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Breast cancer, metastatic Poster lunch Poster Display session

109P - Literature review of visceral and non-visceral metastatic breast cancer (ID 1094)

Presentation Number
109P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • N. Begum
Authors
  • T. Mehmood
  • N. Begum
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Differential efficacy of newly registered therapies in subgroups of metastatic breast cancer (mBC) is an important consideration for their subsequent use in clinical practice. In a systematic literature review, we evaluated differences in outcome regarding progression free survival (PFS), time to progression (TTP), overall survival (OS) and visceral versus non-visceral disease. The impact of HER2- and hormone receptor-status was also considered.

Methods

A systematic literature search (6362 hits) in the meta-Database PubMed was performed for the last 20 years. 257 studies (n = 126,291) were included for further analysis. 69 studies had published data for visceral vs non visceral disease including phase III trials. Out of these 69 studies we selected n = 16 studies (n = 13,083) which looked at the endpoints mentioned above. In order to achieve comparability, we extracted the information of hazard ratios (HR), confidence intervals (CI) and times in weeks (if available) for PFS, TTP, OS of the entire study population, which was divided into three groups: HER2-positive, HER2-negative, unknown HER2 status.

Results

No statistically significant difference in treatment response was found in mBC patients looking at HRs and CIs. Relevant, yet not statistically significant differences were found in the specific response of visceral metastases to modern combination therapies, especially in HER2-positive breast cancer: There was a benefit regarding OS using lapatinib combined with trastuzumab or trastuzumab and docetaxel combined with pertuzumab. Additionally, in two chemotherapy trials, there was a numerical difference between therapy response in visceral vs. non-visceral metastases regarding PFS in the unknown HER2 group, and regarding OS in the HER2 negative group.

Conclusions

In the subgroup analyses, we did not find any significant differences in response rates for visceral vs. non-visceral metastasis. There seems to be a beneficial effect of combination therapies regarding OS in visceral disease. At the present time, metastasis localization should not be used as a predictive marker for choice of systemic therapy in mBC.

Legal entity responsible for the study

Tahir Mehmood

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

110P - Evaluation of eribulin and bevacizumab for the real world treatment of recurrent breast cancer (ID 1140)

Presentation Number
110P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • M. Earashi
Authors
  • M. Earashi
  • K. Matsui
  • K. Maeda
  • W. Fukushima
  • K. Shimada
  • T. Shimizu
  • Z. Nozaki
  • Y. Tanada
  • K. Oyama
  • T. Nagata
  • A. Tsuneda
  • A. Yoshikawa
  • T. Yoshida
  • K. Kiyohara
  • K. Iwata
  • T. Ii
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Recently several new chemotherapeutic agents have been developed and indicated for treatment of recurrent breast cancer. One of them, eribulin have improved overall survival (OS) in EMBRACE trials. On the other hand, bevacizumab has improved progression-free survival (PFS) in several clinical studies, but not extended OS in them. And there are few reports estimating these agents’ effects on OS and PFS of advanced or recurrent breast cancer patients in a real world setting.

Methods

Recurrent breast cancer patients who received chemotherapies in Toyama Breast Cancer Research Group (TBCRG) group institutes from January 2013 to March 2015 were reviewed. Kaplan-Meier method was utilized to estimate OS or PFS, and log-rank test was used to compare OS or PFS. Univariate and multivariate analyses were preformed to find significant factor(s) concerning OS.

Results

Of 208 patients who received chemotherapies in the period mentioned, there were 157 patients who received chemotherapies using both or either of eribulin (Eri), and bevacizumab (Bev). Median age of each group using Eri/Bev were 52.4/54.6. Disease status of Eri/Bev were as follows; 68.8%/79.0% ER positive, 18.8%/11.3% HER2 positive. Metastasis of each group using Eri/Bev were observed at; 51.0%/55.2% bones, 7.3%/8.1% CNS, 56.3%/47.2% lung, and 33.3%/49.6% liver. Response rates and PFS from the starting period of Eri/Bev were 21%/75%, and 387days/297days. Multivariate COX regression analysis disclosed negative HER2 status in Eri group, and liver involvement in Bev group influenced the response rates significantly. Earlier administration of Eri shows better survival durations from primary chemotherapies (1470 days), comparison with those of Bev (1076 days). Response rate/disease control rate of pre-line chemotherapies in Eri group were 32%/57%, and not significantly diffierent from 29%/65% in Bev group, but those of post-line chemotherapies were 21%/63% in Eri group and 6%/28% in Bev group.

