A genomic predictor of response and survival following taxane-anthracycline chemotherapy for invasive breast cancer.

CONTEXT: Prediction of high probability of survival from standard cancer treatments is fundamental for individualized cancer treatment strategies. OBJECTIVE: To develop a predictor of response and survival from chemotherapy for newly diagnosed invasive breast cancer. DESIGN, SETTING, AND PATIENTS: Prospective multicenter study conducted from June 2000 to March 2010 at the M. D. Anderson Cancer Center to develop and test genomic predictors for neoadjuvant chemotherapy. Patients were those with newly diagnosed ERBB2 (HER2 or HER2/neu)-negative breast cancer treated with chemotherapy containing sequential taxane and anthracycline-based regimens (then endocrine therapy if estrogen receptor [ER]-positive). Different predictive signatures for resistance and response to preoperative (neoadjuvant) chemotherapy (stratified according to ER status) were developed from gene expression microarrays of newly diagnosed breast cancer (310 patients). Breast cancer treatment sensitivity was then predicted using the combination of signatures for (1) sensitivity to endocrine therapy, (2) chemoresistance, and (3) chemosensitivity, with independent validation (198 patients) and comparison with other reported genomic predictors of chemotherapy response. MAIN OUTCOME MEASURES: Distant relapse-free survival (DRFS) if predicted treatment sensitive and absolute risk reduction ([ARR], difference in DRFS between 2 predicted groups) at median follow-up (3 years). RESULTS: Patients in the independent validation cohort (99% clinical stage II-III) who were predicted to be treatment sensitive (28%) had 56% (95% CI, 31%-78%) probability of excellent pathologic response and DRFS of 92% (95% CI, 85%-100%), with an ARR of 18% (95% CI, 6%-28%). Survival was predicted in ER-positive (30% predicted sensitive; DRFS, 97% [95% CI, 91%-100%]; ARR, 11% [95% CI, 0.1%-21%]) and ER-negative (26% predicted sensitive; DRFS, 83% [95% CI, 68%-100%]; ARR, 26% [95% CI, 4%-48%]) subsets and was significant in multivariate analysis. Other genomic predictors showed paradoxically worse survival for patients predicted to be responsive to chemotherapy. CONCLUSION: A genomic predictor combining ER status, predicted chemoresistance, predicted chemosensitivity, and predicted endocrine sensitivity identified patients with high probability of survival following taxane and anthracycline chemotherapy.

Complementary and Alternative Medicine Use in Minority and Medically Underserved Oncology Patients: Assessment and Implications.

INTRODUCTION: Complementary and alternative medicine (CAM) use in minority and medically underserved oncology patients is not well documented. We assessed knowledge and utilization of CAM in a sample of these patients receiving treatment at an urban community hospital. METHODS: Patients with cancer were interviewed using an electronic application that depicted specific CAM therapies. Patients were questioned on their knowledge and utilization of therapies, deterrents to use, and interest in using these therapies if they were made available. RESULTS: Patients (n = 165) reported a high awareness and use of CAM therapies. CAM use was highest for prayer (85%), relaxation (54%), special diet (29%), meditation (19%), and massage (18%). Patients' interest in using CAM was high for nearly all therapies. Lack of adequate knowledge and cost of use were reported as deterrents to use. Female patients reported higher use of aromatherapy relative to males (37.1% vs 19.4%, P = .02); those with higher education reported greater use of relaxation (60.8% vs 28.6%, P = .02); non-Hispanics reported higher use of relaxation relative to Hispanics (63.5% vs 44.2%, P = .03), and African American patients reported higher use of relaxation relative to White patients (69.2% vs 50%, P = .03). CONCLUSIONS: CAM use in minority and medically underserved cancer patients is common, but not professionally guided; thus, concerns remain regarding its safe use. Our data underscore the importance of patient-physician dialogue regarding CAM use in this patient population, and interest in access to the medically guided integration of evidence-based CAM therapies.

Pain education for underserved minority cancer patients: a randomized controlled trial.

