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PubMed2003

[Computerized registry of patients with thromboembolic disease in Spain (RIETE): background, objectives, methods, and preliminary results].

BACKGROUND: Venous thromboembolic disease (VTD) is a common and severe condition. Its anticoagulation-based treatment is not without complications and failures. OBJECTIVE: To create in Internet a broad database of patients with venous thromboembolic disease attended at spanish hospitals which might be helpful in the clinical practice. METHODS: Computerized registry of all incident cases of patients with objective diagnosis of VTD attended at 27 spanish hospitals since March, 1st, 2001. All data related to diagnosis, treatment and follow-up during at least a 3-month period were collected. RESULTS: Since March 1st to August 31st, 2001, 573 patients were included (399 with VTD, 108 with PE and 66 with VTD and PE). The mean age of patients was 65.8 years. 10.5 % of patients had at least one risk factor: 5.2% hypoprothrombinemia (< 50%), 3% history of recent hemorrhage, 1.8% creatinine higher than 3 mg/dl, 1.3% hemodynamic unstability, 1.1% pregnancy, and 1% thrombopenia lower than 60000 platelets/mm3. The three-month follow-up period was completed by 35.4% of patients, 21.8 % of them with events (death [4.7%], hemorrhage [12.5%], and VTD relapse [4.2%]). Hypoprothrombinemia was significantly associated with increased risk of complications and history of recent hemorrhage with relapse. CONCLUSIONS: It is feasible to create a database containing information on a relevant number of VTD patients, 10.5% of them with complications. Such information will allow its utilization at short-term for the decision-marking process, particularly for patients with complications.

Adolescent↗

PubMed2004

[Pulmonary hemorrhage and anti-phospholipid syndrome].

The presence of anti-phospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) associated to venous and/or arterial thrombotic phenomena and fetal losses define the anti-phospholipid syndrome. On rare occasions severe hypoprothrombinemia associated with this disease as a cause of hemorrhagic manifestations has been described. In addition very few cases of alveolar hemorrhage in anti-phospolipid syndrome (APS) have been described, being this complication usually related to microthrombosis and/or capillaritis of pulmonary vessels. We describe two patients without previous clinical manifestations of anti-phospholipid syndrome that showed pulmonary hemorrhage with anticardiolipin antibodies positivity. The first of them, a 33-year-old male, began his disease with low prothrombin time and the presence of antiprothrombin antibodies. In the biopsy by thoracoscopy the presence of pulmonary hemorrhage without capillaritis nor thrombotic phenomena was demonstrated, becoming evident certain clinical improvement and normalization of the prothrombin time after receiving immunosuppressive treatment but with persistence of the pulmonary hemorrhage 5 years later. The second case, a 89-year-old male, began his condition with bilateral lung infiltrates and hemoptysis, anticardiolipin antibodies positivity, and thrombopenia, with recurrence of the condition 1 year later. After other etiological possibilities were ruled out, and despite hemorrhagic trait in both patients, we consider that they should be in the clinical context of the anti-phospholipid syndrome, although at this time they did not meet the criteria recognized in order to diagnose this disease. Within the ampliable clinical spectrum of the anti-phospholipid syndrome we should take into account the pulmonary hemorrhage.

Adult↗

PubMed2000

Weekly 24-hour infusion of high-dose 5-fluorouracil plus folinic acid in combination with mitomycin C for the treatment of advanced gastric cancer.

