients were randomized to docetaxel 100 mg/m2 (n=49) or, after protocol amendment, to docetaxel 75 mg/m2 (n=55), or to BSC (n=100), with Lung Cancer Symptom Scale (LCSS) and/or QLQ-C30 (with LC13 module) assessment every 3 weeks. RESULTS: Longitudinal analysis including all available assessments over time showed statistically significant differences in patient-rated pain scores in favor of docetaxel overall (P=0.005) or docetaxel 100 mg/m2 (P=0.003) compared to BSC. Trends in favor of docetaxel were noted on observer-rated scales for fatigue and pain for all docetaxel patients, and for total LCSS score, appetite and fatigue with docetaxel 100 mg/m2. Changes from baseline to the last available assessment (end point) showed significantly (P<0.05) less deterioration in LCSS pain score in patients with docetaxel (75 and 100 mg/m2 combined) than with BSC. An improved mean pain score with docetaxel 100 mg/m2 was contrasted with a deterioration in mean pain score with BSC (P<0.01). There was also significantly less deterioration in the global QOL today score with docetaxel 100 mg/m2 (P<0.01). Similar trends were recorded with QLQ-C30 assessments. CONCLUSIONS: Second-line docetaxel therapy for advanced NSCLC significantly improves survival with a trend towards less deterioration in QOL compared with BSC.

Adult↗
PubMed2004

Quality-of-life assessment in advanced lung cancer: considerations for evaluation in patients receiving chemotherapy.

There is increasing awareness of the need for accurate assessment of quality of life in patients with lung cancer who are on clinical trials and in patient management. Self-reported multidimensional, validated, quality-of-life instruments assess physical, functional, psychological, social, and spiritual dimensions associated with lung cancer and its treatment. Such validated instruments are now available and are being utilized more frequently in clinical trials assessing the value of particular anticancer therapies. Such findings may influence the treatment of choice for patients with non-small-cell lung cancer (NSCLC), particularly in the advanced-disease setting where survival benefits from current treatments are modest, and the majority of patients present with three or more symptoms. Recently, a number of studies assessing quality of life in NSCLC have been published providing more insight into the effects of the disease and its treatment on the patient's perspective. Quality-of-life instruments that include patient reported outcomes ("PROS") and quality-of-life and symptom assessment are the only way to evaluate this crucial aspect of cancer care. As an example, Fossella and colleagues reported notable findings from the largest prospective evaluation (the TAX 326 trial) of quality of life using validated instruments in patients with NSCLC who received chemotherapy. Patients who received a docetaxel plus platinum combination regimen reported modest benefits in both quality of life and in disease-related parameters, such as pain control, weight loss, and performance status, compared to patients randomly assigned to the combination of vinorelbine and cisplatin. Compliance with the PRO assessment was high, supporting the feasibility of prospective quality-of-life evaluations in NSCLC. Important goals include building on these results by including quality-of-life assessment in all major clinical trials, and demonstrating feasible ways to incorporate this evaluation into daily clinical practice.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

Quality-of-life considerations in patients with advanced lung cancer: effect of topotecan on symptom palliation and quality of life.

Key goals in the treatment of lung cancer are to improve both survival and quality of life (QOL). While formal techniques are frequently used to evaluate survival and response, such rigor is used less often in assessing the impact of treatment on quality of life. Many patients with lung cancer are elderly and have complex medical histories and a myriad of comorbidities. In these patients, with limited survival expectations, symptom palliation, quality of life, and convenience of therapy are especially important end points. Indeed, clinical trials are now incorporating symptom scores and QOL outcomes in their designs (now combined as "patient reported outcomes" or PROs). Moreover, symptom palliation correlates well with QOL and survival duration, providing further rationale for therapy selection based on these parameters. The potential palliative and QOL benefits of chemotherapy have been investigated for several agents in lung cancer trials. Of these, topotecan (Hycamtin; GlaxoSmithKline; Philadelphia, PA) is the best characterized in relapsed small cell lung cancer (SCLC). In a phase III trial of topotecan versus cyclophosphamide, doxorubicin (Adriamycin; Bedford Laboratories; Bedford, OH), and vincristine (Oncovin; Eli Lilly and Company; Indianapolis, IN) (CAV) in patients with recurrent SCLC, topotecan was associated with statistically significant (p < 0.05) improvements in general symptoms (e.g., fatigue and interference with daily activity) and disease-specific symptoms (e.g., dyspnea and hoarseness). Moreover, the introduction of oral therapies, such as oral topotecan, may increase the convenience of therapy by reducing the time needed for therapy and the need for frequent venipuncture. This review summarizes the role of chemotherapy in symptom palliation, with an emphasis on the impact of topotecan therapy on symptom parameters in patients with relapsed SCLC and the emerging role of oral therapy in this setting.

Antineoplastic Agents↗
PubMed2003

The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group.

PURPOSE: In early clinical trials with patients receiving highly emetogenic chemotherapy, the neurokinin antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen consisting of a type-three 5-hydroxytryptamine antagonist and a corticosteroid. This multicenter, randomized, double-blind, placebo-controlled phase III study was performed to establish definitively the superiority of the aprepitant regimen versus standard therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). PATIENTS AND METHODS: Patients receiving cisplatin > or = 70 mg/m2 for the first time were given either standard therapy (ondansetron and dexamethasone on day 1; dexamethasone on days 2 to 4) or an aprepitant regimen (aprepitant plus ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2 to 3; dexamethasone on day 4). Patients recorded nausea and vomiting episodes in a diary. The primary end point was complete response (no emesis and no rescue therapy) on days 1 to 5 postcisplatin, analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments. RESULTS: The percentage of patients with complete response on days 1 to 5 was significantly higher in the aprepitant group (72.7% [n = 260] v 52.3% in the standard therapy group [n = 260]), as were the percentages on day 1, and especially on days 2 to 5 (P <.001 for all three comparisons). CONCLUSION: Compared with standard dual therapy, addition of aprepitant was generally well tolerated and provided consistently superior protection against CINV in patients receiving highly emetogenic cisplatin-based chemotherapy.

