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PubMed1983

Cis-platinum plus high-dose methotrexate. Toxicity and efficacy in ovarian carcinoma.

Cis-platinum plus high-dose methotrexate with citrovorum factor rescue underwent an initial evaluation of toxicity in patients with pelvic or abdominal adenocarcinoma and a subsequent efficacy trial in proven ovarian cancers. Forty-five patients with advanced abdominal adenocarcinoma were evaluable for toxicity. Toxicity was minimal and was not exacerbated by the presence of effusions or by modestly compromised renal function. Twenty-six patients had definite ovarian primaries and were evaluable for efficacy. All but four were refractory to standard therapy. Seven achieved either complete response (four) or partial response (three). Four additional patients showed lesser, but clinically important, objective responses. Patients who had not received prior therapy all responded with three of the four attaining complete response lasting from 7-22+ months. This regimen is well tolerated and has definite tumoricidal activity even in heavily pretreated patients.

Adenocarcinoma↗

PubMed1998

A phase II study of high-dose cimetidine and the combination 5-fluorouracil, interferon alpha-2A, and leucovorin in advanced renal cell adenocarcinoma.

Cimetidine is an H2-receptor antagonist used in the management of peptic ulcer disease and other hypersecretory gastrointestinal disorders. This agent has intriguing immunomodulatory characteristics. A phase II trial of cimetidine in 19 patients with advanced malignant melanoma yielded an objective response rate of 16%. Having demonstrated that cimetidine is active in malignant melanoma, the authors conducted a phase II trial of cimetidine, 800 mg twice daily by mouth, in patients with advanced renal cell cancer. Among the 31 eligible patients, only one (3.2%) achieved a regression. It was a partial regression lasting 93 days. Median time to treatment failure was 83 days. The combination of interferon alpha-2A (IFL-RA) and 5-fluorouracil (5-FU) has been shown to be synergistic against experimental cell lines in vitro. Citrovorum factor (CF) added to 5-FU has been shown to improve objective tumor response compared with single-agent 5-FU in patients with advanced colorectal cancer. Fluorinated pyrimidines have shown some activity against renal cell cancer. We conducted a phase II trial of the combination of CF at 20 mg/m2 intravenous push followed by 5-FU at 325 mg/m2 intravenously daily for 5 days every week with interferon alpha-2A 5 x 10(6) units/m2 subcutaneously on days 1, 3, 5 in patients with advanced renal cell cancer. Among the 31 eligible patients, only two (6.5%) achieved a regression. Both were partial regressions. Median time to treatment failure was 84 days. Neither regimen is recommended for further testing in patients with advanced renal cell adenocarcinoma.

Adult↗

PubMed1975

Chemotherapy of osteosarcoma.

Recent advances in the use of chemotherapy for treatment of osteosarcoma have altered out pessimism in this disease. Results are presented from 3 groups of investigators using different agents as adjuvant chemotherapy following immediately upon amputation of the primary. The Roswell Park Memorial Institute began a regime, immediately after amputation, of adriamycin 30 mg/M2 for 3 doses and given every 4-6 weeks. This study was subsequently expanded in a cooperative group (ALGB) and the results on 20 patients analyzed. At 19 months approximately 75 per cent are free of any pulmonary metastases compared with 10-25 per cent expected from amputation alone. Similar results have been obtained by other Centers using different chemotherapeutic agents. In Boston Children's Hospital high dose Methotrexate with citrovorum factor is used. In 12 of these patients local control of the primary by surgery was obtained and of these only 1 developed pulmonary metastases during an observation time of 23 months. At the M. D. Anderson Hospital multi-drug combinations were used including Cyclophosphamide, Vincristine, L-Phenylalamine Mustard and Adriamycin. They reported a survival rate of 55 per cent (10 out of 18). All of these neoplastic agents have toxic side effects but when carefully used these effects are minimized and the quality of life is quite good. Many questions must be answered by future controlled long term follow-up studies.

Amputation, Surgical↗

PubMed1979

Methotrexate concentrations in biological fluids: comparison of results obtained by radioimmunoassay and direct ligand binding radioassay.

A sensitive (sensitivity 2.2 X 10(-9) mol/l) and specific (practically no cross-reaction with circulating folates) radioimmunoassay for the determination of methotrexate concentrations in biological fluids in described and compared with a commercial competitive protein binding assay. Antiserum with high titer was produced in rabbits immunized with MTX-human serum albumin conjugate. Fitness for use in pharmacokinetic drug level determinations was shown in three patients, who received both low doses and high dose therapy combined with citrovorum factor rescue. An excellent correlation was found between plasma and urine MTX concentrations obtained by RIA and competitive protein binding assay. A two-compartment pharmacokinetic model was found adequately describing the serum decay curves, but there was a great interindividual variability in the calculated pharmacokinetic parameters.

