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PubMed1978

Phase I study with neocarzinostatin: tolerance to two hour infusion and continuous infusion.

Neocarzinostatin (NCZ), an acidic polypeptide antibiotic, was given to 47 patients with cancer and leukemia, and tolerance to two schedules, a single dose given as a 2 hour infusion and a continuous infusion over 5 days was investigated. Immediate reactions, including fever, chills, rigor, hypertension and mental confusion, were dose-limiting for the 2 hour infusion schedule, occurring at 3000 U/m2 and higher. Continuous administration for 5 days eliminated the immediate reactions and then hematological toxicity--often prolonged leukopenia and thrombocytopenia--became dose-limiting. Other toxicities of NCZ at both dose schedules included anemia, fever and chills, anorexia, nausea and vomiting, hepatic dysfunction, azotemia, hypophosphatemia, aminoaciduria, stomatitis, phlebitis and/or cellulitis at the venous infusion site and pruritus. Patients with solid tumors who had received little or no prior chemotherapy and had good bone marrow reserve tolerated up to 6000 U/m2/24 hours X 5 days. One patient with previously treated acute myelocytic leukemia was induced into a good partial remission lasting 10 weeks.

Adolescent↗

PubMed1980

The adjuvant treatment of inoperable stage III and IV epidermoid carcinoma of the head and neck with platinum and bleomycin infusions prior to definitive radiotherapy: an RTOG pilot study.

Twenty-nine previously untreated patients with advanced unresectable Stage III or IV epidermoid carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx were entered on a pilot protocol to evaluate the effectiveness and toxicity of platinum-bleomycin infusion chemotherapy administered prior to definitive radiotherapy. Platinum was given by 24-hour continuous I. V. infusion (in an attempt to decrease gastrointestinal and renal toxicity) without mannitol diuresis at a dose of 80--100 mg/m2 on day 1 and repeated on day 22. Bleomycin was administered 15 U/m2 I. V. push on day 3 and was then followed by a five-day continuous I. V. infusion of 15 U/m2/day. Fourteen of 29 (48%) patients achieved an objective partial response on chemotherapy alone (an additional 5 patients or 17% had a minor response). Chemotherapy was well tolerated with 10/29 experiencing no nausea, 4/29 mild nausea alone, and 14/29 experiencing controllable nausea/vomiting. Transient reversible azotemia was noted in 4, skin rash in 3, and anemia in 9 patients. All 29 patients began radiotherapy on day 28; 25 completed radiotherapy and 12/25 (48%) achieved complete tumor clearance; all 12 are currently free of disease with short follow-up. The radiotherapy was well tolerated, completed on schedule, and no unexpected toxicities were encountered. This combined modality approach demonstrated substantial antitumor activity and was able to reduce the significant morbidity from platinum-bleomycin chemotherapy for the treatment of unresectable head and neck carcinoma.

Anemia↗

PubMed1981

Cis-platinum in treatment of advanced or recurrent squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.

Thirty-four patients with advanced or recurrent squamous cell carcinoma of the cervix no longer amenable to control with surgery and/or radiotherapy were treated with cis-platinum 50 mg/m2 intravenously every three weeks. Among 22 patients who had received no prior chemotherapy, three complete and eight partial responses were observed (response rate 50%), whereas only two partial responses were observed among 12 patients who had received prior chemotherapy (response rate 17%). The observed response rate was marginally significantly higher among those with no prior chemotherapy (p = 0.059). The overall frequency of response was 38% (13/34). Responses were observed in those with pelvic (7/20) as well as extrapelvic disease (6/14). Adverse effects included primarily leukopenia (11/34), thrombocytopenia (13/34), nausea and vomiting (29/34), and azotemia (17/34). Adverse effects were generally mild to moderate and hence tolerable. Cis-platinum thus appears to be a highly active agent in the treatment of squamous cell carcinoma of the cervix at the dose and schedule tested.

Adult↗

PubMed1981

Microangiopathic hemolytic anemia, thrombocytopenia, and renal failure in patients treated for adenocarcinoma.

