Antiemetic therapy in patients treated with cisplatin chemotherapy.
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Antiemetics↗
Biomedical subjects
F Roila
Publications and source records attributed to F Roila.
Increased bone pain after suspension of buserelin treatment in disseminated prostatic cancer.
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Bone Neoplasms↗
A double-blind trial comparing antiemetic efficacy and toxicity of metoclopramide versus methylprednisolone versus domperidone in patients receiving doxorubicin chemotherapy alone or in combination with other antiblastic agents.
Nausea and vomiting are reported in approximately 60% of neoplastic patients treated with doxorubicin used alone at doses greater than or equal to 50 mg/m2 or in combination with other noncisplatin antiblastic agents. In a double-blind study we compared the efficacy and tolerability of metoclopramide (MTC) versus Domperidone (DMP) versus methylprednisolone (MP) administered intravenously (i.v.) to inpatients. Forty-four patients entered the trial. The three antiemetic regimens were found equally effective. A complete protection from vomiting/nausea was obtained in 14/11 (93.3%/73.3%) of patients treated with MTC, in 15/14 (100%/93%) of those treated with MP and in 11/11 (78.6%/78.6%) of those treated with DMP. Side effects were slight and not significantly different among the three regimens. In conclusion, i.v. MTC and MP (DMP is no longer available in i.v. formulation) as single agents are an adequate treatment for prevention of nausea and vomiting induced by doxorubicin alone or in combination with other noncisplatin antiblastic agents.
Antiemetics↗
Methylprednisolone versus metoclopramide for prevention of nausea and vomiting in breast cancer patients treated with intravenous cyclophosphamide methotrexate 5-fluorouracil: a double-blind randomized study.
The antiemetic efficacy and toxicity of methylprednisolone (MP) and metoclopramide (MTC) in prevention of nausea and vomiting in breast cancer patients receiving intravenous cyclophosphamide methotrexate 5-fluorouracil (CMF) chemotherapy has been evaluated in a double-blind trial. The two antiemetic drugs (MP vs. MTC) offered the majority of patients a similar complete protection from vomiting (76.5 vs. 66.7%) and nausea (82.4 vs. 81.8%), but in older patients MTC seems more efficacious than MP. Sedation was found more frequently (p = 0.02) in patients treated with MTC. In conclusion, in patients treated with CMF the use of MP as preventive therapy of nausea and vomiting is to be preferred to MTC due to its better tolerability, but in older patients MTC should be considered if MP fails.
Adult↗
A prospective randomized double-blind crossover study comparing the antiemetic activity of alizapride and metoclopramide in patients receiving cisplatin chemotherapy.
We designed a double-blind randomized crossover study to compare the antiemetic activity and toxicity of high-dose intravenous alizapride (3.5 mg/kg) versus high-dose intravenous metoclopramide (1 mg/kg) both combined with intravenous methylprednisolone in 40 untreated cancer patients submitted to cisplatin chemotherapy alone. The mean number of vomiting episodes (3.6 vs. 1.0), length of vomiting (209.8 vs. 80.9 min), and rate of complete prevention of vomiting (25% vs. 68.4%) at first cycle were in favor of metoclopramide, with a statistically significant difference. This difference was not statistically significant in the second cycle after crossover. Toxicity of both treatments was mild and diarrhea was more frequent in the alizapride-treated patients. Preference expressed by the patients was also in favor of metoclopramide. We conclude that alizapride offers less antiemetic protection than metoclopramide in patients receiving cisplatin chemotherapy. Further use of alizapride in such patients is not recommended.
Adult↗
Viridans streptococci septicemia in cancer patients: a clinical study.
Viridans streptococci septicemia was documented in ten cancer patients, 7 of whom were neutropenic (less than 1000/mmc). Pneumonia was presumed to be the source of bacteremia in six patients. Viridans streptococci isolated from sputum culture in an immunocompromised host must be regarded as the potential etiological agent, then further characterized and checked for antibiotic sensitivity.
Adolescent↗
Double-blind controlled trial of the antiemetic efficacy and toxicity of methylprednisolone (MP), metoclopramide (MTC) and domperidone (DMP) in breast cancer patients treated with i.v. CMF.
