Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer.

INTRODUCTION: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. METHODS: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows-Arm A (three-weekly): gemcitabine 1000 mg/m2 infused>30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused>3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused>30 min and paclitaxel 100 mg/m2 infused>1 h, both administered on days 1 and 8 of a 21-day cycle. RESULTS: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P=0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P=0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia. CONCLUSION: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.

Hospital and physician volume or specialization and outcomes in cancer treatment: importance in quality of cancer care.

PURPOSE: To conduct a comprehensive review of the health services literature to search for evidence that hospital or physician volume or specialty affects the outcome of cancer care. METHODS: We reviewed the 1988 to 1999 MEDLINE literature that considered the hypothesis that higher volume or specialization equals better outcome in processes or outcomes of cancer treatments. RESULTS: An extensive, consistent literature that supported a volume-outcome relationship was found for cancers treated with technologically complex surgical procedures, eg, most intra-abdominal and lung cancers. These studies predominantly measured in-hospital or 30-day mortality and used the hospital as the unit of analysis. For cancer primarily treated with low-risk surgery, there were fewer studies. An association with hospital and surgeon volume in colon cancer varied with the volume threshold. For breast cancer, British studies found that physician specialty and volume were associated with improved long-term outcomes, and the single American report showed an association between hospital volume of initial surgery and better 5-year survival. Studies of nonsurgical cancers, principally lymphomas and testicular cancer, were few but consistently showed better long-term outcomes associated with larger hospital volume or specialty focus. Studies in recurrent or metastatic cancer were absent. Across studies, the absolute benefit from care at high-volume centers exceeds the benefit from break-through treatments. CONCLUSION: Although these reports are all retrospective, rely on registries with dated data, rarely have predefined hypotheses, and may have publication and self-interest biases, most support a positive volume-outcome relationship in initial cancer treatment. Given the public fear of cancer, its well-defined first identification, and the tumor-node-metastasis taxonomy, actual cancer care should and can be prospectively measured, assessed, and benchmarked. The literature suggests that, for all forms of cancer, efforts to concentrate its initial care would be appropriate.

Pamidronate in prevention of bone complications in metastatic breast cancer: a cost-effectiveness analysis.

PURPOSE: Pamidronate is effective in reducing bony complications in patients with metastatic breast cancer who have known osteolytic lesions. However, pamidronate does not increase survival and is associated with additional financial costs and inconvenience. We conducted a post-hoc evaluation of the cost-effectiveness of pamidronate using the results of two randomized trials that evaluated pamidronate 90 mg administered intravenously every month versus placebo. PATIENTS AND METHODS: The trials differed only in the initial systemic therapy administered (hormonal or chemotherapy). Total skeletal related events (SREs), including surgery for pathologic fracture, radiation for fracture or pain control, conservatively treated pathologic fracture, spinal cord compression, or hypercalcemia, were taken directly from the trials. Using a societal perspective, direct health care costs were assigned to each SRE. Each group's monthly survival was equal and was projected to decline using observed median survivals. The cost of pamidronate reflected the average wholesale price of the drug plus infusion. The value or disutility of an adverse event per month was evaluated using a zero value (events avoided) or an assigned one (range, 0.2 to 0.8). RESULTS: The cost of pamidronate therapy exceeded the cost savings from prevented adverse events. The difference between the treated and placebo groups was larger with hormonal systemic therapy than with chemotherapy (additional $7,685 compared with $3,968 per woman). The projected net cost per SRE avoided was $3,940 with chemotherapy and $9,390 with hormonal therapy. The cost-effectiveness ratios were $108,200 with chemotherapy and $305, 300 with hormonal therapy per quality-adjusted year. CONCLUSION: Although pamidronate is effective in preventing a feared, common adverse outcome in metastatic breast cancer, its use is associated with high incremental costs per adverse event avoided. The analysis is most sensitive to the costs of pamidronate and pathologic fractures that were asymptomatic or treated conservatively.

Recommended colorectal cancer surveillance guidelines by the American Society of Clinical Oncology.

