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)

One-hundred-twenty patients with advanced lung cancer were treated by the MACC (methotrexate, doxorubicin (Adriamycin), cyclophosphamide and CCNU) regimen. Ninety-eight patients were evaluated. Objective complete response occurred in one case for 27+ months. Partial response was observed in 20 patients lasting for a median of 4.7 months. The overall objective response rate was 21% and the median duration of response was 5.5 months. Stable disease was noted in 44 patients with a median time to progression of 4.7 months from the start of treatment. Tumor progression occurred in 33 cases. There was a significant prolongation of median actuarial survival of responders (11.2 months) vs. stable disease (6.2 months) or vs. non-responders (3.8 months, P less than 0.05). The median actuarial survival for the whole group was 7.3 months. Bone marrow toxicity including thrombocytopenia (less than 100,000 cells/mm3) occurred in 16 patients and leukopenia (less than 3000 cells/mm3) in 24 patients. Forty-seven patients had no hematologic toxicity. Other adverse reactions were nausea and vomiting (50%), stomatitis (16%), alopecia (5%), cardiotoxicity (1%) and fever during leukopenia (1%).
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PMID:Four-drug combination chemotherapy in advanced lung cancer: methotrexate, doxorubicin, cyclophosphamide and CCNU. 702 45

In an attempt to improve upon the 43%-48% regression rates noted for various CAP regimens consisting of cyclophosphamide, doxorubicin (Adriamycin), and cis-diamminedichloroplatinum(II) in various doses and schedules, triazinate was added to that three-drug combination, and the new combination (T-CAP) was evaluated in patients with advanced adenocarcinoma of the lung. T-CAP produced a regression rate of 57% with a 7-week increase in overall median time to progression and a 4-week increase in overall median survival compared to the best of the CAP schedules. More stomatitis and dermatitis were noted with the new combination, but myelosuppression was similar to that of the CAP regimens. These data suggest that further studies with triazinate should be conducted in patients with adenocarcinoma of the lung.
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PMID:Phase II evaluation of the combination of triazinate, cyclophosphamide, doxorubicin, and cis-diamminedichloroplatinum(II) in patients with advanced adenocarcinoma of the lung. 719 2

Thirty patients with unresectable adenocarcinoma of the lung were treated with high doses of 5-fluorouracil, Adriamycin, and mitomycin-C (Hi-FAM). Objective responses were seen in ten patients (one complete and nine partial remissions). No patient with pleural disease responded to treatment. Responses were seen in all other sites of involvement including liver. In a subgroup of patients younger than 65 years, who had not had prior treatment, and who had a performance status of greater than 60 (Karnofsky), an overall response rate of 50% was realized. The overall median survival for responding patients was 10+ months while nonresponders had a median survival of 5.21 months. Patients who had had prior irradiation had a median survival of 4.81 months compared with patients who had not had any prior treatment, whose median survival was 8.45 months. Toxicity was substantial and included primarily bone marrow suppression and stomatitis. Elderly patients with poor performance status and prior treatment tolerated therapy less well. These results indicate that Hi-FAM is useful in selected groups of patients with advanced adenocrcinoma of the lung.
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PMID:5-fluorouracil, adriamycin, and mitomycin-C (Hi-FAM) chemotherapy for adenocarcinoma of the lung. 723 86

Three hundred and thirty-six patients with a variety of tumors were treated with Adriamycin given weekly as an iv bolus of 1 mg/kg with subsequent doses adjusted for hematologic toxicity. This weekly schedule, not utilizing a loading course, resulted in only a 20% incidence of stomatitis. The number of evaluable patients and the percent with objective responses (respectively) according to tumor type were: lung (57 patients, 14%); sarcoma (62, 24%); breast (31, 35%); transitional cell carcinoma (17, 29%); non-Hodgkin's lymphoma (17, 29%); head and neck (16, 13%); colorectal (13, 0); ovarian (eight, 25%); and other (53, 11%). These response frequencies are comparable to those reported for every-3-week regimens using 60-75 mg/m2 of Adriamycin. Sixteen patients were given 450-550 mg/m2 of Adriamycin, five were given 550-600 mg/m2, and ten were given greater than 600 mg/m2. None of the study patients developed definite evidence of drug-induced congestive heart failure. Therefore, Adriamycin given as a weekly schedule provides a clinically effective alternative to the every-3-week schedule of administration. The weekly schedule is associated with tolerable toxicity and a decreased risk of developing drug-induced congestive heart failure.
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PMID:Adriamycin given as a weekly schedule without a loading course: clinically effective with reduced incidence of cardiotoxicity. 737 58

