ABSTRACT
Purpose@#This study aimed to evaluate the incidence and prognosis of second non-breast primary cancer (SNBPC) among Korean survivors of breast cancer. @*Materials and Methods@#Data from the Korean National Health Insurance Service were searched to identify women who received curative surgery for initial breast cancer (IBC) between 2003 and 2008 (n=64,340). Among them, patients with the following characteristics were excluded: other cancer diagnosis before IBC (n=10,866), radiotherapy before IBC (n=349), absence of data on sex or age (n=371), or male (n=248). Accordingly, data of 52,506 women until December 2017 were analyzed. SNBPC was defined as a newly diagnosed SNBPC that occurred 5 years or more after IBC diagnosis. @*Results@#The median follow-up time of all patients was 12.13 years. SNBPC was developed in 3,084 (5.87%) women after a median of 7.61 years following IBC diagnosis. The 10-year incidence of SNBPC was 5.78% (95% confidence interval [CI], 5.56 to 6.00). Higher SNBPC incidence was found in survivors with the following factors: old age at IBC diagnosis, low household income, and receiving combined chemotherapy with endocrine therapy, whereas receiving radiotherapy was related to a lower incidence of SNBPC (hazard ratio, 0.89; p < 0.01). Among the patients with SNBPC, the 5-year survival rate was 62.28% (95% CI, 65.53 to 69.02). @*Conclusion@#Approximately 5% of breast cancer survivors developed SNBPC within 10 years after IBC diagnosis. The risk of SNBPC was associated with patient’s age at IBC diagnosis, income level, and a receipt of systemic treatments.
ABSTRACT
Purpose@#The incidence and prognostic implications of atrial fibrillation (AF) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) are controversial, especially for Korean patients. Furthermore, the pattern of antithrombotic therapy for these patients is unknown. The present study sought to identify the impact of AF on Korean patients undergoing TAVI and demonstrate the status of antithrombotic therapy for these patients. @*Materials and Methods@#A total of 660 patients who underwent TAVI for severe AS were recruited from the nationwide K-TAVI registry in Korea. The enrolled patients were stratified into sinus rhythm (SR) and AF groups. The primary endpoint was all-cause death at 1-year. @*Results@#AF was recorded in 135 patients [pre-existing AF 108 (16.4%) and new-onset AF 27 (4.1%)]. The rate of all-cause death at 1 year was significantly higher in patients with AF than in those with SR [16.2% vs. 6.4%, adjusted hazard ratio (HR): 2.207, 95% confidence interval (CI): 1.182–4.120, p=0.013], regardless of the onset timing of AF. The rate of new pacemaker insertion at 1 year was also significantly higher in patients with AF than in those with SR (14.0% vs. 5.5%, adjusted HR: 3.137, 95%CI: 1.621–6.071, p=0.001).Among AF patients, substantial number of patients received the combination of multiple antithrombotic agents (77.8%), and the most common combination was that of aspirin and clopidogrel (38.1%). @*Conclusion@#AF was an independent predictor of 1-year mortality and new pacemaker insertion in Korean patients undergoing TAVI.
ABSTRACT
This article provides an annual update of Korean breast cancer statistics, including the incidence, tumor stage, type of surgical treatment, and mortality. The data was collected from the Korean Breast Cancer Society registry system and Korean Central Cancer Registry.In 2019, 29,729 women were newly diagnosed with breast cancer. Breast cancer has continued to increase in incidence since 2002 and been the most common cancer in Korean women since 2019. Of the newly diagnosed cases in 2019, 24,820 (83.5%) were of invasive carcinomas, and 4,909 (16.5%) were of carcinoma in situ. The median age of women with breast cancer was 52.8 years, and breast cancer was most commonly diagnosed in the age group of 40–49 years. The number of patients who have undergone breast conserving surgery has continued to increase since 2016, with 68.6% of patients undergoing breast conserving surgery in 2019. The incidence of early-stage breast cancer continues to increase, with stage 0 or I breast cancer accounting for 61.6% of cases. The most common subtype of breast cancer is the hormone receptor-positive human epidermal growth factor receptor 2-negative subtype (63.1%). The 5-year relative survival rate of patients with breast cancer from 2015 to 2019 was 93.6%, with an increase of 14.3% compared to that from 1993 to 1995. This report improves our understanding of breast cancer characteristics in South Korea.
