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At least 91 records · Page 5Linked to original sources
PubMed1999

Comparison of primary angioplasty with conservative therapy in patients with acute myocardial infarction and contraindications for thrombolytic therapy. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

The benefit of primary angioplasty in patients with acute myocardial infarction (AMI) and contraindications for thrombolysis compared to a conservative regimen is still unclear. Out of 5,869 patients with AMI registered by the MITRA trial, 337 (5.7%) patients had at least one strong contraindication for thrombolytic therapy. Out of these 337 patients 46 (13.6%) were treated with primary angioplasty and 276 (86.4%) were treated conservatively. Patients treated conservatively were older (70 years vs. 60 years; P=0.001), had a higher rate of a history with chronic heart failure (14.8% vs. 4.4%; P=0.053), a higher heart rate at admission (86 beats/min vs. 74 beats/min; P=0.001), and a higher prevalence of diabetes mellitus (27.1% vs. 12.8%; P=0.056). Patients treated with primary angioplasty received more often aspirin (91.3% vs. 74.6%; P=0.012), beta-blockers (60.9% vs. 46.1%; P = 0.062), angiotensin converting enzyme (ACE) inhibitors (71.7% vs. 44%; P=0.001), and the so-called optimal adjunctive medication (54.4% vs. 32.3%; P=0.004). Hospital mortality was significantly lower in patients who received primary angioplasty (univariate: 2.2% vs. 24.7%; P=0.001; multivariate: OR=0.46; P=0.0230). In patients with AMI and contraindications for thrombolytic therapy, primary angioplasty was associated with a significantly lower mortality compared to conservative treatment. Therefore, hospitals without the facilities to perform primary angioplasty should try to refer such patients to centers with the facilities for such a service, if this is possible in an acceptable time.

Aged↗
PubMed2001

A treatment planning comparison of 3D conformal therapy, intensity modulated photon therapy and proton therapy for treatment of advanced head and neck tumours.

BACKGROUND AND PURPOSE: In this work, the potential benefits and limitations of different treatment techniques, based on mixed photon-electron beams, 3D conformal therapy, intensity modulated photons (IM) and protons (passively scattered and spot scanned), have been assessed using comparative treatment planning methods in a cohort of patients presenting with advanced head and neck tumours. MATERIAL AND METHODS: Plans for five patients were computed for all modalities using CT scans to delineate target volume (PTV) and organs at risk (OAR) and to predict dose distributions. The prescribed dose to the PTV was 54 Gy, whilst the spinal cord was constrained to a maximum dose of 40.5 Gy for all techniques. Dose volume histograms were used for physical and biological evaluation, which included equivalent uniform dose (EUD) calculations. RESULTS: Excluding the mixed photon-electron technique, PTV coverage was within the defined limits for all techniques, with protons providing significantly improved dose homogeneity, resulting in correspondingly higher EUD results. For the spinal cord, protons also provided the best sparing with maximum doses as low as 17 Gy. Whilst the IM plans were demonstrated to be significantly superior to non-modulated photon plans, they were found to be inferior to protons for both criteria. A similar result was found for the parotid glands. Although they are partially included in the treated volume there is a clear indication that protons, and to a lesser extent IM photons, could play an important role in preserving organ functionality with a consequent improvement of the patient's quality of life. CONCLUSIONS: For advanced head and neck tumours, we have demonstrated that the use of IM photons or protons both have the potential to reduce the possibility of spinal cord toxicity. In addition, a substantial reduction of dose to the parotid glands through the use of protons enhances the interest for such a treatment modality in cases of advanced head and neck tumours. However, in terms of target coverage, the use of 3D conformal therapy, although somewhat inferior in quality to protons or IM photons, has been shown to be a reasonable alternative to the more advanced techniques. In contrast, the conventional technique of mixed photon and electron fields has been shown to be inferior to all other techniques for both target coverage and OAR involvement.

Carcinoma, Squamous Cell↗
PubMed2003

[Severe exacerbation of chronic hepatitis B during therapy with corticosteroids and lamivudine therapy and successful short-term combination therapy with interferon-beta and interferon-gamma].