PURPOSE: This study was performed to investigate the activity and safety of high dose 5-fluorouracil (5-FU) given as a weekly 24-hour infusion in combination with folinic acid plus mitomycin C in patients with advanced gastric cancer. PATIENTS AND METHODS: Chemonaive patients with locally advanced inoperable, recurrent or metastatic gastric cancer were treated with 15 mg/m(2) i.v. mitomycin C as bolus on day 1 of a 7-week cycle followed by a 2-hour infusion of folinic acid (500 mg/m(2)) and a 24-hour infusion of 5-FU (2,600 mg/m(2)) given on days 1, 8, 15, 22, 29, and 36 as outpatient treatment. RESULTS: Thirty evaluable patients (median age 58 years and median ECOG performance status 1) received 1-4 cycles (median 3). 53% of the patients had liver metastases. Treatment-related toxicity was low with 10% of patients experiencing diarrhea >/=grade 3, 3% mucositis grade 3 and 3% nausea grade 3 (CTC). Hematological toxicity was mild with 13% thrombopenia grade 3 and no leukopenia grade 4. Eleven patients achieved a partial remission (major response rate 37%; 95% confidence interval 22-53%). Median time to progression was 5 months and median overall survival time was 7 months. CONCLUSION: This regimen is a well-tolerated outpatient treatment for patients with advanced gastric cancer with efficacy being comparable to other chemotherapy protocols.

Adolescent↗

PubMed2000

Combination of Bolus 5-Fluorouracil, Folinic Acid and Mitomycin C in Advanced Gastric Cancer: Results of a Phase II Trial.

BACKGROUND: Gastric carcinoma still is a worldwide major cause of cancer death. Although various chemotherapy schedules yielded high response rates, median survival rarely exceeds 8-10 months. Many regimens are inevitably associated with significant toxicity which jeopardizes their value as palliative treatment, especially in patients with reduced performances status. Therefore, we initiated a phase II study for the treatment of advanced gastric carcinoma using a bolus regimen with mitomycin C (MMC), 5-fluorouracil (5-FU) and folinic acid (FA), allowing the enrollment of elderly patients or those with reduced performance status (WHO grade 2). PATIENTS AND METHODS: Between 1996 and 1998 we recruited a total of 58 patients with advanced gastric cancer to receive bolus MMC 3 mg/m(2), 5-FU 450 mg/m(2), and FA 100 mg/m(2) on days 1-3. Treatment was repeated on day 22. 53 patients met the inclusion criteria: male n = 36, female n =17; median age 65 (range 26-81); mean WHO status 1 (range 0-2). RESULTS: Out of 53 patients 50 were evaluable for response, all 58 patients who received therapy were evaluable for toxicity. Eleven patients (22%) achieved partial remission (95% CI: 11.5 -36.0%), 24 (48%) no change and 15 (30%) were progressive. Median overall survival was 11.5 months, the median time to progression 6.0 months. Out of 290 treatment cycles the worst toxicities observed (WHO 2/3/4) were as follows: anemia 13/3/1, leukopenia 19/1/1, thrombopenia 11/3/0, nausea/emesis 11/2/0, infections 2/1/0, diarrhea 14/2/0, and stomatitis 6/1/1. One patient developed hemolytic-uremic syndrome. CONCLUSIONS: The tumor control rate (PR + NC) of 70% was comparable to established chemotherapy regimens, while median overall survival was promising. Toxicity was mild, allowing the treatment especially for elderly patients and on outpatient basis. Copyright 2000 S. Karger GmbH, Freiburg

Journal Article↗

PubMed2001

Clopidogrel and side effects.

Clopidogrel is a recently developed thrombocyte inhibitor with fewer side effects. We report 2 patients with purpura and thrombopenia, respectively, due to clopidogrel therapy. As this compound is widely used in clinical practice, the occurrence of hematological and dermal side effects should be considered.

Aged↗

PubMed2004

A long-term follow-up study after split-course irradiation with concurrent chemotherapy (carboplatin) for locally advanced head and neck cancer and a review of the literature.

