Comprehensive Geriatric Assessment Items Research Articles

Determinants of Attitude to a Humanoid Social Robot in Care for Older Adults: A Post-Interaction Study.

BACKGROUND While there is a growing body of research examining opinions on social robots in elderly care, there is a lack of comprehensive studies investigating the underlying factors influencing these opinions. The Godspeed Questionnaire Series (GQS) measures perceptions related to human-robot interactions (HRIs). The Comprehensive Geriatric Assessment (CGA) is widely used to evaluate physical, cognitive, and social functions of older patients. The EASYCare 2010 Standard (EC) is a tool for assessing unmet needs in older individuals. TIAGo, a social humanoid robot, integrates perception, navigation, and HRI capabilities. This study aimed to identify the determinants of perception following interactions between older individuals and TIAGo, utilizing the GQS, selected CGA items, and EC. MATERIAL AND METHODS We analyzed a database of opinions from older individuals who interacted with TIAGo, based on the Users' Needs, Requirements, and Abilities Questionnaire. We examined the relationships between the robot's roles (companion/assistant/useful device), its assistive/social functions, and various characteristics of the older participants. RESULTS The study included 161 participants (mean age: 75.2±9.8 years), comprising 89 women and 113 institutionalized individuals. Positive correlations were observed between the robot's role, its functions, and the participants'; perceptions across most evaluated parameters (Anthropomorphism, Animacy, Likeability, Perceived intelligence, Perceived safety). Only a few individual correlations were found for other parameters. CONCLUSIONS The primary determinant of older individuals' opinions was their perception of the robot. Therefore, involving older adults in the co-design process of such robots is crucial. Additionally, a paradigm shift is needed in the study of humanoid social robots, focusing on successful aging rather than deficits associated with aging.

Multidimensional Oncological Frailty Scale (MOFS): A New Quick-To-Use Tool for Detecting Frailty and Stratifying Risk in Older Patients with Cancer—Development and Validation Pilot Study

Frailty detection with comprehensive geriatric assessment (CGA) is of pivotal importance in older patients with cancer to avoid over- or under-treatment and to detect those at increased risk for poor outcomes. Several tools have been developed to capture the complexity of frailty, but only a few were explicitly conceived for older adults with cancer. The study aimed at developing and validating a multidimensional, easy-to-use diagnostic tool for early-risk stratification in patients with cancer, called the Multidimensional Oncological Frailty Scale (MOFS). In this single-center prospective study, we consecutively enrolled 163 older women (age ≥ 75 years) with breast cancer, screened with a G8 score ≤ 14 during the outpatient preoperative evaluation at our breast centre, as the development cohort. Seventy patients with different types of cancer admitted to our OncoGeriatric Clinic served as the validation cohort. Using stepwise linear regression analysis, we evaluated the relationship between Multidimensional Prognostic Index (MPI) and CGA items, and, finally, realized a screening tool based on the combination of the significant variables. The mean age of the study population was 80.4 ± 5.8 years, while the mean age of the validation cohort was 78.6 ± 6.6 years [42 women (60%)]. A composite model of the Clinical Frailty Scale, G8, and hand grip strength test showed a strong correlation with MPI (R= -0.712, p < 0.001). The MOFS accuracy in the prediction of mortality was optimal in both the development and the validation cohorts (AUC 0.82 and 0.87; p < 0.001 and 0.003, respectively). MOFS represents a new, accurate, quick-to-use frailty screening tool for stratifying the risk of mortality in geriatric cancer patients.

Nurse Practitioner's Geriatric Practice in Japanese Postacute Care Setting

The quality of comprehensive geriatric assessment and medication reconciliation by a nurse practitioner (NP) based in Japan was evaluated by a prospective observational study. Within the 64 inpatients seen by the NP at a postacute care clinic, the achievement rate of 8 comprehensive geriatric assessment items was 93.8%, compared with just 33.8% in the nearby hospital (P < .05). The average volume and the number of types of medication on admission (9.2 and 4.7) and discharge (7.6 and 4.6) tended to decrease without statistical significance. NPs were suggested to have benefits toward geriatric care that may allow for much-needed task shifting in Japan.

Comprehensive Geriatric Assessment Using the Yoitoko Check-Up, a Novel Health Check-Up Providing Positive Feedback to Older Adults: A Before-After Study.

