1.Breast cancer in the Philippines: A financing cost assessment study
Madeleine De rosas-valera ; Julienne Clarize P. Lechuga ; Lourdes Risa S. Yapchiongco ; Necy S. Juat ; Mary Juliet De rosas-labitigan ; Maria Lourdes E. Amarillo ; Leo M. Flores ; Maebel Audrey R. Joaquin ; Adelberto R. Lambinicio
Acta Medica Philippina 2025;59(Early Access 2025):1-9
OBJECTIVES
The aim of the study is to estimate the cost of breast cancer diagnosis, treatment, and management in the Philippines. Specifically, it aims to identify the resource requirements and interventions related to breast cancer diagnosis, treatment, and management, measure resource volumes (number of units), learn to value resource items (unit costs), and determine the total cost of treatment per disease stage.
METHODSThe study covered nine tertiary hospitals, seven of which were government hospitals and two were private hospitals, with all tertiary hospitals providing breast cancer services and accredited by Philippine Health Insurance Corporation (PHIC or PhilHealth) for the Z-Benefit Package. Interventions and services related to breast cancer included radiographic procedures, laboratory and imaging tests, chemotherapy drugs and medications, medical and surgical supplies, surgical rates (for breast surgery), accommodation, staff time and salary/professional fees, and other procedure fees. The study conducted in 2022, examined cost prices of breast cancer interventions and services from stage 1–3B.
Purposive and convenience sampling were used based on PhilHealth accreditation and willingness of hospitals to participate in the study. The study conducted a focus group discussion with oncologists, radiologists, anesthesiologists, and other health care providers to validate the clinical guideline used and to solicit inputs to the costing design, analysis framework, and tools for data collection. Data collection of financial cost information (charge price) was conducted using a set of costing matrices filled out by the various departments of the hospitals. Costs and median rates were calculated across hospitals on diagnostics and imaging tests, surgery costs of both public and private facilities, medical treatment, and radiotherapy.
RESULTSBreast MRI, Breast Panel, and Chest CT Scan are the top 3 most expensive diagnostic procedures ranging from PhP 8,102.00 to PhP 9,800.00 per procedure. Surgical procedures for breast cancer at private hospitals and public hospitals showed huge differences in costs. The cost of a cycle of chemotherapy ranges from PhP 596.70 to PhP 3,700.00 per session, while the cost of targeted therapy can cost up to PhP 46,394.21 per session. A year of hormone therapy ranges from PhP 3,276.00 with the use of Tamoxifen, and up to PhP 68,284.00 with Goserelin. Aromatase inhibitors such as Anastrozole and Letrozole cost from PhP 18,000 to PhP 36,000, respectively. Multiple cycles depending on the diagnosis are prescribed per patient and used in combination with other chemotherapy medications or other therapies such as targeted therapy and hormone therapy are usually taken daily up to 5 to 10 years. Conventional radiotherapy can cost up to PhP 88,150.00 covering 28 sessions, CT simulation, and CT planning.
CONCLUSIONThis cost study provides relevant information and better perspective on benefit development for the PHIC, policy development for Department of Health on where and how to focus their support for the patient’s financial preparedness to address medical and f inancial catastrophes.
PhilHealth needs to guide the health care providers of their costing method and to develop their own integrated, interoperable, and comprehensive cost data library.
It recommends that the government allocate budget and cover for screening and assessment for earlier stage diagnosis of patients and lower health expenditure costs on cancer treatment.
Human ; Breast Neoplasms ; Drug Therapy ; Chemotherapy ; Mastectomy ; Radiotherapy ; Radiation Therapy
2.The magnitude of delay in non-metastatic breast cancer treatment in a Tertiary Hospital: An analysis from 2012 to 2018
Rogelio N. Velasco jr. ; Mark M. Ando ; Mark Anthony U. Javelosa ; Rich Ericson C. King ; Karen Anjela M. Mondragon ; Harold Nathan C. Tan ; Corazon A. Ngelangel ; Irisyl O. Real
Acta Medica Philippina 2025;59(8):45-51
BACKGROUND AND OBJECTIVE
The burden of treatment delay in breast cancer is high, especially among developing countries. Despite adversely affecting morbidity and mortality, treatment delay remains unexplored in the Philippines. This study aimed to determine treatment delays among breast cancer patients in a tertiary hospital during surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy, and to identify predictors of delay.
