Successful combination of amphotericin therapy and surgical resection for fungal necrotizing pneumoniae in a child receiving chemotherapy for leukemia.
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Amphotericin B↗
Biomedical subjects
H Rubie
Publications and source records attributed to H Rubie.
Stage IV neuroblastoma in patients over 1 year of age at diagnosis: consolidation of poor responders with combined busulfan, cyclophosphamide and melphalan followed by in vitro mafosfamide-purged autologous bone marrow transplantation.
In an attempt to improve the poor prognosis of poor responders with stage IV neuroblastoma, a new combined high-dose chemotherapy conditioning regimen was tested. Event-free and overall survival, as well as the incidence of complications, were analysed. Twenty-five children aged 12-146 months at diagnosis entered this study. All were in complete remission (CR) at the time of high-dose chemotherapy. Two or three different protocols had been necessary for them to achieve a CR. High-dose chemotherapy consisted of a combination of busulfan (600 mg/m2), cyclophosphamide (4400 mg/m2) and melphalan (140 mg/m2). It was followed by autologous bone marrow transplantation (ABMT). The bone marrow graft was purged in vitro with mafosfamide. The probability of event-free survival (EFS) at 5 years post-ABMT was 34%, compared to < 8% in a historical series. Toxicity was severe but manageable and 2 complication-related deaths were observed. Veno-occlusive disease was the most frequent extrahaematopoietic complication encountered, but its outcome was always favourable. By using a very intensive conditioning regimen consisting of a combination of three alkylating agents, the EFS of poor responders with metastatic neuroblastoma was improved and similar to that of good responders. When compared with a previously published similar series of patients, the improvement in survival appears probably related to intensification of the conditioning regimen.
Antineoplastic Combined Chemotherapy Protocols↗
Loss of chromosome 1p may have a prognostic value in localised neuroblastoma: results of the French NBL 90 Study. Neuroblastoma Study Group of the Société Française d'Oncologie Pédiatrique (SFOP).
Between March 1990 and December 1994, 316 consecutive children with localised neuroblastoma were registered in the French NBL 90 study. In addition to the assessment of a new chemotherapy regimen in unresectable neuroblastoma, we evaluated the prognostic significance of MYCN amplification and loss of the short arm of chromosome 1 (LOH1p). MYCN was found in 22/225 children (10%) and associated with unfavourable clinical features such as age at diagnosis > 1 year and large and unresectable tumours. LOH1p was observed in 9/91 patients (10%), of whom some had favourable prognostic factors such as age at diagnosis < 1 year (n = 4), INSS stage 1 or 2 (n = 3) and no MYCN amplification (n = 4). Overall survival (OS) and event-free survival (EFS) were, respectively, 56% and 22% (median follow-up: 36 months) for children with LOH1p compared with 97% and 94% for those without (log-rank = 10(-8)). All except 1 of the 5 children with MYCN amplification and LOH1p relapsed and ultimately died of the disease. Among the 4 with LOH1p and no MYCN amplification, recurrence occurred in 3 (2 local, 1 metastatic), all alive in second remission after salvage therapy (12-19 months after the relapse). In multivariate analysis, LOH1p was the strongest prognostic indicator for subsequent relapse. LOH1p appears more discriminant than MYCN amplification for predicting the risk of recurrence in children with localised neuroblastoma. However, its analysis was possible in only 30% of our patients and its final impact on survival should be confirmed in larger, prospective studies in order to stratify subsequent treatment.
Abdominal Neoplasms↗
Acute basophilic leukaemia and translocation t(X;6)(p11;q23).
We report two infants with acute basophilic leukaemia associated with a t(X;6)(p11;q23) as the sole abnormality. Morphologic evidence of basophilic lineage was provided by light and electron microscopy. Both patients also had a similar presentation on diagnosis, characterized by clinical signs consistent with a hyperhistaminaemia syndrome, i.e. urticarian rashes and gastro-intestinal disorders evocative of peptic ulcer. Immunophenotypes differed in the two patients, one expressing CD24, CD13 and CD33, whereas only CD117 was found in the other. Basophilic acute leukaemia, a rare group among acute leukaemias, might be nonrandomly associated with a specific chromosomal abnormality, t(X;6)(p11;q23). This new entity might also be identifiable by an uncommon clinical presentation and occurrence in infancy.
