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Query: UMLS:C0027497 (
nausea
)
23,468
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
Due to the favourable results previously obtained with cisplatin in breast cancer (54% response rate), we studied a second-generation platinum analogue, carboplatin, in patients with previously untreated breast cancer. A total of 20 patients were entered in the study and all were evaluable. The median age was 57 years and all patients were in menopause. Karnofsky scores of 80-100 and 40-70 were registered in 14 and 6 cases, respectively. The predominant metastatic site was soft tissue in 12 subjects, visceral organs in 5 and bone in 3; 14 patients had greater than 2 metastatic sites. Carboplatin was given i.v. at a dose of 400 mg/m2 on day 1, with a 3-week rest period. In 13 patients who did not respond or whose disease recurred after carboplatin treatment, the CMFVP, CAP or
FAC
regimen was given as second line treatment. Carboplatin activity was observed in 4 patients [2 complete remissions (CRs) and 2 partial responses (PRs)], for a response rate of 20% (4/20); the 2 PRs were observed in soft tissue and bone and the 2 CRs, in lung, liver and bone. Remission lasted 2-10 months (mean, 4 months). CMFVP given as second-line chemotherapy to 13 patients produced 7 PRs (7/13, 54%). Toxicity was moderate, producing no drug-related deaths. Anemia (grade I-II) was recorded in seven patients; grade I-II leukopenia, in six; and grade III-IV leukopenia in two (median leukocyte nadir, 1,600/mm3). Thrombocytopenia was observed in three cases (grades I, II and III; median platelet nadir, 47,800/mm3). Unpleasant
nausea
/vomiting was pronounced (12 cases of grade III-IV) in 19 subjects. There were no cases of neuro- or nephrotoxicity. Due to permanent myelosuppression, no more than five cycles could be given. Our study showed that, unlike cisplatin, carboplatin given at a dose of 400 mg/m2 has low antitumorigenic activity in breast cancer patients and produces pronounced myelotoxicity. Additional first-line chemotherapy studies using carboplatin are needed to define the antitumorigenic activity of this platinum analogue.
...
PMID:Carboplatin activity in untreated metastatic breast cancer patients--results of a phase II study. 199 4
Forty-six women with breast cancer treated with adjuvant
FAC
(fluorouracil, doxorubicin and cyclophosphamide) entered a multicenter, randomized, double-blind, cross-over trial in which thiethylperazine (T) (6.5 mg p.o every 8 h x 3 days) plus methylprednisolone (MP) (250 mg i.v. x 2 doses) was compared with thiethylperazine plus placebo. Forty-four patients were evaluable for efficacy. T + MP was significantly better in reducing vomiting (p less than 0.01) and
nausea
(p less than 0.02). The complete protection rate against vomiting was 36% for T + MP compared to 18% for T + placebo, and the percentage of
nausea
grades 0 + 1 (none or slight) was 59% and 27% respectively. The patient preference after cross-over was strikingly in favor of T + MP (70% versus 13%) (p less than 0.001). The most important side-effects of T + MP were facial flushing (22%) and euphoria (27%). Other side-effects, such as dryness of the mouth and sedation, were common after both treatments. In conclusion, the study suggested that T + MP is superior to T alone in protecting from nausea and vomiting induced by
FAC
.
...
PMID:The antiemetic efficacy of thiethylperazine and methylprednisolone versus thiethylperazine and placebo in breast cancer patients treated with adjuvant chemotherapy (fluorouracil, doxorubicin and cyclophosphamide). A randomized, double-blind, cross-over trial. 203 44
From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or
FAC
). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the
FAC
arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for
FAC
. The median time to progression was 273 days for FEC and 314 days for
FAC
; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia,
nausea
, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with
FAC
while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.
...
PMID:Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. 289 33
Phase II studies of p.o. Idarubicin administration, a new daunorubicin analogue (4-demethoxy-daunorubicin), have shown antitumor activity in 23%-31% of previously treated metastatic breast cancer patients, while in untreated patients a response rate of 41% was observed. Our Phase II study has shown an overall response of 23% [1 complete response (CR), 9 partial response (PR), 10/43] with a daily dose of 15 mg/m2 p.o. on days 1,2,3. On the basis of these results we have recently included Idarubicin in combination chemotherapy of breast cancer, substituting Adriamycin by Idarubicin in an
FAC
schedule. Of 50 consecutive metastatic breast cancer patients who entered the study, 42 patients who received greater than 2 cycles were evaluable. There were 22 premenopausal and 20 postmenopausal patients (mean = 51 years). In 25 patients a performance status of 0-2 (ECOG) was registered and in 17 patients it was 3. Previous radiation had been administered in 34, hormonal therapy in 18, and adjuvant chemotherapy (CMF 5, CMFVP 3) in 8 patients; 22 patients had predominant metastatic sites in soft tissues, 18 in visceral organs, and 2 in the bones. The FIC schedule was administered as follows: 5-fluorouracil 500 mg/m2 i.v. days 1 and 8, Idarubicin 15 mg/m2 p.o. days 1, 2 and 3, and cyclophosphamide 500 mg/m2 i.v. day 1. An objective response was observed in 23 (5 CR, 18 PR) out of 42 patients (53%, CR 12%). Soft tissue metastases responded in 55% (12/22), visceral organs in 61% (11/18), and no response was observed in bone lesions (0/2). The median remission duration was 8 months (3-16+). Toxicity was mild, expressed mainly in the form of
nausea
/vomiting, grade I and II in 64% of the patients. Alopecia was very mild (grade I and II in 23% of the patients). Leukopenia grade I-II was observed in 21% of the patients. In 4 patients reversible ECG changes occurred. Left ventricular ejection fraction did not show any pathological changes. The Idarubicin-containing combination chemotherapy we have used has the following characteristics: easier administration (p.o. anthracycline, no risk of tissue extravasation), lower toxicity (cardiotoxicity, alopecia, and myelosuppression in particular), and a notable antitumor activity.