Adult↗

PubMed1978

Refractory acute leukaemia in adults treated with sequential colaspase and high-dose methotrexate.

Thirty-nine adults with acute leukaemia who had relapsed when receiving extensive chemotherapy were treated with a combination of methotrexate and colaspase (L-asparaginase) given sequentially. Patients initially received 50-80 mg/m(2) methotrexate, followed three hours later by intravenous colaspase, 40 000 IU/m(2). Seven days later intravenous methotrexate, 120 mg/m(2) was given. Each dose of methotrexate was followed 24 hours later by colaspase, and the two-day course of treatment was repeated every 7-14 days. The methotrexate dose was increased to tolerance by increments of 40 mg/m(2) with each course, while the colaspase dose remained constant unless abnormal liver function developed, when it was reduced by half.Overall, 18 out of 39 patients achieved complete remission (46%). Of these, 13 out of 21 (62%) had acute lymphoblastic leukaemia, three out of seven (43%) acute undifferentiated leukaemia, and two out of 11 (18%) acute myeloblastic leukaemia. The median duration of complete remission was 20 weeks and the median duration of survival in complete responders was 45 weeks. The median number of courses needed to achieve complete remission was three. The maximum tolerated dose of methotrexate was 400 mg/m(2) (median 200 mg/m(2)). Major side effects were due to colaspase. Methotrexate in doses of up to 400 mg/m(2) caused minimal myelosuppression and stomatitis, which suggested that colaspase given sequentially provides relative protection from methotrexate toxicity without the need for folinic acid (citrovorum factor) rescue.The combination of sequential colaspase and methotrexate is highly effective in reinducing remission in patients with acute lymphoblastic leukaemia or acute undifferentiated leukaemia. The regimen is easy to administer and relatively non-toxic, so it is suitable for use in outpatients, either alone or combined with other agents.

Acute Disease↗

PubMed1989

Malignant fibrous histiocytoma of sternum: an unusual cause of pyrexia of undetermined origin.

Malignant fibrous histiocytoma of the bone is a very rare tumour mainly affecting long bones, and the most common presenting symptom is local pain. A case of malignant fibrous histiocytoma presenting with pyrexia of undetermined origin and arising in the sternum, a localization not previously described, is reported. The patient died with septic shock after multi-drug chemotherapy including high dose methotrexate treatment with citrovorum factor rescue.

Adult↗

PubMed1976

Intrathecal cytostatic chemotherapy of meningitis carcinomatosa. Clinical manifestation and cerebrospinal fluid cytology in a case of metastatic carcinoma of the breast.

Effects of intrathecal cytostatic chemotherapy on the clinical symptoms and cerebrospinal fluid (CSF) findings are being demonstrated in a case of metastatic carcinoma of the breast with sighns of meningeal irritation and cranial nerve involvement. Clinical symptoms disappeared after repeated intrathecal applications of methotrexate. CSF cell counts were reverted to normal but tumor cells were found to be persistant in CSF over a period of 19 months. Risks of combined intrathecal and systemic cytostatic therapy and possible effects of parenteral citrovorum factor applications are being discussed. The importance of continued intrathecal chemotherapy and of regular and thorough examination of CSF cells in meningitis carcinomatosa is emphasized. Cytological methods included investigations on viable CSF cells.

Adenocarcinoma, Mucinous↗

PubMed1980

[Detection of methotrexate in human serum. Comparison between an enzymatic and an enzyme-immunologic method].

High-dose methotrexate therapy with following citrovorum factor rescue necessitates the regular determinations of methotrexate (MTX) serum concentrations. A simple enzymatic assay by MTX induced inhibition of dihydrofolate reductase is described. The results gained with this assay are compared with those of a new enzyme immunoassay (MTX-EMIT). Between 5 X 10(-7) M and 1 X 10(-3) M the results of both tests are nearly the same, and the coefficient of correlation is 0,9980. At MTX concentrations below 5 X 10(-7) M the results of the MTX-EMIT lie nearly always higher than and differ considerably from those of the enzymatic method; the coefficient of correlation is only 0.7007. If it is possible to enhance the sensitivity of the MTX-EMIT, this test enables the very quick and easy determination of MTX serum concentrations in the whole range of clinical importance.

Glucosephosphate Dehydrogenase↗

PubMed1977

Pathologic aspects of chemotherapy response in the treatment of osteogenic sarcoma. An analysis of two cases.