Antineoplastic Combined Chemotherapy Protocols↗
A negative association between Down's syndrome and neuroblastoma.
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Down Syndrome↗
NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology.
PURPOSE: NB87 was designed to test the efficacy of a short, non cross-resistant, induction protocol for unselected patients over 1 year of age with stage 4 neuroblastoma. A secondary objective was to compare in a randomized study the toxicity of two modalities of cisplatin administration. PATIENTS AND METHODS: A total of 183 patients received two cycles of alternating sequences: cyclophosphamide 300 mg/m2/d on days 1 to 5, vincristine 1.5 mg/m2/d on days 1 and 5, and doxorubicin 60 mg/m2/d on day 5 (CADO); and cisplatin 40 mg/m2/d and etoposide 100 mg/m2/d on days 1 to 5 (CVP), followed by surgery of the primary tumor (126 patients). Ninety-one were randomized to receive cisplatin either as bolus (BO; n = 48) or continuous infusion (CI; n = 43). International Neuroblastoma Staging System (INSS) and Response Criteria (INRC) were used with emphasis on skeletal evaluation by meta-iodobenzylguanidine (MIBG). RESULTS: Hematotoxicity was predominant, with a higher incidence of neutropenia (P = .01) for CADO and of thrombocytopenia for CVP (P < .001). Severe infections, as well as nonhematologic toxicities, occurred more often after the first sequence. Gastrointestinal complications were predominant during both courses of CVP. The toxic death rate, including surgery, was 3%. Complete remissions (CRs) were less frequent on MIBG (45%) compared with marrow (66%) or other metastases (61%). Combining all metastatic sites resulted in a 39% CR rate. After surgery, the final CR rate was 42%. Nephrotoxicity was minimal in both arms (92% normal clearance for CI v 82% for BO). Hearing loss greater than 40 dB at 6,000 to 8,000 Hz was reported equally in both arms (n = 6 for CI v n = 5 for BO). CONCLUSION: Intensified chemotherapy using CADO/CVP increases CR rates despite a shorter induction duration. However, the rate of MIBG normalization remains unsatisfactory and could be raised through the dose-intensive use of agents such as cyclophosphamide.
Adolescent↗
N-Myc gene amplification is a major prognostic factor in localized neuroblastoma: results of the French NBL 90 study. Neuroblastoma Study Group of the Société Francaise d'Oncologie Pédiatrique.
PURPOSE: To assess the relevance of N-Myc gene amplification (NMA) as a prognostic factor in localized neuroblastoma (NB) and to evaluate whether less intensive adjuvant treatment is advisable in infants without NMA. PATIENTS AND METHODS: Assessment of NBs included clinical and imaging data to allow tumor-node-metastasis (TNM) staging, biologic determinations (N-Myc gene analysis), and standard histology and work-up to eliminate metastatic spread (metaiodobenzylguanidine [MIBG] scintigraphy and extensive bone marrow staging). Resectability was defined according to imaging findings. Chemotherapy was indicated in children older than 1 year at diagnosis who had postoperative residual disease or lymph node (LN) involvement, in infants with NMA, or as primary treatment in children with an unresectable NB, including dumbbell tumors. Radiotherapy was recommended in children older than 1 who presented with persistent gross residual disease at the end of therapy. RESULTS: Between 1990 and 1994, 316 consecutive children who presented with a localized NB were registered in the NBL 90 study. The median age was 12 months, and 42 patients had dumbbell tumors (13%). NMA was found in 22 of 225 assessable children (10%) and correlated with adverse prognostic indicators such as age older than 1 year, an abdominal primary tumor, a large tumor (T3), and unresectability. Among 186 children who had primary excision, five died of surgery-related