PurposeThe Yoitoko check-up, a novel health check-up providing positive feedback, has been developed to promote health among older adults, and consists of several comprehensive geriatric assessment items. This report aimed to describe the details of the Yoitoko check-up and to explore the future possibility of the check-up by evaluating the participants’ short-term behavioral changes in terms of comprehensive functioning, using a before-after study design.Patients and MethodsFour Yoitoko check-ups were conducted, at 3-month intervals, between December 2018 and September 2019. Study participants aged ≥65 years included those who had undergone ≥2 Yoitoko check-ups. The results of each visit after the second check-ups were retrospectively compared with those of the baseline, and the mean changes and the odds ratios were calculated using a paired t-test or a McNemar test, respectively.ResultsOf 84 participants, the results of 16 (19.0%) participants were analyzed. The mean (standard deviation) age was 75.3 (4.7) years. The mean Tokyo Metropolitan Institute of Gerontology Index of Competence score, a measure of high-level functional capacity, increased 0.9 (95% confidence interval; range, 0.2–1.5) points between the first and second visits.ConclusionWe developed the Yoitoko check-up and introduced the details of it. Our study findings suggested that the Yoitoko check-up may further motivate older adults to improve their health and promote positive behavioral changes. Future studies are needed to evaluate the effectiveness of this novel assessment method.

Determinants of bone health in elderly Japanese men: study design and key findings of the Fujiwara-kyo Osteoporosis Risk in Men (FORMEN) cohort study

BackgroundThe Fujiwara-kyo Osteoporosis Risk in Men (FORMEN) study was launched to investigate risk factors for osteoporotic fractures, interactions of osteoporosis with other non-communicable chronic diseases, and effects of fracture on QOL and mortality.MethodsFORMEN baseline study participants (in 2007 and 2008) included 2012 community-dwelling men (aged 65–93 years) in Nara prefecture, Japan. Clinical follow-up surveys were conducted 5 and 10 years after the baseline survey, and 1539 and 906 men completed them, respectively. Supplemental mail, telephone, and visit surveys were conducted with non-participants to obtain outcome information. Survival and fracture outcomes were determined for 2006 men, with 566 deaths identified and 1233 men remaining in the cohort at 10-year follow-up.CommentsThe baseline survey covered a wide range of bone health-related indices including bone mineral density, trabecular microarchitecture assessment, vertebral imaging for detecting vertebral fractures, and biochemical markers of bone turnover, as well as comprehensive geriatric assessment items. Follow-up surveys were conducted to obtain outcomes including osteoporotic fracture, cardiovascular diseases, initiation of long-term care, and mortality. A complete list of publications relating to the FORMEN study can be found at https://www.med.kindai.ac.jp/pubheal/FORMEN/Publications.html.

P0806RESIDUAL RENAL FUNCTION IS COMPLEMENTARY TO GERIATRIC ASSESSMENT SCORE IN ASSESSING CLINICAL RISK OF ELDERLY PATIENTS

Abstract Background and Aims Renal function impairment is highly pervasive in the elderly and triggers increased morbidity and mortality. Comprehensive geriatric assessment (CGA) is a validated multidisciplinary instrument to assess medical, psychosocial and functional limitations of old patients with diagnostic and risk-stratification purposes. In a focused cohort of frail individuals, we aimed at evaluating possible relationships between single CGA items and renal function. Method 254 consecutive elderly subjects (mean age 79.9±6.6 years, female 65.8%) from the geriatric division of a large Italian community hospital were studied. We collected clinical data including CGA and renal function (CKD-EPI formula). CGA single items included the Cumulative Illness Rating Scale (CIRS), the Exton Smith Scale (ESS), the Mini Nutritional Assessment Short Form (MNA-SF), the Katz‘s Activities of Daily Living (ADL), the Lawton’s Instrumental Activities of Daily Living (IADL), the Short Portable Mental Status Questionnaire (SPMSQ) and the amount of drugs administered (AD). Results Mean eGFR was 66.37±30.94 mL/min/1.73 m2. Overall, the reported CIRS, ESS, MNA, ADL and AD scores were low (7.6±3.3) while IADL and SPMQ were on a mild range, denoting a potential alarm signal for poor prognosis and the risk for adverse outcomes. At univariate analyses, eGFR was significantly associated with CIRS (R=-0.389, p&amp;lt;0.0001), ESS (R=0.355, p&amp;lt;0.0001), MNA (R=0.394, p&amp;lt;0.0001), ADL (R=0.394, p&amp;lt;0.0001), AD (R=-0.374, p&amp;lt;0.0001. while a weak, although significant correlation was found with IADL (R=0.131, p=0.038) and SPMSQ (R=-0.141, p=0.038). In a fully adjusted multivariate analyses only SPMSQ (ß=-0.174, p=0.04), ADL (ß=0.182, p=0.012), IADL (ß =0.209, p=0.003) and AD (ß=-0.354, p&amp;lt;0.0001) remained significant predictors of residual renal function. Conclusion In elderly frail subjects, residual renal function may influence daily life and cognitive activities, the perceived quality of living and the entity of drug assumption. Inclusion of renal function within a comprehensive geriatric assessment could help improving risk stratification in the elderly

