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Background: We describe early dissemination patterns for first-line bevacizumab given for metastatic colorectal cancer treatment., Methods: We analyzed patient surveys and medical records for a population-based cohort with metastatic colorectal cancer treated in multiple regions and health systems in the United States (US). Eligible patients were diagnosed with metastatic colorectal cancer and initiated first-line chemotherapy after US Food & Drug Administration (FDA) bevacizumab approval in February 2004. First-line bevacizumab therapy was defined as receiving bevacizumab within 8 weeks of starting chemotherapy for metastatic colorectal cancer. We evaluated factors associated with first-line bevacizumab treatment using logistic regression., Results: Among 355 patients, 31% received first-line bevacizumab in the two years after FDA approval, including 26% of men, 41% of women, and 16% of those ≥ 75 years. Use rose sharply within 6 months after FDA approval, then plateaued. 20% of patients received bevacizumab in combination with irinotecan; 53% received it with oxaliplatin. Men were less likely than women to receive bevacizumab (adjusted OR 0.55; 95% CI 0.32-0.93; p = 0.026). Patients ≥ 75 years were less likely to receive bevacizumab than patients < 55 years (adjusted OR 0.13; 95% CI 0.04-0.46; p = 0.001)., Conclusions: One-third of eligible metastatic colorectal cancer patients received first-line bevacizumab shortly after FDA approval. Most patients did not receive bevacizumab as part of the regimen used in the pivotal study leading to FDA approval.

Myeloid colony-stimulating factors (CSFs) decrease the risk of febrile neutropenia (FN) from high-risk chemotherapy regimens administered to patients at 20% or greater risk of FN, but little is known about their use in clinical practice. We evaluated CSF use in a multiregional population-based cohort of lung and colorectal cancer patients (N = 1849). Only 17% (95% confidence interval [CI] = 8% to 26%) patients treated with high-risk chemotherapy regimens received CSFs, compared with 18% (95% CI = 16% to 20%) and 10% (95% CI = 8% to 12%) of patients treated with intermediate- (10%-20% risk of FN) and low-risk (<10% risk of FN) chemotherapy regimens, respectively. Using a generalized estimating equation model, we found that enrollment in a health maintenance organization (HMO) was strongly associated with a lower adjusted odds of discretionary CSF use, compared with non-HMO patients (odds ratio = 0.44, 95% CI = 0.32 to 0.60, P < .001). All statistical tests were two-sided. Overall, 96% (95% CI = 93% to 98%) of CSFs were administered in scenarios where CSF therapy is not recommended by evidence-based guidelines. This finding suggests that policies to decrease CSF use in patients at lower or intermediate risk of FN may yield substantial cost savings without compromising patient outcomes.

Objective: To evaluate the cost-effectiveness of 70-gene MammaPrint signature (Agendia Inc, Huntington Beach, CA) vs Adjuvant! Online software (AS) (http://www.adjuvantonline.com) in patients 60 years or younger with early-stage breast cancer., Study Design: Cost-effectiveness and cost-utility analyses from a US payer perspective., Methods: A Markov model with 3 health states was constructed. In the base case model, risk classification and patient outcomes were based on a 70-gene signature validation study. Efficacy of chemotherapy was derived from a published meta-analysis of clinical trials. An alternative model using data from AS and from the Surveillance, Epidemiology and End Results registry was built to examine the external validity of the base case model. The incremental benefits, costs, and cost-effectiveness of treatment guided by 70-gene signature were calculated., Results: In the base case model, 70-gene signature reclassified 29% of patients and spared 10% of patients from chemotherapy. Compared with the AS strategy, the 70-gene signature strategy was associated with $1440 higher total cost per patient and with 0.14 additional life-year or 0.15 additional quality-adjusted life-year. Overall, the incremental cost-effectiveness ratios were approximately $10,000 per life-year or quality-adjusted life-year in the base case model and $700 in the alternative model. The model results were sensitive to estrogen receptor status, the proportion of patients classified as high risk vs low risk, and the overall survival in each risk group., Conclusion: A 70-gene signature is likely to be a cost-effective strategy to guide adjuvant chemotherapy treatment in younger patients with early-stage breast cancer.