Sixty-two patients treated for the first time with i.v. CMF were included in a double-blind comparative study aimed at evaluating the efficacy of 3 different drugs (methylprednisolone (MP), metoclopramide (MTC), and domperidone (DMP) in preventing chemotherapy-induced nausea and vomiting. Complete protection from vomiting/nausea was obtained in 85%/80% in the group treated with MP; in 60%/65% in the group treated with MTC and in 38%/42% in the group treated with DMP. Average number of vomiting episodes was 2.4 with MP, and 1.7 with MTC and 6.2 with DMP. Older patients seem to be a prognostically unfavorable subgroup. Side-effects were mild and infrequent. We conclude that MP and MTC are probably equally efficacious antiemetic treatments in patients undergoing i.v. CMF chemotherapy, but due to the risk of extrapyramidal reactions with MTC, MP probably should be the treatment of choice in these patients.
Age Factors↗
Antiemetic activity of high doses of metoclopramide combined with methylprednisolone versus metoclopramide alone in cisplatin-treated cancer patients: a randomized double-blind trial of the Italian Oncology Group for Clinical Research.
We designed a multicenter, double-blind randomized study to determine the safety and antiemetic effectiveness of intravenous (IV) methylprednisolone (P) combined with high-dose IV metoclopramide (MTC) v MTC alone in 200 untreated cancer patients receiving cisplatin chemotherapy. One hundred eighty-five patients were evaluable for treatment efficacy. MTC plus P was significantly superior to MTC alone in reducing the number and length of vomiting episodes (P = .001 and P = .0008, respectively) and the maximal intensity of nausea (P = .0124 with a score system; P = .0155 with a linear analogue scale) and length of nausea (P = .0056). The subgroup with a major incidence of nausea and vomiting was women, especially young women, outpatients, and those treated with higher doses of cisplatin. Side effects were low and equally distributed between the two treatment groups. We conclude that MTC plus P has greater antiemetic activity than MTC alone in patients receiving cisplatin chemotherapy.
Adult↗
A phase II antiemetic combination (COMD) for cisplatin-induced nausea and vomiting.
Thirteen patients resistant to high-dose metoclopramide (greater than or equal to 5 emetic episodes in 24 h following chemotherapy) were treated in the subsequent course of CDDP chemotherapy with COMD (chlorpromazine, orphenadrine, metoclopramide, dexamethasone). A statistically significant reduction in the number of vomiting episodes was obtained, and 69% of patients showed a better acceptance of CDDP treatment. Subsequently, the same antiemetic combination was administered to 31 untreated patients receiving CDDP alone for the first time: 67.7% obtained complete protection from vomiting with minimal toxicity. According to our experience, COMD is an efficacious and well-tolerated antiemetic combination in cisplatin-treated patients; however, further studies with larger numbers of patients are required to confirm these preliminary results.
Adult↗
Antiemetic effect of high-dose metoclopramide.
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Antineoplastic Agents↗
Evaluation of the antiemetic activity of bromopride in cancer patients treated with i.v. CMF.
In more than 70% of patients undergoing surgery for breast cancer with histologically positive lymph nodes, precautional therapy with CMF (cyclophosphamide, methotrexate, 5-fluorouracil) causes nausea and vomiting. At the present time, the optimal antiemetic therapy has not been found. From May 1983 to March 1984, 35 patients, of whom 34 were evaluable, were entered in a randomized double blind antiemetic treatment with either bromopride (16 patients), a procainamide derivative structurally similar to metoclopramide, or placebo (18 patients). Bromopride (20 mg) and the placebo were administered in a 3-min i.v. injection half an hour before chemotherapy and at 3 1/2 and 7 1/2 following chemotherapy. A complete antiemetic protection was obtained in 9 patients (56.3%) treated with bromopride compared to 5 patients (27.8%) treated with the placebo. A major antiemetic (less than or equal to 2 vomiting episodes) was obtained in 3 patients (18.7%) treated with bromopride compared to 5 patients (27.8%) treated with the placebo. Statistical analysis showed a trend in favor of bromopride (P = 0.058). The most frequent side effect was sedation reported in 6 patients (37.5%) treated with bromopride and 2 patients (11.1%) treated with the placebo (P = 0.06). The study was interrupted when several patients presented vomiting episodes more than 12 h after CMF administration, and thus beyond the foreseeable protective effect of the antiemetic treatment. It is our opinion that the search for an optimal antiemetic regimen in the course of i.v. CMF therapy should consider the administration of antiemetic drugs at least until 12 h after chemotherapy.
Adult↗
A pilot study of high-dose domperidone as an antiemetic in patients treated with cisplatin.
