Incidence, cost, and outcomes of bleeding and chemotherapy dose modification among solid tumor patients with chemotherapy-induced thrombocytopenia.

PURPOSE: To describe the incidence and outcomes of bleeding and chemotherapy dose modifications associated with chemotherapy-induced thrombocytopenia (platelets < 50,000/microL). PATIENTS AND METHODS: Six hundred nine patients with solid tumors or lymphoma were followed-up during 1,262 chemotherapy cycles complicated by thrombocytopenia for development of bleeding, delay or dose reduction of the subsequent cycle, survival, and resource utilization. The association between survival and bleeding or dose modification was examined using the Cox proportional hazards model. Predisposing factors were identified by logistic regression. RESULTS: Bleeding occurred during 9% of cycles among patients with previous bleeding episodes (P <.0001), baseline platelets less than 75,000/microL (P <.0001), bone marrow metastases (P =.001), poor performance status (P =.03), and cisplatin, carboplatin, carmustine or lomustine administration (P =.0002). Major bleeding episodes resulted in shorter survival and higher resource utilization (P <.0001). Chemotherapy delays occurred during 6% of cycles among patients with more than five previous cycles (P =.003), radiotherapy (P =.03), and disseminated disease (P =.04). They experienced similar clinical outcomes but used significantly more resources. Dose reductions occurred during 15% of cycles but were not associated with poor clinical outcomes or excess resource utilization. Significantly shorter survival and higher resource utilization were observed among the 20% of patients who failed to achieve an adequate response to platelet transfusion. CONCLUSION: The incidence of bleeding is low among solid tumor patients overall but exceeds 20% in some subgroups. These subgroups are easily identifiable using routinely available clinical information. A clinical prediction rule is being developed. Poor response to platelet transfusion is a clinically and financially significant downstream effect of thrombocytopenia and warrants further investigation.

Time to clinical response: an outcome of antibiotic therapy of febrile neutropenia with implications for quality and cost of care.

PURPOSE: To determine whether antibiotic regimens with similar rates of response differ significantly in the speed of response and to estimate the impact of this difference on the cost of febrile neutropenia. METHODS: The time point of clinical response was defined by comparing the sensitivity, specificity, and predictive values of alternative objective and subjective definitions. Data from 488 episodes of febrile neutropenia, treated with either of two commonly used antibiotics (coded A or B) during six clinical trials, were pooled to compare the median time to clinical response, days of antibiotic therapy and hospitalization, and estimated costs. RESULTS: Response rates were similar; however, the median time to clinical response was significantly shorter with A-based regimens (5 days) compared with B-based regimens (7 days; P =.003). After 72 hours of therapy, 33% of patients who received A but only 18% of those who received B had responded (P =.01). These differences resulted in fewer days of antibiotic therapy and hospitalization with A-based regimens (7 and 9 days) compared with B-based regimens (9 and 12 days, respectively; P <.04) and in significantly lower estimated median costs ($8,491 v $11,133 per episode; P =.03). Early discharge at the time of clinical response should reduce the median cost from $10,752 to $8,162 (P <.001). CONCLUSION: Despite virtually identical rates of response, time to clinical response and estimated cost of care varied significantly among regimens. An early discharge strategy based on our definition of the time point of clinical response may further reduce the cost of treating non-low-risk patients with febrile neutropenia.

Severity of illness, outcomes, and resource use in elderly cancer patients with deep venous thrombosis.