BACKGROUND: Radiotherapy is often the primary treatment for advanced head and neck cancer, but the rates of locoregional recurrence are high and survival is poor. The purpose of this study was to evaluate the efficacy and toxicity of split-course radiotherapy combined with concurrent carboplatin chemotherapy after long-term follow-up. PATIENTS AND METHODS: From August 1987 to May 1994, 66 patients (54 males, 12 females, mean age 58 years) with advanced inoperable oropharynx cancer were treated at the University of Göttingen, Göttingen, Germany. Tumour localization in the oropharynx was: tonsil (n = 33), base of tongue (n = 28), soft palate (n = 2) and posterior pharyngeal wall (n = 3). Forty-nine patients presented with a T(4) tumour, 15 were T(3) and 2 were T(2). The nodal status was distributed as follows: N0 (n = 7), N1 (n = 5), N2 (n = 28) and N3 (n = 26). A total radiation dose of 5,670 cGy was applied in 6 weeks as a split-course regimen (2 x 2.1 Gy/day, 4 times a week, weeks 1 and 2 and weeks 5 and 6). Concomitant carboplatin chemotherapy was given each radiotherapy day before irradiation (50 mg/m(2)). RESULTS: In December 2003, 12 patients were still alive. Survivors have reached a maximum follow-up of 170.5 months (median 14.3 months). Two- and 5-year overall survival was 32 and 18%, 2-year disease-free survival 27%. Therapy was tolerated moderately (19% grade 3 skin reaction, 26% grade 3 mucositis, 23% grade 3 xerostomia, 20% grade 3 leucopenia, 8% grade 3 thrombopenia and 25% grade 3 anaemia). CONCLUSION: Split-course radiotherapy and concomitant carboplatin chemotherapy can be carried out in inoperable head and neck cancer without severe toxicity. After long-term follow-up, survival rates are unfavourable in this poor prognostic group of patients.

Adult↗

PubMed2005

A phase II trial of raltitrexed (Tomudex) in advanced pancreatic and biliary carcinoma.

PURPOSE: To evaluate the impact of raltitrexed (Tomudex) on the quality of life in a multicenter, phase II study in advanced pancreatic and biliary carcinomas. PATIENTS AND METHODS: Forty-six patients with advanced, histologically proven pancreatic (n = 37, 80.4%) or biliary (n = 9, 19.6%) carcinoma received 3 mg/m2 raltitrexed intravenously once every 3 weeks. For the quality of life assessments, EORTC QLQ-C30 was used, and the evaluation of the clinical benefit was performed according to the 4 criteria of the clinical benefit response. All patients were assessed for safety, and 41 patients were evaluable for objective response. RESULTS: Patients (63% male/37% female) had a mean age of 61.2 years, 71.7% had a PS of 0-1, 78.3% had metastatic disease, and 63% had at least 2 tumoral sites. A total of 176 cycles were administered with a mean of 4 cycles per patient (range 1-12). Three out of 43 patients evaluable for EORTC QLQ-C30 (7.0%; CI(95%) 1.4-19.0%) had a quality of life improvement. Thirty-two patients fulfilled the 4 criteria required to evaluate the clinical benefit response; 5 were responders (15.6%; CI(95%) 5.3-32.8%); 1 patient was a good responder based on both the EORTC questionnaire and the clinical benefit response. Forty-one patients were assessable for response, 3 responded to treatment (response rate: 6.5 %; CI(95%) 1.3-17.9%). Median survival was 4.6 months (CI(95%) 2.9-8.2 months), the 1-year survival rate was 21.8%. The most common grade 3-4 toxicities were neutropenia (8%), leukopenia (8%), thrombopenia (6%), anemia (6%), liver enzyme elevations (11%), asthenia (9%), vomiting (9%), abdominal pain (7%), and phlebitis (6%). One treatment-related death occurred (neutropenic sepsis). CONCLUSION: Raltitrexed appeared to be generally well tolerated and showed a clinical benefit response and/or quality of life improvement in a limited number of patients.

Antimetabolites, Antineoplastic↗

PubMed2006

The role of platelets during reproduction.

