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Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

ABSTRACT: Quality of life data from randomized trials are lacking in older patients with metastatic colorectal cancer (mCRC). In the randomized NORDIC9-study, reduced-dose S1+oxaliplatin (SOx) showed superior efficacy compared to full-dose S1 monotherapy. We hypothesized that treatment with SOx does not result in inferior quality of life. Patients with mCRC aged ≥70 years and that were not a candidate for standard combination chemotherapy were included and randomly assigned to receive either S1 or SOx. The EORTC QLQ-C30 questionnaire was completed at baseline, after 9, and 18 weeks. The primary endpoint was global Quality of Life (QoL) at 9 weeks. For statistical analysis, a non-inferiority design was chosen applying linear mixed effects models for repeated measurements. The results were interpreted according to statistical significance and anchor-based, clinically relevant between-group minimally important differences (MID). A total of 160 patients aged (median (Interquartile range (IQR))) 78 years (76-81) were included. The QLQ-C30 questionnaire was completed by 150, 100, and 60 patients at baseline, at 9, and 18 weeks, respectively. The difference at 9 weeks in global QoL was 6.85 (95%CI-1.94; 15.65) and 7.37 (0.70; 14.05) in the physical functioning domain in favor of SOx exceeding the threshold for MID. At 18 weeks, the between-group MID in physical functioning was preserved. Dose-reduced combination chemotherapy may be recommended in vulnerable older patients with mCRC, rather than full-dose monotherapy.

SUBMITTER: Liposits G

PROVIDER: S-EPMC8198682 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

Liposits Gabor G Eshøj Henrik Rode HR Möller Sören S Winther Stine Brændegaard SB Skuladottir Halla H Ryg Jesper J Hofsli Eva E Shah Carl-Henrik CH Poulsen Laurids Østergaard LØ Berglund Åke Å Qvortrup Camilla C Österlund Pia P Glimelius Bengt B Sorbye Halfdan H Pfeiffer Per P

Cancers 20210526 11

Quality of life data from randomized trials are lacking in older patients with metastatic colorectal cancer (mCRC). In the randomized NORDIC9-study, reduced-dose S1+oxaliplatin (SOx) showed superior efficacy compared to full-dose S1 monotherapy. We hypothesized that treatment with SOx does not result in inferior quality of life. Patients with mCRC aged ≥70 years and that were <i>not</i> a candidate for standard combination chemotherapy were included and randomly assigned to receive either S1 or ...[more]

PMID: 34073363

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Project description:BackgroundThe incidence of esophageal and gastric carcinoma (GEC) in elderly patients is increasing, yet patients ≥75 years have historically been underrepresented in clinical trials. We sought to investigate palliative chemotherapy administration patterns and survival outcomes in older adults.Materials and methodsA retrospective analysis identified patients aged 65-74 (young-old) and ≥75 years (older-old) diagnosed with advanced GEC. Patient and tumor characteristics were recorded, with descriptive analysis, time-to-event data analysis using Kaplan-Meier curves and multivariate Cox proportional hazards regression analysis performed.ResultsOne hundred and ninety-eight "young-old" and 109 'older-old' patients were identified. Patient characteristics were similar between groups except for Charlson Co-morbidity Index (CCI), with lower co-morbidities in the "young-old" compared to "older-old" cohort (P < .001; CCI = 0 in 103 (52%) "young-old" vs 31 (28%) "older-old"). The primary diagnosis in both groups was adenocarcinoma. 119 (60%) "young-old" and 25 (23%) "older-old" patients received chemotherapy (P < .001). Performance status was the primary explanation for chemotherapy non-receipt in both cohorts; age was the explanation in 21 (25%) "older-old" patients and none in the "young-old" patients. PFS for first-line systemic therapy in "young-old" patients was 6.4 (95% CI 5.9-7.6) versus 7.5 months (95% CI 5.1-11.3) in "older-old" patients (P = .69) whilst respective OS was 12.3 (95% CI 10.1-15.5) and 10.4 months (95% CI 9.0-14.6) (P = .0816). Toxicity prompted chemotherapy cessation in 17 (15%) "young-old" and 3 (13%) "older-old" patients (P = .97). Multivariate analysis identified CCI and ECOG performance status as predictive for PFS and OS, respectively. No causative relationship was identified with other variables.ConclusionOur study of real-world older-adults show that significant number of "older-old" patients with GEC do not receive chemotherapy. Among "older-old" adults who do receive systemic therapy, outcomes are comparable; this underscores the importance of geriatric assessment-guided care and suggests that age alone should not be a barrier to receipt of chemotherapy in patients with advanced GEC.

