Biomedical subjects

Craig C Earle

Publications and source records attributed to Craig C Earle.

51 records · Page 3Linked to original sources

PubMed2003

Identifying potential indicators of the quality of end-of-life cancer care from administrative data.

PURPOSE: To explore potential indicators of the quality of end-of-life services for cancer patients that could be monitored using existing administrative data. METHODS: Quality indicators were identified and assessed by literature review for proposed indicators, focus groups with cancer patients and family members to assess candidate indicators and generate new ideas, and an expert panel ranking the meaningfulness and importance of each potential indicator using a modified Delphi approach. RESULTS: There were three major concepts of poor quality of end-of-life cancer care that could be examined using currently-available administrative data (such as Medicare claims): institution of new anticancer therapies or continuation of ongoing treatments very near death; a high number of emergency room visits, inpatient hospital admissions, or intensive care unit days near the end of life; and a high proportion of patients never enrolled in hospice, only admitted in the last few days of life, or dying in an acute-care setting. Concepts such as access to psychosocial and other multidisciplinary services and pain and symptom control are important and may eventually be feasible, but they cannot currently be applied in most data systems. Indicators based on limiting the use of treatments with low probability of benefit or indicators based on economic efficiency were not acceptable to patients, family members, or physicians. CONCLUSION: Several promising claims-based quality indicators were identified that, if found to be valid and reliable within data systems, could be useful in identifying health-care systems in need of improving end-of-life services.

Cancer Care Facilities↗

PubMed2003

Influenza vaccination in elderly patients with advanced colorectal cancer.

PURPOSE: To examine influenza vaccination use in patients undergoing chemotherapy for advanced cancer. METHODS: All Medicare patients treated for stage IV colorectal cancer between 1993 and 1998 while living in one of the regions monitored by the Survival, Epidemiology, and End Results Program who were alive in the fall months and who survived at least 4 months with their cancer were considered eligible to have received vaccination. Their medical bills were analyzed to determine receipt of influenza vaccination and subsequent outcomes. RESULTS: Eligibility criteria were met by 1,225 patients who were undergoing chemotherapy during 1,577 person-years of observation. Overall, 39.7% of patients received influenza vaccination, increasing from 26% in 1993 to 43% in 1998. When vaccination was administered, it was provided by primary care physicians 68% of the time. Vaccinated patients were more likely to be white, of higher socioeconomic status, and to have more comorbidity. Fewer diagnoses of influenza and pneumonia infections were made in vaccinated patients while undergoing treatment. Those patients who were immunized also had fewer chemotherapy interruptions and were more likely to survive through to the beginning of the next fall (hazard ratio, 0.88; 95% confidence interval, 0.77 to 0.99). There was a trend toward decreased resource use among immunized patients. CONCLUSION: This study observed outcomes associated with influenza vaccination that are similar to those reported for patients without cancer. However, rates of immunization are relatively low, and disparities exist for vulnerable populations. As part of delivering high-quality care, oncologists should promote influenza vaccination for their patients who are undergoing treatment for advanced cancer.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

A phase II study of modified deGramont 5-fluorouracil, leucovorin, and oxaliplatin in previously treated patients with metastatic colorectal cancer.

PURPOSE: To evaluate the toxicity and efficacy of a modified deGramont regimen of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin in patients with advanced colorectal cancer who have progressed on at least one but not more than two prior chemotherapy regimens. PATIENTS AND METHODS: Patients with stage 4 colorectal cancer were treated with oxaliplatin 85 mg/m2 by a 2-hour intravenous infusion, followed by leucovorin 500 mg/m2 by a 2-hour intravenous infusion, followed by 5-FU 400 mg/m2 by bolus injection, followed by 5-FU 2.4 g/m2 administered by a 46-hour continuous infusion. Cycles were administered every 2 weeks. RESULTS: Seventy patients were treated and 68 patients had previously received irinotecan. Eleven percent of patients had a partial response, 33% of CEA-evaluable patients had a > or = 50% drop in their CEA level. The median time to progression was 6.2 months, and the median overall survival was 8.7 months. Toxicity was mild to moderate, as 14% of patients experienced grade 3 or 4 neutropenia and 3% of patients experienced grade 3 neuropathy. CONCLUSION: The modified deGramont regimen of 5-FU, leucovorin, and oxaliplatin is tolerable and is associated with a modest degree of antitumor activity in patients who have progressed on both 5-FU and irinotecan.

