Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer.

BACKGROUND: Human epidermal growth factor receptor 2 (HER2)-targeted therapies have not been approved for patients with non-small-cell lung cancer (NSCLC). The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with HER2-mutant NSCLC have not been investigated extensively. METHODS: We conducted a multicenter, international, phase 2 study in which trastuzumab deruxtecan (6.4 mg per kilogram of body weight) was administered to patients who had metastatic HER2-mutant NSCLC that was refractory to standard treatment. The primary outcome was objective response as assessed by independent central review. Secondary outcomes included the duration of response, progression-free survival, overall survival, and safety. Biomarkers of HER2 alterations were assessed. RESULTS: A total of 91 patients were enrolled. The median duration of follow-up was 13.1 months (range, 0.7 to 29.1). Centrally confirmed objective response occurred in 55% of the patients (95% confidence interval [CI], 44 to 65). The median duration of response was 9.3 months (95% CI, 5.7 to 14.7). Median progression-free survival was 8.2 months (95% CI, 6.0 to 11.9), and median overall survival was 17.8 months (95% CI, 13.8 to 22.1). The safety profile was generally consistent with those from previous studies; grade 3 or higher drug-related adverse events occurred in 46% of patients, the most common event being neutropenia (in 19%). Adjudicated drug-related interstitial lung disease occurred in 26% of patients and resulted in death in 2 patients. Responses were observed across different HER2 mutation subtypes, as well as in patients with no detectable HER2 expression or HER2 amplification. CONCLUSIONS: Trastuzumab deruxtecan showed durable anticancer activity in patients with previously treated HER2-mutant NSCLC. The safety profile included interstitial lung disease that was fatal in two cases. Observed toxic effects were generally consistent with those in previously reported studies. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Lung01 ClinicalTrials.gov number, NCT03505710.).

Patient-reported outcomes of multiple myeloma patients treated with panobinostat after ≥2 lines of therapy based on the international phase 3, randomized, double-blind, placebo-controlled PANORAMA-1 trial.

The phase 3 PANORAMA-1 trial led to regulatory approvals of panobinostat (PAN) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of multiple myeloma after ≥2 prior regimens, including BTZ and an immunomodulatory drug. Patient-reported outcomes (PROs) were assessed in PANORAMA-1, with data available for 73 patients in the PAN + BTZ + DEX arm and 74 patients in the placebo (PBO) + BTZ + DEX arm. Per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), global health status/quality of life (QoL) scores initially declined with PAN + BTZ + DEX during the first 24 weeks before approaching baseline scores and remaining steady during the next 24 weeks, with no difference between arms at Week 48. The EORTC QLQ-Myeloma module (EORTC QLQ-MY20) demonstrated initial improvements and subsequent stabilization of disease symptom scores in both arms and initial worsening and subsequent improvement of side effects of treatment scores, with the initial worsening more pronounced and recovery less pronounced with PAN + BTZ + DEX. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scores remained relatively stable and similar between the arms. Overall, these PRO findings support the addition of PAN to the BTZ+DEX regimen as an efficacious treatment option, with limited symptomatology and impact on patients' QoL. The reported results are based on a descriptive analysis of the data. No formal statistical tests have been performed.

Treatment-free interval as a metric of patient experience and a health outcome of value for advanced multiple myeloma: the case for the histone deacetylase inhibitor panobinostat, a next-generation novel agent.

BACKGROUND: Patients with relapsed or relapsed/refractory multiple myeloma (RRMM) face poor treatment options by the time third-line therapy is required, despite advances in overall survival in recent years. Treatment free interval (TFI) and opportunities to maintain quality of life (QoL) have been cited as additional measures of efficacy that can be utilized in personalized treatment decisions. METHODS: The clinical health outcomes data from PANORAMA-1, the pivotal phase-3 trial comparing panobinostat-bortezomib-dexamethasone (PAN-BTZ-DEX) with placebo (PBO)-BTZ-DEX in RRMM patients treated with 1 to 3 prior regimens, retrospectively assessed TFI as a health outcome measure and metric of patient treatment experience relevant to the RRMM population. RESULTS: PAN-BTZ-DEX shows promise for prolonged TFI (mean TFI, 7.49 months; 95% CI, 6.02 to 8.71) compared to PBO-BTZ-DEX (mean TFI, 3.86 months; 95% CI, 3.08 to 4.60) for heavily pre-treated advanced RRMM patients), due to the short duration of therapy and extended progression free-survival. Further, QoL during the TFI was similar to baseline. CONCLUSIONS: PAN-BTZ-DEX provides a treatment regimen with prolonged TFI benefits previously not available for RRMM patients. TFI has not been traditionally measured in clinical trials, but should be assessed in prospective data collection given its value to payers, providers, and patients.

Surrogacy of progression free survival for overall survival in metastatic breast cancer studies: Meta-analyses of published studies.

PURPOSE: PFS is often used as a surrogate endpoint for OS in metastatic breast cancer studies. We have evaluated the association of treatment effect on PFS with significant HROS (and how this association is affected by other factors) in published prospective metastatic breast cancer studies. METHODS: A systematic literature search in PubMed identified prospective metastatic breast cancer studies. Treatment effects on PFS were determined using hazard ratio (HRPFS), increase in median PFS (ΔMEDPFS) and % increase in median PFS (%ΔMEDPFS). Diagnostic accuracy of PFS measures (HRPFS, ΔMEDPFS and %ΔMEDPFS) in predicting significant HROS was assessed using receiver operating characteristic (ROC) curves and classification tree approach (CART). RESULTS: Seventy-four cases (i.e., treatment to control comparisons) from 65 individual publications were identified for the analyses. Of these, 16 cases reported significant treatment effect on HROS at 5% level of significance. Median number of deaths reported in these cases were 153. Area under the ROC curve (AUC) for diagnostic measures as HRPFS, ΔMEDPFS and %ΔMEDPFS were 0.69, 0.70 and 0.75, respectively. Classification tree results identified %ΔMEDPFS and number of deaths as diagnostic measure for significant HROS. Only 7.9% (3/39) cases with ΔMEDPFS shorter than 48.27% reported significant HROS. There were 7 cases with ΔMEDPFS of 48.27% or more and number of deaths reported as 227 or more - of these 5 cases reported significant HROS. CONCLUSION: %ΔMEDPFS was found to be a better diagnostic measure for predicting significant HROS. Our analysis results also suggest that consideration of total number of deaths may further improve its diagnostic performance. Based on our study results, the studies with 50% improvement in median PFS are more likely to produce significant HROS if the total number of OS events at the time of analysis is 227 or more.

Whole-body MR imaging for staging of malignant tumors in pediatric patients: results of the American College of Radiology Imaging Network 6660 Trial.

PURPOSE: To compare whole-body magnetic resonance (MR) imaging with conventional imaging for detection of distant metastases in pediatric patients with common malignant tumors. MATERIALS AND METHODS: This institutional review board-approved, HIPAA-compliant, multicenter prospective cohort study included 188 patients (109 male, 79 female; mean age, 10.2 years; range, < 1 to 21 years) with newly diagnosed lymphoma, neuroblastoma, or soft-tissue sarcoma. Informed consent was obtained and all patients underwent noncontrast material-enhanced whole-body MR imaging and standard-practice conventional imaging. All images were reviewed centrally by 10 pairs of readers. An independent panel verified the presence or absence of distant metastases. Detection of metastasis with whole-body MR and conventional imaging was quantified by using the area under the receiver operating characteristic curve (AUC). The effects of tumor subtype, patient age, and distant skeletal and pulmonary disease on diagnostic accuracy were also analyzed. RESULTS: Of the 134 eligible patients, 66 (33 positive and 33 negative for metastasis) were selected for image review and analysis. Whole-body MR imaging did not meet the noninferiority criterion for accuracy when compared with conventional imaging for detection of metastasis (difference between average AUCs was -0.03 [95% confidence interval: -0.10, 0.04]); however, the average AUC for solid tumors was significantly higher than that for lymphomas (P = .006). More skeletal metastases were detected by using whole-body MR imaging than by using conventional imaging (P = .03), but fewer lung metastases were detected (P < .001). Patient age did not affect accuracy. CONCLUSION: The noninferior accuracy for diagnosis of distant metastasis in patients with common pediatric tumors was not established for the use of whole-body MR imaging compared with conventional methods. However, improved accuracy was seen with whole-body MR imaging in patients with nonlymphomatous tumors.

Use of BI-RADS 3-probably benign category in the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial.

PURPOSE: To determine (a) how often the Breast Imaging Reporting and Data System (BI-RADS) category 3 was used in the American College of Radiology Imaging Network (ACRIN) Digital Mammographic Imaging Screening Trial (DMIST), either at the time of screening mammography or after work-up, (b) how often subjects actually returned for the recommended follow-up examination, and (c) the rate and stages of any malignancies subsequently found in subjects for whom short-term interval follow-up was recommended. MATERIALS AND METHODS: This study was approved by the Institutional Review Board at all institutions where subjects were enrolled. All subjects participating in DMIST gave informed consent and the study was HIPAA-compliant. A total of 47,599 DMIST-eligible and evaluable subjects, all of whom consented to undergo both digital and screen-film mammography, were included in this analysis. Cases referred for short-term interval follow-up based on digital, screen-film, or both imaging examinations were determined. Compliance with the recommendations and the final outcome (malignancy diagnosis at biopsy or no malignancy confirmed through follow-up) of each evaluable case were determined. RESULTS: A total of 1114 of the 47,599 (2.34%) subjects had tumors assigned a BI-RADS 3 category and were recommended to undergo short-interval follow-up. In this study, 791 of 1114 (71%) of the subjects were compliant with the recommendation and returned for short-interval follow-up. Of the women who did not return for short-interval follow-up, 70% (226 of 323) did return for their next annual mammography. Among all subjects whose tumors were assigned a BI-RADS 3 category either at screening mammography or after additional work-up, nine of 1114 (0.81%) were found to have cancer. Of the nine biopsy-proved cancers, six were invasive cancers and three were ductal carcinoma in situ stage Tis-T1c. The invasive cancers were all less than 2 cm in size. CONCLUSION: In DMIST, radiologists used the BI-RADS 3 classification infrequently (2.3% of patients). Tumors assigned a BI-RADS 3 category had a low rate of malignancy. The relatively high rate of noncompliance with short-interval follow-up recommendations (323 of 1114, or 29%) supports prior recommendations that radiologists thoroughly evaluate lesions before placing them in this category.

Comparison of acquisition parameters and breast dose in digital mammography and screen-film mammography in the American College of Radiology Imaging Network digital mammographic imaging screening trial.

OBJECTIVE: The purpose of our study was to compare the technical performance of full-field digital mammography (FFDM) and screen-film mammography. MATERIALS AND METHODS: The American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial enrolled 49,528 women to compare FFDM and screen-film mammography for screening. For quality assurance purposes, technical parameters including breast compression force, compressed breast thickness, mean glandular dose, and the number of additional views needed for complete breast coverage were recorded and analyzed for both FFDM and screen-film mammography on approximately 10% of study subjects at each site. RESULTS: Technical data were compiled on 5,102 study subjects at 33 sites. Clean data were obtained for 4,366 (88%) of those cases. Mean compression force was 10.7 dN for screen-film mammography and 10.1 dN for FFDM (5.5% difference, p < 0.001). Mean compressed breast thickness was 5.3 cm for screen-film mammography and 5.4 cm for FFDM (1.7% difference, p < 0.001). Mean glandular dose per view averaged 2.37 mGy for screen-film mammography and 1.86 mGy for FFDM, 22% lower for digital than screen-film mammography, with sizeable variations among digital manufacturers. Twelve percent of screen-film mammography cases required more than the normal four views, whereas 21% of FFDM cases required more than the four normal views to cover all breast tissue. When extra views were included, mean glandular dose per subject was 4.15 mGy for FFDM and 4.98 mGy for screen-film mammography, 17% lower for FFDM than screen-film mammography. CONCLUSION: Our results show that differences between screen-film mammography and FFDM in compression force and indicated compressed breast thickness were small. On average, FFDM had 22% lower mean glandular dose than screen-film mammography per acquired view, with sizeable variations in average FFDM doses by manufacturer.

Cancer cases from ACRIN digital mammographic imaging screening trial: radiologist analysis with use of a logistic regression model.

