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Breast cancer, metastatic Industry Satellite Symposium Industry Satellite Symposium

Presentation (ID 2284)

Presentation Topic
Breast cancer, metastatic
Lecture Time
12:45 - 14:15
Session Room
Room 325, Singapore, Singapore, Singapore
Date
17.11.2017
Session Time
12:45 - 14:15
Breast cancer, metastatic Poster lunch Poster Display session

97P - Phase II trial of eribulin and S-1 combination therapy for advanced or recurrent breast cancer (ID 1483)

Presentation Number
97P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • T. Iwasa
Authors
  • T. Iwasa
  • J. Tsurutani
  • Y. Mizuno
  • Y. Kojima
  • T. Takashima
  • N. Matsunami
  • T. Morimoto
  • J. Yamamura
  • S. Ohtani
  • Y. Tanabe
  • S. Watanabe
  • R. Kato
  • H. Tanino
  • S. Tokunaga
  • H. Abe
  • S. Tsuyuki
  • F. Hara
  • T. Takano
  • Y. Komoike
  • K. Nakagawa
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Eribulin is a non-taxane microtubule dynamics inhibitor that has been proven to prolong overall survival in patients with breast cancer. S-1, an oral anticancer drug, has demonstrated non-inferiority in overall survival (OS) to taxane as first-line chemotherapy for metastatic breast cancer (MBC). We previouly reported phase I trial results for the combination of these drugs with an overall response rate of 41.7% and median progression free survival (PFS) of 7.6 months. George W et.al (J Clin Oncol 2003) suggested that estrogen receptor negativity, the presence of three or more sites of disease, a short disease-free interval (1 to 24 months), and prior systemic therapy all predicted for impaired overall survival in their multivariate analysis. Considering these factors, we conducted a multicenter phase II study of this combination to further evaluate its safety and efficacy.

Background

Eribulin is a non-taxane microtubule dynamics inhibitor that has been proven to prolong overall survival in patients with advanced and recurrent breast cancer .S-1, an oral anticancer drug, composed of tegafur, gimestat and otastat potassium, has demonstrated non-inferiority in overall survival (OS) to taxane as first-line chemotherapy for metastatic breast cancer (MBC).We previouly reported phase I trial results for the combination of these drugs with an overall response rate of 41.7% and median progression free survival (PFS) of 7.6 months. George W et.al (J Clin Oncol 2003) suggested that estrogen receptor negativity, the presence of three or more sites of disease, a short disease-free interval (1 to 24 months), and prior systemic therapy all predicted for impaired overall survival in their multivariate analysis. Considering these factors, we conducted a multicenter phase II study of this combination to further evaluate its safety and efficacy.

Methods

Recurrent or advanced breast cancer patients previously treated with anthracycline or taxanes were enrolled from September 2014 to May 2016. Patients received Eribulin 1.4 mg/m2 day1 and day8 intravenously and S-1 50 mg/m2 from day1 to day14 orally. Primary objective was to investigate safety and efficacy. Secondary objectives were to evaluate PFS, OS and clinical benefit rate (CBR) using Response Criteria in Solid Tumors (RECIST).

Results

Thirty-two patients were enrolled this trial and 30 patients were evaluable. Objective response rate was 36.7%. There were 3 [10%] complete responses, 8 [26.7%] partial responses and 11 [36.7%] stable diseases. This combination therapy had a manageable safety profiles consistent with the known adverse effects of both drugs. The most common grade3-4 adverse events were neutropenia (22 [73.3%] of 32 patients), leukopenia (13 [43.3%] of 32 patients), febrile neutropenia (3 [9.4%] of 32 patients) and peripheral neuropathy (4 [12.5%] of 32 patients). CBR was 46.7%. The median overall survival and the median PFS was not reached.

Conclusions

We showed tolerability and clinical activity in this combination therapy in a subset of patients with poor prognosis. Eribulin in combination with S-1 may represent a promising treatment option for advanced or recurrent breast cancer patients.

