Prognostic value of G8 for functional decline and 1-year mortality in older patients with cancer: A multicenter prospective study

doi:10.21203/rs.3.rs-4916002/v1

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Prognostic value of G8 for functional decline and 1-year mortality in older patients with cancer: A multicenter prospective study

https://doi.org/10.21203/rs.3.rs-4916002/v1

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Purpose

Geriatric 8 (G8) is a screening tool to identify frail older patients with cancer. Functional decline (FD) is a determinant in quality of life and survival. We aim to determine the predictive value of G8 for FD in patients with cancer after a new treatment, and its prognostic value for 1-year mortality, severe adverse events, and hospitalizations.

Methods

Prospective multicenter cohort study of patients ≥ 65 years old receiving oncologic treatment in two hospitals assessed with baseline G8. Cut-off value of G8: ≤14. Functional status was assessed using Instrumental Activities of Daily Living (IADL). Primary objective was FD, defined as a decrease of 1 point on IADL after two months of treatment.

Results

226 patients were included, 222 started treatments. After two months, IADL was available for 210; twelve patients (5,4%) died before second evaluation. 66.2% (147) presented an altered G8 score. In those with altered G8, 39.3% (53) had FD and in patients with normal G8, only 13.3% (10) (p < 0.001). At final analysis 222 were available for 1-year mortality and 37.8% (84) had died. After one year of treatment beginning, 48.3% (71) of those with altered G8 had died compared with 17.3% (13) of those with normal G8 (p = 0.001).

Conclusion

FD has an important prognostic value in older patients with cancer and this data shows a strong association of baseline G8 with FD and mortality; supporting the routine use of this tool in the management of older patients with cancer.

Older patients

cancer

functional decline

mortality

Latin America

Aging represents a firmly established risk factor for cancer, both in a general sense and across various specific cancer types. As the population of older adults continues to grow, so does the incidence of new cancer cases. The occurrence of cancer increases progressively with advancing age, transitioning from fewer than 25 cases per 100,000 individuals in age groups under 20, to exceeding 1,000 per 100,000 individuals in age groups 60 and above [1]. At present, roughly 60% of malignant tumors and 70% of cancer-related fatalities arise in adults aged 65 or older. It is estimated that by 2030, this demographic will account for 70% of all cancer diagnoses [2].

Older cancer patients are less likely to receive treatment adhering to recommended guidelines, which can detrimentally affect their chances of survival [3]. The primary challenge in caring for elderly cancer patients is the scarcity of data derived from prospective clinical trials. Evidence-based oncology guidelines primarily rely on trials in which older adults are either absent or underrepresented [4]. Less than 25% of patients enrolled in clinical trials at the National Cancer Institute fall within the age bracket of 65 to 74, and less than 10% are aged 75 or above [5].

Older cancer patients comprise a diverse group, and their chronological age provides limited insight into their physiological condition. A Comprehensive Geriatric Assessment (CGA) represents a multidimensional, interdisciplinary evaluation offering a comprehensive overview of an older adult's health, functional status, and reserve capacities. It identifies various medical, functional, cognitive, social, nutritional, and psychological parameters and has demonstrated its ability to predict early mortality following chemotherapy [6].

The CGA is endorsed by the International Society of Geriatric Oncology, as well as the American and European Cancer Societies [7, 8]. However, its routine implementation in clinical practice faces numerous obstacles, including the time required for its execution and the shortage of trained personnel, even within academic hospitals. To better focus on frail patients who stand to benefit the most from the CGA, screening tools have been devised to identify older individuals with a geriatric frailty profile. One such tool is the Geriatric 8 (G8), which has been validated through The ONCODAGE Study [9, 10]. This study, encompassing patients over 70 years old receiving first-line chemotherapy for cancer, revealed that the G8 exhibits high diagnostic accuracy in predicting impairments detected by the CGA. Moreover, it proves prediction of various clinical outcomes, such as functional decline (FD) and survival [11–13]. The G8 demonstrated a sensitivity of 76.5% in predicting abnormal CGA scores in cancer patients, with a specificity of 64.4%.

The primary objective of this study is to assess the correlation between the baseline screening tool, G8, and the presence of FD two months after commencing treatment. Additionally, it seeks to investigate the predictive value of the G8 concerning survival and other clinical outcomes over the course of a year in cancer patients aged 65 and older.

This is a prospective, multicenter, non-interventional study carried out in two hospitals in Buenos Aires, Argentina (CEMIC Center for Medical Education and Clinical Research) and Cuenca, Spain (Hospital Virgen de la Luz) from May 2019 till December 2021.

