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David Cella

Publications and source records attributed to David Cella.

At least 19 recordsLinked to original sources
PubMed2003

Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane).

BACKGROUND: Cancer chemotherapy with some of the taxane class of agents can be associated with significant neurotoxicity, arthralgias, myalgias, and skin changes that may offset the therapeutic benefits of taxane use. METHODS: The authors developed and tested a set of questions to assess these important side effects of taxane therapy from the patient's perspective. The current study evaluated the taxane subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Reliability, validity, and responsiveness to expected change were evaluated in the context of an ongoing clinical trial comparing four cycles of carboplatin plus paclitaxel with a strategy of carboplatin plus paclitaxel until disease progression in patients with advanced nonsmall cell lung carcinoma (NSCLC). RESULTS: The 16-item Taxane subscale score and the 11-item peripheral neuropathy subset both demonstrated excellent internal consistency and concurrent validity, and the scores worsened as one would predict during a 12-week treatment course of taxane therapy. Results of the psychometric analyses supported the use of this subscale for measuring the unwanted adverse consequences of effective cancer therapies. Measuring the patient perception of treatment side effects also allowed a preliminary exploration of the relative quality of life (QOL) impact of symptom relief and treatment toxicity. The results indicated that toxicity and symptom improvement may make relatively equivalent contributions to total QOL as measured by the summary score from a multidimensional QOL instrument, the Functional Assessment of Cancer Therapy-General. However, symptom status and improvement appear to play a stronger role than taxane toxicity in patients' global rating of their QOL. CONCLUSIONS: Future research might examine this question of competing benefits as a potential aid to decision-making regarding the administration of toxic therapies in the setting of advanced disease.

Antineoplastic Agents, Phytogenic↗
PubMed2003

Evaluation of pain associated with oral mucositis during the acute period after administration of high-dose chemotherapy.

BACKGROUND: No single oral mucositis (OM) assessment scale is universally accepted; the most commonly used scales are deficient because they combine subjective and objective measures and do not capture the patient's perspective. Because pain is the hallmark symptom of OM, the authors sought to determine whether a simple measure of patient-reported pain was correlated with objective, physician-assessed measures of OM. The findings of the current study may provide a clinical context for understanding the relation between objective indicators and patients' perceptions of OM. METHODS: Three hundred twenty-three patients receiving stomatotoxic chemotherapy and randomized to receive either iseganan or placebo for treatment of OM underwent periodic objective and subjective evaluations of OM. Objective measures included clinician scoring of stomatitis and dysphagia using the National Cancer Institute Common Toxicity Criteria scales. A subjective measure was obtained by having patients complete a questionnaire (with questions based on an 11-point numeric scale) regarding oral pain. RESULTS: More than 90% of scheduled oral assessments were obtained. Mouth pain scores were closely related to stomatitis and dysphagia; peak mouth pain coincided with peak stomatitis and dysphagia. Analgesic use increased by 0.7 days for each unit rise on the pain scale. Patients receiving iseganan had a significantly lower level of peak mouth pain than did patients receiving placebo (P=0.041). CONCLUSIONS: A separate measurement of patient-reported pain was useful for capturing the patient's perspective on OM and was correlated with the physician's objective assessment. These findings support the use of a simple, patient-reported rating of mouth pain as a clinically relevant and responsive endpoint in clinical trials. This rating system also may provide a straightforward method of following OM in clinical practice.

Adolescent↗
PubMed2003

Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study.

PURPOSE: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. PATIENTS AND METHODS: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. RESULTS: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. CONCLUSION: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.

Adolescent↗
PubMed2003

Early change in patient-reported health during lung cancer chemotherapy predicts clinical outcomes beyond those predicted by baseline report: results from Eastern Cooperative Oncology Group Study 5592.

PURPOSE: To determine the ability of longitudinal patient-reported health (PRH) scores to enhance prediction of clinical outcomes beyond baseline scores. PATIENTS AND METHODS: In 573 advanced non-small-cell lung cancer patients enrolled in a phase III clinical trial, we used baseline and 6-week follow-up PRH scores to predict best response to treatment, disease progression, and survival. Using regression analyses, we tested the predictive ability of the five subscales of the Functional Assessment of Cancer Therapy-Lung (physical, functional, social/family, emotional well-being, and the lung cancer subscale) as well as the trial outcome index (TOI) aggregate score. RESULTS: After clinical factors were controlled for, baseline physical well-being (PWB) and TOI scores predicted all three clinical outcomes. A higher baseline PWB score was associated with a better response to treatment (odds ratio, 1.09; P <.001) and lower risk of death (risk ratio, 0.95; P <.001). Higher baseline TOI score was associated with a lower risk of disease progression (risk ratio, 0.98; P <.001). These two baseline predictors (PWB and TOI) were then used along with 6-week change scores to classify patients into four groups: low baseline-declined, low baseline-improved, high baseline-declined, and high baseline-improved. Patients with low baseline-declined PWB scores showed the worst responses to treatment and survived the shortest duration. Patients with low baseline-declined TOI scores had the shortest time to progression. CONCLUSION: The physical aspects of baseline PRH and PRH change during chemotherapy are significant predictors of clinical outcomes in lung cancer. This has implications for patient stratification in clinical trials and may aid decision-making in clinical practice.