Low-molecular-weight heparins provide new options for outpatient management of deep venous thrombosis. Because elderly patients with cancer are at increased risk of developing deep venous thrombosis, outpatient therapy for treatment of deep venous thrombosis may be important in this population. We compared the severity of illness, outcomes, and cost of deep venous thrombosis in elderly patients with cancer to those seen in younger patients with cancer. We examined all 766 episodes of deep venous thrombosis treated at the University of Texas M.D. Anderson Cancer Center between January 1, 1994 and December 31, 1996. Severity of illness level and predicted risks of mortality and readmission were obtained from a commercially available disease staging system (Inforum System). Observed outcomes and cost were based on data collected from the 766 episodes of deep venous thrombosis at our institution. One hundred nineteen (16%) episodes of deep venous thrombosis occurred in patients 70 years of age or older. The severity of illness scale (1-5, least-most severe) were identical (3.7) in the 3 groups studied (< 70 years, 70-79, years and > or = 80 years). The predicted risk of death during hospitalization (6%, 9%, 8%, respectively, by group, P = 0.12) and readmission in 30 days (5%, 4%, 3%, respectively, P = 0.04) were similar among the groups. The observed death rates during hospitalization were 5%, 6%, and 6%, respectively (P = 0.91), and the rates of hospitalization for deep venous thrombosis recurrence were 22%, 16%, and 28%, respectively (P = 0.27). The similarities in outcomes and resource use between elderly and younger patients suggest that elderly patients with cancer are not at greater risk of serious clinical outcomes or a prolonged clinical course. There is significant potential for outpatient management of these patients.

Mississippi mud in the 1990s: risks and outcomes of vancomycin-associated toxicity in general oncology practice.

BACKGROUND: Discrepancies between the severity of toxicities reported in early clinical trials and recent clinical experience with vancomycin have led to confusion regarding the need for routine serum vancomycin level monitoring and discontinuation of vancomycin when toxicities occur. Therefore, the authors examined the incidence, outcomes, and predictive factors of vancomycin-associated toxicities in general oncology practice with the goal of developing clinically relevant prediction rules and guidelines. METHODS: All 742 consecutive cancer patients who received vancomycin at a comprehensive cancer center during a 3-month period were followed prospectively for the development and outcome of phlebitis, rash, ototoxicity, and nephrotoxicity. Logistic regression was used to derive a multiple variable model of the risk of nephrotoxicity. A clinical prediction rule, the Nephrotoxicity Risk Score, was developed from the risk model and validated prospectively. RESULTS: Phlebitis occurred in 3% of patients (95% confidence interval [95% CI], 2-4%), predominantly those with recently inserted central venous catheters. Rashes occurred in 11% of patients (95% CI, 9-13%); however, all but 4 patients also were receiving beta-lactam antibiotics. Clinical evidence of ototoxicity developed in 6% of patients (95% CI, 4-9%) who were receiving vancomycin plus other ototoxic agents and only 3% of patients (95% CI, 2-5%) not receiving other ototoxic agents (P = 0.08). Nephrotoxicity occurred in 17% of patients (95% CI, 15-20%). Logistic regression revealed that factors associated with an increased risk of nephrotoxicity included administration of other mild to moderate (P = 0.01) or severely nephrotoxic agents (P < 0.001) or an acute physiology and chronic health evaluation (APACHE) score > 40 (P = 0.002). Elevated serum vancomycin peak levels did not reliably predict subsequent nephrotoxicity. CONCLUSIONS: Vancomycin-associated toxicities usually are mild and self-limiting. Some patients are at a significantly higher risk of nephrotoxicity but the authors believe these individuals can be identified reliably with the Nephrotoxicity Risk Index using information available at vancomycin initiation. Further testing of the Nephrotoxicity Risk Index is ongoing.

Demographic risk factors associated with elevated lead levels in Texas children covered by Medicaid.

This is the first large population-based study of demographic risk factors for elevated lead in Texas children. It summarizes data on 92,900 children covered by Medicaid screened for blood lead during the first 6 months of 1993 in Texas. The highest percentage of elevated lead levels (14.3%) was in children 25-36 months of age, with slightly lower percentages in those younger (13% of 19-24 months) and older (12% of 37-48 months) with blood lead levels greater than 10 micrograms/dl. The group with the highest percentage of elevated blood lead levels was 2-4-year-old African American males (17.3%) making this subgroup 3.5 times higher than the group with the lowest percentage-white girls over age 4 (4.8%). Males had higher blood lead levels for all ages and ethnic groups. Three principal risk factors were found for excessive blood lead in children: ethnicity, gender, and age; this is consistent with the second National Health and Nutrition Examination Survey (NHANES II) and Phase I of the NHANES III results demonstrating ethnicity and income association with lead in children in the United States.