Dataset Information

Association between genomic recurrence risk and well-being among breast cancer patients.

ABSTRACT:

Background

Gene expression profiling (GEP) is increasingly used in the rapidly evolving field of personalized medicine. We sought to evaluate the association between GEP-assessed of breast cancer recurrence risk and patients' well-being.

Methods

Participants were Dutch women from 10 hospitals being treated for early stage breast cancer who were enrolled in the MINDACT trial (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy). As part of the trial, they received a disease recurrence risk estimate based on a 70-gene signature and on standard clinical criteria as scored via a modified version of Adjuvant! Online. \Women completed a questionnaire 6-8 weeks after surgery and after their decision regarding adjuvant chemotherapy. The questionnaire assessed perceived understanding, knowledge, risk perception, satisfaction, distress, cancer worry and health-related quality of life (HRQoL), 6-8 weeks after surgery and decision regarding adjuvant chemotherapy.

Results

Women (n?=?347, response rate 62%) reported high satisfaction with and a good understanding of the GEP information they received. Women with low risk estimates from both the standard and genomic tests reported the lowest distress levels. Distress was higher predominately among patients who had received high genomic risk estimates, who did not receive genomic risk estimates, or who received conflicting estimates based on genomic and clinical criteria. Cancer worry was highest for patients with higher risk perceptions and lower satisfaction. Patients with concordant high-risk profiles and those for whom such profiles were not available reported lower quality of life.

Conclusion

Patients were generally satisfied with the information they received about recurrence risk based on genomic testing. Some types of genomic test results were associated with greater distress levels, but not with cancer worry or HRQoL.

Trial registration isrctn

ISRCTN18543567.

SUBMITTER: Retel VP

PROVIDER: S-EPMC3689597 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Association between genomic recurrence risk and well-being among breast cancer patients.

Retèl Valesca P VP Groothuis-Oudshoorn Catharina G M CG Aaronson Neil K NK Brewer Noel T NT Rutgers Emiel J T EJ van Harten Wim H WH

BMC cancer 20130618

<h4>Background</h4>Gene expression profiling (GEP) is increasingly used in the rapidly evolving field of personalized medicine. We sought to evaluate the association between GEP-assessed of breast cancer recurrence risk and patients' well-being.<h4>Methods</h4>Participants were Dutch women from 10 hospitals being treated for early stage breast cancer who were enrolled in the MINDACT trial (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy). As part of the ...[more]

PMID: 23777535

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Project description:ImportanceThe 21-gene assay recurrence score is increasingly used to personalize treatment recommendations for systemic therapy in postmenopausal women with estrogen receptor (ER)- or progesterone receptor (PR)-positive, node-positive breast cancer; however, the relevance of the 21-gene assay to radiotherapy decisions remains uncertain.ObjectiveTo examine the association between recurrence score and locoregional recurrence (LRR) in a postmenopausal patient population treated with adjuvant chemotherapy followed by tamoxifen or tamoxifen alone.Design, setting, and participantsThis cohort study was a retrospective analysis of the Southwest Oncology Group S8814, a phase 3 randomized clinical trial of postmenopausal women with ER/PR-positive, node-positive breast cancer treated with tamoxifen alone, chemotherapy followed by tamoxifen, or concurrent tamoxifen and chemotherapy. Patients at North American clinical centers were enrolled from June 1989 to July 1995. Medical records from patients with recurrence score information were reviewed for LRR and radiotherapy use. Primary analysis included 316 patients and excluded 37 who received both mastectomy and radiotherapy, 9 who received breast-conserving surgery without documented radiotherapy, and 5 with unknown surgical type. All analyses were performed from January 22, 2016, to August 9, 2019.Main outcomes and measuresThe LRR was defined as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes. Time to LRR was tested with log-rank tests and Cox proportional hazards regression for multivariate models.ResultsThe final cohort of this study comprised 316 women with a mean (range) age of 60.4 (44-81) years. Median (interquartile range) follow-up for those without LRR was 8.7 (7.0-10.2) years. Seven LRR events (5.8%) among 121 patients with low recurrence score and 27 LRR events (13.8%) among 195 patients with intermediate or high recurrence score occurred. The estimated 10-year cumulative incidence rates were 9.7% for those with a low recurrence score and 16.5% for the group with intermediate or high recurrence score (P = .02). Among patients who had a mastectomy without radiotherapy (n = 252), the differences in the 10-year actuarial LRR rates remained significant: 7.7 % for the low recurrence score group vs 16.8% for the intermediate or high recurrence score group (P = .03). A multivariable model controlling for randomized treatment, number of positive nodes, and surgical type showed that a higher recurrence score was prognostic for LRR (hazard ratio [HR], 2.36; 95% CI, 1.02-5.45; P = .04). In a subset analysis of patients with a mastectomy and 1 to 3 involved nodes who did not receive radiation therapy, the group with a low recurrence score had a 1.5% rate of LRR, whereas the group with an intermediate or high recurrence score had a 11.1% LRR (P = .051).Conclusions and relevanceThis study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes. This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision-making.

