PCM4EU and PRIME-ROSE: Collaboration for implementation of precision cancer medicine in Europe.

BACKGROUND: In the two European Union (EU)-funded projects, PCM4EU (Personalized Cancer Medicine for all EU citizens) and PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials), we aim to facilitate implementation of precision cancer medicine (PCM) in Europe by leveraging the experience from ongoing national initiatives that have already been particularly successful. PATIENTS AND METHODS: PCM4EU and PRIME-ROSE gather 17 and 24 partners, respectively, from 19 European countries. The projects are based on a network of Drug Rediscovery Protocol (DRUP)-like clinical trials that are currently ongoing or soon to start in 11 different countries, and with more trials expected to be established soon. The main aims of both the projects are to improve implementation pathways from molecular diagnostics to treatment, and reimbursement of diagnostics and tumour-tailored therapies to provide examples of best practices for PCM in Europe. RESULTS: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients.

Prevalence and factors associated with ulcer-related pain in persons with chronic leg ulcers-an explorative study.

AIMS AND OBJECTIVES: The aims of this study were to explore the prevalence of background pain and identify demographic, clinical and psychosocial factors associated with moderate to severe background pain in persons with leg ulcers. BACKGROUND: All chronic leg ulcers are potentially painful. Research indicates that 80% of persons with chronic leg ulcers experience wound-related background pain. However, studies on factors associated with pain have small samples and findings are inconclusive. DESIGN: Exploratory cross-sectional study. METHOD: This quantitative study recruited persons with chronic leg ulcers (N = 252) from two wound care clinics using consecutive sampling method. Data were obtained through screening interview, clinical examination and questionnaires. Logistic regression with stepwise backwards elimination was used to identify factors associated with moderate to severe background pain. The STROBE checklist for cross-sectional studies was used for reporting this study. RESULTS: Background pain was reported by 64% of the participants. Inferential statistical analyses suggest that between 58% and 69% of persons with chronic leg ulcers suffer from this type of pain. Factors associated with moderate to severe pain were older age, female gender, reduced sleep quality and diminished health status. In the final model, reduced sleep quality increased the likelihood of having moderate to severe pain in persons with good health status while not in persons with diminished health status. CONCLUSION: Ulcer-related background pain is common in persons with chronic leg ulcers. Older females reporting insomnia symptoms also had increased risk of moderate to severe ulcer-related background pain. These participants also perceived their health status to be better. RELEVANCE TO CLINICAL PRACTICE: This study demonstrates that ulcer-related background pain and associated factors needs more attention in clinical practice. Furthermore, nurses and other healthcare professionals should integrate biopsychosocial strategies to assess and manage ulcer-related background pain.

Characterizations of uveal melanoma patients with three additional primary malignancies.

PURPOSE: In a population-based cohort of 960 uveal melanoma (UM) patients, we describe patients with three additional malignancies, including one unique patient with four synchronous primary malignancies. METHOD: A descriptive presentation of the clinical course and outcome for UM patients with three additional primary malignancies. RESULTS: After more than 20 years of follow-up of the UM cohort, 11 patients (1.1%) were diagnosed with three additional primary malignancies before, simultaneously or after UM. Among these, one patient had four synchronous primary malignancies, detected during workup for a symptomatic UM. All diagnoses were treated during the following 4 months, firstly the breast cancer, thereafter, the lung and pancreatic cancers and finally the UM. The patient died 3 years later of abdominal carcinomatosis due to the pancreatic cancer. The family history and gene testing did not disclose any genetic predisposition for cancer. A comparison of the four synchronous tumours, morphologically and immunohistochemically, showed no similarities and the expression of antibodies was different. CONCLUSION: Patients with UM may be diagnosed with non-ocular additional primary cancers. Thus, a comprehensive workup is obligatory and a further follow-up of the UM patients seems necessary. The UM is not always the main problem.

Caesarean section in Palestine using the Robson Ten Group Classification System: a population-based birth cohort study.

OBJECTIVE: To analyse the current situation of caesarean section in Palestine using the Robson Ten Group Classification System (TGCS). DESIGN: A population-based birth cohort study. SETTING: Obstetrical departments in three governmental hospitals in Gaza. PARTICIPANTS: All women (18 908) who gave birth between 1 January 2016 and 30 April 2017. METHODS: The contributions of each group to the study population and to the overall rate of caesarean section were calculated, as well as the rate of caesarean section in each TGCS group. Differences in proportions between study hospitals were assessed by χ2 test. MAIN OUTCOME MEASURES: The main outcome was the contributions of each group to the overall caesarean section rate. RESULTS: The overall rate of caesarean section was 22.9% (4337 of 18 908), ranging from 20.6% in hospital 1 to 24.6% in hospital 3. The largest contributors to the overall caesarean section rate were multiparous women with single cephalic full-term pregnancy who had undergone at least one caesarean section (group 5, 42.6%), women with multiple pregnancies (group 8, 11.6%) and those with single cephalic preterm labour (group 10, 8.1%). Statistically significant differences in caesarean section rates between the study hospitals were observed in group 1 (nulliparous women with single cephalic full-term pregnancy and spontaneous labour), group 4 (multiparous with single cephalic full-term pregnancy with induced labour or prelabour caesarean section), group 5 (multiparous with single cephalic full-term pregnancy with previous caesarean section) and in group 7 (multiparous with breech presentation). CONCLUSION: Women in groups 5, 8 and 10 were the largest contributors to the overall caesarean section rate in the study hospitals. Efforts to reduce the differences in obstetrical care between hospitals need to be directed towards increasing the proportion of vaginal births after caesarean section and by reducing primary caesarean section in multiple pregnancies and preterm labour.

Differences in rates and odds for emergency caesarean section in six Palestinian hospitals: a population-based birth cohort study.

OBJECTIVE: To assess the differences in rates and odds for emergency caesarean section among singleton pregnancies in six governmental Palestinian hospitals. DESIGN: A prospective population-based birth cohort study. SETTING: Obstetric departments in six governmental Palestinian hospitals. PARTICIPANTS: 32 321 women scheduled to deliver vaginally from 1 March 2015 until 29 February 2016. METHODS: To assess differences in sociodemographic and antenatal obstetric characteristics by hospital, χ2 test, analysis of variance and Kruskal-Wallis test were applied. Logistic regression was used to estimate differences in odds for emergency caesarean section, and ORs with 95% CIs were assessed. MAIN OUTCOME MEASURES: The primary outcome was the adjusted ORs of emergency caesarean section among singleton pregnancies for five Palestinian hospitals as compared with the reference (Hospital 1). RESULTS: The prevalence of emergency caesarean section varied across hospitals, ranging from 5.8% to 22.6% among primiparous women and between 4.8% and 13.1% among parous women. Compared with the reference hospital, the ORs for emergency caesarean section were increased in all other hospitals, crude ORs ranging from 1.95 (95% CI 1.42 to 2.67) to 4.75 (95% CI 3.49 to 6.46) among primiparous women. For parous women, these differences were less pronounced, crude ORs ranging from 1.37 (95% CI 1.13 to 1.67) to 2.99 (95% CI 2.44 to 3.65). After adjustment for potential confounders, the ORs were reduced but still statistically significant, except for one hospital among parous women. CONCLUSION: Substantial differences in odds for emergency caesarean section between the six Palestinian governmental hospitals were observed. These could not be explained by the studied sociodemographic or antenatal obstetric characteristics.

Impact of stage, management and recurrence on survival rates in laryngeal cancer.

A retrospective, longitudinal study of 1,616 patients with primary laryngeal squamous cell carcinoma (LSCC) at a single center in Norway during 1983-2010 was undertaken to investigate overall survival, disease specific survival, disease-free survival, prognostic factors for overall survival, and impact of recurrence among all-stage laryngeal cancer patients over 15 years' follow-up. The prognostic impact of gender, age, smoking/alcohol, subsite, tumour, node and metastasis staging, period and modality of treatment were evaluated using Kaplan-Meier and Cox proportional hazard analyses. The importance of recurrence on survival was assessed based on case fatality rates. Five-year overall survival was 56.8%, 64.0% and 38.8%, and disease-specific survival was 80.2%, 87% and 61.6%, respectively, for the entire cohort and for glottic and supraglottic LSCC. Old age, advanced-stage LSCC and supraglottic cancer were associated with lower overall survival. The risk of disease-specific death plateaued after five years and varied significantly by subsite. Multivariate analysis of glottic LSCC revealed that surgical treatment improved overall survival, whereas old age, alcohol, T3-T4 status, positive N-status and no treatment were associated with worse survival. In supraglottic LSCC, age, alcohol, and positive N-status had a significant impact on overall survival by multivariate analysis. Five-year overall survival and disease-specific survival among patients with recurrent disease were 34% and 52%, respectively. In conclusion, marked difference in overall survival between glottic and supraglottic LSCC underline the importance of subsite-specific survival analysis. T-status and primary surgical management is essential only for glottic LSCC, emphasizing the importance of correct disease classification. Inferior outcomes in supraglottic LSCC are associated with old age, positive N-status, and improved follow-up routines are necessary. Primary tumor control is essential since recurrence impairs survival considerably in all subsites. The potential benefit of a primary surgical approach towards T3 LSCC awaits further investigation.

Risk of Recurrence in Laryngeal Cancer.

A cohort study was undertaken to analyze the risk of recurrence among 1616 patients with primary squamous cell carcinoma of the larynx from 1983 to 2010 at a single, tertiary academic center in Oslo, Norway. The cohort was followed from the date of diagnosis to September 2011. Competing risk regression analysis assessed the association between various risk factors and the risk of recurrence, where death was considered a competing event. Recurrence was observed in 368 patients (23%) during the study period. The majority (71%) of recurrences involved the location of the primary tumor. The overall risk of recurrence during the first three years after initiating treatment was 20.5%. Increased risk of recurrence was observed in patients with supraglottic cancer, younger patients, those with T2-T3 tumors and in patients treated in the earlier part of the study period. Significant factors for recurrence in glottic carcinomas were age, treatment in the earlier part of the study and T-status, whereas age was a significant factor in supraglottic cancer. N-status appeared less significant. In conclusion, follow-up of laryngeal squamous cell carcinoma should place particular emphasis on the site of the primary tumor, younger patients, cases of supraglottic cancer and T2-T4 primary tumors, especially during the first three years after treatment. More studies are needed to assess the impact of surgical versus non-surgical treatment, and eventually the significance of recurrence, for disease-specific and overall survival in cases of advanced laryngeal squamous cell carcinoma.