Adult↗
PubMed2003

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.

PURPOSE: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. METHODS: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes. RESULTS: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups. CONCLUSION: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

Clinical Protocols↗
PubMed2003

Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population.

PURPOSE: Anemia, highly common among cancer patients, is often an underlying cause of cancer-related fatigue and other quality-of-life (QOL) deficits. Although randomized clinical trials have shown that treatment with epoetin alfa increases hemoglobin levels, reduces fatigue, lessens transfusion requirements, and improves overall QOL, cancer-related anemia and fatigue remain undertreated. This is, in part, because scales and measures of QOL are still relatively unfamiliar to most clinicians and because population-based reference ranges are lacking, thus making clinical trial results difficult to interpret. METHODS: To aid in the interpretation of QOL results from clinical trials, we administered the Functional Assessment of Cancer Therapy-Anemia (FACT-An) QOL instrument to a nationally representative sample of 1,400 people using an Internet survey panel in the United States. We then compared the FACT-An data from the Internet survey with the QOL data of a 375-patient randomized, double-blind clinical trial evaluating epoetin alfa versus placebo in anemic cancer patients. RESULTS: FACT-An, as administered to the survey population, displayed good psychometric properties and was able to discriminate between respondents with histories of specified illnesses, including anemia and cancer, and those without. Comparison of the population norm and clinical trial data showed that treatment with epoetin alfa resulted in clinically meaningful as well as statistically significant improvements in QOL (P <.01). CONCLUSION: Reliable population norm data are now available to aid in the interpretation of clinical trial results where the FACT-An questionnaire is administered. In the clinical trial, treatment with epoetin alfa overcame much of the QOL deficit seen in anemic cancer patients compared with the norm population sample.

Adolescent↗
PubMed2003

Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2.

OBJECTIVE: To develop and validate scales measuring common concerns of patients with choroidal melanoma: perception of appearance, concern about cancer recurrence, and difficulty with vision-dependent activities requiring stereopsis or binocularity. DESIGN: Cross-sectional study within a randomized multicenter clinical trial. METHODS: Eight-hundred forty-two of 1317 patients with choroidal melanoma enrolled in the Collaborative Ocular Melanoma Study (COMS) for medium-sized tumors and randomized to receive iodine 125 brachytherapy or enucleation were interviewed. Scale reliability was evaluated using Cronbach's alpha, and validity was investigated through correlation with existing scales and with data collected during COMS clinical examinations. RESULTS: All 3 proposed scales had good internal consistency reliability. The appearance and recurrence scales had low to moderate correlation with the 36-Item Short-Form Health Survey mental health scale (r = 0.26 and 0.31, respectively) and with the the Hospital Anxiety and Depression Scale depression (r = -0.22 and -0.19) and anxiety (r = -0.27 and -0.42) scales. Appearance scores were significantly associated with occurrence of appearance-altering complications and conditions, recurrence scores were associated with recent removal of the brachytherapy-treated eye, and stereopsis/binocularity scores were higher in patients with good visual acuity in both eyes than in those with good visual acuity in one eye and an enucleated fellow eye. CONCLUSIONS: All 3 proposed scales have good internal consistency, range, and SDs of measurement in the tested population. Based on clinical data, there is evidence of good construct validity for all 3 scales, although there also is evidence that the stereopsis/binocularity scale is sensitive to other aspects of vision in addition to stereopsis and binocularity. The appearance and recurrence scales capture clinically relevant information not available from standard mental health scales.

Adult↗
PubMed2003

Item banking to improve, shorten and computerize self-reported fatigue: an illustration of steps to create a core item bank from the FACIT-Fatigue Scale.

