Dataset Information

Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).

ABSTRACT: Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC.EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ? 2], and weight loss ? 10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities.EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer.Trial registration: NCT02025062.

SUBMITTER: Brugel L

PROVIDER: S-EPMC4081503 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).

Brugel Lydia L Laurent Marie M Caillet Philippe P Radenne Anne A Durand-Zaleski Isabelle I Martin Michel M Baron Melany M de Kermadec Héloïse H Bastuji-Garin Sylvie S Canouï-Poitrine Florence F Paillaud Elena E

BMC cancer 20140613

<h4>Background</h4>Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven ...[more]

PMID: 24923533

Similar Datasets

Project description:BACKGROUND:Head-and-neck squamous cell carcinoma (HNSCC) is one of the most common malignancies globally, and the number of elderly patients diagnosed with HNSCC is increasing. However, as elderly HNSCC patients are underrepresented in clinical trials, current clinical decision making for this cohort largely lacks clinical evidence. METHODS:Elderly patients (?65?years) with HNSCC undergoing (chemo)radiotherapy from 2010 to 2018 at Freiburg University Medical Center were assessed for patterns of care, locoregional control (LRC), progression-free (PFS) and overall survival (OS) regarding definitive and adjuvant treatments. Acute and late therapy-associated toxicities were quantified according to CTCAE v5.0. RESULTS:Two hundred forty-six patients were included in this analysis, of whom 166 received definitive and 80 adjuvant treatment. Two-year rates for OS, PFS and LRC were 56.9, 44.9 and 75.5%, respectively. Survival differed significantly between age groups with an OS of 40 and 22?months and a PFS of 23 and 12?months for patients aged 65-74 or???75?years, respectively (p?<?0.05). Concomitant chemotherapy resulted in improved OS in patients aged 65-74?years compared to radiotherapy alone (p?<?0.05) for definitive treatments, while patients ?75?years did not benefit (p?=?0.904). For adjuvant chemoradiotherapy, a trend towards superior OS rates was observed for patients aged 65-74?years (p?=?0.151). Low performance status (HR?=?2.584, 95% CI 1.561-4.274; p?<?0.001) and smoking (HR?=?1.960, 95% CI 1.109-3.464, p?<?0.05) were the strongest independent prognostic factor in the multivariate analysis for decreased OS. One hundred thirty-eight patients (56.1%) experienced acute grade 3/4 and 45 patients (19.9%) chronic grade 3 toxicities. CONCLUSION:Radiotherapy is a feasible treatment modality for elderly HNSCC patients. The relatively low OS compared to high LRC may reflect age and comorbidities. Concomitant chemotherapy should be critically discussed in elderly HNSCC patients.

Project description:ImportanceData are limited on the prognostic value of human papillomavirus (HPV) status for head and neck carcinoma subsites.ObjectiveTo determine whether HPV positivity at each head and neck subsite is associated with improved overall survival.Design, setting, and participantsThis retrospective population-based cohort study used the National Cancer Database to identify patients diagnosed with head and neck squamous cell carcinomas from January 1, 2010, to December 31, 2014. Patients were classified according to the location of their primary malignancy into 1 of the 6 main subsites of the upper aerodigestive tract: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and sinonasal tract. Patients were also classified by their HPV status. Data collection for this study took place from January 1, 2010, to December 31, 2014. Data analysis was conducted from August 1, 2017, to September 30, 2017.Main outcomes and measuresThe difference in 5-year overall survival between patients with HPV-positive status and those with HPV-negative status in various head and neck carcinoma subsites; the role of HPV status in an unadjusted Cox multivariate regression model.ResultsOf the 175 223 total number of patients identified (129 634 [74.0%] male; 45 589 [26.0%] female; mean [SD] age, 63.1 [11.9] years), 133 273 (76.1%) were ineligible and 41 950 (23.9%) were included in the sample. This sample included 16 644 patients (39.7%) with HPV-positive tumors and 25 306 (60.3%) with HPV-negative tumors. Patients with an HPV-positive status were more likely to be younger, be white, be male, present with local T category tumors, and have poor differentiation on histologic examination. HPV-positive status was associated with survival at 4 tumor subsites: oral cavity (hazard ratio [HR], 0.76; 95% CI, 0.66-0.87), oropharynx (HR, 0.44; 95% CI, 0.41-0.47), hypopharynx (HR, 0.59; 95% CI, 0.45-0.77), and larynx (HR, 0.71; 95% CI, 0.59-0.85). The HPV status was the greatest factor in survival outcome between the HPV-positive and -negative cohorts at the oropharynx subsite (77.6% vs 50.7%; survival difference, 26.9%; 95% CI, 25.6%-28.2%) and hypopharynx subsites (52.2% vs 28.8%; survival difference, 23.4%; 95% CI, 17.5%-29.3%). For the nasopharynx (HR, 1.03; 95% CI, 0.75-1.42) and sinonasal tract (HR, 0.63; 95% CI, 0.39-1.01) subsites, HPV-positive status was not an independent prognostic factor.Conclusions and relevanceHuman papillomavirus positivity was associated with improved survival in 4 subsites (oropharynx, hypopharynx, oral cavity, and larynx), and the largest survival difference was noted in the oropharynx and hypopharynx subsites. In the nasopharynx and sinonasal tract subsites, HPV positivity had no association with overall survival. Given these results, routine testing for HPV at the oropharynx, hypopharynx, oral cavity, and larynx subsites may be warranted.