ABSTRACT
Spontaneous esophageal perforation (also known as Boerhaave syndrome) is associated with sudden increase in intra-esophageal pressure by vomiting, coughing or straining at stool. This case describes a 13-year-old girl who developed the perforation after consuming 270 mg/kg of caffeine tablets for a suicide attempt. Presumably, the perforation was caused primarily by caffeine-induced severe vomiting, and secondarily by caffeine-induced gastric acid secretion with smooth muscle relaxation and by the large amount of caffeine-induced sudden increase in intra-esophageal pressure.
ABSTRACT
Background@#The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. @*Methods@#The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patientoriented composite outcome (POCO) at 2 years. @*Results@#Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group.Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel.Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012,P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. @*Conclusion@#With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES.
ABSTRACT
We report a case of a 14-year-old Korean boy presenting with pain in the left lower quadrant, persisting for over 10 days. Except for the persistent pain, no other symptoms, such as vomiting and diarrhea, were observed. In addition, laboratory findings were normal. He was eventually diagnosed with epiploic appendagitis, a rare disease in children. This case highlights the need for imaging study for early diagnosis of epiploic appendagitis or surgical emergencies in children who visit emergency departments with pain in the left lower quadrant without specific clinical findings.
ABSTRACT
BACKGROUND/OBJECTIVES@#Benign prostatic hyperplasia (BPH) is the most common prostate disease and one of the most common chronic diseases caused by aging in men. On the other hand, there has been no research on BPH using Abeliophyllum distichum Nakai (A.distichum). Therefore, this study investigated the effects of A. distichum on BPH.MATERIALS/METHODS: A. distichum leaves were extracted with distilled water, 70% ethanol, and 95% hexane as solvents. Subsequently, the inhibitory effects of each A. distichum extract on androgen receptor (AR) signaling were evaluated in vitro. The testosterone-induced BPH model was then used to confirm the efficacy of A. distichum leaves in 70% ethanol extract (ADLE). @*RESULTS@#ADLE had the strongest inhibitory effect on AR signaling. A comparison of the activity of ADLE by harvest time showed that the leaves of A. distichum harvested in autumn had a superior inhibitory effect on AR signaling to those harvested at other times. In the BPH rat model, the administration of ADLE reduced the prostate size and prostate epithelial cell thickness significantly and inhibited AR signaling. Subsequently, the administration of ADLE also reduced the expression of growth factors, thereby inactivating the PI3K/AKT pathway. @*CONCLUSIONS@#An analysis of the efficacy of ADLE to relieve BPH showed that the ethanol extract grown in autumn exhibited the highest inhibitory ability of the androgen-signaling related factors in vitro. ADLE also inhibited the expression of growth factors by inhibiting the expression of the androgen-signaling related factors in vivo. Overall, ADLE is proposed as a functional food that is effective in preventing BPH.
ABSTRACT
Background and Objectives@#The outcome benefits of β-blockers in chronic coronary artery disease (CAD) have not been fully assessed. We evaluated the prognostic impact of β-blockers on patients with chronic CAD after percutaneous coronary intervention (PCI). @*Methods@#A total of 3,075 patients with chronic CAD were included from the Grand DrugEluting Stent registry. We analyzed β-blocker prescriptions, including doses and types, in each patient at 3-month intervals from discharge. After propensity score matching, 1,170 pairs of patients (β-blockers vs. no β-blockers) were derived. Primary outcome was defined as a composite endpoint of all-cause death and myocardial infarction (MI). We further analyzed the outcome benefits of different doses (low-, medium-, and high-dose) and types (conventional or vasodilating) of β-blockers. @*Results@#During a median (interquartile range) follow-up of 3.1 (3.0–3.1) years, 134 (5.7%) patients experienced primary outcome. Overall, β-blockers demonstrated no significant benefit in primary outcome (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.63–1.24), all-cause death (HR, 0.87; 95% CI, 0.60–1.25), and MI (HR, 1.25; 95% CI, 0.49–3.15). In subgroup analysis, β-blockers were associated with a lower risk of all-cause death in patients with previous MI and/ or revascularization (HR, 0.38; 95% CI, 0.14–0.99) (p for interaction=0.045). No significant associations were found for the clinical outcomes with different doses and types of β-blockers. @*Conclusions@#Overall, β-blocker therapy was not associated with better clinical outcomes in patients with chronic CAD undergoing PCI. Limited mortality benefit of β-blockers may exist for patients with previous MI and/or revascularization.
