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Biomedical subjects

C Chastang

Publications and source records attributed to C Chastang.

At least 55 records · Page 3Linked to original sources
PubMed1998

Treatment of early AIDS-related Kaposi's sarcoma with oral all-trans-retinoic acid: results of a sequential non-randomized phase II trial. Kaposi's Sarcoma ANRS Study Group. Agence Nationale de Recherches sur le SIDA.

OBJECTIVE: To assess the efficacy and safety of all-trans-retinoic acid (ATRA), a retinoid with antitumour activity that inhibits in vitro the growth of Kaposi's sarcoma cells, in patients with low-risk AIDS-associated Kaposi's sarcoma. DESIGN: Non-randomized phase II study, using a group sequential procedure to determine whether the response rate to ATRA was above 10%. SETTING: Nine referral French centres. PATIENTS: Twenty HIV-seropositive men with CD4 cells > or = 200 x 10(6)/l, low-risk Kaposi's sarcoma [T0I0S0 according to the classification of AIDS Clinical Trials Group (ACTG)] not previously treated with systemic anti-Kaposi's sarcoma agents, and with at least four measurable lesions were included. INTERVENTIONS: ATRA was given orally 45 mg/m2 daily for 12 weeks. MAIN OUTCOME MEASURE: Tumour response evaluated according to ACTG criteria. RESULTS: Nineteen patients were evaluated for response: partial response, stabilization and progression were found in eight (42%), seven (37%), and four (21%) patients, respectively. Gradual flattening and lightening of lesions was observed in responders after at least 2 months of ATRA. All patients with partial response at week 12 pursued ATRA for another 15+/-7 weeks. Further improvement was observed in six patients. Median duration of response was 332 days. Cheilitis, transient headaches and skin dryness were the main toxicities noted. No significant changes in HIV viral burden or serum interleukin-6 pathways were observed. CONCLUSIONS: ATRA is well tolerated and effective enough in Kaposi's sarcoma patients to warrant further evaluation.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Incidence, clinical features, and outcome of all trans-retinoic acid syndrome in 413 cases of newly diagnosed acute promyelocytic leukemia. The European APL Group.

All trans-retinoic acid (ATRA) syndrome is a life-threatening complication of uncertain pathogenesis that can occur during the treatment of acute promyelocytic leukemia (APL) by ATRA. Since its initial description, however, no large series of ATRA syndrome has been reported in detail. We analyzed cases of ATRA syndrome observed in an ongoing European trial of treatment of newly diagnosed APL. In this trial, patients 65 years of age or less with an initial white blood cell count (WBC) less than 5,000/microL were initially randomized between ATRA followed by chemotherapy (CT) (ATRA-->CT group) or ATRA with CT started on day 3; patients with WBC greater than 5,000/microL received ATRA and CT from day 1; patients aged 66 to 75 received ATRA-->CT. In patients with initial WBC less than 5, 000/microL and allocated to ATRA-->CT, CT was rapidly added if WBC was greater than 6,000, 10,000, 15,000/microL by days 5, 10, and 15 of ATRA treatment. A total of 64 (15%) of the 413 patients included in this trial experienced ATRA syndrome during induction treatment. Clinical signs developed after a median of 7 days (range, 0 to 35 days). In two of them, they were in fact present before the onset of ATRA. In 11 patients, they occurred upon recovery from the phase of aplasia due to the addition of CT. Respiratory distress (89% of the patients), fever (81%), pulmonary infiltrates (81%), weight gain (50%), pleural effusion (47%), renal failure (39%), pericardial effusion (19%), cardiac failure (17%), and hypotension (12%) were the main clinical signs, and 63 of the 64 patients had at least three of them. Thirteen patients required mechanical ventilation and two dialysis. A total of 60 patients received CT in addition to ATRA as per protocol or based on increasing WBC; 58 also received high dose dexamethasone (DXM); ATRA was stopped when clinical signs developed in 30 patients. A total of 55 patients (86%) who experienced ATRA syndrome achieved complete remission (CR), as compared with 94% of patients who had no ATRA syndrome (P = .07) and nine (14%) died of ATRA syndrome (5 cases), sepsis (2 cases), leukemic resistance (1 patient), and central nervous system (CNS) bleeding (1 patient). None of the patients who achieved CR and received ATRA for maintenance had ATRA syndrome recurrence. No significant predictive factors of ATRA syndrome, including pretreatment WBC, could be found. Kaplan Meier estimates of relapse, event-free survival (EFS), and survival at 2 years were 32% +/- 10%, 63% +/- 8%, and 68% +/- 7% in patients who had ATRA syndrome as compared with 15% +/- 3%, 77% +/- 2%, and 80% +/- 2% in patients who had no ATRA syndrome (P = .05, P = .003, and P = .03), respectively. In a stepwise Cox model that also included pretreatment prognostic variables, ATRA syndrome remained predictive for EFS and survival. In conclusion, in this multicenter trial where CT was rapidly added to ATRA in case of high or increasing WBC counts and DXM generally also used at the earliest clinical sign, the incidence of ATRA syndrome was 15%, but ATRA syndrome was responsible for death in only 1.2% of the total number of patients treated. However, occurrence of ATRA syndrome was associated with lower EFS and survival.