Following an acute episode of undifferentiated collagenosis/autoimmune disease with joint pain, a 50-year-old female patient with known long-standing chronic hepatitis B was treated orally with corticosteroids (30 mg prednisolone in decreasing doses over a period of six months). During this treatment, exacerbation of hepatitis B and massive flare-up under simultaneous treatment with lamivudine occurred (GOT 530 U/L, GPT 791 U/L). Serology was positive for HBs-Ag and anti-HBc-lgM. HBV-DNA titer was > 400,000 copies/ml in polymerase chain reaction. Considering the increased risk of reactivation of autoimmune phenomena during a six months therapy with interferon-alpha, an intensive combination therapy with interferon-beta and -gamma (2 weeks: 1 x 3 MIU nIFN-beta Fiblaferon i.v.; 3 weeks: 1 x 3 MIU nIFN-beta i.v. plus 1 x 50 microg rIFN-gamma Imukine) was carried out over five weeks. After two months this resulted in a complete viral and biochemical response. During an observation period of twelve months no reactivation of the autoimmune disease occurred.

Anti-Inflammatory Agents↗
PubMed2001

The virological response to highly active antiretroviral therapy over the first 24 weeks of therapy according to the pre-therapy viral load and the weeks 4-8 viral load.

OBJECTIVES: To describe the viral response to HAART by weeks 4 and 8 in previously antiretroviral-naive patients. To assess whether the weeks 4 or 8 viral loads are useful predictors of viral suppression by week 24. DESIGN: A large clinical database including 453 antiretroviral-naive patients whose plasma viral load was monitored every 4 weeks. METHODS: Observed probabilities of achieving a viral load < or = 500 copies/ml by week 24 (days 84-168) from starting highly active antiretroviral therapy (HAART) were calculated according to viral loads at weeks 4 and 8. RESULTS: A total of 42.4% of patients (153/361) reached < or = 500 copies/ml viral load by week 4 and 70.4% (245/348) by week 8. Viral suppression below 500 copies/ml by 4-8 weeks was similar irrespective of the pre-HAART viral load. In patients with viral loads above 10000 copies/ml at week 4, 60.6% (20/33) achieved < or = 500 copies/ml by week 24. In patients with viral loads still above 10000 copies/ml at week 8, only 42.3% (11/26) achieved < or = 500 copies/ml by week 24, and only 33.3% (3/9) maintained viral suppression below 500 copies/ml to week 48. CONCLUSION: Viral loads at weeks 4 and 8 should be monitored to detect early signs of low subsequent viral suppression. For previously antiretroviral-naive patients whose viral loads after 8 weeks of HAART are still above 10000, there is an urgent need to assess adherence to therapy, drug levels and resistance, so management can be modified accordingly to reduce the rate of week 24 virological failure.

Adult↗
PubMed1996

Monotherapy with meropenem versus combination therapy with ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto Infection Program.

Combinations of beta-lactams plus aminoglycosides have been standard therapy for suspected infections in granulocytopenic cancer patients, especially those with profound long-lasting granulocytopenia. With the advent of new broad-spectrum bactericidal antibiotics such as extended-spectrum cephalosporins or carbapenems, the need to combine beta-lactams with aminoglycosides became more controversial. The objective of this prospective randomized multicenter study was to compare the efficacy, safety, and tolerance of meropenem monotherapy with those of the combination of ceftazidime plus amikacin for the empirical treatment of fever in granulocytopenic cancer patients. Of 1,034 randomized patients, 958 were assessable in the intent-to-treat analysis for response to antibacterial therapy, including 483 in the meropenem group and 475 in the ceftazidime-plus-amikacin group. The median durations of neutropenia were 16 and 17 days, respectively. A successful outcome was reported in 270 of 483 (56%) patients treated with monotherapy compared with 245 of 475 (52%) patients treated with the combination group (P = 0.20). The success rates in the monotherapy group and the combination group were similar by type of infection (single gram-negative bacteremia, single gram-positive bacteremia, clinically documented infection, and possible infection). The occurrence of further infections assessed in patients for whom the allocated regimen was not modified did not differ between the two groups (12% in both groups). Mortality due to the presenting infection or further infection was relatively low (8 patients treated with the monotherapy compared with 13 patients treated with the combination). A total of 1,027 patients were evaluable for adverse events; the proportion of those who developed adverse effects was similar between the two groups (29% in both groups), and only 19 (4%) patients in the monotherapy group and 31 (6%) in the combination group experienced an adverse event related or probably related to the study drug. Allergic reactions were the only reason for stopping the protocol antibiotic(s) (3 and 5 patients, respectively). This study confirms that monotherapy with meropenem is as effective as the combination of ceftazidime plus amikacin for the empiric treatment of fever in persistently granulocytopenic cancer patients, and both regimens were well tolerated.