Conclusions

According to our retrospective observation analyses of group data, eribulin did not reduce the effects of subsequent chemotherapies, and improved OS of advanced or recurrent breast cancer patients. We have to reassess the value of new chemotherapeutic agents continuously.

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

111P - Changes in urinary NTX in early phase of denosumab therapy might be a predictive indicator in breast cancer patients with bone metastases (ID 1226)

Presentation Number
111P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • M. Shizuku
Authors
  • M. Shizuku
  • Y. Mizuno
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

There are many reports suggesting that the levels of bone turnover markers (BTM) might be correlated with skeletal-related-events and disease progression in breast cancer patients with bone metastases (BM). We therefore evaluated the correlations OS with the changes in urinary N-telopeptide of type I collagen (u-NTX) in breast cancer patients with BM treated with denosumab (Dmab).

Methods

34 patients were enrolled in this study. All patients received Dmab 120 mg subcutaneously every month and u-NTX was checked at baseline and 1 month after Dmab was administered. We calculated the percentage change of u-NTX level (u-NTX%) [(baseline u-NTX level – 1-month u-NTX level)/baseline u-NTX level] and established a cut-off value by using receiver operating characteristic analysis. OS was defined as the time interval from Dmab administration to the date of death. The patients were divided into two groups by using the cut-off value, and OS was evaluated using the Kaplan-Meier method and analyzed by a log-rank test.

Results

According to the immunohistochemical analysis, estrogen receptor positive and human epidermal growth factor receptor 2 negative (ER+/HER2-) profile was observed in 22 patients, while ER+/HER2+, ER-/HER2+, and ER-/HER2- profiles were observed in 4, 2, and 6 patients, respectively. 2 patients had oligo-BM and 32 patients had multiple-BM. The mean u-NTX% was 0.63 and the established cut-off value was 0.669. The u-NTX% in 19 patients was >0.669 (high u-NTX group) while the remaining 15 patients had u-NTX% under 0.669 (low u-NTX group). OS in the high u-NTX group (n = 19) was significantly longer than in the low u-NTX group (n = 15) (24 months(M) vs 15 months(M), p = 0.005). In 22 ER+/HER2- patients, OS in the high u-NTX group (n = 12) was significantly longer than in the low group (n = 10) (34 M vs 16 M, p = 0.002). Moreover, in 20 patients without other organs metastases, OS in the high u-NTX group (n = 12) was significantly longer than in the low group (n = 8) (24 M vs 15 M, p < 0.001).

Conclusions

High u-NTX% in early phase of treatment could be a promising finding for OS in breast cancer patients with BM treated with Dmab.

Legal entity responsible for the study

Department of Breast Surgery, Yokkaichi Municipal Hospital

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

112P - Phase II trial of metronomic combination chemotherapy with oral regimen in heavily pretreated metastatic breast cancer (ID 1241)

Presentation Number
112P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • R. Prasanna
Authors
  • R. Prasanna
  • E. Prasad
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00
Breast cancer, metastatic Poster lunch Poster Display session

113P - Importance of immunohistochemistry for quick selection of breast cancer patients having BRCA1/2 mutations for their better treatment strategy: Pilot study in eastern India (ID 1971)

Presentation Number
113P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • J. Basak
Authors
  • J. Basak
  • A. Chakraborty
  • A. Mukhopadhyay
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

In India, breast cancer is the second most common malignant condition among women. It is hereditary in 10% of cases, the majority related to mutations in the BRCA1 and BRCA2 genes. The presence of BRCA germline mutations in breast/ovarian carcinomas has been shown to have prognostic and therapeutic significance. Identification of tumours with BRCA defects has therapeutic and prognostic implications. Our objective was to assess whether immunohistochemical analysis (IHC) for BRCA is an effective method for the detection of BRCA dysfunction in hereditary breast carcinoma or not.

