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1.  Polypharmacy and Potentially Inappropriate Medication Use among Older Adults with Cancer Undergoing Chemotherapy: Impact on Chemotherapy-Related Toxicity and Hospitalization During Treatment 
Polypharmacy and potentially inappropriate medication (PIM) use are understudied among older adults with cancer undergoing chemotherapy. The current study’s aims were to evaluate in this population: 1) the prevalence of polypharmacy and PIM use; and 2) the association between these and chemotherapy-related adverse events.
This was a secondary analysis of prospectively collected data of adults age ≥65 years with cancer undergoing chemotherapy. Measures included: the number of daily medications (i.e, polypharmacy); PIM use based on 3 indices [Beers, Zhan, and Drugs to Avoid in the Elderly (DAE) criteria], as well as use of 6 “high-risk” medication classes for adverse drug events (i.e., anticoagulants, antiplatelet agents, opioids, insulin, oral hypoglycemics and antiarrhythmics). Using multivariate logistic regression, the relations were evaluated between these criteria and 1) Grade 3-5 chemotherapy-related toxicity; and 2) hospitalization during chemotherapy.
The patients (N=500; mean age, 73 years, 61% Stage IV disease) took a mean of 5 daily medications (±4; range, 0-23). PIM use among patients was common (up to 29% using Beers criteria). No association was found between the number of daily medications and either toxicity (0-3 medications as reference: 4-9, OR=1.34, 95% CI: 0.92-1.97; ≥10, OR=0.82, 95% CI: 0.45-1.49), or hospitalization (0-3 medications as reference, ≥4, OR=1.34, 95%CI: 0.82-2.18, p=0.24). There was also no association between PIM use and toxicity (p=0.93) or hospitalization (p=0.98). No medication class was associated with either outcome.
Polypharmacy and PIM use were common but werenot associated with chemotherapy-related toxicity or hospitalization in older adults with cancer.
PMCID: PMC4134360  PMID: 25041361
Polypharmacy; Cancer; Elderly; Chemotherapy; Toxicity
2.  Phase 1 Study of VEGF Trap (Aflibercept) Administered Subcutaneously to Patients with Advanced Solid Tumors 
To determine the maximum tolerated dose (MTD) or maximal administered dose (MAD) and pharmacokinetic and safety profiles of subcutaneously administered VEGF Trap (aflibercept), a novel anti-angiogenic agent.
Experimental Design
In this open-label, dose-escalation study, patients with advanced solid tumors were treated with subcutaneous doses of aflibercept at seven dose levels. Patients received a single dose of aflibercept and then underwent safety and pharmacokinetic assessments over the next 4 weeks. Patients then received weekly or bi-weekly treatment over the subsequent 6 weeks. Patients tolerating and benefiting could continue on aflibercept at the same dose and schedule until progression of disease.
Thirty-eight patients received at least one dose of aflibercept. MTD was not reached. Due to solubility/dosing limits with the subcutaneous formulation, 1600mcg/kg/week was the MAD. The most common toxicities were proteinuria (37%), fatigue (32%), injection site reactions (18%), nausea (17%), myalgia and anorexia (16% each), hypertension (13%), and voice hoarseness (11%). Drug-related grade 3–4 toxicity was uncommon (7%) and reversible: dehydration, cerebral ischemia, proteinuria, hypertension, leukopenia, and pulmonary embolism. We identified dose-proportional increases in plasma concentrations of aflibercept bound to VEGF with a t1/2 of 18 days. No anti-aflibercept antibodies were detected. Stable disease was maintained for at least 10 weeks in 18 patients (47%), and 2 patients maintained on study for more than 1 year.
Subcutaneous aflibercept was well-tolerated and had manageable side effects. Its favorable pharmacokinetic profile and potential antitumor activity warrants further evaluation.
PMCID: PMC4211604  PMID: 20028764
angiogenesis; aflibercept; phase 1; VEGF inhibitors; cancer
3.  CA125 Level Association with Chemotherapy Toxicity and Functional Status in Older Women with Ovarian Cancer 
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.
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.
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.
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.
PMCID: PMC3772622  PMID: 23765208
CA125; older women; ovarian cancer; chemotherapy toxicity; functional status
4.  Impact of Prophylactic Conversion to an Extended Infusion Schedule to Prevent Hypersensitivity Reactions in Ovarian Cancer Patients during Carboplatin Retreatment 
Gynecologic oncology  2009;116(3):326-331.
