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The role of maintenance therapy and novel taxanes in ovarian cancer.

OBJECTIVES: Despite several studies reporting various degrees of success, the role of maintenance chemotherapy in ovarian cancer remains controversial. This article reviews the available data and the controversy surrounding maintenance therapy. In addition, the role of novel taxanes, which may offer an improved therapeutic index and reduced toxicity relative to conventional therapies in this setting, is discussed. METHODS: The available randomized clinical data on extended or maintenance therapy in ovarian cancer are reviewed. RESULTS: Available data indicate that patients with ovarian cancer undergoing taxane maintenance chemotherapy exhibit a reduced recurrence rate and a longer progression-free survival. CONCLUSIONS: While an additional randomized trial is needed to confirm these benefits and establish maintenance therapy as the standard of care, the authors conclude that maintenance therapy is a valuable option that should be discussed with patients until further data are available. The Gynecologic Oncology Group 212 trial is a randomized clinical trial that is designed to answer whether taxane maintenance therapy offers a survival advantage as well as to determine the impact of such a therapeutic regimen on a patient's quality of life. This trial is also designed to address some of the questions regarding the role of a novel taxane in maintenance therapy in ovarian cancer.

Antineoplastic Combined Chemotherapy Protocols↗

HIV-related non-Hodgkin's lymphoma: CHOP induction therapy and interferon-alpha-2b/zidovudine maintenance therapy.

In a prospective multicenter study 68 out of 158 patients with HIV infection and malignant lymphoma were assigned to a risk-adapted induction therapy using the following algorithm: High-risk patients fulfilled 2 of 3 criteria: T4 lymphocytes <50/microL; WHO activity index 3 or 4; pre-existing AIDS-defining opportunistic infection. Normal-risk patients received 4 to 6 cycles of CHOP chemotherapy; those that achieved complete remission (CR) received zidovudine (500 mg/d) and interferon-alpha maintenance therapy (5 million units three times a week) for one year. High-risk patients received low-dose CHOP or vincristine/prednisone chemotherapy. Supportive care was performed with pentamidine inhalation and G-CSF. Intrathecal (it) methotrexate was given for CNS prophylaxis. The median survival was 634 days for 38 patients of the normal-risk group and 129 days for 30 patients of the high-risk group. 18 high-risk patients treated with low-dose CHOP had better survival (156 days) than 12 patients treated with vincristine/prednisone (72 days p=0.044). 68% of the patients in the normal-risk group achieved complete remission. 5 out of 18 high-risk patients treated with low-dose CHOP achieved complete remission. Three normal-risk patients developed fatal opportunistic infections during chemotherapy. Immune parameters deteriorated after CHOP induction and partially recovered with maintenance treatment. We conclude that the normal-risk patients survived longer than reported in most published studies. Toxicity was low. Low-dose CHOP seems to be superior to vincristine/prednisone therapy in high-risk patients.

Adult↗

Oral SCH 39304 as primary, salvage, and maintenance therapy for cryptococcal meningitis in AIDS.

To determine the efficacy and toxicity of SCH 39304 in the treatment and suppression of cryptococcal meningitis, we conducted a prospective, noncomparative study in three groups of patients: patients with acute cryptococcal meningitis, patients with acute cryptococcal meningitis in whom other therapies have failed (salvage), and patients who required maintenance therapy. As primary therapy, the patients received up to 14 days or 1 g of amphotericin B followed by SCH 39304 200 mg once daily for 12 weeks. As maintenance therapy, the patients received SCH 39304 600 mg once weekly for 12 months. Of five salvage patients, none completed the study. Two patients died, two patients clinically deteriorated, and one patient was noncompliant. Two of three patients with acute cryptococcal meningitis completed the 12-week primary therapy, and one patient was discontinued from therapy because of a skin rash (95% confidence interval, 14-100%). All four patients who were receiving weekly maintenance therapy followed up to 27 weeks were clinically stable with no change in their serum cryptococcal antigen titer from baseline when the study was prematurely terminated. Elevation of liver function test results developed in three patients and skin rash developed in one patient. The unique pharmacologic and pharmacokinetic properties of SCH 39304 (low incidence of toxicity, long serum half-life, and good penetration into the cerebrospinal fluid) lend promise to pursue other triazole antifungals at higher doses as primary therapy and less frequent dosing for maintenance therapy.

