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- Geyer, C. E., et al.
(författare)
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Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer
- 2022
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Ingår i: Annals of Oncology. - : Elsevier BV. - 0923-7534. ; 33:12, s. 1250-1268
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Tidskriftsartikel (refereegranskat)abstract
- Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Delta 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 35 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDES and DDFS with no new safety signals.
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| 3. |
- Lin, Chung-Ying, et al.
(författare)
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Fear of COVID-19 Scale (FCV-19S) across countries : Measurement invariance issues
- 2021
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Ingår i: Nursing Open. - : John Wiley & Sons. - 2054-1058. ; 8:4, s. 1892-1908
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Tidskriftsartikel (refereegranskat)abstract
- Aim: The threats of novel coronavirus disease 2019 (COVID-19) have caused fears worldwide. The Fear of COVID-19 Scale (FCV-19S) was recently developed to assess the fear of COVID-19. Although many studies found that the FCV-19S is psychometrically sound, it is unclear whether the FCV-19S is invariant across countries. The present study aimed to examine the measurement invariance of the FCV-19S across eleven countries.Design: Cross-sectional study. Methods: Using data collected from prior research on Bangladesh (N = 8,550), United Kingdom (N = 344), Brazil (N = 1,843), Taiwan (N = 539), Italy (N = 249), New Zealand (N = 317), Iran (N = 717), Cuba (N = 772), Pakistan (N = 937), Japan (N = 1,079) and France (N = 316), comprising a total 15,663 participants, the present study used the multigroup confirmatory factor analysis (CFA) and Rasch differential item functioning (DIF) to examine the measurement invariance of the FCV-19S across country, gender and age (children aged below 18 years, young to middle-aged adults aged between 18 and 60 years, and older people aged above 60 years).Results: The unidimensional structure of the FCV-19S was confirmed. Multigroup CFA showed that FCV-19S was partially invariant across country and fully invariant across gender and age. DIF findings were consistent with the findings from multigroup CFA. Many DIF items were displayed for country, few DIF items were displayed for age, and no DIF items were displayed for gender.Conclusion: Based on the results of the present study, the FCV-19S is a good psychometric instrument to assess fear of COVID-19 during the pandemic period. Moreover, the use of FCV-19S is supported in at least ten countries with satisfactory psychometric properties.
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