Adolescent↗
PubMed2006

[Organ preservation, multimodal radical tumor therapy and reduction of therapy-related morbidity--development of diagnostics and therapy of endometrial carcinoma].

Endometrial carcinoma is the most frequent genital malignoma in women. Considering the tumor-biological and prognostically very different subtypes of endometrial carcinoma, an individual therapeutic strategy plays a very important role. Besides the question of an individualized organ-preserving procedure for women who wish to have a baby, the reduction of morbidity by minimally invasive laparoscopic/vaginal surgery is discussed. While adjuvant gestagen therapy is not useful, platinum-containing chemotherapy seems to be effective in certain risk situations. The indication of lymphonodectomy with regard to staging as well as the effect of adjuvant radiation therapy for local control are undisputed. In view of a postulated curative effect, the results of the ongoing prospective studies will make things clearer.

Combined Modality Therapy↗
PubMed2005

Contributions to the study of violence and trauma: multisystemic therapy, exposure therapy, attachment styles, and therapy process research.

The prevention of future violence through engaging violent adolescents in multisystemic therapy and the treatment of trauma with exposure therapy are two of the most important scientific advances in the field of interpersonal violence in the past 20 years. A particularly significant methodological innovation is the development of reliable and valid measures of childhood and adult attachment because attachment deficits and their remediation are central to understanding and treating perpetrators of violence. In the coming decades, we need to refine existing treatment programs to make them effective for cases currently classified as treatment resistant. This will involve psychotherapy process research on the interaction between therapeutic mechanisms of change and unique personal vulnerabilities of treatment-resistant cases.

Adolescent↗
PubMed1993

[Therapy of pronounced pleural and pericardial effusion in metastatic breast cancer with local mitoxantrone and radiation therapy. Presentation of the intrapleural cytologic findings during this therapy].

The method of intrapleural Mitoxantrone therapy in case of metastasizing mammary cancer is presented in form of a case report. The uncomplicated procedure, the high rate of remission and the few side effects are the advantages as compared to other methods of pleurodesis. Mitoxantrone could cause an intrapleural inflammatory reaction. That is supported by the cytologic findings before and after the therapy.

Breast Neoplasms↗
PubMedDate not supplied

[Glycosaminoglycanpolysulfate (GAGPS, Arteparon) for basic therapy of arthrosis. I. Comparative studies, Arteparon forte and physical therapy vs. physical therapy alone].

Glycosaminoglycan polysulphate (GAGPS, Arteparon) is effective as a fundamental therapeutic agent in arthrosis (osteoarthritis). Patients with gonarthrosis and coxarthrosis of activity grade II received intramuscular Arteparon forte injections and physical therapy (group 1, n = 69) or physical therapy only (group 2, n = 46). In group 1 23 patients (33.3%) became free of pain as compared to 3 patients (6.5%) in group 2. No therapeutic success was obtained in 6 patients of group 1 (8.7%) and in 14 individuals (30.4%) of group 2.

Adult↗
PubMedDate not supplied

[Glycosaminoglycanpolysulfate (GAGPS, Arteparon) for basic therapy of arthrosis. II. Comparative studies, Arteparon forte and physical therapy vs. physical therapy alone; late results].