Acquired Immunodeficiency Syndrome↗

Tricyclic maintenance therapy in unipolar depression.

The risk of recurrence of depression must be balanced against the problems and risks of maintenance therapy. The goal of maintenance therapy is to prevent new episodes of depression. A review of the literature reveals that the existing data does not provide sufficient evidence to demonstrate the usefulness of tricyclic maintenance therapy. Nonetheless, it would be premature to conclude that this type of treatment is not useful. Further studies of maintenance therapy are indicated and should include a continuation period of at least 16 weeks during which patients are symptom free (that is, Global Assessment Scale 71 or more). In the interim, each patient should be evaluated individually to determine the optimum duration of treatment.

Antidepressive Agents, Tricyclic↗

Adverse effects in maintenance therapy.

Adverse effects in maintenance therapy with neuroleptic drugs and lithium salts were reviewed with special emphasis on tardive dyskinesia. The possible teratogenicity of neuroleptics and lithium salts was discussed and the chromosomal abnormalities seen in patients treated with lithium salts described.

Antipsychotic Agents↗

Intensive maintenance therapy improves survival in adult acute nonlymphocytic leukemia: an eight-year follow-up.

Although a large majority of adult patients with acute nonlymphocytic leukemia (ANLL) achieve complete remission with present day therapy, eventual relapse and death is the rule rather than the exception. In an effort to improve survival, an intensive maintenance therapy approach was evaluated in 86 patients with ANLL in remission (median age 47 years) entered on study from 1978 to 1982. One-third of patients in remission were randomized to chemotherapy alone, one-third to splenectomy in addition to chemotherapy, and one-third to immunotherapy in addition to chemotherapy. The chemotherapy, which was identical in the three arms of the study, consisted of cytosine arabinoside plus 6-thioguanine, each given at a dose of 100 mg/m2 every 12 hr for a variable number of days, to render the patient's marrow aplastic, and was repeated every three months for three or more years. Median remission duration for patients in all three study groups is 21 months, with 58% of patients remaining in remission at one year. Twenty-five per cent of complete remitters are in continuous complete remission five to nine years after beginning intensive maintenance therapy. The median duration of survival of remitters is 25 months. Neither splenectomy nor immunotherapy had additional impact on remission duration or survival. In comparison with the results of earlier studies at the same institution in patients with similar characteristics, using identical remission induction therapy but less intensive maintenance therapy (46 patients), there has been a significant improvement in remission duration (p less than 0.001) and a significant impact on survival (p = 0.03) attributable to the use of intensive maintenance therapy. Intensive maintenance therapy may cure some adult patients with ANLL.

Acute Disease↗

Maintenance therapy with calcium channel blockers for preventing preterm birth after threatened preterm labour.

BACKGROUND: Calcium channel blocker maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (and usually an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions. OBJECTIVES: To assess the effects of calcium channel blockers as maintenance therapy on preventing preterm birth after threatened preterm labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (31 March 2004); MEDLINE (1966 to March 2004) and DARE (June 2003). SELECTION CRITERIA: Randomised controlled trials of calcium channel blockers used as maintenance therapy to prevent preterm birth after threatened preterm labour, compared with alternative drug therapy, placebo or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the selection criteria, extracted data from the included study and assessed study quality. MAIN RESULTS: One trial of 74 women was included. No difference in the incidence of preterm birth was found when calcium channel blocker (nifedipine) maintenance therapy was compared with no treatment. Twenty-five women out of 37 in each group gave birth before 37 weeks (relative risk 1.00, 95% confidence interval 0.73 to 1.37). The trial did not report stillbirths and neonatal deaths prior to discharge. Neurological follow up of the infants was not addressed. REVIEWERS' CONCLUSIONS: The role of maintenance therapy with calcium channel blockers for preventing preterm birth is not clear. Well designed randomised trials of sufficient size with relevant outcomes are required.

