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1.  CA125 Level Association with Chemotherapy Toxicity and Functional Status in Older Women with Ovarian Cancer 
Objective
Older women with ovarian cancer have increased cancer-related mortality and chemotherapy toxicity. CA125 is a sensitive biomarker for tumor burden. The study evaluates the association between CA125, geriatric assessment (GA), and treatment toxicity.
Methods
This is a secondary subset analysis of patients age ≥65 with ovarian cancer accrued to a multicenter prospective study that developed a predictive toxicity score for older adults with cancer. Clinical and geriatric covariates included sociodemographics, GA (comorbidity, social support, functional, nutritional, psychological, cognitive status), treatment, and labs. Utilizing bivariate analyses, we determined the association of abnormal CA125 (≥35 U/mL) with baseline GA, grade 3–5 toxicity (CTCAE v.3), dose adjustments, and hospitalization. Logistic regression analysis was used to check for potential confounder for association between CA125 and chemotherapy toxicity.
Results
Fifty-one (10%) of 500 patients accrued to the primary study had a diagnosis of ovarian (92%), peritoneal (4%), or fallopian tube (4%) cancer. Median age was 72 (range, 65–86). Forty-six patients (90%) had stage III–IV disease. Twenty-three patients (45%) received first-line chemotherapy, and 34 (67%) received platinum-doublet therapy. Thirty-six (71%) had an abnormal CA125. Grade 3–5 toxicity occurred in 19 patients (37%). Abnormal CA125 was associated with assistance with instrumental activities of daily living (IADL) (p<0.05), lower performance status (p=0.05), grade 3–5 toxicity (p=0.03), non-heme toxicity (p=0.04), and dose reductions (p=0.01). No association between CA125 level and total toxicity score was observed.
Conclusions
Among older women with ovarian cancer, abnormal CA125 was associated with poor pre-treatment functional status and an increased probability of chemotherapy toxicity and dose reduction.
doi:10.1097/IGC.0b013e318299438a
PMCID: PMC3772622  PMID: 23765208
CA125; older women; ovarian cancer; chemotherapy toxicity; functional status
2.  A Novel Approach to Improve Health Status Measurement in Observational Claims-based Studies of Cancer Treatment and Outcomes 
Journal of geriatric oncology  2013;4(2):157-165.
Objectives
To develop and provide initial validation for a multivariate, claims-based prediction model for disability status (DS), a proxy measure of performance status (PS), among older adults. The model was designed to augment information on health status at the point of cancer diagnosis in studies using insurance claims to examine cancer treatment and outcomes.
Materials and Methods
We used data from the 2001–2005 Medicare Current Beneficiary Survey (MCBS), with observations randomly split into estimation and validation subsamples. We developed an algorithm linking self-reported functional status measures to a DS scale, a proxy for the Eastern Cooperative Oncology Group (ECOG) PS scale. The DS measure was dichotomized to focus on good [ECOG 0–2] versus poor [ECOG 3–4] PS. We identified potential claims-based predictors, and estimated multivariate logistic regression models, with poor DS as the dependent measure, using a stepwise approach to select the optimal model. Construct validity was tested by determining whether the predicted DS measure generated by the model was a significant predictor of survival within a validation sample from the MCBS.
Results and Conclusion
One-tenth of beneficiaries met the definition for poor DS. The base model yielded high sensitivity (0.79) and specificity (0.92); positive predictive value=48.3% and negative predictive value=97.8%, c-statistic=0.92 and good model calibration. Adjusted poor claims-based DS was associated with an increased hazard of death (HR=3.53, 95% CI 3.18, 3.92). The ability to assess DS should improve covariate control and reduce indication bias in observational studies of cancer treatment and outcomes based on insurance claims.
doi:10.1016/j.jgo.2012.12.005
PMCID: PMC3685201  PMID: 23795223
Medicare; cancer; health status; observational study; treatment selection bias; functional status
3.  Doublet Chemotherapy in the Elderly Patient With Ovarian Cancer 
The Oncologist  2012;17(11):1450-1460.
This study examines treatment options for older patients with ovarian cancer. Older patients with ovarian cancer have been underrepresented in clinical trials, so the evidence base on which physicians make decisions is lacking. Clinicians need to be aware of the currently available data to aid in treatment decisions.
Learning Objectives
After completing this course, the reader will be able to: Summarize trends in the treatment of older women with ovarian cancer.Describe the potential value of performing a geriatric assessment prior to treatment in older women with ovarian cancer.