Adenocarcinoma↗

PubMed2003

Prognostic factors following curative resection for pancreatic adenocarcinoma: a population-based, linked database analysis of 396 patients.

OBJECTIVE: To analyze prognostic factors influencing pancreatic cancer survival following curative resection, using prospectively collected, population-based data. SUMMARY BACKGROUND DATA: Several studies have analyzed the determinants of long-term survival in postresection pancreatic cancer patients, but the majority of these have been single-institutional chart reviews yielding inconsistent results. METHODS: This retrospective cohort study examined 396 Medicare-eligible patients over age 65 who were diagnosed with nonmetastatic pancreatic adenocarcinoma and who underwent surgical resection with curative intent while residing in one of the 11 Survival, Epidemiology, and End Results (SEER) registries between January 1991 and December 1996. Linked Medicare data provided information on treatment and comorbidity, while linked census tract data supplied sociodemographic characteristics. RESULTS: Median survival for the overall study population was 17.6 months, with 1- and 3-year survival rates of 60.1% and 34.3%, respectively. Survival appears to be gradually improving over time, concomitant with a rise in the proportion of patients undergoing surgery in teaching centers. Prognostic variables significantly diminishing survival on univariate analysis included African American race, treatment not in a teaching hospital, lack of adjuvant chemoradiation therapy, as well as histopathologic factors that included tumor size larger than 2 cm in diameter, moderate to poor histologic grade, and positive lymph node metastases. Higher socioeconomic status was associated both with an increased likelihood of receiving adjuvant therapy and improved overall survival. Multivariate analyses indicated the strongest predictors of survival were adjuvant combined chemoradiotherapy, small tumors (<2 cm in diameter), negative lymph nodes, well-differentiated histology, undergoing surgery in a teaching hospital, and high socioeconomic status. CONCLUSIONS: Although biologic characteristics remain important predictors of survival for patients with resected pancreatic cancer, the most powerful determinant is postoperative adjuvant chemoradiation therapy. An interesting finding that warrants further investigation is the effect of socioeconomic status on both the likelihood of receiving adjuvant treatment and subsequent survival, indicating a possible relationship between the quality of care delivered and outcomes.

Adenocarcinoma↗

PubMed2003

The treatment of locally advanced pancreatic cancer: a practice guideline.

BACKGROUND: Pancreatic adenocarcinoma is the fourth most common cause of adult cancer death. About 50% of patients present with metastatic disease, 20% with resectable disease and the remaining 30% of patients are diagnosed with incurable, locally advanced unresectable but nonmetastatic pancreatic cancer. OBJECTIVES: To evaluate the current evidence regarding treatment of incurable, locally advanced, unresectable but nonmetastatic pancreatic cancer and produce an evidence-based practice guideline. METHODS: A systematic review of the literature was performed. The MEDLINE, CANCERLIT, and Cochrane Library databases were searched using the following medical subject heading search terms: 'pancreatic neoplasms', 'chemotherapy, adjuvant', 'radiotherapy', 'immunotherapy', combined with the text words: 'chemotherapy', 'radiotherapy', 'radiation', 'immunotherapy', combined with terms for the following study designs or publication types: practice guidelines, meta-analyses and randomized controlled trials. The Physician Data Query clinical trials database and the proceedings of the annual meetings of the American Society of Clinical Oncology (1996 to 2001) and the American Society for Therapeutic Radiology and Oncology (1999 to 2001) were searched for reports of new or ongoing trials. Relevant literature was selected and reviewed independently, and the reference lists from these sources were searched for additional trials. Interpretation of evidence was resolved by consensus. RESULTS: Eight randomized trials were obtained that met the inclusion criteria. CONCLUSIONS: Recommendations are to offer combined chemotherapy and radiotherapy to suitable patients. The preferred chemotherapeutic agent to combine with radiotherapy is bolus or infusional 5-fluorouracil, but the optimal mode and duration of 5-fluorouracil delivery is unclear. Chemotherapy alone with gem-citabine is an acceptable alternative.

