Serious postoperative infections following resection of common solid tumors: outcomes, costs, and impact of hospital surgical volume.

PURPOSE: Unlike infections related to chemotherapy-induced neutropenia, postoperative infections occurring in patients with solid malignancy remain largely understudied. Our aim is to evaluate the outcomes and the volume-outcomes relationship associated with postoperative infections following resection of common solid tumors. METHODS: We used Texas Discharge Data to study patients undergoing resection of cancer of the lung, esophagus, stomach, pancreas, colon, or rectum from 01/2002 to 11/2006. From their billing records, we identified ICD-9 codes indicating a diagnosis of serious postoperative infection (SPI), i.e., bacteremia/sepsis, pneumonia, and wound infection, occurring during surgical admission or leading to readmission within 30 days of surgery. Using regression-based techniques, we estimated the impact of SPI on mortality, resource utilization, and costs, as well as the relationship between hospital volume and SPI, after adjusting for confounders and data clustering. RESULTS: SPI occurred following 9.4 % of the 37,582 eligible tumor resections and was independently associated with nearly 12-fold increased odds of in-hospital mortality [95 % confidence interval (95 % CI), 7.2-19.5, P < 0.001]. Patients with SPI required six additional hospital days (95 % CI, 5.9-6.2) at an incremental cost of $16,991 (95 % CI, $16,495-$17,497). Patients who underwent resection at high-volume hospitals had a 16 % decreased odds of developing SPI than those at low-volume hospitals (P = 0.03). CONCLUSIONS: Due to the substantial burden associated with SPI following common solid tumor resections, hospitals must identify more effective prophylactic measures to avert these potentially preventable infections. Additional volume-outcomes research is needed to identify infection prevention processes that can be transferred from high- to lower-volume providers.

Risk of oral and gastrointestinal mucosal injury among patients receiving selected targeted agents: a meta-analysis.

PURPOSE: The purpose of this study was to estimate the risk and severity of oral and gastrointestinal mucosal toxicities associated with selected targeted agents. METHODS: We searched the English-language literature in February 2011 for reports of randomized clinical trials comparing a FDA-approved targeted agent to a standard of care regimens. Long-term follow-up and secondary reports of trials were excluded, leaving 85 studies for analysis. Using meta-analytic methods, we calculated the relative risks of oral and gastrointestinal toxicities, adjusting for sample size using the inverse variance technique. For each targeted agent and each side effect, we calculated the number needed to harm, the number of patients that, if treated with the more toxic regimen, would produce one additional episode of the toxicity. RESULTS: Oral mucositis was significantly more frequent among patients treated with bevacizumab, erlotinib, sorafenib, or sunitinib, although this difference was confined to low-grade mucositis. The clinical significance of these findings is unclear given its low incidence and mild severity. In contrast, diarrhea was significantly more frequent with most of the targeted agents studied, with adjusted relative risks between 1.5 and 4.5. An additional patient with diarrhea will be observed for every three to five patients treated with these targeted agents, compared with conventional regimens. CONCLUSIONS: Oral mucosal toxicities occasionally complicate treatment with these targeted agents, but the clinical significance of this finding is not clear. Diarrhea is a hallmark of treatment with these targeted agents; this side effect should be carefully ascertained to permit early intervention and control.

Time trends and geographic variation in use of minimally invasive breast biopsy.

BACKGROUND: Current guidelines recommend minimally invasive breast biopsy (MIBB) as the gold standard for the diagnosis of breast lesions. The purpose of this study was to describe geographic patterns and time trends in the use of MIBB in Texas. METHODS: We used 100% Texas Medicare claims data (2000-2008) to identify women older than 66 years of age who underwent breast biopsy. Biopsies were classified as open or MIBB. Time trends, racial/ethnic variation, and geographic variation in the use of biopsy techniques were examined. RESULTS: A total of 87,165 breast biopsies were performed on 75,518 breast masses in 67,582 women; 65.8% of the initial biopsies were MIBB. Radiologists performed 70.3% and surgeons performed 26.2% of MIBB. Surgeons performed 94.2% of open biopsies. Hispanic women were less likely to undergo MIBB (55.9%) compared with white (66.6%) and black (68.9%) women (p < 0.0001). Women undergoing MIBB were also more likely to live in metropolitan areas and have higher income and educational levels (p < 0.0001). The rate of MIBB increased from 44.4% in 2001 to 79.1% in 2008 (p < 0.0001). There are clear geographic patterns in MIBB use, with highest use near major cities. Although rates are increasing overall, rates of improvement in the use of MIBB vary considerably across geographic regions and remain persistently low in more rural areas. CONCLUSIONS: Despite an increase in the use of MIBB over time, MIBB use was consistently lower than recommended. We must identify specific barriers in rural areas to effectively change practice and achieve the statewide goal of 90% MIBB.