Eribulin Mesylate as Third or Subsequent Line Chemotherapy for Elderly Patients with Locally Recurrent or Metastatic Breast Cancer: A Multicentric Observational Study of GIOGer (Italian Group of Geriatric Oncology)-ERIBE.

Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend .018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10-10.33) and median OS was 7.31 months (3.70-14.03). The treatment was associated with mild toxicity. Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who are frequently elderly or frail. The assessment of geriatric parameters in the decision-making process can contribute to direct toward the most appropriate therapeutic plan and preserve the quality of life of patients. Eribulin does not seem to affect quality of life or worsen the overall geriatric status; therefore, it can be considered a suitable option for elderly patients with metastatic breast cancer.

Retrospective Analysis of Treatment Outcomes and Geriatric Assessment in Elderly Malignant Lymphoma Patients.

In recent years, the Comprehensive Geriatric Assessment (CGA), which is used in gerontology to assess functioning in elderly individuals, has been said to be useful in geriatric oncology. Therefore, we examined whether items in the CGA were associated with survival time in elderly patients with non-Hodgkin lymphoma (NHL). We conducted the CGA for 93 patients aged ≥ 65 years who had undergone treatment for NHL retrospectively. The CGA includes activities of daily living, instrumental activities of daily living, mood, cognition, nutrition, and the Charlson comorbidity index. For each category, we divided subjects into a "good" group and a "poor" group. In regard to the Charlson comorbidity index, patients were divided into two groups using different cutoffs to divide the groups; the two groups were established according to the division with the largest significant difference in survival time. Multivariate analysis was then performed with the following prognostic factors affecting survival: all CGA items, NHL classification, stage, performance status, and doxorubicin use/non-use. We also performed similar analysis for 43 diffuse large B-cell lymphoma (DLBCL) patients who had undergone anthracycline treatment. Results are factors affecting survival in NHL cases included comorbidity score ≥ 6 (P < 0.0001), doxorubicin non-use (P = 0.005), and cognitive impairment (P = 0.0488). In cases of DLBCL, survival was affected by comorbidity score ≥ 5 (P = 0.0016). High comorbidity score was strongly associated with survival in both NHL and DLBCL.

Identification of clinical parameters predictive of one-year survival using two geriatric tools in clinically fit older patients with hematological malignancies: Major impact of cognition.

Little is known about the reliability of G8 screening tool and the prognostic value of clinical parameters within the Comprehensive Geriatric Assessment (CGA) in clinically fit older patients with hematological malignancies. This study was performed to assess the reliability of G8 as a screening tool and to determine the predictive value of CGA items in terms of 1-year overall survival (OS). G8 and CGA were proposed to 107 consecutive patients (65-89 years) with hematological malignancies assessed by their physicians as clinically fit, meaning not exhibiting geriatric syndromes and/or irreversible comorbidities significantly impairing their daily function, and thus able to receive chemotherapy. Out of 107 patients, 90 patients were evaluable and completed both scales; 72% and 80% were defined as "vulnerable" when evaluated with G8 (≤ 14.5) or CGA (≥ 2 impairments) respectively. The area under ROC-curve of G8 compared to CGA was 0.749±0.051. Neither G8 nor CGA total scores were predictive of 1-year OS. However, age (HR=1.105, 95% CI: 1.016-1.202; p=0.019), diagnosis (HR=5.208, 95% CI: 1.895-14.310; p=0.001) and cognitive status (HR=3.260, 95% CI: 1.043-10.194; p=0.042) were predictive of OS. We conclude that in our selected hematological patients: 1) the G8 score does not help selecting patients for CGA, 2) the G8 and CGA total scores do not predict OS, and 3) in addition to the age and disease itself, cognitive impairment appears to be a powerful prognostic factor.

