In the KATHERINE study (NCT01772472), patients with HER2-positive early breast cancer (EBC) and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy who were treated with adjuvant trastuzumab emtansine (T-DM1) had a 50% reduction in the risk of an invasive disease-free survival (IDFS) event compared to patients treated with adjuvant trastuzumab. In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients. Here, we report safety and efficacy in Chinese patients from KATHERINE.
MethodsPatients with HER2-positive EBC and residual invasive disease after taxane- and trastuzumab-containing neoadjuvant chemotherapy followed by surgery were randomized 1:1 to 14 cycles of adjuvant T-DM1 or trastuzumab. The primary endpoint was time to an IDFS event.
ResultsAmong Chinese patients (T-DM1 n?=?51, trastuzumab n?=?50), T-DM1 treatment resulted in a 43% reduction in risk of an IDFS event compared to trastuzumab (HR?=?0.57; 95% CI 0.25–1.31), with similar results for secondary endpoints. As in the global population, Chinese patients receiving T-DM1 versus trastuzumab had more grade?≥?3 adverse events (AEs; 39.2% versus 4.1%) and AEs leading to treatment discontinuation (27.5% versus 0%). The most common grade?≥?3 AE with T-DM1 was thrombocytopenia (21.6%), a frequency higher than the frequency in the global population (5.7%). Grade?≥?3 hemorrhage was reported in 1 patient (T-DM1 arm).
ConclusionsIn the KATHERINE study, T-DM1 demonstrated increased efficacy compared to trastuzumab in Chinese patients. Consistent with previous data in Asian patients, T-DM1 was associated with more grade?≥?3 AEs, and AEs leading to discontinuation, which was driven by an increase in thrombocytopenia.
相似文献Despite life-saving potential, many women struggle to adhere to adjuvant endocrine therapy (AET) for their breast cancer (BCa). Prior research has demonstrated that emotional distress is a barrier to AET adherence. We followed women from a trial to test the long-term effects of two 5-week post-surgical group-based stress management interventions, cognitive behavioral therapy (CBT), and relaxation training versus an attention-matched health education control, on AET adherence.
MethodsWe conducted a long-term follow-up (median?=?8 years) of women randomized to CBT, relaxation training, or health education after surgery for stage 0–3 BCa. We measured adherence with the Endocrine Therapy Medication Usage Questionnaire (ETMUQ). First, we established factors on the ETMUQ via confirmatory factor analysis. We then used Bayesian structural equation modeling to regress these factors on study arm, controlling for age and treatments received.
ResultsOf those who completed long-term follow-up (n?=?59, 44.7%), over half (n?=?33; 55.9%) reported problems with adherence generally. Women receiving relaxation training (n?=?15) had better adherence than those receiving health education (n?=?24) on the Forgetfulness/Inconsistency [B(SE)?=?0.25(0.14), p?=?0.049] and Intentional Nonadherence [B(SE)?=?0.31(0.14), p?=?0.018] factors of the ETMUQ. Similar results were observed for those receiving relaxation training compared to CBT (n?=?20): Forgetfulness/Inconsistency [B(SE)?=???0.47(0.25), p?=?0.031]; Intentional Nonadherence [B(SE)?=???0.31(0.15), p?=?0.027].
ConclusionWomen receiving relaxation training were less likely to (1) forget to take their AET and (2) intentionally miss doses of AET in the long term compared to women receiving health education or CBT. This is evidence for the need of randomized trials that aim to improve adherence by incorporating theoretically based behavioral change techniques.
Trial registration and datesTrial 2R01-CA-064710 was registered March 26, 2006.
相似文献To investigate the survival difference between limited axillary surgery and full axillary lymph node dissection (ALND) in patients with 1–3 positive sentinel lymph node biopsies (SLNBs) after neoadjuvant chemotherapy (NAC).
MethodWe retrospectively analyzed data from 676 patients who underwent surgery between 2007 and 2017 with cT1–4, cN0–3, cM0 breast cancer at the time of diagnosis and 1–3 positive SLNBs after NAC. The patients received either SLNB only or completed level I or II ALND based on SLNB results. After propensity score matching, 483 patients who had undergone SLNB only (n?=?188) and ALND (n?=?295) were included. We examined overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival and compared them between the subgroups.
