1Division of Hematology-Oncology, Department of Medicine, Seoul St. Mary’s Hospital, Seoul, Korea
2Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Seoul, Korea
3Division of Hematology-Oncology, Department of Medicine, Seoul National University Hospital, Seoul, Korea
4Division of Hematology-Oncology, Department of Medicine, Gachon University Gil Hospital, Incheon, Korea
5Division of Hematology-Oncology, Department of Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
6Division of Hematology-Oncology, Department of Medicine, Korea University Anam Hospital, Seoul, Korea
7Eli Lilly and Company, Shanghai, China
8Eli Lilly and Company, Seoul, Korea
9Eli Lilly Interamerica Inc., Buenos Aires, Argentina
Copyright © 2016 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.
XW, JSK, and MO are employees of Eli Lilly and Company. MO owns shares in Eli Lilly Pty Ltd. JH Kang is an Advisory Board member for Eli Lilly and Company. MJA has consulted/advised for Eli Lilly and Company. DWK has consulted/advised for Eli Lilly and Company. KP has consulted/advised for Astellas, Astra-Zeneca, AVEO, and Boehringer. EKC, JH Kim, and SWS have no conflicts of interest to disclose.
This study was sponsored by Eli Lilly and Company, manufacturer/licensee of pemetrexed (Alimta®). Medical writing assistance was provided by Rose Boutros, PhD, and Julie Ely, PhD, CMPP, of ProScribe - Envision Pharma Group, and was funded by Eli Lilly. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2).
Pemetrexed plus cisplatin (n=51) |
Gefitinib (n=60) |
|||
---|---|---|---|---|
Grades 1-2 | Grades 3-4 | Grades 1-2 | Grades 3-4 | |
Patients with ≥ 1 TEAE | 30 (58.8) | 13 (25.5) | 41 (68.3) | 7 (11.7) |
Hematologic | ||||
Neutrophils/granulocytes | 5 (9.8) | 9 (17.6) | 0 | 0 |
Non-hematologic | ||||
ALT | 0 | 1 (2.0) | 4 (6.7) | 3 (5.0) |
AST | 0 | 0 | 5 (8.3) | 2 (3.3) |
Anorexia | 15 (29.4) | 1 (2.0) | 3 (5.0) | 0 |
Constipation | 4 (7.8) | 0 | 0 | 0 |
Diarrhoea | 6 (11.8) | 0 | 12 (20.0) | 2 (3.3) |
Dry skin | 0 | 0 | 8 (13.3) | 0 |
Fatiguea) | 3 (5.9) | 1 (2.0) | 6 (10.0) | 0 |
Hair loss | 5 (9.8) | 0 | 2 (3.3) | 0 |
Hemorrhagea) | 3 (5.9) | 0 | 2 (3.3) | 0 |
Mucositisa) | 1 (2.0) | 0 | 6 (10.0) | 0 |
Nausea | 24 (47.1) | 2 (3.9) | 4 (6.7) | 0 |
Neuropathy, sensory | 9 (17.6) | 0 | 2 (3.3) | 0 |
Paina) | 6 (11.8) | 0 | 2 (3.3) | 1 (1.7) |
Pruritus, itching | 5 (9.8) | 0 | 18 (30.0) | 0 |
Skin rasha) | 3 (5.9) | 0 | 31 (51.7) | 1 (1.7) |
Vomiting | 11 (21.6) | 3 (5.9) | 0 | 0 |
Values are presented as number (%). ALT, alanine aminotransferase; AST, aspartate transaminase; TEAE, treatment-emergent adverse event. Events are maximum grade per National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE, ver. 3.0).
a) Fatigue, hemorrhage, mucositis, pain, and skin rash are combined from some specific CTCAE terms.