A liposome-entrapped liposome form of Adriamycin (Lip-ADM) has been demonstrated to cause less myocardial and gastrointestinal toxicity than free ADM. In the present study, Lip-ADM prepared by the remote loading method was administered to 3 patients with metastatic adenocarcinoma of the liver via a reservoir with the catheter located in the proper hepatic artery. The primary tumor was gastric cancer in 2 patients and sigmoid colon cancer in 1. Lip-ADM was administered at doses of 10, 20 or 50 mg per time. The total ADM dose was 170, 490, and 760 mg, respectively. No severe adverse effects, such as nausea, vomiting, stomatitis, alopecia or cardiotoxicity, were observed in any of the patients. Although mild leukocytopenia (2,800/microliters) was observed in 1 patient, anemia or thrombocytopenia did not occur. The survival time was respectively 6, 15, and 17 months from the start of Lip-ADM administration. A partial response was obtained in 1 patient and stable disease in 1 patient. Administration of Lip-ADM via a reservoir appears to be a useful treatment for patients with metastatic adenocarcinoma of the liver, since the low toxicity of this preparation allows an increase of the total dose of ADM.
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PMID:Intra-arterial liposomal adriamycin for metastatic adenocarcinoma of the liver. 758 1

In preclinical studies, a doxorubicin liposome formulation containing polyethylene-glycol (Doxil) shows a long circulation time in plasma, enhanced accumulation in murine tumors, and a superior therapeutic activity over free (unencapsulated) doxorubicin (DOX). The purpose of this study was to characterize the pharmacokinetics of Doxil in cancer patients in comparison with free DOX and examine its accumulation in malignant effusions. The pharmacokinetics of doxorubicin and/or liposome-associated doxorubicin were analyzed in seven patients after injections of equivalent doses of free DOX and Doxil and in an additional group of nine patients after injection of Doxil only. Two dose levels were examined, 25 and 50 mg/m2. When possible, drug levels were also measured in malignant effusions. The plasma elimination of Doxil followed a biexponential curve with half-lives of 2 and 45 h (median values), most of the dose being cleared from plasma under the longer half-life. Nearly 100% of the drug detected in plasma after Doxil injection was in liposome-encapsulated form. A slow plasma clearance (0.1 liter/h for Doxil versus 45 liters/h for free DOX) and a small volume of distribution (4 liters for Doxil versus 254 liters for free DOX) are characteristic of Doxil. Doxorubicin metabolites were detected in the urine of Doxil-treated patients with a pattern similar to that reported for free DOX, although the overall urinary excretion of drug and metabolites was significantly reduced. Doxil treatment resulted in a 4- to 16-fold enhancement of drug levels in malignant effusions, peaking between 3 to 7 days after injection. Stomatitis related to Doxil occurred in 5 of 15 evaluable patients and appears to be the most significant side effect in heavily pretreated patients. The results of this study are consistent with preclinical findings indicating that the pharmacokinetics of doxorubicin are drastically altered using Doxil and follow a pattern dictated by the liposome carrier. The enhanced drug accumulation in malignant effusions is apparently related to liposome longevity in circulation. Further clinical investigation is needed to establish the relevance of these findings with regard to the ability of liposomes to modify the delivery of doxorubicin to solid tumors and its pattern of antitumor activity.
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PMID:Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. 831 89

Fifty-three patients with AIDS-related Kaposi's sarcoma and no previous treatment with cytotoxic chemotherapy enrolled in a phase II multicenter study to evaluate the safety and efficacy of weekly doxorubicin treatment. Doxorubicin was given intravenously at a dose of 15 mg/m2. Patients were stratified for purposes of analyses by tumor burden and coexistence of HIV-associated signs and symptoms; stratum I included patients with cutaneous disease alone and no symptoms, and stratum II included patients with visceral disease, tumor-associated edema, a previous opportunistic infection, or systemic symptoms. Fifty-one patients were evaluable for toxicity and 50 for tumor response. Five patients had a partial response (10%); 32, a minor response (64%); 12, no change (24%); and one, progression (2%) as the best measurable response. Partial response durations ranged from 4 to 14 weeks. Fifteen patients subsequently showed progression while on treatment. A significantly greater number of patients in stratum I (20.1%) had a partial response compared with those in stratum II (0%, p = 0.009). The major toxicities included nausea (37%), stomatitis (9.8%), mucositis (13.7%), and moderate to severe neutropenia (71%). Neutropenia was dose limiting and resulted in discontinuation of doxorubicin in 18% of the patients. Two patients developed cardiac toxicity. In conclusion, doxorubicin treatment induced relatively few tumor responses and remission durations were short. Treatment was limited by a high rate of toxicity.
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PMID:Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. 845 Apr 1