OBJECTIVE: To determine the most effective, evidence-based, postoperative surveillance strategy for the detection of recurrent colon and rectal cancer. Tests are to be recommended only if they have an impact on the outcomes listed below. POTENTIAL INTERVENTION: All tests described in the literature for postoperative monitoring were considered. In addition, the data were critically evaluated to determine the optimal frequency of monitoring. OUTCOMES: Outcomes of interest included overall and disease-free survival, quality of life, toxicity reduction, and cost-effectiveness. The American Society of Clinical Oncology (ASCO) Colorectal Cancer Surveillance Expert Panel was guided by the principle of cost minimization, ie, when two strategies were believed to be equally effective, the least expensive test was recommended. EVIDENCE: A complete MEDLINE search was performed of the past 20 years of the medical literature. Keywords included colorectal cancer, follow-up, and carcinoembryonic antigen, as well as the names of the specific tests. The search was broadened by articles from the tumor marker ASCO panel literature search, as well as from bibliographies of selected articles. VALUES: Levels of evidence and guideline grades were rated by a standard process. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. BENEFITS/HARMS/COSTS: The possible consequences of false-positive and false-negative tests were considered in evaluating a preference for one of two tests that provide similar information. Cost alone was not a determining factor. RECOMMENDATIONS: The expert panel's recommended postoperative monitoring schema is discussed in this article. VALIDATION: Five outside reviewers, the ASCO Health Services Research Committee, and the ASCO Board of Directors examined this document. SPONSOR: American Society of Clinical Oncology.

A rural cancer outreach program lowers patient care costs and benefits both the rural hospitals and sponsoring academic medical center.

The Rural Cancer Outreach Program (RCOP) between two rural hospitals and the Medical College of Virginia's Massey Cancer Center (MCC) was developed to bring state-of-the-art cancer care to medically underserved rural patients. The financial impact of the RCOP on both the rural hospitals and the MCC was analyzed. Pre- and post-RCOP financial data were collected on 1,745 cancer patients treated at the participating centers, two rural community hospitals and the MCC. The main outcome measures were costs (estimated reimbursement from all sources), revenues, contribution margins and profit (or loss) of the program. The RCOP may have enhanced access to cancer care for rural patients at less cost to society. The net annual cost per patient fell from $10,233 to $3,862 associated with more use of outpatient services, more efficient use of resources, and the shift to a less expensive locus of care. The cost for each rural patient admitted to the Medical College of Virginia fell by more than 40 percent compared with only an 8 percent decrease for all other cancer patients. The rural hospitals experienced rapid growth of their programs to more than 200 new patients yearly, and the RCOP generated significant profits for them. MCC benefited from increased referrals from RCOP service areas by 330 percent for cancer patients and by 9 percent for non-cancer patients during the same time period. While it did not generate a major profit for the MCC, the RCOP generated enough revenue to cover costs of the program. The RCOP had a positive financial impact on the rural and academic medical center hospitals, provided state-of-the-art care near home for rural patients and was associated with lower overall cancer treatment costs.

A sociodemographic and economic comparison of breast reconstruction, mastectomy, and conservative surgery.

BACKGROUND: There are a variety of surgical choices for women with early-stage breast cancer, including breast-conserving surgery, mastectomy, or mastectomy plus reconstructive surgery. This report examines some of the factors that affect these choices and the costs of the various treatment options. METHODS: Data from the Virginia Cancer Registry were linked to insurance claims from the Trigon Blue Cross and Blue Shield Company for women with local and regional staged breast cancer from 1989 to 1991 in Virginia. Multivariate analyses and cost studies were performed. RESULTS: There were 592 women who underwent breast-conserving surgery (BCS, 26%), mastectomy (58%), or mastectomy plus reconstruction (16%). Increasing age reduced the use of reconstruction. The choice of reconstruction was not affected by tumor size, nodal status, or race. Sixty percent of women had immediate breast reconstruction at the time of mastectomy; the majority had the implant procedure. The cost of BCS ($21,582) was higher than that of mastectomy ($16,122, P < .01). The costs for BCS and mastectomy were significantly lower than for mastectomy plus reconstruction ($31,047, P < .05). The 2-year cost for immediate reconstruction was $8200 less than for delayed procedures and was similar to the cost of BCS. CONCLUSIONS: Age was the driving force in reconstruction decisions. Clinical factors such as tumor size and nodal status were more important for the choice between BCS and mastectomy. There are significant cost differences between the various procedures. For a similar cosmetic outcome, BCS is less expensive than breast reconstruction. When reconstruction is required, a simultaneous procedure is less expensive.