Objective: To examine variables influencing colony-stimulating factor (CSF) prescription as primary prophylaxis versus other use during patients' initial chemotherapy course among a large sample of health insurance records., Study Design: Retrospective cohort study., Methods: Adults 25 years or older with a diagnosis of breast, colorectal, or non-small cell lung cancer (NSCLC) between January 1, 2002, and December 31, 2005, were identified from the western Washington State Surveillance, Epidemiology, and End Results Seattle Puget Sound registry. We linked these records to health insurance claims. Chemotherapy regimens identified from insurance claims were categorized as carrying high, intermediate, or low risk of myelosuppression according to the National Comprehensive Cancer Network guidelines and the literature. Colony-stimulating factor use was described as primary prophylaxis, other use, or no use, and logistic regression analysis identified factors associated with CSF use., Results: For patients with breast cancer, colorectal cancer, and NSCLC, respectively, 58%, 0%, and 28% received CSFs as primary prophylaxis in conjunction with high-risk chemotherapy regimens, whereas 10%, 7%, and 21% did so in conjunction with low-risk chemotherapy regimens. Prophylactic CSF use increased from 2002 to 2005 for breast cancer but remained constant for colorectal cancer and for NSCLC., Conclusions: As primary prophylaxis, CSF use is underutilized based on recommendations for patients having cancer who receive chemotherapy regimens carrying high febrile neutropenia risk and may be overutilized for patients who receive chemotherapy regimens carrying low febrile neutropenia risk. Further research is needed to understand the barriers to implementing guidelines in clinical practice.

Background: In a meta-analysis of data from randomized trials, the risk of febrile neutropenia during myelosuppressive chemotherapy was reported to be lower with pegfilgrastim prophylaxis than filgrastim prophylaxis. However, there is limited information on the comparative effectiveness of these agents in clinical practice., Objective: This study was undertaken to compare the risks of hospitalization for neutropenic complications of chemotherapy in US clinical practice in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis., Methods: This was a retrospective cohort study employing a US health insurance database. The source population included all patients who received chemotherapy for a primary solid tumor between January 2003 and December 2005 and who received filgrastim or pegfilgrastim during their first course of chemotherapy. All unique chemotherapy cycles were identified for each patient, and cycles in which pegfilgrastim or filgrastim was administered by cycle day 5 (considered to represent prophylaxis) were selected and pooled for analysis. The risks of hospitalization for neutro-penic complications (using both narrow and broad criteria) and for any reason were then compared between cycles in which filgrastim or pegfilgrastim prophylaxis was administered. Generalized estimating equations were used to control for potential confounding variables., Results: Filgrastim prophylaxis was used in 1193 unique chemotherapy cycles (mean [SD] number of days per cycle, 4.5 [3.3]); for pegfilgrastim prophylaxis, the number of unique chemotherapy cycles was 14,570. First-cycle use represented 16% of all cycles analyzed. The mean ages of patients receiving filgrastim and pegfilgrastim prophylaxis were 61 and 60 years, respectively. Breast cancer was the most common tumor type (52% and 51%), followed by non-Hodgkin's lymphoma (21% and 18%) and lung cancer (11% and 15%). Hospitalization for neutropenic complications (narrow criterion) occurred during 2.1% of filgrastim cycles and 1.2% of pegfilgrastim cycles; hospitalization for neutropenic complications (broad criterion) occurred in a respective 4.8% and 3.1% of cycles; and hospitalization for all causes occurred in 8.7% and 6.3% of cycles (all, P < 0.01). The risks of hospitalization were consistently lower for chemotherapy cycles that involved pegfilgrastim prophylaxis compared with filgrastim prophylaxis (odds ratios = 0.64-0.73; P < 0.05)., Conclusion: The risk of hospitalization for neutro-penic complications during cancer chemotherapy in clinical practice was approximately one third higher among patients who received filgrastim prophylaxis than among those who received pegfilgrastim prophylaxis.

The structure of health care has been rapidly evolving in response to financial pressures and demands to improve quality. Little work has documented the structure of care and its impact in the context of breast cancer care. We conducted a survey to characterize Los Angeles physicians caring for breast cancer patients and the structural landscape of the healthcare system in which they practice. Cross-sectional survey of physicians who treated a population-based cohort of breast cancer patients. We surveyed 477 physicians, targeting all Los Angeles County medical oncologists, radiation oncologists, and surgeons reported by patients participating in the Los Angeles Women's Health Study (77% response rate). Specialty-specific questionnaires were developed. Items were based on the structure and quality of care literature, cognitive interviews with cancer care specialists, and existing physician survey instruments. Breast cancer care providers in Los Angeles are diverse, with one-third non-white and 46% speaking a non-English language. Group practice is most common, (37% single specialty, 16% group-model HMO, 8% multi-specialty group). Minimal teaching involvement predominates. Mean new breast cancer patient volumes are relatively high (8 per month overall; six for surgeons), representing 46% of new cancer patients. Physicians reported high career satisfaction levels (83-92%). Physicians were least satisfied with the amount of time spent with patients (82%). Data from this study represent important building blocks for further analyses to determine the impact of structural characteristics on the quality of care that breast cancer patient's experience.