ResultAt a median follow-up of 59.4 months, no significant statistical difference was observed in overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival between SLNB only and ALND. No significant differences were observed in the 5-year axillary recurrence-free survival (93.1% vs. 94.0%, hazard ratio [HR]?=?0.94, 95% confidence interval [CI]?=?0.43–2.05, p?=?0.876) and 5-year overall survival (97.7% vs. 97.3%, HR?=?1.65, 95% CI?=?0.58–4.65, p?=?0.347) between the two groups.
ConclusionOur analysis suggests that SLNB alone may be a possible option for patients with 1–3 sentinel node-positive breast cancer following NAC without significant compromise of recurrence or overall survival.
相似文献To compare the diagnostic performance of ring-type dedicated breast PET (dbPET), whole-body PET (WBPET), and DCE-MRI for predicting pathological complete response (pCR) after neoadjuvant chemotherapy (NAC).
MethodsThis prospective study included 29 women with histologically proven breast cancer on needle biopsy between July 2016 and July 2019 (age: mean 55 years; range 35–78). Patients underwent WBPET followed by ring-type dbPET and DCE-MRI pre- and post-NAC for preoperative evaluation. pCR was defined as an invasive tumor that disappeared in the breast. Standardized uptake values corrected for lean body mass (SULpeak) were calculated for dbPET and WBPET scans. Maximum tumor length was measured in DCE-MRI images.
Reduction rates were calculated for quantitative evaluation. Two radiologists independently evaluated the qualitative findings. Reduction rates and qualitative findings were compared between the pCR (n?=?7) and non-pCR (n?=?22) groups for each modality. Differences in quantitative and qualitative data between the two groups were analyzed statistically.
ResultsSignificant differences were observed in the reduction rates of dbPET and DCE-MRI (P?=?0.01 and 0.03, respectively) between the two groups. Univariate and multiple logistic regression analyses revealed that SULpeak reduction rates in WBPET and dbPET (P?=?0.02 and P?=?0.01, respectively) and in dbPET (odds ratio, 16.00; 95% CI 1.57–162.10; P?=?0.01) were significant indicators associated with pCR, respectively. No between-group differences were observed in qualitative findings in the three modalities.
ConclusionSULpeak reduction rate of dbPET?>?82% was an independent indicator associated with pCR after NAC in breast cancer.
相似文献Pregnancy-associated breast cancer (PABC) poses a clinical challenge and its prognosis remains controversial. During the pregnancy and postpartum periods, the breast undergoes biological events that may uniquely influence disease behavior and treatment response. This study aimed to assess if a PABC diagnosis influences survival compared to non-PABC.
MethodsA single-center record review was performed to identify PABC patients diagnosed from January 2007 through June 2018. Two controls were matched to each PABC case by stage, immunohistochemical (IHC) subtype, age (±?3) and year of diagnosis (±?2). Disease-free survival (DFS) and overall survival (OS) were estimated with the Kaplan–Meier method and compared with the log-rank test. Multivariate analysis was used to assess the impact of PABC on outcomes.
Results125 PABC patients (pregnant: 62; postpartum: 63) and 250 controls were included. Median follow-up was 67.7 and 73.4 months, respectively. 4-year DFS was 62% in pregnant vs 78% in controls (p?=?0.010), and 63% in postpartum vs 83% in controls (p?=?0.034). Subanalysis by IHC subtype revealed a significantly inferior DFS in PABC with hormone receptor-positive/HER2-negative (p?=?0.032) and HER2-positive disease (p?=?0.005) compared to corresponding non-PABC patients. 4-year OS was similar between case groups and controls. Multivariate analysis supported the independent impact of pregnant and postpartum status on DFS (p?<?0.05).
ConclusionPatients diagnosed during pregnancy and early postpartum are at high risk of recurrence. Further research is warranted to better characterize PABC tumor biology and enable the identification of novel therapeutic interventions to improve treatment outcomes.