Demodex gatoi: new species of hair follicle mite (Acari: Demodecidae) from the domestic cat (Carnivora: Felidae).

Demodex gatoi sp. nov. is described in all its life stages from the domestic cat. The host was diagnosed with presumptive feline acquired immunodeficiency syndrome and harbored enormous numbers of both D. gatoi and D. cati Hirst, 1919. Unlike D. cati, which inhabits the hair follicles, D. gatoi resides on the epidermal surface. More than half of the D. gatoi population sampled was made up of ova indicating rapid population growth.

Predictors of Medicare costs in elderly beneficiaries with breast, colorectal, lung, or prostate cancer.

BACKGROUND: Determining the apportionment of costs of cancer care and identifying factors that predict costs are important for planning ethical resource allocation for cancer care, especially in markets where managed care has grown. DESIGN: This study linked tumor registry data with Medicare administrative claims to determine the costs of care for breast, colorectal, lung and prostate cancers during the initial year subsequent to diagnosis, and to develop models to identify factors predicting costs. SUBJECTS: Patients with a diagnosis of breast (n = 1,952), colorectal (n = 2,563), lung (n = 3,331) or prostate cancer (n = 3,179) diagnosed from 1985 through 1988. RESULTS: The average costs during the initial treatment period were $12,141 (s.d. = $10,434) for breast cancer, $24,910 (s.d. = $14,870) for colorectal cancer, $21,351 (s.d. = $14,813) for lung cancer, and $14,361 (s.d. = $11,216) for prostate cancer. Using least squares regression analysis, factors significantly associated with cost included comorbidity, hospital length of stay, type of therapy, and ZIP level income for all four cancer sites. Access to health care resources was variably associated with costs of care. Total R2 ranged from 38% (prostate) to 49% (breast). The prediction error for the regression models ranged from < 1% to 4%, by cancer site. CONCLUSIONS: Linking administrative claims with state tumor registry data can accurately predict costs of cancer care during the first year subsequent to diagnosis for cancer patients. Regression models using both data sources may be useful to health plans and providers and in determining appropriate prospective reimbursement for cancer, particularly with increasing HMO penetration and decreased ability to capture complete and accurate utilization and cost data on this population.

A comparison of patterns of care of nonsmall cell lung carcinoma patients in a younger and Medigap commercially insured cohort.

BACKGROUND: The objective of this study was to examine and compare lifetime treatment patterns and hospitalization of incident nonsmall cell lung carcinoma (NSCLC) between pre-Medicare eligible (age < 65 years) and supplemental Medigap (age > or = 65 years) enrollees in a commercially insured cohort using insurance claims. METHODS: Claims from Virginia Blue Cross and Blue Shield beneficiaries with NSCLC submitted between 1989-1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, disease stage, and type of tumor. Initial treatment categories were stratified using Physicians' Current Procedural Terminology codes. RESULTS: There were 1706 incident NSCLC patients; 349 were age < or = 64 years ("younger") and 1212 were age > or = 65 years ("elderly"). Having commercial insurance was not associated with any survival advantage compared with national averages at 2 years. In comparison with elderly patients, younger patients more often were treated with surgery for local disease (80.2% vs. 54.8%) and surgery alone or in combination with radiation for regional disease (51.9% vs. 32.0%). Radiation was used more often in elderly patients compared with younger patients with local disease (30.5% vs. 14.0%) but less often in patients with distant disease (76.2% vs. 54.9%). Compared with elderly patients, younger patients presenting with distant disease received more chemotherapy (18.8% vs. 5.1%; P <0.001); late palliative use of chemotherapy or radiation occurred in only 4-8% of younger patients. Compared with elderly patients, younger patients with regional or distant disease spent more days in the hospital (compared with national averages at 2 years: regional disease, 30.0 vs. 23.9 days; distant disease, 33.0 vs. 21.4 days; P <0.0001). CONCLUSIONS: The results of this study show that more comprehensive health insurance is not associated with better outcomes in patients with NSCLC. Age specific trends for greater use of surgery, radiation, and total hospitalization in younger patients is consistent with other reports. Commercial health care claims supplemented by clinical staging from cancer registries can address long term practice patterns in patients with cancer.

Performance measurement in cancer care: uses and challenges.