Administration, Oral↗
PubMed2003

Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting.

BACKGROUND: The neurokinin-1 antagonist aprepitant (EMEND; Merck Research Laboratories, West Point, PA) has been shown to reduce chemotherapy-induced nausea and vomiting when it is given with a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The current study sought to define the most appropriate dose regimen of oral aprepitant. METHODS: This multicenter, randomized, double-blind, placebo-controlled study was conducted in patients with cancer who were receiving initial cisplatin (> or = 70 mg/m(2)) and standard antiemetic therapy (intravenous ondansetron plus oral dexamethasone). Patients were randomized to receive standard therapy plus either aprepitant 375 mg on Day 1 and 250 mg on Days 2-5, aprepitant 125 mg on Day 1 and 80 mg on Days 2-5, or placebo. Due to an apparent interaction with dexamethasone suggested by pharmacokinetic data obtained while the study was ongoing, the aprepitant 375/250 mg dose was discontinued and replaced with aprepitant 40 mg on Day 1 and 25 mg on Days 2-5, and a new randomization schedule was generated. Patients recorded nausea and emesis in a diary. The primary endpoint was complete response (no emesis and no rescue therapy), which was analyzed using an intent-to-treat approach with data obtained after the dose adjustment. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments, and included all available data. RESULTS: The percentages of patients who achieved a complete response in the overall study period were 71.0% for the aprepitant 125/80-mg group (n = 131 patients), 58.8% for the aprepitant 40/25-mg group (n = 119 patients), and 43.7% for the standard therapy group (n = 126 patients; P < 0.05 for either aprepitant regimen vs. standard therapy). Rates for Day 1 were 83.2% for the aprepitant 125/80-mg group, 75.6% for aprepitant 40/25-mg group, and 71.4% for the standard therapy group (P < 0.05 for aprepitant 125/80 mg vs. standard therapy), and rates on Days 2-5 were 72.7% for the aprepitant 125/80-mg group, 63.9% for the aprepitant 40/25-mg group, and 45.2% for the standard therapy group (P < 0.01 for either aprepitant group vs. standard therapy). The efficacy of the aprepitant 375/250-mg regimen was similar to that of the aprepitant 125/80-mg regimen. The overall incidence of adverse events was generally similar across treatment groups: 85% in the aprepitant 375/250-mg group (n = 34 patients), 76% in the aprepitant 125/80-mg group (n = 214 patients), 71% in the aprepitant 40/25-mg group (n = 120 patients), and 72% in the standard therapy group (n = 212 patients), with the exception of a higher incidence of infection in the aprepitant 125/80-mg group (13%) compared with the standard therapy group (4%). CONCLUSIONS: When it was added to a standard regimen of intravenous ondansetron and oral dexamethasone in the current study, aprepitant reduced chemotherapy-induced nausea and vomiting and was generally well tolerated, although increases in infection were noted that were assumed to be due to elevated dexamethasone levels as a result of the pharmacokinetic interaction. The aprepitant 125/80-mg regimen had the most favorable benefit:risk profile.

Administration, Oral↗
PubMed2002

Antiemetic guidelines: creating a more practical treatment approach.

Antiemetic guidelines from a variety of professional organizations have been available for several years. It is unclear just how often these guidelines have been used, however; data indicate that some practitioners still do not treat their patients according to the recommendations. Some of those involved in the creation of the original guidelines convened to try to create a simpler, more practical approach to the use of antiemetics in preventing chemotherapy-induced nausea and vomiting. The group's intention was to clarify available guidelines and produce a practical document, based on evidence, that could be used in everyday practice. The group created four consensus statements that would serve as a basis for their recommendations. One primary strategy used was to have chemotherapy-induced nausea and vomiting viewed as a single process that can occur throughout a treatment cycle, and not so much as an acute and a delayed process, as is usual in clinical trials. Patients' management should be considered over a 4- to 5-day period, rather than primarily dealing with the day of treatment only. The group created three tables: emetic risk of chemotherapy; treatment options based on emetic category; and antiemetic dosing recommendations. Use of these tables should make appropriate antiemetic selection more straightforward and easier for the practitioner in an everyday setting. Although this document alone may not solve all the challenges with appropriate antiemetic management, it will hopefully prove to be a step in the right direction.

Antiemetics↗
PubMed2002

New agents, new treatment, and antiemetic therapy.

With the introduction of newer antineoplastic agents, the challenge for supportive care is enlarging. For the most part, these targeted therapies are given in addition to more classic anticancer drugs, either in combination or in sequence, underscoring the need for prevention of emesis and attention to all treatment toxicities. Strategies for preventing these side effects need to be investigated while appropriately addressing more familiar problems such as emesis. Two directions for improving emetic control are clear. First is the development of newer antiemetics that enhance current control rates, and second is the proper use of existing agents in all emetic settings. This report outlines the rationale behind the development of neurokinin type 1 antagonists, and reviews consensus recommendations in the prevention of acute and delayed emesis.

Antiemetics↗