complications. Primary chemotherapy was given to 130 patients, which allowed removal of the tumor in all but four. The 5-year overall survival (OS) and event-free survival (EFS) rates were, respectively, 91% and 84% with a median follow-up time of 36 months. The outcome of infants and older children was similar (P = .2). EFS of patients with resectable tumors was slightly better than with unresectable primary tumors (EFS, 89% v 78%; P = .02). In dumbbell NBs, neurologic recovery was achieved in 74% of cases that presented with symptoms, and initial laminectomy was avoided in 75% of children. In a univariate analysis, large tumors, high neuron-specific enolase (NSE) and lactate dehydrogenase (LDH) levels, positive LNs, macroscopic residue, and NMA adversely influenced outcome. In the multivariate analysis, NMA was the most powerful unfavorable predictive indicator: OS and EFS rates for these children were 36% and 32%, compared with 98% and 90% in nonamplified tumors (P < .001). CONCLUSION: Our data confirm the overall good prognosis of localized NBs, even when unresectable. NMA is the most relevant adverse prognostic factor in localized NBs, and more intensive treatment should be investigated in these patients. Prospective studies of other biologic factors are warranted to tailor therapy more accurately. The EFS of children who underwent primary surgery was excellent, and further justifies elimination of adjuvant treatment provided they have no NMA. Despite the elimination of postoperative therapy, infants with non-NMA tumors have an excellent outcome, which suggests that initial chemotherapy can be further reduced in case of unresectable NBs.
Adolescent↗
Late effects of allogeneic bone marrow transplantation for children with acute myeloblastic leukemia in first complete remission: the impact of conditioning regimen without total-body irradiation--a report from the Société Française de Greffe de Moelle.
PURPOSE: To evaluate growth, thyroid function, puberty, cardiac function, and the incidence of cataracts in children who received allogeneic bone marrow transplantation (BMT) for acute myeloblastic leukemia (AML) in first complete remission (CR) after a preparation with or without total-body irradiation (TBI). PATIENTS AND METHODS: Among 45 children studied, 26 received busulfan-cyclophosphamide (Bu-Cy) in preparation for transplantation and 19 received TBI. TBI was fractionated in nine cases and delivered as a single dose in 10. Four children in the Bu-Cy group and none in the TBI group had received prior cranial radiation. The mean follow-up duration after BMT was 5.9 years for the whole group. RESULTS: The mean cumulative changes in height SD score (SDS) were -0.86 at 3 years and -1.56 at 5 years in the TBI group, whereas these changes were only -0.05 and -0.17 in the Bu-Cy group (P < .01 at 3 and 5 years). The 6-year probability of hypothyroidism was 9% +/- 8% in the Bu-Cy group and 43% +/- 15% after TBI (P < .02). Pubertal development after Bu-Cy was assessable in two girls and five boys: both girls had primary ovarian failure, whereas Leydig cell function appeared to be preserved in the five boys. One child who had received anthracycline when he was less than 1 year old developed cardiac dysfunction 4 years after Bu-Cy. The 6-year probability of cataracts was 70% +/- 13% in the TBI group and 0% after Bu-Cy. CONCLUSION: The use of Bu-Cy represents an alternative transplant cytoreductive regimen for children with AML in first CR, which can reduce the risk of posttransplant growth impairment, thyroid dysfunction, Leydig cell damage, and the incidence of cataracts.
Adolescent↗
The treatment of neuroblastoma with intraspinal extension with chemotherapy followed by surgical removal of residual disease. A prospective study of 42 patients--results of the NBL 90 Study of the French Society of Pediatric Oncology.