Methods

We have selected 231 patients for BRCA1/2 mutation detection during Aug.2010 to Oct.2015 from the breast cancer patients attended our hospital, NCRI. After taking written consent 4-5ml peripheral blood and/or operated tissue (where possible) were collected from BC patients. BRCA1/2 mutations were identified by ARMS-PCR, DNA sequencing and whole genome sequencing. We performed IHC staining with BRCA1 and BRCA2 antibody to distinguish tumour status between patients according to their indication of BRCA1 or BRCA2 mutation.

Results

Average age of the patients was 45.87±1.57 yrs. BRCA1/2 mutations were identified in 24 (10.38%) patientsthrough above mentioned methods. Tumour samples fromnine BRCA positive cases and 15BRCA negative cases were chosen for investigation of IHC. Out of 9 samples with BRCA mutations, 7were BRCA immunostainingnegative, with absence of nuclear or cytoplasmic staining. On the otherhand, from the 15 patients negative for mutations in both genes, 12 were positive for BRCA1immunostaining with a clear nuclear immunoreactivity in tumour cells. From ROCcurve analysis, it was found that IHC negativity (area- 0.211, CI: 0.011-0.411) isassociated (p = 0.02) with BRCA positivity.

Conclusions

In conclusion, we observed a high specificity for the prediction of BRCA1/2 carriers withimmunohistochemistry using BRCA antibody. Validation of this assay, using a larger sample, will allow using immunohistochemistry to decide which high-risk patients should be screenedfirst for the BRCA mutation gene.

Clinical trial identification

NA

Legal entity responsible for the study

Netaji Suibhas Chandra Bose Cancer Research Institue

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

115P - Triple negative breast cancer: Survival and age at time of diagnosis among the Lebanese population (ID 811)

Presentation Number
115P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • C. Kassab
Authors
  • C. Kassab
  • F. Nasr
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Invasive triple-negative breast cancer accounts for 10-20% of breast cancers and is responsible for a high percentage of breast cancer-related deaths. It is indeed a very aggressive tumor that is associated with a poor prognosis with high risk of relapse and a short disease-free survival. It is treated by chemotherapy only and does not benefit from targeted therapy until now. The purpose of this study was to analyze progression-free survival (PFS) and overall survival (OS) after the change of therapeutic modalities, and the age at diagnosis of triple-negative breast cancer in Lebanese women and to compare the age distribution with a preceding Lebanese study and a recent American study of 38,813 patients nationwide.

Methods

Data were collected from hospitals and pathology laboratories across Lebanon. The collection was based on the following inclusion criteria: female diagnosed with an invasive TNBC between 2010 and 2016. PFS was studied in 193 cases, the overall survival analysis was done on 63 cases and the age at time of diagnosis on 387 cases. The statistical analysis was done using Student t tests.

Results

PFS improved from 19 to 35 months after the change of therapeutic protocols and the OS increased from 19 to 23 months (p < 0.001). The average age at time of diagnosis was approximately 56 years, compared with 52 years in the previous Lebanese study and there was a clear age disparity of the age at time of diagnosis between and Lebanese and American study when comparing patients of identical age groups. The age at diagnosis does not depend on the geographical area.

Conclusions

The new therapeutic protocols proved to be more effective, but screening programs must be done at an earlier age. The findings may be pertinent for the Lebanese patients and warrant further evaluation in different ethnic groups and populations.

Clinical trial identification

NA

Legal entity responsible for the study

Holy Spirit University of Kaslik

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

116P - Real world data on use of palbociclib in hormone-receptor (ER) positive HER2 negative metastatic breast cancer (MBC) among Asian patients (ID 1871)

Presentation Number
116P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • J. Chiu
Authors
  • J. Chiu
  • R. Leung
  • H. Sze
  • P. Teo
  • P. Choi
  • T. Lam
  • T. Yau
  • P. Cheng
  • F. Cheung
  • P. Cheung
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Palbociclib has been approved by the US FDA since 2015 yet safety and efficacy data among Asian patients is limited. This study reports the use of this drug in ER-positive HER2-negative MBC in Hong Kong as real world practice.