Calcium Channel Blockers↗

Feasibility of discontinuation of corticosteroid maintenance therapy in heart transplantation.

Corticosteroid maintenance immunosuppression therapy was successfully discontinued in 24 of 46 patients (52%) who underwent orthotopic heart transplantation between March 8, 1985 and September 1, 1986. In the remaining 22 patients three or more rejection episodes occurred within a 4-month period, and these patients were subsequently maintained on low to moderate dosages of corticosteroids. Patients successfully withdrawn from corticosteroid maintenance (group 1) have remained rejection free for 208 +/- 33 days (mean +/- SEM) after discontinuation of the maintenance therapy with corticosteroids, and their immunosuppression therapy has consisted only of cyclosporine (mean overall cumulative dose 198 +/- 11 mg/m2/day [5.17 +/- 0.35 mg/kg/day]) and azathioprine (mean overall cumulative dose 67.7 +/- 5.4 mg/m2/day [1.74 +/- 0.13 mg/kg/day]), with the most recent serum cyclosporine level and white blood cell count being 146 +/- 10 ng/ml and 5400 +/- 200/microliters, respectively. In contrast to the patients who continue to require maintenance therapy with corticosteroids (group 2), group 1 patients developed their first episode of rejection later (46.8 +/- 8.3 days versus 25.4 +/- 6.1 days, p = 0.040) and reject less frequently during the first 4 months after transplantation (1.7 +/- 0.2 episodes versus 2.6 +/- 0.2 episodes, p = 0.005) as well as during the entire follow-up period (0.21 +/- 0.02 episodes/month versus 0.30 +/- 0.02 episodes/month, p = 0.005). The decreased propensity to reject and subsequent corticosteroid discontinuation resulted in a decreased cumulative dose of corticosteroids in group 1 patients (10.9 +/- 1.9 mg prednisone equivalent/m2/day [0.28 +/- 0.04 mg/kg/day] versus 17.0 +/- 1.2 mg prednisone equivalent/m2/day [0.42 +/- 0.04 mg/kg/day], p = 0.011 [p = 0.026]).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenal Cortex Hormones↗

Induction and maintenance therapy of cytomegalovirus central nervous system infection in HIV-infected patients.

OBJECTIVE: To evaluate the efficacy and safety of the foscarnet-ganciclovir combination in induction therapy (IT) and maintenance therapy (MT) for cytomegalovirus (CMV) central neurological disorders in HIV-infected patients. DESIGN: An open pilot non-comparative multicentre study. METHODS: Thirty-one patients with acute CMV encephalitis (CMVe) (n = 17) or CMV myelitis (CMVm) (n = 14) during the era before highly active antiretroviral therapy (HAART) received intravenous IT with foscarnet 90 mg/kg plus ganciclovir 5 mg/kg twice a day followed by MT. The primary endpoint was clinical efficacy, assessed at the end of the induction phase. RESULTS: The foscarnet-ganciclovir combination in IT resulted in a 74% (23 out of 31 patients) clinical improvement or stabilization. Eight patients did not respond clinically. Side-effects leading to drug discontinuation occurred in 10 patients during IT. Among the 23 patients who qualified for the maintenance phase, CMV disease progressed in 10, with a median time to the first relapse of 126 days (range 64-264 days). Overall, the median survival time was 3 months [95% confidence interval (CI), 2-4 months]. CONCLUSION: The combination of foscarnet and ganciclovir can safely be used for CMV central nervous system (CNS) infection, with an improvement or stabilization in 74% of patients. Life-long MT with this combination is recommended as long as the immune system is profoundly impaired.

AIDS-Related Opportunistic Infections↗

Quantitation of 6-thioguanine residues in peripheral blood leukocyte DNA obtained from patients receiving 6-mercaptopurine-based maintenance therapy.