Acute Kidney Injury↗
PubMed1998

Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Cooperative Group on Melanoma.

BACKGROUND: Owing to the limited efficacy of therapy on melanoma at the stage of distant metastases, a well-tolerated adjuvant therapy is needed for patients with high-risk primary melanoma. Our hypothesis was that an adjuvant treatment with low doses of interferon alpha could be effective in patients with localised melanoma. METHODS: After resection of a primary cutaneous melanoma thicker than 1.5 mm, patients without clinically detectable node metastases were randomly assigned to receive either 3x10(6) IU interferon alpha-2a, three-times weekly for 18 months, or no treatment. The primary endpoint was the relapse-free interval. FINDINGS: 499 patients were enrolled, of whom 489 were eligible. When used as part of a sequential procedure, interferon alpha-2a was of significant benefit for relapse-free interval (p=0.038). A long-term analysis, after a median follow-up of 5 years, showed a significant extension of relapse-free interval (p=0.035) and a clear trend towards an increase in overall survival (p=0.059) in interferon alpha-2a-treated patients compared with controls. There were 100 relapses and 59 deaths among the 244 interferon alpha-2a-treated patients compared with 119 relapses and 76 deaths among the 245 controls. The estimated 3-year-relapse rates were 32% in the interferon alpha-2a group and 44% in controls; the 3-year death rates were 15% and 21%, respectively. Only 10% of patients experienced WHO grade 3 or 4 adverse events. Treatment was compatible with normal daily life. INTERPRETATION: Adjuvant therapy of high-risk melanoma with low doses of interferon alpha-2a for 18 months is safe and is beneficial when started before clinically detectable node metastases develop.

Antineoplastic Agents↗
PubMed1998

Treating ectopic pregnancy with the combination of mifepristone and methotrexate: a phase II nonrandomized study.

OBJECTIVE: Our goal was to compare the use of a combination of methotrexate and mifepristone with methotrexate alone in the medical management of ectopic pregnancy. STUDY DESIGN: This was a preliminary nonrandomized phase II study. All patients with progressing ectopic pregnancy meeting criteria for medical management were included. Treatment consisted of 50 mg/m2 of methotrexate injected intramuscularly and 600 mg of mifepristone, administered orally, compared with a previous group who received only 50 mg/m2 of methotrexate injected intramuscularly. RESULTS: Of the 30 patients treated with the combination, there was only 1 failure, whereas medical treatment had failed for 11 of 42 patients treated with methotrexate alone. CONCLUSIONS: The combination of mifepristone and methotrexate decreased the risk of failure in medical treatment of ectopic pregnancy.

Abortifacient Agents, Steroidal↗
PubMed1998

Reinforced regimen of interferon alfa-2a reduces the incidence of cirrhosis in patients with chronic hepatitis C: a multicentre randomised trial. Multicentre GER-CYT-04 Group.