Methods

The demographic data, treatment response, and toxicity profile of patients received palbociclib were collected in a prospectively maintained database. Patients were from both the public and private sectors. The study is supported by the Hong Kong Breast Cancer Foundation.

Results

Fifty-four patients who have received palbociclib for the first time were recruited in the database. The median age was 51 year (range 34-81) and all patients were ethnic Chinese. All were post-menopausal by natural state (67%) or by ovarian suppression. Over half (55%) obtained palbociclib from the name-patient program prior to the launch of the drug in Hong Kong in Jan 2017. The proportion of first line use was 30% prior to- and 36% after the official launch of palbociclib. The partner endocrine therapy (ET) was aromatase inhibitor (39% letrozole, 11% exemestane) or fulvestrant (50%). Except for 4 patients, the majority (93%) were started on the standard dose of 125 mg/day. Of those started on 125 mg/day, 43% developed Gd 3 neutropenia, and 7% had Gd 4 neutropenia during the first cycle; 31% had dose reduction to 100 mg/day on second cycle. Other adverse events (AEs) included anemia (4%), thrombocytopenia (9%), stomatitis (5%), hand-foot syndrome (4%), fatigue (4%), and low appetite (4%). All these were Gd 1-2. No patient had neutropenic fever. Response assessment was available in 37 cases. The disease control rate was 70%. Many responded patients had visceral disease (54%) and were heavily pretreated (chemotherapy 1 line 15%, > =2 lines 35%; ET > =2 lines 27%; mTOR inhibitor 12%).

Conclusions

This is the first real world data reporting the preliminary efficacy and AEs of palbociclib among ER-positive HER2-negative MBC patients from Hong Kong. Palbociclib was well tolerated. The experience is consistent with published literature of Palbociclib. The use of palbociclib in Hong Kong is often in the second or later line setting and the cause remains to be elucidated.

Clinical trial identification

Not applicable

Legal entity responsible for the study

N/A

Funding

Pfizer

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

117P - The role of ELF3 in metastasis of triple negative breast cancer (ID 1256)

Presentation Number
117P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • S. Park
Authors
  • S. Park
  • Y. Kwon
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Triple negative breast cancer (TNBC) is categorized by a lack in estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor 2 receptor (HER2). TNBC is known to be more aggressive and lethal than other types of breast cancer because of their highly invasive and migratory ability. However, the mechanisms and main contributors of their metastatic ability are still unclear. ETS transcription factors are related with tumorigenesis in many tissues including breast epithelium. Among them, ELF3 (ESX/ESE1) is an epithelial-specific gene that is specifically associated with breast cancer and has been amplified in early breast cancer. The potential role of ELF3 in cytoplasm is presented, but the mechanism of ability to regulate tumor-associated gene expression and breast cell survival for ELF3 are not yet known. Several studies have suggested that the role of EMT is important in the aggressiveness and metastasis of TNBC. It is also known to play an important role in the formation of tumors in most invasive cancer. The main functions of EMT, such as down-regulation of E-cadherin and up-regulation of MMP, are known to be regulated by transcription factors including Snail, Slug and ZEB1.

Methods

For investigation of ELF3 ability in TNBC, we performed a series of assays; western blot, wound healing, invasion, soft-agar colony formation, flow cytometry, anoikis, CAM and immunofluorescence assays.

Results

In this study, we found that ELF3, an ETS transcription factor, was expressed low and high in mesenchymal and epithelial type of TNBC cell lines, respectively. Remarkably, overexpressed ELF3 in the highly invasive TNBC cell lines, MDA-MB-231 and BT549, suppressed EMT by attenuating the expression of several EMT-associated proteins (Vimentin, Slug and MMPs). Moreover, ELF3 overexpression reduced the tumor growth of BT549 in chick embryo chorioallantoic membrane (CAM) model.

Conclusions

Although high ELF3 expression has been known to be associated with tumorigenesis of other breast cancer types, overexpression of ELF3 in TNBC suppressed the metastatic potential of invasive TNBC cells. Our results suggest the important role for ELF3 in metastasis of TNBC.

