Karin Ribi

Postoperative hemithoracic radiotherapy has been used to treat malignant pleural mesothelioma, but it has not been assessed in a randomised trial. We assessed high-dose hemithoracic radiotherapy after neoadjuvant chemotherapy and extrapleural pneumonectomy in patients with malignant pleural mesothelioma. We did this phase 2 trial in two parts at 14 hospitals in Switzerland, Belgium, and Germany. We enrolled patients with pathologically confirmed malignant pleural mesothelioma; resectable TNM stages T1-3 N0-2, M0; WHO performance status 0-1; age 18-70 years. In part 1, patients were given three cycles of neoadjuvant chemotherapy (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 given every 3 weeks) and extrapleural pneumonectomy; the primary endpoint was complete macroscopic resection (R0-1). In part 2, participants with complete macroscopic resection were randomly assigned (1:1) to receive high-dose radiotherapy or not. The target volume for radiotherapy encompassed the enti...

Fathers of children with chronic diseases have been underrepresented in research studies. This paper reviews the literature on coping and psychological adjustment in fathers of chronically ill children. Most of the available studies involving fathers did focus on mothers and therefore did not assess specific father-related research questions. Moreover, current knowledge of fathers of chronically ill children is limited by a number of methodological problems. First, there is a lack of theoretical models. In addition definition and assessment of psychological adjustment is inconsistent. Second, several important potential predictors of father's coping and adjustment have not been investigated hitherto, such as illness appraisals and personality. Third stress and burdens specific to the fathers parenting role haven't been assessed. Due to this limitations it is rather difficult to obtain conclusive evidence on psychosocial issues in fathers with chronically ill children. Future...

This phase II trial aimed to evaluate feasibility and efficacy of a first-line combination of targeted therapies for advanced non-squamous NSCLC: bevacizumab (B) and erlotinib (E), followed by platinum-based CT at disease progression (PD). 103 patients with advanced non-squamous NSCLC were treated with B (15 mg/kg day 1 of each 21-day cycle) and E (150 mg daily) until PD or unacceptable toxicity. Upon PD patients received 6 cycles of CT (cisplatin/carboplatin and gemcitabine). The primary endpoint was disease stabilization rate (DSR) after 12 weeks of BE treatment. 101 patients were evaluable. Under BE, DSR at week 12 was 54.5%. 73 patients had at least stable disease (SD), including 1 complete remission and 17 partial responses (PR). No unexpected toxicities were observed. Median time to progression (TTP) under BE was 4.1 months. 62 patients started CT; 35 received at least 4 cycles (6 PR, 32 SD). At a median follow-up of 36 months, median overall survival (OS) was 14.1 months. First-line BE treatment followed by a fixed CT regimen at PD is feasible with acceptable toxicity and activity. In a non-squamous NSCLC population unselected for EGFR status, we found OS rates similar to standard CT.

... evidence regarding the “categorical” (diagnosis) versus “non-categorical” (diagnosis-independent dimensions) position is mixed, with different studies reporting con-flicting findings (Gartstein, Short, Vannatta, & Noll, 1999; Thompson, Gustafson, Gil, Godfrey, & Bennett Murphy ...

... psychosoziale Konsequenzen haben und zu einer verminderten Lebensqualität führen, sondern auch die Compliance mit der medizinischen Be-handlung entscheidend beeinträchtigen (Aaron et al ... Kindheit und Entwicklung 12 (3), 184ą192 Hogrefe-Verlag, Göttingen 2003 ...

Objective: To determine rates of posttraumatic stress disorder (PTSD) and symptoms in mothers and fathers of children with newly diagnosed type 1 diabetes. Methods: Parents of 38 children with newly diagnosed type 1 diabetes were assessed with the Posttraumatic Diagnostic Scale 6 weeks after diagnosis. Results: Twenty-four percent of the mothers and 22% of the fathers met full diagnostic criteria

ABSTRACT: Aromatase inhibitors are an important component of treatment for most postmenopausal women with hormone receptor-positive, early-stage breast cancer. Women taking aromatase inhibitors experience very low levels of circulating estrogen. This might be expected to result in cognitive dysfunction given the important relationship between estrogen and cognition in the basic science literature. Several studies have examined the cognitive effects of