The antimetabolite 6-mercaptopurine is widely utilized in maintenance therapy for childhood acute lymphoblastic leukemia. Following p.o. administration, this prodrug undergoes extensive biotransformation, resulting in the generation of a plethora of metabolites including 2'-deoxy-6-thioguanosine triphosphate. Incorporation of 6-thioguanine (6-TG) bases into DNA is generally considered to be central to thiopurine-mediated cytotoxicity. We have developed a novel precolumn derivatization HPLC technique for quantifying 6-TG base accumulation into leukocyte DNA obtained from acute lymphoblastic leukemia patients receiving 6-mercaptopurine maintenance therapy. The method is based on enzymatic degradation of DNA to 2'-deoxyribonucleosides and the derivatization of released 2'-deoxy-6-thioguanosine with a thiol-reactive reagent containing a 7-amino-4-methylcoumarin-3-acetic acid fluorophore. The 2'-deoxy-6-thioguanosine-7-amino-4-methylcoumarin-3-acetic acid adduct is resolved by reversed-phase HPLC and quantified fluorometrically. Assay response is linear from 15 pmol to 60 fmol 6-TG bases/microgram DNA with a limit of quantitation corresponding to the incorporation of 1 6-TG residue per 50,000 bases. In a small cohort of acute lymphoblastic leukemia patients receiving p.o. 6-mercaptopurine-based maintenance therapy, significant interindividual variation in the accumulation of 6-TG bases into leukocyte DNA was revealed. The determined levels of drug base incorporation ranged from 95 to 710 fmol 6-TG bases/microgram DNA (6-TG base:nucleotide ratio 1:32,000 to 1:4,000). The assay may provide a novel methodology for pharmacological monitoring of thiopurine therapy either in the routine clinical setting or during studies of alternative routes of drug delivery.

Cell Line↗

Influence of the response to induction therapy on the rate of progression of cytomegalovirus retinitis in AIDS patients on intravitreal maintenance therapy.

In order to assess whether complete inactivation of retinitis at the end of induction therapy leads to delayed progression during maintenance therapy with weekly intravitreal ganciclovir, the time to the first progression to retinitis was evaluated in 27 AIDS patients (34 eyes) with stable cytomegalovirus retinitis. Data were censored before the introduction of protease inhibitors. Overall, retinitis progressed in 22 of 34 eyes in a median time of 12 weeks (mean +/- SD, 33 +/- 9 weeks). However, retinitis progressed in 15 of 19 eyes in which only partial inactivation was achieved following induction therapy (median time, 10 weeks; mean +/- SD, 17 +/- 4 weeks) but in only 7 of 15 eyes when complete inactivation was obtained (median time, 59 weeks; mean +/- SD, 56 +/- 19 weeks) (P= 0.02). There were no differences between the groups in CD4+ cell counts, drugs, route of induction treatment, or length of induction therapy. Induction therapy should be prolonged until complete inactivation of retinitis is obtained, since achieving only a partial response appears to be a factor in earlier progression when patients are switched to maintenance therapy with intravitreal ganciclovir.

AIDS-Related Opportunistic Infections↗

Phase II study of fludarabine combined with interferon-alpha-2a followed by maintenance therapy with interferon-alpha-2a in patients with low-grade non-hodgkin's lymphoma.