Background: Febrile neutropenia (FN) is a serious adverse event associated with myelotoxic chemotherapy that predisposes patients to life-threatening bacterial infections. Prophylaxis with granulocyte colony-stimulating factors (G-CSFs) from the first cycle of chemotherapy is recommended by the 2006 American Society of Clinical Oncology, 2008 National Comprehensive Cancer Network and 2006 European Organisation for Research and Treatment of Cancer guidelines when the overall risk of FN is approximately 20% or higher. Once-per-cycle pegfilgrastim and daily filgrastim are two commonly used G-CSFs with different dosing schedules and associated costs., Objective: To evaluate the cost effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the UK., Methods: A decision-analytic model was constructed from the UK NHS perspective with a lifetime study horizon. The model simulated three clinical scenarios: scenario 1 assumed that pegfilgrastim and filgrastim had differential impact on the risk of FN; scenario 2 assumed additional differential impact on FN-related mortality; and scenario 3 assumed additional differential impact on chemotherapy relative dose intensity (RDI) with long-term survival effects. The base-case population included 45-year-old women with stage II breast cancer receiving four chemotherapy cycles, with an FN risk of approximately 20% or higher. Model inputs, including FN risk, FN case-fatality, RDI, impact of RDI on survival and utility scores, were based on a review of the literature and expert panel validation. Using data from the literature, it was estimated that the absolute risk of FN associated with pegfilgrastim was 5.5% lower than with 11-day filgrastim (7% vs 12.5%), and 10.5% lower than with 6-day filgrastim (7% vs 17.5%). Costs were taken from official price lists or the literature and included drugs, drug administration, FN-related hospitalizations and subsequent medical costs. Breast cancer mortality and all-cause mortality were obtained from official statistics. The main outcome measures were the costs ( pound, year 2006 values) per percentage decrease in (absolute) FN risk, per FN event avoided, per life-year gained (LYG), and per QALY gained. Model robustness was tested using deterministic and probabilistic sensitivity analyses., Results: Pegfilgrastim was cost saving compared with 11-day filgrastim ( pound 3196 vs pound 4315). Compared with 6-day filgrastim, pegfilgrastim was associated with a cost of pound 4200 per FN event avoided, or pound 42 per 1% decrease in absolute risk of FN, in scenario 1. In scenario 2, pegfilgrastim provided 0.055 more LYGs or 0.052 more QALYs at a minimal cost increase of pound 441 ( pound 3196 vs pound 2754) per person, yielding an incremental cost-effectiveness ratio (ICER) of pound 8075/LYG or pound 8526/QALY. In scenario 3, when all potential benefits of G-CSF were considered, the ICER became pound 3955/LYG or pound 4161/QALY. Results were most sensitive to the relative risk of FN for 6-day filgrastim versus pegfilgrastim., Conclusion: In this UK analysis, pegfilgrastim appears to dominate 11-day use of filgrastim. The value of pegfilgrastim versus 6-day filgrastim at pound 4161-8526/QALY was very favourable compared with the commonly used threshold in the UK. In this setting, primary prophylaxis with pegfilgrastim may be cost effective compared with filgrastim.

Background: For women with early stage breast cancer, physician-patient discussion of breast reconstruction is an essential step in their participation in the decision-making process for their treatments. This study examines sociodemographic variation of physician-patient discussion of breast reconstruction and explores the impact of this discussion on the use of breast reconstruction., Methods: We used data from the Los Angeles Women's Study, a population-based study of women 50 years and older with breast cancer. Bivariate and multivariate logistic regression models were used to estimate the impact of patient and hospital characteristics on self-reported receipt of physician-patient discussion and use of breast reconstruction., Results: Of 315 post-mastectomy women, 81% and 27% reported physician-patient discussion and use of breast reconstruction, respectively. In multivariable analysis, women with an annual income <$20,000 were less likely to have physician-patient discussion than women with annual income > or =$40,000 (OR = 0.23, 95% CI 0.07-0.82). Among the subset of women with physician-patient discussion, chest wall radiation, a known characteristic associated with higher rates of reconstruction complications, became an additional significant negative predictor of reconstruction., Conclusions: Lower income women are at risk of not receiving physician-patient discussion of breast reconstruction. Physician-patient discussion of breast reconstruction appears to decrease the use of breast reconstruction among women with clinical characteristics associated with higher rates of reconstruction complications and failure. This highlights the need for interventions to increase physician-patient discussion of breast reconstruction among lower income women.