Five to 9 months after a comparative study of 2 groups of patients with coxarthrosis and gonarthrosis, 69 individuals (group 1) receiving Arteparon forte injections and physical therapy and 46 persons (group 2) with physical therapy only, questioneer with specific questions was sent out. From 72 questioneers mailed 55 were returned to the investigators of the study. 53 questioneers were suitable for evaluation: 40 in the group 1 and 13 in group 2. 62.5% of the patients in group 1 described their condition improved as compared to 30.8% in group 2. In 46.1% of the patients in group 2 the condition had deteriorated; this occurred in only 17.5% of group 1.

Adult↗
PubMed1991

Comparison of the Radiation Therapy Oncology Group and American Joint Committee on Cancer staging systems among patients with non-small cell lung cancer receiving hyperfractionated radiation therapy. A report of the Radiation Therapy Oncology Group protocol 83-11.

Since 1973, the Radiation Therapy Oncology Group (RTOG) has staged and stratified patients in non-small cell lung cancer (NSCLC) protocols according to the RTOG staging system. In 1985, the American Joint Committee on Cancer (AJCC) revised its lung cancer staging system, with the principle differences from the RTOG system being the staging of involvement of the chest wall and of contralateral mediastinal and hilar lymph nodes. To determine if the AJCC system discriminated outcome differently than the RTOG system in a nonoperative series, all 850 evaluable patients treated with hyperfractionated radiation therapy (RT) on the RTOG protocol 83-11 were restaged by the AJCC system. There was 67% agreement in patient distribution between the following comparable stages in each system: RTOG Stage II/AJCC Stage II; RTOG Stage III/AJCC Stage IIIA; and RTOG Stage IV/AJCC Stage IIIB. Both systems successfully predicted for survival (P less than 0.001), although the RTOG staging was more discriminating (relative risk ratios, 1.59 versus 1.38). Among the 507 favorable patients (those with less than or equal to 5% weight loss and Karnofsky performance status [KPS] of 70 to 100), the RTOG staging was also more predictive (P = 0.004 versus P = 0.01). When RTOG Stage III (462 patients) was divided into those without contralateral mediastinal or hilar adenopathy (AJCC Stage II/IIIA) and those with (AJCC Stage IIIB), a significant survival (P = 0.0001) was noted with 2-year survival rates of 26% versus 4%, respectively. When AJCC Stage IIIA (348 patients) was divided into the patients without chest wall invasion (RTOG Stage II/III) and those with (RTOG Stage IV), a difference in 2-year survival of 22% versus 10% was observed (P = 0.002). Although both staging systems independently predict for survival, a fusion of both staging systems is the most discriminating of outcome. Future nonoperative studies in locally advanced NSCLC should stratify for contralateral nodal involvement (per AJCC staging) and chest wall invasion (per RTOG staging).

Carcinoma, Non-Small-Cell Lung↗
PubMed2002

Safety and efficacy of only 2 weeks of ticlopidine therapy in patients at increased risk of coronary stent thrombosis: results from the Antiplatelet Therapy alone versus Lovenox plus Antiplatelet therapy in patients at increased risk of Stent Thrombosis (ATLAST) trial.

BACKGROUND: Controversy exists regarding the frequency of late stent thrombosis among patients treated with intracoronary stents and the most appropriate duration of treatment with a thienopyridine that is required to prevent this complication. METHODS: We analyzed the frequency of stent thrombosis and other ischemic events in the Antiplatelet Therapy alone versus Lovenox plus Antiplatelet therapy in patients at increased risk of Stent Thrombosis (ATLAST) trial. In the ATLAST trial, 1102 patients at increased risk of stent thrombosis (ST-elevation myocardial infarction within 48 hours, diffuse distal disease, a large amount of thrombus, acute closure, residual dissection, etc) were randomly assigned to receive either enoxaparin (40 or 60 mg given every 12 hours for 14 days) or placebo; all patients received aspirin (325 mg daily) and ticlopidine (250 mg twice daily) for only 14 days. RESULTS: The primary end point, the 30-day combined incidence of death, nonfatal myocardial infarction, and urgent revascularization, was reached in 2.3% of patients (1.8% of patients taking enoxaparin vs 2.7% of patients taking placebo; P =.295). However, during the 15th through 30th days, the frequency of ischemic events was only 0.73%, and only 0.27% (3/1102) of patients had possible stent thrombosis (95% CI 0.06, 0.77). CONCLUSION: The frequency of stent thrombosis and other adverse ischemic events in the 15th through 30th days after stent placement in even high-risk stent patients treated with ticlopidine for only 2 weeks is low whether or not enoxaparin is administered.

