Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0038362 (stomatitis)
 8,852 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A Phase I trial of pirarubicin (4'-O-tetrahydropyranyl-doxorubicin) was undertaken to study its toxicity and to gain preliminary knowledge of its efficacy. The dose was escalated by increments of 10 from 30 to 70 mg/m2. Out of 20 patients, 19 were evaluable for toxicity and response to treatment. Hematologic toxicity was dose limiting and dose related. Other adverse effects included nausea and vomiting, hair loss, and stomatitis. No acute cardiotoxicity was encountered. In 2 patients with metastatic breast cancer who had not been pretreated with cytostatic agents, a partial remission was achieved lasting for 5 months. In 6 patients, tumor parameters did not change for a median of 3 months, and 11 patients suffered progressive disease.
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PMID:Phase I study of pirarubicin. 316 56

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

Fifty-nine evaluable patients under 65 years of age with measurable metastatic breast cancer and without prior chemotherapy were randomly assigned to treatment with fluorouracil, Adriamycin (Adria Laboratories, Columbus, OH), and cyclophosphamide (FAC) at standard or high doses (100% to 260% higher than standard FAC) following a dose escalation schedule. Patients randomized to the high-dose FAC received the first three cycles of therapy within a protected environment. Subsequent cycles for this group were administered at standard doses of FAC in an ambulatory setting, the same as for the control group. After reaching 450 mg/m2 of Adriamycin, patients in both groups continued treatment with cyclophosphamide, methotrexate, and fluorouracil until there was disease progression. Analysis of pretreatment patient characteristics showed an even distribution for most known pretreatment factors, although the control group had slightly (but nonsignificantly) more favorable prognostic characteristics. Fourteen patients (24%) achieved a complete remission (CR) and 32 (54%) achieved a partial remission (PR), for an overall major response rate of 78%. There were no differences in overall, CR, or PR rates between the high-dose FAC and control groups. The median response durations were 11 and 10 months for the protected environment and control groups, respectively, and the median survival was 20 months for both groups. Hematologic, gastrointestinal (GI), and infection-related complications were significantly more frequent and severe in the group treated with high-dose chemotherapy. Stomatitis, diarrhea, and skin toxicity were dose-limiting. However, there were no treatment-related deaths. High-dose induction combination chemotherapy with the agents used in this study failed to increase the response rate or survival duration, and resulted in a substantial increase in toxicity.
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PMID:Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study. 381 4

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

Forty-four patients with measurable metastatic breast cancer have been entered in a randomized study comparing mitoxantrone to doxorubicin as a component of front-line combination chemotherapy. Patients were stratified according to whether or not they had previously received adjuvant chemotherapy. Initial doses of cyclophosphamide and 5-fluorouracil were 500 mg/m2 for both regimens, with either mitoxantrone, 10 mg/m2, or doxorubicin, 50 mg/m2. All drugs were given on day 1 only, with treatments repeated every 3 weeks. Doses were adjusted according to blood count nadirs. Responses have been observed in both of the treatment groups, though it is too early to determine the relative efficacy of the two regimens. Toxicity was comparable on the two treatment regimens except that far less alopecia and stomatitis were associated with the mitoxantrone therapy. No congestive heart failure has been seen. The combination of cyclophosphamide-mitoxantrone-5-fluorouracil is reasonably well tolerated, with myelosuppression being dose limiting. In both treatment groups of this study, reliance on the leucocyte count, rather than the granulocyte count, as a basis for dose alteration or treatment delay would lead to excessive dose reductions, many fewer dose escalations, and much more treatment delay.
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PMID:A randomized comparison of cyclophosphamide-mitoxantrone-5-fluorouracil v cyclophosphamide-doxorubicin-5-fluorouracil in advanced breast cancer: preliminary observations. 638 61

Thirty-five patients with advanced metastatic breast cancer refractory to prior chemotherapy were treated with vindesine given at a fixed dose as a continuous 5-day infusion of 1.5 mg/day every 4 weeks. All patients were considered evaluable, and there were four patients with partial responses for more than 3 months (11%) and 13 patients with stable disease (37%). Two of the four responders had had disease progression on other vinca alkaloids. None of the responders had proven doxorubicin resistance. Side-effects included myelosuppression, neurotoxicity, nausea, stomatitis and fever, but these were seldom dose-limiting. The results--together with the results of other single-agent studies of vindesine summarized in the paper--indicate that the drug is an active agent in advanced breast cancer. However, the optimum way of administering vindesine and its inclusion in first-line therapy needs further study.
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PMID:Vindesine in the treatment of metastatic breast cancer. 654 81

