ObjectivesIn the CheckMate 141 trial (NCT02105636), nivolumab demonstrated survival, health-related quality of life, and healthcare resource utilization benefits vs single-agent therapy of investigator’s choice (IC) (methotrexate, docetaxel or cetuximab) in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We assessed between-treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST).MethodsSurvival data from CheckMate 141 (nivolumab, n = 240; IC, n = 121) was partitioned into toxicity (TOX), time without symptoms or toxicity (TWiST), and relapse (REL). TOX was defined as time spent with all-cause grade 3–4 adverse events after randomization, before disease progression. TWiST was defined as time not in TOX or REL. REL was defined as time between disease progression and death. Utility values derived from three-level EuroQol five-dimensional questionnaire data from CheckMate 141 were used to calculate Q-TWiST as the utility-weighted sum of the mean duration in each health state.ResultsThe between-group difference in Q-TWiST score was 1.23 months (95% confidence interval 1.17–1.29) favoring nivolumab (p < 0.001). The nivolumab group experienced significantly longer mean time in TWiST (3.82 vs 2.78 months) and REL (4.02 vs 3.30 months) compared with the IC group (p < 0.001). Mean time in TOX was lower for nivolumab vs IC (0.30 vs 0.37 months, p < 0.001).ConclusionsIn CheckMate 141, nivolumab resulted in statistically significant and clinically meaningful gains (relative difference > 10%) in quality-adjusted survival vs standard of care in patients with R/M SCCHN.
Background Although current therapy for patients with early-stage squamous cell carcinoma of the head and neck (SCCHN) is potentially curative, the recurrence rate is high. Patients with recurrent or metastatic (R/M) SCCHN have a poor prognosis and substantial disease burden, including impaired health-related quality of life (HRQoL), productivity loss and indirect costs, such as need for caregiver support. The aim of this study was to characterize the impact of R/M SCCHN and its first-line treatment on patient and caregiver quality of life, daily activities and work productivity using real-world evidence from Europe. Methods This was a multicentre retrospective study of patients with R/M SCCHN in France, Germany, Italy, Spain and the United Kingdom incorporating patient and caregiver surveys, and a physician-reported medical chart review, conducted between January and May 2019. Patients aged 18 or over with a physician confirmed diagnosis R/M SCCHN completed four validated measures of disease activity and its impact on quality of life and work productivity, while caregivers also completed questionnaire to assess the burden of providing care. Physicians provided data for clinical characteristics, patient management, testing history and treatment patterns. Results A total of 195 medical/clinical oncologists provided data for 937, predominantly male (72%) patients, with almost half of patients aged over 65 years. The most frequently reported symptoms were fatigue (43%), weight loss (40%), pain (35%) and difficulty swallowing (32%). The EXTREME regimen was the most common first line therapy in over half of patients, who reported moderate or extreme pain/discomfort, and anxiety/depression, and problems with self-care resulting in a diminished health status compared with the general population. Only 14% were employed with high absenteeism or presenteeism, and over half of patients had a caregiver for whom the burden of care was substantial. Conclusion Our results provide real-world insight into the multi-faceted burden associated with R/M SCCHN. The combination of poor HRQoL and the impairment in daily activities, social life and employment illustrates the wider impact of R/M SCCHN on patients and their caregivers, and highlights a need for novel 1 L treatment regimens to improve the humanistic and productivity burdens of this cancer.
sociated with treatment and productivity loss over a one year period at vaccine steady state (i.e. when all women are vaccinated), current vs. future burden assuming 95% vaccine coverage. The MR incidence data on abnormal PAP and CINs were extrapolated from the relative proportion of abnormal PAP, precancerous lesions and CC previously published. Vaccination effectiveness was based on clinical trial data and HPV distribution for Russia and Eastern Europe. Medical costs were estimated from resources used and listed Russian price. Indirect costs include unpaid taxes, illness allowance and regional GDP foregone. No discount was applied. Sensitivity analyses were conducted on main parameters (number of lesions, vaccine effectiveness, costs). RESULTS: Vaccination with the bivalent HPV vaccine in the MR was estimated to prevent 13,737 abnormal PAP (112.6 m.rub.), 11,750 CIN1 (296.1 m.rub.), 4,222 CIN2/3 (259.3 m.rub.), 504 CC (98.9 m.rub.), 199 cases of lifelong disability (44.6 m.rub.) and 276 cases of CC deaths annually. Total cost offsets could amount to 811.6 m.rub. (664.8 m.rub. treatment cost only) representing 2.5x annual cost of vaccinating one cohort of 12 year-old girls (328.9 m.rub.) (2.0x vs. treatment cost only). The benefit-to-cost ratio (cost offset/vaccination cost) ranged from 1.8 to 3.1 over the sensitivity analyses. CONCLUSIONS: Implementation of HPV vaccination in the MR could significantly decrease cervical HPV-infection disease-related burden. The cost of vaccination, at steady state, could be fully compensated by the cost offset.
Objectives: Reviewing the statistical indicators of mortality we see that cancer is in second most common cause of death after cardiovascular diseases. Cervical cancer is the seventh most common type of cancer (among women) in Europe. According to current estimations, there are 58,373 new diagnosed out of 3,257 million women older than 15 years, from which 24,404 ends with death. There is an organized screening system in Hungary since 2003. Most women participate "traditionally", out of this system or ignore invitation and do not accept the opportunity. This behaviour is typical among Romany population, which is Hungary's largest ethnic group. Many stereotypes live in our society about Romany people, like starting sexual activity early, giving birth to many children. MethOds: A quantitative, cross-sectional study was carried out. Our sample consisted of Romany women from Zala, Baranya and Somogy county, Hungary (N= 368). The main topic was reasons for staying away from cervical cancer screening in our self-made questionnaire. During statistical analysis we calculated descriptive statistics, χ 2-test and test (p< 0.05). Results: Mean age of responders was 36.43±11.27 years. 17.39% never attended gynaecological screening. Mean age of participants in screening (82.34%) was 21.14±6.97 at their first time. Educational attainment is an influencing factor in participation (p< 0.05). The non-participation rate of those who: have finished only elementary school is 22.6%, hold vocational training certificate is 11.9%, have finished high school is 9.1%, while 100% of women with higher education attended. cOnclusiOns: It is important to make Romany women aware of process of screening, it's possible gain, barriers and accidental side effects, and most importantly the risks of staying away from screening. IT is also crucial to evolve such a health-conscious behaviour, which allows them to identify cervical cancer before the occurrence of symptoms therefore lowering mortality rate.
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