Adenocarcinoma↗

PubMed2002

The outcomes and costs of acute myeloid leukemia among the elderly.

BACKGROUND: The incidence of acute myeloid leukemia (AML) among the elderly can be expected to grow as the population continues to age. However, data on current treatment practices and costs for this form of cancer are sparse. METHODS: We used a retrospective inception cohort design and data from a linkage between 11 Surveillance, Epidemiology, and End Results cancer registries and Medicare administrative claims. We evaluated survival, use of health care resources, use of chemotherapy, and Medicare payments among adults 65 years and older with an initial diagnosis of AML between January 1, 1991, and December 31, 1996. RESULTS: A total of 2657 elderly patients with AML and complete Medicare claims data were identified. The prognosis for these patients was poor, with median survival estimated to be 2 months and a 2-year survival rate of 6%. Mean +/- SE total Medicare payments were $41,594 +/- $870 (in 1998 US dollars), 84% of which was attributed to inpatient payments. In the 2 years after the AML diagnosis, 790 patients (30%) underwent chemotherapy treatment. These patients had costs almost 3 times higher than those of other patients, and their median survival was 6 months longer. The use of hospice care was rare (17% of patients). CONCLUSIONS: Among the elderly, AML is associated with a poor prognosis and substantial costs during the relatively few remaining months of life. Moreover, most patients do not receive active treatment with chemotherapy or hospice services. Further work is needed to characterize this disease and the patient-related factors that influence treatment decisions and associated health outcomes.

Acute Disease↗

PubMed2002

A phase II trial of gemcitabine in patients with advanced hepatocellular carcinoma.

BACKGROUND: There is no effective systemic therapy for patients with hepatocellular carcinoma. A recent trial reported a moderate antitumor activity for gemcitabine among Asian patients with advanced hepatocellular carcinoma. This led to our examination of the efficacy and tolerability of the drug in a population of U.S. patients. METHODS: Thirty patients with measurable, unresectable, or metastatic hepatocellular carcinoma who had received at least one previous form of systemic therapy were enrolled. All patients were required to have adequate major organ function and performance status. Patients received gemcitabine (1000 mg/m(2) intravenously over 30 minutes weekly) for 3 consecutive weeks followed by a 1-week rest. Patients were assessed radiographically every 8 weeks. RESULTS: All 30 patients were evaluable for response and toxicity. Ninety cycles of therapy were administered (median 2, range 1-8). No complete or partial responses were observed. Nine patients (30%) had stable disease (median duration 7.4 months, range 2-17). Median survival for all 30 patients was 6.9 months (95% confidence interval, 4.5-13.5) and the 1-year survival rate was 40%. Mild hematologic toxicity occurred. Two patients (7%) developed Grade 4 neutropenia and one patient (3%) experienced Grade 3 thrombocytopenia. There were no episodes of febrile neutropenia. One patient who had previously undergone orthotopic liver transplantation developed hemolytic-uremic syndrome that resolved with discontinuation of chemotherapy and plasmapheresis. CONCLUSIONS: Although generally well tolerated, gemcitabine had minimal effect in patients with advanced hepatocellular carcinoma.

Adult↗

PubMed2002

Outcomes in patients treated with gemtuzumab ozogamicin for relapsed acute myelogenous leukemia.

The outcomes of treatment with gemtuzumab ozogamicin compared with those of conventional chemotherapy for relapse of acute myelogenous leukemia (AML) were studied. The gemtuzumab ozogamicin group consisted of 104 patients treated in 15 U.S. and 25 European centers for first relapse of AML between May 1997 and December 1998. Conventional chemotherapy recipients consisted of 22 historical control patients who received treatment for their first occurrence of AML at a Boston teaching hospital between January 1991 and December 1994 and who subsequently underwent conventional inpatient reinduction chemotherapy for relapse. Patients in the gemtuzumab ozogamicin group received a two-hour i.v. infusion of 9 mg/m2 for up to three doses with at least two weeks between doses, while the historical controls received conventional chemotherapy, usually consisting of continuous-infusion cytarabine (days 1-7) plus mitoxantrone. Outcomes evaluated included differences in survival and hospitalization (occurrence and duration) for up to six weeks. Both stratified and multivariate regression methods were used in making comparisons. Adjusting for baseline differences, six-week survival rates were similar in the two groups (95% for the historical control group versus 89% for the gemtuzumab ozogamicin group). However, gemtuzumab ozogamicin recipients had significantly fewer total hospital days (adjusted mean, 19 days, versus 35 days), which was consistent with the higher prevalence of outpatient chemotherapy in this group (43% versus 0% among the historical controls). The difference in the number of hospital days was consistent across various baseline and demographic factors. Gemtuzumab ozogamicin appeared to be associated with equivalent survival and fewer total days of hospitalization than conventional chemotherapy in adults with relapsed AML.

Adult↗

PubMed2002

Impact of referral patterns on the use of chemotherapy for lung cancer.

PURPOSE: To determine the extent to which unexplained variation in the use of chemotherapy for advanced lung cancer is due to access to oncologists' services as opposed to treatment decisions made after seeing an oncologist. METHODS: We performed a retrospective cohort study of 12,015 patients over age 65 diagnosed with metastatic lung cancer between 1991 and 1996 while living in one of 11 regions monitored by a Survival, Epidemiology, and End Results (SEER) tumor registry. Assessment by an oncologist and subsequent treatment with chemotherapy were determined by examining linked Medicare claims. RESULTS: Of patients who did not receive chemotherapy, 36% were never assessed by a physician who provides chemotherapy. Patients living in certain areas, those diagnosed in more recent years, and those who received care in a teaching hospital were all more likely to see a cancer specialist. These factors were unrelated to subsequent treatment decisions, however. Conversely, age and comorbidity did not have a significant effect on whether a patient was seen by an oncologist, but they were associated with the likelihood of subsequently receiving chemotherapy. Black race, probably acting as a proxy for lower socioeconomic status, was associated with both a diminished likelihood of seeing a cancer specialist and subsequently receiving chemotherapy. CONCLUSION: Nonmedical factors are important determinants of whether a lung cancer patient is seen by a physician who provides chemotherapy. After seeing such a physician, treatment decisions seem to be mostly explained by appropriate medical factors. Racial and socioeconomic disparities still exist at both steps, however. As therapeutic options expand, referring physicians must ensure that biases and barriers to care do not deprive patients of the opportunity to consider all of their treatment options.

Black or African American↗

PubMed2002

A Phase II study of gemcitabine and docetaxel in patients with metastatic pancreatic carcinoma.

BACKGROUND: Patients with metastatic pancreatic carcinoma have a poor survival. Chemotherapy with gemcitabine is the standard first-line treatment. In a Phase II trial at one academic cancer center, the clinical safety and activity of combining gemcitabine and docetaxel were assessed. METHODS: Patients with previously untreated, advanced pancreatic carcinoma were eligible. Bidimensionally measurable disease or evaluable disease with an elevated tumor marker, good performance status, and adequate organ function were required. Patients received docetaxel 60 mg/m(2) on Day 1 and gemcitabine 600 mg/m(2) on Days 1, 8, and 15 every 28 days. Ciprofloxacin was administered on Days 8-18. Dose attenuations were made as indicated for toxicity. Patients were restaged radiographically after every two cycles. RESULTS: Thirty-four patients were enrolled, and 33 patients were evaluable for response. There were 23 men and 10 women among the evaluable patients. The median age was 63 years, and all patients had an Eastern Cooperative Oncology Group performance status of 0 or 1. Three patients had received prior chemoradiation for postresection adjuvant therapy. One hundred forty-six cycles of chemotherapy were administered, and 5 cycles (3%) in 4 patients (12%) were complicated by febrile neutropenia. Twenty percent and 11% of patients on Day 8 and Day 15 doses of gemcitabine, respectively, were omitted for toxicity. The objective response rate was 18%, and the median survival was 8.9 months (95% confidence interval, 5.2-11.2 months). The 1-year survival rate was 29%. CONCLUSIONS: The combination of gemcitabine and docetaxel in patients with advanced pancreatic carcinoma is well tolerated and is associated with moderate activity despite aggressive dose reduction. Whether combination regimens are more effective than single agents in the treatment of patients with pancreatic carcinoma awaits evaluation in randomized studies.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

Measuring complications of cancer treatment using the SEER-Medicare data.

