Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0042963 (vomiting)
31,883 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Fifteen patients with advanced carcinoma of the breast who had failed prior chemotherapy, were treated with recombinant gamma interferon at a dose of 2mg/m2 (1mg = 2.4 X 10(7) international units) intravenously for five consecutive days every other week. The median patient age was 51 and all patients had a performance status of 0-2 (Karnofsky greater than or equal to 50). Thirteen patients had two or three sites of metastatic disease and seven were estrogen receptor positive. No complete or partial responses were noted. Although some patients had brief periods of stable disease, almost all patients progressed after one or two courses. Only one patient was able to receive six courses of induction therapy and a brief course of maintenance. Flu-like symptoms and nausea were seen in all patients; vomiting and anorexia were frequent. Hepatic toxicity manifested by enzyme elevation was common and was most severe in patients with liver metastases. In this study a highly purified biologically active gamma interferon was not associated with anti-tumor activity in previously treated women with metastatic breast cancer.
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PMID:Recombinant gamma interferon in advanced breast cancer: a phase II trial. 310 90

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.
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PMID:Combination chemotherapy with 5-fluorouracil, oral Idarubicin, and cyclophosphamide (FIC) in metastatic breast cancer--an open phase II study. 316 12

The National Cancer Institute of Canada (NCIC) Clinical Trials Group conducted a phase II study of the oral antiandrogen flutamide in 33 patients with metastatic breast cancer. Eight patients had received no prior systemic therapy for their metastatic disease and 13 had only one site of metastasis. Toxicity occurred in 18 of the 33 patients and was primarily gastrointestinal. It ranged in severity from mild to severe with 4 patients discontinuing treatment early because of nausea, vomiting, diarrhea or stomatitis. One response, of 8 weeks duration, was noted in 29 evaluable patients. We conclude that flutamide does not have meaningful antitumour activity in breast cancer and plan no further trials of the drug in this disease.
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PMID:Phase II study of flutamide in patients with metastatic breast cancer. A National Cancer Institute of Canada Clinical Trials Group study. 319 86

Nine patients with metastatic breast cancer received 30 x 10(6) I.U. of Interferon - Betaser (Betaseron) intravenously daily times five for two consecutive weeks followed by a two week rest period. Only one patient received more than one such cycle of Betaseron. The drug was well tolerated in eight of these patients. One patient, with liver metastases and liver dysfunction, developed hepatic decompensation during therapy. Toxicity consisted of anorexia, chills, fever, fatigue and nausea with an occasional patient having emesis. One patient developed severe thrombocytopenia, two, significant leukopenia and nine, mild elevations of serum transaminase. Two patients developed beta interferon binding antibodies but none developed neutralizing antibodies. No anti-tumor responses were seen and disease progression occurred rapidly during the four week cycle in eight of nine patients.
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PMID:Phase II trial of recombinant beta (IFN-betaser) interferon in the treatment of metastatic breast cancer. 319 87

Between March 1984 and May 1985, 29 patients with metastatic breast cancer and high-risk prognostic factors were treated with vincristine, 1.4 mg/m2 IV on day 1, Adriamycin, 40 mg/m2 IV on day 1, and prednimustine, 100 mg/m2 PO on days 3 to 7. Courses were repeated every 3 weeks. At the present time, 26 patients are evaluable for tumor response; 29 are evaluable for toxicity. Fourteen of 26 patients (53.8%) achieved a partial response lasting 2 to 9 months (median 5.5+). A complete response was not recorded. Ten of 26 patients (38.5%) had stable disease; two patients (7.7%) showed a primary tumor progression. Most common side effects were nausea, vomiting, and alopecia, all generally mild to moderate. Fourteen of 29 patients developed leukocytopenia, mainly of WHO grade 1; thrombocytopenia was registered in one patient only and a fall of hemoglobin in three patients only. In 15 patients, no hematologic toxicity occurred. These preliminary data suggest good antitumor activity and acceptable toxicity for vincristine-Adriamycin-prednimustine in patients with metastatic breast cancer.
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PMID:A preliminary analysis of combination therapy with vincristine, adriamycin, and prednimustine (VAP) in advanced breast cancer: a phase II study. 375 64

Mitoxantrone (Novantrone; dihydroxyanthracenedione) is an anthraquinone previously shown to be active in human breast cancer. It appears to have less toxicity than doxorubicin. Results of this phase II-III randomized cross-over trial to determine the relative efficacy and toxicity of mitoxantrone in comparison to doxorubicin, are presented. Patients with measurable, recurrent breast cancer with limited prior chemotherapy with or without radiotherapy for metastatic disease, and who had not been exposed to prior doxorubicin, were randomized to receive either mitoxantrone or doxorubicin every three weeks with cross-over on progression. Response rates, duration of remission, time to treatment failure, and drug toxicity, including cardiac toxicity evaluated with serial radionuclide angiocardiography, were evaluated. Differences in the response rates for the two groups were not statistically significant. Neither time to treatment failure nor duration of response are significantly different (p greater than 0.05). With respect to toxicity, mitoxantrone treated patients consistently exhibited a lower incidence and less severe drug toxicity as compared to their doxorubicin-treated counterparts. Cardiac toxicity was carefully monitored and thus four patients on doxorubicin have had drug related congestive heart failure, as compared to none on mitoxantrone. In summary, mitoxantrone appears to be as active as doxorubicin in patients with stage IV breast cancer previously treated with chemotherapy; however, mitoxantrone causes significantly less nausea, vomiting, stomatitis and alopecia at doses which induce equal or greater myelosuppression than doxorubicin, and appears to be less cardiotoxic.
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PMID:A randomized trial comparing mitoxantrone with doxorubicin in patients with stage IV breast cancer. 389 78