Cancer treatment in elderly patients: evidence and clinical research

In 2020 the percentage of patients with a diagnosis of cancer in people with more than 65 years will exceed 70% and 28% in ethnic minorities. The treatment of cancer in these populations is challenging for the oncologists due to socio-economic issues such as poverty, reduced access to the hospital care, level of education. The clinical pathway "diagnosis-treatment-cure", typical of the care of young patients has to be integrated in elderly patients with a more individualized treatment by means of comprehensive geriatric assessment (CGA). IADL (Instrumental Activities of Daily Living) have the best predictive role in oncological setting and their impairment significantly correlate with overall survival, chemotherapy toxicities and thirty days postoperative morbidities. The CGA is universally accepted as the most appropriate instrument to analitically evaluate the age related problems of elderly patients. The role of CGA is crucial to identify geriatric issues not easily diagnosed, to predict treatment toxicities, functional or cognitive decline, post operative complications and to estimate life expectancy. The CGA items are predictive of severe toxicity, however it is not clearly established which are the best performers and the best cut-offs points. Today CGA is integrated with physical performance tests (the most widely used is the "time up and go" test) and laboratory assay of Interleukin 6 and D-Dimer that correlate with mortality and physical decline. There are few prospective studies that evaluated the role of CGA in treatment choice. The first is a phase II study in solid tumors, the second is a haematological trial on non Hodgkin lymphoma. The largest trial is a 571 patients observational series that confirmed the role of CGA in decision making. The administration of CGA is time consuming and consequently some screening tools were developed. VES-13 is a 13 items tool that explores prevalently the functional status and the self reported health status. VES-13 showed a good sensibility (87.3%) but a low specificity (62%) with respect to CGA for the diagnosis of patients with disabilities. Overcash et al. proposed an abbreviated form of CGA using a reduced number of items of ADL, IADL, MMSE and GDS. There was a good correlation between complete and reduced scales (coefficient of correlation 0.8). G8 is a screening tool composed of 8 questions that explore functional, cognitive and nutritional status. The score with the best equilibrium between sensibility and specificity was 14 (sensibility 85% and specificity 65%). In the first observational trial age, hystotype, chemotherapy dose, haemoglobin (man: 11 g/dL; women: 10 g/dL), creatinine clearance less than 34 mL/min (Jelliffe formula), earing problems, at least a fall in the last six months, walking problems, low social activity, were related to a major risk of toxicity; in another trial IADL, diastolic blood pressure, LDH and MAX2 index were predictive of haematological toxicity, while performance status, Mini-Mental Status score, Mini-Nutritional Assessment (MNA) score and MAX2 index were predictive of non haematological toxicity. Based on these parameters a 0-2 score was developed. A recent "position article" of EORTC (European organization for Research and Treatment of Cancer) and SIOG analyzed the pro and the contra of the use of some indicators in elderly patients. The overall survival (OS) frequently used in classical clinical trial could give wrong messages as there are some competitive risks of death in elderly patients. Another important indicator is the disease specific survival (DSS). Concerning the design of clinical trials, a possible strategy is to enrol elderly patients without upper age limit and to plan stratification. An interesting trial design is the so called "extended trial" that allow to re-open the arm of a trial in which a too low number of older patients was enrolled.