BACKGROUND/AIMS: Our aim was to assess and compare the long-term effect of interferon at standard (6 months) and reinforced dose and duration regimens in chronic hepatitis C. METHODS: A multicentre institutional trial included 244 previously untreated patients with chronic hepatitis C, without cirrhosis, who were randomly allocated to either standard (3 MU thrice a week for 24 weeks; n=120) or reinforced (6 MU daily for 12 days, 6 MU thrice a week for 22 weeks, 3 MU thrice a week for 24 weeks; n=124) regimens. The main endpoint was sustained ALT response at 72 weeks (18 months); secondary end-points were virological (branched DNA and PCR) and histological responses (incidence of cirrhosis) at month 18. RESULTS: Sustained ALT response was observed in five patients (4%, 95% confidence interval 0-8%) in the standard group and in 21 patients (18%, 95% confidence interval 11-25%), from the reinforced group (p=0.002), in agreement with virological response in 21 (81%) patients. Cirrhosis at month 18 was observed in ten (10%) patients in the standard group and one (1%) in the reinforced group (p=0.004). CONCLUSIONS: The standard regimen of interferon, in chronic hepatitis C, confers a minimal sustained response rate at 18 months and may not prevent the occurrence of cirrhosis. Reinforced regimens allow sustained response to be reached in a limited number of patients and reduce the risk of cirrhosis during 18 months of follow-up.

Adult↗
PubMed1998

Albendazole for treatment and prophylaxis of microsporidiosis due to Encephalitozoon intestinalis in patients with AIDS: a randomized double-blind controlled trial.

A double-blind placebo-controlled trial was conducted to assess the efficacy and safety of albendazole (400 mg twice daily for 3 weeks) for the treatment of Encephalitozoon intestinalis infection in patients with AIDS. Clearance of microsporidia from the intestinal tract was obtained in 4 of 4 patients in the albendazole group versus 0 of 4 in the control group (P = .01, one-sided Fisher's exact test) and was associated with significant clinical benefit. All 4 controls subsequently cleared microsporidia following open-labeled albendazole treatment. To investigate the effect of albendazole in preventing relapse, these 8 patients were then randomly assigned to receive either albendazole (400 mg twice daily) or no treatment for the next 12 months. Albendazole significantly delayed the occurrence of relapse (P = .04, one-sided log-rank test). In human immunodeficiency virus-infected patients with E. intestinalis infection, albendazole has parasitologic and clinical efficacy and reduces the risk of relapse.

AIDS-Related Opportunistic Infections↗
PubMed1998

Prospective assessment of an intervention to rationalize prescribing of nonsteroidal anti-inflammatory drugs.

Guidelines for the prescription of nonsteroidal anti-inflammatory drugs (NSAIDs), drawn in the Health Ministry and published by the Drug Regulatory Agency, were introduced in the emergency department of a university hospital. The main objective was to determine, in this prospective, before-and-after study, whether a teaching program could help doctors improve their NSAID prescribing practices. Correct prescribing included limiting NSAIDs to their most admitted indications, avoiding their prescription to accident-prone patients, and reducing treatment duration and daily dosage. An overall reduction of NSAID prescriptions was also expected. Prescribing errors were divided into violations (prescribing when unwarranted or against a contraindication) and inadequacies (if the compound or treatment schedule was not suited to the condition addressed). We measured the effect of the intervention 45 days after its initiation. Twenty-seven doctors participated in the two study phases (595 and 520 patients) and wrote 50 NSAID prescriptions in each (8.4% and 9. 6% of patients, respectively; P = 0.44). Prescribing errors decreased from 20% to 14% of cases (P = 0.60). There was a trend toward more prescriptions conforming to the Drug Regulatory Agency guidelines (P = 0.08). Treatment duration decreased from 10.4 +/- 5. 4 to 9.0 +/- 4.0 days (P = 0.03). The teaching of guidelines has helped physicians to improve their NSAID prescribing practices; however, it did not succeed in curbing the overall prescription rate. Unrestricted lists that include soft indications may influence younger doctors into prescribing more NSAIDs.

Adult↗
PubMed1998

Cord blood banking and transplant in Europe. Eurocord.

