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PubMed1990

Definition of refractoriness against conventional chemotherapy in acute myeloid leukemia: a proposal based on the results of retreatment by thioguanine, cytosine arabinoside, and daunorubicin (TAD 9) in 150 patients with relapse after standardized first line therapy.

Response to salvage therapy at first and second relapse was analyzed in 150 patients with acute myeloid leukemia (AML) to improve the characterization of relapsed AML and to deduce from this analysis a proposal for the definition of refractoriness against conventional therapy. Salvage treatment consisted of a repetition of the TAD 9 regimen which was already applied as induction protocol at initial diagnosis. All patients were recruited from the multicenter 1982 trial of the German AML Cooperative Group and had thus received a standardized first line treatment. Response at first relapse was significantly related to the duration of the first remission. From 38 patients relapsing within 6 months after successful induction therapy, only 11 (28%) achieved a second complete remission as compared to 58 of 98 (59%) cases with later occurring relapses (p less than 0.01). This difference was due to a significantly higher incidence of persistent leukemia in the former group and not biased by differences in early death rates. No other variable was found predictive for the response to salvage treatment including age, WBC, serum LDH, morphologic subtype, presence or absence of DNA aneuploidy as detected by flow cytometry or maintenance chemotherapy. A low remission rate of 28% was also obtained in the 14 patients at second relapse. These data indicate that patients with a duration of their first remission of more than 6 months cannot be considered as being refractory against standard chemotherapy while patients with early relapses and second recurrences have a response rate of less than 30% due to refractory disease. Hence, the following criteria are proposed for the definition of refractoriness against standard chemotherapy in advanced AML: (a) nonresponse to first-line induction therapy, (b) early relapse within 6 to 12 months of first remission, (c) relapse after 6 to 12 months of first remission and failure on a reinduction attempt with established regimens, (d) second and subsequent relapses. These criteria may provide a useful rationale for the selection of the most appropriate treatment at relapse. They may also serve as eligibility criteria for clinical phase I/II studies and will facilitate interstudy comparisons.

Adult↗
PubMed2004

Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial.

CONTEXT: Initial treatment of major depressive disorder in adolescents may include cognitive-behavioral therapy (CBT) or a selective serotonin reuptake inhibitor (SSRI). However, little is known about their relative or combined effectiveness. OBJECTIVE: To evaluate the effectiveness of 4 treatments among adolescents with major depressive disorder. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of a volunteer sample of 439 patients between the ages of 12 to 17 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of major depressive disorder. The trial was conducted at 13 US academic and community clinics between spring 2000 and summer 2003. INTERVENTIONS: Twelve weeks of (1) fluoxetine alone (10 to 40 mg/d), (2) CBT alone, (3) CBT with fluoxetine (10 to 40 mg/d), or (4) placebo (equivalent to 10 to 40 mg/d). Placebo and fluoxetine alone were administered double-blind; CBT alone and CBT with fluoxetine were administered unblinded. MAIN OUTCOME MEASURES: Children's Depression Rating Scale-Revised total score and, for responder analysis, a (dichotomized) Clinical Global Impressions improvement score. RESULTS: Compared with placebo, the combination of fluoxetine with CBT was statistically significant (P =.001) on the Children's Depression Rating Scale-Revised. Compared with fluoxetine alone (P =.02) and CBT alone (P =.01), treatment of fluoxetine with CBT was superior. Fluoxetine alone is a superior treatment to CBT alone (P =.01). Rates of response for fluoxetine with CBT were 71.0% (95% confidence interval [CI], 62%-80%); fluoxetine alone, 60.6% (95% CI, 51%-70%); CBT alone, 43.2% (95% CI, 34%-52%); and placebo, 34.8% (95% CI, 26%-44%). On the Clinical Global Impressions improvement responder analysis, the 2 fluoxetine-containing conditions were statistically superior to CBT and to placebo. Clinically significant suicidal thinking, which was present in 29% of the sample at baseline, improved significantly in all 4 treatment groups. Fluoxetine with CBT showed the greatest reduction (P =.02). Seven (1.6%) of 439 patients attempted suicide; there were no completed suicides. CONCLUSION: The combination of fluoxetine with CBT offered the most favorable tradeoff between benefit and risk for adolescents with major depressive disorder.

Adolescent↗
PubMed2005

The Treatment for Adolescents With Depression Study (TADS): demographic and clinical characteristics.

OBJECTIVE: The Treatment for Adolescents With Depression Study is a multicenter, randomized clinical trial sponsored by the NIMH. This study is designed to evaluate the short- and long-term effectiveness of four treatments for adolescents with major depressive disorder: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely, pill placebo. This report describes the demographic and clinical characteristics of the sample and addresses external validity. METHOD: Participants are 439 adolescents, aged 12-17 years inclusively, with a primary DSM-IV diagnosis of current major depressive disorder. Baseline data are summarized and compared with those from national samples and previous trials. RESULTS: The sample composition is 54.4% girls, 73.8% white, 12.5% African American, and 8.9% Hispanic. The mean Child Depression Rating Scale-Revised total score is 60.1 (SD = 10.4, range 45-98) with 86.0% experiencing their first major depressive episode. The most common concurrent diagnoses are generalized anxiety disorder (15.3%), attention-deficit/hyperactivity disorder (13.7%), oppositional defiant disorder (13.2%), social phobia (10.7%), and dysthymia (10.5%). Demographic results are consistent with data from national samples and large psychopharmacology trials involving depressed adolescents. CONCLUSIONS: The Treatment for Adolescents With Depression Study provides a large, diverse, and representative sample of depressed adolescents that highlights the complexity of major depressive disorder in adolescents and provides a rich source for explicating the effects of moderator and mediator variables on baseline psychopathology and treatment outcome.