Prognostic Value of Neuro-Psychological and Biological Factors in Clinically Fit Older Patients with Hematological Malignancies

BACKGROUND: A Comprehensive Geriatric Assessment (CGA) is recommended to detect vulnerable cancer patients for whom chemotherapy may lead to severe impairment on functionality, quality of life, or survival. Although CGA is useful for a better management of older patients with unsuspected problems, little is known about the reliability of CGA - or G8 screening tool - to optimize the therapeutic approach in a specific patient with a malignant hemopathy. Particularly, the prognostic value of cognitive functions, psychological status and other selected biological factors in older patients with hematological malignancies admitted to receive chemotherapy, are poorly investigated.AIM: To assess in clinically fit (go and slow go) patients with malignant hemopathies, the reliability of G8 screening and CGA as a prognostic tool to predict overall survival (OS) and particularly, the predictive value of neuro-psychological and biological factors, in terms of one-year OS.POPULATION AND METHODS: Between Oct 2010 and June 2013, G8 and CGA were proposed to 107 consecutive older patients (65+-yrs) with hematological malignancies, admitted to the hospital and judged clinically fit, by their refereeing physicians, to receive chemotherapy. An initial full-dose or reduced-dose chemotherapy has been administrated to these patients according to a multidisciplinary team decision. The nutritional status was screened by MNA and the cognitive functions by MMS and MoCARESULTS: Ninety patients -completely assessed for G8 and CGA- were evaluable for one year OS; Non Hodgkin’s Lymphoma (53%), Multiple myeloma (16%), Acute Myeloid Leukemia and Myelodysplastic Syndrome (15%), Chronic Lymphocytic Leukemia (14%) and Myeloproliferative Neoplasms (2%). Median age is 74 (65-89) yrs. 56% are males. 72% and 80%, were considered as “vulnerable” when evaluated with G8 (≤14.5) or CGA (≥2 impairments), respectively. The area under ROC-curve of G8 compared to CGA was 0.749 ± 0.051 (sensibility = 79.2% and specificity =55.6%). During the first year of follow-up, 28% (n=22) of older patients treated for hematological malignancies died. The leading cause of death (82%) was indeed the disease progression. Retrospectively, neither the G8 nor the CGA total score had an impact with the initial treatment choice and were not predictive for one-year OS. In addition, regarding patients characteristics, in a multivariate analysis (Cox proportional hazard model), age (p=0.015; HR=1.12) and diagnosis (p<0.001; HR=7.2), were major prognostic factors in terms of OS. Regarding specific CGA items, a multivariate analysis concluded that unsuspected cognitive impairment (evaluated with a MMS and a MoCA) had the strongest prognostic value (p=0.03; HR=3.560) in terms of OS.DISCUSSION: In our clinically fit hematological patients, a poor G8 or CGA score does not translate into a worse survival, more likely because of two reasons: the disease itself remains the major cause of death and malnutrition, a reversible impairment after effective treatments, strongly impacts on G8 and CGA. The objective of an effective screening tool should thus be the identification of the population who could benefit from optimal treatment combined with an comprehensive management of unsuspected specific problems.CONCLUSIONS: Our observations in “clinically fit” older hematological patients suggest that 1) the major cause of death is the disease itself and the priority should be to identify all patients susceptible to benefit from full dose chemotherapy 2) a poor G8 screening or an abnormal CGA are not specific enough and does not translate into a worse one year OS 3) some specific factors in the CGA (such as neuro-cognitive impairments) are highly correlated with one-year OS 4) age remain a continuous variable with a poor prognostic factor. Prospective trials are needed to further determine whether the combination of optimal treatment and improved management of impaired functions, including cognition, could lead to a better OS. DisclosuresNo relevant conflicts of interest to declare.

An integrated analysis of comprehensive geriatric assessment (CGA) in elderly patients with non-small cell lung cancer (NSCLC) (JCOG1115-A).