The number of cord blood transplants has been increasing very quickly with more than 250 cases reported to Eurocord Registry and more than 500 patients transplanted via the New York Cord Blood Bank. Cord blood transplants have been performed either with related or unrelated cord blood. Several cord blood banks established a group called Netcord whose goal is the standardization of the procedures, the organization of internal audits for accreditation and qualification, and the communication and exchange by internet of donor search on an international basis. More than 15,000 units of frozen cord blood are currently available and this number is increasing rapidly worldwide. Analysis of the clinical results has shown that related cord blood transplants give better results than unrelated cord blood transplants. Factors associated with better survival in related and unrelated cord blood transplants were lower age, diagnosis, with better results in inborn errors and in good risk children with acute leukemia. A larger number of nucleated cells in the transplant and the recipient being negative for CMV serology were also favourable risk factors for survival. Engraftment was improved with higher numbers of cells and HLA identity. Graft versus Host disease was reduced when compared to transplants of adult allogeneic bone marrow or peripheral blood progenitor cells. HLA disparities did not influence GVH; the only factor associated with increased GVH was positive CMV serology in the recipient. This study shows that cord blood is an alternative source of hematopoietic stem cells for allogeneic transplantation in children and in some adults. HLA disparity is not a limiting factor but the number of cells infused is important; currently the use of a number of nucleated cells inferior to 1 x 10(7)/kg is not recommended. Several questions remain including the criteria of choice of the donor, the indications in children and in adults, the comparison of cord blood transplants to other sources of hematopoietic stem cells and the role of growth factors and expansion for improving the speed of engraftment.

Adult↗
PubMed1998

Variability in knee radiographing: implication for definition of radiological progression in medial knee osteoarthritis.

OBJECTIVES: (1) To assess reproducibility of medial knee joint space width (JSW) measurement in healthy subjects and osteoarthritic (OA) patients. (2) To define minimal relevant radiological change in knee JSW based on the reproducibility of its measurement. PATIENTS AND METHODS: (1) Healthy volunteers: in the first part of the study, 20 knees of healthy adult volunteers were radiographed in the weightbearing, anteroposterior extended view, twice, two weeks apart, using three different radiographic procedures: (a) without guidelines, (b) with guidelines and without fluoroscopy, (c) with guidelines and fluoroscopy. (2) Knee OA patients: in the second part of the study, 36 knees of OA patients were radiographed twice with guidelines and without fluoroscopy. JSW was measured blindly using a graduated magnifying glass. Based on the Bland and Altman graphic approach, cut off points defining minimal relevant radiological change are proposed. RESULTS: Standard deviation (SD) of differences in JSW measurement between two sets of knee radiographs in healthy subjects were 0.66 mm for radiography performed without guidelines, 0.37 mm for radiography performed with guidelines and without fluoroscopy, and 0.31 mm for radiography with guidelines and fluoroscopy. SD of differences in JSW measurement in OA patients were 0.32 mm for radiography performed with guidelines and without fluoroscopy. A minimal relevant change in JSW between two radiographs performed in healthy subjects can be defined by a change of at least 1.29 or 0.59 mm when radiographs are taken without guidelines, and with guidelines and fluoroscopy, respectively. When radiographs are taken with guidelines and without fluoroscopy, the change must be at least 0.73 mm. A similar figure, 0.64 mm was observed in knee OA patients. CONCLUSION: Definition of radiological progression varies greatly according to the radiographic procedure chosen. Use of guidelines reduces the threshold of progression required to consider that change between two measures is relevant.

Adult↗
PubMed1998

Outpatient treatment with subcutaneous interleukin-2 and interferon alfa administration in combination with fluorouracil in patients with metastatic renal cell carcinoma: results of a sequential nonrandomized phase II study. Subcutaneous Administration Propeukin Program Cooperative Group.