2.1. Patient eligibility

Patients aged ≥ 65 years old, with no upper limit of age, with histological or cytological confirmation of malignancy, scheduled to receive specific oncologic treatment at diagnosis or at disease progression/relapse, including chemotherapy, immunotherapy or combined treatment for malignant solid tumors were eligible for prospective inclusion in this study.

This research complied with the guidelines for human studies and was ethically conducted in accordance with the World Medical Association Declaration of Helsinki. The inclusion of patients in the study was approved by the local institutional review boards of both participating institutions (CEMIC Ethics Committee approval #1222, Hospital Virgen de la Luz Ethics Committee approval #3098). Informed consent was given by all patients before any data collection.

2.2. Geriatric assessment and functional status assessment

Before starting chemotherapy, the geriatric screening tool, G8, was performed in all patients by the oncologist leading the study (see supplementary material). The G8 consists of eight items covering multiple CGA domains (See supplementary material). Seven items are derived from the original mini nutritional assessment questionnaire (MNA); appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-perception of health and one item concerns the patient's age. The G8 score ranged from zero to 17. The cut-off value for an impaired score was set below or equal to 14. A score of ≤ 14 is considered a marker for frailty with lower scores indicating greater functional impairments [9].

Functional status (FS) was assessed using Lawton's Instrumental Activities of Daily Living (IADL) at baseline along with the G8 and after two months of treatment [14] (see supplementary material). This second evaluation was carried out by telephone or at the time of coming to the hospital for treatment. FD was defined as a decrease of 1 point on the IADL scale between the beginning of chemotherapy and after two months of treatment.

2.3. Clinical outcomes

The primary objective of the study was to assess the relationship between the initial G8 score and the presence of FD after two months of starting treatment in patients 65 years of age or older. Secondary objectives were to assess the relationship between G8 score with one year survival and other clinical outcomes within two months: severe toxicity assessed by Common Terminology Criteria for Adverse Events grade 3–4 (CTCAE G 3–4) and hospitalizations due to treatment related. The following clinical variables were collected from clinical records: age, gender, cancer subtype and stage at the time of diagnosis and at the time of current treatment. Regarding treatment, the number of previous treatments was recorded and, with respect to the treatment about to begin, the treatment schedule and the treatment line were recorded; Whether it was chemotherapy, immunotherapy, or targeted therapy, alone or combined treatment, as well as the use of concomitant radiotherapy, were recorded.

The presence of severe adverse events assessed according to the CTCAE v5.0, the presence of discontinuation of treatment and hospital admissions due to treatment toxicity was assessed after two months of treatment by reading clinical records findings and by asking the participants at the time of the second FS evaluation. Survival status was assessed one year after starting treatment for all patients included.

2.4. Statistical analysis

Descriptive statistics were used to summarize the baseline characteristics of the study population. Categorical variables were reported as frequencies and percentages, while continuous variables were presented as means and standard deviations (SD) or medians and interquartile ranges (IQR), as appropriate.

A univariate analysis was performed with chi square test for G8 and categorical variables and log rank test for continuous variables. The association between the G8 screening tool and FD and was assessed using logistic regression analysis, with adjustment for potential confounders including age, sex, cancer type, comorbidities, and treatment modality. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported.

All statistical analyses were performed using R version 4.1.0 (R Foundation for Statistical Computing, Vienna, Austria). A two-sided P-value of < 0.05 was considered statistically significant.

3.1. Patient and clinical characteristics

Between May 2019 and December 2021, 226 patients from two centers were recruited. Of the 226 patients, 222 started treatment and were included for analysis. After two months, FS data was available for 210 patients, as twelve patients (5.4%) died before the second assessment. All these patients had an altered baseline G8 score. Here, we present results for FD of the remaining 210 patients and survival status of the 222 patients included for analysis (Fig. 1).

Median age was 74 years (IQR 70–80) and 54.5% (121) were males. Lung cancer was the most frequent primary tumor corresponding to 25.7% (57) of patients, followed by colorectal 18.5% (41) and breast cancer 12.6% (28). At the time of inclusion in the study, 73.4% had newly diagnosed cancer, whereas 27.6% had disease progression/relapse. Regarding the stage, most patients had stage IV disease (56.7%, 126) while 43.3% had localized disease.

At baseline, 66.2% (147) presented an altered G8 score and median IADL at baseline was 8 (RIC 7–8). Further patient and clinical characteristics are listed in Table 1.