Fatigue is a common symptom among cancer patients and the general population. Due to its subjective nature, fatigue has been difficult to effectively and efficiently assess. Modern computerized adaptive testing (CAT) can enable precise assessment of fatigue using a small number of items from a fatigue item bank. CAT enables brief assessment by selecting questions from an item bank that provide the maximum amount of information given a person's previous responses. This article illustrates steps to prepare such an item bank, using 13 items from the Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-F) as the basis. Samples included 1022 cancer patients and 1010 people from the general population. An Item Response Theory (IRT)-based rating scale model, a polytomous extension of the Rasch dichotomous model was utilized. Nine items demonstrating acceptable psychometric properties were selected and positioned on the fatigue continuum. The fatigue levels measured by these nine items along with their response categories covered 66.8% of the general population and 82.6% of the cancer patients. Although the operational CAT algorithms to handle polytomously scored items are still in progress, we illustrated how CAT may work by using nine core items to measure level of fatigue. Using this illustration, a fatigue measure comparable to its full-length 13-item scale administration was obtained using four items. The resulting item bank can serve as a core to which will be added a psychometrically sound and operational item bank covering the entire fatigue continuum.

Adult↗
PubMed2003

Health outcomes assessment in vulnerable populations: measurement challenges and recommendations.

With growing recognition that some population subgroups are particularly vulnerable to receiving suboptimal health care and achieving poor health outcomes, innovative techniques are required for collecting and evaluating health outcomes data. Research is also needed to better understand the causal pathways linking vulnerability with health outcomes. This article focuses on patients with a chronic illness (cancer) who also have low literacy and/or poor English language skills. We summarize the association among literacy, language, ethnicity, and health outcomes; describe innovative technologies to enhance communication; and discuss the advantages of using psychometric measurement models in health outcomes assessment. Results from our ongoing research projects are presented, including the development of an audiovisual computer-based testing platform for self-administration of questionnaires. Such innovative multimedia technologies allow patients with limited or even no reading ability to participate in outcomes assessment and have the potential to be incorporated into a clinical setting with minimal burden on staff and patients. Appropriate methods are also needed to evaluate measurement equivalence across diverse patient groups, that is, the extent to which items in a questionnaire perform similarly across groups. Item response theory measurement models provide a strategy for differentiating between measurement bias and real differences that may exist between groups. Recommendations for clinical practice and research are offered specifically to address medically underserved and vulnerable populations.

Activities of Daily Living↗
PubMed2003

Issues in the development of an item bank.

OBJECTIVE: To describe and illustrate 2 issues involved in the development of an item bank that can be used to improve measurement across settings and over time. DESIGN: Secondary (psychometric) analysis of data collected on existing quality of life (QOL) instruments. SETTING: Five cancer clinics in hospital settings in various parts of the United States; 523 solo or group practices in 3 major US cities; and an inpatient rehabilitation hospital in a large metropolitan area. PARTICIPANTS: Illustration 1: 399 persons being treated for or having a history of cancer, 170 persons being treated for human immunodeficiency virus (HIV), 328 persons with stroke assessed during and after acute rehabilitation, and 433 persons being treated for multiple sclerosis. Illustration 2: 1714 persons with cancer and/or HIV participating in a large-scale multisite study, 3429 persons with prevalent treatable chronic health conditions, and 125 persons with stage IV metastatic breast cancer. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: QOL as measured by 10 different instruments. RESULTS: The illustrations show that (1). core items, which functioned similarly across 4 diagnostic groups, can be identified and used to construct instruments measuring physical function that are tailored to each of these groups, and (2). items from 3 separate datasets can be linked to create a dataset that can serve as an initial pain item bank. CONCLUSION: The methodology exists to develop item banks to develop better measures of QOL.

Acute Disease↗
PubMed2003

Impact of ZD1839 on non-small cell lung cancer-related symptoms as measured by the functional assessment of cancer therapy-lung scale.

The majority of patients with non-small cell lung cancer (NSCLC) present with advanced disease, which is associated with a poor prognosis and symptoms such as pain, coughing, and shortness of breath. In patients who present at an earlier stage, the progressive nature of NSCLC and its resistance to treatment often result in recurrence, with the associated symptoms of advanced disease. These symptoms negatively affect patient quality of life and performance status rating, both of which are predictive of treatment response and survival. There is increasing interest in using assessments of improvements in symptoms and quality of life as outcomes in clinical trials for patients with advanced NSCLC. Patients with NSCLC have limited therapeutic options. Even those patients who are able to tolerate chemotherapy can expect median survival increases of only 2 to 4 months. The new targeted therapies for lung cancer, in contrast, are relatively nontoxic and may provide benefits for symptoms and quality of life in addition to tumor responses. The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale is a validated, sensitive, and reliable patient questionnaire that evaluates and quantifies quality of life across several dimensions, including lung cancer-related symptoms (Lung Cancer Subscale). The Lung Cancer Subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). A change of two points reflects a clinically significant change in NSCLC-related symptoms and quality of life. In phase I studies and also in the Iressa Dose Evaluation in Advanced Lung Cancer (IDEAL)-1 and IDEAL-2 phase II monotherapy trials, treatment of patients with advanced NSCLC with the epidermal growth factor receptor-tyrosine kinase inhibitor ZD1839 (Iressa; AstraZeneca Pharmaceuticals LP, Wilmington, DE) has shown tumor responses as well as rapid improvements in NSCLC-related symptoms and quality of life. In IDEAL-1 and IDEAL-2, improvements in NSCLC-related symptoms and quality of life, as measured by FACT-L, correlated with tumor response, and improvements in symptoms also correlated with progression-free and overall survival. Although symptom response is correlated with tumor response, it is also uniquely predictive of progression-free and overall survival. The FACT-L questionnaire has also been included in phase III trials of ZD1839 treatment in combination with chemotherapy regimens.