Project description:Cancer treatments for older patients must account for heterogeneity in health and functional status. Guidelines advocate the use of geriatric assessments (GAs), but comprehensive assessments are laborious and the utility of specific GA domains remains unclear. The identification of specific domains as prognostic factors may support survival predictions and treatment decisions. We aimed to evaluate the associations between several GA domains and overall survival in older cancer patients. We linked cancer registry data and administrative claims data from cancer patients residing in Osaka Prefecture, Japan. The subjects were patients aged ≥70 years who received a diagnosis of gastric, colorectal, or lung cancer between 2010 and 2014 at 36 designated cancer care hospitals. The following three GA domains were assessed at cancer diagnosis: functional status through activities of daily living (ADL), comorbidities, and nutritional status through body mass index. Cox proportional hazards models were constructed for the three cancer types to estimate each domain's prognostic effect while adjusting for gender, age, and cancer stage. Adjusted hazard ratios (HRs) for all-cause mortality were calculated. We identified 5,559, 4,746, and 4,837 patients with gastric, colorectal, and lung cancer respectively. ADL impairment (HRs: 1.39-3.34, 1.64-2.86, and 1.24-3.21 for gastric, colorectal, and lung cancer, respectively), comorbidities (1.32-1.58, 1.33-1.97, and 1.19-1.29 for gastric, colorectal, and lung cancer, respectively), and underweight (1.36, 1.51, and 1.54 for gastric, colorectal, and lung cancer, respectively) were significantly associated with poorer overall survival. In contrast, overweight was significantly associated with improved overall survival (HRs: 0.82 and 0.89 for gastric and lung cancer respectively). The addition of the three domains increased the models' C-statistics (0.816 to 0.836, 0.764 to 0.787, and 0.759 to 0.783 for gastric, colorectal, and lung cancer respectively). Incorporating these factors into initial patient evaluations during diagnosis may aid prognostic predictions and treatment strategies in geriatric oncology.

Project description:ImportanceWhile the adverse association between smoking and head and neck squamous cell carcinoma (HNSCC) survival has been well described, there are also inconclusive studies and those that report no significant changes in HNSCC survival and overall mortality due to smoking. There is also a lack of studies investigating the association of marital status on smoking status at diagnosis for patients with HNSCC.ObjectiveTo examine the association between patient smoking status at HNSCC diagnosis and survival and the association between marital status and smoking in these patients.Design, setting, and participantsThis retrospective cohort study was conducted by querying the Saint Louis University Hospital Tumor Registry for adults with a diagnosis of HNSCC and treated at the university academic medical center between 1997 and 2012; 463 confirmed cases were analyzed.Main outcomes and measuresCox proportional hazards regression analysis was used to evaluate association of survival with smoking status at diagnosis and covariates. A multivariate logistic regression model was used to assess whether marital status was associated with smoking at diagnosis adjusting for covariates.ResultsOf the 463 total patients (338 men, 125 women), 92 (19.9%) were aged 18 to 49 years; 233 (50.3%) were aged 50 to 65 years; and 138 (29.8%) were older than 65 years. Overall, 56.2% of patients were smokers at diagnosis (n = 260); 49.6% were married (n = 228); and the mortality rate was 54.9% (254 died). A majority of patients were white (81.0%; n = 375). Smokers at diagnosis were more likely to be younger (ie, <65 years), unmarried, and to drink alcohol. We found a statistically significant difference in median survival time between smokers (89 months; 95% CI, 65-123 months) and nonsmokers at diagnosis (208 months; 95% CI, 129-235 months). In the adjusted Cox proportional hazards model, patients who were smokers at diagnosis were almost twice as likely to die during the study period as nonsmokers (hazard ratio, 1.98; 95% CI, 1.42-2.77). In the multivariate logistic regression analysis, unmarried patients were 76% more likely to use tobacco than married patients (adjusted odds ratio, 1.76; 95% CI, 1.08-2.84).Conclusions and relevanceSmokers were almost twice as likely as nonsmokers to die during the study period. We also found that those who were married were less likely to be smokers at diagnosis. Our study suggests that individualized cancer care should incorporate social support and management of cancer risk behaviors.

Dataset Information

Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).

Publications

Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets