Marianne N. Prout

Predictors of Tamoxifen Discontinuation Among Older Women With Estrogen Receptor–Positive Breast Cancer

PURPOSE Five years of adjuvant tamoxifen therapy for estrogen receptor (ER) -positive breast cancer is more effective than 2 years of use. However, information on tamoxifen discontinuation is scanty. We sought to identify predictors of tamoxifen discontinuation among older women with breast cancer. PATIENTS AND METHODS Within six health care delivery systems, we identified women >or= 65 years old diagnosed with stage I to IIB ER-positive or indeterminant breast cancer between 1990 and 1994 who had filled a prescription for adjuvant tamoxifen. We observed them for 5 years after initial tamoxifen prescription. We used automated pharmacy records to validate tamoxifen prescription information abstracted from medical records. The primary end point was tamoxifen discontinuation, operationalized as ever discontinuing tamoxifen during 5 years of follow-up. We used Cox proportional hazards to identify predictors of tamoxifen discontinuation. RESULTS Of 961 women who were prescribed tamoxifen, 49% discontinued tamoxifen before the completion of 5 years. Discontinuers were more likely to be aged 75 to less than 80 years (v < 70 years; hazard ratio [HR] = 1.41; 95% CI, 1.06 to 1.87), be aged >or= 80 years (HR = 2.02; 95% CI, 1.53 to 2.66), have an increase in Charlson Comorbidity Index at 3 years from diagnosis (HR = 1.52; 95% CI, 1.18 to 1.95), have an increase in the number of cardiopulmonary comorbidities at 3 years (HR = 1.75; 95% CI, 1.34 to 2.28), have indeterminant ER status (v ER-positive status; HR = 1.36; 95% CI, 1.00 to 1.85), and have received breast-conserving surgery (BCS) without radiotherapy (v mastectomy; HR = 1.62; 95% CI, 1.18 to 2.22). CONCLUSION Attention to nonadherence among older women at risk of discontinuation, particularly those receiving BCS without radiotherapy, might improve breast cancer outcomes for these women.

A most stubborn bias: No adjustment method fully resolves confounding by indication in observational studies

OBJECTIVE To evaluate the effectiveness of methods that control for confounding by indication, we compared breast cancer recurrence rates among women receiving adjuvant chemotherapy with those who did not. STUDY DESIGN AND SETTING In a medical record review-based study of breast cancer treatment in older women (n=1798) diagnosed between 1990 and 1994, our crude analysis suggested that adjuvant chemotherapy was positively associated with recurrence (hazard ratio [HR]=2.6; 95% confidence interval [CI]=1.9, 3.5). We expected a protective effect, so postulated that the crude association was confounded by indications for chemotherapy. We attempted to adjust for this confounding by restriction, multivariable regression, propensity scores (PSs), and instrumental variable (IV) methods. RESULTS After restricting to women at high risk for recurrence (n=946), chemotherapy was not associated with recurrence (HR=1.1; 95% CI=0.7, 1.6) using multivariable regression. PS adjustment yielded similar results (HR=1.3; 95% CI=0.8, 2.0). The IV-like method yielded a protective estimate (HR=0.9; 95% CI=0.2, 4.3); however, imbalances of measured factors across levels of the IV suggested residual confounding. CONCLUSION Conventional methods do not control for unmeasured factors, which often remain important when addressing confounding by indication. PS and IV analysis methods can be useful under specific situations, but neither method adequately controlled confounding by indication in this study.

Screening for melanoma/skin cancer: Theoretic and practical considerations

There is increasing national interest concerning strategies for the early detection of melanoma/skin cancer. Screening has been implemented on a national scale in an effort to decrease morbidity and mortality from this disease; however, many crucial questions about the proper methods and ultimate value of screening remain unanswered. In this review we apply the scientific principles of cancer screening to dermatology, address the theoretic and practical challenges of cancer screening in terms of melanoma/skin cancer, analyze existing data on skin cancer screening, and identify issues that require future research.

Evaluation of melanoma/skin cancer screening in Massachusetts. Preliminary results

Although screening for melanoma/skin cancer is theoretically of value, few data are available to evaluate its effectiveness or the value of a visual exam by a dermatologist as a cancer screening tool. From the 2560 persons screened for melanoma/skin cancer in Massachusetts in 1986 and 1987, the authors followed the positive screenees to determine their final diagnosis. The authors obtained information on 85% of these persons, and found nine malignant melanomas, 91 non‐melanoma skin cancers, 39 dysplastic nevi, and three congenital nevi. The sensitivity of the visual exam by a dermatologist was 89% to 97% and the predictive value positive was 35% to 75% for skin cancer. The authors conclude that the yield of screening is equivalent to that of other major cancer screening efforts and that the sensitivity and predictive value of the visual examination by the dermatologist is appropriate for a cancer screening tool.

Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women's Health

Recent attention to reducing health disparities among population groups has focused on the need to include in clinical studies, especially clinical trials, participants who represent the diversity of the populations to which study results will be applied. While scientists generally applaud the goal of broadening the characteristics of participants in clinical trials, they are faced with multiple challenges as they seek to include historically underrepresented populations in their research. This article examines the historical and sociocultural context of participation by underrepresented groups, especially women and minorities, in clinical trials, identifies major barriers and challenges facing researchers, and suggests strategies for meeting these challenges. The article draws upon the experiences of the investigators affiliated with the National Centers of Excellence of Womens Health (CoEs).

Years of potential life lost: Another indicator of the impact of cutaneous malignant melanoma on society

Years of potential life lost (YPLL) is an indicator of premature mortality that complements traditional incidence and mortality rates and that facilitates comparisons among different cancers. We calculated YPLL from cutaneous melanoma and 11 other cancers routinely recorded and tracked by Surveillance, Epidemiology and End Results (SEER). YPLL from cutaneous melanoma ranked eighth for persons younger than 65 years of age and fourth for those 20 to 49 years of age. An average of 17.1 YPLL per death were due to melanoma, one of the highest rates for adult-onset cancers. The results of our study, the first to apply YPLL to cutaneous melanoma, emphasize the disproportionate impact of this cancer on young and middle-aged adults and reemphasize the importance of this cancer as a public health priority.

Recurrences and second primary breast cancers in older women with initial early-stage disease.

The association between common breast cancer therapies and recurrences and second primary breast cancers in older women is unclear, although older women are less likely to receive common therapies.

The Impact of a Novel Computer-Based Decision Aid on Shared Decision Making for Colorectal Cancer Screening: A Randomized Trial

Background. Eliciting patients’ preferences within a framework of shared decision making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening adherence. Our objective was to assess the effectiveness of a novel decision aid on SDM in the primary care setting. Methods. An interactive, computer-based decision aid for CRC screening was developed and evaluated within the context of a randomized controlled trial. A total of 665 average-risk patients (mean age, 57 years; 60% female; 63% black, 6% Hispanic) were allocated to 1 of 2 intervention arms (decision aid alone, decision aid plus personalized risk assessment) or a control arm. The interventions were delivered just prior to a scheduled primary care visit. Outcome measures (patient preferences, knowledge, satisfaction with the decision-making process [SDMP], concordance between patient preference and test ordered, and intentions) were evaluated using prestudy/poststudy visit questionnaires and electronic scheduling. Results. Overall, 95% of patients in the intervention arms identified a preferred screening option based on values placed on individual test features. Mean cumulative knowledge, SDMP, and intention scores were significantly higher for both intervention groups compared with the control group. Concordance between patient preference and test ordered was 59%. Patients who preferred colonoscopy were more likely to have a test ordered than those who preferred an alternative option (83% v. 70%; P < 0.01). Intention scores were significantly higher when the test ordered reflected patient preferences. Conclusions. Our interactive computer-based decision aid facilitates SDM, but overall effectiveness is determined by the extent to which providers comply with patient preferences.

Improving Breast Cancer Control via the Use of Community Health Workers in South Africa: A Critical Review

Breast cancer is a growing concern in low- and middle-income countries (LMCs). We explore community health worker (CHW) programs and describe their potential use in LMCs. We use South Africa as an example of how CHWs could improve access to breast health care because of its middle-income status, existing cancer centers, and history of CHW programs. CHWs could assume three main roles along the cancer control continuum: health education, screening, and patient navigation. By raising awareness about breast cancer through education, women are more likely to undergo screening. Many more women can be screened resulting in earlier-stage disease if CHWs are trained to perform clinical breast exams. As patient navigators, CHWs can guide women through the screening and treatment process. It is suggested that these roles be combined within existing CHW programs to maximize resources and improve breast cancer outcomes in LMCs.

Systematic underreporting of cutaneous malignant melanoma in Massachusetts: Possible implications for national incidence figures

An independent tabulation of incidence of cutaneous malignant melanoma in Massachusetts indicates that 12% and perhaps as many as 19% of new cases of cutaneous malignant melanoma in Massachusetts are not recorded in the Massachusetts Cancer Registry, significantly more than the expected 5% (p = 0.0001). The increasing number of nonhospital medical settings in which melanomas can be diagnosed and/or treated appears to account for this discrepancy. We suspect that these findings in Massachusetts also apply to cancer reporting systems in other regions of the United States. We suggest that the true incidence of cutaneous malignant melanoma in Massachusetts, and perhaps in the United States, may be significantly higher than reported.