6112 Background: The number of elderly NSCLC patients is increasing all over the world. Actual age and ECOG PS is not always efficient to select "fit-elderly" for chemotherapy. We integrated the data from two phase III trial (JCOG0207, JCOG0803/WJOG4307L) and evaluated 4 CGA items as well as age and PS to determine whether they would predict survival, response and toxicities. Methods: Eligibility criteria of both trials included histologically or cytologically proven NSCLC; stage III/IV; age 70 or more; ECOG PS of 0-1; unfit for bolus cisplatin; no prior treatment; adequate organ function. Patients were randomized to receive either weekly docetaxel (D) or D plus cisplatin (DP) in J0207, and either 3-weekly D or DP in J0803/W4307L. This study included all eligible pts for whom all of 4 CGA items (Activity of Daily Living [ADL], Instrumental Activity of Daily Living [IADL], Mini-Mental State Examination [MMSE], Geriatric Depression Scale [GDS-15]) were assessed before treatment. Primary endpoint was overall survival (OS). Survival curves are estimated by Kaplan-Meier method and multivariate analysis for OS adjusting baseline factors were performed by using stratified Cox regression model. Results: This analysis included 331 pts (J0207/J0803-W4307L: 105/226) in total. The result of multivariate analysis for OS was shown in the table. After adjusting baseline factors, MMSE as well as sex and PS was significantly associated with OS. None of the CGA items were associated with response and toxicities. Conclusions: It is not actual age but MMSE and PS that is useful for predicting prognosis of elderly pts. MMSE should be taken into consideration to determine the indication of chemotherapy for elderly pts. [Table: see text]

Quality of life, geriatric assessment and survival in elderly patients with non-small-cell lung cancer treated with carboplatin–gemcitabine or carboplatin–paclitaxel: NVALT-3 a phase III study

BackgroundElderly patients with advanced non-small-cell lung cancer (NSCLC) may derive similar benefit from platinum-based chemotherapy as younger patients. Quality of life (QoL) and comprehensive geriatric assessment (CGA) is often advocated to assess benefits and risks. Patients and methodsA total of 181 chemotherapy-naive patients [≥70 years, performance score (PS) of 0–2] with stage III–IV NSCLC received carboplatin and gemcitabine (CG) (n = 90) or carboplatin and paclitaxel (CP) (n = 91) every 3 weeks for up to four cycles. Primary end point was change in global QoL from baseline compared with week 18. Pretreatment CGA and mini geriatric assessment during and after treatment were undertaken. A principal component (PC) analysis was carried out to determine the underlying dimensions of CGA and QoL and subsequently related to survival. ResultsThere were no changes in QoL after treatment. The number of QoL responders (CG arm, 12%; CP arm, 5%) was not significantly different. CGA items were only associated with neuropsychiatric toxicity. Quality-adjusted survival was not different between treatment arms. The PC analysis derived from nine CGA, six QoL and one PS score indicated only one dominant dimension. This dimension was strongly prognostic, and physical and role functioning, Groningen Frailty Indicator and Geriatric Depression Scale were its largest contributors. ConclusionsPaclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner. CGA and QoL items measure one underlying dimension, which is highly prognostic.

Incorporation of a comprehensive geriatric assessment (CGA) into a randomized phase III trial for metastatic breast cancer (MBC): The PELICAN study.

1070 Background: PELICAN is a randomized phase III trial evaluating efficacy and safety of pegylated liposomal doxorubicin (PLD) vs. capecitabine (CAP) as first-line therapy in patients (pts) with MBC. CGA results and correlation to time to progression (TTP), overall survival (OS), and time to treatment failure (TTF) were evaluated. Methods: CGA comprised data on activities of daily living (ADL), instrumental sctivities of daily living (IADL), Karnofsky performance status (KPS), comorbidity (CIRS-G), and the number of comedications. According to CGA, pts were classified into 3 groups. Single and combined CGA items were analyzed for association with treatment burden and efficacy outcome (TTP, OS, TTF) using Fisher's exact test, Wilcoxon test, and logistic regression. Results: Data from 210 pts (105 PLD, 105 CAP) with a median age of 62 y (22-85) were analyzed. 123 pts (59%) were <65 y and 87 pts (41%) ≥65 y. CGA scores were available from 152 pts. According to CGA, 113 pts were considered fit (group 1, 74%), 15 compromised (group 2, 10%), and 24 frail (group 3, 16%). Pts with a good KPS (≥ 90%) (n=46) had a significantly longer TTP vs. pts with a worse KPS (n=44) (median KPS 100%: 8.7 mo; 90%: 8.6 mo; ≤ 90%: 3.8 mo; p=0.0027). CGA, ADL, and IADL scores, and CIRS-G did not have a significant impact on TTP. In terms of OS, a high KPS (≥ 90%) significantly increased OS (median 100%: 27.5 mo; 90%: 32.1; <90%: 18.4 mo; p=0.0034). IADL score 8 and CIRS-G 0-3 also correlated with longer OS vs. IADL score <8 (24.1 vs. 17.8 mo, p=0.0061) and CIRS-G >3 (median 0-1: 30.0 mo; 2-3: 32.1 mo; >3: 17.8 mo; p<0.0001). A high KPS increased TTF significantly (median 100%: 5.8.mo; 90%: 4.6 mo, ≤ 90%: 3.0 mo; p=0.0076). Pts with IADL score <8 had a longer TTP (13.7 vs 2.6 mo, p=0.0272), OS (22.7 vs. 4.0 mo, p=0.0031) and TTF (4.6 vs. 2.5 mo, p=0.0043) in the PLD vs. CAP arm. Conclusions: KPS was the most striking predictive factor in this analysis with respect to correlation to TTF and OS. Pts with IADL score <8 treated with PLD had better outcome than pts in CAP arm. Incorporation of CGA into a phase III trial is feasible and yields valuable information for deciding best therapy for MBC patients. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Essex Pharma Essex Pharma, Schering-Plough Essex Pharma, Schering-Plough Schering-Plough, University Hospital Hamburg-Eppendorf Schering-Plough