BACKGROUND: The linkage of SEER registry data with Medicare claims allows the longitudinal tracking of health care and outcomes for patients after a cancer diagnosis. One category of outcomes amenable to research using Medicare claims is complications of cancer treatments: the unintentional, adverse side effects or sequelae of interventions used to treat or palliate cancer patients. RESEARCH DESIGN: The authors review some of the methods and limitations of using Medicare claims to identify both acute and chronic complications of cancer treatments, and present an original analysis comparing survey-based and claims-based complications following radical prostatectomy for prostate cancer to illustrate some of the potential limitations inherent in using claims for this purpose. RESULTS: Utility of the Medicare claims for identifying postdischarge complications varies by the patient type, the initial treatment used, and any subsequent treatment of complications. For patients undergoing surgical interventions, Medicare claims can be used to identify most acute inpatient complications. However, claims data cannot be used as effectively in the long-term to capture chronic complications, particularly when the complication does not consistently prompt an intervention. CONCLUSION: Researchers who use the SEER-Medicare-linked database to assess long-term complications of cancer treatments should exercise caution when designing and interpreting studies. Ideally, for studies of most chronic complications of cancer care, validation studies similar to the one performed here would provide valuable additional evidence to assess the credibility of conclusions based on claims data.

Aged↗

PubMed2002

Methodological issues in the use of administrative claims data to study surveillance after cancer treatment.

BACKGROUND: Administrative claims databases linked to tumor registry data provide an excellent opportunity for studying the follow-up care of cancer patients. RESEARCH DESIGN: Methodological principles of study design are reviewed, using examples drawn from the recently published literature. RESULTS: Most follow-up care is outpatient-based. Therefore, in studies using Medicare claims, the patient should be eligible for Medicare Part B and should not be enrolled in a Medicare HMO. In studies of surveillance testing, it may be appropriate to exclude subjects who are near death, in a hospice, or in whom a new or recurrent cancer develops. The definition of the period for measurements of surveillance testing requires consideration, as does periodicity in patterns of testing. Several analytic methods can be employed, from proportions undergoing testing to survival analysis methods. Measurement of 'surveillance tests' among control subjects (those without cancer) may be useful for comparison with cancer patients. To date, administrative claims data have been most useful in studies investigating the quality of, and disparities in, cancer care. CONCLUSION: With appropriate attention to methodological issues, linked tumor registry and administrative databases can provide important insights into the quality of survivorship care for cancer.

Aged↗

PubMed2002

Identifying cancer relapse using SEER-Medicare data.

INTRODUCTION: Tumor registries capture valid information at the time of cancer diagnosis, but often do not conduct longitudinal follow-up evaluations. However, investigators may be interested in questions relating to subsequent relapsed disease. Linking administrative data to registry data, as in the creation of the SEER (Surveillance, Epidemiology, and End Results) and Medicare data set, can provide the ability to infer the occurrence of relapse in selected situations. METHODS: The authors created different algorithms to detect relapse of acute myelogenous leukemia (AML). A retrospective cohort of patients with AML was identified, and both their billing data and medical records were obtained. The algorithms were then applied to the billing data, the results were compared with medical record review. RESULTS: Eighty-nine patients were identified, of whom 22 were treated for relapsed AML. The sensitivity of the best algorithm for detecting relapse was 86%, and the specificity 99%, with a positive predictive value of 95% and a negative predictive value of 96%. CONCLUSIONS: Identification of relapse from SEER-Medicare data using clinical algorithms is feasible for cancers where a majority of patients receive treatment for relapse, without a "watch and wait" strategy, and where that treatment is with a modality that can be detected in billing data (ie, intravenous chemotherapy, radiation, surgery, or all three). Optimal analytic situations are ones in which the investigator is mostly interested in positive predictive value, less interested in sensitivity, and wants to evaluate outcomes among those patients who receive treatment for their relapsed disease. However, the accuracy of such an approach for cancers other than AML has not yet been established.

Aged↗

PubMed2002

Neoadjuvant or adjuvant therapy for resectable gastric cancer? A practice guideline.