Coronary Thrombosis↗
PubMed1979

The acute changes seen in cardiac glycoside receptor sites, 86rubidium uptake and intracellular sodium concentrations in the erythrocytes of patients during the early phases of digoxin therapy are not found during chronic therapy: pharmacological and therapeutic implications for chronic digoxin therapy.

1 Measurements of the binding of 12-alpha-[3H]-digoxin to the membranes of intact erythrocytes, erythrocyte 86rubidium uptake and intraerythrocytic sodium concentrations have been made in the red cells of various groups of patients--those who have not received digoxin, those during the early phases of treatment, those during chronic (greater than 2 months) treatment, and those toxic. 2 The values of those measurements in the patients in the early phases of therapy and in the toxic patients differed significantly from those of the untreated patients. 3 However, the values in the chronically treated patients were not different from those of the untreated patients. 4 The results suggest that the biochemical pharmacological effects of digoxin which occur during the early phases of therapy do not persist in the long-term. 5 The possible clinical significance of these observations is discussed.

Aged↗
PubMed1995

Adjuvant therapy with 5-fluoro-1-(2-tetrahydrofuryl)-2,4 (1H,3H)-pyrimidinedione (UFT) and Bestatin in patients with transitional cell carcinoma of the bladder--comparison between UFT therapy alone and UFT therapy in combination with Bestatin.

To prevent postoperative recurrence a randomized prospective trial was performed on 45 patients with bladder cancers by dividing them into 2 groups given either UFT therapy alone or UFT therapy in combination with Bestatin. In principle, oral administration of these drugs was initiated 4 weeks postoperatively and continued for a period of 1 year. Bestatin was given at the dose of 30 mg/day after breakfast per os, and UFT at the dose of 400 mg/day twice a day per os. After a median follow-up period of 628 days the relapse-free rate was 43.5% for the group given UFT alone and 81.8% for the group given a combination of UFT plus Bestatin, showing a significantly more favorable result in the latter group. In patients with a solitary and papillary tumor the relapse-free rate was significantly better in the UFT plus Bestatin group compared with the group of UFT alone. Accordingly, it was suggested that postoperative administration of UFT in combination with Bestatin is more effective in preventing recurrence of bladder cancer, compared with the administration of UFT alone.

Administration, Oral↗
PubMed2005

Total therapy 2 without thalidomide in comparison with total therapy 1: role of intensified induction and posttransplantation consolidation therapies.

Patients with myeloma, treated on the thalidomide arm of total therapy 2 (TT2), had a higher complete response (CR) rate and improved event-free survival (EFS) but not overall survival (OS). To evaluate the benefit of TT2's posttandem autotransplant consolidation chemotherapy and dexamethasone maintenance, outcomes were compared on TT2 without thalidomide (n = 345; median follow-up, 3.5 years) and on predecessor trial TT1 (n = 231; median follow-up, 11.5 years). CR rates were similar (43% vs 41%); however, 5-year estimates of continuous CR (45% vs 32%, P < .001) and 5-year EFS (43% vs 28%, P < .001) were superior with TT2, with a trend for improved OS (62% vs 57%; P = .11). OS was also superior among patients achieving CR and receiving the second transplantation early after the first transplantation. Superior EFS and OS with TT2 versus TT1 was noted in the two thirds presenting without cytogenetic abnormalities (CAs); 4-year posttandem transplantation OS for patients with CAs was 47% with TT1 and 76% with TT2 when combination chemotherapy rather than DEX was applied for consolidation (P = .040). Thus, TT2 (without thalidomide) improved OS of patients without CAs; those with CAs benefited from posttransplantation consolidation chemotherapy. The favorable effects of CR and rapidly sequenced second transplantation attest to the validity of a melphalan dose-response effect in myeloma.