Microangiopathic hemolytic anemia and thrombocytopenia secondary to disseminated intravascular coagulation is a well-described complication of widely metastatic carcinoma. The authors report four cases of gastric carcinoma, one case of colon cancer, and one case of adenocarcinoma of unknown primary in which the patient developed a syndrome analogous to thrombotic thrombocytopenic purpura, consisting of microangiopathic hemolytic anemia, thrombocytopenia, and renal failure without definite evidence of disseminated intravascular coagulation. In contrast to previous reports, postmortem examination in three of the cases revealed no recurrence or only microscopic foci of residual tumor. In the remaining three, there was clinical and pathologic evidence of grossly disseminated carcinoma. Also in contrast to previous cases, all patients evidenced azotemia and proteinuria at the onset of the syndrome and ultimately uremia was a contributing cause of death. Coagulation profiles showed prolonged thrombin times and elevated fibrin degradation products in four instances and did not distinguish the patients with grossly metastatic disease from those with no tumor or only microscopic residua. Circulating immune complexes containing carcinoembryonic antigen were found in the patient with metastatic colon carcinoma. The syndrome was clinically identical whether or not grossly metastatic tumor was present, and it should not be attributed to advanced disease without definite clinical or pathologic evidence of a recurrence.

Acute Kidney Injury↗

PubMed1982

Efficacy study of intensive cis-platin therapy in advanced non-small cell bronchogenic carcinoma.

Thirty patients with advanced non-small cell bronchogenic carcinoma were treated with cis-platin, 75 mg/M2 weekly for three weeks, then every three weeks. Eighteen were ambulatory, 22 had distant metastases, 14 had prior irradiation, and none had prior chemotherapy. Ten patients (33%) had objective remissions lasting a median of three months. Responders lived a median of five months, compared to three months for nonresponders. Transient mild azotemia was noted in twelve patients. Cis-platin has definite but modest activity in non-small cell bronchogenic carcinoma.

Adenocarcinoma↗

PubMed1983

Adjuvant chemotherapy with cis-diamminodichloroplatinum II and 120-hour infusion 5-fluorouracil in Stage III and IV squamous cell carcinoma of the head and neck.

A prospective study was carried out to investigate the effectiveness and toxicity of three courses of combination high-dose bolus CDDP and 120-hour continuous infusion 5-FU every three weeks prior to definitive surgery and/or radiation therapy in 35 patients with locally advanced Stage III and IV squamous cell carcinoma of the head and neck. Twenty-two patients (63%) achieved a CR and 11 (31%) a PR after three cycles of chemotherapy, for an objective response rate of 94%. Toxicity was clinically acceptable. Nausea and vomiting occurred in 23 of 35 (66%) without any patients discontinuing therapy for this reason. Leukopenia in 13 (37%) and reversible azotemia in six (17%). Following three courses of chemotherapy, 13 patients had surgical resection and 12 patients had radiation therapy. Ten of these 35 patients had no pathologic evidence of cancer in the surgical specimen or preradiation therapy biopsy. Only two patients of those achieving a complete objective response have relapsed. However, the median follow-up has been short. The authors concluded that three courses of CDDP and 5-FU is a highly effective and safe adjuvant treatment in patients with advanced carcinoma of the head and neck.

Carcinoma, Squamous Cell↗

PubMed1984

Race, poverty, and survival in multiple myeloma.

To identify possible interracial differences in the behavior of multiple myeloma, the records of 52 black myeloma patients at Harlem Hospital Center (HHC) and 46 black and 46 white patients at Columbia-Presbyterian Medical Center (CPMC) were reviewed. In addition to clinical variables such as tumor burden, azotemia, and hypoalbuminemia, the effect of poverty on prognosis was examined, using socioeconomic indices from the United States census block group data of each patient. The median survival of CPMC black and white patients was comparable (34 and 29 months, respectively) whereas that of the HHC group was 12 months (Breslow test, P less than 0.0001). Overcrowding and hypoalbuminemia were the most significant prognostic factors by multivariate regression analysis on all 144 patients (P = 0.001); for HHC patients, overcrowding was the single significant variable affecting survival (P = 0.004). By all socioeconomic indices, HHC patients were more impoverished than CPMC patients (P less than 0.001); they also presented with more advanced disease. Race is not a significant prognostic factor in myeloma, whereas the effect of socioeconomic status on survival appears to equal that of previously described clinical features.

Adult↗

PubMed1987

Presacral myelolipoma.

Extramedullary tumors of hematopoietic tissue can be divided into two categories: those associated with a bone marrow disorder, myelolipomas which have no apparent relation to a bone marrow disorder. The etiology of myelolipoma is unknown and the vast majority are adrenal in location. Extramedullary myelolipomas are usually presacral in location and none of the approximately ten reported cases has been diagnosed before surgery. Although radiographic and ultrasound features of myelolipomas are relatively characteristic, they are not specific and biopsy is required for diagnosis. Microscopic diagnosis requires demonstration of benign lipomatous tissue admixed with cellular hematopoietic tissue resembling normal bone marrow. This study reports a patient with presacral myelolipoma and an unusual finding of urinary retention and azotemia associated with compression of urinary bladder neck by the myelolipoma.