Unnecessary, inappropriate, and futile care are given in all areas of health care including cancer care. Not only does such care increase costs and waste precious resources, but patients may have adverse outcomes when the wrong care is given. One of the ways to address this issue is to measure performance with the use of administrative data sets. Through performance measurement, the best providers can be chosen, providers can be rewarded on the basis of the quality of their performance, opportunities for improvement can be identified, and variation in practice can be minimized. Purchasers should take leadership role in creating data sets that will enhance, clinical performance. Specifically, purchasers should require the following from payers: 1) staging information; 2) requirements and/or incentives for proper International Classification of Diseases coding, including other important (comorbid) conditions; 3) incentives or requirements for proper data collection if the payer is using a reimbursement strategy that places the risk on the provider; and 4) a willingness to collect and report information to providers of care, with a view toward increasing quality and decreasing the costs of cancer care. Demanding better clinical performance can lead to better outcomes. Once good data is presented to patients and providers, better clinical behavior and improved cancer care systems will quickly follow.

Costs of care associated with non-small-cell lung cancer in a commercially insured cohort.

PURPOSE: To examine the cost of incident cases of non-small-cell lung cancer (NSCLC) in a commercially insured cohort. METHODS: Claims from Virginia Blue Cross and Blue Shield (BCBS) beneficiaries with lung cancer from 1989 to 1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, stage, and type of cancer at diagnosis. Costs for all medical care included insurance payment, copayments, and deductibles for 2 years after diagnosis or until death. RESULTS: Three hundred forty-nine incident NSCLC patients were evaluated. The mean 2-year cost for each patient after diagnosis or until death was $47,941 (95% confidence interval, $43,758 to $52,124). Total average costs and hospital days were significantly lower for local disease ($37,514, 21.2 days), but were similar for regional ($52,797, 30.0 days) and distant ($49,382, 33.0 days) disease. Hospital days accounted for 48% and hospital-based claims for 70% of costs. Initial treatments, which included radiation, unadjusted for stage, had the lowest survival rates and the highest costs, and were associated with the most hospital days. Initial stage, race, gender, and age were not predictors of total 2-year costs. The independent predictors of total 2-year costs were type of treatment: any radiation therapy, any surgery, or any chemotherapy (all, P < .001). Inpatient hospital days was only a modest predictor of costs after adjusting for type of treatment. Patients who survived less than 1 year spent 30.5 days in hospital and had an average cost of $47,280. CONCLUSION: The direct health care costs of younger NSCLC patients care are substantial. These results should serve as a benchmark for future comparisons as the United States market shifts to managed care.

Neutropenia and neoplasia: an overview of the pharmacoeconomics of sargramostim in cancer therapy.

Sargramostim is a myeloid growth factor that is widely used as adjunctive support in patients with neutropenia. Sargramostim enhances neutrophil recovery and myeloid engraftment, reduces infectious complications, and shortens the duration of hospitalization in selected patients. The high cost of sargramostim and other myeloid growth factors and their ability to reduce infections and days of hospitalization have generated interest in their pharmacoeconomic impact. Cost minimization studies in patients receiving chemotherapy for acute myelogenous leukemia and in recipients of autologous bone marrow transplantation (BMT) show estimated cost savings with sargramostim of 1996 US$12,513 and 1994 US$14,500, respectively. These data are consistent with cost savings of 1989 US$16,000 using molgramostim in autologous BMT recipients. Although no pharmacoeconomic data have been published in patients with other conditions, clinical outcomes research demonstrates a clear benefit for sargramostim administration in recipients of peripheral blood progenitor cell and allogeneic BMT and in patients who experience graft delay or failure. Because of reductions in the duration of hospitalization and infectious complications, economic outcomes of these conditions would probably also support sargramostim use. More data regarding the use of sargramostim for chemotherapy-induced neutropenia are required to properly assess the pharmacoeconomic impact in these patients.

Demodex sinocricetuli: new species of hair follicle mite (Acari:Demodecidae) from the Chinese form of the striped hamster, Cricetulus barabensis (Rodentia:Muridae).

Demodex sinocricetuli sp. nov. is described in all its life stages from the Chinese form of the striped hamster, Cricetulus barabensis. A large sample size of > 11,500 mites (96% adults and only 4% ova and immatures) was surveyed. The cause of the apparent reproductive stasis is not known. Limited data sets from other demodecid species reveal populations that are 42-82% adult.