...
PMID:Combination chemotherapy with 5-fluorouracil, oral Idarubicin, and cyclophosphamide (FIC) in metastatic breast cancer--an open phase II study. 316 12
239 patients were evaluable: 116 in the
FAC
arm, 123 in the FEC arm. There is no significant difference in the therapeutic responses between 2 regimens: 52 +/- 9% vs 49 +/- 9%. Duration of responses (273 vs 303 d) and overall survival were also similar. FEC appears less myelotoxic, less toxic also in terms
nausea
, vomiting and grade 3 alopecia than the adriamycin combination. 9 patients required treatment cessation due to grade 2 cardiac dysfunction with 3 CHF, against no case in the epirubicin regimen.
...
PMID:[French FAC vs FEC study in advanced breast cancer]. 352 69
Tumoricidal responses and tumor regressions have been observed after plasma perfusion over Staphylococcus aureus Cowan I (SAC), or purified protein A immobilized on solid supports. This system was initially studied in a single human patient and then extended to dogs with spontaneous mammary carcinoma, an excellent model of human breast cancer. In the single patient and dogs with mammary tumors, perfusion of plasma over protein A bearing staphylococcus resulted in tumor necrosis and tumor regression. Tumor reduction or growth retardation with similar perfusion systems has been noted in various feline and rodent tumor models. Tumoricidal responses were also observed in canine tumors after perfusion over commercial protein A which was immobilized in a collodion charcoal matrix (PACC). These responses were amplified when a subtherapeutic and nontoxic dose of cytarabine was given after perfusion. Similar tumor reduction in murine and feline tumor models has been noted after perfusion of autologous serum over protein A immobilized on various other solid supports. The PACC perfusion system was extended to five consecutive patients with advanced breast adenocarcinoma. Four of five patients showed tumor regression after perfusion of small volumes of autologous or homologous plasma over PACC. Patients also experienced pyrexia,
nausea
, vomiting, and significant cardiopulmonary toxicity. Detailed hemodynamic studies of these effects showed that the major pathophysiology involved a decline in total peripheral resistance associated with an increase in cardiac output. With reduction of immobilized protein A quantity and diminution in plasma perfusion rate, the cardiopulmonary toxicity associated with treatments was diminished. Chemotherapy given as
FAC
to a single patient shortly after concluding perfusion therapy resulted in rapid regression of residual large tumor masses. Studies focusing on the mechanism of the tumoricidal responses have examined changes in sera after incubation or perfusion over immobilized SAC or PACC. Major findings include (1) the identification of protein A leaching from PACC and SAC after serum perfusion and appearing in the effluent as Clq binding oligomers composed predominantly of IgG and protein A but also containing IgA, IgM and C3 with a molecular weight range of 600,000 to 2,000,000; (2) the identification of C3a anaphylatoxins in serum perfused over PACC or SAC; (3) the recognition that several enterotoxins, in particular enterotoxin B are present in commercial protein A preparation.(ABSTRACT TRUNCATED AT 400 WORDS)
...
PMID:Protein A and staphylococcal products in neoplastic disease. 390 35
Since November 1981, 90 cancer patients treated with cytotoxic chemotherapy (CMF,
FAC
, FAM) have been studied to evaluate whether the administration of Synchrodyn 1-17, 100 micrograms i.m. a day for 15 consecutive days, could reduce some side effects caused by the cytotoxic drugs.
Nausea
, vomiting and weakness which are the most frequent side effects generally found to be very upsetting to patients, were less pronounced in the treated patients than in patients treated with a placebo. The performance status was not modified by the treatment. Skin pigmentation was noted in the majority of cases and it appeared to be related to the sustained treatment with high dosages of the peptide. Some side effects were observed in the treated patients such as sodium retention and hypertension, hyperglycemia. Successively we have begun to study the circadian rhythm of the cortisol, which often changes during the advanced stages of the illness and which chemotherapy does not seem to alter.
...