METHODSA cross-sectional study was conducted among breast cancer patients seen between January 1, 2012 to December 31, 2018. The following outcomes were investigated: ≥90 days from initial diagnosis to surgery, ≥8 weeks from diagnosis to initiation of neoadjuvant chemotherapy, and >120 days from diagnosis to initiation of adjuvant chemotherapy. Summary statistics were reported as percent for categorical data and as mean for continuous data. The individual correlations were performed using Chi-square for qualitative data and t-test for quantitative data while predictors were determined through logistic regression.
RESULTSA total of 324 patients were included in this study. The majority of the patients were less than 65 years old living in urban areas. More than half of the patients were overweight or obese, hypertensive, and diabetic. The following delays were observed: 61.1% (n = 198) with any type of delay, 23.8% (n = 53) with delay in surgery, 53.8% (n = 120) with delay in adjuvant chemotherapy, and 74.3% (n = 75) with delay in neoadjuvant chemotherapy. The patients noted to have any type of delay were more likely to be hypertensive (p = 0.046) and residing in urban areas (p = 0.041). There were no differences in the distribution of age, body mass index, and presence of co-morbid conditions such as hypertension, diabetes mellitus, coronary artery disease, and heart failure among those with any form of delay compared with no delay.
CONCLUSIONThe present study shows the presence of treatment delay among breast cancer patients and may be used to enact policy changes to optimize breast cancer care delivery. Further studies may be done to identify other factors affecting these delays and policy changes are recommended to address these gaps in surgery and chemotherapy administration among breast cancer patients.
Breast Neoplasms ; Breast Cancer ; Quality Of Health Care ; Treatment Delay
3.Predictive importance of weight during neoadjuvant chemotherapy on pathologic response and survival outcomes in patients with breast cancer
Philippine Journal of Internal Medicine 2025;63(3):89-97
OBJECTIVES
The influence of weight change on the response to neoadjuvant chemotherapy (NAC) among adult Filipino patients with breast cancer remains unclear. Currently, there has been increasing evidence that weight gain during NAC is associated with increased recurrence risk and decreased survival. This study aimed to investigate this relationship and identify significant predictors of pathologic complete response (pCR), overall survival (OS) and disease-free survival (DFS).
METHODSThis is a retrospective study using data from 52 female patients who received NAC for stage II or III breast cancer and had complete records of weight before and after NAC. Significant predictors of pCR such as host factors and tumor characteristics and associations between weight change and pCR, OS and DFS were examined using univariate and multivariable logistic regression analyses.
RESULTSThe average weight of all patients before NAC was 57.0 kg while the average weight of all patients after NAC was 59.5 kg. The average BMI of all patients before NAC was 25.8 kg/m2. In total, 29 patients (55.8%) were classified in the overweight/obese (OW/OB) group, and the rest were classified in the normal weight/underweight (NW/UW) group. The pCR rate was 51.3% in the OW/OB group versus 48.7% in the NW/UW group (p = 0.11). Initial BMI was a significant factor for achieving pCR (hazard ratio, 3.85; 95% confidence interval [CI], 1.72-8.60, p = 0.001), suggesting that a higher initial BMI was associated with an increased likelihood of achieving pCR. Initial BMI was also an independent prognostic factor for OS (p = 0.0006) and DFS (p = 0.0005). On the other hand, no significant correlation was seen between pCR rates as well as OFS and DFS (p = 0.0551) among patients whose weight changed during the course of treatment.
CONCLUSIONThese findings suggest that while initial weight may significantly predict pCR rates and affect DFS and OS, weight change during treatment may not be as influential. Further research is needed to validate these findings in more diverse and larger patient populations.
Human ; Breast Neoplasms ; Neoadjuvant Chemotherapy ; Neoadjuvant Therapy ; Pathologic Complete Response ; Prognostic Factors ; Prognosis
4.Breast cancer in the Philippines: A financing cost assessment study.