The availability of mice with defined defects within the hemostatic system enabled researchers to identify a role the coagulation system for embryonic and placental development. However, the role of platelets during development has only recently been experimentally addressed, giving some insight into potential functions of platelets during development. Thus, a quantitative embryonic platelet defect (severe thrombopenia secondary to NF-E2 deficiency) is associated with an embryonic growth retardation and reduced vascularisation of the placenta. Maternal platelet deficiency is associated with placental hemorrhage, which, however, does not impair embryonic or maternal survival. In vitro studies established that platelets or platelet conditioned medium regulate the invasive properties of human extravillous trophoblast cells and induce a phenotypical switch of trophoblast cells. These data imply that platelets are of relevance during placentation. Conversely, platelets and the formation of platelet-fibrin aggregates are dispensable for the development of the embryo proper, establishing that the lethal phenotypes observed in some embryo slacking coagulation regulators does not result from an inability to form platelet-fibrin aggregates, but likely reflects altered protease dependent signaling during vascular development.

Animals↗

PubMed1990

Silent renal microangiography after mitomycin C therapy.

Mitomycin C (MMC) is an alkylating agent which has been associated with microangiopathic hemolytic anemia and acute renal failure, with an overall incidence between 2 and 10%. This complication can develop several months after the initiation of chemotherapy. Isolated renal impairment without overt microangiopathic hemolytic anemia, although reported, is less frequently documented. We describe a 63-year-old man who developed progressive renal failure without any evidence of hemolysis or thrombopenia 10 months after beginning chemotherapy with MMC and Ftorafur. A renal biopsy displayed features of microangiopathy. The patient required the institution of chronic hemodialysis. In conclusion, it is important to be aware of this indolent but severe renal complication in patients treated with MMC. Urinary parameters and renal function should be monitored over a long period for an early diagnosis.

Adenocarcinoma↗

PubMed1996

Typical and atypical hemolytic uremic syndrome.

The hemolytic uremic syndrome is the most frequent cause of acute renal failure in childhood. In the vast majority of patients, the syndrome of acute hemolysis, thrombopenia and renal dysfunction is preceded by an episode of diarrhea with or without bloody stools. This colitis is caused by different strains of Escherichia coli which produce shiga like toxins. These toxins are responsible for both hemolysis and renal disease. There are good reasons for distinguishing patients with D (+) HUS and those without prodromal diarrhea [D (-) HUS], especially since the outcome in the latter group is less predictable and on average fairly unfavorable. D (+) HUS has also been labeled 'typical HUS' and D (-) HUS as 'atypical HUS'. This has led to some oversimplification, in that atypical has become synonymous with poor outcome. Our experience comprises 20 D (-) HUS patients, of whom 14 did extremely well. Scrutinizing the data of our patients lead to the conclusion that, within the D (-) group, some have a 'typical course' and display complete cure whereas those with an 'atypical course' either die or have severe sequelae.

Diarrhea↗

PubMed1982

Antirifampicin antibodies in acute rifampicin-associated renal failure.

5 patients with acute renal failure (3 with thrombopenia and hemolysis) induced by the reintroduction of rifampicin are described. No correlation was found between the severity of clinical manifestations and the total dose taken by the patients. In all but 1 patient, antirifampicin antibodies were detected. Antibodies suggested to be of the IgM class were detected in all 3 patients with hematological disorders. The pattern of non-specific acute tubular necrosis found in the 2 biopsied patients, indistinguishable from that of ischemic origin, raised the possibility of a vascular-mediated damage. In 3 patients, the possibility of a triggering immunoallergic mechanism is discussed.

Acute Kidney Injury↗

PubMed1982

[Coagulation disorders in tumors and hemoblastoses].