Oncologists perform a range of pharmacological and nonpharmacological interventions to manage the symptoms of outpatients with advanced cancer. The aim of this study was to develop and test a symptom management performance checklist (SyMPeC) to review medical charts. First, the content of the checklist was determined by consensus of an interprofessional team. The SyMPeC was tested using the data set of the SAKK 96/06 E-MOSAIC (Electronical Monitoring of Symptoms and Syndromes Associated with Cancer) trial, which included six consecutive visits from 247 patients. In a test data set (half of the data) of medical charts, two people extracted and quantified the definitions of the parameters (content validity). To assess the inter-rater reliability, three independent researchers used the SyMPeC on a random sample (10% of the test data set), and Fleiss's kappa was calculated. To test external validity, the interventions retrieved by the SyMPeC chart review were compared with nurse-led assessment of patient-perceived oncologists' palliative interventions. Five categories of symptoms were included: pain, fatigue, anorexia/nausea, dyspnea, and depression/anxiety. Interventions were categorized as symptom specific or symptom unspecific. In the test data set of 123 patients, 402 unspecific and 299 symptom-specific pharmacological interventions were detected. Nonpharmacological interventions (n = 242) were mostly symptom unspecific. Fleiss's kappa for symptom and intervention detections was K = 0.7 and K = 0.86, respectively. In 1003 of 1167 visits (86%), there was a match between SyMPeC and nurse-led assessment. Seventy-nine percent (195 of 247) of patients had no or one mismatch. Chart review by SyMPeC seems reliable to detect symptom management interventions by oncologists in outpatient clinics. Nonpharmacological interventions were less symptom specific. A template for documentation is needed for standardization.

This study investigated satisfaction with treatment decision (SWTD), decision-making preferences (DMP), and main treatment goals, as well as evaluated factors that predict SWTD, in patients receiving palliative cancer treatment at a Swiss oncology network. Patients receiving a new line of palliative treatment completed a questionnaire 4-6 weeks after the treatment decision. Patient questionnaires were used to collect data on sociodemographics, SWTD (primary outcome measure), main treatment goal, DMP, health locus of control (HLoC), and several quality of life (QoL) domains. Predictors of SWTD (6 = worst; 30 = best) were evaluated by uni- and multivariate regression models. Of 480 participating patients in eight hospitals and two private practices, 445 completed all questions regarding the primary outcome measure. Forty-five percent of patients preferred shared, while 44 % preferred doctor-directed, decision-making. Median duration of consultation was 30 (range: 10-200) minutes. Overall, 73 % of patients reported high SWTD (≥24 points). In the univariate analyses, global and physical QoL, performance status, treatment goal, HLoC, prognosis, and duration of consultation were significant predictors of SWTD. In the multivariate analysis, the only significant predictor of SWTD was duration of consultation (p = 0.01). Most patients indicated hope for improvement (46 %), followed by hope for longer life (26 %) and better quality of life (23 %), as their main treatment goal. Our results indicate that high SWTD can be achieved in most patients with a 30-min consultation. Determining the patient's main treatment goal and DMP adds important information that should be considered before discussing a new line of palliative treatment.

The purpose of this investigation was firstly to assess the overall frequency of subjectively experienced symptoms self-reported by patients receiving endocrine therapy and secondly to compare these symptoms with side effects assessed by clinicians in pivotal trials. Unselected patients with early and advanced breast cancer receiving endocrine therapy were approached consecutively during a routine outpatient visit. They received a questionnaire called Checklist for Patients with Endocrine Therapy (C-PET), a validated self-assessment tool to determine prespecified symptoms associated with endocrine therapy. Data on toxicity were also obtained from previously published trials. 405 patients were approached and 373 agreed to participate in this study. Some symptoms were significantly more often recorded by the women in the adjuvant setting completing the C-PET than by physicians' reports in pivotal trials: hot flushes/sweats (C-PET 70%, ATAC 40% and BIG1-98 38%), low energy (C-PET 45%, ATAC 15% and BIG1-98 9%), fluid retention (C-PET 22% and BIG1-98 7%) and vaginal dryness (C-PET 30% and BIG1-98 3%). Similar differences were observed in the metastatic and adjuvant setting. A simple tool like the C-PET questionnaire is able to reflect the treatment burden of endocrine therapies and may be helpful to improve communication between patients and care providers. Some symptoms were significantly more often reported by the women in the C-PET than by physicians in pivotal trials.

To study the outcomes in long-term survivors of paediatric medulloblastoma (MB), we followed 51 consecutive children who were treated between 1980 and 2000 in a single institution. In 18 of 26 survivors (mean follow-up time 12.2 years), tumour control, neurological, endocrine, and neurocognitive complications and their impact on behavioural and psychological adjustment, and health-related quality of life (QoL) were comprehensively assessed using qualitative and quantitative measures. Endocrine deficits occurred in 61 %, neurological complications in 72 %, and significant school problems in 72 %. All patients had significant deficits in neurocognitive functioning: attention and processing speed was impaired in 79 %, learning and memory in 88 %, language in 56 %, visual perception in 50 %, and executive functions in 64 %. In comparison with healthy controls, social functioning was rated by the patients as the QoL dimension most affected. Parents' ratings were considerably lower than those of the patients. No MB survivor > 18 years of age (n = 12) had a boy- or girlfriend. Because of their treatment, including craniospinal radiotherapy, MB long-time survivors are not only at great risk for neurological, endocrine, and neurocognitive complications, but also of social isolation thereby decreasing self-rated QoL substantially.