Legal entity responsible for the study

Eisai

Funding

Eisai

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

102P - Multicenter phase 2 trial of varlitinib versus lapatinib in combination with capecitabine in patients with HER2+ metastatic breast cancer (MBC) who failed prior trastuzumab therapy (ID 987)

Presentation Number
102P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • S. Lee
Authors
  • S. Lee
  • S. Chen
  • M. Dai
  • G. Lee
  • C. Liu
  • A. Chan
  • H. Chang
  • L. Tseng
  • W. Chay
  • L. Chow
  • J. Peneyra
  • K. Rau
  • H. Wang
  • A. Guancia
  • M. Head
  • J. Chiu
  • B. Robinson
  • B. Lindmark
  • N. McIntyre
  • C. Hsieh
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Varlitinib, a tyrosine kinase inhibitor of the ErbB family (EGFR, HER2 and HER4), showed anti-tumor activity in trastuzumab-resistant models and in patients with trastuzumab-resistant, chemotherapy-refractory MBC in a phase 1 study. This study compared the efficacy and safety of varlitinib plus capecitabine (VC) versus lapatinib plus capecitabine (LC) in HER2+ MBC patients who failed prior trastuzumab therapy.

Methods

The primary objective was to assess percentage change in tumor size at week 12. Objective response rate (ORR), safety and drug exposure were also assessed. Patients who received at least one dose of study treatment were included in primary analysis. Sensitivity analysis for primary objective and ORR were performed in patients who remained on study for more than 30 days.

Results

From Dec 2014 to Aug 2016, 24 patients were randomized to the VC arm (400mg BID) and 26 to the LC arm (1250mg QD) in 16 sites in 6 countries. Percentage of tumor size reduction was numerically higher in VC than LC (-31.00% vs. -19.37%, one-sided p = 0.132). ORR in the VC arm (40.9%) was similar to LC arm (45.5%), p = 1.000. Sensitivity analysis showed numerically superior ORR and statistically significant higher reduction of tumor size in VC compared to LC (60% vs. 45.5%, p = 0.508; mean, -34.6% vs.-19.4%, one-sided p = 0.075) All patients had at least 1 AE. Severe AE(s) were observed in 13 patients (54.2%) in the VC arm and 11(42.3%) in the LC arm. The most common AE was diarrhea (66.7%) in the VC arm and were diarrhea and palmar-plantar erythrodysaesthesia syndrome (both 50%) in the LC arm. Median intended exposure and percentage of intended dose were lower in the VC arm (115.5 days, 74.6%) indicating more frequent dose interruption, dose reduction and treatment discontinuation than the LC arm (135.0 days, 99.05%).

Conclusions

Sensitivity analysis showed greater tumor size reduction and improved ORR for VC arm when the combination was administrated for more than 30 days. Reduced intended exposure and dose intensity for the VC arm suggests a dose reduction of varlitinib may be considered when combined with capecitabine for the 2nd line treatment of HER2+ MBC.

Clinical trial identification

NCT02338245.

Legal entity responsible for the study

ASLAN pharmaceuticals

Funding

ASLAN pharmaceuticals

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

106P - Eribulin mesylate for HER2- metastatic breast cancer; analyses of pattern of disease progression and outcomes from the real world (ID 1477)

Presentation Number
106P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • J. Watanabe
Authors
  • J. Watanabe
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

The subanalysis of prospective randomized trials of E suggested E suppressed development of new lesion [NL] and it led to improvement of overall survival (Twelves, BCRT, 2015), however, behaviors of disease in real-world patients (pts) have not been well discussed.

Methods

Outcomes of HER2-MBC pts who received E at our institute from November 2011 to present were reviewed. Statistical analyses were performed using the chi-square test, the Kaplan-Meyer method.