415 patients with adenosquamous carcinoma of the pancreas: a population-based analysis of prognosis and survival.

BACKGROUND: Adenosquamous carcinoma of the pancreas is rare. Our understanding of the disease and its prognosis comes mainly from small retrospective studies. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) database (1988 to 2007), we identified patients with adenosquamous carcinoma (n = 415) or adenocarcinoma (n = 45,693) of the pancreas. The demographics, tumor characteristics, resection status, and survival were compared between the groups. RESULTS: Compared with patients with adenocarcinoma, patients with adenosquamous carcinoma were more likely to have disease located in the pancreatic body and tail (44.6% versus 53.5%, P < 0.0001). While the stage distribution was similar between the two groups, adenosquamous carcinomas were more likely to be poorly differentiated (71% versus 45%, P < 0.0001), node positive (53% versus 47%, P < 0.0001), and larger (5.7 versus 4.3 cm, P < 0.0001). For locoregional disease, resection increased over time from 26% in 1988 to 56% in 2007. The overall 2-y survival was 11% in both groups. Following resection, patients with adenosquamous carcinoma had worse 2-y survival (29% versus 36%, P < 0.0001). Resection was the strongest independent predictor of survival for patients with locoregional pancreatic adenosquamous carcinoma (HR 2.35, 95% CI = 1.47-3.76). CONCLUSIONS: This is the first population-based study to evaluate outcomes in adenosquamous carcinoma of the pancreas. Compared with pancreatic adenocarcinoma, adenosquamous carcinoma was more likely to occur in the pancreatic tail, be poorly differentiated, larger, and node positive. The long-term survival following surgical resection is significantly worse for adenosquamous cancers; however, patients with adenosquamous carcinoma can still benefit from surgical resection, which is the strongest predictor of survival.

End-of-life care in Medicare beneficiaries dying with pancreatic cancer.

BACKGROUND: The authors' goal was to characterize hospice enrollment and aggressiveness of care for pancreatic cancer patients at the end of life. METHODS: Surveillance, Epidemiology, and End Results and linked Medicare claims data (1992-2006) were used to identify patients with pancreatic cancer who had died (n = 22,818). The authors evaluated hospice use, hospice enrollment ≥ 4 weeks before death, and aggressiveness of care as measured by receipt of chemotherapy, acute care hospitalization, and intensive care unit (ICU) admission in the last month of life. RESULTS: Overall, 56.9% of patients enrolled in hospice, and 35.9% of hospice users enrolled for 4 weeks or more. Hospice use increased from 36.2% in 1992-1994 to 67.2% in 2004-2006 (P < .0001). Admission to the ICU and receipt of chemotherapy in the last month of life increased from 15.5% to 19.6% (P < .0001) and from 8.1% to 16.4% (P < .0001), respectively. Among patients with locoregional disease, those who underwent resection were less likely to enroll in hospice before death and much less likely to enroll early. They were also more likely to receive chemotherapy (14% vs 9%, P < .0001), be admitted to an acute care hospital (61% vs 53%, P < .0001), and be admitted to an ICU (27% vs 15%, P < .0001) in the last month of life. CONCLUSIONS: Although hospice use increased over time, there was a simultaneous decrease in early enrollment and increase in aggressive care at the end of life for patients with pancreatic cancer.

Mammography capacity impact on screening rates and breast cancer stage at diagnosis.