Repeated exposure to carboplatin can lead to hypersensitivity reactions during retreatment with carboplatin. This may prevent its further use in platinum-sensitive ovarian cancer patients. At our institution, an increasing proportion of patients are prophylactically converted to an extended schedule of infusion after 8 cycles of carboplatin. We sought to determine whether an incrementally increasing, extended 3-hour infusion of carboplatin was associated with a lower rate of hypersensitivity reactions compared to the standard 30-minute schedule in sequentially treated patients.
We performed a retrospective electronic medical record review of patients with recurrent ovarian cancer retreated with carboplatin at our institution from 01/98–12/08.
Seven hundred seventy-seven patients with relapsed ovarian, fallopian tube, or primary peritoneal cancer were retreated with carboplatin and met study inclusion criteria. Of these, 117 (17%) developed hypersensitivity reactions during second-line or greater carboplatin-based treatment for recurrent disease. Only 6 (3.4%) of the 174 patients who received the extended schedule developed hypersensitivity reactions (0% grade 4; 1.7% grade 3) compared to 111 (21%) of 533 patients in the standard schedule group (12% grade 4; 77% grade 3). The first hypersensitivity episode occurred after a median of 16 platinum (carboplatin and cisplatin) treatments in the extended group compared to 9 in the standard group. Using the Fisher-exact test, there was an association with a reduced incidence of hypersensitivity reactions with the extended infusion schedule (P<0.001).
Our data suggest appropriate premedication and prophylactic conversion to an extended infusion during carboplatin retreatment may reduce hypersensitivity reactions.
PMCID: PMC4369374  PMID: 19944454
Carboplatin; anaphylaxis; hypersensitivity reaction; ovarian cancer; peritoneal cancer; adverse drug reactions
5.  Phase II Study of Intraperitoneal Paclitaxel Plus Cisplatin and Intravenous Paclitaxel Plus Bevacizumab As Adjuvant Treatment of Optimal Stage II/III Epithelial Ovarian Cancer 
Journal of Clinical Oncology  2011;29(35):4662-4668.
Intraperitoneal (IP) cisplatin and intravenous (IV) or IP paclitaxel constitute a standard therapy for optimally debulked ovarian cancer. Bevacizumab prolongs progression-free survival (PFS) when included in first-line IV chemotherapy. In this study, the safety and feasibility of adding bevacizumab to a first-line IP regimen were assessed.
Patients and Methods
Treatment was as follows: paclitaxel 135 mg/m2 IV over 3 hours day 1, cisplatin 75 mg/m2 IP day 2, and paclitaxel 60 mg/m2 IP day 8. Bevacizumab 15 mg/kg IV was given after paclitaxel on day 1 beginning in cycle 2. After six cycles of chemotherapy, bevacizumab was given every 3 weeks for 17 additional treatments. The primary end point was safety and tolerability determined by whether 60% of patients completed six cycles of IV/IP chemotherapy.
Of 41 treated patients, 30 (73%) received six cycles of IV/IP chemotherapy and 35 (85%) received at least four cycles. Three (27%) of those who discontinued chemotherapy did so because of complications related to bevacizumab (hypertension, n = 2; perforation, n = 1). Grades 3 to 4 toxicities included neutropenia (34%), vasovagal syncope (10%), hypertension (7%), nausea/vomiting (7%), hypomagnesemia (7%), and abdominal pain (7%). There were three grade 3 small bowel obstructions (7%) during cycles 3, 9, and 15. One patient died following rectosigmoid anastomotic dehiscence during cycle 4. Estimated median PFS is 28.6 months (95% CI, 19.1 to 38.9 months). Three patients (7%) had IP port malfunction.
The addition of bevacizumab to this IP regimen is feasible; however, bevacizumab may increase the risk of bowel obstruction/perforation. The observed median PFS is similar to that seen with IP/IV chemotherapy alone.
PMCID: PMC3667619  PMID: 22067389
6.  Predicting Chemotherapy Toxicity in Older Adults With Cancer: A Prospective Multicenter Study 
Journal of Clinical Oncology  2011;29(25):3457-3465.
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.
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).
A risk stratification schema can establish the risk of chemotherapy toxicity in older adults. Geriatric assessment variables independently predicted the risk of toxicity.
PMCID: PMC3624700  PMID: 21810685
7.  Treatment Patterns of FIGO Stage IB2 Cervical Cancer: A Single-Institution Experience of Radical Hysterectomy with Individualized Postoperative Therapy and Definitive Radiation Therapy 
Gynecologic oncology  2008;111(2):265-270.