Background: When 2 treatment choices (ie, mastectomy vs. breast conserving therapy) show no difference in a primary clinical outcome (ie, survival), patient satisfaction becomes an important marker of the quality of care received., Objectives: To assess the impact of physician-patient discussion of primary surgical treatment outcomes on patients' satisfaction with medical care (MC) among women with incident breast cancer (BC)., Method: We used self-report data of a population-based survey of 495 women >or=50 years of age with stage I-II BC in Los Angeles, California in 2000 conducted a mean of 7.5 and 24 months after diagnosis. Using multivariable analyses, we evaluated the impact of physician-patient outcome discussions (ie, BC recurrence, BC survival, breast appearance, and arm swelling/pain/movement difficulty) on patient satisfaction at baseline and follow-up., Results: Most women were satisfied with their MC (>65%). More than half reported physician-patient discussions of BC recurrence (54%), breast appearance (50%), and arm pain/swelling/movement difficulty (55%). Thirty-one percent discussed BC survival. Women who discussed arm swelling, pain, movement difficulty were significantly more likely to be satisfied at baseline (odds ratio: 1.8, 95% confidence interval: 1.1-3.0, P < 0.05) and follow-up (odds ratio: 1.9, 95% confidence interval: 1.2-3.0, P > 0.01). The more treatment outcomes patients discussed with their physicians, the higher patient satisfaction ratings were at baseline and follow-up., Conclusions: Physician-patient discussions of BC treatment outcomes were highly correlated with patients' satisfaction with overall MC regardless of the procedure received. This suggests that the quality of BC care should include assessments of physician-patient communication.

OBJECTIVES: Patients with cancer who are treated with chemotherapy report adverse events during their treatment, which can affect their quality of life and increase the likelihood that their treatment will not be completed. In this study, patients' perceptions of the physician-patient relationship and communication about cancer-related issues, particularly adverse events were examined. METHODS: We surveyed 508 patients with cancer concerning the occurrence of adverse events and their relationship and communication with their physicians regarding cancer, treatment, and adverse events. RESULTS: Most individuals surveyed (>90%) discussed diagnosis, treatment plan, goals, and schedule, and potential adverse events with their physicians before initiating chemotherapy; approximately 75% of these individuals understood these topics completely or very well. Physician-patient discussions of adverse events were common, with tiredness, nausea and vomiting, and loss of appetite discussed prior to chemotherapy in over 80% of communications. These events were also the most often experienced (ranging in 95% to 64% of the respondents) along with low white blood cell counts (WBCs), which were experienced in 67% of respondents. Approximately 75% of the individuals reported that their overall quality of life was affected by adverse events. CONCLUSIONS: These findings suggest that discussions alone do not provide patients with sufficient understanding of the events, nor do they appear to adequately equip patients to cope with them. Therefore, efforts to improve cancer care should focus on developing tools to improve patients' understanding of the toxicities of chemotherapy, as well as providing resources to reduce the effects of adverse events.

Objectives: To examine the use of financial incentives related to performance on quality measures reported by oncologists and surgeons associated with a population-based cohort of patients with breast cancer in Los Angeles County, California, and to explore the physician and practice characteristics associated with the use of these incentives among breast cancer care providers., Study Design: Cross-sectional observational study., Methods: Physician self-reported financial arrangements from a survey of 348 medical oncologists, radiation oncologists, and surgeons caring for patients with breast cancer in Los Angeles County (response rate, 76%). Physicians were asked whether they were subject to financial incentives for quality (ie, patient satisfaction surveys and adherence to practice guidelines). We examined the prevalence and correlates of incentives and performed multivariate logistic regression analyses to assess predictors of incentives, controlling for other covariates., Results: Twenty percent of respondents reported incentives based on patient satisfaction, and 15% reported incentives based on guideline adherence. The use of incentives for quality in this cohort of oncologists and surgeons was modest and was primarily associated with staff- or group-model health maintenance organization (HMO) settings. In other settings, important predictors were partial physician ownership interest, large practice size, and capitation., Conclusions: Most cancer care providers in Los Angeles County outside of staff- or group-model HMOs are not subject to explicit financial incentives based on quality-of-care measures. Those who are, seem more likely to be associated with large practice settings. New approaches are needed to direct financial incentives for quality toward specialists outside of staff- or group-model HMOs if pay-for-performance programs are to succeed in influencing care.