Project description:BackgroundPolypharmacy is an important issue in the care of older patients with cancer, as it increases the risk of unfavorable outcomes. We estimated the prevalence of polypharmacy, potentially inappropriate medication (PIM) use, and drug-drug interactions (DDIs) in older patients with cancer in Korea and their associations with clinical outcomes.Subjects, materials, and methodsThis was a secondary analysis of a prospective observational study of geriatric patients with cancer undergoing first-line palliative chemotherapy. Eligible patients were older adults (≥70 years) with histologically diagnosed solid cancer who were candidates for first-line palliative chemotherapy. All patients enrolled in this study received a geriatric assessment (GA) at baseline. We reviewed the daily medications taken by patients at the time of GA before starting chemotherapy. PIMs were assessed according to the 2015 Beers criteria, and DDIs were assessed by a clinical pharmacist using Lexi-comp Drug Interactions. We evaluated the association between polypharmacy and clinical outcomes including treatment-related toxicity, and hospitalization using logistic regression and Cox regression analyses.ResultsIn total, 301 patients (median age 75 years; range, 70-93) were enrolled; the most common cancer types were colorectal cancer (28.9%) and lung cancer (24.6%). Mean number of daily medications was 4.7 (±3.1; range, 0-14). The prevalence of polypharmacy (≥5 medications) was 45.2% and that of excessive polypharmacy (≥10 medications) was 8.6%. PIM use was detected in 137 (45.5%) patients. Clinically significant DDIs were detected in 92 (30.6%) patients. Polypharmacy was significantly associated with hospitalization or emergency room (ER) visits (odds ratio: 1.73 [1.18-2.55], p < .01). Neither polypharmacy nor PIM use showed association with treatment-related toxicity.ConclusionPolypharmacy, PIM use, and potential major DDIs were prevalent in Korean geriatric patients with cancer. Polypharmacy was associated with a higher risk of hospitalization or ER visits during the chemotherapy period.Implications for practiceThis study, which included 301 older Korean patients with cancer, highlights the increased prevalence of polypharmacy in this population planning to receive palliative chemotherapy. The prevalence of polypharmacy and excessive polypharmacy was 45.2% and 8.6%, respectively. The prescription of potentially inappropriate medications (PIMs) was detected in 45.5% and clinically significant drug-drug interaction in 30.6% of patients. Given the association of polypharmacy with increased hospitalization or emergency room visits, this study points to the need for increased awareness and intervention to minimize polypharmacy in the geriatric cancer population undergoing chemotherapy. Moreover, specific criteria for establishing PIMs should be adopted for the treatment of older adults with cancer.

Project description:Colorectal cancer (CRC) is a serious disease that may lead to the occurrence of anxiety and depression; however, at present, little is known about the role of care intervention in the mental health of patients with CRC receiving adjuvant chemotherapy. Hence, an incremental patient care program (IPCP) was designed and its effects on anxiety, depression and quality of life (QoL) in patients with CRC receiving adjuvant chemotherapy was assessed. A total of consecutivel 298 patients with CRC who had undergone surgery were recruited for the present randomized, controlled study. Patients were randomly assigned to the IPCP group or the control group at a 1:1 ratio. In the IPCP group, patients received IPCP and conventional care, whereas in the control group, patients received only conventional care. The sp ecific interventions included in IPCP were patient health education, physical exercise, telephone counseling, regular examinations and care activities. Anxiety, depression and QoL were assessed using the Hospital Anxiety and Depression Scale (HADS) and the European Organization for Research and Treatment of Cancer QoL Questionnaire (QLQ-C30) scale. IPCP slightly decreased the anxiety grade at month (M) 6 compared with that of the controls (P=0.070). The IPCP group exhibited a significant improvement in the HADS depression score at M6 vs. M0 (P<0.001), and the depression grade was reduced in the IPCP group compared with that in the controls (P=0.037). Regarding QoL, the QLQ-C30 global health status score at M6 vs. M0 was increased (P=0.035) and the QLQ-C30 symptoms score at M6 vs. M0 was decreased (P=0.002) in the IPCP group compared with that in the controls, but no difference was observed in the QLQ-C30 function score between the two groups. Subgroup analysis by tumor-nodes-metastasis stage (II or III) demonstrated similar trends to those mentioned above. In conclusion, participation in the IPCP led to a slight decrease in anxiety, and contributed to a significant reduction in depression and an improvement in QoL in patients with CRC receiving adjuvant chemotherapy.

Project description:BackgroundThe concept of home-based palliative care has been recently introduced in Bangladesh, but the patients' quality of life remains unexplored. This study aimed to assess the quality of life and its determinants of the cancer patients receiving home-based palliative care in Dhaka, Bangladesh.MethodsThis cross-sectional study was conducted among 51 surviving cancer patients above 18 years registered under the home-based care service of the Department of Palliative Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Data was collected by face-to-face interview using a structured questionnaire based on the "Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal)" questionnaire from February to March 2019. Descriptive analysis was done for the socio-demographic, disease and treatment related factors. Mann-Whiteney U test, Kruskal-Wallis H test, and logistic regression were done to determine the relationships between independent variables and QoL.ResultThe majority of the patients (76.5%) were women. The mean age of the respondents was 56.2±4.8 years. Common primary sites of cancer were breast (39.2%), gastrointestinal (17.6%), and genitourinary system (23.5%). The median duration of getting home-based care was four months. The most prevalent problems were pain, sadness, feeling ill, and lack of satisfaction regarding sexual life. The majority (88.2%) of the patients had an average and above-average quality of life. Although, 92.1%patients had average or above-average social and emotional wellbeing, 60.8% had below-average physical wellbeing. Patients' marital status, belief about disease prognosis, and duration of getting home-based care had a positive influence, and age negatively influenced the quality of life.ConclusionThe majority of the patients receiving home-based palliative care in Dhaka city had average or above-average quality of life. However, these patients had better social and emotional wellbeing, but the physical wellbeing and symptom control were below-average according to the individual domain.

Dataset Information

Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

Publications

Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

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