Legal entity responsible for the study

Ewha Womans University

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Proffered paper session 3 Proffered Paper session

Invited Discussant 95O and 96O (ID 2160)

Presentation Topic
Breast cancer, metastatic
Lecture Time
10:24 - 10:39
Speakers
  • J. Tsang
Authors
  • J. Tsang
Session Room
Hall 405, Singapore, Singapore, Singapore
Date
19.11.2017
Session Time
08:30 - 10:45
Breast cancer, metastatic Proffered paper session 3 Proffered Paper session

Invited Discussant 92O, 93O and 94O (ID 2159)

Presentation Topic
Breast cancer, metastatic
Lecture Time
09:45 - 10:00
Speakers
  • Y. Lu
Authors
  • Y. Lu
Session Room
Hall 405, Singapore, Singapore, Singapore
Date
19.11.2017
Session Time
08:30 - 10:45
Breast cancer, metastatic Proffered paper session 3 Proffered Paper session

91O_PR - Analysis of the gaps on metastatic breast cancer policies and advocacy efforts to support policy development across the patient journey in Asia (ID 1668)

Presentation Number
91O_PR
Presentation Topic
Breast cancer, metastatic
Lecture Time
08:42 - 08:54
Speakers
  • K. Hunt
Authors
  • K. Hunt
  • F. Cardoso
  • M. Thrift-Perry
  • A. Cabanes
  • T. Cruz
  • K. Faircloth
Session Room
Hall 405, Singapore, Singapore, Singapore
Date
19.11.2017
Session Time
08:30 - 10:45

Abstract

Background

In Asia, efficient metastatic breast cancer (mBC) diagnosis, treatment and care is hindered by cultural beliefs and the stigmatization of breast cancer (BC). Despite increasing recognition and efforts from policymakers, advocacy groups and the wider healthcare community, there is urgent need for targeted action and stakeholder collaboration to improve patient outcomes.

Methods

A comprehensive analysis of National Cancer Control Plans (NCCPs), policies and programs was conducted in Japan and South Korea, two developed Asian healthcare systems. Policy components were aligned to the BC/mBC patient journey, and evaluated using standardized criteria on adoption of NCCP goals, and BC/mBC policies and programs. Advocacy initiatives were identified in the policy analysis in Japan and South Korea and through an advocacy promising practice implemented in China.

Results

There has been considerable BC/mBC policy development in Asia but gaps persist across all areas of the patient journey. The analysis finds that cultural beliefs act as barriers to diagnosis and treatment, and deter policy development. For instance, BC/mBC stigmatization is not efficiently tackled due to low levels of trained primary care healthcare professionals (HCPs). This deficiency is also reflected in limited patient awareness and disease prevention, inefficient care coordination, disproportionate emphasis on surgery versus treatment, and use of complementary and alternative medicines. Similarly, access to palliative care and rehabilitative support remain important prevalent needs. Advocacy efforts identified in Japan, South Korea and China sought to fill policy gaps. In China, a model aimed at strengthening primary HCPs through a culturally-adapted BC education toolkit showed promising results for replication in other settings.

Conclusions

Engaging with stakeholders across the patient journey is critical to address cultural barriers and unmet needs of BC/mBC patients. Policy initiatives and promising practices in this research exemplify successful multi-stakeholder engagement to inform further advocacy and policy development.

Legal entity responsible for the study

Susan G. Komen; Pfizer, Inc.

Funding

Pfizer, Inc.

Disclosure

F. Cardoso: Consultant: Astellas/Medivation AstraZeneca Celgene Daiichi-Sankyo Eisai GE Oncology Genentech GlaxoSmithKline (GSK) Macrogenics Merck-Sharp Merus BV Mylan Novartis Pfizer Pierre-Fabre Roche Sanofi Teva. M. Thrift-Perry, K. Faircloth: Pfizer, Inc. All other authors have declared no conflicts of interest.