Thromboembolic and haemorrhagic complications are not rarely seen in the course of malignant diseases. The underlying coagulation disorders were investigated by means of coagulation analysis in 61 patients with solid tumors and 60 control persons as well as 51 patients with leukemia and 50 control persons. As a cause for the thrombotic diathesis in patients with solid tumors and leukemias can be demonstrated a hypercoagulability (shortened PTT and raised factor VIII activity). In addition we found a raised level of fibrinogen, a hypofibrinolysis (prolonged euglobulin lysis time) and in increased platelet aggregation in patients with solid tumors. Predominantly bleeding complications in leukemias are caused by thrombopenia. Another reason, however, may be an activated fibrinolysis or a clot instability because of the reduction of factor XIII. Pathogenetic mechanisms, underlying the tumor induced coagulation disorders, as for example the release of tumor cell thromboplastins from malignant cells are discussed.

Adult↗

PubMed1992

Russell's viper venom: effects on coagulating whole blood in vitro.

Russell's viper venom (RVV) leads to a strong activation of the coagulation system with consumptive coagulopathy and thrombopenia. For better comprehension of the pathophysiologic process, the effect of RVV was examined in an in vitro model of hemostasis. The stimulation of the coagulation system and of platelet activity can be discriminated by sequential measuring of fibrinopeptide A (FPA) generation and platelet factor 4 (PF 4) release, respectively. In coagulating whole blood both parameters show a parallel response curve in the control series (n = 6) with an initial slow phase followed by a rapid phase after 4.7 +/- 0.8 min (FPA) and 6.0 +/- 0.9 min (PF 4) of the incubation period. Varying concentrations of RVV (15, 50, 100 and 1,000 ng/ml; n = 6 each) cause a dose-dependent stimulation of FPA generation as well as of PF 4 secretion. Clot formation time shows a decrease from 9 min (controls) to 6.3 +/- 2.0 min (100 ng/ml RVV) and 2.7 +/- 0.5 min (1,000 ng/ml), respectively. The concomitant addition of antithrombin III (AT III, 20 U/ml) and RVV (100 ng/ml) leads to a nearly complete normalization of hemostasis in vitro. The beginning of the rapid activation phase is comparable to that of the control group, clot formation does not occur during the 10-min incubation period. Heparin (1 IU/ml) acts as an antagonist not only of the venom-induced FPA generation, but also of the PF 4 release. Prostaglandin E1 (PGE1) (150 ng/ml) does not inhibit the RVV-stimulated FPA generation, but causes a moderate inhibition of PF 4 secretion, especially during the rapid phase.(ABSTRACT TRUNCATED AT 250 WORDS)

Dose-Response Relationship, Drug↗

PubMed1990

[Fotemustine, a new nitrosourea derivative. Current status of development].

Fotemustine is a new chloronitrosourea recently developed by the French company Servier. It is chemically characterized by the graft of an aminophosphonic acid on the chloronitrosourea radical, which makes it highly lipophil. The preclinical studies revealed a lower mutagenicity and hepatotoxicity when compared to BCNU. The pharmacokinetic studies showed a high body clearance and a short half-life. The phase I study enabled us to determine the definitive treatment schedule: 100 mg/m2/week during 3-4 consecutive weeks followed by 5 weeks' rest and a maintenance therapy of 100 mg/m2 every 3 weeks for stabilized or responding patients. Fotemustine should be given as a 1-h intravenous infusion, protected from daylight. There was no life-threatening toxicity and positive activity was observed in different tumors and especially melanomas. This indication was thus chosen for the phase II study. Among the 153 evaluable patients, the response rate reached 24.2%. It depended on the location of the metastatic sites, with 25% brain metastases, 19.2% visceral metastases, 8.8% liver metastases and 31.8% skin and lymph node metastases. The median duration of response was 22 weeks. The median overall survival of responding patients reached 85 weeks, while it dropped to 52 weeks in case of minor response or stabilization and 17 weeks in case of progression. The hematological toxicity was moderate (WHO grade III and IV: 46.3% leukopenia and 40.3% thrombopenia) and delayed as for other nitrosoureas (nadir: white blood cells: day 44 and thrombocytes: day 35).(ABSTRACT TRUNCATED AT 250 WORDS)

Antineoplastic Agents↗

PubMed1990

[Alpha 2-interferon in kidney cancer. Experiences with 6 patients].

