Jennifer Malin

Risk of hospitalization for neutropenic complications of chemotherapy in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis: A retrospective cohort study

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-Hodgkins 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.

Comparative effectiveness of filgrastim, pegfilgrastim, and sargramostim as prophylaxis against hospitalization for neutropenic complications in patients with cancer receiving chemotherapy.

BackgroundComparative effectiveness of filgrastim, pegfilgrastim, and sargramostim in preventing hospitalization for febrile neutropenia (FN) during myelosuppressive chemotherapy has not been well characterized and is an important clinical question in oncology. MethodsThis study used a retrospective cohort design and US healthcare claims data. Source population included patients with solid tumors receiving filgrastim, pegfilgrastim, or sargramostim during their first observed course of chemotherapy between July 2001 and June 2007. For each patient, every unique chemotherapy cycle during the course was identified, along with each cycle in which filgrastim, pegfilgrastim, or sargramostim was administered by the fifth day of the cycle (ie, as prophylaxis). Risks of hospitalization for neutropenic complications (broad definition: admission with a diagnosis of neutropenia, fever, or infection; narrow definition: admission with a diagnosis of neutropenia) and for any reason were examined on a cycle-specific basis during all the cycles in which colony-stimulating factor prophylaxis was administered. Unadjusted and adjusted odds ratios (ORs) for hospitalization were estimated. ResultsRisk (unadjusted) of hospitalization for neutropenic complications (narrow definition) was 2.1% for filgrastim prophylaxis (n=8286), 1.1% for pegfilgrastim prophylaxis (n=67,247), and 2.5% for sargramostim prophylaxis (n=1736). Corresponding risks of hospitalization based on the broad definition were 4.0%, 2.6%, and 5.1%. Risks of all-cause hospitalization were 7.9%, 5.3%, and 9.6%, respectively. Adjusted odds of hospitalization were significantly higher for filgrastim [OR (range across the 3 alternative measures of hospitalization): 1.58-1.79; P<0.001] and sargramostim (OR: 1.89-2.68; P<0.001) versus pegfilgrastim. ConclusionsRisk of hospitalization for neutropenic complications during cancer chemotherapy is lower with pegfilgrastim prophylaxis than with filgrastim or sargramostim prophylaxis.

Developing a reliable, valid, and feasible plan for quality-of-care measurement for cancer: how should we measure?

Background. Recent changes in the US health care delivery system have raised expectations that the medical marketplace will compete on quality and cost of care. This effort will require a systematic evaluation of the measurement of quality of care as it applies to cancer and other critical conditions. Objectives. To articulate the components of the design of quality-of-care measurement systems that must be considered and optimally manipulated to generate feasible, reliable, and valid data pertinent to patients with cancer. Research Design. A synthesis of information obtained from literature reviews and experience. Measures. Four key areas of design that influence quality-of-care measurement scores are discussed: case identification, data source, data-collection strategies, and the quality of the care-measurement model. Results. Challenges associated with these design and measurement strategies are defined and discussed. Conclusions. Policy analyses vary as a function of measurement domains. The design of a quality-of-care measurement system should consider trade-offs between validity and burden by considering the intricate relations between domains of measurement.

Impact of primary prophylaxis on febrile neutropenia within community practices in the US.

Abstract Objective: To determine if granulocyte-colony-stimulating factor (G-CSF) primary prophylaxis is associated with a lower risk of febrile neutropenia (FN) than non-primary prophylaxis. Methods: This was a retrospective, cohort study of medical records from a random sample of patients with solid tumours and lymphomas treated in 99 community oncology practices in 2003 (n=5319). Consecutively-sampled patients treated with chemotherapy and either filgrastim (Neupogen*,†), pegfilgrastim (Neulasta*,†) or no G-CSF were included (n=3123). Multivariate logistic regression estimated the odds of FN in patients receiving G-CSF primary prophylaxis (within 3 days of first chemotherapy cycle) compared with non-primary prophylaxis (delayed or no G-CSF). Results: Patients receiving primary prophylaxis were less likely to develop FN than patients receiving non-primary prophylaxis (OR=0.49, 95% CI 0.34–0.71, p<0.001). Chemotherapy characteristics were associated with development of FN including, receipt of at least three chemotherapy drugs versus one (OR=2.13, 95% CI 1.17–3.89, p=0.014) and regimens with at least one myelosuppressive drug (OR=2.37, 95% CI 1.19–4.73, p=0.014). Conclusion: Patients receiving G-CSF primary prophylaxis had significantly lower odds of developing FN than those receiving non-primary prophylaxis. Incidence of FN may be underestimated, as care not recorded in the medical oncologists chart was not captured.

Using breast cancer quality indicators in a vulnerable population

Adherence to quality indicators may be especially important to disease‐specific outcomes for uninsured, vulnerable patients. The objective of this study was to measure adherence to National Initiative for Cancer Care Quality (NICCQ) breast cancer quality indicators in a public hospital and compare performance to published rates in a previously collected 5‐city cohort.

