Trends and Outcomes of Venous Thromboembolism in Hospitalized Patients With Ovarian Cancer: Results From Nationwide Inpatient Sample Database 2003 to 2011.

OBJECTIVE: Venous thromboembolism (VTE) is a major cause of mortality and morbidity in hospitalized patients with malignancy. Nationwide Inpatient Sample database was analyzed to determine the trends in the rate of hospitalization and mortality from VTE in hospitalized ovarian cancer patients and assess its economic impact and resource utilization. METHOD: We queried the 2003 to 2011 Nationwide Inpatient Sample database from Healthcare Cost and Utilization project (Agency of Healthcare Research and Quality) to identify all adults (age ≥18 years) ovarian cancer. Patients hospitalized with VTE as one of the top 3 discharge diagnoses were also identified. Demographic characteristics and in-hospital outcomes of this population were compared with ovarian cancer patients without VTE. Binary logistic regression analysis was used to obtain adjusted odds ratios (ORs). RESULTS: A total of 34,249 (3.5%) of a total of 981,386 hospitalized ovarian cancer patients had an accompanying diagnosis of VTE. Mean age of the study population was 64 years. After adjusting for potential confounders, compared with those without VTE, ovarian cancer patients with VTE had significantly higher inpatient mortality (6.2% vs 4.3%; OR, 1.12 [confidence interval (CI), 1.06-1.17]; P < .001), longer length of stay (5 vs 4 days; OR, 1.40 [CI, 1.36-1.43]; P < .001), higher average cost of hospitalization (US $26,000 vs US $22,000; OR, 1.10 [CI, 1.07-1.13]; P < .001), and greater disability at discharge (OR, 1.34 [CI, 1.31-1.38]; P < .001). Although the annual number of VTE admissions in ovarian cancer patients increased, in-hospital mortality declined from 10.9% in 2003 to 5.3% in 2011. CONCLUSIONS: Venous thromboembolism in hospitalized patients with ovarian cancer is associated with higher inpatient mortality, length of stay, higher cost of hospitalization, and disability at discharge. The hospitalization rate has increased, but the inpatient mortality rate has declined over study period.

Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

PURPOSE: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. METHODS: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. RESULTS: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. CONCLUSION: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

Controversies in antiepidermal growth factor receptor therapy in metastatic colorectal cancer.

The randomized first-line trials, including the CRYSTAL trial, the OPUS trial, and the PRIME trial, have demonstrated the significant efficacy of cetuximab or panitumumab in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type tumors. The addition of an antiepidermal growth factor receptor (anti-EGFR)-directed monoclonal antibody to chemotherapy for these patients significantly improved progression-free survival, response rates, and R0 resection rates to a greater extent than overall survival compared with patients who received chemotherapy alone. However, 2 recent randomized phase 3 trials, the MRC COIN trial and the Nordic VII trial, reported an unexpected lack of benefit from the addition of cetuximab to chemotherapy in the first-line setting. In addition, recent retrospective analyses performed on a pooled data set from major clinical trials added more complexity, reporting an unexpected association of KRAS G13D mutation with a better clinical outcome compared with patients who had other KRAS mutations in the first-line and salvage settings, whereas the other independent analysis failed to demonstrate a benefit from panitumumab in patients with the same KRAS G13D mutation. The anti-EGFR monoclonal antibody-associated skin toxicity and the controversial strategies of management also are discussed. In this review, the authors analyze the previous randomized clinical trials and more critically re-evaluate recent trials and subgroup analyses to derive 3 factors that need to be taken into consideration regarding the addition of EGFR-directed monoclonal antibodies to chemotherapy: the preclinical data on mechanisms of action between chemotherapy and anti-EGFR antibodies along with mechanisms of resistance to anti-EGFR antibodies, the role of cross-over events in overall survival data, and the significant dose reductions of chemotherapeutic agents when combined with anti-EGFR agents.

The effect of diabetes on oxaliplatin-induced peripheral neuropathy.

