Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy.

Lofters, W.; Pater, Joseph L.; Zee, Benny; Dempsey, Ellen; Walde, David; Moquin, Jean Pierre; Wilson, Kenneth S.; Hoskins, Paul; Guévin, R.; Verma, Shailendra; Navari, Rudolph M.; Krook, James E.; Hainsworth, John D.; Palmer, Michael; Chin, Christine

doi:10.1200/jco.1997.15.8.2966

Cited by 93 publications

(35 citation statements)

References 24 publications

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“…Dexamethasone given before chemotherapy has been shown to reduce acute nausea and vomiting (Cassileth et al, 1983;Kris et al, 1989;Smith et al, 1991;Smyth et al, 1991;Roila et al, 1991Roila et al, , 1992Hesketh et al, 1994Hesketh et al, , 1995Adams et al, 1995;Latreille et al, 1995;Lofters et al, 1997;Warr, 1997;Ioannidis et al, 2000). Dexamethasone given after highly emetogenic chemotherapy reduces delayed emesis (1997a, b;Herrstedt et al, 1998;Ioannidis et al, 2000) and is recommended by all the antiemetic guidelines (1997a, b, 1999Gralla et al, 1999Gralla et al, , 2001Koeller et al, 2002).…”

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confidence: 99%

Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy

Vardy

Chiew

Galica

et al. 2005

JCO

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The role of dexamethasone to reduce delayed emesis following highly emetogenic chemotherapy is proven, but there is less evidence of benefit after mild -moderately emetogenic regimens. Here, we develop and evaluate a Dexamethasone Symptom Questionnaire (DSQ) to assess the side effects of dexamethasone in the week after patients receive moderately emetogenic chemotherapy. The DSQ was first optimised with the aid of a focus group. Sixty patients receiving oral dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy for cancer completed and then evaluated the DSQ. Patients reported that the DSQ was clearly worded and addressed items important to them. Patients receiving dexamethasone reported moderate-severe problems with insomnia (45%), indigestion/epigastric discomfort (27%), agitation (27%), increased appetite (19%), weight gain (16%) and acne (15%) in the week following chemotherapy. The side effects of dexamethasone may outweigh its benefits when used with moderately emetogenic chemotherapy. A randomised, double-blind crossover trial is underway to determine the effect of dexamethasone on nausea and vomiting, and the impact of side effects of dexamethasone and of nausea and vomiting on quality of life.

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confidence: 99%

Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy

Vardy

Chiew

Galica

et al. 2005

JCO

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“…Another 1,000 patients received cardiotoxic chemotherapy, including anthracyclines [14,15]. These data demonstrate that the frequency of small, transient ECG changes with dolasetron is similar to those of other 5-HT 3 receptor antagonists [3,7,12,[16][17][18][19].…”

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confidence: 72%

Evidence for Equivalent Electrocardiographic Changes Among the 5-HT3 Receptor Antagonists

Ellis

Dozier

2003

The Oncologist

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Greater understanding of the underlying etiology and biology of breast cancer is enabling the clinical development of targeted therapies for metastatic breast cancer (MBC). Following the successful introduction of trastuzumab, the first human epidermal growth factor receptor (HER) biologically targeted therapy to become widely used in MBC patients, other agents have been developed. Novel agents include monoclonal antibodies such as pertuzumab, which bind to receptors on the cell surface, and tyrosine kinase inhibitors (TKIs) such as lapatinib, which target intracellular pathways such as that of the epidermal growth factor receptor. There is also growing clinical experience with antiangiogenic agents, particularly in combination with chemotherapy. These include the monoclonal antibody bevacizumab, which targets vascular endothelial growth factor receptor, and multitargeted TKIs with antiangiogenic and antiproliferative activities, such as sunitinib. Combination treatment with multiple agents targeting both the HER family and angiogenic pathways (e.g., trastuzumab plus bevacizumab) is also showing activity in the clinical setting. Despite recent advances, there are unanswered questions regarding the management of MBC with targeted agents. Future studies are necessary to determine the optimal combinations, doses, and schedules required to maximize clinical activity while minimizing toxicity. Despite the temptation to use a targeted agent in all patients, identification of patient subgroups most likely to benefit must be a key goal and will be critical to the successful future use of these treatments. The aim of this review is to summarize some of the key signaling pathways involved in tumor progression and some of the novel therapies that are in development for MBC.

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“…The American Society of Clinical Oncology guidelines regarding patients who experience nausea and vomiting despite optimal prophylaxis are to reevaluate the patient risk and to determine if the correct antiemetic regimen has been used [11]. For moderately emetogenic chemotherapy, this translates to treating patients with standard antiemetic prophylaxis for highly emetogenic therapies by adding aprepitant or fosaprepitant along with a corticosteroid [11,12,13,14,15]. By assessing the incidence of failure, as we did in this analysis, we were able to show that by using PALO as first-line CINV prevention, we were able to effectively decrease the need for antiemetic prophylaxis escalation as outlined by American Society of Clinical Oncology guidelines.…”

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confidence: 99%

Antiemetic Control with Palonosetron in Patients with Gastrointestinal Cancer Receiving a Fluoropyrimidine-Based Regimen in Addition to Either Irinotecan or Oxaliplatin: A Retrospective Study

et al. 2012

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Background: For moderately emetogenic chemotherapy, palonosetron (PALO) is reported to provide complete control of chemotherapy-induced nausea and vomiting (CINV) in 69% of patients. Prior to August 2009, our gastrointestinal (GI) cancer patients receiving the moderately emetogenic compounds oxaliplatin or irinotecan plus a fluoropyrimidine regimen received ondansetron and dexamethasone orally on day 1 of chemotherapy for CINV prevention. Beginning in August of 2009, ondansetron was replaced by PALO 0.25 mg (intravenous push). Methods: This is a single-institution retrospective study of GI cancer patients who received oxaliplatin or irinotecan plus a fluoropyrimidine. Failure of an antiemetic regimen was defined as grade ≥1 vomiting or grade ≥2 nausea (Common Terminology Criteria for Adverse Events, version 3) on days 1 through 5 following chemotherapy. Patients were divided for analysis into pre-PALO and post-PALO cohorts. Fisher’s exact test compared cohort differences. Results: A total of 305 patients were included in the study, with 157 patients in the pre-PALO cohort and 148 in the post-PALO cohort. For all patients, the risk of antiemetic failure was reduced from 50.3% [95% confidence interval (CI) 42.2–58.4%] to 28.4% (95% CI 21.3–36.4%) with PALO. This reduction in the relative risk of antiemetic failure was observed in all subgroups. Conclusion: The addition of PALO may provide increased control of CINV for the moderately emetogenic regimens of oxaliplatin or irinotecan plus a fluoropyrimidine in GI cancer patients.

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Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy.

Cited by 93 publications

References 24 publications

Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy

Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy

Evidence for Equivalent Electrocardiographic Changes Among the 5-HT3 Receptor Antagonists

Antiemetic Control with Palonosetron in Patients with Gastrointestinal Cancer Receiving a Fluoropyrimidine-Based Regimen in Addition to Either Irinotecan or Oxaliplatin: A Retrospective Study

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