Validation of the Portuguese version of functional assessment of cancer therapy-fatigue (FACT-F) in Brazilian cancer patients.

GOALS OF WORK: The purpose of this study was to validate the Portuguese version of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) in order to establish its assessment properties, including validity and reliability in a sample of Brazilian cancer patients. MATERIALS AND METHODS: Two hundred seventy patients with different types of cancer were included for this study; the mean age was 50.5 years. The reliability was assessed by internal consistency and reproducibility. Construct validity was assessed through convergent validity and discriminant validity. Convergent validity was examined by comparing the FACT-F to the SF-36. Discriminant validity of the FACT-F evaluated the ability of the scale to differentiate defined groups, discriminating patients according to Eastern Cooperative Oncology Group Performance Status and different stages of disease. MAIN RESULTS: FACT-F had high internal consistency (Cronbach alpha coefficient was 0.78 for physical well-being, 0.68 for social/family well-being, 0.75 for emotional well-being, 0.74 for functional well-being, 0.91 for fatigue, and 0.92 for total FACT-F). The range of test-retest intraclass correlation was from 0.72 to 0.91 (p < 0.0001). The Pearson product correlation revealed good correlations between the total FACT-F and subscales of the SF-36 in most dimensions, ranging from r = 0.51 to r = 0.76, except for SF-36 physical (r = 0.31). The positive correlations between the SF-36 vitality scale and FACT-F total (r = 0.76) and the fatigue subscale (r = 0.77) support the convergent validity. CONCLUSIONS: The Portuguese version of FACT-F is a reliable and valid instrument to assess quality of life and fatigue, representing a valid tool to screen cancer-related fatigue in Brazilian cancer patients.

Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2.

PURPOSE: To compare single-agent pemetrexed (P) versus the combination of carboplatin and pemetrexed (CP) in first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. PATIENTS AND METHODS: In a multicenter phase III randomized trial, patients with advanced NSCLC, ECOG PS of 2, any histology at first and later amended to nonsquamous only, no prior chemotherapy, and adequate organ function were randomly assigned to P alone (500 mg/m(2)) or CP (area under the curve of 5 and 500 mg/m(2), respectively) administered every 3 weeks for a total of four cycles. The primary end point was overall survival (OS). RESULTS: A total of 205 eligible patients were enrolled from eight centers in Brazil and one in the United States from April 2008 to July 2011. The response rates were 10.3% for P and 23.8% for CP (P = .032). In the intent-to-treat population, the median PFS was 2.8 months for P and 5.8 months for CP (hazard ratio [HR], 0.46; 95% CI, 0.35 to 0.63; P < .001), and the median OS was 5.3 months for P and 9.3 months for CP (HR, 0.62; 95% CI, 0.46 to 0.83; P = .001). One-year survival rates were 21.9% and 40.1%, respectively. Similar results were seen when patients with squamous disease were excluded from the analysis. Anemia (grade 3, 3.9%; grade 4, 11.7%) and neutropenia (grade 3, 1%; grade 4, 6.8%) were more frequent with CP. There were four treatment-related deaths in the CP arm. CONCLUSION: Combination chemotherapy with CP significantly improves survival in patients with advanced NSCLC and ECOG PS of 2.

Reproducibility of functional assessment of Cancer therapy-fatigue (FACT-F) questionnaire for cancer patients

Objective: The objective of this study was evaluating the reproducibility in Portuguese of Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire for cancer patients by applying it according to the test-retest method. Material and Methods: Subjects were 85 cancer patients with an average age of 51.0 years, being 56 (65.9%) women and 29 (34.1%) men. FACT-F questionnaire consists of 40 items, divided in five domains, and is applied for evaluating quality of life and fatigue in patients with cancer. We used as a measuring tool intraclass correlation coefficient values obtained from two measures of test-retest and scatter plot proposed by Bland-Altman. Results: In 36.5% of cases the questionnaire was self-administered, and in 63.5% of the cases read by an interviewer and filled after verbal answer. Intraclass correlation coefficient values found for the domains were: physical well-being 0.72; social/family well-being 0.91; emotional well-being 0.90; functional well-being 0.86; fatigue subscale 0.88, and for the FACT-F 0.91. The Bland-Altman plot showed to be adequate, since most points were within the limits of reliability. Conclusions: FACT-F questionnaire in Portuguese has good test-retest reproducibility in patients with different types of cancer, performance status and stages.