PURPOSE: To determine which factors contributed to the Digital Mammographic Imaging Screening Trial (DMIST) cancer detection results. MATERIALS AND METHODS: This project was HIPAA compliant and institutional review board approved. Seven radiologist readers reviewed the film hard-copy (screen-film) and digital mammograms in DMIST cancer cases and assessed the factors that contributed to lesion visibility on both types of images. Two multinomial logistic regression models were used to analyze the combined and condensed visibility ratings assigned by the readers to the paired digital and screen-film images. RESULTS: Readers most frequently attributed differences in DMIST cancer visibility to variations in image contrast--not differences in positioning or compression--between digital and screen-film mammography. The odds of a cancer being more visible on a digital mammogram--rather than being equally visible on digital and screen-film mammograms--were significantly greater for women with dense breasts than for women with nondense breasts, even with the data adjusted for patient age, lesion type, and mammography system (odds ratio, 2.28; P < .0001). The odds of a cancer being more visible at digital mammography--rather than being equally visible at digital and screen-film mammography--were significantly greater for lesions imaged with the General Electric digital mammography system than for lesions imaged with the Fischer (P = .0070) and Fuji (P = .0070) devices. CONCLUSION: The significantly better diagnostic accuracy of digital mammography, as compared with screen-film mammography, in women with dense breasts demonstrated in the DMIST was most likely attributable to differences in image contrast, which were most likely due to the inherent system performance improvements that are available with digital mammography. The authors conclude that the DMIST results were attributable primarily to differences in the display and acquisition characteristics of the mammography devices rather than to reader variability.

Effectiveness of different methods for delivering tailored nutrition education to low income, ethnically diverse adults.

BACKGROUND: Computer-tailored written nutrition interventions have been shown to be more effective than non-tailored materials in changing diet, but continued research is needed. Your Healthy Life/Su Vida Saludable (YHL-SVS) was an intervention study with low income, ethnically diverse, English and Spanish-speaking participants to determine which methods of delivering tailored written nutrition materials were most effective in lowering fat and increasing fruit and vegetable (F&V) intake. METHODS: YHL-SVS was a randomized controlled trial with four experimental conditions: 1) Nontailored (NT) comparison group; 2) Single Tailored (ST) packet; 3) Multiple Tailored (MT) packet mailed in four installments; 4) Multiple Re-Tailored (MRT) MT packets re-tailored between mailings via brief phone surveys. A baseline telephone survey collected information for tailoring as well as evaluation. Follow-up evaluation surveys were collected 4- and 7-months later. Primary outcomes included F&V intake and fat related behaviors. Descriptive statistics, paired t-test and ANOVA were used to examine the effectiveness of different methods of delivering tailored nutrition information. RESULTS: Both the ST and MT groups reported significantly higher F&V intake at 4-months than the NT and MRT groups. At 7 months, only the MT group still had significantly higher F&V intake compared to the NT group. For changes in fat-related behaviors, both the MT and MRT groups showed more change than NT at 4 months, but at 7 months, while these differences persisted, they were no longer statistically significant. There was a significant interaction of experimental group by education for change in F&V intake (P = .0085) with the lowest educational group demonstrating the most change. CONCLUSION: In this study, tailored interventions were more effective than non-tailored interventions in improving the short-term dietary behaviors of low income, ethnically diverse participants. Delivery of information in multiple smaller doses over time appeared to improve effectiveness. Future studies should determine which variables are mediators of dietary change and whether these differ by participant demographics. Moreover, future research should differentiate the effects of tailoring vs. cultural adaptation in ethnically diverse populations and study the dissemination of tailored interventions into community-based settings. TRIAL REGISTRATION: Current Controlled Trials # NCT00301691.

Comparison of soft-copy and hard-copy reading for full-field digital mammography.

PURPOSE: To compare radiologists' performance in detecting breast cancer when reading full-field digital mammographic (FFDM) images either displayed on monitors or printed on film. MATERIALS AND METHODS: This study received investigational review board approval and was HIPAA compliant, with waiver of informed consent. A reader study was conducted in which 26 radiologists read screening FFDM images displayed on high-resolution monitors (soft-copy digital) and printed on film (hard-copy digital). Three hundred thirty-three cases were selected from the Digital Mammography Image Screening Trial screening study (n = 49,528). Of these, 117 were from patients who received a diagnosis of breast cancer within 15 months of undergoing screening mammography. The digital mammograms were displayed on mammographic workstations and printed on film according to the manufacturer's specifications. Readers read both hard-copy and soft-copy images 6 weeks apart. Each radiologist read a subset of the total images. Twenty-two readers were assigned to evaluate images from one of three FFDM systems, and four readers were assigned to evaluate images from two mammographic systems. Each radiologist assigned a malignancy score on the basis of overall impression by using a seven-point scale, where 1 = definitely not malignant and 7 = definitely malignant. RESULTS: There were no significant differences in the areas under the receiver operating characteristic curves (AUCs) for the primary comparison. The AUCs for soft-copy and hard-copy were 0.75 and 0.76, respectively (95% confidence interval: -0.04, 0.01; P = .36). Secondary analyses showed no significant differences in AUCs on the basis of manufacturer type, lesion type, or breast density. CONCLUSION: Soft-copy reading does not provide an advantage in the interpretation of digital mammograms. However, the display formats were not optimized and display software remains an evolving process, particularly for soft-copy reading.