OBJECTIVE: To make recommendations on the use of neoadjuvant or adjuvant therapy in addition to surgery in patients with resectable gastric cancer (T1-4, N1-2, M0). OPTIONS: Neoadjuvant or adjuvant treatments compared with "curative" surgery alone. OUTCOMES: Overall survival, disease-free survival, and adverse effects. EVIDENCE: The MEDLINE, CANCERLIT and Cochrane Library databases and relevant conference proceedings were searched to identify randomized trials. VALUES: Evidence was selected and reviewed by one member of the Cancer Care Ontario Practice Guidelines Initiative (CCOPGI) Gastrointestinal Cancer Disease Site Group and methodologists. A systematic review of the published literature was combined with a consensus process around the interpretation of the evidence in the context of conventional practice, to develop an evidence-based practice guideline. This report has been reviewed and approved by the Gastrointestinal Cancer Disease Site Group, comprising medical oncologists, radiation oncologists, surgeons, a pathologist and 2 community representatives. BENEFITS, HARMS AND COSTS: When compared with surgery alone, at 3 years adjuvant chemoradiotherapy has been shown to increase overall survival by 9% (50% v. 41%, p = 0.005) and to improve relapse-free survival from 31% to 48% (p = 0.001). At 5 years, it has been shown to increase overall survival by 11.6% (40% v. 28.4%) and to improve relapse-free survival from 25% to 38% (p < 0.001). Treatment has been associated with toxic deaths in 1% of patients. The most frequent adverse effects (> grade 3 [Southwest Oncology Group toxicity scale] are hematologic (54%), gastrointestinal (33%), influenza-like (9%), infectious (6%) and neurologic (4%). The radiation fields used can possibly damage the left kidney, resulting in hypertension and other renal problems. Furthermore, this therapy could increase the demand on radiation resources. Physicians and patients should understand the tradeoffs between survival benefit and toxicity and cost before making treatment decisions. RECOMMENDATIONS: After surgical resection, patients whose tumours have penetrated the muscularis propria or involve regional lymph nodes should be considered for adjuvant combined chemoradiotherapy. The current standard protocol consists of 1 cycle of 5-fluorouracil (5-FU) (425 mg/m2 daily) and leucovorin (20 mg/m2 daily) administered daily for 5 days, followed 1 month later by 45 Gy (1.8 Gy/d) of radiation given with 5-FU (400 mg/m2 daily) and leucovorin (20 mg/m2 daily) on days 1 through 4 and the last 3 days of radiation. One month after completion of radiation, 2 cycles of 5-FU (425 mg/m2 daily) and leucovorin (20 mg/m2 daily) in a daily regimen for 5 days are given at monthly intervals. There is no evidence on which to make a recommendation for patients with node-negative tumours that have not penetrated the muscularis propria. For patients unable to undergo radiation, adjuvant chemotherapy alone may be of benefit, particularly for those with lymph-node metastases. The optimal regimen remains to be defined. There is insufficient evidence from randomized trials to recommend neoadjuvant chemotherapy, or neoadjuvant or adjuvant radiotherapy or immunotherapy, either alone or in combination, outside a clinical trial. VALIDATION: A draft version of this document was circulated to 166 clinicians using a 21-item feedback questionnaire. Ninety-nine (63%) returned the questionnaire, and 74 of these indicated that the guideline was relevant to their clinical practice and completed the survey. Of the 74 clinicians, 52 (70%) agreed that the document should be approved as a practice guideline. SPONSORS: The CCOPGI is supported by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Chemotherapy, Adjuvant↗

PubMedDate not supplied

Does reimbursement influence chemotherapy treatment for cancer patients?

Before the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, Medicare reimbursed physicians for chemotherapy drugs at rates that greatly exceeded physicians' costs for those drugs. We examined the effect of physician reimbursement on chemotherapy treatment of Medicare beneficiaries older than age sixty-five with metastatic lung, breast, colorectal, or other gastrointestinal cancers between 1995 and 1998 (9,357 patients). A physician's decision to administer chemotherapy to metastatic cancer patients was not measurably affected by higher reimbursement. Providers who were more generously reimbursed, however, prescribed more-costly chemotherapy regimens to metastatic breast, colorectal, and lung cancer patients.

Aged↗