Randomized trials suggest improved disease-free survival in low-grade non-Hodgkin's lymphoma (LGNHL) when interferon is combined with multiagent chemotherapy. This phase II trial was conducted to investigate the feasibility of combining fludarabine monophosphate (fludarabine) and IFN in a regimen for treatment of LGNHL. Twenty-one patients were evaluable. Median age was 55 years, and patients had been treated with an average of 1.7 chemotherapy regimens before enrollment. Patients received 25 mg/m2 of fludarabine intravenously on days 1 through 5 followed by 2 x 10(6) U/m2 of interferon-alpha-2a subcutaneously on days 22 through 26. Cycles were repeated every 4 weeks with delays and dose modifications for significant cytopenias. Patients were restaged after cycles 4 and 8, and those with at least a partial response to therapy were given maintenance therapy consisting of 2 x 10(6) U/m2 interferon-alpha-2a subcutaneously three times per week for 6 months. The overall response rate was 76% with a 25% complete response (CR) rate. Overall response rates were 75% (3/4 with 2 CR's) for chemotherapy-naive patients and 76% (13/17 with 3 CR's) for previously treated patients. Median time to progression was 12 months, and currently two patients are without evidence of progression at a median follow-up of 55 months. Grade III or greater toxicities included neutropenia (39%), anemia (17%), thrombocytopenia (5%), fevers/chills (5%), and fatigue (5%). Fludarabine and interferon can be effectively and safely combined in a regimen with significant activity against LGNHL. A modification of this regimen may be suitable for further study.

Adult↗

Principles of maintenance therapy.

Although follicular non-Hodgkin's lymphoma may respond well to induction therapy, almost all patients will eventually relapse. To reduce the frequency of relapses and prolong disease-free intervals, maintenance treatment may be given to patients who respond or have stable disease after induction therapy. Maintenance treatment is given at regular intervals over prolonged periods in patients who may be asymptomatic, and so it is important that administration is simple, toxicity is minimal and that there is clear evidence of efficacy. The monoclonal antibody rituximab has many characteristics essential for a maintenance therapy: it is both effective and very well tolerated, and can maintain active concentrations in the blood with intervals of several months between administrations, enabling patients to continue with normal life while on maintenance therapy. Randomized trials of rituximab maintenance therapy have confirmed that remissions can be prolonged, and in one randomized trial, early results suggest a survival benefit. The optimal schedule for maintenance therapy has not yet been defined.

Animals↗

Effect of periodontal therapy in smokers and non-smokers with advanced periodontal disease: results after maintenance therapy for a minimum of 5 years.

BACKGROUND: Longitudinal clinical studies show smoking is a risk factor for periodontal disease progression. It has also been documented that smoking impairs healing after periodontal therapy. However, the longitudinal effect of smoking on treatment results in patients who undergo long-term maintenance therapy has not been extensively investigated. This study clinically and radiographically compared smoking and non-smoking patients who had been treated for advanced periodontal disease and who received maintenance therapy for a minimum of 5 years. METHODS: Twenty-nine patients were selected over a 6-month period when they presented for a regularly scheduled visit in a private office. Patients were selected on the basis of initially having lost 50% of bone support on 50% of their teeth; had received follow-up therapy for at least 5 years; were compliant at 75% of the appointments; and had plaque scores < 20% in 75% of the visits. All patients had received non-surgical and surgical therapy as required for pocket elimination. Fourteen were active smokers during the entire maintenance period. Clinical measurements of probing depths and presence of plaque and gingivitis and a new set of standardized radiographs were taken. RESULTS: Smokers had higher mean radiographic bone loss values prior to treatment (7.52 +/- 1.39 versus 6.65 +/- 1.39) and at the final examination (7.32 +/- 1.42 versus 6.29 +/- 1.29) mean radiographic bone loss as well as initial, immediate post-therapy, and final percent of pockets > or = 6 mm (1.42% +/- 1.87% versus 0.60% +/- 1.11%). Differences were not statistically significant. Over 5 to 8 years, seven sites in four non-smokers and 11 sites in six smokers exhibited radiographic bone loss > or = 2 mm. One tooth in a non-smoker and three teeth in two smokers were lost. In a logistic regression analysis, smoking increased the odds ratio 10.7 times of having > or = 1 site with bone loss > or = 2 mm. CONCLUSION: The present study on a small group of patients treated for advanced periodontal disease and well maintained over 5 to 8 years showed no statistically significant differences between smokers and non-smokers in clinical probing depth and radiographic bone loss measurements.