Accuracy of soft-copy digital mammography versus that of screen-film mammography according to digital manufacturer: ACRIN DMIST retrospective multireader study.

PURPOSE: To retrospectively compare the accuracy for cancer diagnosis of digital mammography with soft-copy interpretation with that of screen-film mammography for each digital equipment manufacturer, by using results of biopsy and follow-up as the reference standard. MATERIALS AND METHODS: The primary HIPAA-compliant Digital Mammographic Imaging Screening Trial (DMIST) was approved by the institutional review board of each study site, and informed consent was obtained. The approvals and consent included use of data for future HIPAA-compliant retrospective research. The American College of Radiology Imaging Network DMIST collected screening mammography studies performed by using both digital and screen-film mammography in 49 528 women (mean age, 54.6 years; range, 19-92 years). Digital mammography systems from four manufacturers (Fischer, Fuji, GE, and Hologic) were used. For each digital manufacturer, a cancer-enriched reader set of women screened with both digital and screen-film mammography in DMIST was constructed. Each reader set contained all cancer-containing studies known for each digital manufacturer at the time of reader set selection, together with a subset of negative and benign studies. For each reader set, six or 12 experienced radiologists attended two randomly ordered reading sessions 6 weeks apart. Each radiologist identified suspicious findings and rated suspicion of breast cancer in identified lesions by using a seven-point scale. Results were analyzed according to digital manufacturer by using areas under the receiver operating characteristic curve (AUCs), sensitivity, and specificity for soft-copy digital and screen-film mammography. Results for Hologic digital are not presented owing to the fact that few cancer cases were available. The implemented design provided 80% power to detect average AUC differences of 0.09, 0.08, and 0.06 for Fischer, Fuji, and GE, respectively. RESULTS: No significant difference in AUC, sensitivity, or specificity was found between Fischer, Fuji, and GE soft-copy digital and screen-film mammography. Large reader variations occurred with each modality. CONCLUSION: No statistically significant differences were found between soft-copy digital and screen-film mammography for Fischer, Fuji, and GE digital mammography equipment.

Cost-effectiveness of digital mammography breast cancer screening.

BACKGROUND: The DMIST (Digital Mammography Imaging Screening Trial) reported improved breast cancer detection with digital mammography compared with film mammography in selected population subgroups, but it did not assess the economic value of digital relative to film mammography screening. OBJECTIVE: To evaluate the cost-effectiveness of digital mammography screening for breast cancer. DESIGN: Validated, discrete-event simulation model. DATA SOURCES: Data from DMIST and publicly available U.S. data. TARGET POPULATION: U.S. women age 40 years or older. TIME HORIZON: Lifetime. PERSPECTIVE: Societal and Medicare. INTERVENTION: All-film mammography screening; all-digital mammography screening; and targeted digital mammography screening, which is age-targeted digital mammography (for women <50 years of age) and age- and density-targeted digital mammography (for women <50 years of age or women > or =50 years of age with dense breasts). OUTCOME MEASURES: Cost per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: All-digital mammography screening cost $331,000 (95% CI, $268,000 to $403,000) per QALY gained relative to all-film mammography screening but was more costly and less effective than targeted digital mammography screening. Targeted digital mammography screening resulted in more screen-detected cases of cancer and fewer deaths from cancer than either all-film or all-digital mammography screening, with cost-effectiveness estimates ranging from $26,500 (CI, $21,000 to $33,000) per QALY gained for age-targeted digital mammography to $84,500 (CI, $75,000 to $93,000) per QALY gained for age- and density-targeted digital mammography. In the Medicare population, the cost-effectiveness of density-targeted digital mammography screening varied from a base-case estimate of $97,000 (CI, $77,000 to $131,000) to $257,000 per QALY gained (CI, $91,000 to $536,000) in the alternative-case analyses, in which the sensitivity of film mammography was increased and the sensitivity of digital mammography in women with nondense breasts was decreased. RESULTS OF SENSITIVITY ANALYSIS: Results were sensitive to the cost of digital mammography and to the prevalence of dense breasts. LIMITATIONS: Results were dependent on model assumptions and DMIST findings. CONCLUSION: Relative to film mammography, screening for breast cancer by using all-digital mammography is not cost-effective. Age-targeted screening with digital mammography seems cost-effective, whereas density-targeted screening strategies are more costly and of uncertain value, particularly among women age 65 years or older.