PMID:ACTH 1-17 effects in oncology. 609 Dec 45
In a pilot study a combination of metoclopramide and dexamethasone was administered to 29 patients receiving emetogenic chemotherapy. Metoclopramide was given intravenously (IV) at a dose of 0.5 mg/kg one-half hour before the start of chemotherapy, and then given at the same dose orally two, five, and eight hours after chemotherapy. Dexamethasone was given at a dose of 10 mg IV immediately following the first dose of metoclopramide, then given at a dose of 8 mg orally six, 12, and 18 hours after chemotherapy. The chemotherapy regimens most commonly used were standard
FAC
, FAM, and BACOD regimens. Twenty-six of 29 patients received outpatient treatment. Complete protection against both nausea and vomiting was seen in 69% (20/29) patients; six others (21%) experienced mild
nausea
but no vomiting, resulting in 90% (26/29) of the patients having total emetic protection with combination metoclopramide and dexamethasone. Eighty-eight percent (15/17) of the patients with no prior chemotherapy had no
nausea
or vomiting, one (6%) had only mild
nausea
, and the remaining patient (6%) had one emesis. Forty-two percent (5/12) of the patients with prior chemotherapy had complete antinausea and emetic protection, five (42%) had
nausea
without vomiting, and the remaining two patients experienced one or two emesis. Side effects were minimal when present and included mild drowsiness (five patients), akathisia (three patients), diarrhea (one patient), and hot flashes (one patient). Combination metoclopramide and dexamethasone therapy can effectively prevent emesis in 94% of patients receiving potentially emetogenic chemotherapy and can prevent
nausea
and emesis in 88% of untreated patients. Studies defining the optimal dose and scheduling needed to maintain such antinausea and antiemetic protection are necessary.
...
PMID:Combination metoclopramide and dexamethasone: an effective antiemetic regimen in outpatients receiving non-cisplatin chemotherapy. 647 Jul 55
The antiemetic efficacy of ondansetron and dexamethasone (Ondex) was randomly compared to that of high-dose metoclopramide, dexamethasone, and orphenadrine (Control) in the prevention of emesis induced by cyclophosphamide-doxorubicin chemotherapy in 64 chemotherapy-naive breast cancer patients. For the control of acute emesis (day 1), patients were randomized to receive either ondasetron 8 mg p.o. 1 hour prior to chemotherapy (CT) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v. 40 minutes prior to CT (Ondex) or dexamethasone 20 mg i.v. 40 minutes prior to CT, orphenadrine 40 mg i.m. 35 minutes prior to CT and metoclopramide 3 mg/kg i.v. 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o. every 3 hours for 4 times (Control). To control delayed emesis, patients on Ondex received ondansetron 8 mg PO t.i.d. days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o. q.i.d. and dexamethasone 8 mg i.m. b.i.d. days 2 and 3. Complete and major control of acute emesis was observed in 74%/94% and 44%/67% of patients treated with Ondex and Control, respectively (p < .01/p < .005). Acute
nausea
was absent in 38% and 34% of patients treated with Ondex and Control, respectively (p = NS). Complete and major control of delayed emesis (days 2-5) was observed in 65%/91% versus 44%/66% of patients in the Ondex and Control arms, respectively (p = NS/p < .01). In patients receiving 6 courses of FEC/
FAC
, control of acute emesis was significantly superior with Ondex at all treatment courses.
...
PMID:Ondansetron and dexamethasone versus standard combination antiemetic therapy. A randomized trial for the prevention of acute and delayed emesis induced by cyclophosphamide-doxorubicin chemotherapy and maintenance of antiemetic effect at subsequent courses. 797 74
The aim of our single-center, prospective, randomized, open study was to evaluate the antiemetic efficacy and tolerability of a regimen based on a single oral dose of ondansetron 8 mg in comparison with a metoclopramide-based regimen, for prevention of acute
FAC
(fluorouracil, doxorubicin and cyclophosphamide) chemotherapy-induced emesis. A total of 149 chemotherapy-naive, female outpatients, under 50 years of age and with no history of alcohol consumption, scheduled to receive their first cycle of
FAC
chemotherapy, were included. The patients received either oral ondansetron (8 mg) or metoclopramide (1.5 mg/kg, i.v.), both combined with dexamethasone (16 mg, i.v.) and alprazolam (0.5 mg t.i.d. orally). No antiemetic prophylaxis was given for delayed emesis. Complete control of acute vomiting was obtained in 69/74 (93%) of patients receiving ondansetron, and in 49/75 (65%) of those receiving metoclopramide (p=0.00003). Complete control of acute
nausea
was obtained in 58% of patients receiving ondansetron and in 36% of those receiving metoclopramide (p=0.007). Complete prevention of delayed vomiting/
nausea
was achieved in 73%/20% and 60%/16% of patients, respectively. Sedation was more frequent in the metoclopramide arm (p=0.04). As far as we know this is the first study that supports the efficacy of a regimen based on a single oral dose of ondansetron 8 mg in the prevention of acute
FAC
chemotherapy-induced emesis. The ondansetron regimen was highly effective in female patients and was superior to the metoclopramide based regimen.
...
PMID:High efficacy of a single oral dose of ondansetron 8 mg versus a metoclopramide regimen in the prevention of acute emesis induced by fluorouracil, doxorubicin and cyclophosphamide (FAC) chemotherapy for breast cancer. 1112 67
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