PC/G (n=54) | Gefitinib (n=60) | Total (n=114) | p-value | |
---|---|---|---|---|
Sex | ||||
Male | 10 (18.5) | 13 (21.7) | 23 (20.2) | 0.816 |
Female | 44 (81.5) | 47 (78.3) | 91 (79.8) | |
Age (yr) | ||||
Mean (range) | 59.43 (30.7-80.7) | 62.16 (30.5-79.2) | 60.87 (30.5-80.7) | 0.161 |
< 65 | 35 (64.8) | 36 (60.0) | 71 (62.3) | 0.699 |
≥ 65 | 19 (35.2) | 24 (40.0) | 43 (37.7) | |
Smoking status | ||||
Never-smoker | 52 (96.3) | 55 (91.7) | 107 (93.9) | 0.443 |
Light ex-smoker | 2 (3.7) | 5 (8.3) | 7 (6.1) | |
Stage of disease | ||||
IIIB | 4 (7.4) | 6 (10.0) | 10 (8.8) | 0.746 |
IV | 50 (92.6) | 54 (90.0) | 104 (91.2) | |
ECOG performance status | ||||
0 | 24 (44.4) | 25 (41.7) | 49 (43.0) | 0.850 |
1 | 30 (55.6) | 35 (58.3) | 65 (57.0) | |
EGFR mutation status | ||||
Patients who provided samples | 20 (37.0) | 20 (33.3) | 40 (35.1) | - |
EGFR mutated | 4 (7.4) | 8 (13.3) | 12 (10.5) | |
EGFR not mutated | 3 (5.6) | 5 (8.3) | 8 (7.0) | |
EGFR unknown | 13 (24.1) | 7 (11.7) | 20 (17.5) |
Pemetrexed plus cisplatin (n=51) |
Gefitinib (n=60) |
|||
---|---|---|---|---|
Grades 1-2 | Grades 3-4 | Grades 1-2 | Grades 3-4 | |
Patients with ≥ 1 TEAE | 30 (58.8) | 13 (25.5) | 41 (68.3) | 7 (11.7) |
Hematologic | ||||
Neutrophils/granulocytes | 5 (9.8) | 9 (17.6) | 0 | 0 |
Non-hematologic | ||||
ALT | 0 | 1 (2.0) | 4 (6.7) | 3 (5.0) |
AST | 0 | 0 | 5 (8.3) | 2 (3.3) |
Anorexia | 15 (29.4) | 1 (2.0) | 3 (5.0) | 0 |
Constipation | 4 (7.8) | 0 | 0 | 0 |
Diarrhoea | 6 (11.8) | 0 | 12 (20.0) | 2 (3.3) |
Dry skin | 0 | 0 | 8 (13.3) | 0 |
Fatigue |
3 (5.9) | 1 (2.0) | 6 (10.0) | 0 |
Hair loss | 5 (9.8) | 0 | 2 (3.3) | 0 |
Hemorrhage |
3 (5.9) | 0 | 2 (3.3) | 0 |
Mucositis |
1 (2.0) | 0 | 6 (10.0) | 0 |
Nausea | 24 (47.1) | 2 (3.9) | 4 (6.7) | 0 |
Neuropathy, sensory | 9 (17.6) | 0 | 2 (3.3) | 0 |
Pain |
6 (11.8) | 0 | 2 (3.3) | 1 (1.7) |
Pruritus, itching | 5 (9.8) | 0 | 18 (30.0) | 0 |
Skin rash |
3 (5.9) | 0 | 31 (51.7) | 1 (1.7) |
Vomiting | 11 (21.6) | 3 (5.9) | 0 | 0 |
Values are presented as number (%) unless otherwise indicated. PC/G, pemetrexed-cisplatin/gefitinib; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor.
Values are presented as number (%). ALT, alanine aminotransferase; AST, aspartate transaminase; TEAE, treatment-emergent adverse event. Events are maximum grade per National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE, ver. 3.0). Fatigue, hemorrhage, mucositis, pain, and skin rash are combined from some specific CTCAE terms.