In patients with malignant pleural mesothelioma undergoing a multimodality therapy, treatment toxicity may outweigh the benefit of progression-free survival. The subjective experience across different treatment phases is an important clinical outcome. This study compares a standard with an individual quality of life (QoL) measure used in a multi-center phase II trial. Sixty-one patients with stage I-III technically operable pleural mesothelioma were treated with preoperative chemotherapy, followed by pleuropneumonectomy and subsequent radiotherapy. QoL was assessed at baseline, at day 1 of cycle 3, and 1, 3 and 6 months post-surgery by using the Rotterdam Symptom Checklist (RSCL) and the Schedule for the Evaluation of Quality of Life-Direct Weighting (SEIQoL-DW), a measure that is based on five individually nominated and weighted QoL-domains. Completion rates were 98% (RSCL) and 92% (SEIQoL) at baseline and 98%/89% at cycle 3, respectively. Of the operated patients (N=45) RSCL and SEIQoL were available from 86%/72%, 93%/74%, and 94%/76% at months 1, 3, and 6 post-surgery. Average assessment time for the SEIQoL was 24min compared to 8min needed for the RSCL. Median changes from baseline indicate that both RSCL QoL overall score and SEIQoL index remained stable during chemotherapy with a clinically significant deterioration (change>or=8 points) 1 month after surgery (median change of -66 and -14 for RSCL and SEIQoL, respectively). RSCL QoL overall scores improved thereafter, but remained beneath baseline level until 6 months after surgery. SEIQoL scores improved to baseline-level at month 3 after surgery, but worsened again at month 6. RSCL QoL overall score and SEIQoL index were moderately correlated at baseline (r=.30; p<or=.05) and at 6-month follow-up (r=.42; p<or=.05) but not at the other time points. The SEIQoL assessment seems to be feasible within a phase II clinical trial, but may require more effort from staff. More distinctive QoL changes in accordance with clinical changes were measured with the RSCL. Our findings suggest that the two measures are not interchangeable: the RSCL is to favor when mainly information related to the course of disease- and treatment is of interest.

GOALS OF WORK: In patients with locally advanced esophageal cancer, only those responding to the treatment ultimately benefit from preoperative chemoradiation. We investigated whether changes in subjective dysphagia or eating restrictions after two cycles of induction chemotherapy can predict histopathological tumor response observed after chemoradiation. In addition, we examined general long-term quality of life (QoL) and, in particular, eating restrictions after esophagectomy. MATERIALS AND METHODS: Patients with resectable, locally advanced squamous cell- or adenocarcinoma of the esophagus were treated with two cycles of chemotherapy followed by chemoradiation and surgery. They were asked to complete the EORTC oesophageal-specific QoL module (EORTC QLQ-OES24), and linear analogue self-assessment QoL indicators, before and during neoadjuvant therapy and quarterly until 1 year postoperatively. A median change of at least eight points was considered as clinically meaningful. MAIN RE...

Previous studies consistently found remarkable prevalence rates of posttraumatic stress symptoms (PTSS) and posttraumatic stress disorders (PTSD) in pediatric patients and their parents. Findings suggest a significant association between child and parent PTSS. The present study examined, in a sample of pediatric patients with different conditions, incidence rates and determinants of PTSS and PTSD in the patients, and their mothers and fathers. Also, associations of maternal, paternal and child PTSS and PTSD were analyzed. Two hundred and nine children (aged 6.5-14.5 years) were interviewed 5-6 weeks after an accident or a new diagnosis of cancer or diabetes mellitus type 1 by means of the Child PTSD Reaction Index. Their mothers (n = 180) and fathers (n = 175) were assessed with the Posttraumatic Diagnostic Scale. Children reported PTSS levels in the mild range. Sixteen percent of the fathers and 23.9% of the mothers met full DSM-IV diagnostic criteria for current PTSD. Type of trauma impacted differently on parents and children. In children, accident-related injury was associated with higher PTSS scores. Conversely, in parents, diagnosis of cancer in their child was associated with more symptoms. Functional status of the child was also found to be an important predictor of PTSS in children and parents. PTSS scores of mothers and fathers were significantly correlated with each other. However, child PTSS were not significantly related to PTSS of mothers and fathers. This was true for total scores as well as for DSM-IV symptom clusters. There is a need for careful evaluation of PTSS and PTSD in pediatric patients with accidental injuries or sudden onset of severe chronic diseases and in their respective parents. Importantly, children, their mothers, and their fathers should be assessed separately, because a significant association between child and parental PTSS may not exist.