Incorporation of a Comprehensive Geriatric Assessment (CGA) into a randomized phase III trial for metastatic breast cancer: The PELICAN Study

9551 Background: The PELICAN trial is a randomized phase III trial evaluating efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line therapy in patients (pts) with metastatic breast cancer who are not considered candidates for combination chemotherapy. Randomisation was stratified according to age (cut-off 65 years) and anthracycline pretreatment. CGA results and adverse events (AEs), dose reductions, and number of applied cycles were evaluated. Methods: CGA comprised data on activities of daily living (ADL), instrumental activities of daily living (IADL), ECOG and Karnofsky performance score, comorbidity (CIRS-G), and number of comedication. According to CGA, pts were classified into groups 1–3 (Balducci 2000). Associations of CGA groups and single CGA items with outcome measures were assessed using Fisher's exact test, Wilcoxon test, and logistic regression. Results: Results of 210 pts, mean age 61 years (SD 11; range 22–85) were analysed. According to CGA, 102 pts were considered fit (group 1, 72%), 21 compromised (group 2, 15%), and 19 frail (group 3, 13%). Age was associated neither with overall AEs, nor with dose reductions or number of applied cycles. However, the following significant associations were observed: any AE and number of comedication (p=0.026); less hand foot syndrome (HFS) and CGA group 2/3 (p=0.032); and more constitutional symptomes and age &gt;=65 as well as CGA group 2/3 (p=0.002 and 0.015, respectively). Comedication was the variable most frequently associated with single AEs (dermatology other than HFS, p=0.038; gastrointestinal, p=0.035; constitutional symptomes, p=0.002; pain, p=0.001; pulmonary, p&lt;0.0001; fatigue, p=0.01). Whereas no association between any item and dose reduction was found, CIRS-G grade 3–4 was associated with a reduced number of applied cycles (p=0.049). Conclusions: Incorporation of CGA into a phase III trial is feasible and yields information that would otherwise have been missed. Results of CGA should be validated prospectively in treatment algorithms for this population. [Table: see text]

Factors associated with long hospital stay in geriatric wards in Japan

Background: To reduce the length of stay (LOS) in hospital, the factors associated with extended LOS have to be identified.Methods: A comprehensive geriatric assessment (CGA) of patients in a geriatric ward was carried out to identify the factors associated with LOS of more than 28 days.Results: Of 193 patients (&gt; 65 years old) who had been admitted to the geriatric ward of Nagoya University Hospital from home, 118 patients had complete CGA data sets. The CGA items were studied within 1 week of admission and analysis was performed by Chi‐squared followed by multilogistic analysis. Chi‐squared analysis demonstrated that many of the basic activities of daily living (BADL) and instrumental ADL (IADL) had a significant association with longer LOS, but the contribution of psychological factors, assessed by mini‐mental state examination and Geriatric Depression Scale‐15, was relatively small. Multilogistic analysis showed that dependence on dressing assistance and medication assistance significantly increased the chance of having a LOS longer than 28 days.Conclusion: Intervention to improve the ability to dress and take medication independently may reduce LOS.