Purpose: This study examines the burden of symptoms by treatment type and patient characteristics in a population-based sample of newly diagnosed breast cancer patients., Methods: Using the Los Angeles County SEER Registry Rapid Case Ascertainment, we identified a cohort of breast cancer patients in 2000 and conducted telephone surveys in English and Spanish among participants., Results: We completed interviews of 1,219 breast cancer patients and found almost half (46%) had at least one severe symptom (any of the following: nausea/vomiting, arm problems, hot flashes, vaginal dryness, difficulty sleeping) that interfered with her daily functioning or mood. Multi-variate analysis controlling for patient characteristics and treatment showed that older (OR=0.90; P<0.000), black (OR=0.50; P<0.000), Hispanic Spanish-speaking (OR=0.37; P<0.000), widowed or never married (OR=0.68; P=0.049), and working (OR=0.72; P=0.024) women were less likely to report severe symptoms than other women. Number of comorbid conditions (OR=1.21; P<0.000) and receipt of chemotherapy (OR=1.48; P=0.040) were positively associated with reporting symptoms., Conclusion: These findings estimate the prevalence of several mutable symptoms in breast cancer patients that can be addressed by appropriate treatments. Comorbidity is a significant predictor of symptoms, especially amongst those receiving chemotherapy. Variation in symptom reporting occurred by race/ethnicity and other sociodemographic characteristics, raising questions of different thresholds for reporting symptoms or truly fewer symptoms for some sociodemographic groups. Population-based estimates of the probability of symptoms in women with incident breast cancer can be used to provide patient education about potential outcomes following the treatment of breast cancer.

Purpose: With improved patient survival from breast cancer, more interest has evolved regarding the symptoms women experience in association with breast cancer treatments. We studied the extent to which symptoms for women with incident breast cancer are addressed by their physicians and how symptom management varies with patient characteristics., Methods: As part of the Los Angeles Women's (LAW) Study, we categorized women from a population-based study of incident breast cancer (n = 1,219) as having an unmet need if she had at least one severe symptom (any of the following: nausea/vomiting, arm problems, hot flashes, vaginal dryness, difficulty sleeping) for which she did not receive the help she wanted. Multivariable analyses predicted having any unmet need as a function of patient demographic and health characteristics., Results: The prevalence of unmet need varied by the type of symptom with the highest proportion of women receiving help for nausea and vomiting (0.91) and the lowest for vaginal dryness (0.48). Black women (OR = 3.61, 95% CI: [1.57, 8.31]), and Spanish-speaking Hispanic women (OR = 2.69, 95% CI: [1.22, 5.94]) were significantly more likely than white women to report an unmet need. More black and Hispanic women compared to white women cited the doctor not thinking treatment would benefit her (P = 0.02), not appreciating how much the problem bothered her (P = 0.03), not knowing about treatments (P < 0.0001), or insurance/cost barriers (P = 0.009) as reasons for her unmet need., Conclusion: These results show the persistence of racial disparities in the receipt of appropriate care within the health care system.

Background: The number of long-term survivors after a cancer diagnosis is increasing, yet relatively few studies have addressed survivors' reported symptoms beyond the initial year after diagnosis., Methods: The symptom reports of 474 survivors of colon and rectal cancer from 5 US metropolitan areas were collected during 2002-2003 as part a larger study of the quality of care for patients with cancer diagnosed in 1998. The relation between the prevalence of reported symptoms and prior treatments received was analyzed, adjusting statistically for other patient characteristics., Results: Sixty-nine percent of the survivors had colon cancer and 31% had rectal cancer. The most commonly reported symptoms were "fatigue" (23%), "negative feelings about body appearance" (14%), "diarrhea" (13%), and "constipation" (7%). Higher percentages of respondents attributed health effects to cancer or its treatment including "worry about health" (24%), "physical discomfort" (19%), and "activity limitations" (15%). In general, prior treatment was not associated with symptom prevalence. However, radiation therapy recipients and patients that received a diverting ostomy were more likely than others to report some of the symptoms we studied. Attribution of health effects to disease or treatment did not vary by prior treatment except that recipients of radiation therapy were more likely than others to report limitations in their activities (30% vs 10%; P = .003)., Conclusions: Among colorectal cancer survivors the prevalence of symptoms at 4 years was low and relatively comparable to published estimates for the general population, but some survivors continue to attribute health effects to cancer or its treatment.