BACKGROUND: Mammography capacity in the U.S. reportedly is adequate, but has not been examined in nonmetropolitan areas. This study examined the relationships between in-county mammography facilities and rates of mammography screening and late-stage diagnosis of breast cancers. METHODS: The association between a mammography facility in the county of residence (2002-2004) and the odds of screening within 2 years were examined (in 2007) among Texas women aged >40 years who responded to the 2004 Behavioral Risk Factor Surveillance System survey, using multivariate logistic regression to control for age, race, ethnicity, education, income, self-reported health, insurance, and usual source of care. Similarly, the association between an in-county mammography facility and the odds of diagnosis with locally advanced or disseminated disease was examined among Texas women aged >40 years who developed breast cancer in 2004. RESULTS: Half of the 254 counties in Texas had no mammography facility. After controlling for confounding factors, an in-county facility was associated with significantly higher odds of screening (OR=3.27; p=0.03) and lower odds of late-stage breast cancer at diagnosis (OR=0.36; 95% CI=0.26-0.51; p<0.001). The risks of late-stage diagnosis were higher for African-American women (OR=1.52; 95% CI=1.22-1.89; p<0.001) and Hispanic women (OR=1.23; 95% CI=0.99-1.53; p=0.06) than for white women. CONCLUSIONS: Although mammography capacity in the U.S. may be adequate on average, the unequal distribution of facilities results in large rural areas without facilities. Screening rates in these areas are suboptimal and are associated with late-stage diagnosis of breast cancer.

Hospitalizations for infection in cancer patients: impact of an aging population.

GOAL OF WORK: The aim of this study was to assess the impact of an aging US population on inpatient costs and resource utilization in cancer patients admitted for infection. MATERIALS AND METHODS: From the Texas inpatient public use files (Texas Health Care Information Collection), which include all hospitals except federal institutions, we selected residents with cancer who also had a principal or admitting diagnosis of pneumonia, bacteremia/sepsis, or other documented infection in 2001. Selected admission records were directly adjusted by projected age-specific cancer prevalence totals for years 2006 and 2025 using surveillance epidemiology end results (SEER) and US census data. Charges were inflated to 2006 consumer price index for medical care then converted to costs using Texas Medicare cost-to-charge ratios. RESULTS: Over 9% of nearly 200,000 Texans admitted for infection in 2001 also had cancer. Projecting these results nationally, 318,000 discharges in cancer patients at a cost of $3.1 billion (B, 95% CI $2.8B, $3.4B) and 2.3 million (M) bed days would have been attributed to infections in 2006. By the year 2025, adjusting only for the aging population, costs could increase 45% to $4.5B (95% CI $4.1B, $4.9), with 27% more (3.4 M) hospital bed days occupied. CONCLUSIONS: Consequent to an aging population and the resulting increase in cancer prevalence, the healthcare burden of managing hospital admissions for infection in the vulnerable cancer population could be greatly magnified unless risk-based treatment and preventive strategies such as appropriate immunizations and infection control measures are implemented.

Gender and age differences in blood utilization and length of stay in radical cystectomy: a population-based study.

OBJECTIVE: Radical cystectomy is a major surgical procedure associated with significant blood loss and lengthy hospital stays. This surgical procedure is more challenging in women than men due to anatomical-based differences. We evaluated resource utilization and complication rates of patients undergoing radical cystectomy or exenteration using the Texas Hospital In-Patient Discharge Data Collection. METHODS: This was a retrospective study of 1,493 patients, 35 years of age or older, who underwent radical cystectomy for bladder cancer from January 2000 to December 2003. We evaluated blood product charges, length of stay, and complication rates during hospitalization. RESULTS: In this sample, 24% of the patients (n = 356) were women. Overall, women had significantly increased blood product charges and length of stay compared to men, $1,392.87 vs. $718.21 (P < 0.001) and 12.72 vs. 11.64 (P = 0.03), respectively. During hospitalization, 26 of the patients died. No differences in mortality or complication rates were observed between men and women. Multivariate analysis showed that female sex (P < 0.001) and age (P = 0.003) were independent predictors of increased blood product charges. Multivariate analysis showed that female sex (P = 0.015), age (P = 0.003), and Charlson's comorbidity index >1 (P = 0.05) were predictors of longer length of stay. CONCLUSION: Women and older patients with bladder cancer are at risk of increased blood products utilization and length of hospital stay after a radical cystectomy. Appropriate postoperative care and referrals should improve postoperative outcomes for these vulnerable patients.

Clinical model of cost of bladder cancer in the elderly.