Antineoplastic Agents↗
PubMed2003

Developing an initial physical function item bank from existing sources.

The objective of this article is to illustrate incremental item banking using health-related quality of life data collected from two samples of patients receiving cancer treatment. The kinds of decisions one faces in establishing an item bank for computerized adaptive testing are also illustrated. Pre-calibration procedures include: identifying common items across databases; creating a new database with data from each pool; reverse-scoring "negative" items; identifying rating scales used in items; identifying pivot points in each rating scale; pivot anchoring items at comparable rating scale categories; and identifying items in each instrument that measure the construct of interest. A series of calibrations were conducted in which a small proportion of new items were added to the common core and misfitting items were identified and deleted until an initial item bank has been developed.

Adaptation, Psychological↗
PubMed2002

Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.

Anemia resulting from cancer or its treatment is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin. To address uncertainties regarding indications and efficacy, the American Society of Clinical Oncology and the American Society of Hematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin (Hgb) concentration below 10 g/dL. Use of epoetin for patients with less severe anemia (Hgb level below 12 g/dL but never below 10 g/dL) should be determined by clinical circumstances. Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly (150 U/kg) for a minimum of 4 weeks. Less strong evidence supports an alternative weekly (40 000 U/wk) dosing regimen, based on common clinical practice. With either administration schedule, dose escalation should be considered for those not responding to the initial dose. In the absence of response, continuing epoetin beyond 6-8 weeks does not appear to be beneficial. Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one randomized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy; however, there are no published high-quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy. Therefore, for anemic patients with hematologic malignancies it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin.

Anemia↗
PubMed2002

Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.

Anemia resulting from cancer, or its treatment, is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin. To address uncertainties regarding indications and efficacy, the American Society of Clinical Oncology and the American Society of Hematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin level less than 10 g/dL. Use of epoetin for patients with less severe anemia (hemoglobin < 12 g/dL but never below 10 g/dL) should be determined by clinical circumstances. Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly (150 U/kg tiw) for a minimum of 4 weeks. Less strong evidence supports an alternative weekly (40,000 U/wk) dosing regimen, based on common clinical practice. With either administration schedule, dose escalation should be considered for those not responding to the initial dose. In the absence of response, continuing epoetin beyond 6 to 8 weeks does not appear to be beneficial. Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one randomized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy; however, there are no published high-quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy. Therefore, for anemic patients with hematologic malignancies, it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin.

Anemia↗
PubMed2002

Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy.

BACKGROUND: Hemoglobin increases have been associated with quality of life (QOL) improvements in anemic cancer patients treated with epoetin alfa, but intervention generally has been reserved for symptomatic anemia or hemoglobin < 10 g/dL. Relationships among hemoglobin, functional status, and patient reported QOL have not been well characterized. METHODS: Data from two open-label, community-based trials of epoetin alfa therapy that enrolled 4382 anemic cancer patients undergoing chemotherapy were used to evaluate the relationship between hemoglobin changes and QOL changes. The authors measured QOL using the Linear Analog Scale Assessment (LASA) and the more detailed, disease-specific Functional Assessment of Cancer Therapy-Anemia (FACT-An) instrument. Analyses were performed to determine the incremental change in QOL associated with hemoglobin increases (1 g/dL increments). RESULTS: Cross-sectional analyses showed a nonlinear relationship and significant positive correlation between high hemoglobin levels and high LASA and FACT-An scores (r = 0.25 and 0.29, respectively, P < 0.01). Patients with hemoglobin increases of > or = 2 g/dL reported statistically significant improvements in five FACT-An items selected a priori specifically to reflect functional capacity. An incremental analysis used regression methods to identify the longitudinal relationship between incremental changes in hemoglobin and QOL scores. This relationship was found to be nonlinear, with the maximum QOL gain occurring at a hemoglobin level of 12 g/dL (range, 11-13 g/dL). Patients with low baseline QOL scores and longer time periods between baseline and final QOL assessments experienced significantly (P < 0.05) greater increases in overall QOL. Progressive disease at baseline, change in disease status from baseline to end of study, and increase in self-reported pain or nausea all had significant (P < 0.05) negative effects on QOL scores. CONCLUSIONS: A direct relationship exists between hemoglobin increases during epoetin alfa therapy and corresponding QOL improvements in cancer patients receiving chemotherapy across the clinically relevant hemoglobin range of 8-14 g/dL. These data suggest that the maximal incremental gain in QOL occurs when hemoglobin is in the range of 11-13 g/dL.