This article is available for continuing medical education credit at CME.TheOncologist.com
The aging of the population has focused on the need to evaluate older patients with cancer. Approximately 50% of patients with ovarian cancer will be older than age 65 years. Increasing age has been associated with decreased survival. It is uncertain whether this relates to biologic factors, treatment factors, or both. There is concern that undertreatment may be associated with decreased survival. Older patients with ovarian cancer have been underrepresented in clinical trials. Therefore, the evidence base on which make decisions is lacking. Clinicians need to be aware of the currently available data to aid in treatment decisions. Doublet therapy is the most common standard treatment in epithelial ovarian cancer. It usually consists of a taxane and a platinum compound. A series of cooperative group studies in both the United States and Europe established intravenous paclitaxel and carboplatin as the most common standard in optimally debulked patients. The recent introduction of intraperitoneal therapy has complicated decision making in terms of which older patients would benefit from this more toxic therapy. In relapsed patients, the issue of platinum sensitivity is critical in deciding whether to reutilize platinum compounds. It is unclear whether single agents or combinations are superior, particularly in older patients. Geriatric assessment is an important component of decision making. Prospective studies are needed to develop strategies to determine the optimal treatment for older patients with ovarian cancer.
doi:10.1634/theoncologist.2012-0155
PMCID: PMC3500367  PMID: 22915061
Ovarian cancer; Elderly; Geriatrics; Chemotherapy
4.  Toxicity of Bevacizumab in Combination with Chemotherapy in Older Patients 
The Oncologist  2013;18(4):408-414.
Heart disease is more common in those who do not receive bevacizumab. Older patients who receive bevacizumab with chemotherapy have higher odds of developing a grade 3–5 toxicity compared with those who receive chemotherapy alone.
Learning Objectives
Compare characteristics of older patients that receive bevacizumab plus chemotherapy to those treated with chemotherapy alone for advanced NSCLC and CRC.Compare outcomes between older patients treated with bevacizumab plus chemotherapy to chemotherapy alone for advanced NSCLC and CRC.Describe toxicities in older patients treated with bevacizumab plus chemotherapy for advanced NSCLC and CRC.
Background.
Bevacizumab leads to improved survival for patients with metastatic colorectal cancer (CRC) or non-small cell lung cancer (NSCLC) when added to chemotherapy. Little is known about factors associated with receipt of bevacizumab, or whether bevacizamab is associated with increased toxicity when added to chemotherapy.
Patients and Methods.
We conducted a prospective study of patients aged ≥65 years, which evaluated the association between geriatric assessment (GA) metrics and chemotherapy toxicity. We examined differences in characteristics and outcomes of patients with CRC and NSCLC cancers who received bevacizumab with chemotherapy versus chemotherapy alone.
Results.
From a total of 207 patients, 27 (13%) received bevacizumab plus chemotherapy and 180 (87%) received chemotherapy alone. Groups were similar in sociodemographic and cancer characteristics. There were no baseline differences in GA domains except that patients with heart disease were less likely to receive bevacizumab (4% vs. 26%, p = .01). Seventy-eight percent of patients who had bevacizumab had grade 3–5 toxicity compared to only 57% who received chemotherapy alone (p = .06). Patients receiving bevacizumab were more likely to develop grade 3 hypertension than those who received chemotherapy alone (15% vs. 2%, p < .01). In multivariable analysis, factors associated with grade 3 or more toxicity included: bevacizumab (OR: 2.86, p = .04), CRC (OR: 2.54, p < .01), and baseline anemia (OR: 2.58, p = .03).
Conclusion.
Heart disease was more common in those who did not receive bevacizumab. Older patients who receive bevacizumab with chemotherapy have a higher odds of developing a grade 3–5 toxicity compared with those who receive chemotherapy alone.
doi:10.1634/theoncologist.2012-0351
PMCID: PMC3639527  PMID: 23576485
Chemotherapy; Geriatric assessment; Bevacizumab; Drug toxicity; Health services for the aged
5.  Use of Complementary Medications among Older Adults with Cancer 
Cancer  2012;118(19):4815-4823.
BACKGROUND
Little is known about complementary medication use among older adults with cancer, particularly those undergoing chemotherapy. The purpose of this study was to evaluate the prevalence of complementary medication use and to identify factors associated with its use among older adults with cancer.
METHODS
The prevalence of complementary medication use (defined as herbal agents, minerals, or other dietary supplements excluding vitamins) was evaluated in a cohort of adults aged ≥65 years who were about to start chemotherapy for their cancer. The association between complementary medication use and patient characteristics (sociodemographics; comorbidity; functional, nutritional, psychological, and cognitive status); medication use (number of medications and concurrent vitamin use); and cancer characteristics (type and stage) was analyzed.