PURPOSE: We report the results of the Subcutaneous Administration Propeukin Program (SCAPP) II trial of an outpatient treatment in renal cell carcinoma using interleukin-2 (IL-2) and interferon alfa-2a (IFN-alpha) administered subcutaneously in combination with fluorouracil (5-FU). The objective of this multicenter trial was to confirm that the combination of IL-2, IFN-alpha, and 5-FU leads to a response rate greater than 20%. PATIENTS AND METHODS: Patients with metastatic renal cell carcinoma were included in this study. During the induction phase of the treatment, which lasted 10 weeks, IL-2 and IFN-alpha were administered subcutaneously three times a week for 8 weeks at doses of 18 MIU and 9 MIU, respectively. During these 8 weeks, every Monday, 5-FU was administered at a dose of 750 mg by intravenous infusion over 30 minutes. After evaluation, responding patients or patients with stable disease (SD) were given maintenance treatment, until disease progression (PD) or the appearance of unacceptable toxicity. Each maintenance cycle consisted of a 2-week treatment followed by a three-week rest period. During treatment, IL-2 and IFN-alpha were administered subcutaneously three times a week at doses of 18 MIU and 9 MIU, respectively. Every Monday, 5-FU was administered at a dose of 750 mg by intravenous infusion over 30 minutes. RESULTS: This trial was closed when the sixth sequential analysis showed the lack of benefit from this combination. At the end of the induction period, of 62 patients, 12 (19%; 95% confidence interval [CI], 10% to 31%) reached an objective response, including one complete response (CR), 16 presented with SD, and 27 showed PD. Twenty-seven patients (43%) developed severe toxicity that required reduction of the planned doses (13 patients), delayed treatment (eight patients), or treatment termination (six patients). Seventeen patients were given maintenance treatment. One- and 2-year survival rates were estimated at 55% and 33%, respectively. The 2-year survival rate was 15% in 11 patients who presented with three poor-prognosis factors and 41% in 51 patients who initially presented with no, one, or two poor-prognosis factors (P = .04). CONCLUSION: As in other recently published studies that used 5-FU, IL-2, and IFN-alpha, the multicenter SCAPP II trial in patients with metastatic renal cell carcinoma generated severe toxicity. This sequential trial failed to confirm the favorable results previously obtained by Atzpodien and Sella with this combination of three drugs. Its efficacy, assessed on the response and survival rates, is near to the results observed in programs that used IL-2 alone given subcutaneously.

Adult↗
PubMed1998

Prognostic significance of supraclavicular lymph nodes in small cell lung cancer: a study from four consecutive clinical trials, including 1,370 patients. "Petites Cellules" Group.

STUDY OBJECTIVE: To determine the prognostic significance of supraclavicular lymph node (SCLN) involvement in small cell lung cancer. MATERIALS AND METHODS: Patients (1,370) with small cell lung cancer were included in four consecutive clinical trials and classified as having either limited or extensive forms of disease using the Veterans Administration staging system. RESULTS: SCLN was present in 17% of patients (n = 234). Median survival was 258 days for patients with SCLN (n = 234) and 297 days for patients without SCLN (n = 1136) (p = 0.002). SCLN involvement was correlated with the presence of distant metastases at baseline (169 vs 65, p = < 0.001). Median survival was 375 days for patients with limited forms without SCLN (n = 529), 332 days for those with limited forms with SCLN (n = 65) (p = 0.12), 244 days for those with extensive forms without SCLN (n = 604), and 228 days for those with extensive forms with SCLN (n = 169) (p = 0.94). The 2-year survival rates were 17%, 12%, 2%, and 4%, respectively. Cox models confirmed that SCLN did not provide any significant additional prognostic information. CONCLUSION: SCLN is highly correlated with extensive forms explaining its overall prognostic value. In limited disease, SCLN is only a minor poor prognostic factor, not justifying any amendment to the staging system currently used.

Adult↗
PubMed1998

Related cord blood transplants: the Eurocord experience from 78 transplants. Eurocord Transplant group.