Female↗

PubMed1990

Chemotherapy with cisplatin and 5-fluorouracil for penile and urethral squamous cell carcinomas.

Six men with either recurrent (n = 4) or unresectable (n = 2) squamous cell carcinoma of the penis (n = 5) and urethra (n = 1) received chemotherapy with cisplatin intravenously at a dose of 100 mg/m2. This was followed 24 hours later by a continuous intravenous infusion of 5-fluorouracil (5-FU) at a dose of 960 mg/m2/d for five days every 3 to 4 weeks. There was universal alopecia. The other toxicities were mild and consisted of mucositis, nausea, vomiting, reversible creatininemia, and transient azotemia. After chemotherapy, five patients had a clinical partial response and one had a complete response. Of the five patients with no metastases, three had residual unresectable tumors. These three patients received radiation and survived for 6, 8, and 20 months after the start of chemotherapy. The other two patients were rendered disease-free by surgery. The first patient, who was a partial responder to chemotherapy, survived for 26 months. The second patient, who was a clinical complete responder, had excision of microscopic disease and is disease-free at 32+ months after the start of chemotherapy. This is the first article to report that the combination of cisplatin and 5-FU is active in penile and urethral carcinomas. After chemotherapy, surgery may be useful in selected patients to accurately assess response and excise localized residual tumors. Patients rendered tumor-free may achieve long-term survival.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1993

The diagnosis of prostatic carcinoma.

The increased incidence of prostatic carcinoma is the result of several factors including increased awareness among clinicians and the public of the significance of carcinoma of the prostate, the aging of the American population, and improvements in diagnostic methods. Most patients in whom prostatic cancer currently is diagnosed are evaluated because of symptoms of bladder outlet obstruction or abnormalities found by digital rectal examination (DRE). Incidentally detected carcinoma of the prostate on simple prostatectomy specimens (transurethral resection or open) occurs in 10-20% of patients. DRE abnormalities, leading to prostatic needle biopsy, explain most of the remaining diagnoses. Rarely, patients have other signs and symptoms, such as azotemia, weakness, anemia, and bone pain. Needle biopsy of the prostate is performed, generally, in the United States; however, aspiration cytologic examination is used widely in Europe. Ultrasound-guided needle biopsy is gaining increasing utility in many centers, all but replacing digitally guided prostate biopsies. The role of transrectal ultrasonography for diagnosis recently has fallen into some disfavor. Prostate-specific antigen assays represent a potentially important diagnostic test for prostatic cancer; however, its utility in this regard continues to be investigated.

Biomarkers, Tumor↗

PubMed2001

A Phase I study of cis-malonato[(4R,5R)-4,5-bis(aminomethyl)-1,3-dioxolane] platinum(II) in patients with advanced malignancies.

BACKGROUND: A Phase I study of cis-malonato[(4R,5R)-4,5-bis(aminomethyl)-1,3-dioxolane] platinum(II) (SKI 2053R), a new platinum derivative, was performed to determine the maximum tolerated dose (MTD), the dose limiting toxicities (DLTs), and the pharmacokinetic profile of SKI 2053R in patients with advanced, refractory malignancies. METHODS: Twenty-one patients were entered into the study. SKI 2053R was administered with an intravenous infusion over 1 hour every 4 weeks. The SKI 2053R dose was escalated from 40 mg/m(2) up to 480 mg/m(2) using a modified Fibonacci scheme. Pharmacokinetic analysis was done in all patients to determine the total and ultrafiltrable platinum concentrations in both the plasma and the urine. RESULTS: All patients were evaluable for toxicity and response. There was no significant toxicity with dosages up to 360 mg/m(2). At 480 mg/m(2), two of three patients developed Grade 4 hepatotoxicity, Grade 3 leukopenia and thrombocytopenia, and Grade 2 azotemia and proteinuria. Other toxicity included nausea and emesis, but it was controlled with antiemetics. SKI 2053R did not cause significant neurotoxicity or mucositis. There were 4 patients with stable disease among the 21 patients. Plasma decay of the total and free platinum concentrations was best fitted by using a two-compartment, open model. The terminal plasma half-life of the total platinum after SKI 2053R administration ranged from 63.4 hours to 114.1 hours in dosages ranging from 40 mg/m(2) to 480 mg/m(2) without significant dose dependency. However, the terminal plasma half-life of the free platinum concentration showed a significant dose dependent, incremental pattern. The renal excretion of SKI 2053R measured as platinum ranged from 49% to 75% of the administered dose. CONCLUSIONS: The MTD of SKI 2053R was 480 mg/m(2). The major DLTs were hepatotoxicity, nephrotoxicity, and myelosuppression. The recommended starting dose for a subsequent Phase II study is 360 mg/m(2) once every 4 weeks.