ABSTRACT
A twenty-four-year-old patient presented with elbow ankylosis with a range of motion of 5° secondary to failed osteosynthesis 11 months after the internal fixation of an intra-articular distal humerus fracture. The computed tomography scan showed the impaction of the coronoid process into a comminuted fracture of the trochlea, as well as the presence of heterotopic ossification. Intra-articular osteotomy was performed and the range of motion was improved to 90° (20° to 110° flexion). Ten years postoperatively, the range of motion, and the distance in the ulnohumeral joint space, was preserved. In the case of elbow ankylosis secondary to the failed osteosynthesis of the intraarticular distal humerus fracture and malunions with cartilage injury, intra-articular corrective osteotomy may help achieve congruency even when the articular cartilage is damaged.
ABSTRACT
Background@#Peripheral nerve injury is one of the most common injuries that might occur in oral and maxillofacial surgery. The purpose of this study was to determine the effect of FK506 loaded with collagen membrane and fibrin glue on the promotion of nerve regeneration after traction nerve injury in a rat model. @*Methods@#Thirty male Sprague-Dawley rats were divided into three groups: group A (n = 10), a sham group whose sciatic nerve was exposed without any injury; and groups B (n = 10) and C (n = 10), which underwent traction nerve injury using 200 g of traction force for 1 min. The injured nerve in group C was covered with a collagen membrane soaked with FK506 (0.5 mg/0.1 mL) and fibrin glue. Functional analysis and microscopic evaluation were performed at 2 and 4 weeks after injury. @*Results@#The sciatic function index was − 5.78 ± 3.07 for group A, − 20.69 ± 5.22 for group B, and − 12.01 ± 4.20 for group C at 2 weeks after injury. However, at 4 weeks, the sciatic function index was − 5.58 ± 2.45 for group A, − 19.69 ± 4.81 for group B, and − 11.95 ± 1.94 for group C. In both periods, statistically significant differences were found among the groups (p<0.017). Histomorphometric evaluation revealed improved nerve regeneration in group C compared to that in group B. However, no statistical differences in axonal density were found among the three groups (p < 0.017). @*Conclusion@#Localized FK506 with collagen membrane and fibrin glue could promote axonal regeneration in a rat model of traction nerve injury.
ABSTRACT
Purpose@#Raloxifene is a selective estrogen receptor modulator (SERM), and raloxifene treatment for osteoporosis is reimbursable under the Korean National Health Insurance.Evidence suggests that SERMs use reduces the risk of breast cancer in Asian population.Herein, we retrospectively investigated the protective effect of raloxifene on breast cancer rates in Korean population. @*Methods@#Using the Health Insurance Review and Assessment Service database, we selected women with osteoporosis aged 50 years and above. Patients treated for at least 2 years with raloxifene were assigned to the user group, whereas the remaining patients were assigned to the non-user group. The effect on breast cancer risk was assessed using the Cox proportionalhazards model with a time-dependent covariate to adjust for immortal time bias. @*Results@#A total of 322,870 women who were registered between 2010 and 2011 were included.The user group comprised 0.7% (n = 2,307) of the total population. The mean age was 65.7 ± 8.0 years and 67.2 ± 8.6 years in the user and non-user groups, respectively (p < 0.001). There was no difference in the previous use of estrogen replacement between the 2 groups (p = 0.087). The incidence of breast cancer per 1,000 person-years was 0.49 (n = 8) and 0.68 (n = 1,714) in the user and non-user groups, respectively (hazard ratio [HR], 0.63, 95% confidence interval [CI], 0.32–1.27). HR decreased with increase in the treatment duration, but this change was not statistically significant (HR, 1.00, 95% CI, 0.32–3.11 in 2–3 years; HR, 0.63, 95% CI, 0.20–1.94 in 3–4 years; and HR, 0.41, 95% CI, 0.10–1.65 in 4–5 years). @*Conclusion@#Long-term treatment with raloxifene in women with osteoporosis was not significantly associated with a reduction in breast cancer rates. However, further investigation is required for a conclusive proof.