Table 1

*Patient’s characteristics (n = 222)*
	Variables	n	%
	Institution (%)
	CEMIC	155	(69.8)
	Hospital V de la Luz	67	(30.2)
	Age, years
	Median [IQR]	74	[70–80]
	Sex (%)
	Female	101	(45.5)
	Male	121	(54.5)
	G8 at baseline
	>14	75	(33.8)
	≤14	147	(66.2)
	Tumor site (%)
	Lung	57	(25.7)
	CCR	41	(18.5)
	Breast	28	(12.6)
	Kidney/Bladder	27	(12.2)
	Prostate	17	(7.7)
	Pancreas	14	(6.3)
	Other gynecologic tumors	13	(5.9)
	Esophagus/GEJ/Gastric	8	(3.6)
	Others	17	(13.8)
	Disease extension (%)
	Localized	96	(43.4)
	Metastatic	126	(56.7)
	Lines of treatment (%)
	Neo/adjuvant	90	(43.4)
	1L	92	(41.4)
	≥2L	40	(18.1)
	Type of treatment
	ChT alone	168	(75.7)
	ICI alone	14	(6.3)
	TKi	4	(1.8)
	ChT/ICI	9	(4.0)
	ICI/Tki	2	(0.9)
	ChT/RT	25	(11.3)
Abbreviations: CCR: colorectal cancer. UGE: Gastroesophageal junction ChT: chemotherapy, ICI Immune: checkpoint Inhibitors,
TKi: tyrosine kinase inhibitor, RT: radiotherapy

3.2. Prognostic value of Geriatric 8 for FD and 1-year survival

Among the 222 patients included, 210 patients were included in the FD analysis; the remaining twelve patients had died by the time of the 2-month evaluation. 100% of these patients had an altered baseline G8 value. Sixty-three patients (30%) experienced FD. In those patients with altered G8, 39.3% (53) had FD and in those patients with normal G8, only 13.3% (10) had FD after two months of treatment (p < 0.001) (see Fig. 2a). At the time of final data analysis, 222 were available for 1-year mortality analysis and 37.8% (84) had died. An altered G8 at baseline showed a strong prognostic value for survival. After one year of treatment beginning, 48.3% (71) of those with altered G8 had died compared with 17.3% (13) of those with normal G8 (p = 0.001) (see Fig. 2b). Other variables associated with one year mortality were age, line of treatment and stage 4 disease (Table 2). In multivariate analysis, adjusted by age, type of tumor (lung, breast, GI, GU), metastatic disease, line and type of treatment (chemotherapy vs others), G8 maintains its significant association with 1-year mortality (odds ratio [OR] 4.65; IC95% 2.21–9.80; p < 0.001).

Table 2

Univariate analysis of factors associated with functional decline adjusted for age, stage
Variable	OR	CI 95%	P
Altered G8	4.46	2.26–8.79	< 0.001
Age	1.04	1.00-1.09	0.05
Metastatic disease	5.86	3.09–11.13	< 0.001
Line of treatment Adjuvant/Neoadjuvant First line Second or Posterior lines	Ref 5.95 4.52	2.99–11.86 1.97–10.40	< 0.001 < 0.001
Functional decline at 2 months of treatment	4.11	2.20–7.68	< 0.001

2-month FD was also a predictor of 1 year mortality, as 57.1% (36) of the patients that developed FD were dead at 1 year, while only 24.5% (36) were dead if FD was not detected (p < 0.001). Among the patients with normal G8 who did not present FD at two months, 15.4% (10/65) died one year after starting treatment; while patients with normal G8 at baseline and FD at two months, 30% (3/10) had died within a year (p = 0.45).

3.3. Treatment related toxicity and hospitalizations due to adverse effects in patients with survival at 2-month evaluation

Of the 210 patients that were evaluated at two months of treatment, 39.0% (82) presented Grade 3 or 4 toxicity and 12.4% (26) were admitted due to treatment related toxicity. Nevertheless, in this population, altered G8 could not predict these situations. Among patients with altered G8 at baseline, 39.3% (53) presented severe adverse events vs 38.7% (29) in those with normal G8 (p = 0.93). Admission due to toxicity were registered in 13.3% (18) patients with altered G8 and 10.7% (8) with normal G8 (p = 0.57).

Approximately half of cancer cases and a majority of cancer-related deaths afflict individuals aged 65 and older, as reported by previous research [15]. Conventional oncology tools lack the precision necessary to differentiate older patients who are more susceptible to treatment-related complications. The G8 assessment tool represents a pioneering effort tailored explicitly for older cancer patients. In this study, we present prospective findings from a cohort of Spanish-speaking patients aged over 65 with cancer. We reveal that an abnormal G8 score at baseline is associated with an elevated risk of functional decline (FD) two months into treatment and increased mortality after one year.

