ObjectivesChemotherapy-induced oral mucositis (OM) is a debilitating side effect. In addition to standard therapy, patients often use complementary and alternative medicine to treat OM.DesignDouble blind randomised placebo controlled study assessing propolis (bee glue) efficacy for chemotherapy-induced severe OM treatment.SettingUniversity Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia.InterventionsPaediatric patients undergoing chemotherapy were randomly assigned to propolis (n=19) or placebo groups (n=21). Patients were introduced to a unified oral care protocol and asked to apply propolis or placebo to vestibular mucosa twice daily. Oral mucosa was assessed with the Oral Assessment Guide (OAG) twice a week when the patients were in hospital. Patients were followed for the period of the chemotherapy or for the first 6 months of the chemotherapy. An OAG score of 3 was considered to be severe OM and analysed.Main outcome measurementsThree dependent variables (a) OM episode frequency, (b) mean number of assessment visits, at which an OAG 3 score was noted, expressing mean OM duration, (c) mean number of OAG 3 scores expressing mean OM severity) were reduced to a single variable using principal component analysis. A new variable (FDS) was used as the dependent variable in ANCOVA model analysis to show the differences between study groups.ResultsSevere OM was seen in 42% and 48% of patients in the propolis and placebo group, respectively. FDS was not statistically significant between study groups (p=0.59).ConclusionsAccording to our study results, propolis cannot be recommended for severe OM treatment.
COBISS.SI-ID: 30911449
From 2002 to 2007, the International BerlinFrankfurtMünster Study Group conducted a prospective randomized clinical trial (ALL ICBFM 2002) for the management of childhood acute lymphoblastic leukemia (ALL) in 15 countries on three continents. The aim of this trial was to explore the impact of differential delayed intensification (DI) on outcome in all risk groups.For this trial, 5,060 eligible patients were divided into three risk groups according to age, WBC, early treatment response, and unfavorable genetic aberrations. DI was randomized as follows: standard risk (SR), two 4week intensive elements (protocol III) versus one 7week protocol II; intermediate risk (IR), protocol III × 3 versus protocol II × 1; high risk (HR), protocol III × 3 versus either protocol II × 2 (Associazione Italiana Ematologia Oncologia Pediatrica [AIEOP] option), or 3 HR blocks plus single protocol II (BerlinFrankfurtMünster [BFM] option).At 5 years, the probabilities of eventfree survival and survival were 74% (± 1%) and 82% (± 1%) for all 5,060 eligible patients, 81% and 90% for the SR (n = 1,564), 75% and 83% for the IR (n = 2,650), and 55% and 62% for the HR (n = 846) groups, respectively. No improvement was accomplished by more intense and/or prolonged DI. The ALL ICBFM 2002 trial is a good example of international collaboration in pediatric oncology. A wide platform of countries able to run randomized studies in ALL has been established. Although the alternative DI did not improve outcome compared with standard treatment and the overall results are worse than those achieved by longer established leukemia groups, the national results have generally improved.
COBISS.SI-ID: 1232812
Few monozygotic twin pairs with concordant leukemia has been described so far. The interval between the onsets of overt disease in each of the twins is variable usually from some months to some years. We present a unique case of monozygotic and monohorionic twins who developed AML with unusually long difference of disease onset, in which we investigated the genetic background. Both twins carried a germline Nterminal frameshift CEBPA mutation, a 19base pair deletion (c.147_165del, p.Glu50fs). Interestingly, at the time of diagnosis of AML both twins carried an additional identical somatic Cterminal mutation: an inframe insertion of aminoacid lysine (c.936_937dupAAG, p.313_314insLys). Twin A, also had the third mutation in Cterminal part of CEBPA gene, somatic inframe deletion of 50 aminoacids (c.911_1060del, p.304353del). We suspect that this mutation has arisen in one twin and has been interplacentaly transferred to other twin in utero. The syngenic bone marrow donor twin developed AML 13 years after the diagnosis of her twin.
COBISS.SI-ID: 864940
This study is the first comprehensive analyses of the US national trends in pediatric AML induction mortality and resource utilization. Using resource utilization data as a proxy for adverse events, adverse event rates reported on clinical trials substantially underestimated the clinical toxicities of all pediatric AML induction regimens.
COBISS.SI-ID: 668844
Purpose: Patients treated for childhood acute lymphoblastic leukemia (ALL) areconsidered to be at increased risk of developing second neoplasm. The aim of our study was to identify DNA repair polymorphisms contributing to the risk of second neoplasm in clinically well-characterized Slovenian patients treated for childhood ALL. Methods: Pediatric patients diagnosed with ALL between 1971 and 2001 were included in the study. According to the identified clinical risk factors for second neoplasm, a matched set of cases with second neoplasm and controls was selected and genotyped for 11 DNA repair polymorphisms. Results: Among 359 pediatric patients with ALL, 20 second neoplasms were observed. The dose of radiotherapy (P = 0.011), administration of epipodophyllotoxins (P = 0.006), and the dose of anthracyclines (P ( 0.001)showed a significant association with the risk of second neoplasm. Amonggenetic factors, we observed a significant association of NBN 1197G allele with increased risk of second neoplasms (RR = 4.36; 95 % CI: 1.19-15.98; P = 0.026), while the risk was decreased in carriers of XRCC3-316Gallele compared with patients with wild-type genotype (RR = 0.20; 95 % CI: 0.04-0.99; P = 0.049). Conclusions: Our results suggest an important role of NBN 1197A)G and XRCC3-316A)G polymorphisms in the development of second neoplasm in patients treated for childhood ALL.
COBISS.SI-ID: 30003929