Background: Among breast cancer patients, tamoxifen use is associated with reduced risk of disease relapse and death, but it is often difficult for women to sustain therapy during the 5 years required to obtain maximum benefit., Objectives: We sought to examine the influence of patient-centered care activities on ongoing tamoxifen use 4 years after initiation, we examined key components of patient-centered care and rates of ongoing tamoxifen., Methods: Using a prospective cohort study that included observational data from the National Initiative for Cancer Care Quality (NICCQ), we studied 881 patients with stage I-III breast cancer who were registered with an initial diagnosis in 1998 by an American College of Surgeons-approved hospital cancer registry in 1 of 5 metropolitan areas, who initiated tamoxifen treatment. A patient survey and medical record abstraction were used as measurements., Results: Among women who initiated tamoxifen, 79% were still taking it 4 years later. Other than older age and the severity of side effects, other demographic, clinical and cancer characteristics, and treatments did not predict ongoing tamoxifen use. In contrast, after adjusting for these factors, the proportion of patients with ongoing tamoxifen use was lower for patients reporting less support than needed (82% vs. 69%, P = 0.0051), less than wanted role in decision-making (80% vs. 70%, P = 0.0486), decision-making about tamoxifen without doctor input (79% vs. 64%, P = 0.0182), and for patients who weren't told about side effects in advance (82% vs. 72%, P = 0.0016)., Conclusions: Although age and the severity of side-effects remain important, patient-centered care was a primary mediator of patient adherence to ongoing cancer treatment with tamoxifen.

Goals of Work: The National Cancer Institute's Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium is conducting a population-based study of newly diagnosed patients with lung and colorectal cancer to describe the experience of persons living with cancer and to understand which barriers present the most significant obstacles to their receipt of appropriate care. The keystone to this effort is the baseline patient survey administered approximately 4 months after diagnosis., Patients and Methods: We developed a survey to obtain information from patients newly diagnosed with lung and colorectal cancer about their personal characteristics, decision making, experience of care, and outcomes. We conducted a pilot study to evaluate the feasibility of a lengthy and clinically detailed interview in a convenience sample of patients within 8 months of diagnosis (n=71)., Main Results: The median length of the interviews was 75 min for patients with lung cancer (range 43-130) and 82 min for patients with colorectal cancer (range 46-119). Most patients had received some form of treatment for their cancer: 66.1% had undergone surgery, 28.2% had received radiation therapy, and 54.9% were treated with chemotherapy. In addition, 26.7% reported their overall health was less than 70 on a 0-100 scale, demonstrating that patients with substantial health impairment were able to complete the survey., Conclusions: A clinically detailed survey of newly diagnosed lung and colorectal cancer patients is feasible. A modified version of this survey is being fielded by the CanCORS Consortium and should provide much needed population-based data regarding patients' experiences across the continuum of cancer care and their outcomes.

Purpose: In 1999, the National Cancer Policy Board called attention to the quality of cancer care in the United States and recommended establishing a quality monitoring system with the capability of regularly reporting on the quality of care for patients with cancer., Methods: Using data from a patient survey 4 years after diagnosis and review of medical records, we determined the percentage of stage I to III breast cancer and stage II to III colorectal cancer survivors in five metropolitan statistical areas (MSAs) across the United States who received recommended care specified by a comprehensive set of explicit quality measures., Results: Two thousand three hundred sixty-six (63%) of 3,775 eligible patients responded to the survey, and 85% consented to have their medical records reviewed. Our final analytic sample (n = 1,765) included 47% of the eligible patients. Patients with breast and colorectal cancer received 86% of recommended care (95% CI, 86% to 87%) and 78% of recommended care (95% CI, 77% to 79%), respectively. Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and significant variation across MSAs was observed for seven quality measures. The percent adherence was less than 85% for 14 of the 25 colorectal cancer measures, and one quality measure demonstrated statistically significant variation across the MSAs., Conclusion: Initial management of patients with breast and colorectal cancer in the United States seemed consistent with evidence-based practice; however, substantial variation in adherence to some quality measures point to significant opportunities for improvement.