Results

We identified total 128 (90 ER+, 38 ER-) HER2-MBC who received E at least 2 cycles in our institute. Median age at the initiation of E were as follows; overall, 58 (range 30-77); ER+, 60 (30-77); ER- 55.5 (32-71). Median number of regimens prior to E were as follows; overall, 1 (range 0-8); ER+, 1 (0-6); ER-, 2 (0-8). While all pts had a history of anthracycline and/or taxane in ER- subset, Number of involved organ were 2 (1-5) in overall and both subsets and no significant difference was seen in the pattern of visceral involvement. Most of (122/128, 95.5%) the pts was discontinued E therapy, and median time-to-treatment failure (TTF) were as follows; overall, 125.0 days (95% confidence interval [CI] 43.0-328.0); ER+, 134.0 days (95%CI 62.0-314.0); ER-, 104.0 (95%CI 42.0-230.0). Reasons for the discontinuation of E were as follows; progression of known lesion(s), 77 (63.1%); development of NL, 27 (22.1%), decrease of performance status, 11 (9.0%); intolerable toxicity, 6 (4.9%); other, 1 (0.9%). In ER- subset, development of NL was more frequently seen compared to ER+ subset, however, it was not statistically significant. (7/20 vs 10/67, P = 0.12, chi-square). Multivariate cox regression analyses disclosed some risk factors for TTF as follows; liver metastasis, hazard ratio [HR] 0.39, P < 0.05; soft tissue metastasis, HR 0.53, P < 0.05; ≥3 involved organs, HR 2.99, P < 0.05; taxane for early breast cancer, HR 2.50, P < 0.05. When limited to ER+ pts who received E as 2nd-line therapy (N = 40), only one (2.5%) pt developed NL and there was a positive relationship between TTF and OS after E (Spearman's roh=0.64, p < 0.0001).

Conclusions

Our single institutional review with some limitations disclosed eribulin monotherapy revealed equivalent effect shown in prospective studies.

Legal entity responsible for the study

Junichiro Watanabe

Funding

None

Disclosure

J. Watanabe: Advisory board member of Eisai Co., Ltd. Honoraria from Eisai Co., Ltd.

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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

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

98P - Effect of postmastectomy radiotherapy on breast cancer with isolated tumor cells or micrometastases in regional lymph nodes: A propensity score matched analysis using the SEER database (ID 1526)

Presentation Number
98P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • W. Xia
Authors
  • Q. Zheng
  • W. Xia
  • Q. Lu
  • S. Wang
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Postmastectomy radiotherapy (PMRT) has been strongly considered for patients with 1-3 positive axillary nodes (ALNs). In addition, the indications for PMRT are expanding to patients with negative ALNs but have multiple high-risk recurrence factors. However, For patients with isolated tumor cells. We aimed to determine the effects of PMRT on survival of patients with ITCs or ALNs micrometastases of breast cancer.

Methods

We identified patients with ITCs or ALNs micrometastases after mastectomy from the Surveillance, Epidemiology, and End Results database from 2004 to 2014. Overall survival (OS) and breast cancer-specific mortality (BCSM) were compared among patients received PMRT or not, using propensity score-matched analyses. Cox proportional hazards models and competing-risk models were performed in OS and BCSM analyses, respectively.

Results

We identified 11,622 eligible cases. PMRT was administered to 1,728 patients. Treatment was less frequent among patients who were older, patients with high-income, and patients with right-side tumor. OS at 5 years and 10 years were 88.1% and 74.2% in PMRT group, and were 87.8% and 77.3% in non-PMRT group, respectively. Five-year and 10-year cumulative BCSM rate were 6.4% and 12.3% in PMRT group, and were 6.6% and 14.1% in non-PMRT group, respectively. OS and BCSM were unaffected by PMRT after adjusting for multiple confounders (OS, hazard ratio, 0.92; 95% CI, 0.74 to 1.16; BCSM, subhazard ratio, 0.89; 95% CI, 0.67-1.18).

Conclusions

To our knowledge, this is the largest study to date of the effect of radiotherapy on survival in breast cancer with ITCs or ALN micrometastases. In this population-based study, we do not find survival benefit of PMRT on patients with ITCs or ALN micrometastases.