Adult↗

Treatment options for initial maintenance therapy of persistent asthma: a review of inhaled corticosteroids and leukotriene receptor antagonists.

Inhaled corticosteroids (ICSs) are recognized as the cornerstone of asthma therapy. They are considered to be the most effective anti-inflammatory medication currently available for the treatment of persistent asthma, regardless of its severity. Leukotriene receptor antagonists (LTRAs) are also used as initial maintenance therapy in patients whose asthma is uncontrolled by bronchodilators alone. There are now sufficient data available to allow a comparison of the relative effectiveness and cost-effectiveness of LTRAs and ICSs as initial maintenance therapy. The consensus from the studies reviewed in this article demonstrates that ICSs are more effective than LTRAs as initial maintenance therapy. In particular, studies on fluticasone propionate have shown that it was more effective than LTRAs in clinical outcomes: producing greater improvements in lung function and asthma control; as measured by either forced expiratory volume in 1 second (FEV1) or peak expiratory flow (PEF); by a greater reduction in daytime and night-time asthma symptoms; and short-acting beta2-agonist use. This superiority was also seen when patients were switched from an LTRA to fluticasone propionate. Similar findings have been demonstrated with beclomethasone dipropionate (BDP), showing that, in adults, this inhaled steroid also had a greater effect on pulmonary function and symptom scores than did LTRAs. Quality of life assessments showed that fluticasone propionate achieved improvements that were deemed to be clinically meaningful; these changes were significantly greater than those achieved with LTRAs. However, questionnaire-based patient preference studies comparing BDP with LTRAs showed that children and adolescents generally preferred an LTRA to BDP. A number of comparative analyses showed that inhaled fluticasone propionate is more cost-effective than either montelukast or zafirlukast; these analyses used cost per symptom-free day and cost per successfully treated patient as outcome measures, from the perspective of a third-party payer. In general, these results were supported by resource utilisation studies in real-world settings. Asthma treatment guidelines (e.g. GINA, 2002) recommend combination therapy with ICSs and a long-acting beta2-agonist as initial maintenance therapy if the disease is of sufficient severity. Studies that assessed the effectiveness, cost-effectiveness, and quality of life achieved with a salmeterol fluticasone propionate combination as initial maintenance therapy also showed it to be superior to LTRAs. In conclusion, in terms of efficacy and quality of life, fluticasone propionate is more effective than LTRAs as initial maintenance therapy and is associated with significantly lower healthcare costs and less frequent use of healthcare resources than LTRAs. There is also evidence to suggest that initial maintenance therapy with the combination of an inhaled steroid plus a long-acting beta-agonist bronchodilator may be a more effective option for the management of persistent asthma than treatment with a single-controller agent alone (ICS or LTRA).

Administration, Inhalation↗

Dose-related difference in progression rates of cytomegalovirus retinopathy during foscarnet maintenance therapy. AIDS Clinical Trials Group Protocol 915 Team.

PURPOSE: A previous dose-ranging study of foscarnet maintenance therapy for cytomegalovirus retinopathy showed a positive relationship between dose and survival but could not confirm a relationship between dose and time to first progression. This retrospective analysis of data from that study was undertaken to determine whether there was a relationship between dose and progression rates, which reflects the amount of retina destroyed when progression occurs. METHODS: Patients were randomly given one of two foscarnet maintenance therapy doses (90 mg/kg of body weight/day [FOS-90 group] or 120 mg/kg of body weight/day [FOS-120 group] after induction therapy. Using baseline and follow-up photographs and pre-established definitions and methodology in a masked analysis, posterior progression rates and foveal proximity rates for individual lesions, selected by prospectively defined criteria, were calculated in each patient. Rates were compared between groups. RESULTS: The following median rates were greater for the FOS-90 group (N = 8) than for the FOS-120 group (N = 10): greatest maximum rate at which lesions enlarged in a posterior direction (43.5 vs 12.5 microns/day; P = .002); posterior progression rate for lesions closest to the fovea (42.8 vs 5.5 microns/day; P = .010); and maximum foveal proximity rate for either eye (32.3 vs 3.4 microns/day; P = .031). CONCLUSION: Patients receiving higher doses of foscarnet have slower rates of progression and therefore less retinal tissue damage during maintenance therapy. A foscarnet maintenance therapy dose of 120 mg/kg of body weight/day instead of 90 mg/kg of body weight/day may help to preserve vision in patients with cytomegalovirus retinopathy.