Measuring standards of care for early breast cancer in an insured population.

PURPOSE: To demonstrate the use of a combined data base to evaluate the care for local/regional invasive breast cancer in a large insured population of women aged less than 64 years. PATIENTS AND METHODS: We linked the procedural and hospital claims from Blue Cross Blue Shield (BCBS) of Virginia with clinical stage data from the Virginia Cancer Registry (VCR) from 1989 to 1991. A total of 918 women were assessed with a median age of 50 years; 68% had tumors less than 2 cm, 30% had positive axillary nodes, and 68% were assessed as having local summary stage. A quality-of-care "report card" was used based on standards of care from international Consensus Conferences. RESULTS: Eight percent had a mastectomy as the initial biopsy procedure. Sixty-nine percent of women ultimately underwent mastectomy. Of those women who underwent lumpectomy, 86% had subsequent radiation. Within 3 months of diagnosis, 43% had a bone scan and 20% a computed tomography (CT) scan. Of women with positive axillary lymph nodes, 83% aged less than 51 years and 52% aged 51 to 64 years received chemotherapy. Fifty-six percent of all women had claims from a medical oncologist. Of women having a total mastectomy, 27% had claims from a plastic surgeon. Sixty-six percent to 76% of women had a mammogram, 24% a bone scan, and 14% a CT scan in the 0-18 and 18-36 month intervals following primary treatment. CONCLUSION: This study confirms the feasibility of linking sources of data that provide complementary information needed to develop measurements regarding standards of quality and efficiency of oncologic care. This report should serve as an initial benchmark while we await reports from other populations to define the best practice.

How long does it take to get a "do not resuscitate" order?

UNLABELLED: Less than 50% of physicians know the resuscitation wishes of their patients and only a small fraction of patients have completed "do not resuscitate" (DNR) orders before death. One of the common reasons given by physicians is that the process of "getting a DNR" takes too long, and some authorities have suggested that additional reimbursement is needed. The purpose of this study is to assess how long the DNR education and consent process actually takes in practice. Our study group was a convenience sample of consecutive patients seen by experienced oncologists in a community and academic practice setting. Physicians were asked to record the time spent in DNR discussions with patients, the outcomes, and their comments. DNR orders were obtained on 16 of 22 patients with a single interview lasting a mean time of 16 minutes. Additional DNR orders were obtained on two more patients after a second interview of 6 patients, mean time 17.5 minutes. After a third interview of 4 patients, mean time 23 minutes, only 2 of 22 patients would not allow DNR orders. Of these two, one died intubated in the intensive care unit and the other underwent continued unsuccessful induction therapy for acute leukemia before dying. CONCLUSION: DNR orders can be obtained on nearly all patients within the time frame of an inpatient or outpatient visit. Time is not the main obstacle to DNR discussions, and additional reimbursement for additional time is not necessary. A small subset of patients continue to refuse DNR orders. Physician and patient reluctance to broach the subject may be a bigger impediment than time.

Ability of Medicare claims data and cancer registries to identify cancer cases and treatment.

The objective of this study is to compare the ability of Medicare and cancer registry data to identify incident cancer cases and initial surgical therapy both singly and in combination. Data from the Virginia Cancer Registry (VCR) were linked to Medicare claims files (Medical Provider Analysis and Review File (MEDPAR)) for Virginia residents aged 65 years and over with breast, colorectal, lung, or prostate cancer diagnosed between 1986 and 1989. MEDPAR found 73-83% of cancer cases identified by VCR. Factors significantly associated with MEDPAR missing a case that was reported to VCR included younger age, male gender, living in an urban area, higher social class, in situ disease, and lack of cancer treatment. A total of 70-82% of cancer cases identified through Medicare claims were reported to the VCR. Older age, female gender, nonwhite race, comorbid conditions, no surgical procedures, multiple cancer admissions, and the position of the cancer diagnostic code on the MEDPAR record were factors significantly related to being missed by the VCR. The rate of capturing initial surgical therapies was similar to that of identifying cases. Combining information from VCR and MEDPAR resulted in increasing sensitivity for identifying incident cases to 92-97%. Using combined data from independent sources may improve reporting, increase the accuracy of cancer incidence estimates, and provide an opportunity to identify reasons for missing data.