BACKGROUND: Neuroblastoma is the most common malignant cause of spinal compression in the pediatric population. More than 30% of patients who are impaired prior to treatment remain impaired after the completion of therapy. Those who do not improve after decompressive laminectomy may go on to develop severe delayed spinal deformities. METHODS: To decrease the long term sequelae of routine neurosurgical intervention for all intraspinal extensions of neuroblastoma, the French NBL 90 Study was formulated to use chemotherapy as a first-line treatment for all nonmetastatic neuroblastomas with intraspinal extension. Neurosurgical decompression and excision was recommended only for patients demonstrating rapid neurologic deterioration. RESULTS: The overall survival of the 42 patients registered was 97%. Initial neurologic impairment was present in 27 patients (64%), including 11 with paraplegia. Thirty-two patients received chemotherapy as first-line treatment. Complete regression of the intraspinal component was observed in 13 patients and partial regression of greater than 50% of the initial volume in 5 patients. Of 19 evaluable patients presenting with a neurologic deficit and treated with primary chemotherapy, recovery was completed in 11 and partial in 3. Four patients failed to recover from long-standing pretreatment paraplegia. Only one patient worsened during therapy, and recovered completely after emergent neurosurgical intervention. Seven patients underwent initial neurosurgical procedures; six had a neurologic deficit and five recovered completely, including all three who presented with acute onset of paraplegia. Three patients had extraspinal surgery as exclusive treatment. Six patients (15%) suffered severe neurologic sequelae. Only one of the patients who underwent surgery required spinal stabilization for progressive deformity, but follow-up is limited. CONCLUSIONS: By treating patients with dumbbell neuroblastoma initially with chemotherapy, the authors were able to reduce the size of the intraspinal mass in 58% of patients, improve partial neurologic deficits in 92%, and avoid neurosurgical decompression in 60%. Neurologic deficits also improved in 83% of patients requiring emergent neurosurgical intervention.
Adolescent↗
Metastatic neuroblastoma in children older than one year: prognostic significance of the initial metaiodobenzylguanidine scan and proposal for a scoring system.
BACKGROUND: Metaiodobenzylguanidine (mIBG) is a guanethidine analog that has demonstrated a high sensitivity and specificity in detecting bone metastases in about 90% of metastatic neuroblastomas. However, the predictive value of initial mIBG scan in neuroblastoma patients older than 1 year of age regarding response to initial chemotherapy has yet to be ascertained. Therefore, a scoring system for grading the positivity of mIBG scans was devised and applied in a retrospective study in an attempt to determine whether this score had a prognostic value in neuroblastoma patients older than 1 year of age at diagnosis. METHODS: Eighty-six children, older than 1 year of age, with metastatic neuroblastomas were homogeneously treated and had a mIBG scan performed at diagnosis and following the induction regimen to assess bone metastases. Each mIBG scan was assigned a reproducible score and the predictive value of the initial mIBG score was assessed in order to evaluate response to induction regimen. RESULTS: The relative risk of failing to achieve complete remission after four courses of induction therapy was 6.9 times higher in patients who had more than four mIBG spots at diagnosis. A multivariate analysis including the established prognostic factors revealed that the initial mIBG score was the only significant factor (P < 0.001). CONCLUSIONS: The initial mIBG scan is of prognostic significance to predict response to chemotherapy for metastatic neuroblastoma in children older than 1 year of age. A prospective study comparing this initial mIBG score with other recently established prognostic factors is warranted.
3-Iodobenzylguanidine↗
High incidence of the t(2;5)(p23;q35) translocation in anaplastic large cell lymphoma and its lack of detection in Hodgkin's disease. Comparison of cytogenetic analysis, reverse transcriptase-polymerase chain reaction, and P-80 immunostaining.