ABSTRACT
Purpose@#Ductal carcinoma In Situ (DCIS) is common in South Korea. We evaluated the patterns of axillary surgery among patients with DCIS to highlight the need for compliance with the updated national guidelines. We also evaluated whether sentinel lymph node biopsy (SLNB) was performed in accordance with the national guidelines. @*Methods@#The Korean Health Insurance Review and Assessment Service-National Inpatient Sample database was searched for patients with DCIS (2009–2015) to identify axillary surgery patterns by breast surgery type, year of diagnosis, age at diagnosis, and the location and volume of surgeries for DCIS at the hospital. The rates of SLNB and axillary dissection were compared using descriptive statistics and univariate analyses. Analyses were also conducted using the chi-squared test and multiple logistic regression analysis. @*Results@#We identified 16,315 Korean women who underwent surgery for DCIS, including 11,292 cases of SLNB (69.2%) and 131 cases of axillary lymph node dissection (0.8%).Breast-conserving surgery (BCS) was performed in 10,323 patients (63.3%) with an SLNB rate of 56.0%, while total mastectomy (TM) was performed in 5,992 patients (36.7%), with an SLNB rate of 92.0%. During 2009–2015, the SLNB rate during TM increased from 88.23% to 92.80%. SLNB was influenced by hospital region and surgical volume, and hospitals performing low volumes of surgeries were significantly more likely to perform SLNB regardless of the surgery type (odds ratio, 1.372; 95% confidence interval, 1.265–1.488). @*Conclusion@#Although the Korean guidelines recommend SLNB for all TM procedures and select BCS procedures for DCIS, relatively high rates of SLNB were performed for BCS, and there was inter-hospital variability in performing SLNB. Improved compliance with the guidelines by the surgeons is critical for Korean patients with DCIS.
ABSTRACT
Purpose@#Raloxifene is a selective estrogen receptor modulator (SERM), and raloxifene treatment for osteoporosis is reimbursable under the Korean National Health Insurance.Evidence suggests that SERMs use reduces the risk of breast cancer in Asian population.Herein, we retrospectively investigated the protective effect of raloxifene on breast cancer rates in Korean population. @*Methods@#Using the Health Insurance Review and Assessment Service database, we selected women with osteoporosis aged 50 years and above. Patients treated for at least 2 years with raloxifene were assigned to the user group, whereas the remaining patients were assigned to the non-user group. The effect on breast cancer risk was assessed using the Cox proportionalhazards model with a time-dependent covariate to adjust for immortal time bias. @*Results@#A total of 322,870 women who were registered between 2010 and 2011 were included.The user group comprised 0.7% (n = 2,307) of the total population. The mean age was 65.7 ± 8.0 years and 67.2 ± 8.6 years in the user and non-user groups, respectively (p < 0.001). There was no difference in the previous use of estrogen replacement between the 2 groups (p = 0.087). The incidence of breast cancer per 1,000 person-years was 0.49 (n = 8) and 0.68 (n = 1,714) in the user and non-user groups, respectively (hazard ratio [HR], 0.63, 95% confidence interval [CI], 0.32–1.27). HR decreased with increase in the treatment duration, but this change was not statistically significant (HR, 1.00, 95% CI, 0.32–3.11 in 2–3 years; HR, 0.63, 95% CI, 0.20–1.94 in 3–4 years; and HR, 0.41, 95% CI, 0.10–1.65 in 4–5 years). @*Conclusion@#Long-term treatment with raloxifene in women with osteoporosis was not significantly associated with a reduction in breast cancer rates. However, further investigation is required for a conclusive proof.
ABSTRACT
Purpose@#Ductal carcinoma In Situ (DCIS) is common in South Korea. We evaluated the patterns of axillary surgery among patients with DCIS to highlight the need for compliance with the updated national guidelines. We also evaluated whether sentinel lymph node biopsy (SLNB) was performed in accordance with the national guidelines. @*Methods@#The Korean Health Insurance Review and Assessment Service-National Inpatient Sample database was searched for patients with DCIS (2009–2015) to identify axillary surgery patterns by breast surgery type, year of diagnosis, age at diagnosis, and the location and volume of surgeries for DCIS at the hospital. The rates of SLNB and axillary dissection were compared using descriptive statistics and univariate analyses. Analyses were also conducted using the chi-squared test and multiple logistic regression analysis. @*Results@#We identified 16,315 Korean women who underwent surgery for DCIS, including 11,292 cases of SLNB (69.2%) and 131 cases of axillary lymph node dissection (0.8%).Breast-conserving surgery (BCS) was performed in 10,323 patients (63.3%) with an SLNB rate of 56.0%, while total mastectomy (TM) was performed in 5,992 patients (36.7%), with an SLNB rate of 92.0%. During 2009–2015, the SLNB rate during TM increased from 88.23% to 92.80%. SLNB was influenced by hospital region and surgical volume, and hospitals performing low volumes of surgeries were significantly more likely to perform SLNB regardless of the surgery type (odds ratio, 1.372; 95% confidence interval, 1.265–1.488). @*Conclusion@#Although the Korean guidelines recommend SLNB for all TM procedures and select BCS procedures for DCIS, relatively high rates of SLNB were performed for BCS, and there was inter-hospital variability in performing SLNB. Improved compliance with the guidelines by the surgeons is critical for Korean patients with DCIS.
