Prevention of Delayed Nausea: A University of Rochester Cancer Center Community Clinical Oncology Program Study of Patients Receiving Chemotherapy
ABSTRACT PURPOSE We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. PATIENTS AND METHODS Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: -0.01 (95% CI, -0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, -0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: -0.03 (95% CI, -0.24 to 0.19; P = .56). CONCLUSION The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.
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ABSTRACT: Abstract Background: Hyperglycemia occurs in cancer patients receiving high-dose steroids with cyclophosphamide, doxorubicin, vincristine, and dexamethasone (hyper-CVAD) protocol. The purpose of our study was to determine insulin requirements in patients with hyperglycemia on hyper-CVAD therapy using a systematic algorithm. Subjects and Methods: We did a retrospective chart review of 23 leukemia inpatients with hyperglycemia (two glucose values >250 mg/dL) on hyper-CVAD chemotherapy managed by the Endocrine Diabetes Inpatient Team algorithm. We reviewed demographic and glycemic data, insulin dosages, and use of oral hypoglycemic agents. Using our algorithm, the dose of insulin for each patient was titrated daily and with each subsequent cycle of hyper-CVAD. Results: Ninety-one percent of patients had known diabetes. The median body mass index was 32.5 (range, 21.6-40.9) kg/m(2), and median age was 61 (range, 40-80) years. The overall trend in glucose values across cycles showed a statistically significant decrease with each subsequent cycle of hyper-CVAD. Hyperglycemia accounted for 81% of glucose measurements in the first cycle and 60% of glucose values in the last cycle. Patients received 1-1.3 units/kg of insulin per cycle, and insulin requirements were similar across cycles. The distribution of basal versus bolus insulin for each cycle was 63-77% prandial and 23-37% basal. Nine of the 23 patients had at least one glucose value <70 mg/dL, which accounted for 1.3% of all recorded glucose values. None of the patients had severe hypoglycemia. Conclusions: Multiple-dose insulin therapy initiated at 1-1.2 units/kg/day, distributed as 25% basal and 75% prandial, reduced hyperglycemia in patients who were receiving high-dose dexamethasone as part of hyper-CVAD.Diabetes Technology & Therapeutics 10/2014; DOI:10.1089/dia.2014.0115 · 2.29 Impact Factor
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ABSTRACT: Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naïve patients with solid cancers. Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m(2); range 50 to 75 mg/m(2)) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV. The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations. RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.Cancer Research and Treatment 09/2013; 45(3):172-7. DOI:10.4143/crt.2013.45.3.172 · 2.98 Impact Factor
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ABSTRACT: Background:We evaluated the efficacy of aprepitant plus granisetron and an increased dose of dexamethasone in selected patients undergoing moderately emetogenic chemotherapy (MEC).Methods:Nondrinking women <70 years undergoing MEC were randomly assigned to aprepitant (day 1, 125 mg; days 2 and 3, 80 mg) or placebo. Dexamethasone on days 1-3 was 12, 4, and 4 mg with aprepitant and 20, 8, and 8 mg with placebo. The primary end point was complete response (CR; no emesis or rescue therapy) during 120 h of the first cycle. Logistic regression analysis was performed to identify predictors of overall CR.Results:Of the 94 patients enrolled, 91 were assessable. Most received carboplatin-based chemotherapy. In the aprepitant (n=45) and placebo (n=46) groups, the overall, acute (day 1), and delayed (days 2-5) CR rates were 62% and 52%, 98% and 96%, and 62% and 52%, respectively. Although not statistically significant, the overall CR rate was 10% higher in the aprepitant group. Both regimens were well tolerated. On multivariate analysis, advanced ovarian cancer (OR, 0.26 (0.10-0.72)) was independently associated with a lower CR.Conclusion:Even with an increased dose of dexamethasone, aprepitant seemed more effective than placebo in these selected patients undergoing MEC; however, delayed phase management remains a significant problem.British Journal of Cancer advance online publication, 16 July 2013; doi:10.1038/bjc.2013.400 www.bjcancer.com.British Journal of Cancer 07/2013; 109(4). DOI:10.1038/bjc.2013.400 · 4.82 Impact Factor