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Breast cancer, metastatic Proffered paper session 3 Proffered Paper session

92O - Everolimus (EVE) + letrozole (LET) in Asian patients with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC): Results of a subgroup analysis from the BOLERO-4 study (ID 1008)

Presentation Number
92O
Presentation Topic
Breast cancer, metastatic
Lecture Time
09:09 - 09:21
Speakers
  • T. Toyama
Authors
  • T. Toyama
  • J. Jeong
  • V. Srimuninnimit
  • V. Sriuranpong
  • W. Noh
  • K. Tsugawa
  • M. Takahashi
  • H. Iwase
  • C. Arce
  • A. Ridolfi
  • C. Lin
  • M. Royce
  • F. Cardoso
Session Room
Hall 405, Singapore, Singapore, Singapore
Date
19.11.2017
Session Time
08:30 - 10:45

Abstract

Background

Results from the primary analysis of the open-label, single-arm, phase 2 study BOLERO-4 demonstrated that first-line (1L) EVE + LET was an effective combination with a manageable safety profile in postmenopausal patients with ER+ HER2− ABC. Here, we present results from a predefined subgroup analysis of 1L progression-free survival (PFS) and safety by race (Asian versus non-Asian).

Methods

Patients received EVE 10 mg/day + LET 2.5 mg/day until disease progression, unacceptable toxicity, or withdrawal of consent. 1L PFS per local investigator assessment was analyzed overall on the full analysis set (FAS; primary endpoint) and by patient subgroup. This study was not designed to use the SWISH protocol for prevention for stomatitis.

Results

At the data cutoff (December 17, 2016), 44 Asian and 158 non-Asian (Caucasian 72%; Black 4%; Pacific Islander <1%; other 2%) patients had a median PFS and 18- and 24-month KM estimated PFS rates similar to the FAS (Table). In general, all grade adverse events (AEs), regardless of causality or severity, were more common among Asian patients versus non-Asians and the overall population, particularly for stomatitis, weight decreased, anemia, hyperglycemia, decreased appetite, rash and nasopharyngitis. AEs were mostly grade 1–2 in severity and anemia was the most common grade 3–4 AE among both Asian (20%) and non-Asian (8%) patients.

FASRACE
N = 202Asian (n = 44)Non-Asian (n = 158)
No. of PFS events, n (%)108 (53.5)26 (59.1)82 (51.9)
Median PFS (95% CI), months22.0 (18.1–25.1)20.3 (14.8–26.0)22.0 (17.1–25.7)
KM estimated PFS rate (95% CI), %
18-months58.8 (50.9–65.8)65.8 (49.1–78.1)56.7 (47.5–64.8)
24-months42.9 (35.0–50.5)44.0 (28.0–58.8)42.8 (33.7–51.5)
CI, confidence interval; KM, Kaplan-Meier

Conclusions

Results from this predefined subgroup analysis were consistent with previously reported BOLERO-4 data, showing that 1L EVE + LET offers clinical benefits irrespective of patient race, with no new safety signals reported. Although some AEs were more common among Asian patients versus non-Asians and the overall population, they were mostly grade 1–2 in severity.

Clinical trial identification

NCT01698918 EudraCT Number (EU number) 2012-003065-17

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation

Funding

Novartis Pharmaceuticals Corporation

Disclosure

T. Toyama: Research funding from Eisai, Chugai, Novartis, Nippon Kayaku, Kyowa Hakko Kirin, Daiichi-Sankyo, Takeda, J. Jeong: Research funding from Dong-A, Boryung, LG Life Sciences, Antigen; Honoraria from Roche, Alvogen, Novartis, Pfizer, Covidien, V. Sriuranpong: Honoraria from Novartis, Roche, MSD, Sanofi, Eisai, AstraZeneca, H. Iwase: Research funding from AstraZeneca, Chugai-Roche, Taiho, Daiichi-Sankyo, Novartis, Pfizer, Kyowa Hakko-Kirin, Eisai; Honoraria from AstraZeneca, Novartis, Takeda, Chugai-Roche. C. Arce: Novartis employee, A. Ridolfi: Novartis Pharma SAS employee, C. Lin: Novartis employee and stocks, M. Royce: Research funding from Novartis; Consultant for Celltrion, BCI; Honoraria from Novartis, Syndax, F. Cardoso: Research funding for clinical trials by institution; consultant for Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GSK, MacroGenics, Merck, Merus BV, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Teva

All other authors have declared no conflicts of interest.

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