Thirty-three patients with metastatic breast cancer who have failed prior combination chemotherapy including adriamycin, cyclophosphamide, 5-fluorouracil and methotrexate, were treated with AZQ given on a 5-day I.V. schedule repeated every 4 weeks. The starting doses were 6 or 8 mg/m2/day for poor- and good-risk patients, respectively. There were two partial responses among 29 evaluable patients. Both had soft tissue and/or lymph node involvement. Six patients had stable disease. Myelosuppression, predominantly thrombocytopenia, was dose-limiting. Other toxicities were mild, including nausea, vomiting, anorexia, diarrhea, stomatitis, and malaise. Our results indicate that AZQ given on the 5-day schedule is unlikely to be effective in the treatment of refractory breast cancer.
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PMID:Phase II clinical evaluation of AZQ in metastatic breast cancer. 683 5

104 nonrandomized patients suffering from metastatic breast cancer were treated with monthly cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF). One group (group A, 44 patients) received low-dose CMF and another one (group B, 60 patients) received standard doses. In both cases, therapy was cycled every 29 days. Group A patients had a response rate of 50.7%, including 5 complete remissions. The median duration of response was 8.2 months. For group B patients, the response rate was of 68.1%, including 10 complete remissions. The median duration of response was 10.6 months. Toxicity was greater in group B patients, the main side effects being nausea, vomiting, leukopenia, thrombocytopenia, alopecia and stomatitis.
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PMID:Cyclic combination chemotherapy for metastatic breast cancer: comparison of two CMF schedules. 702 95

Sixty patients with metastatic breast cancer refractory to prior doxorubicin combinations were randomized by performance status, dominant disease site, and number of involved organ sites to receive vindesine either as a bolus injection of 3-4 mg/m2 iv every 10-14 days or as a continuous 5-day infusion of 1-1.2 mg/m2/day every 21 days. There were two patients with partial responses (7%) and six with stable disease among the 26 evaluable patients who received bolus injections. Of the 25 evaluable patients who received continuous infusions, seven achieved a partial response (28%) and 11 had stable disease (0.001 less than P less than 0.005). Thirteen patients, after failing to respond to bolus vindesine, were given continuous infusions. Of these, 11 were evaluable and four had partial response (36%). Responses were seen in all organ sites of involvement, with response duration ranging from 2 to 9+ months. Side effects included nausea, vomiting, stomatitis, constipation, neuropathy, fever, and myelosuppression. Except for myelosuppression, which was more evident with the continuous infusion schedule, no significant difference was seen in the frequency of side effects encountered with the two schedules. These results confirmed that there is an improved therapeutic index for vindesine when it is given as a continuous 5-day infusion.
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PMID:Vindesine in the treatment of refractory breast cancer: improvement in therapeutic index with continuous 5-day infusion. 727 12

The aim of this study was to determine if lonidamine (LND) supplementation to single-agent epirubicin (EPI) could reverse anthracycline resistance in patients with metastatic breast cancer. 45 patients with metastatic breast cancer were treated with EPI 120 mg/m2 by intravenous (i.v.) bolus every 3 weeks. Patients who progressed were given the same chemotherapy regimen on day 4 in combination with oral LND, 150 mg on day 1, 300 mg on day 2 and 450 mg on days 3-5. Among the 40 evaluable patients, 6 complete responses (CR) and 14 partial responses (PR) were achieved with EPI treatment alone for an overall response rate of 50%. The median duration of response was 6.5 months. Among the 25 patients treated with EPI+LND, 5 PR (21% of 24 evaluable patients) were observed with a median duration of response of 7 months. The median survival in patients receiving both treatments was 20 months. The survival for all patients was 18 months. The survival of patients receiving LND was not significantly longer than for the other patients. Myelotoxicity was the most common side-effect followed by alopecia, nausea and vomiting, and stomatitis. LND-related toxic effects were mild-to-moderate epigastralgia and myalgia. Anthracycline-related toxicity was the same in the two treatment groups. This study indicates that LND may circumvent clinical resistance to EPI without altering the pattern or severity of the toxicity of this anthracycline. Continued investigation of the clinical modulation of EPI resistance by LND in breast cancer is warranted, hopefully in patients with known multidrug resistance status.
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PMID:Intrapatient comparison of single-agent epirubicin with or without lonidamine in metastatic breast cancer. 748 10


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