Spirituality in Oncology: Relations between Spirituality, Its Facets, and Psychological and Demographic Factors in Cancer Patients in Germany.

INTRODUCTION: Cancer diagnoses are constantly increasing in clinical practice. Therefore, more and more patients are interested in how they can actively participate in the process of treatment. Spirituality represents a hidden issue of the population, which counts as a branch of complementary and alternative treatment. Therefore, the aim of our study was to investigate whether there are associations between spirituality and demographic and psychosocial factors, as well as religious beliefs, in cancer patients. METHODS: We conducted a survey with 451 participants in 10 oncology centers between March and July 2021. A composition of the following 9 different questionnaires was used to collect data on spirituality, demographics, resilience, self-efficiency, life satisfaction, and sense of coherence: Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp12), General Life Satisfaction Short Scale (L-1), Resilienzskala Kurzform (RS-13), Sense of Coherence Scale - Leipziger Kurzform (SOC-L9), Allgemeine Selbstwirksamkeit Kurzskala (AKSU), Adolescent Food Habits Checklist, Likert-Scale of daily activities, questionnaire of the Working group Prävention und Integrative Onkologie (PRiO), and personal opinion on the cause of the disease. Calculated data and analyzed group differences using ANOVA Bonferroni were used to test associations between spirituality and the variables studied. For more detailed examination of spirituality, we took a closer look at the different components of spirituality - peace, meaning, and faith - and their relation to each other (three-factor spirituality analyses). RESULTS: Higher spirituality scores in total as well as meaning, peace, and faith were each associated with higher levels of resilience and life satisfaction. Higher religious belief was found to be associated with higher spiritual attitudes. High personal self-efficiency was found in people with higher spiritual beliefs in general as well as higher meaning and peace. Meaning and peace emerge as essential components of spiritual well-being and show a stronger association with expressions of general spirituality than faith. CONCLUSION: Spirituality takes a crucial role among the resources of life-threatening diseases. As such, further research is needed to expand and integrate patient options into a modernized concept of care. Our data indicate that higher spiritual well-being is associated with a more tolerant approach to illness. Thus, addressing spiritual needs in therapy is associated with better psychological adjustment to the individual situation and reduces negative distress. To promote spiritual needs in the future, cognitive as well as affective components of spirituality should be emphasized.

SWITCH: A Randomised, Sequential, Open-label Study to Evaluate the Efficacy and Safety of Sorafenib-sunitinib Versus Sunitinib-sorafenib in the Treatment of Metastatic Renal Cell Cancer.

BACKGROUND: Understanding how to sequence targeted therapies for metastatic renal cell carcinoma (mRCC) is important for maximisation of clinical benefit. OBJECTIVES: To prospectively evaluate sequential use of the multikinase inhibitors sorafenib followed by sunitinib (So-Su) versus sunitinib followed by sorafenib (Su-So) in patients with mRCC. DESIGN, SETTING, AND PARTICIPANTS: The multicentre, randomised, open-label, phase 3 SWITCH study assessed So-Su versus Su-So in patients with mRCC without prior systemic therapy, and stratified by Memorial Sloan Kettering Cancer Center risk score (favourable or intermediate). INTERVENTION: Patients were randomised to sorafenib 400mg twice daily followed, on progression or intolerable toxicity, by sunitinib 50mg once daily (4 wk on, 2 wk off) (So-Su), or vice versa (Su-So). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was improvement in progression-free survival (PFS) with So-Su versus Su-So, assessed from randomisation to progression or death during second-line therapy. Secondary endpoints included overall survival (OS) and safety. RESULTS AND LIMITATIONS: In total, 365 patients were randomised (So-Su, n=182; Su-So, n=183). There was no significant difference in total PFS between So-Su and Su-So (median 12.5 vs 14.9 mo; hazard ratio [HR] 1.01; 90% confidence interval [CI] 0.81-1.27; p=0.5 for superiority). OS was similar for So-Su and Su-So (median 31.5 and 30.2 mo; HR 1.00, 90% CI 0.77-1.30; p=0.5 for superiority). More So-Su patients than Su-So patients reached protocol-defined second-line therapy (57% vs 42%). Overall, adverse event rates were generally similar between the treatment arms. The most frequent any-grade treatment-emergent first-line adverse events were diarrhoea (54%) and hand-foot skin reaction (39%) for sorafenib; and diarrhoea (40%) and fatigue (40%) for sunitinib. CONCLUSIONS: Total PFS was not superior with So-Su versus Su-So. These results demonstrate that sorafenib followed by sunitinib and vice versa provide similar clinical benefit in mRCC. PATIENT SUMMARY: We investigated if total progression-free survival (PFS) is improved in patients with advanced/metastatic kidney cancer who are treated with sorafenib and then with sunitinib (So-Su), compared with sunitinib and then sorafenib (Su-So). We found that total PFS was not improved with So-Su compared with Su-So, but both treatment options were similarly effective in patients with advanced/metastatic kidney cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00732914, www.clinicaltrials.gov.

Phase III trial of irinotecan plus infusional 5-fluorouracil/folinic acid versus irinotecan plus oxaliplatin as first-line treatment of advanced colorectal cancer.

PURPOSE: To determine whether irinotecan plus oxaliplatin (mIROX) is superior to irinotecan plus infusional 5-fluorouracil, leucovorin (FUFIRI) as first-line therapy of patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: A phase III, randomised, open-label multicentre study compared standard treatment with FUFIRI (irinotecan 80 mg/m(2), 5-fluorouracil 2000 mg/m(2), folinic acid 500 mg/m(2) weekly times 6) to mIROX using an identical schedule of irinotecan plus oxaliplatin 85 mg/m(2) applied on days 1, 15 and 29 of a 7-week cycle. The primary end-point was progression-free survival (PFS). RESULTS: A total of 479 eligible patients were randomly assigned. Progression-free survival was 7.2 months in the mIROX arm and 8.2 months in the FUFIRI arm [hazard ratio=1.14; 95% confidence interval (CI) 0.94-1.37; P=0.178]. Comparable results were also obtained for overall survival time with 19 months in the mIROX-arm and 22 months in the FUFIRI-arm (hazard ratio=1.08, P=0.276). Both regimens induced an identical objective response rate (ORR) of 41%, but disease control rate (ORR plus stable disease) was significantly greater in the FUFIRI group (81% versus 68%, P=0.001). Most frequent grades 1-4 side-effects of mIROX and FUFIRI treatment were nausea (80% versus 73%) and delayed diarrhoea (79% versus 68%). Grades 3-4 toxicities were generally below 10%, except for diarrhoea which was more frequent in the mIROX-arm compared to the FUFIRI-arm (19% versus 30%, P=0.006) CONCLUSION: mIROX failed to show superior activity compared to high-dose 5-FU/folinic acid plus irinotecan. Due to better tolerability the combination of high-dose 5-FU/folinic acid and irinotecan remains a standard of care in first-line treatment of metastatic colorectal cancer.