Eurocord Transplant has established a registry for studying results of cord blood transplant. We have analyzed 78 patients who have received a related CBT between October 1988 and December 1996. The median follow-up time was 29 months (1-99). The median age was 5 years (0.2-20), median weight 19 kg (5-50). Forty-six patients had a malignant disease: 32 acute leukemia (AL), six chronic myeloid leukemia (CML), four myelodysplastic syndrome, two neuroblastoma and two non-Hodgkin lymphoma. Thirty-two patients were transplanted for non-malignant diseases including 17 bone marrow failure syndromes (BMFS), three sickle cell anemia, five thalassemia and seven inborn errors. The donor was an HLA-identical sibling in 60 cases and an HLA-mismatched donor in 18 cases. As conditioning, 36 patients received irradiation and 40 patients received associated busulfan-containing regimens. GVHD prophylaxis consisted of CsA alone in 36 cases, CsA associated with prednisone in eight cases, CsA, methotrexate (Mtx) with or without prednisone in 28 cases and CsA with monoclonal antibody or ATG in four cases. The median number of nucleated cells (NC) infused/kg was 3.9 x 10(7) (0.7-15). One-year survival was 63 +/- 6%. Age, weight, HLA identity and negative cytomegalovirus (CMV) serology in the recipient were significant favorable prognostic factors. Among these 78 patients, the incidence of grade > or = II GVHD was 9% in HLA-matched CBT and 50% in mismatched CBT (P < 0.001). Neutrophil engraftment was associated with age <6 years (P = 0.02) and weight <20 kg (P = 0.02). It was 73% in patients receiving <3.7 x 10(7) nucleated cells (NC) infused/kg and 85% in patients receiving more (P = 0.06). Favorable factors for platelets engraftment were age <6 years (P = 0.03), weight <20 kg (P = 0.002) and HLA identity (P < 0.0001). Related cord blood transplantation offers a good alternative to BMT. Theses results are in favor of freezing cord blood in families in whom a transplant might be indicated.

Adolescent↗
PubMed1998

Cord blood transplantation for children with acute leukemia. Eurocord Transplant Group.

Over the past decade, allogeneic cord blood transplantation (CBT) has been widely used for treating patients with malignant disorders. However, the reported low incidence of GVHD observed after allogeneic CBT might be a major drawback in leukemic recipients and at present it is not clear whether CBT really predisposes patients to an increased risk of leukemia relapse. In order to further elucidate the role of CBT in children with hematological malignancies, 54 patients with ALL or AML given either a related (31 cases) or an unrelated (23 cases) CBT in 25 centers participating in the Eurocord Registry were analyzed. Overall survival of related and unrelated CBT recipients was substantially similar, the most important factor influencing patients' outcome being disease state at time of transplantation. In fact, due to a markedly increased relapse rate, poor-risk children (ie patients transplanted in more advanced disease) experienced a significantly worse EFS than those given CBT in a more favorable disease phase (ie CR1 or CR2). These data confirm that allogeneic CBT from either a related or an unrelated donor is a feasible procedure able to cure a significant proportion of children with acute leukemia, especially if transplanted in a favorable phase of disease.

Acute Disease↗
PubMed1998

European results of unrelated cord blood transplants. Eurocord group.

This report summarizes the results of unrelated cord blood transplants. Sixty-five patients were reported to Eurocord. One year survival was 29%. Factors associated with survival were diagnosis, inborn errors had a better survival than leukemia or aplastic anemia; higher number of cells infused and negative pre-transplant CMV serology were also favorable factors. Granulocyte and platelet engraftment were associated with a higher number of nucleated cells infused, GVH incidence was low especially in CMV negative patients, it was not associated with the degree of HLA disparity. These results were similar to other series reported in the USA and showed the benefit of using mismatched unrelated cord blood in clearly defined situations.

Adolescent↗
PubMed1998

Cord blood banking and transplant in Europe. Eurocord.

Cord blood banks have increased the use of cord blood transplants (CBT) for patients with hematological disorders. EUROCORD has established a registry for providing information on the outcome of CBT. Questionnaires were sent to all EUROCORD members to collect information on patients transplanted from 1988 to 1996. One hundred and forty-three CBT, performed in 45 centers, were analyzed for survival, engraftment and graft-versus-host disease (GVHD). Results in recipients of related and unrelated transplants were analyzed separately. In 78 patients who received CB from a related donor, 1-year survival was 63 +/- 6%. Age, weight, HLA identity and negative cytomegalovirus (CMV) serology in the recipient were significant favorable prognostic factors. Among these 78 patients, the incidence of grade > or = II GVHD was 9% in HLA matched CBT and 50% in mismatched CBT. Neutrophil engraftment was associated with age < 6 years (P = 0.02), weight < 20 kg (P = 0.02). It was 73% in patients receiving < 3.7 x 10(7) nucleated cells (NC) infused/kg and 85% in patients receiving more (P = 0.06). Among 65 patients, who received CB from an unrelated donor, 1-year survival was 29 +/- 7%. Negative recipient CMV serology was associated with improved survival (P = 0.01). Acute GVHD > or = II was observed in 40% of these patients. Negative recipient CMV serology was the most important factor for predicting GVHD (P = 0.04). Neutrophil recovery was 76% in patients receiving < 3.7 x 10(7) NC/kg and 94% in patients receiving more (P = 0.008). Cord blood is a feasible alternative source of hematopoietic stem cells for treating patients with various hematological disorders.