PURPOSE: Previous studies found that African American and Hispanic cancer patients are at risk for undertreatment of pain. We evaluated the efficacy of a pain education intervention for underserved minority patients. PATIENTS AND METHODS: Ninety-seven underserved African American and Hispanic outpatients with cancer-related pain were enrolled onto a randomized clinical trial of pain management education. The patients in the education group received a culture-specific video and booklet on pain management. The control group received a video and booklet on nutrition. A research nurse met with each patient to review the materials. We measured changes in pain intensity and pain-related interference 2 to 10 weeks after the intervention, as well as changes in quality of life, perceived pain control, functional status, analgesics, and physician pain assessments. RESULTS: Physicians underestimated baseline pain intensity and provided inadequate analgesics for more than 50% of the sample. Although the ratings for pain intensity and pain interference decreased over time for both groups, there was no statistically significant difference between groups. Pain education did not affect quality of life, perceived pain control, or functional status. African American patients in the education but not the control group reported a significant decrease in pain worst ratings from baseline to first follow-up (P < .01), although this decrease was not maintained at subsequent assessments. CONCLUSION: Brief education had limited impact on pain outcomes for underserved minority patients, suggesting that more intensive education for patients and interventions for physicians are needed.

Caregiver symptom burden: the risk of caring for an underserved patient with advanced cancer.

BACKGROUND: The growing diversity of the population of the United States and the high burden of cancer-related symptoms reflect the need for caregiver research within underserved groups. In this longitudinal study, the authors assessed changes in symptom severity in caregivers and underserved minority patients diagnosed with advanced solid tumors who were being treated at public hospitals. METHODS: A total of 85 matched patient-caregiver dyads completed the M. D. Anderson Symptom Inventory 3 times during 20 weeks of chemotherapy. At each time point, symptom severity and interference with daily activities were assessed. Group-based trajectory modeling was used to classify caregivers into high-symptom or low-symptom burden groups. RESULTS: Sadness and distress were more prevalent among caregivers (P = .005). Symptom burden remained stable among caregivers in the high-symptom group (40%), whereas the low-symptom group (60%) demonstrated a statistically significant decrease over time. Multivariate analysis found being a family-member caregiver (adjusted odds ratio [ADJ-OR], 4.1; 95% confidence interval [95% CI], 1.4-11.6) and caring for a highly symptomatic patient (ADJ-OR, 8.0; 95% CI, 1.5-41.4), rather than race, ethnicity, or sociodemographic characteristics, were significant predictors of the caregiver's membership in the high-symptom burden group. CONCLUSIONS: Approximately 40% of the caregivers in the current study were found to be at an increased risk for moderate to severe sadness and distress, which remained severe throughout the patient's treatment course at public hospitals. To the authors' knowledge, this study marks the first time that the concept of symptom burden has been used to measure caregiver burden, and the first time that symptom burden has been measured and documented in dyads of caregivers and underserved minority patients. Cancer 2011. © 2010 American Cancer Society.

Levels of symptom burden during chemotherapy for advanced lung cancer: differences between public hospitals and a tertiary cancer center.

PURPOSE: We compared risk factors for high disease- and treatment-related symptom burden over 15 weeks of therapy in medically underserved patients with advanced non-small-cell lung cancer and in patients treated at a tertiary cancer center. PATIENTS AND METHODS: We monitored symptom severity weekly during chemotherapy. Patients were recruited from a tertiary cancer center (n=101) and three public hospitals treating the medically underserved (n=80). We used a composite symptom-severity score and group-based trajectory analysis to form two groups: one with consistently more severe symptoms and another with less severe symptoms. We examined predictors of group membership. RESULTS: Seventy percent of the sample (n=126) reported low symptom-severity levels that decreased during therapy; 30% (n=55) had consistently severe symptoms throughout the study. In multivariate analysis, patients with good performance status being treated in public hospitals were significantly more likely than patients treated at the tertiary cancer center to be in the high-symptom group (odds ratio, 5.6; 95% CI, 2.1 to 14.6; P = .001) and to report significantly higher symptom interference (P = .001). Other univariate predictors of high-symptom group membership included variables associated with being medically underserved (eg, having less education, being single, and being nonwhite). No group differences by ethnicity were observed in the public hospitals. Medically underserved patients were less likely to receive adequate pain management. CONCLUSION: Patients with advanced lung cancer and good performance status treated at public hospitals were more likely than those treated at a tertiary cancer center to experience substantial symptoms during chemotherapy.