1Center for Breast Cancer, National Cancer Center, Goyang, Korea
2Department of Oncology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4Division of Hematology-Oncology, Pusan National University Hospital, Busan, Korea
5Medical Oncology Center, Seoul National University Hospital, Seoul, Korea
6Division of Hematology-Oncology, Gachon University Gil Medical Center, Incheon, Korea
7Division of Hematology-Oncology, Kosin University Gospel Hospital, Busan, Korea
8Division of HematologyOncology, Keimyung University Dongsan Medical Center, Daegu, Korea
9Department of Hematology-Oncology, Korea University Guro Hospital, Seoul, Korea
10Division of HematologyOncology, Daegu Catholic University Medical Center, Daegu, Korea
11Division of Hematology-Oncology, Daegu Fatima Hospital, Daegu, Korea
12Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea
13Division of Hematology-Oncology, Inha University Hospital, Incheon, Korea
14Division of Hematology-Oncology, National Health Insurance Service Ilsan Hospital, Goyang, Korea
15Division of Hematology-Oncology, Kyung Hee University Medical Center, Seoul, Korea
16Samyang Biopharmaceuticals Corporation, Seoul, Korea
Copyright © 2017 by the Korean Cancer Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Co-author Mi Ryung Jin is an employee of Samyang Biopharmaceuticals Corporation. All remaining authors have declared that they have no conflicts of interest.
Variable | Genexol-PM (n=105) | Genexol (n=107) | p-value |
---|---|---|---|
Age (yr) | 49.0 (28.0-72.0) | 52.0 (25.0-78.0) | 0.02 |
Menstruation status | |||
Premenopausal | 61 (58.1) | 49 (45.8) | 0.10 |
Postmenopausal | 44 (41.9) | 58 (54.2) | |
ECOG status | |||
0 | 47 (44.8) | 31 (29.0) | 0.02 |
1 | 53 (50.5) | 68 (63.6) | |
2 | 5 (4.8) | 8 (7.5) | |
DFI (yr) | 2.2 (0.2-8.7) | 3.0 (0.2-9.1) | 0.34 |
No. target lesions | |||
< 3 | 90 (85.7) | 94 (87.9) | 0.65 |
≥ 3 | 15 (14.3) | 13 (12.2) | |
Visceral metastasis | |||
Yes | 71 (67.6) | 65 (60.8) | 0.30 |
No | 34 (32.4) | 42 (39.3) | |
ER or PgR status | |||
Positive | 75 (71.4) | 82 (76.6) | 0.63 |
Negative | 28 (26.7) | 24 (22.4) | |
Unknown | 2 (1.9) | 1 (0.9) | |
De novo stage IV breast cancer | |||
Yes | 71 (67.6) | 74 (69.2) | 0.81 |
No | 34 (32.4) | 33 (30.8) | |
Previous chemotherapya) | |||
Yes | 16 (15.2) | 14 (13.1) | 0.70 |
No | 89 (84.8) | 93 (86.9) |
Variable | Genexol-PM (n=105) | Genexol (n=107) | p-value |
---|---|---|---|
Objective response ratea) | 41 (39.1) | 26 (24.3) | 0.021 |
Complete response | 0 | 0 | |
Partial response | 41 (39.1) | 26 (24.3) | |
Stable disease | 46 (43.8) | 56 (52.3) | |
Progressive disease | 7 (6.7) | 16 (15.0) | |
Not evaluated | 11 (10.5) | 9 (9.4) |
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Variable | Genexol-PM (n=105) | Genexol (n=107) | p-value |
---|---|---|---|
Age (yr) | 49.0 (28.0-72.0) | 52.0 (25.0-78.0) | 0.02 |
Menstruation status | |||
Premenopausal | 61 (58.1) | 49 (45.8) | 0.10 |
Postmenopausal | 44 (41.9) | 58 (54.2) | |