Fifty-six cases of anaplastic large cell lymphoma (ALCL), 23 cases of Hodgkin's disease, and 16 cases of diffuse large cell lymphoma were investigated for the t(2;5)(p23;q35) translocation. The translocation was detected by using cytogenetic analysis, reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemistry with P80 antibody directed against the kinase domain of anaplastic lymphoma kinase (ALK) of the chimeric NPM/ALK protein. In all but three cases of ALCL, we found an agreement between cytogenetic analysis, RT-PCR, and P80 staining. However, in one case, the t(2;5) translocation was detected with cytogenetic analysis, but RT-PCR and P80 staining were found to be negative. Conversely, in another case the karyotype was normal, but the hybrid mRNA and P80 staining were found to be positive. In one case, malignant cells showed a translocation involving chromosomes 1q25 and 2p23 and were strongly positive for P80 staining. Such a result could be expected because P80 antibody detects the kinase domaine of the ALK protein encoded by chromosome 2p23. Overall 73.2% (41 of 56) of cases were found to be positive. However, the highest percentage (23 of 26 cases; 88.5%) of P80 positive cases was found in children compared with 60% (18 of 30 cases) in adult ALCL (P < .05). In Hodgkin's disease, Reed-Sternberg cells were found to be clearly negative by RT-PCR and with P80 antibody. The latter results suggest that Hodgkin's disease and t(2;5)-positive ALCL are distinct biological entities and that the demonstration of the t(2;5) translocation is of diagnostic importance in differentiating these two entities. The results of the present study indicate that immunohistochemistry with P80 antibody is a reliable method for detecting NPM/ALK chimeric protein.
Adolescent↗
[Testicular biopsy at the stopping of the treatment in acute lymphoblastic leukemia: value of the immunohistochemical detection of residual blasts].
BACKGROUND: The prognostic value of clinical and histological detection of testicular leukemia after completion of therapy is still debated. Immunohistochemical study could improve the results of this detection. PATIENTS AND METHODS: Between 1982 and 1992, 70 consecutive boys with acute lymphoblastic leukemia (ALL) and treated with the same therapeutic regimen were included in the study. Testicular biopsy (TB) was surgical and bilateral. One piece of tissue was fixed and analysed by conventional microscopy. An immunohistochemical study was performed on the other sample with a panel of anti-T and anti-B Mc Ab, including JCB 117 (anti-CD79a) which stains early pre B lymphoblasts. RESULTS: Twenty-five children relapsed while on treatment and did not undergo TB. Among the 45 boys who underwent routine TB, one had a diffuse infiltration seen in conventional histology. Thirty-nine had normal morphological and immunohistochemical study: among them, six relapsed subsequently in bone marrow; in this group, event free survival (EFS) was 85 +/- 10% with a median follow-up of 80 months after the biopsy. In the five remaining boys, anti-CD79a was found positive on blasts in four cases and anti-CD3 in one case; four of those relapsed, including two in the testes during the year following the biopsy; EFS was 20 +/- 36% (P = 0.001). CONCLUSIONS: New Mc Ab such as JCB 117 (anti-CD79a) might detect a minimal residual disease in the testes of children treated for ALL, particularly on routine histological material. These results, if confirmed in larger series, might influence further therapeutic strategy.
Adolescent↗
Population pharmacokinetics of carboplatin in children.
OBJECTIVES: In pediatric patients, administration of carboplatin according to body surface area results in a large variation in the area under the plasma ultrafilterable carboplatin concentration versus time curve. A population pharmacokinetic study using the NONMEM program was undertaken to determine the effects of a variety of covariates on the clearance of ultrafilterable carboplatin. PATIENTS: Plasma carboplatin pharmacokinetics were determined in 57 children (2 months to 18 years old, with serum creatinine levels ranging from 27 to 268 mumol/L) treated for various tumor types. RESULTS: The best fit corresponded to the formula: clearance (ml/min) = 2.85.weight.(1-0.00357.serum creatinine).(1-0.372.Np) + 8.7 (with serum creatinine in micromoles per liter, weight in kilograms, and Np = 1 or 0 for unilateral nephrectomy or not, respectively). The interindividual variability in clearance, as expressed by the coefficient of variation, decreased from 74% (no covariates) to 49% by taking account of weight, and to 29% under the final regression formula. CONCLUSION: The ability of this formula to predict carboplatin clearance in children should be evaluated prospectively and compared to a method based on the determination of the glomerular filtration rate.
Adolescent↗
Child cerebrospinal fluid analysis by capillary electrophoresis and laser-induced fluorescence detection.
