IntroductionBreast cancer survival rates are lower for African American women than for white women. Obesity, high-fat diets, and lack of regular physical activity increase risk for breast cancer recurrence, comorbid conditions, and premature death. Eighty-two percent of African American women are overweight or obese, partly because of unhealthy eating and exercise patterns. Although successful weight loss and lifestyle interventions for breast cancer survivors are documented, none has considered the needs of African American breast cancer survivors. This study assessed the feasibility and impact of Moving Forward, a culturally tailored weight loss program for African American breast cancer survivors.MethodsThe study used a pre-post design with a convenience sample of 23 African American breast cancer survivors. The 6-month intervention was theory-based and incorporated qualitative data from focus groups with the targeted community, urban African American breast cancer survivors. Data on weight, body mass index (BMI), diet, physical activity, social support, and quality of life were collected at baseline and at 6 months.ResultsAfter the intervention, we noted significant differences in weight, BMI, dietary fat intake, vegetable consumption, vigorous physical activity, and social support.ConclusionThis is the first published report of Moving Forward, a weight loss intervention designed for African American breast cancer survivors. Although a randomized trial is needed to establish efficacy, the positive results of this intervention suggest that this weight loss intervention may be feasible for African American breast cancer survivors. Lifestyle interventions may reduce the disparities in breast cancer mortality rates.
IMPORTANCETyrosine kinase inhibitors (TKIs) have been associated with improved survival of patients with chronic myeloid leukemia (CML) but are also associated with adverse effects, especially fatigue and diarrhea. Discontinuation of TKIs is safe and is associated with the successful achievement of treatment-free remission (TFR) for some patients.OBJECTIVE To evaluate molecular recurrence (MRec) and patient-reported outcomes (PROs) after TKI discontinuation for US patients with CML. DESIGN, SETTING, AND PARTICIPANTSThe Life After Stopping TKIs (LAST) study was a prospective single-group nonrandomized clinical trial that enrolled 172 patients from 14 US academic medical centers from December 18, 2014, to December 12, 2016, with a minimum follow-up of 3 years. Participants were adults with chronic-phase CML whose disease was well controlled with imatinib, dasatinib, nilotinib, or bosutinib. Statistical analysis was performed from August 13, 2019, to March 23, 2020. INTERVENTION Discontinuation of TKIs.MAIN OUTCOMES AND MEASURES Molecular recurrence, defined as loss of major molecular response (BCR-ABL1 International Scale ratio >0.1%) by central laboratory testing, and PROs (Patient-Reported Outcomes Measurement Information System computerized adaptive tests) were monitored. Droplet digital polymerase chain reaction (ddPCR) was performed on samples with undetectable BCR-ABL1 by standard real-time quantitative polymerase chain reaction (RQ-PCR). RESULTSOf 172 patients, 89 were women (51.7%), and the median age was 60 years (range, 21-86 years). Of 171 patients evaluable for molecular analysis, 112 (65.5%) stayed in major molecular response, and 104 (60.8%) achieved TFR. Undetectable BCR-ABL1 by either ddPCR or RQ-PCR at the time of TKI discontinuation (hazard ratio, 3.60; 95% CI, 1.99-6.50; P < .001) and at 3 months (hazard ratio, 5.86; 95% CI, 3.07-11.1; P < .001) was independently associated with MRec. Molecular recurrence for patients with detectable BCR-ABL1 by RQ-PCR was 50.0% (14 of 28), undetectable BCR-ABL1 by RQ-PCR but detectable by ddPCR was 64.3% (36 of 56), and undetectable BCR-ABL1 by both ddPCR and RQ-PCR was 10.3% (9 of 87) (P Յ .001). Of the 112 patients in TFR at 12 months, 90 (80.4%) had a clinically meaningful improvement in fatigue, 39 (34.8%) had a clinically meaningful improvement in depression, 98 (87.5%) had a clinically meaningful improvement in diarrhea, 24 (21.4%) had a clinically meaningful improvement in sleep disturbance, and 5 (4.5%) had a clinically meaningful improvement in pain interference. Restarting a TKI resulted in worsening of PROs. CONCLUSIONS AND RELEVANCEIn this study, TKI discontinuation was safe, and 60.8% of patients remained in TFR. Discontinuation of TKIs was associated with improvements in PROs. These findings should assist patients and physicians in their decision-making regarding discontinuation of TKIs. Detectable BCR-ABL1 by RQ-PCR or ddPCR at the time of TKI discontinuation was associated with higher risk of MRec; clinical application of this finding should be c...
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