The treatment of FIGO stage IB2 cervical cancer is controversial. Our aim was to assess treatment patterns, outcomes, and complications in patients with stage IB2 cervical cancer.
A retrospective study of patients with stage IB2 cervical carcinoma at a single institution between January 1982 and September 2006 was performed. To adequately control treatment variables, we only included patients who underwent their entire treatment at our institution. Toxicity was assessed using NCI Common Toxicity Criteria (CTC).
We identified 82 patients, of whom 47 met the strict inclusion criteria. Of these, 27 patients (57%) underwent primary radical hysterectomy (RH) and 20 (43%) were treated with definitive radiation/chemoradiation therapy (RT/CRT). Patients selected for RT/CRT had a higher American Society of Anesthesiologist (ASA) score than those selected for surgery (P=0.037). The 3-year progression free survival rate was 52% for the RH group and 55% for the RT/CRT group (P=0.977). The 3-year overall survival rates were 72% and 55%, respectively (P=0.161). Overall, 52% of patients in the RH group received postoperative radiation therapy as part of their adjuvant treatment. CTC grade 3, 4, and 5 complications affected 5 patients (19%) in the RH group and 3 (15%) in the RT/CRT group.
Both RH and definitive RT/CRT are adequate management strategies for patients with FIGO stage IB2 cervical cancer. However, there was a subset of patients in whom RH as monotherapy was appropriate. Further studies are needed to evaluate the role of new preoperative models that will accurately identify these patients.
PMCID: PMC3932675  PMID: 18774596
FIGO stage IB2 cervical carcinoma; radical hysterectomy; chemoradiation therapy
8.  The translational imperative: Making cell therapy simple and effective ☆ 
Acta biomaterialia  2012;8(12):4200-4207.
The current practice of cell therapy, in which multipotent or terminally differentiated cells are injected into tissues or intravenously, is inefficient. Few therapeutic cells are retained at the site of administration and engraftment is low. An injectable and biologically appropriate vehicle for delivery, retention, growth and differentiation of therapeutic cells is needed to improve the efficacy of cell therapy. We focus on a hyaluronan-based semi-synthetic extracellular matrix (sECM), HyStem®, which is a manufacturable, approvable and affordable clinical product. The composition of this sECM can be customized for use with mesenchymal stem cells as well as cells derived from embryonic or induced pluripotent sources. In addition, it can support therapeutic uses of progenitor and mature cell populations obtained from skin, fat, liver, heart, muscle, bone, cartilage, nerves and other tissues. This overview presents four pre-clinical uses of HyStem® for cell therapy to repair injured vocal folds, improve post-myocardial infarct heart function, regenerate damaged liver tissue and restore brain function following ischemic stroke. Finally, we address the real-world limitations – manufacture, regulation, market acceptance and financing – surrounding cell therapy and the development of clinical combination products.
PMCID: PMC3488131  PMID: 22776825
HyStem®; Cell therapy; ECM; Hyaluronic acid; Cell engraftment
9.  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
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.
PMCID: PMC3500367  PMID: 22915061
Ovarian cancer; Elderly; Geriatrics; Chemotherapy
10.  Use of Complementary Medications among Older Adults with Cancer 
Cancer  2012;118(19):4815-4823.
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.
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.
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).
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.
PMCID: PMC3366170  PMID: 22359348
Herbals; Complementary Medicine; Older Adults; Cancer; Chemotherapy
11.  Senior Adult Oncology 
PMCID: PMC3656650  PMID: 22308515
NCCN Clinical Practice Guidelines; NCCN Guidelines; senior adult; elderly; advanced age; older patient; comprehensive geriatric assessment; cancer treatment
12.  Implementing a Geriatric Assessment in Cooperative Group Clinical Cancer Trials: CALGB 360401 
Journal of Clinical Oncology  2011;29(10):1290-1296.
Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting.
Patients and Methods
Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured.
Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion.
This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.
PMCID: PMC3083997  PMID: 21357782
13.  Phase I trial of weekly cisplatin, irinotecan and paclitaxel in patients with advanced gastrointestinal cancer 
Investigational new drugs  2008;27(4):366-373.
To determine the maximum tolerated dose (MTD), toxicities, and suitable dose for weekly 1-h paclitaxel combined with weekly cisplatin and irinotecan to treat advanced gastrointestinal malignancies.