Madeleine DE ROSAS-VALERA ; Julienne Clarize P. LECHUGA ; Lourdes Risa S. YAPCHIONGCO ; Necy S. JUAT ; Mary Juliet DE ROSAS-LABITIGAN ; Maria Lourdes E. AMARILLO ; Leo M. FLORES ; Maebel Audrey R. JOAQUIN ; Adelberto R. LAMBINICIO
Acta Medica Philippina 2025;59(17):7-15
OBJECTIVES
The aim of the study is to estimate the cost of breast cancer diagnosis, treatment, and management in the Philippines. Specifically, it aims to identify the resource requirements and interventions related to breast cancer diagnosis, treatment, and management, measure resource volumes (number of units), learn to value resource items (unit costs), and determine the total cost of treatment per disease stage.
METHODSThe study covered nine tertiary hospitals, seven of which were government hospitals and two were private hospitals, with all tertiary hospitals providing breast cancer services and accredited by Philippine Health Insurance Corporation (PHIC or PhilHealth) for the Z-Benefit Package. Interventions and services related to breast cancer included radiographic procedures, laboratory and imaging tests, chemotherapy drugs and medications, medical and surgical supplies, surgical rates (for breast surgery), accommodation, staff time and salary/professional fees, and other procedure fees. The study conducted in 2022, examined cost prices of breast cancer interventions and services from stage 1–3B.
Purposive and convenience sampling were used based on PhilHealth accreditation and willingness of hospitals to participate in the study. The study conducted a focus group discussion with oncologists, radiologists, anesthesiologists, and other health care providers to validate the clinical guideline used and to solicit inputs to the costing design, analysis framework, and tools for data collection. Data collection of financial cost information (charge price) was conducted using a set of costing matrices filled out by the various departments of the hospitals. Costs and median rates were calculated across hospitals on diagnostics and imaging tests, surgery costs of both public and private facilities, medical treatment, and radiotherapy.
RESULTSBreast MRI, Breast Panel, and Chest CT Scan are the top 3 most expensive diagnostic procedures ranging from PhP 8,102.00 to PhP 9,800.00 per procedure. Surgical procedures for breast cancer at private hospitals and public hospitals showed huge differences in costs. The cost of a cycle of chemotherapy ranges from PhP 596.70 to PhP 3,700.00 per session, while the cost of targeted therapy can cost up to PhP 46,394.21 per session. A year of hormone therapy ranges from PhP 3,276.00 with the use of Tamoxifen, and up to PhP 68,284.00 with Goserelin. Aromatase inhibitors such as Anastrozole and Letrozole cost from PhP 18,000 to PhP 36,000, respectively. Multiple cycles depending on the diagnosis are prescribed per patient and used in combination with other chemotherapy medications or other therapies such as targeted therapy and hormone therapy are usually taken daily up to 5 to 10 years. Conventional radiotherapy can cost up to PhP 88,150.00 covering 28 sessions, CT simulation, and CT planning.
CONCLUSIONThis cost study provides relevant information and better perspective on benefit development for the PHIC, policy development for Department of Health on where and how to focus their support for the patient’s financial preparedness to address medical and f inancial catastrophes.
PhilHealth needs to guide the health care providers of their costing method and to develop their own integrated, interoperable, and comprehensive cost data library.
It recommends that the government allocate budget and cover for screening and assessment for earlier stage diagnosis of patients and lower health expenditure costs on cancer treatment.
Human ; Breast Neoplasms ; Drug Therapy ; Chemotherapy ; Mastectomy ; Radiotherapy ; Radiation Therapy
5.Effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing modified radical mastectomy for breast cancer.
Li YAN ; Bin SUN ; Meiyan ZHOU ; Yan ZHANG ; Fei GAO ; Qianwen ZHAO ; Liwei WANG
Chinese Acupuncture & Moxibustion 2025;45(2):162-166
OBJECTIVE:
To observe the effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative pain in patients undergoing modified radical mastectomy for breast cancer.