ABSTRACT
Purpose@#The threshold levels for symptom development of pollinosis vary among studies and countries. This study aimed to determine currently used threshold levels for it. @*Methods@#Oak, pine, Japanese hop, and ragweed pollen samples were collected daily for 8 years from the Seoul and Guri areas. A total of 792 subjects with allergy to these pollens were recruited. The symptom index (SI) was assessed through telephone interviews and allergy questionnaires, and data were analyzed using decision tree. @*Results@#The risk index for oak pollen allergy was “mild” when the pollen count was 0–2 grains/m3 , “moderate” when it was 3–11 grains/m3 , “severe” when it was 12–28 grains/m3 , and “dangerous” when it was ≥ 29 grains/m3 . The risk level for pine pollen allergy was “mild” when the pollen count was 0–4 grains/m 3 , “moderate” when it was 5–42 grains/m3 , “severe” when it was 43–66 grains/m3 , and “dangerous” when it was ≥ 67 grains/m3 . For Japanese hop pollen allergy, the risk level was “mild” when the pollen count was 0–8 grains/m3 , “moderate” when it was 9–10 grains/m3 , “severe” when it was 11–19 grains/m3 , and “dangerous” when it was ≥ 20 grains/m3 . Finally, for ragweed, the risk level was “mild” when the pollen count was 0–1 grains/m3 , “moderate” when it was 2–6 grains/m3 , “severe” when it was 7–33 grains/m3 , and “dangerous” when it was ≥ 34 grains/m3 . @*Conclusions@#Revising the threshold levels for the risk index for pollen allergies may be useful for developing pollen prediction models for patients with pollen allergies in Korea.
ABSTRACT
Background and Objectives@#The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices. @*Methods@#A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days. @*Results@#The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs.0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm2 ; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, allcause mortality, and disabling stroke at 1 year were similar between the 2 groups. @*Conclusions@#Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.
ABSTRACT
No abstract available.
ABSTRACT
PURPOSE: Deep vein thrombosis (DVT) is the third most common cause of cardiovascular morbidity and mortality. Anticoagulation has been the primary treatment modality for acute DVT. However, catheter-directed thrombolysis (CDT) has recently become widely accepted as an additional therapy to anticoagulation. We assessed comparative outcomes in patients with acute DVT who underwent anticoagulation therapy alone (ACA) group and those treated with CDT group. MATERIALS AND METHODS: We retrospectively reviewed medical records of 149 patients with DVT from January 2011 to December 2015. We compared patients who received ACA group (n=120) and those who received CDT plus anticoagulation (CDT group, n=29). We analyzed the prevalence of lesions, thrombus removal rate in each lesion, and recurrence-free rate between the two groups. RESULTS: We found thrombus involvement in a total of 281 lesions in the ACA group and 85 lesions in the CDT group. For the distribution of lesions in each group, those in the femoral vein accounted for 34.2% of all lesions and those in the popliteal vein accounted for 31.7%. During follow-up, the overall thrombus removal rate was 91.1% in the ACA group and 87.0% in the CDT group (P=0.273). The recurrence-free rate was higher in the CDT group in a log-rank test; however, there was no statistically significant difference between the two groups (P=0.594). CONCLUSION: According to our results, there was no significant difference in thrombus removal and recurrence-free rates between the CDT and ACA groups. ACA still has an important role in the treatment of DVT.
Subject(s)
Humans , Anticoagulants , Femoral Vein , Follow-Up Studies , Lower Extremity , Medical Records , Mortality , Popliteal Vein , Prevalence , Retrospective Studies , Thrombolytic Therapy , Thrombosis , Venous ThrombosisABSTRACT
Secondary upper extremity lymphedema after lymph node dissection in breast cancer patients is a major complication affecting their quality of life. As lymphatic function is compromised before symptoms develop in most cases, early diagnosis and intervention before symptomatic manifestation is known to prevent severe progression of lymphedema. In this case report, we present a patient with secondary lymphedema, whose disease could be diagnosed at an early stage using indocyanine green (ICG) lymphography. The patient had mild edema of the left upper extremity that regressed with elevation, had normal lymph vessel distribution without dermal backflow pattern in lymphoscintigraphy. Her symptom improved after early prescription of complex decongestive physiotherapy. We conclude that ICG lymphography could be an effective diagnostic tool in addition to other imaging methods, for early diagnosis and intervention of lymphedema.
ABSTRACT
PURPOSE: BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. MATERIALS AND METHODS: Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored. RESULTS: p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib. CONCLUSION: The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.