We report on 6 male patients with advanced renal cell carcinoma without prior chemotherapy. They were treated by recombinant alpha 2-interferon in a toxicity limited dosage. The maximal tolerated dose was 3 x 5 x 10(6) U/wk. to 3 x 20 x 10(6) U/wk., limited by flu-like symptoms in 5 cases, by thrombopenia in 1. We observed a response in 3 cases (2 partial remissions, 1 mixed response) lasting for 10, 11 and 13 months, respectively. This comparatively good result may be due to patient characteristics (little pretreatment, pulmonary metastasis, good performance status) as well as to a medium dosage. Occurrence of response after termination of interferon therapy in two cases are of particular interest.

Carcinoma, Renal Cell↗

PubMed1975

Combination chemotherapy with CCNU (NSC-79037),hexamethylmelamine (NSC-13875) and methotrexate (NSC-740) in advanced bronchogenic carcinoma.

18 patients with metastatic or recurrent bronchogenic carcinoma and one patient with a squamous cell carcinoma of the trachea were treated with a combination of CCNU, hexamethylmelamine and methotrexate. Objective remissions were observed in 3/19 (16%): 1 complete, 1 partial (greater than 50%) and 1 incomplete (less than 50%). However, the patient with the complete response was the only drug death, on day 21. Remission duration in the other two patients was 3 and 9+ months respectively. One patient with oat cell carcinoma experienced no tumor progression for 5 months. This combination resulted in severe gastrointestinal toxicity in 5/19, severe thrombopenia in 12/19 and severe neutropenia in 6/19. We conclude that the combination as used here resulted in no increased clinical effectiveness and proved to be quite toxic.

Aged↗

PubMed1989

Prednimustine treatment in malignant lymphomas.

Prednimustine (Stereocyt, Leo 1031) is a chlorambucil ester of prednisolone. Results from clinical trials confirm that prednimustine is active in malignant lymphomas. The efficacy of Stereocyt was evaluated in 25 patients, who were divided into three subgroups: 10 patients with refractory Hodgkin's disease and 7 with refractory non-Hodgkin lymphoma (NHL), while 8 patients received prednimustine as primary therapy for low-grade NHL. Totally 17 partial remissions were observed in all three groups of patients. Leukopenia and thrombopenia were induced in 3 patients, but were mild and reversible after withdrawal of the drug.

Adult↗

PubMed1991

Ifosfamide and mesna for the treatment of advanced squamous cell head and neck cancer. A GETLAC study.

High-dose ifosfamide/mesna was administrated to 28 mostly pretreated patients with locally advanced and metastatic head and neck cancer who failed conventional surgery/radiation treatment. Primary sites include tongue (5), salivary gland (3), floor of mouth (5), oropharynx (2), hypopharynx (5) and larynx (8). The dose and schedule of ifosfamide (IF) was 3.5 g/m2 8 h, i.v. infusion, days 1-5, every 28 days, and mesna was given as 20% of IF dose intravenous bolus injection at 0, 2, 4, 6 and 8 h; mesna 40% of IF dose was given by oral route at 10 and 12 h, days 1-5, every 28 days. All patients were evaluable for both toxicity and response. 14 patients had received prior treatment with surgery plus radiation therapy and 14 patients radiation therapy. Following chemotherapy, 4 patients (14.2%) achieved complete remission and 8 patients (28.5%) achieved partial remission, with an overall response rate of 42.7%. Toxicity was reported for 186 cycles and ranged from mild to moderate: anemia 4, leukopenia 6, thrombopenia 1, nausea and vomiting 12, alopecia 28, microscopic hematuria 3, increased transaminase 1. No CNS symptoms and renal toxicity were registered. Median duration of survival is 11+ months (range 3+ to 18+ months). Nine patients died. We conclude that ifosfamide/mesna at this dose and schedule has a significant activity in recurrent head and neck cancer, and produces minimal toxicity.

Adult↗