Legal entity responsible for the study

Sun Yat-sen University Cancer Center

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

103P - Efficacy of T-DM1 in patients with HER2-positive metastatic breast cancer previously treated with pertuzumab (ID 1223)

Presentation Number
103P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • K. Matsui
Authors
  • K. Matsui
  • A. Yoshikawa
  • K. Oyama
  • Z. Nozaki
  • Y. Tanada
  • M. Earashi
  • K. Kiyohara
  • T. Nagata
  • W. Fukushima
  • T. Shimizu
  • K. Maeda
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

The standard therapy for primary treatment of HER2-positive metastatic breast cancer (MBC) is combination therapy of pertuzumab (PER), trastuzumab (HER) and docetaxel (DTX). Although the effectiveness of trastuzumab emtansine (T-DM1) after HER treatment has been reported, there are few reports on the effectiveness of T-DM1 for patients treated with PER. We retrospectively investigated the effectiveness of T-DM1 on HER2-positive MBC previously treated with PER.

Methods

Between October 2013 and June 2017, 79 patients with HER2-positive MBC were treated with PER. 44 patients were investigated the subsequent treatment. 34 patients received T-DM1, and 10 patients received treatment other than T-DM1 after PER treatment.

Results

Median treatment line was 3.0 (1-9) vs 4.0 (1-9) in the T-DM1 treatment and other than T-DM1 treatment, respectively. The response rate was CR 0% vs 0%, PR 36.0% vs 25%, SD 32.0% vs 62.5%, PD 32.0% vs 12.5%, respectively. The objective response rate was 36.0% vs 20.0%. The clinical benefit rate was 48.0% vs 50.0%. Median time to treatment failure was 6.6 months vs 2.9 months, respectively. There was a significant difference in median overall survival; median not reached vs 19.6 months (p = 0.04).

Conclusions

OS was significantly better with administration of T-DM1 after PER treatment. Based on the results of this study, it was confirmed that efficacy of T-DM1 in patients with HER2-positive metastatic breast cancer previously treated with PER.

Legal entity responsible for the study

Koshi Matsui

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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Breast cancer, metastatic Poster lunch Poster Display session

107P - The utility of risk factors proposed in a prospective clinical trial in the management of ER-positive, HER2-negative metastatic breast cancer patients: Feedback from the real world (ID 1491)

Presentation Number
107P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • K. Yoshitsugu
Authors
  • K. Yoshitsugu
  • J. Watanabe
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

Some risk factors (RFs) in the management of ER-positive, HER2-negative metastatic breast cancer (ER+HER2-MBC), such as a shorter disease-free interval (DFI), visceral involvement or high tumor burden, have been identified in prospective clinical trials; however, the utility of those RFs in the real world has not been well discussed.

Methods

We reviewed our medical records from 2002 to present to assess the utility of RFs (DFI≤24 months [DFI≤24M]; visceral metastases [VIS]; prior (neo)adjuvant anthracycline and/or taxane [A/T]; or ≥ 3 metastatic organs [≥3 ORG]) defined in the TURANDOT risk factor analyses (Brodowicz T, Br J Cancer, 2014), a first-line bevacizumab trial of HR+HER2-MBC patients. According to the analysis, patients with ≥2 RFs were classified as “high-risk (HiR)”, and others were classified as “low-risk (LoR)”. Statistical analyses were performed using the Kaplan-Meyer method and a multivariate COX regression analysis.

Results

We identified 311 ER+HER2-MBC (224 recurrent, 87 advanced) patients who underwent chemotherapy (CTx). The most common RF at the initiation of first-line CTx was VIS (N = 186, 59.8%), followed by A/T, ≥3 ORG and DFI≤24M. The distribution of RFs was as follows: 0 in 89 (28.6%), 1 in 93 (29.9%), 2 in 94 (30.2%), 3 in 30 (9.6%), and 4 in 5 (1.7%). The survival from the initiation of CTx (OSCTx) was significantly poorer in HiR patients than LoR ones (median 815.0 vs. 1062.0 days, p < 0.001, log-rank) in all MBC patients, as well as in 87 advanced BC patients (median 825.0 vs. 1160.0 days, P < 0.05, log-rank). There was no significant difference in the OSCTx between patients with 0 and 1 RF (P = 0.90). In addition, in recurrent BC (rBC) patients, there was no significant difference in the OSCTx between patients with 2 and ≥3 RFs (P = 0.10). Multivariate analyses revealed ≥3 ORG and DFI≤24M as significant RFs (P < 0.05) for all rBC patients (hazard ratios 1.61 and 1.49, respectively).