Project description:Importance:Making a good decision about breast reconstruction requires predicting how one would feel after the procedure, but people tend to overestimate the impact of events on future well-being. Objective:To assess how well patients predict future well-being after mastectomy, with or without immediate reconstruction, with the following a priori hypotheses: Patients will overestimate the negative impact of mastectomy and positive impact of reconstruction, and prediction accuracy will be associated with decision satisfaction and decision regret. Design, Setting, and Participants:This prospective cohort survey study was conducted at a single, multidisciplinary academic oncology clinic from July 2012 to February 2014. Adult women undergoing mastectomy for stage 1, 2, or 3 invasive ductal or lobular breast cancer, ductal carcinoma in situ, or prophylaxis were invited to participate. Data analysis was conducted from September 2015 to October 2017. Exposures:Mastectomy only or mastectomy with immediate reconstruction. Main Outcomes and Measures:Preoperative measures predicted were 12-month happiness (Cantril Ladder) and quality of life, predicted satisfaction with breasts, sexual attractiveness, breast numbness, and pain (measured with BreastQ single items). Measures at 12 months postoperative added the Decision Regret Scale and Satisfaction With Decisions Scale. Results:Of 214 eligible patients, 182 consecutive patients were approached, and 145 enrolled (80%). Of these 145 patients, 131 returned surveys (72%) and 111 of these remained at 12 months (88%). Fifteen who had delayed reconstruction were excluded from analysis, leaving a final cohort of 96 women; 54 had not had reconstruction and 42 had had reconstruction. The mean (SD) age of the cohort was 53.9 (12.1) years; 73 (76%) were white; 50 (52%) were college graduates; 54 (56%) were privately insured; 69 (72%) had disease at stages 0, 1, or 2; and 31 (32%) received adjuvant radiation. Patients having mastectomy without reconstruction underestimated future well-being in all domains. Differences were significant for quality of life scores (mean predicted, 68 vs mean actual, 74; t50, -2.47; P?=?.02) and satisfaction with breasts-clothed (mean predicted, 2.4 vs mean actual, 2.8; t49, -2.11; P?=?.04). Patients undergoing mastectomy with reconstruction overestimated future well-being in all but 1 domain. Differences were significant for satisfaction with breasts-unclothed (mean predicted, 3.1 vs mean actual, 2.6; t41, 2.70; P?=?.01); sexual attractiveness-clothed (mean predicted, 3.7 vs mean actual, 3.3; t39, 2.29; P?=?.03); sexual attractiveness-unclothed (mean predicted, 3.3 vs mean actual, 2.3; t40, 5.57; P?<?.001). Both groups experienced more numbness than predicted (mean predicted, 2.79 and 2.72 for mastectomy only and mastectomy with reconstruction groups, respectively; mean actual, 3.52 and 3.56, respectively; t47, -3.4 and t38, -2.9, respectively; P?<?.01). Patients who were less happy (??=?6.3; P?=?.02) or had greater pain (??=?8.7; P?<?.001) than predicted had greater regret. Conclusions and Relevance:Patients underestimated future well-being after mastectomy and overestimated well-being after reconstruction. Misprediction was associated with regret. Decision support for breast reconstruction should address expectations about well-being.

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Dataset Information

Association between genomic recurrence risk and well-being among breast cancer patients.

Background

Methods

Results

Conclusion

Trial registration isrctn

Publications

Association between genomic recurrence risk and well-being among breast cancer patients.

Similar Datasets

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