Adult↗

PubMed2000

Dichotomic effects of IFN-gamma on the development of systemic lupus erythematosus-like syndrome in MRL-lpr / lpr mice.

Systemic lupus erythematosus (SLE)-prone female MRL-lpr / lpr (MRL-lpr) mice were treated with mouse or rat IFN-gamma under different experimental conditions, both prophylactically in 6- to 8 week-old animals and therapeutically in 12- to 18-week-old SLE-affected mice. It was found that IFN-gamma heterogeneously modulated the course of the disease in MRL-lpr mice. When administered prophylactically, IFN-gamma favorably modulated the histological, serological and clinical signs of the disease. Relative to untreated or PBS-treated control animals, the MRL-lpr mice which received IFN gamma were virtually free of inflammatory infiltration of the kidneys and the lungs, had lower levels of azotemia with reduction of both circulating IgG1, IgG2a and IgG3 and anti-double strand (ds) and single strand (ss) DNA antibodies, milder skin vasculitis, significantly reduced enlargement of their lymph nodes and lower weight of the spleens. IFN-gamma also lowered the rate of mortality of MRL-lpr mice. In contrast to these findings, therapeutically administered IFN-gamma worsened the course of the disease in MRL-lpr mice, which exhibited increased proteinuria, higher levels of IgG2a and IgG3 and anti-ds and -ss DNA antibodies, more aggressive nephritis and died at an earlier age than PBS-treated control mice. The dichotomic effect of IFN-gamma on disease manifestation in MRL-lpr mice offers new insights into the complex role of this cytokine in the regulation of systemic autoimmunity such as SLE.

Animals↗

PubMed1991

Retroperitoneal fibrosis accompanying immune thrombocytopenia.

Retroperitoneal fibrosis represents an idiopathic systemic fibrosing syndrome which leads to the development of progressive hydronephrosis and azotemia (Stewart and Friberg: Southern Medical Journal 77:1185-1187, 1984; Morad et al.: American Journal of Medicine 82:363-366, 1987). Evidence in the literature supports a hypothesis that retroperitoneal fibrosis represents a systemic autoimmune process (Lichon et al.: Journal of Rheumatology 11:373, 374, 1984; Lipman et al.: JAMA 196:204-206, 1966; Littlejohn and Keystone: Journal of Rheumatology 8:665-669, 1981; Katz et al.: American Journal of Clinical Pathology 67:436-439, 1977). We report a case of a patient with retroperitoneal fibrosis, immune thrombocytopenia, presence of antinuclear antibody, and direct Coombs positivity which provides further evidence that retroperitoneal fibrosis is an autoimmune process. Progressive obstructive uropathy related to his fibrosis led to bilateral hydronephrosis and significant renal function impairment. Also, he developed marked immune thrombocytopenia. Treatment with prednisone produced a dramatic response in both platelet count and renal function.

Aged↗

PubMed2005

Severe lead poisoning in the plastics industry: a report of three cases.

BACKGROUND: Lead stabilizers (e.g., lead sulfate, lead stearate) are common additives in plastics used in electrical devices. In 1997, three plastics compounders at one California company were severely lead-poisoned. METHODS: The poisonings were investigated by interviewing the workers, employer, and treating physician and reviewing medical records and environmental monitoring results. In addition to measuring blood lead levels (BLLs), noninvasive K X-ray fluorescence was used to measure bone lead concentration of the index case. RESULTS: Blood lead concentrations of the three workers at time of diagnosis were 159, 114, and 108 microg/dl. The worker with highest exposure presented with clinical findings of crampy abdominal pain, constipation, normocytic anemia, fatigue, and reversible azotemia. Bone lead concentration in his tibia, calcaneous, and patella were 102, 219, and 182 ppm, respectively. The poisonings resulted from uncontrolled use of powdered lead sulfate stabilizer. CONCLUSION: Clinicians should be aware of potential serious overexposure to lead in compounding of plastics.

Abdominal Pain↗

PubMed1992

New syndrome involving the visual, auditory, respiratory, gastrointestinal, and renal systems.

A previously undescribed fatal multisystem syndrome involving the eyes, ears, lungs, intestines, and kidneys occurred in sibs. They both presented during early childhood with cataracts, otitis media, intestinal malabsorption, chronic respiratory infection, and failure to thrive. Later, they developed recurrent pneumonia (one was shown to have immotile bronchial cilia) and progressive azotemia leading to end-stage renal disease (ESRD) by late childhood. Both died of overwhelming infection (sepsis, meningitis). An autosomal recessive mode of inheritance is proposed since the normal parents were distant cousins, and 4 other sibs were normal.

