PubMed Health⌕ Search

Biomedical subjects

C Basurto

Publications and source records attributed to C Basurto.

27 records · Page 2Linked to original sources

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↗

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↗

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↗

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↗

Results of a prospective study with high-dose etoposide, thiotepa and carboplatin and peripheral blood stem cell rescue for high-risk stage II-IIIA and selected stage IV breast cancer patients.

AIMS AND BACKGROUND: To investigate the safety and efficacy of a high-dose chemotherapy regimen with etoposide, carboplatin and thiotepa in high-risk stage II-IIIA breast cancer and in responsive metastatic patients. STUDY DESIGN: From April 1992 to December 1998, 24 patients with high-risk stage II-IIIA breast cancer (> or = 9 positive nodes) and 9 responsive metastatic patients were enrolled in the trial. After induction chemotherapy with an anthracycline-based regimen, peripheral blood stem cells were mobilized with cyclophosphamide (7 g/m2) and G-CSF (5-16 microg/kg/s.c./day). The high-dose chemotherapy regimen consisted of etoposide (1000 mg/m2), carboplatin (800 mg/m2) and thiotepa (500 mg/m2). At the end of the high-dose chemotherapy, all stage II-IIIA patients received radiotherapy to the breast or chest wall and draining nodes; stage IV patients were irradiated to sites of disease, if feasible. All ER+ and/or PgR+ patients were treated with hormone therapy. RESULTS: For stage II-IIIA high-risk patients, the median follow-up was 4.36 years (range, 1.93-6.94), and the Kaplan-Meier estimate at 5 years of disease-free survival and overall survival was 54.8 +/- 11% SE and 76.73 +/- 9.4% SE, respectively. For metastatic patients, the median follow-up was 4.93 years (range, 4.15-7.95), and the Kaplan-Meier estimate at 5 years of progression-free survival and overall survival was 22.2 +/- 13.9% SE and 76.2 +/- 14.8% SE, respectively. No treatment-related deaths were observed. CONCLUSIONS: Our results are comparable to those obtained in other high-dose chemotherapy trials but do not seem to be superior to conventional-dose therapy given to similar patients.

Adult↗