INTRODUCTION: Chemotherapy-induced neurotoxicity is a significant source of morbidity for cancer patients. This study aimed to assess the relationship between preexisting diabetes and clinically significant (National Cancer Institute Common Toxicity Criteria grades 2 and 3) OXIPN; between diabetes, and the cumulative dose at onset of OXIPN; and between other preexisting medical conditions and the development of OXIPN. MATERIALS AND METHODS: We reviewed medical records of all patients with stage II-IV colon cancer treated in the Albert Einstein Cancer Center, Philadelphia, with oxaliplatin from 2005 to 2009. Exclusion criteria included preexisting neuropathy, previous neurotoxic chemotherapy exposure, and incomplete medical records. The NCI Common Toxicity Criteria was used to grade sensory neuropathy. Univariate analysis was used to estimate odds ratios and confidence limits for prevalence of OXIPN in patients with and without diabetes. The mean level and cumulative doses were compared using the t test. RESULTS: Sixty-two patients met the study criteria; 23 oxaliplatin-treated patients were excluded. The crude incidence of any OXIPN was 65%. There was no relationship found between development of OXIPN and the presence of diabetes, smoking, hypertension, or statin use. However, the mean cumulative dose of oxaliplatin was significantly lower for patients with diabetes who developed neuropathy, compared with those without diabetes (388 vs. 610 mg/m(2); P = .021). CONCLUSION: Although the presence of diabetes did not appear to affect the severity of OXIPN, patients with diabetes developed OXIPN at a lower cumulative dose of oxaliplatin (P < .05). The results may have implications for treatment of patients with diabetes and colon cancer.

Quality of life and symptom attribution in long-term colon cancer survivors.

AIMS AND OBJECTIVES: This study investigates how long-term colon cancer survivors evaluate their health, functional status and quality of life, and whether there are differences based on age, gender or ethnicity. METHODS: Thirty long-term survivors of at least stage I colon cancer were interviewed in person between December 2004 and May 2005. The interview protocol included the Medical Outcomes Study 36-Item Short Form, Quality of Life--Cancer Survivor, and study-specific questions that asked about physical and non-physical problems they attributed to colon cancer. RESULTS: Substantial percentages of survivors attributed their problems with lack of energy (83%), sexual functioning (67%), bowel problems (63%), poor body image (47%) and emotional problems (40%) to having had colon cancer. Of those problems attributed to colon cancer, sexual functioning and pain were given the highest severity rankings by survivors. The majority of long-term colon cancer survivors reported distress regarding future diagnostic tests, a second cancer, and spread of cancer. Women reported greater problems completing daily activities as a result of physical problems (P = 0.003) and more pain (P = 0.07) than men. African Americans appear to report marginally better overall quality of life (P = 0.07) and psychological well-being than whites (P = 0.07). CONCLUSION: The majority of long-term colon cancer survivors with resected colon cancer and disease-free for 5 years reported problems with low energy, sexual functioning and bowel problems.

Life-sustaining treatments in patients who died of chronic congestive heart failure compared with metastatic cancer.

INTRODUCTION: Life-sustaining treatments such as cardiopulmonary resuscitation, mechanical ventilation, vasopressors, and admission to critical care units, if used when recovery chance was remote, may unnecessarily cause discomfort and increase cost of care. Outcomes of these treatments in chronic, refractory congestive heart failure (CHF) and metastatic cancer patients were poor. Although both conditions were the leading causes of death, previous studies indicated that hospice utilization and do-not-resuscitate orders were less common in CHF patients. To date, the use of life-sustaining treatments in these patients and the influence of do-not-resuscitate orders remains unknown. METHOD: We conducted a retrospective medical record review of the patients who died in our hospital in 1999 and had discharge diagnoses of CHF or cancer. Medical records were screened for seriously ill patients according to the modified SUPPORT criteria, which included patients with CHF functional class IV or ejection fraction of 20% or less at baseline and with metastatic cancer not receiving any curative treatments. Analyses were performed using SPSS, version 9.0. RESULTS: There were 58 and 82 patients in CHF and cancer groups, respectively. CHF patients were older (78.8 vs. 67.3 yrs, p < .001) and stayed in the hospital longer (11.9 vs. 7.9 days, p = .014). The majority of patients in both groups received do-not-resuscitate orders before death (84% and 72%, respectively). CHF patients received do-not-resuscitate orders later than did cancer patients (6.7 vs. 2.8 days, p = .006). However, there was no significant difference in prevalence of do-not-resuscitate orders. All studied life-sustaining treatments were more common in CHF patients than in cancer patients. A subgroup analysis between CHF patients with do-not-resuscitate orders and those without do-not-resuscitate orders revealed cardiopulmonary resuscitation to be the only treatment less common in those with do-not-resuscitate orders. CONCLUSIONS: Patients who died of chronic, refractory CHF received more life-sustaining treatments than did patients who died of metastatic cancer.