Child, Preschool↗

PubMed1980

The C1q binding assay in systemic lupus erythematosus: discordance with disease activity.

To investigate the relationship of C1q binding assay (C1qBA) to disease activity in systemic lupus erythematosus (SLE), a retrospective study was carried out on 232 C1qBA performed in 33 patients with SLE. When initial values were assessed (33 tests in 33 patients), there was no relationship between positive and negative C1qBA and abnormal renal function (P = 0.482, Fisher exact test). Of 87 tests performed during active renal disease, 34 (39%) were positive; of 48 tests during active non-renal disease, 25 (52%) were positive; of 83 tests when the disease was inactive, 45 (54%) were positive; and of 14 tests during episodes of infection, 10 (71%) were positive. Corresponding means for the C1qBA were follows: renal 65.66, non-renal 78.02, inactive 56.04, infection 135.79 (no significant differences by Student's t-test). There was no significant relationship with the C1qBA when comparing active disease (renal and non-renal) with inactive disease (chi 2 Yates = 1.875, P = 0.171). When renal function abnormalities were analyzed separately, the C1qBA values were independent of azotemia or proteinuria (chi 2 Yates = 1.399, P = 0.237). Patients were seen with progressive renal disease who had consistently negative C1qBA, as well as patients with benign clinical courses despite elevated C1qBA. The discordance of the C1qBA results with disease activity in SLE highlights the limitations of immune complex (IC) determinations by a single technique, and stresses the importance of evaluating such tests in terms of both their specificity and sensitivity. These data further suggest that the relationship of IC to the disease process in SLE may be a complex one.

Complement C1↗

PubMed1993

Cyclosporine in systemic sclerosis. Results of a forty-eight-week open safety study in ten patients.

OBJECTIVE: To evaluate safety and efficacy of cyclosporin A (CSA) treatment in systemic sclerosis (SSc). METHODS: Ten patients with < or = 60 months of SSc were entered into a 48-week open study of CSA. Patients with hypertension or azotemia were excluded. Concurrent use of nonsteroidal antiinflammatory agents or diuretics was not permitted. The extent of cutaneous and visceral involvement at 48 weeks and at study entry were compared. RESULTS: Adverse reactions (especially nephrotoxicity) were frequent, usually transient, often dose-limiting, and usually associated with CSA doses > or = 3-4 mg/kg/day. Skin thickening decreased significantly (P < 0.001), while pulmonary and cardiac involvement remained unchanged. CONCLUSION: CSA should undergo blinded controlled study in patients with SSc.

Adult↗

PubMed2006

Prevention and reversal of nephritis in MRL/lpr mice with a single injection of C-reactive protein.

OBJECTIVE: C-reactive protein (CRP) is an acute-phase serum protein with binding reactivity to nuclear autoantigens and immunomodulatory function. The MRL/lpr mouse is an important model of human systemic lupus erythematosus (SLE). These mice develop high-titer anti-DNA antibodies and immune complex-mediated nephritis and exhibit progressive lymphadenopathy. The mortality rate among these mice is 50% by age 18-20 weeks; the most frequent cause of death is glomerulonephritis. The present study was undertaken to determine whether treatment of mice with CRP would affect the course of lupus nephritis. METHODS: MRL/lpr mice were treated with a single 200-mug injection of CRP at either age 6 weeks (before disease onset) or age 13 or 15 weeks (when proteinuria had reached high levels). Proteinuria was measured weekly, and levels of anti-double-stranded DNA autoantibodies and blood urea nitrogen were determined monthly. Glomerular immune complex deposition and renal pathology were assessed in mice ages 15 weeks and 17 weeks. RESULTS: Early CRP treatment markedly delayed the onset of proteinuria and lymphadenopathy, increased survival, and reduced levels of autoantibodies to DNA. Treatment of mice with active disease reversed proteinuria and prolonged survival. Renal disease was decreased in CRP-treated mice, with a marked suppression of glomerular pathology, tubular degeneration, and interstitial inflammation, which correlated with the decrease in proteinuria and azotemia. CONCLUSION: These findings demonstrate that systemic suppression of autoimmunity is initiated by a single injection of CRP. Long-term maintenance of CRP-mediated protection was reversed by injection of an anti-CD25 monoclonal antibody but not by macrophage depletion, suggesting that disease suppression is maintained by CD25-bearing T cells.

Animals↗