A dose-finding multicenter study was undertaken to evaluate the antiemetic efficacy of domperidone, an antidopaminergic drug, which has been proposed as a suitable alternative to high-dose metoclopramide in the control of cisplatin-induced nausea and vomiting. Forty-five patients were treated with different increasing high doses of domperidone (30, 60, 120 or 150 mg) administered by i.v. infusion over 20 min every 2 hr for a total of four doses for each patient, starting 30 min before chemotherapy. The number of episodes of emesis, the duration of nausea and vomiting and side-effects were recorded. Results do not suggest any specific difference in protective effect between the regimens tested. Moreover, occurrence of serious side-effects indicated that the safety of high-dose domperidone is doubtful.
Adolescent↗
Antiemetic activity of two different high doses of metoclopramide in cisplatin-treated cancer patients: a randomized double-blind trial of the Italian Oncology Group for Clinical Research.
High-dose metoclopramide has been proposed as an effective antiemetic agent in patients treated with cisplatin. Its optimal dosage schedule, however, has not yet been completely defined. We report the results of a multicenter, double-blind, randomized clinical trial where the efficacy and safety of two fixed high-dose regimens of metoclopramide (60 and 120 mg, respectively) have been tested in 112 patients receiving cisplatin treatment. No statistically significant difference has been found between the two groups. In patients treated with cisplatin at doses greater than 100 mg/m2, the higher dose regimen seems more efficacious, but this result should be confirmed in a larger group of patients. Treatment was generally well-tolerated. However, a consistent percentage of patients (about 60%) still present with vomiting, and this makes further investigation necessary.
Adult↗
Empiric antimicrobial therapy in febrile granulocytopenic patients. Randomized prospective comparison of amikacin plus piperacillin with or without parenteral trimethoprim/sulphamethoxazole.
In a prospective randomized trial parenteral trimethoprim/sulphamethoxazole was added to amikacin plus piperacillin in order to compare triple-drug antibiotic combination with a standard regimen as empiric therapy of fever in patients with granulocytopenia. One hundred and sixty-one episodes were evaluated; 74 episodes with amikacin plus piperacillin and 87 episodes with amikacin plus piperacillin plus trimethoprim/sulphamethoxazole. The overall response to therapy (63% vs. 84%) as well as the response of microbiologically documented infections (60% vs. 82%) was significantly better in patients treated with the triple-drug combination (p less than 0.05). However, no statistically significant differences in response to antibiotics at different infection sites or with regard to any single pathogen was found between the two groups. Trimethoprim/sulphamethoxazole seemed to be responsible for additional toxicity (nausea and vomiting) when added to amikacin plus piperacillin, but these side-effects were clearly related to the rate of infusion of trimethoprim/sulphamethoxazole. The findings of this study support the use of a three-drug versus a two-drug combination as empiric antibiotic regimen in febrile granulocytopenic patients.
Adolescent↗
Prevention of chemotherapy-induced emesis: the state of the art.
In the last decade research on antiemetic therapy has determined relevant advances in the prevention of chemotherapy-induced emesis. In fact, 70-80% of patients submitted to highly or moderately emetogenic drugs achieve complete protection against vomiting during the first cycle of chemotherapy. In the prevention of acute emesis induced by a high single dose (> or 50 mg/m2) or a low dose (20-40 mg/m2) of cisplatin repeated for 4-5 days, a combination of ondansetron plus dexamethasone was shown to be more efficacious and less toxic than the combination of high dose metoclopramide plus dexamethasone plus diphenhydramine. Few studies have been performed for the prevention of delayed emesis induced by cisplatin. At present, the combination of oral dexamethasone plus metoclopramide seems to offer the best protection and should be considered the treatment of choice. For the prevention of acute emesis induced by moderately emetogenic drugs, corticosteroids (dexamethasone and methylprednisolone) and the new 5-HT3 receptor antagonists have a similar efficacy and a low toxicity. On a cost basis, corticosteroids must be considered the drug of choice while 5-HT3 receptor antagonists should be used only in patients refractory to corticosteroids or in those who cannot tolerate them.
Antiemetics↗
Ondansetron plus dexamethasone compared to the 'standard' metoclopramide combination.