Two patients with osteogenic sarcoma of the proximal tibia were treated pre-operatively with intensive chemotherapy with high dose methotrexate (HDMTX) with citrovorum factor rescue (CFR) and adriamycin (ADR). One patient died before surgery. The other underwent en bloc resection of the primary tumor with prosthetic replacement of the involved tibia, following by adjuvant chemotherapy consisting of HDMTX with CFR and ADR, but died of metastases. Complete control of the primary or metastatic tumor was not achieved. It is emphasised that intensive multiple drug chemotherapy should be administered with extreme caution. The histologic findings are carefully analysed in relation to objective tumor response and toxic chemotherapy effects.

Adolescent↗

PubMed1987

Histological changes following high-dose methotrexate and cisplatinum administration and the influence of dosage scheduling.

Histological changes were studied in experimental animals following the intraperitoneal administration of high-dose cisplatin with or without high-dose methotrexate and citrovorum factor. There were pronounced renal toxicities with high-dose (10 mg/kg) cisplatin, particularly involving distal tubules with glomerular congestion. However, lower toxicities were noted with reduced dosage of cisplatin (5 mg/kg) and especially if given once as a single bolus injection instead of a 5-day regimen. Renal and hepatic toxicities were marked with concomitant methotrexate administration leading to hemorrhagic diathesis and shorter survival. However, toxicities were relatively reduced when cisplatin was given as a single bolus injection instead of a 5-day divided course. Such information may prove helpful in future planning of combination chemotherapy in patients with malignancies using these two agents.

Animals↗

PubMed1992

Conservative treatment of ectopic pregnancy and its effect on corpus luteum activity.

Corpus luteum activity was monitored in 15 women undergoing nonsurgical management of ectopic pregnancy with local methotrexate injection followed by alternating oral methotrexate and citrovorum factor (group A, n = 8) or local methotrexate injection alone (group B, n = 7). All patients initially demonstrated a viable corpus luteum (plasma progesterone ranged from 1.4 to 19 ng/ml). The treatment was successful in 14, with the exception of one whose tube ruptured 11 days after local administration of methotrexate, despite a continuous decrease in beta human chorionic gonadotropin, 17 beta-estradiol and plasma progesterone levels. There seems to be no correlation between the success of the treatment and the behavior of beta human chorionic gonadotropin, 17 beta-estradiol and plasma progesterone. Three patients from group A and two from group B displayed an initial rise in beta human chorionic gonadotropin following the initiation of the therapy, but the corpus luteum response differed. In group B patients, 17 beta-estradiol and plasma progesterone levels increased in parallel with beta human chorionic gonadotropin. Group A patients displayed a continuous decrease in 17 beta-estradiol and plasma progesterone levels despite the elevation of beta human chorionic gonadotropin, suggesting a possible effect of the systemic methotrexate on corpus luteum activity.

Adolescent↗

PubMed1983

Treatment of primary osteosarcoma with intra-arterial and intravenous high-dose methotrexate.

In an effort to achieve high concentrations and prolonged exposure times, high-dose methotrexate (MTX) was administered by the intra-arterial route over 6 hours at a dose of 12.5 g/m2 to nine patients with osteosarcoma. This was followed by citrovorum factor (CF) rescue, which was initiated 12 hours after completion of the infusion (MTX-CF). The regimen achieved high local concentrations over a finite period. No toxicity was encountered. Treatment was administered at weekly intervals, during which intravenous MTX-CF was interposed if facilities for intra-arterial administration were not available. However, despite increases in local venous concentrations and exposure times, only four of nine patients (44%) responded. This is similar to responses achieved with 7.5 g/m2 (48%) with CF initiated 2 hours after completion of the infusion. Higher MTX doses, intra-arterial administration, and prolongation of cytotoxic exposure time did not confer a therapeutic advantage as opposed to "conventional" intravenous high doses.

Adolescent↗

PubMed1979

Combination chemotherapy in advanced postmenopausal mammary carcinoma. A comparison between VAC and VACM therapy.

A randomized trial comparing Vincristine, Adriamycin, Cyclophosphamide (VAC) with or without Methotrexate with citrovorum factor rescue (VACM) was performed in 64 patients with metastatic postmenopausal mammary carcinoma. Previous treatment of metastases, dominant site of metastases and performance condition were similar in the patients. No significant difference was found in the response rates (complete remission + partial remission; VAC 21/31, VACM 25/33), in the duration of the remissions or in the survivals. The duration of remission in CR was significantly longer than in PR. No serious side effects were observed. The VAC regimen is preferable, particularly with respect to the costs and the simple procedure of administration.

Adult↗

PubMed1990

Methotrexate-induced leukoencephalopathy is treatable with high-dose folinic acid: a case report and analysis of the literature.

