Treatment program

All high risk patients were treated with nine alternating courses (days 1-6) of according to the ALL-BFM 90 regimen (Figure 17.11) at 3 weekly intervals. Criteria to commence chemotherapy included (1) neutrophil count (ANC) 0.2 X 109 l, (2) platelet count 50 X 109 l and (3) oral temperature < 38.5 C for at least 3 days. Children randomized to r-GCSF received 5 g kg day subcutaneously from day 7 of each cycle and continued till day 20. If ANC on day 20 was < 0.2 X 109 l, GCSF was continued...

Study design

Patients received standard induction chemotherapy with ifosfamide and etoposide, cyclophosphamide and doxorubicin (see Figure 3.8). Local control from week 9 consisted of surgical resection and radiation therapy depending on tumor size and response (see Table 3.1). Following this, patients were randomized to receive cyclophosphamide at 1 g m2 versus 1.5 g m2 combined with doxorubicin and alternated with ifosfamide and etoposide (see Figure 3.8). Treatment lasted 41 weeks.

Study 8

Sullivan MP, Chen T, Dyment PG, Hvizdala E, Steuber CP. Equivalence of intrathecal chemotherapy and radiotherapy as central nervous system prophylaxis in children with acute lymphatic leukaemia a Pediatric Oncology Study Group. Blood 1982 60 948-58. South West Oncology Group Study 7420 (AlinC-11) was a prospective multicenter randomized study and ran from September 1974 to October 1976. Previously untreated children and adolescents below 18 years of age were enrolled on the study.

Study 4

Schrappe M, Reiter A, Zimmermann M, Harbott J, Ludwig W-D, Henze G, Gadner H, Odenwald E, Riehm H. Long-term results of four consecutive trials in childhood ALL performed by the ALL-BFM study group from 1981 to 1995. Leukaemia 2000 14 2205-22. ALL-BFM 83 was a multicenter prospective randomized study with treatment stratified according to the BFM (Berlin-Frankfurt-Munster) risk criteria. ALL-BFM 83 began in October 1983 and was closed in September 1986. The study was open to all patients less...

Study 17

Tubergen DG, Gilchrist GS, O'Brien RT, Coccia PF, Sather HN, Waskerwitz MJ, Denman Hammond G. Prevention of CNS disease in intermediate risk acute lymphoblastic leukemia comparison of cranial irradiation and intrathecal methotrexate and the importance of systemic therapy a Children's Cancer Group Report. J Clin Oncol 1993 11 520-6. This was a Children's Cancer Group Study (CCG-105) and was a prospective randomised trial that ran from May 1983 to April 1989. The trial was based on a 2 X 4...

Results economic assessment

Hospital stay was significantly shorter in the GCSF group compared to control group (53.9 days versus 63.5 days p 0.025), while the number of platelet units transfused were significantly higher in the GCSF group (4.7 versus 3.2 p 0.01). Red cell transfusions were similar in both groups (6 versus 5.7 p 0.898). Costing according to the resource category indicated that for the GCSF group, hospitalization cost was significantly reduced (US 21,883 versus US 25,780) while the costs of platelet...

Outcome

Two hundred and eleven patients were registered onto the study. Nine were non-eligible due to prior chemotherapy or performance status, and 10 were excluded due to inadequate data collection. One hundred and eighty-three patients completed induction chemotherapy. Ninety-one patients were randomized on the schedule study 43 received continuous infusion platinum and 48 bolus. They were well matched for age, sex, primary location, catecholamine increase, MIBG, marrow positivity and other secondary...

25th Anniversary

BPatient average number of days per cycle. bPatient average number of days per cycle. difference between the two groups of patients with regard to delay in chemotherapy (p 0.16) or duration of hospitalization (p 0.22), there was statistically significant difference in the number days of ANC < 500 il favoring the r-metHuGCSF group (p 0.017). There was no difference in the 2-year event-free survival (EFS) rates (71 ) between the r-metHuGCSF and non-r-metHuGCSF groups (log rank p-value, 0.52).

Eligibility

Patients under the age of 25 years with ECOG performance status 0-1, no marrow metastases with desmoplastic small round cell tumors (DSRG) and primitive neuroectodermal tumor (PNET). Included bone and soft tissue Ewing's Sarcoma. Initial staging comprised CT or MRI of primary, bone scan and CT chest. There was institutional review of all pathology. Method and site of randomization are not described. The primary end point of the study was to estimate the proportion of patients receiving the...

Details of the study

Eligible patients comprised those with stage 3 or 4 disease of any age who had achieved complete response or very good partial response after induction and consolidation chemotherapy and surgery to the primary site. Randomization was carried out at the United Kingdom Children's Cancer Study Group (UKCCSG) Data Centre. Method of randomization, difference anticipated or numbers of patients needed are not given in detail. There was no stratification for risk factors. This was a double blind...

Acute myeloid leukemia

Commentaries by Judith Chessells and Vaskar Saha The long-term survival for children with acute myeloid leukemia has improved steadily over the past 20 years.1-11 Acute myeloid leukemia is a rare disease in childhood and it is difficult to accrue sufficient numbers for randomized trials. Yet the need for such trials is pressing since as survival improves it becomes more important to refine therapy and avoid late effects of treatment. One approach to this problem, adopted by the UK Medical...

Randomized clinical trials

Randomized clinical trials in medulloblastoma have addressed the following important hypotheses 1 Adjuvant or neoadjuvant chemotherapy will improve survival. 2 A new chemotherapy regimen will be superior to the standard regimen in improving survival. 3 The dose of cranial-spinal radiotherapy can be reduced and thereby reduce long-term morbidity of therapy in some groups. 4 Utilizing chemotherapy with reduced dose cranial-spinal radiotherapy will improve survival rates while decreasing long-term...

Info

Cycles of consolidation chemotherapy to be given for a total of 4 times, up to week 41. MTX methotrexate (600mg m2 6 hour infusion) CF citrovorum factor (15mg 6 weekly X 12) VCR vincristine (1.5mg m2 IV max 2mg) ADR Adriamycin (doxorubicin) 70 mg m2 IV CYP cyclophosphamide (1200 mg m2 IV). This study was designed and executed by the EORTC between 1978 and 1983. Two hundred and forty patients below the age of 30 years were registered, of whom 205 were evaluable. Exclusions were due to low grade...

Evaluation of cardiotoxicity

MUGA scans using technetium 99 m pertechnetate labeled red blood cells was used to determine doxoru-bicin cardiotoxicity. These were performed at baseline and at 6-12 weeks after the 210,310,360 and 410 mg m2 cumulative doses of doxorubicin. All MUGA scans were reviewed by three nuclear medicine physicians who were blinded to the patient's randomization and clinical status. Dose-limiting cardiotoxicity was defined as a reduction in the LVEF to < 45 , or decrease in the LVEF by > 20...