OBJECTIVES: To develop a population-based clinical model of bladder cancer (BC) care costs and identify cost drivers. METHODS: We retrospectively reviewed a cohort of 4863 patients with BC identified from the linked Surveillance, Epidemiology and End Results-Medicare database, aged at least 65 years and diagnosed between 1994 and 1996. We collected the records of Medicare reimbursements (a surrogate of costs) through 1998 and classified them into clinically relevant intervals and care types by disease invasiveness to derive the cumulative costs of care. We calculated the incremental resource use costs using sex and age-matched controls from a 5% general population sample and compared similarly matched patients with other cancer (OC). We inflated all costs to 2006 U.S. dollars. RESULTS: The annual cost of care for all patients with muscle-invasive BC (MIBC) was $35.72M (95% confidence interval $35.69M to $35.75M), 70% more than the $21.03M (95% confidence interval $21.00M to $21.05M) for patients with non-MIBC. The major cost drivers, regardless of disease stage, were diagnostic/surveillance and complications, accounting for up to 43% and 37% of BC care costs, respectively. Comorbidity-adjusted incremental annual resource costs per patient with MIBC were more than four times greater than those for patients with non-MIBC, similar to those of OC controls (P = 0.490-0.913), except for inpatient (P = 0.002) and hospice (P <0.001) costs, which were both statistically significantly lower. Annual adjusted incremental Medicare reimbursements totaled $36.3M for non-MIBC and $96.1 million for MIBC. CONCLUSIONS: The results of this study have indicated that a reduction of BC care costs could be realized with strategies inhibiting disease progression and reducing the occurrence and severity of complications.

Outcomes and cost of outpatient or inpatient management of 712 patients with febrile neutropenia.

PURPOSE: We retrospectively compared the outcomes and costs of outpatient and inpatient management of low-risk outpatients who presented to an emergency department with febrile neutropenia (FN). PATIENTS AND METHODS: A single episode of FN was randomly chosen from each of 712 consecutive, low-risk solid tumor outpatients who had been treated prospectively on a clinical pathway (1997-2003). Their medical records were reviewed retrospectively for overall success (resolution of all signs and symptoms of infection without modification of antibiotics, major medical complications, or intensive care unit admission) and nine secondary outcomes. Outcomes were assessed by physician investigators who were blinded to management strategy. Outcomes and costs (payer's perspective) in 529 low-risk outpatients were compared with 123 low-risk patients who were psychosocially ineligible for outpatient management (no access to caregiver, telephone, or transportation; residence > 30 minutes from treating center; poor compliance with previous outpatient therapy) using univariate statistical tests. RESULTS: Overall success was 80% among low-risk outpatients and 79% among low-risk inpatients. Response to initial antibiotics was 81% among outpatients and 80% among inpatients (P = .94); 21% of those initially treated as outpatients subsequently required hospitalization. All patients ultimately responded to antibiotics; there were no deaths. Serious complications were rare (1%) and equally frequent between the groups. The mean cost of therapy among inpatients was double that of outpatients ($15,231 v $7,772; P < .001). CONCLUSION: Outpatient management of low-risk patients with FN is as safe and effective as inpatient management of low-risk patients and is significantly less costly.

In-hospital complications of autologous hematopoietic stem cell transplantation for lymphoid malignancies: clinical and economic outcomes from the Nationwide Inpatient Sample.

BACKGROUND: Autologous hematopoietic stem cell transplantation (auto HSCT) is standard of care therapy for multiple myeloma and Hodgkin and non-Hodgkin lymphomas in front-line and salvage settings, respectively. Complications remain common, but population-based estimates of their frequency and relative contribution to cost are not available. METHODS: A retrospective cohort comprised of 8891 patients with multiple myeloma and lymphoma admitted to US hospitals for auto HSCT over a 2-year period (2000-2001) was extracted from the Nationwide Inpatient Sample (NIS). Patient characteristics, vital status, and total hospital charges were obtained directly from the NIS. Transplant characteristics and outcomes were identified by ICD-9-CM codes. Mean hospital charges were examined by outcome and transformed into cost by using Medicare cost-to-charge ratios. Factors associated with hospital cost, length of stay, and in-hospital mortality were explored by using multivariate regression. RESULTS: The mean hospital cost for auto HSCT during this period was $51,312. Significant complications were documented for >50% of admissions. Infectious complications (~60%) and stomatitis (~40%) were the most frequent, and both were associated with increased hospital costs (range, $15,000 to $50,000). In-hospital mortality was rare (<5%) but was associated with markedly increased cost when it occurred. Pretransplant conditioning with total body irradiation was strongly associated with infectious complications, higher cost, and death. CONCLUSIONS: Adverse events are both common and costly after auto HSCT. Strategies to minimize complications could significantly reduce not only morbidity and mortality but also the cost of the procedure. Administrative data can be profitably exploited to investigate outcomes in this population.