Conclusions

Our review suggests that RFs such as high tumor burden and shorter DFI identified in prospective randomized studies are applicable to patients in the real world, even with heterogeneous backgrounds.

Legal entity responsible for the study

Junichiro Watanabe

Funding

None

Disclosure

J. Watanabe: Honoraria from AstraZeneca Japan, Chugai Pharmaceuticals, Eisai, Novartis Pharma Japan, Taiho pharmaceuticals, and advisory board member of AstraZeneca Japan, Eisai.

All other 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

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

100P - Impact of perioperative fluoropyrimidines on the efficacy of capecitabine in patients with advanced breast cancer: A retrospective study (ID 1155)

Presentation Number
100P
Presentation Topic
Breast cancer, metastatic
Lecture Time
13:00 - 13:00
Speakers
  • S. Iizumi
Authors
  • S. Iizumi
  • A. Shimomura
  • T. Shimoi
  • K. Sudo
  • E. Noguchi
  • K. Yonemori
  • C. Shimizu
  • Y. Fujiwara
  • K. Tamura
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

Background

It is unclear whether perioperative fluoropyrimidine (FP) use impacts the efficacy of capecitabine in advanced breast cancer treatment.

Methods

Medical records of patients with advanced breast cancer who received capecitabine between 2008 and 2016 at National Cancer Center Hospital (Tokyo, Japan) were reviewed. Progression-free survival (PFS), overall survival (OS), tumor response, and adverse events (AEs) were compared between a FP group (prior perioperative FP use) and a non-FP group (no prior FP use). To evaluate the effect of prior perioperative FP use on survival outcomes, hazard ratios (HRs) for PFS and OS were estimated for the FP group compared with the non-FP group.

Results

A total of 289 patients (FP group: n = 106; non-FP group: n = 183) were analyzed. Patient characteristics were similar between the two groups. The median recurrence-free interval (RFI) was 3.94 (range: 0.27-20.11) years in the FP group and 4.24 (range: 0.27-27.07) years in the non-FP group (p = 0.402). The FP group had poorer PFS than the non-FP group (univariate HR: 1.33; 95% confidence interval [CI]: 1.03-1.72, p = 0.028; multivariate HR: 1.33; 95% CI: 1.02-1.73; p = 0.034). However, OS was similar between the groups (univariate HR: 1.16; 95% CI: 0.84-1.62; p = 0.368; multivariate HR: 1.06; 95% CI: 0.74-1.51; p = 0.755). Multivariate HRs for PFS for the FP group with short RFI and long RFI (cutoff: RFI=4 years) separately were 1.56 (95% CI: 1.06-2.28; p = 0.025) and 1.20 (95% CI: 0.84-1.70; p = 0.326), respectively. With different cutoffs (RFI=3, 4, and 5 years), the ranges of adjusted HRs for PFS were 1.32-1.67 with short RFI, and 1.00-1.25 with long RFI. A trend for larger HR for the FP group with short RFI than with long RFI was also seen for OS with different cutoffs of RFI. The response rate (FP group vs. non-FP group) was 21.0% vs. 14.8% (p = 0.306), and the disease control rate was 59.9% vs. 54.5% (p = 0.422). There was no significant difference in AEs between the two groups.

Conclusions

Capecitabine can be used for patients with advanced breast cancer with FP use history, as OS does not correlate with prior FP use. For patients with FP use history, RFI may be a relevant factor for treatment selection.

Legal entity responsible for the study

National Cancer Center Hospital

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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