Adolescent↗
PubMed2006

Treatment for Adolescents with Depression Study (TADS): safety results.

OBJECTIVE: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). METHOD: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort. RESULTS: Depressed adolescents reported high rates of physical symptoms at baseline, which improved as depression improved. Sedation, insomnia, vomiting, and upper abdominal pain occurred in at least 2% of those treated with FLX and/or COMB and at twice the rate of placebo. The rate of psychiatric AEs was 11% in FLX, 5.6% in COMB, 4.5% in PBO, and 0.9% in CBT. Suicidal ideation improved overall, with greatest improvement in COMB. Twenty-four suicide-related events occurred during the 12-week period: 5 patients (4.7%) in COMB, 10 (9.2%) in FLX, 5 (4.5%) in CBT, and 3 (2.7%) in placebo. Statistically, only FLX had more suicide-related events than PBO (p =.0402, odds ratio (OR) = 3.7, 95% CI 1.00-63.7). Only five actual attempts occurred (2 COMB, 2 FLX, 1 CBT, 0 PBO). There were no suicide completions. CONCLUSIONS: Different methods for eliciting AEs produce different results. In general, as depression improves, physical complaints and suicidal ideation decrease in proportion to treatment benefit. In this study, psychiatric AEs and suicide-related events are more common in FLX-treated patients. COMB treatment may offer a more favorable safety profile than medication alone in adolescent depression.

Adolescent↗
PubMed2006

Functioning and quality of life in the Treatment for Adolescents with Depression Study (TADS).

OBJECTIVE: To test whether 12-week treatment of major depression improved the level of functioning, global health, and quality of life of adolescents. METHOD: The Treatment for Adolescents With Depression Study was a multisite, randomized clinical trial of fluoxetine, cognitive-behavioral therapy (CBT), their combination (COMB), or clinical management with placebo in 439 adolescents with major depression. Functioning was measured with the Children's Global Assessment Scale (CGAS), global health with the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), and quality of life with the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). Random-effects regression models were applied to the data. RESULTS: Compared with placebo, COMB was effective on the CGAS (p < .0001), HoNOSCA (p < .05), and PQ-LES-Q (p < .001), whereas fluoxetine was superior to placebo on the CGAS only (p < .05). COMB was superior to fluoxetine on the CGAS (p < .05) and PQ-LES-Q (p = .001). Fluoxetine was superior to CBT on the CGAS (p < .01). CBT monotherapy was not statistically different from the placebo group on any of the measures assessed. Treatment effects were mediated by improvement in depressive symptoms measured on the Child Depression Rating Scale-Revised. CONCLUSIONS: The combination of fluoxetine and CBT was effective in improving functioning, global health, and quality of life in depressed adolescents. Fluoxetine monotherapy improved functioning.

Adolescent↗
PubMedDate not supplied

Iatrogenic arteriovenous fistula in a renal allograft: the result of a TAD guidewire injury.

A case is presented of an iatrogenic arteriovenous fistula developing in a renal allograft following guidewire manipulation during transplant renal artery angioplasty. Hyperdynamic flow through the fistula was causing a shunt of blood away from the renal cortex as demonstrated on sonography and scintigraphy. Selective embolization was performed, correcting the maldistribution of flow to the peripheral renal cortex. The diagnosis and difficulty in management of asymptomatic renal arteriovenous fistulae is also discussed.

Angiography↗
PubMed2000

Functional evaluation of Tadenan on micturition and experimental prostate growth induced with exogenous dihydrotestosterone.

OBJECTIVES: To evaluate the effect of Tadenan (TAD; Pygeum africanum extract) pretreatment on the micturition characteristics of conscious and anesthetized rats consequent to dihydrotestosterone (DHT) administration and to examine the influence of such treatment on the growth of the prostate. METHODS: Studies using 40 adult Sprague-Dawley male rats were performed during a 7-week period. These animals were treated with DHT 1.25 mg/kg subcutaneously dissolved in peanut oil and/or TAD 100 mg/kg orally dissolved in sesame oil, except for the controls, which received vehicle only. Rats were divided into four groups: group 1 (control), vehicle only; group 2, DHT administered during weeks 3 and 4; group 3, TAD pretreatment, administered during weeks 1 and 2, followed by the combined administration of DHT and TAD during weeks 3 and 4 and TAD only during weeks 5 to 7; and group 4, continuous TAD treatment for 7 weeks. Micturition of conscious rats was evaluated in metabolic chambers, and in anesthetized rats, cystometrograms were done at the end of 7 weeks. RESULTS: DHT or DHT plus TAD did not produce significant changes in the volume but did reduce the frequency of micturition. TAD given alone significantly increased the volume of micturition and the rate of urine production. Cystometrographic studies in anesthetized rats revealed that DHT produced micturition characteristics similar to obstruction. The DHT plus TAD and TAD pretreatment data showed no significant difference from controls, suggesting that in the presence of TAD, the effects of DHT were negated. The total prostate weight of DHT and DHT plus TAD pretreated rats increased, and in the TAD group, these values decreased to lower than controls; growth of the ventral lobes was suppressed in the presence of TAD. CONCLUSIONS: These results demonstrate that TAD pretreatment significantly reduces the "obstructive" effects of DHT on micturition, counteracts the hormone-induced enlargement of the prostate, and reduces prostate weight in the ventral but not the dorsal lobe.

Animals↗