RESULTS
The cohort included 545 patients [mean age 73 years (range 65–91); 52% female] with cancer (61% Stage IV). Seventeen percent (N=93) of these patients reported using ≥1 complementary medications [mean number of complementary medications among users was 2 (range 1–10)]. Complementary medication use was associated with: 1) earlier cancer stage, with 29% of those with stages I–II vs. 17% with III–IV (OR=2.05, 95% CI:1.21–3.49); and 2) less impairment with instrumental activities of daily living (OR=1.39, 95% CI:1.12–1.73).
CONCLUSIONS
Complementary medication use was reported by 17% of older adults with cancer and was more common among those with less advanced disease (receiving adjuvant potentially curative treatment) and higher functional status. Further studies are needed to determine the association between complementary medication use and cancer outcomes among older adults.
doi:10.1002/cncr.27427
PMCID: PMC3366170  PMID: 22359348
Herbals; Complementary Medicine; Older Adults; Cancer; Chemotherapy
6.  Predicting Chemotherapy Toxicity in Older Adults With Cancer: A Prospective Multicenter Study 
Journal of Clinical Oncology  2011;29(25):3457-3465.
Purpose
Older adults are vulnerable to chemotherapy toxicity; however, there are limited data to identify those at risk. The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity.
Patients and Methods
Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics, tumor/treatment variables, laboratory test results, and geriatric assessment variables (function, comorbidity, cognition, psychological state, social activity/support, and nutritional status). Patients were followed through the chemotherapy course to capture grade 3 (severe), grade 4 (life-threatening or disabling), and grade 5 (death) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Results
In total, 500 patients with a mean age of 73 years (range, 65 to 91 years) with stage I to IV lung (29%), GI (27%), gynecologic (17%), breast (11%), genitourinary (10%), or other (6%) cancer joined this prospective study. Grade 3 to 5 toxicity occurred in 53% of the patients (39% grade 3, 12% grade 4, 2% grade 5). A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables, laboratory test values, and patient, tumor, and treatment characteristics. A scoring system in which the median risk score was 7 (range, 0 to 19) and risk stratification schema (risk score: percent incidence of grade 3 to 5 toxicity) identified older adults at low (0 to 5 points; 30%), intermediate (6 to 9 points; 52%), or high risk (10 to 19 points; 83%) of chemotherapy toxicity (P < .001).
Conclusion
A risk stratification schema can establish the risk of chemotherapy toxicity in older adults. Geriatric assessment variables independently predicted the risk of toxicity.
doi:10.1200/JCO.2011.34.7625
PMCID: PMC3624700  PMID: 21810685
7.  Distress in Older Patients With Cancer 
Journal of Clinical Oncology  2009;27(26):4346-4351.
Purpose
To determine the predictors of distress in older patients with cancer.
Patients and Methods
Patients age ≥ 65 years with a solid tumor or lymphoma completed a questionnaire that addressed these geriatric assessment domains: functional status, comorbidity, psychological state, nutritional status, and social support. Patients self-rated their level of distress on a scale of zero to 10 using a validated screening tool called the Distress Thermometer. The relationship between distress and geriatric assessment scores was examined.
Results
The geriatric assessment questionnaire was completed by 245 patients (mean age, 76 years; standard deviation [SD], 7 years; range, 65 to 95 years) with cancer (36% stage IV; 71% female). Of these, 87% also completed the Distress Thermometer, with 41% (n = 87) reporting a distress score of ≥ 4 on a scale of zero to 10 (mean score, 3; SD, 3; range, zero to 10). Bivariate analyses demonstrated an association between higher distress (≥ 4) and poorer physical function, increased comorbid medical conditions, poor eyesight, inability to complete the questionnaire alone, and requiring more time to complete the questionnaire. In a multivariate regression model based on the significant bivariate findings, poorer physical function (increased need for assistance with instrumental activities of daily living [P = .015] and lower physical function score on the Medical Outcomes Survey [P = .018]) correlated significantly with a higher distress score.
Conclusion
Significant distress was identified in 41% of older patients with cancer. Poorer physical function was the best predictor of distress. Further studies are needed to determine whether interventions that improve or assist with physical functioning can help to decrease distress in older adults with cancer.
doi:10.1200/JCO.2008.19.9463
PMCID: PMC2799049  PMID: 19652074

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