METHODS:
A total of 140 female patients scheduled for unilateral modified radical mastectomy for breast cancer undergoing general anesthesia were randomized into a TEAS group (70 cases) and a sham TEAS group (70 cases, 2 cases dropped out). Patients in both groups received TEAS or sham TEAS at bilateral Neiguan (PC6), Zusanli (ST36), and Danzhong (CV17), respectively, from 30 min before anesthesia induction until the end of surgery, and on 1st, 2nd, and 3rd days after surgery for 30 min a time, once a day. On 1st, 2nd, and 3rd days after surgery, the pain visual analogue scale (VAS) score was observed; on 3, 6, 12 months after surgery, the incidence rate of chronic pain was observed; before surgery, and on 1st, 3rd, and 7th days after surgery, the serum levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6 and IL-10 were detected; the number of analgesia pump press, rescue analgesia, and the occurrence of adverse reaction after surgery were recorded in the two groups.
RESULTS:
In the TEAS group, the VAS scores on 1st and 2nd days after surgery, and the incidence rates of chronic pain on 3 and 6 months after surgery were lower than those in the sham TEAS group (P<0.05). On 1st, 3rd, and 7th days after surgery, the serum levels of TNF-α, IL-6, and IL-10 were increased compared with those before surgery in both groups (P<0.05, P<0.01); the above indexes in the TEAS group were lower than those in the sham TEAS group (P<0.05). The number of analgesia pump press and the incidence rate of rescue analgesia after surgery in the TEAS group were lower than those in the sham TEAS group (P<0.05). There was no statistically significant difference in the incidence of adverse reactions after surgery between the two groups (P>0.05).
CONCLUSION
TEAS can effectively improve both the postoperative acute pain and chronic pain in patients undergoing modified radical mastectomy for breast cancer, the mechanism may relate to inhibiting the inflammatory reaction.
Humans
;
Female
;
Acupuncture Points
;
Pain, Postoperative/blood*
;
Middle Aged
;
Breast Neoplasms/surgery*
;
Adult
;
Transcutaneous Electric Nerve Stimulation
;
Mastectomy, Modified Radical/adverse effects*
;
Interleukin-6/blood*
;
Tumor Necrosis Factor-alpha/blood*
;
Interleukin-10/blood*
;
Aged
6.Pregnancy-associated breast cancer: Management of the mother, fetus and tumour.
Andrea TAN ; Weining WANG ; Cheryl LONG ; Zewen ZHANG ; Joanne NGEOW ; Citra MATTAR
Annals of the Academy of Medicine, Singapore 2025;54(4):235-246
INTRODUCTION:
Pregnancy-associated breast cancer (PABC) is described as breast cancer diagnosed within pregnancy or within 1 year postpartum. PABC is becoming more common due to delayed childbearing, with older maternal age increasing the likelihood of tumorigenesis coinciding with pregnancy. Our review aims to outline the important principles of managing PABC, and discusses future fertility implications, genetic testing and postnatal considera-tions that are not often considered in other existing reviews.
METHOD:
A literature search was conducted using PubMed, Cochrane and Google Scholar databases.
RESULTS:
A persistent breast mass in pregnant women should be evaluated with a breast ultrasound. Total mastectomy is the standard treatment in the first trimester. Chemotherapy is contraindicated in the first trimesters, but can be given in the second and third trimester, and stopped before 35 weeks. Radiotherapy should be delayed until delivery, and hormone receptor therapy is contraindicated in pregnancy. A multidisciplinary team involving an obstetrician, medical oncologist and other allied health professionals is crucial. Delivery should be planned as close to 37 weeks as possible, and at least 3 weeks after the last chemotherapy cycle. Vaginal delivery is preferred, and breastfeeding can resume 14 days after the last chemotherapy regime.
CONCLUSION
A breast mass in a pregnant woman should not be dismissed. PABC must be managed by multidisciplinary teams at tertiary medical centres with access to surgery and chemoradiation therapies. Management strategies must include safe manage-ment and delivery of the fetus, contraception and future fertility planning.
Humans
;
Female
;
Pregnancy
;
Breast Neoplasms/diagnosis*
;
Pregnancy Complications, Neoplastic/diagnosis*
;
Mastectomy
;
Delivery, Obstetric
7.Evaluating the impact of relative dose intensity on efficacy of trastuzumab deruxtecan for metastatic breast cancer in the real-world clinical setting.