Leuprolide (Lupron, TAP Pharmaceuticals, North Chicago), a gonadotropin-releasing hormone analogue, was administered to 26 premenopausal women with metastatic breast cancer. Of 25 evaluable patients, 11 (44%) had a partial response with a median duration of 39 weeks and five (20%) remained stable. Six patients showed early rapid progression of their disease. Toxicity was mild and included hot flashes, nausea, vomiting, and headache. Leuprolide induced amenorrhea in all patients who received treatment for ten weeks or longer. We conclude that this GnRH analogue provides a safe and effective means of producing medical castration in premenopausal patients with metastatic breast carcinoma.
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PMID:Medical castration produced by the GnRH analogue leuprolide to treat metastatic breast cancer. 392 58

The new anthracendione mitoxantrone, an anthraquinone derivate with structural similarities to doxorubicin (adriamycin) is active in the treatment of patients with metastatic breast cancer. It has less acute toxicity than doxorubicin, may be non cross resistant with doxorubicin and appears to have less cardiotoxicity. Phase-II-studies have confirmed antitumor activity ranging from 6 to 36%, mitoxantrone combined with conventional drugs produced response rates between 25 and 90%. 32 heavily pretreated patients--nearly 70% had visceral metastasis--were assigned to treatment with vindesine 3 mg/m2 i.v. and mitoxantrone 10 to 12 mg/m2 by i.v. infusion. Treatment cycles initially were repeated every 3 weeks. 25/32 patients are available for response. There were 1 complete remission (4%), 3 partial remissions (12%), 2 minor responses (8%) (remissions + minor responses = 24%), 7 no change (28%) and 12 failures (48%). Response durations were 11, 8, +5, +6 months. The acute toxicity was mild, nausea or vomiting grade greater than or equal to 2 were found only in 4/32 patients (12%), the rate of alopecia grade greater than or equal to 2 was 28% (only 2 patients [6%] required a wig). Myelosuppression on the other hand was moderate. Nearly two thirds of patients developed leucopenia less than 2,0 X 10(9)/I, in 22% of patients platelet nadir less than 100,0 X 10(9)/I was registered. In conclusion these preliminary results suggest an improvement in therapeutic index with this treatment regimen.
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PMID:[Mitoxantrone in a combination regimen in advanced breast cancer]. 409 6

Patients with visceral patterns of metastatic breast cancer were stratified according to dominant metastatic site and performance status and then randomized to therapy with cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) or CAF alternating with a "cell-cycle active" regimen including cytosine arabinoside, methotrexate with leucovorin rescue, and oncovin ( CAMELEON ). One hundred eighty-seven patients were randomized; response rate for CAF was 44% and for CAF + CAMELEON , 40%. Durations of disease control and survival were not significantly different. Toxicity of CAF was as anticipated with predominant granulocytopenia, vomiting, and alopecia. Toxicity of CAMELEON was less severe than that of CAF, and CAF toxicity was not worsened by preceding courses of CAMELEON ; however, the CAF- CAMELEON regimen was cumbersome and complex leading to both physician and patient noncompliance. Contrary to the preliminary results of a pilot study, and preliminary reports of the present trial suggesting benefit for the CAF- CAMELEON regimen the present randomized trial does not confirm any significant benefit of CAF- CAMELEON over CAF alone in patients with visceral metastatic breast cancer although this conclusion must be viewed in light of the high inevaluability rate due to patient and physician noncompliance.
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PMID:Randomized trial of cyclophosphamide, doxorubicin, and 5-fluorouracil alone or alternating with a "cycle active" non-cross-resistant combination in women with visceral metastatic breast cancer: a Southeastern Cancer Study Group project. 637 57

A randomized trial began in 1980 comparing the efficacy and toxicity of mitoxantrone and doxorubicin. Patients with metastatic breast cancer unresponsive to cyclophosphamide-methotrexate-5-fluorouracil with or without tamoxifen were randomized to either mitoxantrone, 12 mg/m2, or doxorubicin, 60 mg/m2, every 3 weeks. Patients were crossed over to the alternative treatment if they progressed after two courses or fail to respond after four courses. Fifty-nine patients have been randomized at the present time, and most of these have a performance status near to normal. During initial therapy, partial responses were obtained in 10 of 25 patients receiving doxorubicin, and a further 12 showed stable disease; 3 showed progressive disease. Of the 26 patients who received mitoxantrone as initial therapy, 7 achieved a partial response, 14 had stable disease, and 5 progressive disease. Twenty-seven patients received doxorubicin or mitoxantrone as secondary therapy; two patients each responded to these drugs, suggesting a lack of cross-resistance. The median time to response was 48 days for doxorubicin and 57 days for mitoxantrone. The duration of partial responses measured from the onset of response was similar for both drugs, being 84 days for doxorubicin and 96 days for mitoxantrone. Hematologic toxicity, vomiting, alopecia, and fatigue tended to be less frequent and less severe with mitoxantrone than with doxorubicin. Mitoxantrone appears to be an effective and well-tolerated agent for breast cancer. Definitive comparisons will be available at the completion of this study.
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PMID:A comparative trial of mitoxantrone and doxorubicin in patients with minimally pretreated breast cancer. 638 59


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