Capillary electrophoresis with laser-induced fluorescence detection (CE-LIF) was used to analyze a 50-microliters sample of cerebrospinal fluid from leukaemic children treated with high doses of methotrexate. Free amino acids and primary amines are labelled with fluorescein isothiocyanate prior to analysis. Electropherograms containing more than 50 peaks were obtained in less than 22 min. Twenty-one peaks were identified, and 19 were quantitated. Observed differences in individual amino acid levels are compared with healthy reference values. The results indicate that CE-LIF is useful as a selective, rapid and sensitive tool for the determination of free amino acids and amines in clinical biology studies.
Adolescent↗
Comparison of methods for the estimation of carboplatin pharmacokinetics in paediatric cancer patients.
The antitumour and toxic effects of platinum drugs, in particular carboplatin, have been related to their plasma concentration and this has led to the concept of a target area under the plasma concentration-time curve (AUC) for carboplatin dosing. A formula based on renal function has been successfully applied to carboplatin dosing in adults and modified versions have also been proposed for paediatric patients. In order to monitor carboplatin AUC with maximum efficiency and minimum patient inconvenience, limited sampling strategies are desirable. A population method with Bayesian estimation is described, based on one or two samples taken following a dose of carboplatin. Population data were obtained from 22 paediatric patients treated with 200-1000 mg/m2 carboplatin as a 60-90 min infusion. Ultrafilterable carboplatin was determined by atomic absorption spectrophotometry. A two compartment model was fitted to each data set using the Maximum Likelihood estimator of the ADAPT programme. These parameter estimates provided the prior means and covariance matrix for the Bayesian estimator using a lognormal distribution. The test data sets consisted of ultrafilterable carboplatin concentrations in 23 patients (aged 1 month-18 years) who received similar treatment. The two compartment model was fitted to data sets containing one or two points, using the Bayesian maximum a posteriori (MAP) estimator and an error model derived from the population error model parameters. Results from the Bayesian analysis and other methods for the estimation of AUC, including relating clearance to surface area or to renal function, were evaluated by comparing the AUC estimate with the AUC determined by model-independent analysis. Overall, the optimal sampling strategy performed better than estimates based on renal function, which had a median bias of 5% and precision of 22%. With one data point at 60 min postinfusion, the median bias and precision were 3 and 6%, respectively. Addition of a second data point at 30 min during the infusion improved the estimate slightly (median bias -2%, precision 3%). Bayesian estimation produced more reliable estimates of AUC compared to values based on renal function, which in turn was slightly better than using surface area. A technique, developed in adult patients, for estimating AUC from a measurement of 24 h total plasma platinum was comparable to estimates based on renal function, but was less reliable. The estimation of carboplatin AUC can be performed using only one or two plasma samples and Bayesian analysis. This approach is less biased and more precise than methods based on surface area, renal function or total platinum at 24 h postdose, but is probably best used in combination with dosing based on renal function.
Adolescent↗
Bone marrow involvement in anaplastic large cell lymphoma. Immunohistochemical detection of minimal disease and its prognostic significance.
Bone marrow involvement by anaplastic large cell anaplastic large cell (ALC) lymphoma can be difficult to detect on routine morphologic examination alone. In a series of 42 patients with ALC lymphoma, the authors analyzed: (1) the usefulness of a limited panel of monoclonal antibodies directed against CD30 (Ber-H2, HRS4) and epithelial marrow involvement on routinely processed biopsy specimens; and (2) the prognostic significance of bone marrow involvement as detected on both morphologic and immunohistochemical grounds. On conventional examination, 17% of the patients were found to have bone marrow involvement at diagnosis. However, after immunohistochemical analysis, occult malignant cells were detected in 23% of the patients with negative bone marrow biopsy on routine histology. The low percentage of positive cases on routine morphologic examination compared to immunohistochemical examination was related to: (1) the scarcity of neoplastic cells which were scattered among hematopoietic cells; (2) the difficulty of distinguishing malignant cells from immature hematopoietic elements; and (3) the absence of alteration of the reticulin network. The authors observed a significant association between marrow infiltration and the presence of hematologic abnormalities (mostly anemia or cytopenias) at diagnosis, both in children and adult patients. More importantly, a significant lower survival was seen in patients with bone marrow involvement compared to those without bone marrow involvement. Immunohistochemistry with anti-CD30 and anti-EMA antibodies should be performed systematically in bone marrow biopsies from patients with ALC lymphoma to reliably identify the presence of bone marrow involvement that appears to carry a poor prognosis.