Han Yi LEE ; Vivianne SHIH ; Jack Junjie CHAN ; Shun Zi LIONG ; Ryan Shea Ying Cong TAN ; Jun MA ; Bernard Ji Guang CHUA ; Joshua Zhi Chien TAN ; Chuan Yaw LEE ; Wei Ling TEO ; Su-Ming TAN ; Phyu NITAR ; Yoon Sim YAP ; Mabel WONG ; Rebecca DENT ; Fuh Yong WONG ; Tira J TAN
Annals of the Academy of Medicine, Singapore 2025;54(8):458-466
INTRODUCTION:
Trastuzumab deruxtecan (T-DXd) has revolutionised treatment for metastatic breast cancer (MBC). While effective, its high cost and toxicities, such as fatigue and nausea, pose challenges.
METHOD:
Medical records from the Joint Breast Cancer Registry in Singapore were used to study MBC patients treated with T-DXd (February 2021-June 2024). This study was conducted to address whether reducing dose intensity and density may have an adverse effect on treatment outcomes.
RESULTS:
Eighty-seven MBC patients were treated with T-DXd, with a median age of 59 years. At the time of data cutoff, 32.1% of patients were still receiving T-DXd. Over half (54%) of the patients received treatment with an initial relative dose intensity (RDI) of <;85%. Overall median real-world progression-free survival (rwPFS) was 8.1 months. rwPFS was similar between RDI groups (<85%: 8.7 months, <85%: 8.1 months, P=0.62). However, human epidermal growth receptor 2 (HER2)-positive patients showed significantly better rwPFS outcomes compared to HER2-low patients (8.8 versus 2.5 months, P<0.001). Only 16% with central nervous system (CNS) involvement had CNS progressive disease on treatment. No significant progression-free survival (PFS) differences were found between patients with or without CNS disease, regardless of RDI groups. Five patients (5.7%) developed interstitial lung disease (ILD), with 3 (3.4%) having grade 3 events. Two required high-dose steroids and none were rechallenged after ILD. There were no fatalities.
CONCLUSION
Our study demonstrated that reduced dose intensity and density had no significant impact on rwPFS or treatment-related toxicities. Furthermore, only 5.7% of patients developed ILD. T-Dxd provided good control of CNS disease, with 82% of patients achieving CNS disease control.
Humans
;
Female
;
Breast Neoplasms/mortality*
;
Middle Aged
;
Trastuzumab/adverse effects*
;
Aged
;
Adult
;
Singapore/epidemiology*
;
Antineoplastic Agents, Immunological/adverse effects*
;
Camptothecin/adverse effects*
;
Immunoconjugates/adverse effects*
;
Retrospective Studies
;
Progression-Free Survival
;
Receptor, ErbB-2/metabolism*
;
Neoplasm Metastasis
;
Dose-Response Relationship, Drug
;
Treatment Outcome
;
Registries
8.Advancing breast cancer and lung cancer screening: Expert perspectives to advance programmes in Singapore.
Clive TAN ; Ern Yu TAN ; Geak Poh TAN ; Ravindran KANESVARAN
Annals of the Academy of Medicine, Singapore 2025;54(8):498-504
INTRODUCTION:
The high prevalence and mortality rates of breast cancer and lung cancer in Singapore necessitate robust screening programmes to enable early detection and intervention for improved patient outcomes, yet 2024 uptake and coverage remain suboptimal. This narrative review synthesises expert perspectives from a recent roundtable discussion and proposes strategies to advance breast cancer and lung cancer screening programmes.
METHOD:
A 2024 roundtable convened clinical practitioners, health policymakers, researchers and patient advocates discussed current challenges and opportunities for improving cancer screening in Singapore. Perspectives and insights were analysed to identify themes related to existing programme gaps, opportunities for innovation and implementation challenges.
DISCUSSION:
Singapore's national breast cancer screening programme has been in place for over 2 decades, yet screening uptake remains suboptimal. A national lung cancer screening programme, in contrast, is still in its early stages of implementation. Regardless, employment of risk stratification approaches that integrate genetic, demographic and lifestyle factors could enhance screening effectiveness by identifying high-risk indivi-duals, while also taking local epidemiological trends into consideration. Integration of digital health technologies, artificial intelligence and behavioural change models can enhance cancer screening uptake and accuracy to overcome barriers such as low awareness, cultural beliefs and socioeconomic factors that contribute to low participation rates.