Adolescent↗
PubMed1997

Outcome of cord-blood transplantation from related and unrelated donors. Eurocord Transplant Group and the European Blood and Marrow Transplantation Group.

BACKGROUND: Cord-blood banks have increased the use of cord-blood transplantation in patients with hematologic disorders. We have established a registry containing information on the outcome of cord-blood transplantation. METHODS: We sent questionnaires to 45 transplantation centers for information on patients receiving cord-blood transplants from 1988 to 1996. Reports on 143 transplantations, performed at 45 centers, were studied, and the responses were analyzed separately according to whether the donor was related or unrelated to the recipient. RESULTS: Among 78 recipients of cord blood from related donors, the Kaplan-Meier estimate of survival at one year was 63 percent. Younger age, lower weight, transplants from HLA-identical donors, and cytomegalovirus-negative serologic results in the recipient were favorable prognostic factors. Graft-versus-host-disease of at least grade II occurred at estimated rates of 9 percent in 60 recipients of HLA-matched cord blood and 50 percent in 18 recipients of HLA-mismatched cord blood. Neutrophil engraftment was associated with an age of less than six years (P = 0.02) and a weight of less than 20 kg (P = 0.02), and it occurred in 85 percent of patients receiving 37 million or more nucleated cells per kilogram of body weight. Among 65 patients who received cord blood from unrelated donors, the Kaplan-Meier estimate of survival at one year was 29 percent. Cytomegalovirus-negative serologic status in these recipients was associated with improved survival (P = 0.03) and was the most important predictor of graft-versus-host disease (P = 0.04). Neutrophil recovery occurred in 94 percent of the patients who received 37 million or more nucleated cells per kilogram from unrelated donors. CONCLUSIONS: Cord blood is a feasible alternative source of hematopoietic stem cells for pediatric and some adult patients with major hematologic disorders, particularly if the donor and the recipient are related.

Acute Disease↗
PubMed1997

Interferon alfa-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia. French Chronic Myeloid Leukemia Study Group.

BACKGROUND: Treatment with interferon prolongs survival in chronic myelogenous leukemia. We conducted a clinical trial to assess the efficacy of treatment with a combination of interferon and cytarabine. METHODS: Previously untreated patients with chronic myelogenous leukemia were randomly assigned to receive either hydroxyurea (50 mg per kilogram of body weight per day) and interferon alfa-2b (5 million units per square meter of body-surface area per day), or hydroxyurea and interferon in the same dosages plus monthly courses of cytarabine (20 mg per square meter per day, for 10 days). The end points were overall survival, complete hematologic remission at 6 months, and major cytogenetic response (less than 35 percent Philadelphia chromosome-positive cells in the bone marrow) at 12 months. RESULTS: The trial was stopped when a sequential analysis showed a benefit of interferon and cytarabine. A significant improvement in survival was observed in the interferon-cytarabine group (360 patients) as compared with the interferon group (361 patients) (P=0.02; relative risk of death, 0.64; 95 percent confidence interval, 0.44 to 0.93). After three years, the survival rate was 85.7 percent with interferon and cytarabine and 79.1 percent with interferon alone. The rate of hematologic response was higher in the interferon-cytarabine group than in the interferon group (P=0.003). Major cytogenetic responses were observed 12 months after randomization in 126 of 311 patients treated with interferon and cytarabine (41 percent) and in 75 of 314 patients treated with interferon only (24 percent, P<0.001). CONCLUSIONS: The combination of interferon and cytarabine, as compared with interferon alone, increases the rate of major cytogenetic response and prolongs survival in patients with the chronic phase of chronic myelogenous leukemia.

Adolescent↗