Quality of Care for Breast Cancer for Uninsured Women in California Under the Breast and Cervical Cancer Prevention Treatment Act

PURPOSE The objective of this study was to evaluate the quality of care provided to uninsured women with breast cancer who received treatment through the Breast and Cervical Cancer Prevention Treatment Program (BCCTP). METHODS Participants included women with stage I to III breast cancer (n = 658) from a consecutive sample of women 18 years or older who received coverage through the California BCCTP between February 2003 and September 2005 who consented to a survey and medical record review (61% response rate). Quality of breast cancer care was evaluated using 29 evidence-based quality measures developed for the National Initiative for Cancer Care Quality (NICCQ). NICCQ, a largely insured cohort of women diagnosed with stage I to III breast cancer in 1998, was used to benchmark the results. RESULTS Twenty-three percent of women presented with stage III disease compared with fewer than 10% nationally. Patients received 93% of recommended care (95% CI, 92% to 93%). Adherence to recommended care within domains ranged from 87% for post-treatment surveillance (95% CI, 84% to 90%) to 97% for diagnostic evaluation (95% CI, 96% to 97%). Compared to the NICCQ cohort, adherence to quality measures was as good or better for the BCCPT cohort in all domains except post-treatment surveillance. CONCLUSION The BCCTP has made important inroads in providing poor, uninsured women with access to high quality care when faced with the diagnosis of breast cancer; however, many present at an advanced stage, which is associated with worse outcomes.

Lower patient ratings of physician communication are associated with unmet need for symptom management in patients with lung and colorectal cancer

PURPOSE Little is known about factors associated with unmet needs for symptom management in patients with cancer. METHODS Patients with a new diagnosis of lung and colorectal cancer from the diverse nationally representative Cancer Care Outcomes Research and Surveillance cohort completed a survey approximately 5 months after diagnosis (N = 5,422). We estimated the prevalence of unmet need for symptom management, defined as patients who report that they wanted help for at least one common symptom (pain, fatigue, depression, nausea/vomiting, cough, dyspnea, diarrhea) during the 4 weeks before the survey but did not receive it. We identified patient factors associated with unmet need by using logistic regression with random effects to account for clustering within study sites. RESULTS Overall, 15% (791 of 5,422) of patients had at least one unmet need for symptom management. Adjusting for sociodemographic and clinical factors, African American race, being uninsured or poor, having early-stage lung cancer, and the presence of moderate to severe symptoms were associated with unmet need (all P < .05). Furthermore, patients who rated their physicians communication score < 80 (on a 0 to 100 scale) had adjusted rates of an unmet need for symptom management that were more than twice as high as patients who rated their physicians with a perfect communication score (23.1% v 10.0%; P < .001). CONCLUSION A significant minority of patients with newly diagnosed lung and colorectal cancer report unmet needs for symptom management. Interventions to improve symptom management should consider the importance of physician communication to the patients experience of disease.

Colony-Stimulating Factor Use and Impact on Febrile Neutropenia Among Patients with Newly Diagnosed Breast, Colorectal, or Non–Small Cell Lung Cancer Who Were Receiving Chemotherapy

To determine the impact of primary prophylactic colony‐stimulating factor (CSF) use on febrile neutropenia in a large patient population receiving contemporary chemotherapy regimens to treat breast cancer, colorectal cancer, or non–small cell lung cancer (NSCLC).

The structural landscape of the health care system for breast cancer care: results from the Los Angeles Women's Health Study.

Abstract:  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.

How might VA-Medicare differences inform the delivery of end-of-life cancer care?

In this issue of Cancer, Keating et al evaluated differences in the use of aggressive medical interventions during the last 30 days of life between elderly patients with metastatic lung or colorectal cancer treated in the Veterans Health Administration (VHA) medical system or under fee-for-service Medicare. By using propensity score matching to control for differences in the patient populations, they compared receipt of chemotherapy within 14 days of death, intensive-care unit admissions within 30 days of death, and >1 emergency room visit within 30 days of death for 2913 male veterans who were diagnosed or received their initial course of treatment in the Department of Veterans Affairs (VA) and 2913 nonveterans by using linked VA-Medicare data (for veterans) and SEER-Medicare data (for nonveterans). Adjusted comparison found nonveterans more likely than veterans to receive chemotherapy within 14 days of death (7.5% vs 4.6%), more likely to be admitted to an intensive care unit (19.7% vs 12.5%), or to make more than 1 emergency room visit (14.7% vs 13.1%) in their last month of life. Although aggressive medical interventions may, at times, be indicated in patients with metastatic cancer, their use at the end of life raises concerns. Although much of the focus on high-intensity late-life care is about cost, such care also likely worsens symptom control and quality of life without improving survival. The multisite, prospective, longitudinal, Coping With Cancer cohort study focused on patients with advanced cancer and their informal caregivers. Among the 332 participants who died, investigators found that more aggressive medical care was associated with worse patient quality of life and higher risk of major depressive disorder in bereaved caregivers, whereas longer hospice stays were associated with better patient quality of life. Wright et al found lower rates of ventilation (1.6% vs 11.0%), resuscitation (0.8% vs 6.7%), and intensive-care unit admission (4.1% vs 12.4%), as well as earlier hospice enrollment (65.6% vs 44.5%) among patients who reported having end-of-life discussions. In the larger cohort of 603 patients, baseline end-of-life discussions were also associated with one-third lower overall costs. 2,3 Although the Keating et al study does not elucidate the reasons for the differences it observed, the authors offer several possible explanations. They suggest that 1 critical difference between VA and fee-for-service Medicare is the absence in VA services of financial incentives that reward providers for providing high-cost aggressive interventions when patients and families may be better served by quality-of-life–focused care. In addition, better end-of-life care may be fostered by the VA’s integrated delivery system, which is tied together with an electronic medical record, and includes comprehensive services delivered in community clinics, long-term care, and hospitals. Furthermore, perhaps veterans who tend to be sicker and more disabled than the general population are more predisposed than nonveterans to limit aggressive care when they are nearing the end of life. In support of these hypotheses, the VA differs from the Medicare environment in important ways. For one, hospitals, physicians, and patients face different, complex, financial incentives in the 2 systems, although the manner and extent to which they may influence end-of-life care have not been examined. Under fee-for-service Medicare, hospitals typically function as third-party purchasers, and Medicare’s physician incentives to restrict care are limited, although costs to