The aging process is closely associated with an increased burden of comorbidities and a decline in functional capacities, particularly in comparison to younger populations. Consequently, a comprehensive evaluation with a personalized approach to each patient is imperative [16, 17]. The prevalence of older adults varies significantly among regions, with a notable concentration in less developed areas. In Latin America, the availability of healthcare resources varies widely among different regions. Similarly, models of care in geriatric oncology for older patients exhibit heterogeneity and require adaptation to the unique circumstances of each institution [18]. We emphasize the significance of conducting prospective studies using easily applicable tools, irrespective of the clinical practice setting, that possess high diagnostic sensitivity for frailty detection and prognostic value for critical clinical variables such as mortality.

Existing guidelines for the care of older cancer patients consistently recommend the routine use of a Comprehensive Geriatric Assessment (CGA) to identify patients at elevated risk of chemotherapy-related toxicity. Impairments across various domains of CGA are correlated with an increased risk of treatment-related complications, functional decline, reduced quality of life, and poorer survival [19]. However, due to the time-consuming nature of CGA, its feasibility, and its necessity for all patients, it is not consistently adopted among oncologists. A survey conducted by ASCO's Geriatric Oncology Task Force revealed that while 52% of providers were aware of ASCO Guidelines recommendations, most CGA tools were employed less than 50% of the time. Commonly cited barriers included time constraints, lack of support staff, and insufficient training or knowledge concerning geriatric assessment [20].

For this reason, there is growing interest in utilizing concise screening tools to identify individuals with a geriatric profile, with the intent of focusing on frail patients. A two-step screening strategy is generally recommended, starting with a screening tool like the G8 and subsequently conducting a CGA only if the screening score is abnormal [21]. A comprehensive systematic review on the diagnostic accuracy and the association of the G8 with various clinical outcomes revealed that, compared to other frailty screening tools, the G8 exhibited exceptional sensitivity and was one of the most frequently investigated tools [11].

To our knowledge, there are approximately a dozen geriatricians and oncologists in Argentina with any degree of training or interest in geriatric oncology. Despite the evident need for specialized units catering to the care and treatment of elderly cancer patients, there is a notable absence of geriatric oncology units in the country.

Kenis et al. conducted one of the largest studies evaluating the impact of systematic geriatric screening and assessment on older cancer patients in general oncology practice. Their findings indicate that geriatric screening using the G8 enables the identification of approximately 29% of "fit" patients who do not require a CGA prior to treatment decision-making. However, 71% of older cancer patients still necessitate further assessment via CGA, revealing deeper insights into underlying issues in a significant proportion of patients [22]. In our patient cohort, 66.2% exhibited a geriatric high-risk profile based on the G8 assessment. While populations in different studies may not be homogenous, these results align with the prevalence observed in other studies, which often approximates 75% or even exceeds 80% [12, 23]. It is noteworthy that both studies encompassed patients aged 70 and older, mirroring our study's patient population, the first included patients at the initial diagnosis or disease progression/relapse, in line with our study's scope, but the second only patients on first-line treatment.

Functional status plays a pivotal role in the overall quality of life for older patients, with many preferring to forgo treatment rather than endure treatment-related functional or cognitive impairments, even when facing a severe illness like cancer ²³. FD during cancer treatment is a prevalent issue, especially among older patients [24, 25]. Multiple studies have demonstrated its adverse prognostic value in older cancer patients undergoing chemotherapy, with associations observed between FD and inferior clinical outcomes, diminished survival, and decreased quality of life [17]. To facilitate responsible treatment decisions for older cancer patients, the early detection and prevention of FD are paramount. However, a consensus regarding the criteria for defining functional impairment, the choice of measurement instrument (Instrumental Activities of Daily Living, IADL, vs. Activities of Daily Living, ADL), and the monitoring timeframe remains elusive. In our study, we opted to document FD after two months of treatment, employing a threshold of a one-point change in IADL score for early FD detection. Our results correlate with other studies that demonstrated an independent association between an abnormal G8 score and FD during cancer treatment [13, 26, 27].

While variations in follow-up duration and measurement instruments exist, one study showed that FD occurred in approximately one-third of older cancer patients undergoing chemotherapy and had a strong predictive value for survival [28]. In our study, FD, measured by IADL, was identified in approximately 30% of the overall patient population and 39% of those with altered G8 scores at baseline. Additionally, Kenis et al. identified two screening tools, one of which was the G8, with a robust prognostic value for FD (defined as an increase of ≥ 2 points on the ADL scale and as a decrease of ≥ 1 point on the IADL scale) and overall survival [13].