ECOG status | |||
0 | 47 (44.8) | 31 (29.0) | 0.02 |
1 | 53 (50.5) | 68 (63.6) | |
2 | 5 (4.8) | 8 (7.5) | |
DFI (yr) | 2.2 (0.2-8.7) | 3.0 (0.2-9.1) | 0.34 |
No. target lesions | |||
< 3 | 90 (85.7) | 94 (87.9) | 0.65 |
≥ 3 | 15 (14.3) | 13 (12.2) | |
Visceral metastasis | |||
Yes | 71 (67.6) | 65 (60.8) | 0.30 |
No | 34 (32.4) | 42 (39.3) | |
ER or PgR status | |||
Positive | 75 (71.4) | 82 (76.6) | 0.63 |
Negative | 28 (26.7) | 24 (22.4) | |
Unknown | 2 (1.9) | 1 (0.9) | |
De novo stage IV breast cancer | |||
Yes | 71 (67.6) | 74 (69.2) | 0.81 |
No | 34 (32.4) | 33 (30.8) | |
Previous chemotherapy |
|||
Yes | 16 (15.2) | 14 (13.1) | 0.70 |
No | 89 (84.8) | 93 (86.9) |
Variable | Genexol-PM (n=105) | Genexol (n=107) | p-value |
---|---|---|---|
Objective response rate |
41 (39.1) | 26 (24.3) | 0.021 |
Complete response | 0 | 0 | |
Partial response | 41 (39.1) | 26 (24.3) | |
Stable disease | 46 (43.8) | 56 (52.3) | |
Progressive disease | 7 (6.7) | 16 (15.0) | |
Not evaluated | 11 (10.5) | 9 (9.4) |
Variable | Univariate |
Multivariate |
||
---|---|---|---|---|
HR (95% CI) | p-value | HR (95% CI) | p-value | |
Age (≥ 45 yr vs. < 45 yr) | 0.99 (0.52-1.89) | 0.97 | ||
Genexol-PM vs. Genexol | 2.14 (1.17-3.93) | 0.01 | 2.20 (1.20-4.06) | 0.01 |
Premenopausal vs. postmenopausal | 0.98 (0.54-1.77) | 0.94 | ||
Visceral involvement (yes vs. no) | 1.11 (0.60-2.07) | 0.73 | ||
Previous treatment (no vs. yes) | 2.29 (0.88-5.95) | 0.09 | 2.41 (0.92-6.35) | 0.07 |
Hormone receptor (positive vs. negative) | 0.97 (0.51-1.85) | 0.92 |
Adverse event | Genexol-PM (n=105) |
Genexol (n=107) |
||||
---|---|---|---|---|---|---|
Grade 1 | Grade 2 | ≥ Grade 3 | Grade 1 | Grade 2 | ≥ Grade 3 | |
Neutropenia | 0 | 3 (2.9) | 72 (68.6) | 0 | 8 (7.5) | 43 (40.2) |
Febrile neutropenia | 0 | 1 (1.0) | 3 (2.9) | 0 | 0 | 3 (2.8) |
Myalgia | 26 (24.8) | 28 (26.7) | 9 (8.6) | 32 (29.9) | 26 (24.3) | 8 (7.5) |
Nausea | 25 (23.8) | 14 (13.3) | 3 (2.9) | 42 (39.3) | 6 (5.6) | 1 (0.9) |
Neuropathy peripheral | 13 (12.4) | 16 (15.2) | 8 (7.6) | 27 (25.2) | 14 (13.1) | 8 (7.5) |
Constipation | 17 (16.2) | 22 (21.0) | 0 | 23 (21.5) | 17 (15.9) | 0 |
Arthralgia | 11 (10.5) | 12 (11.4) | 1 (1.0) | 9 (8.4) | 14 (13.1) | 3 (2.8) |
Asthenia | 8 (7.6) | 4 (3.8) | 4 (3.8) | 14 (13.1) | 11 (10.3) | 1 (0.9) |
Rash | 16 (15.2) | 11 (10.5) | 2 (1.9) | 12 (11.2) | 9 (8.4) | 4 (3.8) |
Pruritus | 13 (12.4) | 9 (8.6) | 0 | 17 (15.9) | 8 (7.5) | 0 |
Insomnia | 13 (12.4) | 7 (6.7) | 1 (1.0) | 10 (9.3) | 7 (6.5) | 0 |
Hypersensitivity | 5 (4.8) | 8 (7.6) | 3 (2.9) | 2 (1.9) | 1 (0.9) | 1 (0.9) |
Values are presented as median (range) or number (%). ECOG, Eastern Cooperative Oncology Group; DFI, disease-free interval; ER, estrogen receptor; PgR, progesterone receptor. Systemic cytotoxic chemotherapy for metastatic disease.
Values are presented as number (%). Objective response rate=complete response+partial response.
HR, hazard ratio; CI, confidence interval.
Values are presented as number (%).