Mistletoe Extract in Patients With Advanced Pancreatic Cancer: a Double-Blind, Randomized, Placebo-Controlled Tial (MISTRAL)

BACKGROUND: Patients with advanced pancreatic cancer have limited survival and few treatment options. We studied whether mistletoe extract (ME), in addition to comprehensive oncological treatment and palliative care, prolongs overall survival (OS) and improves health-related quality of life (HRQoL). METHODS: The double-blind, placebo-controlled MISTRAL trial was conducted in Swedish oncology centers. The main inclusion criteria were advanced exocrine pancreatic cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The subjects were randomly assigned to ME (n=143) or placebo (n=147) and were stratified by study site and by eligibility (yes/no) for palliative chemotherapy (June 2016-December 2021). ME or placebo was injected subcutaneously three times a week for nine months. The primary endpoint was overall survival (OS); one of the secondary endpoints was the HRQoL dimension global health/QoL (EORTC-QLQ-C30), as assessed at seven time points over nine months. Trial registration: EudraCT 2014-004552-64, NCT02948309. RESULTS: No statistically significant benefit of adding ME to standard treatment was seen with respect to either OS or global health/ QoL. The adjusted hazard ratio for OS was 1.13 [0.89; 1.44], with a median survival time of 7.8 and 8.3 months for ME and placebo, respectively. The figures for the HRQoL dimension "global health/QoL" were similar in the two groups (p=0.86). The number, severity, and outcome of the reported adverse events were similar as well, except for more common local skin reactions at ME injection sites (66% vs. 1%). CONCLUSION: ME is unlikely to have a clinically significant effect on OS or the HRQoL dimension global health/QoL when administered in patients with advanced pancreatic cancer in addition to comprehensive cancer care.

Evaluation of a new PVC-free catheter material for intermittent catheterization: a prospective, randomized, crossover study.

OBJECTIVE: Polyvinyl chloride (PVC) is commonly used as a catheter material in catheters for clean intermittent catheterization (CIC) but, owing mainly to environmental concerns, a PVC-free material has been proposed. The objective of this study was to compare patients' tolerability for catheters made of PVC and a newly developed PVC-free material. MATERIAL AND METHODS: This was a prospective, randomized, crossover study in 104 male patients with maintained urethra sensibility who practised CIC. The patients evaluated in a randomized order a PVC and a PVC-free LoFric® catheter after 1 week's use of each. The material properties and tolerability, i.e. reported perceived discomfort, of each catheter were compared and adverse events documented. RESULTS: Twenty-nine (28%) and 15 (14%) patients reported discomfort when using the PVC catheter and the PVC-free LoFric catheter, respectively. A comparison showed that five patients (5%) reported discomfort with the PVC-free and not with the PVC catheter, and 19 patients (18%) reported discomfort with the PVC and not with the PVC-free catheter (p = 0.0066). Forty patients reported a total of 91 adverse events, of which the most common were discomfort in terms of pain, a burning sensation and bleeding. CONCLUSIONS: Generally low discomfort rates were reported in the study population, suggesting a high tolerance for CIC with catheters of both the PVC and the PVC-free materials. The lowest discomfort was, however, found when CIC was performed using the PVC-free LoFric catheter.

Prophylactic pelvic irradiation as part of primary therapy in uterine sarcomas.

In a complete geographic series of 155 cases of primary uterine sarcomas, prophylactic pelvic irradiation was used as standard postoperative therapy in the majority of the cases. Vaginal brachytherapy was also added as a boost. The histology was leiomyosarcoma in 62 cases (40%), carcinosarcoma in 60 (39%), endometrial stromal sarcoma in 25 (16%), and other types in 8 cases (5%). The primary surgery was extended hysterectomy in 11 cases (7%), simple hysterectomy in 110 (71%), and supravaginal hysterectomy in 12 (8%). In 22 cases (14%) no major surgery was possible. In the complete series, 62 recurrences (40%) were recorded. Local (9%), regional (9%), and distant recurrences (28%) were the most frequent. The type of surgery was associated with the risk of tumor recurrence. Extended surgery reduced the risk of local and regional recurrences. The 5-year overall survival rate was 42% and the recurrence-free survival (RFS) was 37%. The number of mitoses was significantly (P=0.007) associated with survival. The locoregional RFS rate was 75% for patients treated with adjuvant irradiation and 83% for patients treated with primary surgery alone. Serious late tissue reactions from the bladder and intestine occurred in 7% of the irradiated cases. The locoregional tumor control rate was high in this series of patients, but no significant difference was found between patients treated with surgery alone and surgery plus postoperative pelvic irradiation. This was true for all histological subtypes of the uterine sarcomas. However, this was not a randomized study and selection bias cannot be ruled out.

TEXTURAL PROPERTIES OF DEHYDRATED FOODS. RELATIONSHIPS WITH THE THERMODYNAMICS OF WATER VAPOR SORPTION.

Textural properties of pre-cooked, freeze-dried beef and of special bite-size space foods, all of which were designed for consumption without prior rehydration, were determined by instrumental and sensory methods at different relative humidity points of the moisture sorption isotherm. Supplemental instrumental measurements were also made on completely rehydrated pre-cooked, freeze-dried beef. In general, as the relative humidity increased, the mechanical properties of hardness and cohesive-ness (Szczesniak) increased, whereas the mechanical property called the crushability index (Drake) and the sensory property 'ease of biting' decreased. Close relationships were found between the heat of sorption and the sensory rating of heat evolved in the mouth during chewing of initially dry meat samples. Good correlations were also obtained between other thermodynamic functions and textural properties.