Psychosocial and economic impact of cancer.

This article explores the psychosocial and economic implications of cancer and their relevance to the clinician. After a general overview of the topic, the authors focus on aspects of particular importance to the dental professional, including the psychosocial and economic implications of the oral complications of cancer and its therapy, head and neck cancers, and special issues among children with cancer and cancer survivors.

Economic impact of palifermin on the costs of hospitalization for autologous hematopoietic stem-cell transplant: analysis of phase 3 trial results.

A double-blind, randomized trial showed that, compared with placebo, palifermin (recombinant human keratinocyte growth factor) reduced the frequency and duration of oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy and total-body irradiation with autologous stem-cell support. This previously published study also showed a significant reduction in the incidence of adverse subsequent outcomes. The objective of this study was to estimate the impact of palifermin prophylaxis on hospital costs of transplantation in the trial. This was a retrospective, economic analysis of estimated costs for a previously published clinical trial. Costs were not collected during the trial. Therefore, we estimated the direct medical costs of hospitalization using hospital charges from similar patients' hospitalization charges selected from the National Inpatient Sample, a population-based, nationally representative sample of hospital claims. Costs were estimated from charges using Medicare's state-specific cost-to-charge ratios. These cost estimates were applied to the outcome data (incidence of febrile neutropenia, bacteremia/fungemia, or pneumonia, and use of total parenteral nutrition) from the clinical trial. Patients were those with hematologic malignancies who received high-dose chemotherapy and total-body irradiation with autologous stem cell transplant. We compared the estimated total hospital costs (in 2005 United States dollars) incurred by patients who received palifermin in the clinical trial with those incurred by patients who received placebo. Costs were analyzed from the provider's perspective. The mean cost of a hospital day in this population varied between $2,834, when no adverse outcomes occurred, and $4,663, when all 4 outcomes occurred. Reductions in adverse outcomes and their associated hospital stay offset the acquisition price of palifermin. A nonsignificant mean savings of $3,595 per patient (95% confidence interval: $2,090-$5,103) was observed. In sensitivity analyses, this observation was robust to all plausible values of per diem hospital costs and hypothetic per diem outpatient costs. In addition to its previously demonstrated clinical benefit, palifermin prophylaxis offers a favorable economic profile among patients with hematologic malignancies who receive total body irradiation and autologous stem cell support.

Cost-effectiveness of influenza vaccination in working-age cancer patients.

BACKGROUND: Despite recommendations to immunize all patients at an increased risk of influenza complications, the vaccine utilization among high-risk nonelderly adults remains low and its cost-effectiveness is unclear. In the current study, the authors analyzed the cost-effectiveness of influenza vaccination in working-age (ages 20-64 years) cancer patients. METHODS: The authors developed a decision-analytic model, from the societal perspective, using epidemiologic, vaccine effectiveness, resource utilization, cost, survival, and utility data from published sources, supplemented with data collected from the authors' own institutional accounting system. Two strategies were compared: influenza vaccination of working-age cancer patients and no vaccination. The base-case patient was assumed to be a 51-year-old cancer patient (the mean age for the National Cancer Institute's Surveillance, Epidemiology, and End Results [SEER] population of working-age patients within 5 years of cancer diagnosis). RESULTS: The effectiveness of the influenza vaccine was 6.02 quality-adjusted life-years (QALYs) at a cost of $30.10. The effectiveness of the no vaccination strategy was 6.01 QALYs at a cost of $27.86. Compared with the no vaccination strategy, the incremental cost-effectiveness ratio of vaccinating working-age cancer patients would be $224.00 per QALY gained. Using the benchmark of $50,000 per QALY, the model was only sensitive to changes in cancer survival (threshold of 2.8 months). CONCLUSIONS: The influenza vaccine is cost-effective for working-age cancer patients with a life expectancy of >or=3 months. All working-age cancer patients who are within 5 years of cancer diagnosis and have a life expectancy of at least 3 months should be vaccinated against influenza.

Risk, outcomes, and costs of radiation-induced oral mucositis among patients with head-and-neck malignancies.