An episode of leukoencephalopathy is reported in a 13-year-old girl who, after standard radiotherapy for a posterior fossa medulloblastoma, received 8 treatments with a protocol containing a 4-hour infusion of 500 mg/m2 methotrexate and 12 mg intrathecal methotrexate. The leukoencephalopathy, documented clinically and by CT and EEG, cleared after 2350 mg of leucovorin (citrovorum factor, folinic acid) was given in addition to the 135 mg given as part of the therapy. A review of the literature suggests that leukoencephalopathy may be prevented by high doses of leucovorin and can be treated by high doses, if lower doses were used initially. When high dose leucovorin was not used, residual neurological damage is not unusual.

Adolescent↗

PubMedDate not supplied

Overdose of vinblastine in a child with Langerhans' cell histiocytosis: toxicity and salvage therapy.

The therapeutic index of antineoplastic agents is generally low, therefore, errors in administration can cause severe, life-threatening toxicity. The publication of cases of overdoses may provide useful information on the causes of the mistakes, on drug-induced toxic effects, and on salvage therapy. We report a case of vinblastine overdose in a child affected by Langerhans' cell histiocytosis, Hand-Schüller-Christian syndrome according with the previous classification of histiocytosis X. To our knowledge this is the highest dose of vinblastine ever administered. The child was given salvage therapy with steroids and citrovorum factor. Major side effects were neurologic toxicity (seizures, coma) and marrow aplasia, which improved and gradually resolved beginning day 12.

Adrenal Cortex Hormones↗

PubMed1993

Pathological responses to preoperative high-dose methotrexate chemotherapy in osteosarcoma--experience in Korea cancer hospital.

During the last decade, many clinical investigators at various cancer centers have reported the efficacy of various chemotherapeutic agents in the treatment of osteosarcoma. The regimens using high-dose methotrexate (HDMTX) with citrovorum factor rescue are now considered to be one of the most effective treatments of choice. From December 1989 to May 1991, sixteen patients with Enneking's stage (Enneking et al., 1980) IIB osteosarcoma of the extremities were treated with a high-dose methotrexate regimen. After two cycles of preoperative chemotherapy, an operation was performed; either limb salvage or amputation. The resected lesions were examined pathologically and classified according to Huvos' criteria. On pathological examination, 8 (50%) cases showed Grade IV; 1 (6.25%) Grade III; 4 (25%) Grade II; and 3 (18.75%) Grade I. The types of surgery performed were tumor prosthesis replacement (11); wide resection with or without reconstruction (2); resection and arthrodesis (1); and amputation (2).

Adolescent↗

PubMedDate not supplied

Hepatic artery infusion chemotherapy for colorectal liver metastases.

Twenty-two patients with hepatic colorectal metastases had Infusaid pumps implanted for hepatic artery infusion chemotherapy, or HAIC. Prior to pump placement, 19 of the 22 patients received percutaneous HAIC with 5-fluorouracil and citrovorum factor. Floxuridine, 0.2 mg/kg/d, was administered via the Infusaid pump and was alternated with saline solution every 2 weeks. HAIC responsiveness was defined as a 50% or greater reduction in the sum of all diameters of measured lesions on computerized tomography scans and no evidence of extra-hepatic tumor. Nine patients (41%) had a favorable response to HAIC; four (18%) had a partial response to percutaneous HAIC and five (23%) were considered pump responders. All responders had pretreatment liver replacement of less than 50%. The mean survival after pump placement was 13.6 months for responders and 11.1 months for non-responders. Although there were no operative deaths, the morbidity rate was 36%, and 31% of patients manifested significant chemotherapy toxicity. While toxicity is not insignificant and there is no survival benefit, the Infusaid pump is a reliable drug delivery system for HAIC, and may result in regression of colorectal liver metastases in patients with less than 50% hepatic replacement.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1976

Multidisciplinary curative treatment for disseminated carcinoma of the breast.

Eighty-four patients with disseminated breast carcinoma were treated with the combination of hormonal therapy and combination chemotherapy from the time of diagnosis. Hormonal treatment included castration for women still menstruating, estrogens for women menopausal for greater than 5 years, and androgens or progesterone for women menopausal for less than 5 years. Combination chemotherapy consisted of monthly 5-day courses of 5-fluorouracil (500 mg/day, Days 1-5), cyclophosphamide (300 mg/day, Days 1 and 4), vincristine (1 mg/day, Days 2 and 5), and methotrexate (100 mg, Day 1) followed by citrovorum factor (12 mg/day, Days 2 and 3). The overall response rate was 83.3%: 43 CRs (51%) and 27 PRs. The median survival time was 17 months: 6 months for the failures, 12 months for the 27 PRs, and 27 months for the 43 CRs. Fifteen patients with CR are still alive: one after 16 months, one after 17 months, two after 19 months, and one each after 23, 24, 25, 31, 35, 37, 38, 43, 48, 68 and 70 months.

Androgens↗