Evidence-based guidelines recommend regular colorectal cancer (CRC) screening for adults 50 years and older, yet screening rates remain very low. In this paper we describe the challenges associated with recruitment and retention of provider organizations (POs) for a group randomized, controlled effectiveness trial to increase CRC screening, among patients in a managed care health insurance plan. Using the health plan as the sampling frame, we recruited POs to test a facilitated quality improvement program to increase CRC screening. Defined eligibility and recruitment procedures were used as part of this process. We successfully recruited 36 POs over the course of 9 months; however, there were many challenges associated with the recruitment and retention process, including difficulties in (a) identifying the PO medical director and the individual authorized to agree to study participation, (b) making contact with the medical director, and (c) obtaining the materials necessary to initiate the study. All of these factors delayed the research substantially. Retention activities were also a major challenge in that one-third of the medical directors changed during the course of the intervention. This study benefited from a strong partnership between the health plan and the research group. Although many challenges exist, there are tremendous opportunities that result from the design and conduct of effectiveness research in existing POs. Successful implementation of programs that are feasible and take advantage of existing quality improvement mechanisms within the PO has potential to improve CRC screening rates and can have a major public health impact.

Purpose: Decisions regarding treatment for early-stage prostate cancer are frustrated not only by inadequate evidence favoring one treatment modality but also by the absence of data comparing quality among providers. In fact, the choice of provider may be as important as the choice of treatment. We undertook this study to develop an infrastructure to evaluate variations in quality of care for men with early-stage prostate cancer., Methods: We enlisted several sources to develop a list of proposed quality-of-care indicators and covariates. After an extensive structured literature review and a series of focus groups with patients and their spouses, we conducted structured interviews with national academic leaders in prostate cancer treatment. We then convened an expert panel using the RAND consensus method to discuss and rate the validity and feasibility of the proposed quality indicators and covariates., Results: The panel endorsed 49 quality-of-care indicators and 14 covariates, which make up our final list of candidate measures. Several domains of quality are represented in the selected indicators, including patient volume, pretreatment referrals, preoperative testing, interpretation of pathology specimens, and 10-year disease-free survival. Covariates include measures of case-mix, such as patient age and comorbidity., Conclusion: This study establishes a foundation on which to build quality-of-care assessment tools to evaluate the treatment of early-stage prostate cancer. The next step is to field-test the indicators for feasibility, reliability, validity, and clinical utility in a population-based sample. This work will begin to inform medical decision-making for patients and their physicians.

Purpose: The delivery of quality care to all patients with cancer has been named as a national priority within the American health care system. This article addresses the issues critical to case identification in cancer quality measurement and recommends possible strategies for accurately identifying a population of cancer patients., Methods: We present the measurement issues associated with the basic challenges of case identification strategies for quality measurement. We discuss two basic challenges: (1) accurately identifying all patients with the defining characteristics (eg, a diagnosis of breast cancer), and (2) identifying only patients with these characteristics., Results: Possible options for identifying newly diagnosed patients include using claims or other administrative data, cancer registries, cancer registry rapid case ascertainment, pathology laboratories, and physicians' offices. In the published literature, the sensitivity of claims varies from 75% to 95%, whereas central registries must have a 90% completeness rate to be certified. Most of these approaches, however, involve limitations to obtaining valid and comparable data across multiple settings., Conclusion: Using an existing data collection system staffed by skilled data collectors and managers should result in substantially more accurate and timely data. Registry officials and the government agencies that provide their support should be encouraged to adopt quality-of-care analyses as an important purpose of the registry system and to enhance their capacity to rapidly ascertain cases, collect the appropriate identifying information needed for patient contact, and verify stage at diagnosis. In order to meet the growing demand for timely, accurate information about quality of care, registries are likely to require additional support so they can enhance their capacity to rapidly ascertain cases, collect the appropriate identifying information needed for patient contact, and verify stage at diagnosis.

Purpose: To critically review studies that describe patterns of care for breast cancer patients and to examine the data sources used for case identification and determining patterns of care., Methods: We searched the MEDLINE database (National Library of Medicine, Bethesda, MD) in August 2001 for studies of breast cancer care published from January 1985 to June 2001. Thirty-eight articles, describing 32 studies, met the inclusion criteria for this review., Results: According to the patterns of care literature, approximately 10% of women do not have an axillary lymph node dissection, 11% to 26% do not have their hormone receptor status reported, 20% do not receive radiation after breast-conserving surgery, and 30% to 70% of women with lymph node-positive breast cancer are not prescribed tamoxifen. Twenty-five (78%) of the studies relied on cancer registries for case identification. Cancer registries (47%) and the medical record (38%) were the most frequent sources of data on process of care. Twenty percent of the articles reported using more than one data source to determine patterns of care., Conclusion: Although more patterns of care research has taken place in breast cancer than in any other oncologic condition, we found the available data had many limitations. These limitations highlight the challenges of quality-of-care research. To track changes in the quality of cancer care that may result from our rapidly transforming health care system, we need reliable data on the quality of current practice.