PURPOSE: To study the risk, outcomes, and costs of radiation-induced oral mucositis (OM) among patients receiving radiotherapy (RT) to head and neck primary cancers. METHODS AND MATERIALS: A retrospective cohort consisting of 204 consecutive head-and-neck cancer patients who received RT with or without chemotherapy during 2002 was formed; their records were reviewed for clinical and resource use information. Patients who had received prior therapy, had second primary cancers, or received palliative radiation therapy were excluded. The risk of OM was analyzed by multiple variable logistic regression. The cost of care was computed from the provider's perspective in 2006 U.S. dollars and compared among patients with and without OM. RESULTS: Oral mucositis occurred in 91% of patients; in 66% it was severe (Grade 3-4). Oral mucositis was more common among patients with oral cavity or oropharynx primaries (odds ratio [OR], 44.5; 95% confidence interval [CI], 5.2 to >100; p < 0.001), those who received chemotherapy (OR = 7.8; 95% CI, 1.5-41.6; p = 0.02), and those who were treated with altered fractionation schedules (OR = 6.3; 95% CI, 1.1-35.1; p = 0.03). Patients with OM were significantly more likely to have severe pain (54% vs. 6%; p < 0.001) and a weight loss of > or =5% (60% vs. 17%; p < 0.001). Oral mucositis was associated with an incremental cost of $1700-$6000, depending on the grade. CONCLUSIONS: Head-and-neck RT causes OM in virtually all patients. Oral mucositis is associated with severe pain, significant weight loss, increased resource use, and excess cost. Preventive strategies are needed.

Clinical model of lifetime cost of treating bladder cancer and associated complications.

OBJECTIVES: To estimate the lifetime cost of bladder cancer and the contribution of complications to the total costs. METHODS: We reviewed the medical records of a retrospective cohort of 208 patients with bladder cancer who registered at our comprehensive cancer center from 1991 to 1999. We multiplied the number of resources used during management of bladder cancer by their unit charges. We converted charges into costs using the Medicare cost-to-charge ratio and inflated these to 2005 U.S. dollars. We estimated future costs by creating two extreme hypothetical scenarios. In the best-case scenario, we assumed patients with superficial disease developed recurrences at the cohort's mean rate and that patients with muscle-invasive disease were disease free after definitive therapy. Survival was based on the U.S. life expectancy in both cases. In the worst-case scenario, we assumed patients with superficial disease developed muscle-invasive disease and that all patients subsequently died of bladder cancer. RESULTS: The average cost of bladder cancer was 65,158 dollars among the cohort patients. Sixty percent of this cost (39,393 dollars) was associated with surveillance and treatment of recurrences, and 30% (19,811 dollars) was attributable to complications. The lifetime cost of bladder cancer was lower for the worst-case scenario (99,270 dollars) than for the best-case scenario (120,684 dollars). However, a greater proportion of the costs were attributable to complications with the worst-case scenario (43%, 42,290 dollars) compared with the best (28%, 34,169 dollars). CONCLUSIONS: The management of bladder cancer and its associated complications results in a major economic burden. More cost-effective surveillance strategies and approaches for preventing complications are crucial to minimizing the disease's clinical and economic consequences.

Comparative outcomes of bladder cancer.

OBJECTIVE: To compare the survival of women and men with transitional cell bladder cancer. METHODS: We used the Surveillance Epidemiology and End Results database to identify patients aged 35 years or older diagnosed with bladder cancer between 1991 and 2001 actively followed up. We excluded cases diagnosed by autopsy or death certificates and those of unknown race. We used Cox proportional hazard regression to analyze survival in patients with advanced disease. RESULTS: Of the 31,009 patients meeting eligibility criteria, 26.7% were women. Median age at diagnosis for women and men was 72 and 70 years, respectively. Regional disease was diagnosed in 20.3% of white women and 35.5% of African-American women, compared with only 17.6% of white men and 25.9% of African-American men (P < .001). Increased age, African-American race, and being female significantly increased the hazard of death (hazard ratio [HR] 1.037, 95% confidence interval [CI] 1,034-1.041; HR 1.402, 95% CI 1.187-1.656; and HR 1.842, 95% CI 1.158-2.931). CONCLUSION: Women with bladder cancer, particularly African-Americans, have shorter survival. This is partially explained by higher risk of diagnosis with poorly differentiated tumors, advanced stage, and advanced age. Women should be targeted for timely diagnosis. LEVEL OF EVIDENCE: II-2.

Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants.

BACKGROUND: The generalizability of clinical trial results is questionable, because fewer than 5% of cancer patients participate. The authors examined the comparability of clinical trial participants and nonparticipants and the potential impact of differences. METHODS: A retrospective cohort of 19,340 cancer patients who were diagnosed between January 1990 and December 1997 was characterized by trial participation. The distributions of prognostically important factors among trial participants were compared with the distributions among nonparticipants and the population of patients diagnosed during the same period in the Surveillance, Epidemiology, and End Results population. The impact of these factors on survival was examined by using a Cox proportional hazards analysis. RESULTS: Trial participants were younger and had better performance status and fewer comorbid conditions compared with nonparticipants. However, participants were more likely to have locally advanced disease, positive lymph node status, poorly differentiated tumors, liver metastases, and multiple metastatic sites. The former factors were associated with significantly longer survival, whereas the later factors were associated with significantly shorter survival. CONCLUSIONS: The lack of comparability between trial participants and nonparticipants called into question the generalizability of clinical trial results. Although selective recruitment for clinical trials is justified, the authors encourage the use of population-based trials of effectiveness in "all comers."

Epidemiology of treatment-associated mucosal injury after treatment with newer regimens for lymphoma, breast, lung, or colorectal cancer.

GOALS OF WORK: Oral and gastrointestinal (GI) mucositis are frequent complications of chemotherapy and radiotherapy for cancer, contributing to not only the morbidity of treatment but its cost as well. The risk associated with specific chemotherapeutic agents, alone and in combination, has been characterized previously. In the current study, we sought to estimate the risk associated with newer regimens for the treatment of non-Hodgkin's lymphoma (NHL) and common solid tumors. METHODS: We reviewed published studies reporting phase II and III clinical trials of dose-dense regimens for breast cancer and NHL, TAC (docetaxel, adriamycin, cyclophosphamide) chemotherapy for breast cancer, and infusional 5-fluorouracil-based regimens for colorectal cancer. Platinum-, gemcitabine-, and taxane-based regimens for lung cancer, either alone or in combination with radiotherapy, were also considered. Using modified meta-analysis methods, we calculated quality-adjusted estimates of the risk for oral and GI mucositis by tumor type and regimen. Case reports are used to emphasize the relevance of the findings for patient care. MAIN RESULTS: Our findings demonstrate that mucosal toxicity remains an important complication of cancer treatment. Moreover, innovations in drug combinations, scheduling, or mode of administration significantly modulate the risk for both oral and GI mucositis. CONCLUSIONS: Ongoing review of the clinical trial experience will remain important as newer, targeted agents enter standard clinical practice.

Cancer in an incarcerated population.

BACKGROUND: The challenge posed to prison health systems in the U.S. by an immense incarcerated population is significant. However, the patterns of presentation and associated mortality of cancer among the incarcerated population is unknown. METHODS: An historical cohort of cancers diagnosed among inmates of the Texas Department of Criminal Justice over the course of 20 years who were followed at the University of Texas Medical Branch in Galveston, Texas was identified. There were 1807 inmates who were diagnosed with cancer. Two cohorts were chosen for comparison: a random sample of 179,757 patients from the Surveillance, Epidemiology, and End Results (SEER) registry, and an age-matched, gender-matched, race-matched SEER population comprised of 6124 patients (MSEER). Disease sites and associated mortality of the inmate cancer patients were determined and compared with SEER cohorts. RESULTS: A marked rise in cancer diagnoses among inmates paralleled the rise in the inmate population. The leading cancers were lung carcinoma, non-Hodgkin lymphoma (NHL), and carcinomas of the oral cavity and pharynx. Among women, cervical carcinoma was the most common. Lung carcinoma, NHL, and hepatic carcinoma accounted for more cancer deaths among inmates than in the SEER cohort (P < 0.0001 for all comparisons). Lung carcinoma, hepatic carcinoma, and NHL were significantly more common in the inmate cohort than in the MSEER cohort (P < 0.001 for all comparisons). The median survival was inferior in the inmate cohort (21 mos) compared with the SEER cohort (55 mos) and the MSEER cohort (54 mos) (P < 0.0001 for both comparisons). CONCLUSIONS: Cancers with unique epidemiology and high associated mortality have emerged among the incarcerated. This has significant implications for prison health systems.