相似文献While the association between diagnosis of breast cancer and post-diagnosis psychological distress has been well documented, data regarding pre-diagnosis psychological distress in the breast cancer population are limited. Here, we assessed pre-diagnosis major life stressors and breast cancer outcomes, namely stage of disease and choice of surgery, in a single-center population.
MethodsPatients with newly diagnosed clinical stage 0–3 breast cancer seen at Mayo Clinic Florida between June 11, 2018, and October 7, 2019, were administered voluntary telephone surveys to assess major life stressors during the 24 months preceding their cancer diagnosis. Subsequent clinical outcomes of cancer stage at diagnosis and surgical treatment were obtained through retrospective chart review. Study subjects who had experienced major life stressors and those who had not were compared using Chi-square tests.
ResultsOf 222 patients who were included, 51.3% reported experiencing a major life event before breast cancer diagnosis. 43.9% of these patients endorsed family-related stress. 21.1% had experienced multiple stressors. 1.8% described financial stress. Although more patients in the group with pre-diagnosis stress had carcinoma in situ (21.1% versus 13.0%, p?=?0.11) and fewer had stage T1/T2 disease (64% versus 73.1%, p?=?0.14) than in the group without stress, these differences were not statistically significant. More patients with pre-diagnosis stress chose mastectomy (34.2% versus 22.2%, p?=?0.048).
ConclusionsPsychological distress is prevalent prior to breast cancer diagnosis and may merit early intervention. While additional study in diverse populations is needed, current data suggest possible associations between pre-diagnosis psychological distress and surgical decision making, specifically mastectomy.
相似文献Routine health checkup and cancer screening rates among women are suboptimal, partially due to the health care disparities by race/ethnicity in the USA. This study examined the previously understudied associations between routine health checkup, cervical cancer screening, and breast cancer screening by race/ethnicity using the national representative sample of women.
MethodsData were obtained from three cycles (2017, 2018, and 2019) of the Health Information National Trends Survey (HINTS) (n?=?12,227). Survey-weighted logistic regressions were evaluated to assess associations between routine health checkup and cervical and breast cancer screening compliance with the established guidelines with the age criteria and frequency of screening by race/ethnicity (Black, White, Hispanic, and Other).
ResultsThis study included 6,941 women in the cervical cancer screening and 8,005 women for breast cancer screening, considering the age criteria. Women who had received routine health checkups were more likely to meet the cervical cancer screening guideline (Odds ratio?3.24, p?<?0.05) and breast cancer screening guideline (OR?5.86, p?<?0.05) compared to women who did not receive routine health checkups. While routine health checkups were associated with both types of cancer screenings in most racial/ethnic groups, analyses stratified by race/ethnicity suggest that Hispanic women and Other women did not benefit from routine health checkup in relation to cervical and breast cancer screening, respectively.
ConclusionPromotion of routine health checkups could promote cancer screening among women across racial/ethnic groups, although specific racial/ethnic groups may require additional support.
相似文献Clinical and genomic data from patients with early-stage breast cancer suggest more aggressive disease in premenopausal women. However, the association between age, disease course, and molecular profile from liquid biopsy in metastatic breast cancer (MBC) is not well characterized.
MethodsPatients were classified as premenopausal (< 45 years), perimenopausal (45–55 years), or postmenopausal (>?55 years). Cohort 1 consisted of patients with MBC who consented for prospective serial evaluation of circulating tumor cells (CTCs) using CellSearch?. Cohort 2 included patients who, as part of routine care, had circulating tumor DNA (ctDNA) sequenced by the Guardant360? assay. Clinicopathologic data were collected from retrospective review to compare disease features between premenopausal and postmenopausal women.