Thirty patients with metastatic or locally advanced (unresectable or recurrent) gastrointestinal solid tumors were enrolled on this single-center, phase I study. Patients were treated with paclitaxel given over 1h at 1 of 4 dose levels (40, 50, 65, or 80 mg/m2). Paclitaxel was followed by fixed doses of cisplatin (30 mg/m2) and irinotecan (50 mg/m2). All treatment was administered sequentially, once a week, in 6-week cycles (4 weeks on, 2 weeks off). Dose-limiting toxicity (DLT) was defined as a 2-week delay in treatment for grade 3 or 4 non-hematologic toxicity, neutropenic fever, a 1-week delay for grade 4 hematologic toxicity, or a 2-week delay for grade 3 hematologic toxicity.
Thirty patients were recruited; 28 patients were assessable for safety. Most of the patients (70%) had no prior chemotherapy. The primary first-cycle DLTs were neutropenia, diarrhea, and nausea. Paclitaxel at 65 mg/m2 was defined as the MTD. The most common grade 3–4 toxicities observed during all cycles were neutropenia (57%), febrile neutropenia (11%), diarrhea (29%), fatigue (29%), and nausea (18%). No patients had G-CSF (Neupogen, Amgen Inc., Thousand Oaks, CA) support. Responses were observed in gastric, esophageal, and pancreatic cancers.
Paclitaxel at 65 mg/m2, cisplatin (30 mg/m2), and irinotecan (50 mg/m2) given weekly can be safely administered to patients with solid tumor malignancies. To improve cumulative toxicities, a schedule modification was required (3-week cycle; 2-on, 1-off) Neutropenia was the most common DLT. This combination showed substantial activity, particularly in patients with gastric and esophageal adenocarcinoma, and phase II evaluation could be considered.
PMCID: PMC3219507  PMID: 18956138
Cisplatin; Irinotecan; Paclitaxel; Phase I; Gastrointestinal cancer
14.  A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced solid tumors 
Investigational New Drugs  2011;30(5):1958-1961.
Targeting angiogenesis is a valid anti-cancer strategy. Aflibercept is designed to sequester circulating vascular endothelial growth factor (VEGF) by preventing VEGF from binding to its receptors. This phase I study was to evaluate a new formulation of subcutaneously administered aflibercept in patients with advanced solid tumors. Here we report our experience with the toxicity, pharmacokinetic profile and efficacy of the new 100 mg/mL subcutaneous (SC) formulation of aflibercept administered at a dose of at 4 mg/kg every 2 weeks.
PMCID: PMC3432791  PMID: 22002018
Phase I study; Aflibercept; Angiogenesis inhibitor; Subcutaneously administration
15.  Phase I Study of Intravenous Vascular Endothelial Growth Factor Trap, Aflibercept, in Patients With Advanced Solid Tumors 
Journal of Clinical Oncology  2009;28(2):207-214.
Vascular endothelial growth factor (VEGF) Trap (aflibercept) is an angiogenesis inhibitor comprising portions of the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of human immunoglobulin G. This phase I study was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VEGF Trap administered intravenously (IV) every 2 weeks.
Patients and Methods
Patients with refractory solid tumors or non-Hodgkin's lymphoma with adequate organ function were eligible. Pharmacokinetic/pharmacodynamic markers included measurement of plasma VEGF bound to VEGF Trap and free VEGF Trap. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) was incorporated to measure the biologic effects of the drug on tumor vascularity and permeability.
The study enrolled 47 patients at doses ranging from 0.3 to 7.0 mg/kg IV every 2 weeks. Dose-limiting toxicities were rectal ulceration and proteinuria at the 7.0 mg/kg dose. Other mechanism-specific toxicities included hypertension. On the basis of these observations and on pharmacokinetics, the recommended phase II dose of VEGF Trap as a single agent is 4 mg/kg every 2 weeks. Three RECIST (Response Evaluation Criteria in Solid Tumors) –defined partial responses were observed, one at the 3.0 mg/kg and two at the 7.0 mg/kg dose level. Maximum plasma concentration of free VEGF Trap increased proportionally with dose. Maximal VEGF-bound VEGF Trap complex levels were reached at doses ≥ 2.0 mg/kg. Changes in volume transfer constant measured by DCE-MRI at baseline and at 24 hours after administration indicate a possible dose-related change in this pharmacodynamic marker.
IV VEGF Trap was well tolerated at the dose levels tested. Pharmacodynamic and pharmacokinetic markers were indicative of VEGF blockade.
PMCID: PMC2815710  PMID: 19949018
16.  Distress in Older Patients With Cancer 
Journal of Clinical Oncology  2009;27(26):4346-4351.
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.
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.
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.
PMCID: PMC2799049  PMID: 19652074

Results 1-16 (16)