Objectives: In 1999, California was considering legislation to fund breast cancer treatment for its uninsured. We sought to define the most cost-effective breast cancer benefits package in order to inform this debate., Methods: We use cost-effectiveness analysis to calculate the additional costs and benefits of various adjuvant therapy strategies, radiation after breast conserving surgery, and reconstruction compared to those of surgery alone in order to define the most cost-effective breast cancer benefits package for uninsured women., Results: Using cost-effectiveness analysis, we define a Minimum Breast Cancer Benefits Package that includes only the most cost-effective life-saving breast cancer treatments. To provide these benefits for an estimated 550 breast cancer patients will cost $10,200,000. We present two options that each cost an additional $1,700,000 - to expand the benefits to these patients to include post-mastectomy radiation and breast reconstruction; or to provide the Minimum Package to an additional 93 uninsured women., Conclusions: California legislators must decide whether to offer comprehensive benefits to a limited number of breast cancer patients or to provide only the most life-saving treatments to a greater number of women.

Background: Various groups have called for a national system to monitor the quality of cancer care. The validity of cancer registry data for quality of cancer care has not been well studied. We investigated the validity of such information in the California Cancer Registry., Methods: We compared registry data associated with care with data abstracted from the medical records of patients diagnosed with breast cancer. We also calculated a quality score for each subject by determining the proportion of four evidence-based quality indicators that were met and then compared overall quality scores obtained from registry and medical record data. All statistical tests were two-sided., Results: Records of 304 patients were studied. Compared with the medical record data gold standard, the accuracy of registry data was higher for hospital-based services (sensitivity = 95.0% for mastectomy, 94.9% for lumpectomy, and 95.9% for lymph node dissection) than for ambulatory services (sensitivity = 9.8% for biopsy, 72.2% for radiation therapy, 55.6% for chemotherapy, and 36.2% for hormone therapy). On average, quality scores calculated from registry data were 11 percentage points (95% confidence interval [CI] = 9 to 13 percentage points, P<.001) lower than those calculated from medical record data. Quality scores calculated from registry data were 5 percentage points (95% CI = 3 to 7 percentage points) lower for patients with stage I breast cancer, 16 percentage points (95% CI = 12 to 20 percentage points) lower for patients with stage II breast cancer, and 20 percentage points (95% CI = 8 to 32 percentage points) lower for patients with stage III breast cancer than were corresponding scores calculated from medical record data (all P<.001). The greater difference in quality scores for stage II and III patients revealed that disease severity and setting of care affected the validity of registry data., Conclusions: Cancer registry data for quality measurement may not be valid for all care settings, but registries could provide the infrastructure for collecting data on the quality of cancer care. We urge that funding be increased to augment data collection by cancer registries.

Background: To the authors' knowledge, no analysis has examined the specific components of drug spending for overall cancer care. The authors' objective was to quantify and characterize trends in outpatient drug expenditures for cancer patients., Methods: The authors retrospectively analyzed pharmacy and outpatient professional claims data from commercial and Medicare health maintenance organization enrollees with a solid tumor diagnosis in 1995 and 1998. Charges were subdivided by type of drug (antineoplastic drugs, chemotherapy adjuncts, supportive drugs, and drugs unrelated to cancer treatment)., Results: In 1995, 14,663 cancer patients received outpatient drug treatment and 13,829 patients in 1998. Total charges increased from $17.9 million (mean charge of $1218 per patient) to $27.9 million (mean charge of $2003 per patient), an average annual increase of 16%. Antineoplastic therapy constituted the largest component of cancer-related drug costs (67%) and represented 76% of the increase from 1995 to 1998. Most charges were incurred in the professional setting for agents administered by injection. The primary explanation for the increases appeared to be a shift in treatment patterns toward newer, more expensive antineoplastic agents. Supportive therapy represented 17% of the increase in cancer drug costs, followed by chemotherapy adjuncts (7%). Charges for drugs unrelated to cancer therapy increased by 21% per year., Conclusions: Antineoplastic therapy administered in an office or clinic was the single most important cost driver, with newer more expensive agents replacing older, less expensive drugs. Attempts to understand and control outpatient drug cost increases for cancer patients should focus primarily on antineoplastic therapy, especially the appropriate substitution of newer agents for older, less expensive alternatives. Some non-chemotherapy cancer drugs may offer an opportunity to improve quality of life with a relatively small effect on overall cancer drug costs., (Copyright 2002 American Cancer Society. DOI 10.1002/cncr.10347)