Aged↗
PubMed2000

Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix.

PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. CONCLUSION: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.

Adult↗
PubMed2003

High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy.

PURPOSE: To determine whether high-dose therapy (HDT) with autologous stem-cell transplantation (ASCT) should be included in the initial consolidative treatment of patients with advanced, unfavorable Hodgkin's lymphoma (HL). PATIENTS AND METHODS: One hundred sixty-three patients achieving complete remission (CR) or partial remission (PR) with four initial courses of doxorubicin, bleomycin, vinblastine, and dacarbazine, or other doxorubicin-containing regimens, were randomly assigned to receive HDT plus ASCT (83 patients) versus four courses of conventional chemotherapy (80 patients). Unfavorable HL was defined as the presence of at least two of the following poor prognostic factors: high lactate dehydrogenase level, large mediastinal mass (greater than at least 33% of the thoracic diameter), more than one extranodal site, low hematocrit level, and inguinal involvement. RESULTS: At the end of the treatment program, 92% of patients in arm A and 89% in arm B achieved a CR (P =.6). After a median follow-up of 48 months, the 5-year failure-free survival rates were 75% (95% confidence interval [CI], 65 to 85) in arm A and 82% (95% CI, 73 to 90) in arm B (P =.4). The 5-year overall survival rates were 88% (95% CI, 80 to 96) in arm A and 88% (95% CI, 79 to 96) in arm B (P =.99). The 5-year relapse-free survival rates were 88% in arm A (95% CI, 80 to 96) and 94% in arm B (95% CI, 88 to 100), and the difference was not significant (P =.3). CONCLUSION: Patients with advanced unfavorable HL achieving CR or PR after four courses of doxorubicin-containing regimens have a favorable outcome with conventional chemotherapy. No benefit from an early intensification with HDT and ASCT was shown.

Adolescent↗
PubMed1996

High-dose therapy autologous stem cell transplantation vs conventional therapy for patients with advanced Hodgkin's disease responding to first-line therapy: analysis of clinical characteristics of 51 patients enrolled in the HD01 protocol. EBMT/ANZLG/Intergroup HD01 Trial.

Whether high-dose therapy (HDT) plus autologous stem cell transplantation (ASCT) ought to be included in the initial treatment plan for those patients with unfavourable Hodgkin's disease, a wide cooperative study (HD01 protocol) was approved, comparing HDT followed by ASCT vs conventional chemotherapy (CT). Patients were eligible for the study if they had at least two of the following adverse prognostic factors: high serum LDH levels, mediastinal mass >0.45, more than one extranodal involved site, low hematocrit (<34% for women and <38% for men), and inguinal involvement. Those patients achieving complete or partial remission with four courses of ABVD or ABVD-containing chemotherapy were randomized to receive either HDT plus ASCT or four additional courses of chemotherapy, followed by ASCT in second remission, if appropriate. Between April 1993 and September 1995, 55 patients from 14 different centers have been enrolled into the trial. Twenty patients (45%) were in stage IV, and 37 patients (84%) had systemic symptoms. Twenty-seven patients (61%) had two adverse prognostic factors, and 17 patients (39%) had three or more risk factors. After four cycles of ABVD-containing CT, 44 patients were assessable for response. Overall 12 patients achieved CR (27%), 25 obtained a PR (57%) and seven patients failed to respond (16%). Thirty-six patients were randomized between ASCT (20 patients) or four additional cycles of conventional CT (16 patients). With a median follow-up after ASCT of 13 months (range 1-23 months), no major ASCT-related toxicity has been reported to the trial office. In conclusion, the first 44 patients registered in the HD01 trial and assessable for response, had a very aggressive disease and responded poorly to conventional CT, thus warranting a more aggressive approach, such as HDT followed by ASCT.

Adolescent↗