AIDS-Related Opportunistic Infections↗

[Treatment of multiple myeloma with high-dose chemotherapy and transplantation of autologous hematopoietic stem cells and subsequent maintenance therapy with interferon alfa-2b or interferon alfa 2b and dexamethasone. Report of the ongoing study of the "4W" Czech Myeloma Group].

We report our results with high-dose chemotherapy in previously untreated multiple myeloma patients (4 courses of VAD chemotherapy, collection of PBSC after priming with cyclophosphamide, 5 g/m2, high-dose chemotherapy with melphalan, 200 mg/m2). Second transplantation was indicated only for patients who did not achieve remission after the first high-dose therapy (paraprotein lower than 25% of the pretreatment value). For the second transplantation melphalan (200 mg/m2) with methylprednisolone (1.5 g for 5 days) were used as conditioning regimen. After high-dose therapy all patients were randomized into two arms of maintenance therapy: interferon alpha-2b or sequential maintenance therapy (interferon alpha-2b for 3 months followed after 4 week pause by 40 mg of dexamethasone days 1-4, 10-13 and 20-23. The administration of interferon alpha was resumed four weeks after the last dexamethasone for next three months. The maintenance therapy continued for 48 months or until the progression. Fifty-five patients were enrolled in the study from January 1996 to August 1997. Thirty-five patients have undergone the first transplantation and 57% of them reached complete remission. There were 10% of non-responders after the first high-dose regimen. The mean time to reach white blood cell count above 1 x 10(9)/L after the application of high dose melphalan and platelets more than 50 x 10(9)/L were 12.2 (range 6-16 days) and 12.4 (range 0-25 days), respectively. Grade 4 mucositis according to SWOG classification requiring total parenteral nutrition was presented in 40% of the patients. The mean number of 1 unit of platelets and 2 units of packed red blood cells transfusions were given within the posttransplant period. Early transplant related mortality was 3%. This paper describes the response and tolerance of each particular step of therapy. The follow-up has been too short to evaluate event-free and overall survivals.

Adolescent↗

Maintenance therapy with H2-receptor antagonist until assessment of Helicobacter pylori eradication can reduce recurrence of peptic ulcer after successful eradication of the organism: prospective randomized controlled trial.

PURPOSE: This study examined the possible relationship between peptic ulcer recurrence and the presence or absence of maintenance therapy with an H(2)-receptor antagonist performed until evaluation of Helicobacter pylori eradication. METHODS: The subjects were 483 patients with peptic ulcer (281 gastric ulcer and 202 duodenal ulcer) who were diagnosed as H. pylori positive. After receiving eradication therapy for H. pylori, patients were allocated at random to one of three different maintenance therapies: control group (no maintenance therapy), H(2)-receptor antagonist half-dose group, and H(2)-receptor antagonist full-dose group. The maintenance therapy was performed for 4 weeks until evaluation of H. pylori eradication. RESULTS: Among the 25 patients with a recurrent ulcer, 18 patients (72%) had a recurrence at the time of or before evaluation of H. pylori eradication. In the control group, the rate of ulcer recurrence occurring before evaluation of H. pylori eradication was 10.5% (14/133). This rate was significantly higher than those in the H(2)-receptor antagonist half-dose group (2.9%, 4/136) and the full-dose group (0%, 0/135). CONCLUSION: The results of this study suggest that maintenance therapy with an H(2)-receptor antagonist performed after eradication therapy until evaluation of H. pylori eradication is likely to greatly reduce the ulcer recurrence rate without affecting evaluation of H. pylori eradication.

Adult↗