Doxorubicin is an antineoplastic drug which has in vitro and in vivo activity against a number of malignancies including Kaposi's sarcoma. Incorporation of doxorubicin into polyethylene glycol-coated (pegylated) liposomes alters the pharmacokinetics of the drug. Liposomal doxorubicin has a smaller volume of distribution and slower plasma clearance than standard free doxorubicin. The liposomal formulation achieves higher concentrations in the highly vascularised lesions of Kaposi's sarcoma than in normal tissue. Liposomal doxorubicin monotherapy in patients with AIDS-related Kaposi's sarcoma produced overall response rates (complete plus partial) of 43 and 59% in large comparative studies and 67 to 100% in noncomparative studies which included > or = 20 patients. In comparative studies, liposomal doxorubicin was significantly more effective than the combination of standard doxorubicin, bleomycin and vincristine (overall response rates of 43 and 25%, respectively) and bleomycin and vincristine (BV) [overall response rates of 59 and 23%, respectively]. In addition, overall response rates to the liposomal drug were higher in both treatment arms of 2 smaller comparative studies which compared liposomal doxorubicin with BV, but significant between-treatment differences were not detected. Patient numbers in these 2 studies, however, may have been too small to detect significant differences. Liposomal doxorubicin is generally well tolerated. Myelosuppression is the most common dose-limiting adverse effect in patients with AIDS and Kaposi's sarcoma. Neutropenia occurs most often; anaemia and thrombocytopenia occur less frequently, as do nausea and vomiting and stomatitis. Palmar-plantar erythrodysaesthesia occurs in some patients, most commonly after 6 to 8 weeks of chemotherapy. Although symptoms may occasionally be severe, the syndrome usually does not require dosage reduction or treatment delay. Limited data suggest that the incidence of cardiotoxicity may be lower after liposomal doxorubicin than after equivalent doses of standard doxorubicin. Overall, liposomal doxorubicin appears to be one of the most active single agents available for treating patients with AIDS-related Kaposi's sarcoma. The therapeutic potential of liposomal doxorubicin administered in combination with other active agents to patients with Kaposi's sarcoma is, as yet, unknown. However, administered alone, the drug seems to be more effective than the best available combination chemotherapy regimens.
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PMID:Polyethylene glycol-liposomal doxorubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the management of AIDS-related Kaposi's sarcoma. 907 48

We treated 20 women with locally advanced breast cancer between January 1991 and September 1996. The treatment regimen included 4 cycles of intensive doxorubicin (30 mg/m2/d on 3 consecutive days every 2 weeks with G-CSF support), followed by appropriate surgery, followed by high dose therapy with cyclophosphamide, carboplatin and thiotepa (STAMP V, CTCb). Of the 20 patients, seven presented with inflammatory breast cancer, three with Stage IIIB, seven with stage IIIA, one with multifocal Stage IIB and two with Stage IV M1 (ipsilateral supraclavicular lymph node involvement) (including one who had an inflammatory primary) disease. Six patients had not undergone mastectomy at the time of entering the protocol. These six received the doxorubicin in a neoadjuvant fashion and were thus evaluable for tumor response. The remaining 14 received doxorubicin as adjuvant therapy prior to intensification and transplantation. All patients underwent local-regional radiation therapy and were placed on oral tamoxifen. Doxorubicin was well tolerated in this schedule with all but three patients receiving all their cycles on schedule. Both BM and PBPC were easily collected after this regimen and, when reinfused, resulted in the prompt recovery of granulocytes (median 11 days to 500 absolute granulocyte count) and platelets (median 13 days to 20,000 platelets). The six patients who received doxorubicin prior to mastectomy all had major clinical responses, but were found to have microscopic focii of breast cancer in the mastectomy specimens. The overall treatment was well tolerated with the exception of one treatment-related death (5%). The overall and relapse free survival are 70% and 58% respectively with a median follow-up of 40 months (range 12-74 months). When the Stage IV patients are censored, the relapse-free survival rate is 69%. In the bone marrow transplant phase of treatment, the major non-hematologic toxicities were stomatitis (70%) and anorexia requiring parental nutrition (75%).
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PMID:Durable remission of locally advanced breast cancer with multimodality management. 978 15

Doxorubicin and paclitaxel both display strong antitumor activity in the treatment of breast cancer. The optimal schedule of this combination, however, remains undefined. In this phase I and pharmacologic study, we administered weekly 12 mg/m2 doxorubicin as a bolus infusion immediately followed by a 1 h 80 mg/m2 paclitaxel infusion to patients with metastatic breast cancer. A total of 119 weekly courses were delivered to seven patients. Grade IV neutropenia was observed in two patients at the first dose level, thus already defining the maximum tolerated dose. Pronounced non-hematologic toxicities were mild neuropathy (grade I: 39%) and stomatitis (grade I: 19%, grade II: 8%). No signs of cardiac toxicity were observed with this dose schedule. Three partial responses were achieved in this group of heavily pretreated patients. The pharmacokinetics of paclitaxel, doxorubicin and Cremophor EL with this schedule were analyzed. Overall, the schedule was well tolerated and combined with its preliminary response rate justifies further evaluation in phase II studies.
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PMID:Phase I and pharmacologic study of weekly doxorubicin and 1 h infusional paclitaxel in patients with advanced breast cancer. 982 24


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