ResultsPremenopausal women represented 26% of 138 patients in Cohort 1 and 21% of 253 patients in Cohort 2. In Cohort 1, younger patients had a shorter time to metastases and a higher prevalence of lung and brain metastases. Overall, there were similar rates of?≥?5 CTCs/7.5 mL, HER2?+?CTC expression, and CTC clusters between pre- and postmenopausal women. However, for those with triple negative breast cancer, premenopausal women had a higher proportion of?≥?5 CTCs/7.5 mL. In Cohort 2, premenopausal women had a higher incidence of FGFR1 (OR 2.75, p?=?0.022) and CCND2 (OR 6.91, p?=?0.024) alterations. There was no difference in the ctDNA mutant allele frequency or the number of detected alterations between these age groups.
ConclusionsOur data reveal that premenopausal women diagnosed with MBC have unique clinical, pathologic, and molecular features when compared to their postmenopausal counterparts. Our results highlight FGFR1 inhibitors as potential therapeutics of particular interest among premenopausal women.
相似文献Operative complications affect recurrence in non-breast malignancies. Rising rates of mastectomy with immediate reconstruction and their increased post-operative complications fuel concerns for poorer outcome in breast cancer (BC). We sought to determine the effect of complications on recurrence in BC patients.
MethodsA single-institution retrospective review was conducted of incident BC treated with mastectomy and immediate reconstruction. Overall survival and recurrence were compared between patients with complications to those without.
ResultsOf 201 patients (350 mastectomies, 86 nipple-sparing), 62 (30.8%) had a surgical complication. Patients with complications were older, but groups were similar for type of reconstruction, tobacco use, hormone receptor status, HER2, lymphovascular invasion, and pathologic stage (all p?>?0.05). Twenty-two complications (10.9%) were infection, 5 (2.5%) dehiscence, 14 flap necrosis (7%), 21 hematomas (10.4%), and 8 nipple necroses (9%). Recurrence occurred in 18 (8.9%) patients: 4 local, 2 regional, and 12 distant. After 8.9 years of median follow-up, patients with complications trended towards higher recurrence (hazard ratio (HR) 2.23, log-rank p?=?0.08, Cox regression p?=?0.05), particularly with nipple necrosis (HR 3.28, log-rank p?=?0.09, regression p?=?0.06). Patients with other complications had similar recurrence-free survival to those without (all p?>?0.05). Higher stage (HR 13.66, log-rank p?=?0.03) and adjuvant radiation (HR 2.78, log-rank p?=?0.04) cases were more likely to recur. Patients with complications had similar overall survival to those without (log-rank p?>?0.05).
ConclusionBC patients with surgical complications do not have lower overall survival. This finding may be due to the improved prognosis compared to non-breast malignancies.
相似文献To identify a structure to explain the relationship between socio-clinico factors, necessity-concerns beliefs, and perceived barriers to adherence with adjuvant endocrine therapy (AET) amongst women with breast cancer.
MethodsParticipants were 244 patients with early-stage breast cancer recruited from two tertiary hospitals from May 2015 to December 2018 who completed questionnaires on medication adherence (Simplified Medication Adherence Questionnaire), necessity-concerns beliefs (Beliefs about Medicine Questionnaire), and barriers to adherence (Adherence Starts with Knowledge Questionnaire). Socio-clinico variables were collected via interview and medical records review. Structural equation modelling was applied to examine the relationships between these variables and possible mediating effects of necessity-concerns beliefs on adherence to AET.
ResultsThe median age of the study participants was 61 (range 32–80) years and the median duration on AET was 1.6 (IQR 1.2–2.6) years. Adherence was positively associated with age (β?=?0.145, 95% CI: 0.011 to 0.279, p?=?0.034) and negatively associated with barriers (β?=?? 0.381, 95% CI: ? 0.511 to ? 0.251, p?<?0.001). There was no effect of Necessity (β?=?0.006, 95% CI: ? 0.145 to 0.158, p?=?0.933) or Concerns (β?=?0.041, 95% CI: ? 0.117 to 0.199, p?=?0.614) on adherence. Necessity-concerns beliefs were also not significant mediators in the relationship between socio-clinico factors and medication adherence.
ConclusionsOlder age and lower barriers to adherence were associated with higher adherence scores. Necessity-concerns beliefs did not have a significant effect on adherence as majority of the patients identified forgetfulness as a reason for non-adherence.
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