Diagnostic accuracy of digital versus film mammography: exploratory analysis of selected population subgroups in DMIST.

PURPOSE: To retrospectively compare the accuracy of digital versus film mammography in population subgroups of the Digital Mammographic Imaging Screening Trial (DMIST) defined by combinations of age, menopausal status, and breast density, by using either biopsy results or follow-up information as the reference standard. MATERIALS AND METHODS: DMIST included women who underwent both digital and film screening mammography. Institutional review board approval at all participating sites and informed consent from all participating women in compliance with HIPAA was obtained for DMIST and this retrospective analysis. Areas under the receiver operating characteristic curve (AUCs) for each modality were compared within each subgroup evaluated (age < 50 vs 50-64 vs >or= 65 years, dense vs nondense breasts at mammography, and pre- or perimenopausal vs postmenopausal status for the two younger age cohorts [10 new subgroups in toto]) while controlling for multiple comparisons (P < .002 indicated a significant difference). All DMIST cancers were evaluated with respect to mammographic detection method (digital vs film vs both vs neither), mammographic lesion type (mass, calcifications, or other), digital machine type, mammographic and pathologic size and diagnosis, existence of prior mammographic study at time of interpretation, months since prior mammographic study, and compressed breast thickness. RESULTS: Thirty-three centers enrolled 49 528 women. Breast cancer status was determined for 42,760 women, the group included in this study. Pre- or perimenopausal women younger than 50 years who had dense breasts at film mammography comprised the only subgroup for which digital mammography was significantly better than film (AUCs, 0.79 vs 0.54; P = .0015). Breast Imaging Reporting and Data System-based sensitivity in this subgroup was 0.59 for digital and 0.27 for film mammography. AUCs were not significantly different in any of the other subgroups. For women aged 65 years or older with fatty breasts, the AUC showed a nonsignificant tendency toward film being better than digital mammography (AUCs, 0.88 vs 0.70; P = .0025). CONCLUSION: Digital mammography performed significantly better than film for pre- and perimenopausal women younger than 50 years with dense breasts, but film tended nonsignificantly to perform better for women aged 65 years or older with fatty breasts.

Assessing fat-related dietary behaviors among black women: reliability and validity of a new Food Habits Questionnaire.

OBJECTIVE: To describe the development of the SisterTalk Food Habits Questionnaire (STFHQ). DESIGN: Formative research was conducted to adapt previous tools for the study's target population. A pilot tool (168 questions) was tested. The new 94-question tool was then used for evaluation of the SisterTalk project. Lastly, a 4-week reliability calibration study of the revised STFHQ was conducted in comparison with a food frequency questionnaire (FFQ). ANALYSIS: Reliability was assessed using test-retest correlations. Validity was assessed by correlations between STFHQ scores with FFQ calculated calories, total fat (g) and percentage of calories from fat. Three scoring methods (ie, introductory, product, and detail) were calculated along with inclusion or exclusion of dining out questions and alternate methods of scoring for food items not consumed. RESULTS: Reliability (correlation) was 0.87. Inclusion of dining out questions and imputation of zero for food items never consumed were more highly associated with fat intake than other scoring methods. The introductory score was most highly correlated with fat (g), whereas the product and detail scoring methods correlated highest with percentage of calories from fat. Responsiveness to the SisterTalk intervention was highest with the detail score. CONCLUSIONS AND IMPLICATIONS: The STFHQ is a reliable and valid tool that may be useful for evaluating dietary change for black women.