Adolescent↗
Morbidity using subcutaneous ports and efficacy of vancomycin flushing in cancer.
An evaluation of totally implanted venous access systems inserted in 163 consecutive children with cancer is reported. From 1988 to 1994, 180 subcutaneous ports were inserted in children more than 1 year old. Initial diagnosis was acute leukaemia (n = 79), non-Hodgkin's lymphoma (n = 33), and solid tumour (n = 51). Median age was 85 months. All venous procedures were performed through the device. Chemotherapy was either moderate (n = 13) or intensive (n = 119) or very intensive (n = 48), including 16 patients undergoing marrow transplantation. Cumulative venous access totalled 55,770 patient days with a mean of 305 days/subcutaneous port. The cause of device removal was, end of treatment (n = 111), death due to malignancy (n = 20), catheter related infection (n = 7), and occlusion of the system (n = 4). Mechanical complications occurred in 19 ports; 16 were due to clots, of which 14 were cleared with instillation of urokinase. Documented infectious episodes occurred in 47 ports, recurred once in 14, and twice in five cases. Among these infections, 47 were septicaemic; 31 due to Staphylococcus epidermidis. Twenty seven of initial septic episodes were considered to be catheter related; the rate was 15%/subcutaneous port or 0.05/100 catheter days. Risk factors for the development of a first infection were age below 4 years and the time of use. Since February 1993, vancomycin (50 micrograms/ml) has been given and this has reduced the rate of S epidermidis infection from 26/83 subcutaneous port to 4/97. Life table analysis showed that the infection free interval for staphylococcus was significantly better after this technique ws initiated (log rank rest=0.02). Time saved was approximately 30minutes/patient/week compared with external catheters, or 45 hours/month for the cohort of children treated. Subcutaneous ports in paediatric cancer patients are reliable, safe, and durable and may offer an attractive alternative to external catheters for prolonged venous access and intensive treatment.
Adolescent↗
Phase I-II study of interleukin-2 after high-dose chemotherapy and autologous bone marrow transplantation in poorly responding neuroblastoma.
Despite intensification of treatment with high-dose chemotherapy (HDC) and autologous bone marrow transplantation (AMBT), the prognosis of poorly responding metastatic neuroblastoma remains bad. Recombinant IL-2 (rIL-2) was used after ABMT to enhance the immune response against the tumor and thereby to improve survival of these patients. In this study, five courses of rIL-2 were administered as a continuous intravenous infusion every 2 weeks, the first course lasting 5 days, and the other four 2 days. rIL-2 treatment was to begin within 120 days of BMT. This study demonstrates the feasibility of rIL-2 soon after HDC and ABMT. The maximum tolerated dose (MTD) was 12 x 10(6) U/m2/day. Clinical toxicity was similar to that observed in adults, moderately increased by the proximity of ABMT; in a previous study we demonstrated that the MTD in non-grafted children was 18 x 10(6) U/M2/day. Nevertheless, half of the patients were not able to receive rIL-2 therapy after ABMT, and only 6/12 received 100% of the planned dose, mainly because of thrombocytopenia. If peripheral stem cell transplantation is demonstrated to enhance platelet recovery, more patients could be treated with rIL-2 with the present schedule. Earlier administration of low-dose rIL-2 after BMT associated with ex vivo rIL-2 treatment of the graft could be a more valid way of using rIL-2 to improve survival.
Antineoplastic Combined Chemotherapy Protocols↗