Anemia↗
PubMed2002

Measuring health-related quality of life in patients with hepatobiliary cancers: the functional assessment of cancer therapy-hepatobiliary questionnaire.

PURPOSE: This is the first report on the development and initial validation of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire, a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. The FACT-Hep consists of the 27-item FACT-G, which assesses generic HRQL concerns, and the newly validated 18-item Hepatobiliary Subscale (HS), which assesses disease-specific issues. PATIENTS AND METHODS: The development of the HS followed a four-phase process of item generation, item reduction, scale construction, and reliability/validity testing. Two independent samples were studied: item generation (sample 1; n = 30) and reliability/validity testing (sample 2; n = 51). RESULTS: In sample 2, all subscales and aggregated scores showed high internal consistency at initial assessment (Cronbach's alpha range, 0.72 to 0.94) and retesting (Cronbach's alpha range, 0.81 to 0.94). Measurement stability over a 3- to 7-day period was also high for all aggregated scales (test-retest correlation range, 0.84 to 0.91; intraclass correlation coefficient range, 0.82 to 0.90). Convergent and divergent validity were demonstrated by examining relationships between FACT subscales and mood, social support, and social desirability. Finally, when performance status and treatment status were used to divide sample 2, the HS differentiated groups to a degree comparable to the Physical and Functional Well-Being subscales of the FACT-G, thereby contributing favorably to a 32-item Trial Outcome Index. In addition to the 18 validated, scored items in the HS, seven treatment-related items may be appended, if clinically indicated, as a separate subscale. CONCLUSION: The 45-item FACT-Hep can be used independently as a brief measure of disease-related symptoms and functioning. Alone or paired with the FACT-G, the HS has promise for use in assessing the disease-specific HRQL of patients with hepatobiliary cancers.

Adult↗
PubMed2002

Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial.

BACKGROUND: Older patients, even if fit, are often considered incapable of tolerating platinum-based systemic therapy. We performed a retrospective analysis of Eastern Cooperative Oncology Group (ECOG) 5592, a phase III randomized trial of platinum-based chemotherapy regimens for non-small-cell lung cancer (NSCLC), and compared outcomes in enrollees 70 years of age and older with those in younger patients. METHODS: ECOG carried out a randomized phase III trial of cisplatin plus either etoposide or paclitaxel in chemotherapy-naïve NSCLC patients with stages III(B) or IV disease. Toxic effects, response rates, and survival rates were compared between age groups. All P values were two-sided. RESULTS: A total of 574 patients enrolled from August 1993 through December 1994 were evaluable. Eighty-six (15%) were 70 years old or older. Older patients had a higher incidence of cardiovascular (P =.009) and respiratory (P =.04) comorbidities and nonanalgesic medication use (P =.02). Leukopenia (P<.001) and neuropsychiatric toxicity (P =.002) were more common in elderly men than in younger men. Elderly women lost more weight than younger women (P =.006). Other toxic effects were similar in older and younger patients. The proportions with clinical partial or complete response (21.5% versus 23.3%; Fisher's exact test, P =.66), median time to progression (4.37 versus 4.30 months; log-rank test, P =.29), and survival distribution (log-rank test, P =.29; median survival, 9.05 versus 8.53 months; 1-year survival, 38% versus 29%; and 2-year survival, 14% versus 12%) were similar in patients younger than 70 years and 70 years old or older. Baseline quality-of-life and treatment-outcome indices were similar. Equivalent declines over time in functional well-being occurred in both groups. CONCLUSION: Response rate, toxicity, and survival in fit, elderly NSCLC patients receiving platinum-based treatment appear to be similar to those in younger patients, although patients 70 years old or older have more comorbidities and can expect more leukopenia and neuropsychiatric toxicity. Advanced age alone should not preclude appropriate NSCLC treatment.

Aged↗