In the original ONCODAGE cohort, an abnormal G8 score was independently associated with one-year survival [10]. A study by Chakiba et al. highlighted the G8 as the sole significant factor linked to FD and early mortality [12]. Our study contributes to solidifying the predictive value of the G8 at the outset of treatment, emphasizing the routine use of the G8 in managing older cancer patients.

To our knowledge, our study represents the first prospective examination in Latin America establishing the prognostic value of the G8 in older cancer patients initiating treatment. While a pilot study in Uruguay involving 32 patients previously explored the use of CGA in guiding treatment decisions and preventing treatment-related toxicities among older cancer patients, it did not directly assess the relationship between G8 scores and functional impairment or mortality ²⁹. Authors from Mexico, Brazil, and other regions have touched upon this topic, yet they did not directly evaluate the association between G8 and functional impairment or mortality [30–33].

Until recently, only three Latin-American countries with representatives from the International Society of Geriatric Oncology (SIOG) were identified: Mexico, Brazil, and Chile. Collaborative efforts have enabled us to better understand our population's characteristics and generate evidence within the region. This initiative has laid the groundwork for the establishment of a specialized treatment area for older cancer patients within healthcare facilities that lack geriatricians. In this model, oncologists initially conduct frailty screening, followed by recommendations for the most suitable treatment, taking into consideration the potential for better outcomes with reduced risks of toxicities.

Decisions pertaining to cancer therapy should always weigh the impact of cancer and its treatment on the patient's quality of life and remaining survival, while also accounting for the factors that place certain older adults at greater risk for complications. As highlighted by Fried et al. regarding treatment preferences among older adults, a significant majority would opt to forego a life-saving therapy if it entailed a substantial risk of functional and cognitive impairment [34]. Advancing our understanding of cancer treatment in older patients equips us to offer optimal care, a challenge that persists to this day. Although our study was non-interventional, the next step involves evaluating whether we can mitigate or treat FD through early interventions when needed. This approach aims not only to identify patients requiring customized treatment but also to address those experiencing FD during treatment, a population at elevated risk for mortality. Emerging evidence suggests that geriatric interventions may potentially reverse this phenomenon and enhance treatment tolerability and feasibility, particularly in older patients receiving systemic cancer therapy. However, substantiating these findings in older cancer patients remains a challenge [35].

It is important to acknowledge certain limitations in our study. While our patient population encompasses individuals from two Spanish-speaking countries, we recognize that these populations may not be entirely comparable. Nevertheless, we underscore the importance of disseminating research conducted in this region. Furthermore, population heterogeneity may arise based on disease setting, tumor type, and treatment regimen. Most of the studies cited in our discussion focused on patients receiving chemotherapy, while our study also included patients treated with modern modalities like tyrosine kinase inhibitors (TKI) and immunotherapy. These treatments are known to have distinct and sometimes less toxic adverse event profiles, albeit in a small subset of patients. It would be worthwhile to evaluate this subgroup and assess the prognostic value of screening tools within this context.

Although G8 was developed as a screening tool, here we demonstrated that an altered baseline score of G8 is a strong independent prognostic factor for FD and survival in patients with cancer ≥ 65 years receiving specific oncologic treatment. This data reinforces the routine use in the management of these patients in every assistance setting. G8 is a simple and fast screening tools and we believe this is highly reproducible in everyday clinical practice and therefore could be implemented in all kinds of models of care.

Conflict of interest:

The authors declare that they have no competing interests.

Fundings:

The authors acknowledge to have no funding.

Author Contribution

Study concept and design: MRS, PMData acquisition: MRS, MJMG, AOQuality control of data and algorithms: PM, MRS, FP, MG, GRData analysis and interpretation: PM, MRDStatistical analysis: PMManuscript preparation: MRSManuscript editing: MRS, PMManuscript review: All authors reviewed the manuscript

Acknowledgements:

The authors would like to thank all the patients, trained nurses at day hospital and treating physicians in both centers.

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Prognostic value of G8 for functional decline and 1-year mortality in older patients with cancer: A multicenter prospective study

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Abstract

Purpose

Methods

Results

Conclusion

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1. INTRODUCTION

2. Materials and methods

2.1. Patient eligibility

2.2. Geriatric assessment and functional status assessment

2.4. Statistical analysis

3. RESULTS

3.1. Patient and clinical characteristics

3.2. Prognostic value of Geriatric 8 for FD and 1-year survival

4. Discussion

5. Conclusions

Declarations

Conflict of interest:

Fundings:

Author Contribution

Acknowledgements:

References

Additional Declarations

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Version 1