This paper describes a multicentre, double-blind, parallel group study which compared ondansetron (0.15 mg/kg i.v. x 3) plus dexamethasone (20 mg i.v.) with metoclopramide (3 mg/kg i.v. x 2) plus dexamethasone (20 mg i.v.) and diphenhydramine (50 mg i.v.) for the prevention of cisplatin-induced emesis and nausea. Two hundred and eighty-nine consecutive patients receiving chemotherapy containing cisplatin at doses > or = 50 mg/m2 entered the study and 267 patients were evaluable for efficacy. The ondansetron regimen was significantly superior compared with the metoclopramide regimen in the control of acute emesis and nausea. Ondansetron plus dexamethasone provided complete protection against retching and vomiting in 79% of patients compared with 59% of patients given the metoclopramide combination (p < 0.002). Similarly ondansetron plus dexamethasone completely prevented nausea in 77% of patients, whereas the metoclopramide combination protected 66% of patients (p < 0.051). Success (no nausea and no emesis) was afforded to 69% of those patients given ondansetron plus dexamethasone as opposed to 50% of patients given the metoclopramide combination (p < 0.003). From day 2-4 all patients received the same anti-emetic regimen of oral metoclopramide and intramuscular dexamethasone. Significantly fewer patients who had received the ondansetron regimen on day 1 vomited on days 2 and 3 compared with those who had received the triple drug combination (84-86 and 68-71%, respectively, p < 0.006). Nausea was also better controlled in this group on day 2. On subsequent cisplatin cycles, the incidence of acute vomiting rose to 53% in those patients given the metoclopramide regimen, but remained low (26%) in the group treated with ondansetron plus dexamethasone. Patients receiving the metoclopramide regimen had significantly more sedation than patients receiving ondansetron plus dexamethasone (12 vs. 2%; p < 0.005). Extrapyramidal reactions were only observed in metoclopramide-treated patients (3%). The results of this study suggest that ondansetron plus dexamethasone is a more effective and better tolerated anti-emetic regimen compared with metoclopramide plus dexamethasone and diphenhydramine for the prevention of acute cisplatin-induced emesis.
Cisplatin↗
Prevention of radiotherapy-induced emesis.
The severity of nausea and vomiting in patients undergoing radiotherapy is lower than that associated with chemotherapy regimens, but its duration may be considerably longer. Total body irradiation and irradiation of the upper part of the abdomen or whole abdomen are considered the most emetogenic regimens in radiotherapy. Instead, the emetogenic potential is considered moderate in radiotherapy of the thorax, pelvis and lower half-body irradiation, and low in radiotherapy of head and neck, extremities, brain and skin. In contrast to the very extensive literature on the prevention of chemotherapy-induced emesis, relatively few studies have been published on patients submitted to radiotherapy. Metoclopramide, prochlorperazine and cannabinoids offer only limited symptom control in patients undergoing radiotherapy of moderate to severe emetogenic potential. Double-blind randomized studies showed the superior antiemetic efficacy of the 5-HT3 antagonists with respect to placebo and to the older antiemetic drugs in patients submitted to single dose or fractionated doses of radiotherapy to the upper abdomen, to lower hemibody radiotherapy and to total body irradiation. In all these cases the 5-HT3 antagonists should be considered the antiemetic treatment of choice and should be administered as prophylactic agents. The optimal duration of antiemetic therapy with the 5-HT3 antagonists is unknown. Whether corticosteroids added to the 5-HT3 antagonists will increase their antiemetic efficacy, as in chemotherapy-treated patients, remains to be demonstrated in double-blind controlled trials. Patients submitted to radiotherapy of low emetogenic risk do not require any antiemetic prophylaxis. In this case a rescue antiemetic treatment can be administered if patients present vomiting or moderate to severe nausea.
Antiemetics↗
[Outcome research: rationales and objectives].
Outcome research measures the clinical, economic and humanistic outcomes of pharmacological therapies on patients suffering from different diseases. Outcome research can be applied either to phase II and III clinical trials to assess new drugs for registration or to already marketed drugs to assess their real value when used in clinical practice in a large population of patients. Oncology can be a major field of application because there is a large amount of new treatments put on the market, often without demonstration of significant improvement in survival or Quality of Life but with higher prices than the old molecules. Patients and disease specific outcomes have been identified for cancer by a Working Group set up by the American Society of Clinical Oncology, with the former being defined as more critical to establish the value of new treatments. Survival, drug toxicity and impact on Quality of Life are the most important patient's outcomes to consider before recommending anti-cancer therapies for use in clinical practice. The present paper will describe the outcomes in oncology and will deal with the transferability to clinical practice of the results of clinical trials.
Clinical Trials as Topic↗