Melanoma early detection with thorough skin self-examination: the "Check It Out" randomized trial.

BACKGROUND: Monthly thorough skin self-examination (TSSE) is an important practice for early melanoma detection that is performed by a small minority of the population. DESIGN: A randomized trial was conducted to determine whether a multicomponent intervention can increase TSSE performance and to describe the effects on performance of skin surgeries compared with a similar control intervention focused on diet. SETTING/PARTICIPANTS: One thousand three hundred fifty-six patients attending a routine primary care visit in southeastern New England participated in this trial. INTERVENTIONS: Participants received instructional materials, including cues and aids, a video, and a brief counseling session and (at 3 weeks) a brief follow-up phone call (from a health educator) and tailored feedback letters. MEASURES: Performance of TSSE assessed by telephone interview and having a surgical procedure performed on the skin were confirmed by examining medical records. RESULTS: TSSE was performed by substantially more participants at 2, 6, and 12 months in the intervention group than in the control group (55% vs 35%, p<0.0001 at 12 months). We also noted that a substantially higher proportion in the intervention group had skin surgery in the first 6 months (8.0% vs 3.6%, p=0.0005), but there was no difference at 6 to 12 months (3.9% vs 3.3%, p=0.5). CONCLUSIONS: The TSSE intervention was effective in increasing performance of TSSE, in that it resulted in increased surgery on the skin, and that increase in skin procedures only persisted for 6 months. Intervention to increase TSSE may result in long-term benefit in early detection of melanoma while causing only a short-term excess of skin surgeries.

Diagnostic performance of digital versus film mammography for breast-cancer screening.

BACKGROUND: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. METHODS: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. RESULTS: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). CONCLUSIONS: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.)

Longitudinal trajectories of depression and anxiety in a prospective community study: the Zurich Cohort Study.

BACKGROUND: The dearth of long-term follow-up studies of community-based samples and differences in methodology in existing studies highlight the need for research designed to examine the stability, comorbidity, and diagnostic thresholds of depression and anxiety in the community. METHODS: Prospective study of a community-based cohort aged 19 and 20 years from the canton of Zurich, Switzerland. Semistructured diagnostic interviews were administered by clinically experienced interviewers at 5 assessment points during a 15-year period. The format of the interview permitted assessment of major mental disorders at both the diagnostic and subthreshold levels. RESULTS: Comorbid anxiety and depression tended to be far more persistent than either syndrome alone. Individuals with anxiety states alone tended to develop either depression alone or comorbid anxiety and depression as they progressed through adulthood. In contrast, depression alone and depression comorbid with anxiety tended to be more stable than anxiety alone over time. The patterns of stability were similar for subthreshold- and threshold-level disorders. CONCLUSIONS: These findings have important implications for classification and treatment of affective disorders. The greater stability of comorbid anxiety and depression than either disorder alone illustrates the importance of further investigation of comorbid states compared with noncomorbid states in etiologic and treatment research. The persistence of subthreshold-level depression and anxiety from early to mid adulthood also suggests the importance of characterizing the continuum of expression of depression and anxiety rather than adhering to strict diagnostic thresholds.

Developmental trajectories of cocaine-and-other-drug-exposed and non-cocaine-exposed children.

Few data are available concerning the trajectories of mental and motor development across time for cocaine-exposed children compared with others. Findings are presented from individual group curve analyses of the mental and motor development measured by the Bayley Scales of Infant Development-II (BSID-II) on repeated visits from 3 through 36 months of a group of prenatally cocaine-and-other-drug-exposed children (n = 265) compared with those exposed to no drugs (n = 129) or no-cocaine-but-other-drugs (n = 66), including alcohol and/or tobacco. Across time, there was a general decline in motor performance but cocaine-exposed-infants showed a trend toward a greater decrease than children in the other two comparison groups. For mental performance, there was also a decline across age but only through 24 months and no differences in the trajectory of the cocaine-exposed group compared to the other two. And, across all assessment ages, cocaine-exposed-infants showed lower BSID-II mental performance compared to both non-drug and non-cocaine-exposed children. Results suggest that prenatally cocaine-exposed children show delayed developmental indices, particularly in their mental performance, but their trajectories across time are similar to those from impoverished, non-cocaine-exposed groups.