CONCLUSION
Key recommendations include enhancing public awareness, refining screening guidelines, expanding access and applying innovative technologies. A coordinated effort among stakeholders is crucial to continually assess and enhance screening programmes to narrow the practice-policy gap and ultimately reduce breast cancer and lung cancer burden in Singapore.
Humans
;
Singapore/epidemiology*
;
Lung Neoplasms/epidemiology*
;
Breast Neoplasms/epidemiology*
;
Early Detection of Cancer/methods*
;
Female
;
Mass Screening/organization & administration*
9.Effect of Huaier granule on prognosis of breast cancer: A single-center propensity score matching retrospective study.
Qianqian GUO ; Yuting PENG ; Ge ZHANG ; Huan LIN ; Qianjun CHEN
Chinese Medical Journal 2025;138(1):93-98
BACKGROUND:
Huaier granule is an important medicinal fungus extract widely used in cancer treatment. Previous retrospective studies have reported its effectiveness in breast cancer patients, but the imbalanced baseline characteristics of participants could have biased the results. Therefore, this retrospective study aimed to examine the efficacy of Huaier granule on the prognosis of breast cancer patients.
METHODS:
In this single-center cohort study, breast cancer patients diagnosed and treated at the Guangdong Provincial Hospital of Chinese Medicine between 2009 and 2017 were selected. The data were retrospectively analyzed and divided into two groups according to whether the patients received Huaier granules. The propensity score matching (PSM) method was used to eliminate selection bias. The disease-free survival (DFS) and overall survival (OS) for these groups were compared using the Kaplan-Meier method and the Cox regression.
RESULTS:
This study included 214 early invasive breast cancer patients, 107 in the Huaier group and 107 in the control group. In the Kaplan-Meier analysis, the 2-year and 5-year DFS rates were significantly different in the Huaier group and control group (hazard ratio [HR], 0.495; 95% confidence interval [CI], 0.257-0.953; P = 0.023). The 2-year and 5-year OS rates were also significantly different (HR, 0.308; 95% CI, 0.148-0.644; P = 0.001). On multivariable Cox regression, Huaier granule was associated with improved DFS (HR, 0.440; 95% CI, 0.223-0.868; P = 0.018) and OS (HR, 0.236; 95% CI, 0.103-0.540; P = 0.001).
CONCLUSION
In this retrospective study, Huaier granules improved the DFS and OS of early invasive breast cancer patients, providing real-world evidence for further prospective studies on treating breast cancer with Huaier granules.
Humans
;
Breast Neoplasms/mortality*
;
Retrospective Studies
;
Female
;
Propensity Score
;
Middle Aged
;
Adult
;
Prognosis
;
Disease-Free Survival
;
Kaplan-Meier Estimate
;
Aged
;
Proportional Hazards Models
;
Complex Mixtures/therapeutic use*
;
Drugs, Chinese Herbal/therapeutic use*
;
Trametes
10.Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial.
Xichun HU ; Qingyuan ZHANG ; Tao SUN ; Yongmei YIN ; Huiping LI ; Min YAN ; Zhongsheng TONG ; Man LI ; Yue'e TENG ; Christina Pimentel OPPERMANN ; Govind Babu KANAKASETTY ; Ma Coccia PORTUGAL ; Liu YANG ; Wanli ZHANG ; Zefei JIANG
Chinese Medical Journal 2025;138(12):1477-1486
BACKGROUND:
In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis.
METHODS:
In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL).
RESULTS:
In cohort A (abemaciclib: n = 207; placebo: n = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n = 104; placebo: n = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo.
CONCLUSIONS:
Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02763566).
Humans
;
Female
;
Fulvestrant/therapeutic use*
;
Breast Neoplasms/metabolism*
;
Aminopyridines/therapeutic use*
;
Benzimidazoles/therapeutic use*
;
Middle Aged
;
Aromatase Inhibitors/therapeutic use*
;
Aged
;
Receptor, ErbB-2/metabolism*
;
Adult
;
Letrozole/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Anastrozole/therapeutic use*


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