A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - A final report.

BACKGROUND: The use of chemotherapy to manage newly diagnosed low grade glioma (LGG) was first introduced in the 1980s. One randomised trial has studied two- versus four-drug regimens with a duration of 12 months of treatment after resection. METHODS: Within the European comprehensive treatment strategy for childhood LGG, the International Society of Paediatric Oncology-Low Grade Glioma (SIOP LGG) Committee launched a randomised trial involving 118 institutions and 11 countries to investigate the addition of etoposide (100 mg/m2, days 1, 2 & 3) to a four-course induction of vincristine (1.5 mg/m2 × 10 wkly) and carboplatin (550 mg/m2 q 3 weekly) as part of 18-month continuing treatment programme. Patients were recruited after imaging diagnosis, resection or biopsy with progressive disease/symptoms. Some 497 newly diagnosed patients (M/F 231/266; median age 4.26 years (interquartile range (IQR) 2.02-7.06)) were randomised to receive vincristine carboplatin (VC) (n = 249) or VC plus etoposide (VCE) during induction (n = 248), stratified by age and tumour site. FINDINGS: No differences between the two arms were found in term of survival and radiological response. Response and non-progression rates at 24 weeks for VC and VCE, were 46% versus 41%, and 93% versus 91% respectively; 5-year Progression-Free Survival (PFS) and Overall Survival (OS) were 46% (StDev 3.5) versus 45% (StDev 3.5) and 89% (StDev 2.1) versus 89% (StDev 2.1) respectively. Age and diencephalic syndrome are adverse clinical risk factors for PFS and OS. 5-year OS for patients in early progression at week 24 were 46% (StDev 13.8) and 49% (StDev 16.5) in the two arms, respectively. INTERPRETATION: The addition of etoposide to VC did not improve PFS or OS. High non-progression rates at 24 weeks justify retaining VC as standard first-line therapy. Infants with diencephalic syndrome and early progression need new treatments to be tested. Future trials should use neurological/visual and toxicity outcomes and be designed to discriminate between the impact on disease outcomes of 'duration of therapy' and 'age at stopping therapy'.

A multidisciplinary approach to improve preoperative understanding and reduce anxiety: a randomised study.

BACKGROUND: Emotional factors may influence reception of information provided during informed consent leading to incomplete understanding and reduced satisfaction. OBJECTIVE: This study was designed to test the hypothesis that a multidisciplinary approach could improve understanding of the information provided by the anaesthesiologist and in turn, reduce anxiety. DESIGN: A randomised controlled clinical trial. SETTING: Veneto Oncology Institute, Italian comprehensive cancer centre. Recruitment from December 2008 to June 2010. PATIENTS: Two hundred and fifty-one women requiring anaesthesia for breast cancer surgery. INTERVENTIONS: Women undergoing surgery for primary breast cancer were randomly assigned to either the structured anaesthesiology interview group (SAI) or the integrated multidisciplinary psycho-oncological approach (IPA). In the IPA arm, patients underwent an interview with the psycho-oncologist. Subsequently, and prior to preoperative anaesthesia evaluation, the psycho-oncologist informed the anaesthesiologist of the type of communicative strategy to adopt for each individual. In the SAI arm, patients received only the anaesthesiology interview. MAIN OUTCOME MEASURES: Anxiety as assessed by State-Trait Anxiety Inventory (STAI) questionnaire. RESULTS: Two hundred and fifty-one patients were randomised and 234 analysed: 124 in the IPA arm and 110 in the SAI arm. For both groups, mean anxiety scores, according to the STAI questionnaire, were statistically lower after the anaesthesiology visit than at baseline, with a reduction of 6.5 points for the IPA arm [95% confidence interval (CI) 4.6 to 8.4, P < 0.0001] and 4.7 points for the SAI arm (95% CI 2.6 to 6.7, P < 0.0001). There were no significant differences between the two groups in the mean anxiety score before and after the interview. For highly anxious patients, the STAI score decreased significantly more in the IPA group (10.2 points, 95% CI 7.4 to 13.0) than in the SAI group (6.8 points, 95% CI 3.8 to 9.8), P = 0.024.The information provided during the anaesthesiology visit was correctly understood by more than 80% of patients and was similar in both groups. CONCLUSION: In breast cancer surgical patients with high levels of preoperative anxiety, a multidisciplinary approach with psycho-oncological intervention proved to be useful at the preoperative anaesthesiology interview.