1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Division of Hematology-Oncology, Department of Medicine, Ewha Womans University School of Medicine, Seoul, Korea
3Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Copyright © 2022 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/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Ethical Statement
This study was reviewed and approved by our institutional review board (IRB number: 2013-07-149) (ClinicalTrial.gov Identifier: NCT05008237). All patients provided written informed consent before enrollment in accordance with the Declaration of Helsinki.
Author Contributions
Conceived and designed the analysis: Lee SJ, Ahn MJ.
Collected the data: Kim HR, Lee SJ, Park S, Jung HA, Lee SH, Jeong HS, Chung MK, Ahn MJ.
Contributed data or analysis tools: Kim HR, Lee SJ, Park S, Jung HA, Lee SH, Jeong HS, Chung MK, Ahn MJ.
Performed the analysis: Kim HR.
Wrote the paper: Kim HR, Ahn MJ.
Conflicts of Interest
This study was supported in part by Dong-A pharmaceutical company.
Characteristic | No. (%) (n=41) |
---|---|
Age, median (range, yr) | 58 (32–73) |
Sex | |
Male | 24 (58.5) |
Female | 17 (41.5) |
ECOG PS | |
0 | 1 (2.4) |
1 | 40 (97.6) |
Primary site of cancer | |
Salivary gland | 32 (78.0) |
Trachea | 2 (4.9) |
Nasal cavity | 2 (4.9) |
Oral cavity | 2 (4.9) |
Lacrimal glanda) | 2 (4.9) |
Eyelid | 1 (2.4) |
Histology | |
Adenoid cystic carcinoma | 26 (63.4) |
Adenocarcinoma | 3 (7.3) |
Ductal carcinoma | 10 (24.4) |
Mucoepidermoid carcinoma | 1 (2.4) |
Non-keratinizing squamous cell carcinomaa) | 1 (2.4) |
Site of metastasis | |
Lung | 31 (75.6) |
Liver | 4 (9.8) |
Bone | 6 (14.6) |
Kidney | 2 (4.9) |
Skin | 2 (4.9) |
Brain | 1 (2.4) |
Esophagus | 1 (2.4) |
Stomach | 1 (2.4) |
Regional lymph nodes | 6 (14.6) |
Distant lymph nodes | 4 (9.8) |
Previous treatment | |
Yes | 39 (95.1) |
Surgery | 36 (87.8) |
Radiation | 32 (78.0) |
Concurrent chemoradiotherapy | 4 (9.8) |
Systemic chemotherapyb) | 5 (12.2) |
No | 2 (4.9) |
EGOG PS, Eastern Cooperative Oncology Group performance status.
a) The disease was confirmed in the lacrimal gland biopsy, and no other suggestive primary lesions were found in systemic workup or follow-up; So, it was finally determined as lacrimal gland origin squamous cell carcinoma,
b) One neoadjuvant, two adjuvant, and two palliative chemotherapies, which were completed more than 6 months prior to study entry.
Best response | Total patients (n=41) | Histological subtypes | |
---|---|---|---|
ACC (n=26) | Other subtypes (n=15) | ||
CR | 3 (7.3) | 1 (3.8) | 2 (13.3)a) |
PR | 16 (39.0) | 5 (19.2) | 11 (73.3) |
ORR | 19 (46.3) | 6 (23.1) | 13 (86.6) |
SD | 22 (53.7) | 20 (76.9) | 2 (13.3) |
PD | - | - | - |
Characteristics of eligible patients
Characteristic | No. (%) (n=41) |
---|---|
Age, median (range, yr) | 58 (32–73) |
Sex | |
Male | 24 (58.5) |
Female | 17 (41.5) |
ECOG PS | |
0 | 1 (2.4) |
1 | 40 (97.6) |
Primary site of cancer | |
Salivary gland | 32 (78.0) |
Trachea | 2 (4.9) |
Nasal cavity | 2 (4.9) |
Oral cavity | 2 (4.9) |
Lacrimal gland |
2 (4.9) |
Eyelid | 1 (2.4) |
Histology | |
Adenoid cystic carcinoma | 26 (63.4) |
Adenocarcinoma | 3 (7.3) |
Ductal carcinoma | 10 (24.4) |
Mucoepidermoid carcinoma | 1 (2.4) |
Non-keratinizing squamous cell carcinoma |
1 (2.4) |
Site of metastasis | |
Lung | 31 (75.6) |
Liver | 4 (9.8) |
Bone | 6 (14.6) |
Kidney | 2 (4.9) |
Skin | 2 (4.9) |
Brain | 1 (2.4) |
Esophagus | 1 (2.4) |
Stomach | 1 (2.4) |
Regional lymph nodes | 6 (14.6) |
Distant lymph nodes | 4 (9.8) |
Previous treatment | |
Yes | 39 (95.1) |
Surgery | 36 (87.8) |
Radiation | 32 (78.0) |
Concurrent chemoradiotherapy | 4 (9.8) |
Systemic chemotherapy |
5 (12.2) |
No | 2 (4.9) |
EGOG PS, Eastern Cooperative Oncology Group performance status.
a)The disease was confirmed in the lacrimal gland biopsy, and no other suggestive primary lesions were found in systemic workup or follow-up; So, it was finally determined as lacrimal gland origin squamous cell carcinoma,
b)One neoadjuvant, two adjuvant, and two palliative chemotherapies, which were completed more than 6 months prior to study entry.
Best response rates
Best response | Total patients (n=41) | Histological subtypes | |
---|---|---|---|
ACC (n=26) | Other subtypes (n=15) | ||
CR | 3 (7.3) | 1 (3.8) | 2 (13.3) |
PR | 16 (39.0) | 5 (19.2) | 11 (73.3) |
ORR | 19 (46.3) | 6 (23.1) | 13 (86.6) |
SD | 22 (53.7) | 20 (76.9) | 2 (13.3) |
PD | - | - | - |
Values are presented as number (%). ACC, adenoid cystic carcinoma; CR, complete response; −, non-evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
a)1 of mucoepidermoid carcinoma and 1 of non-keratinizing squamous cell carcinoma.
Adverse events for all patients
Adverse events | Any grade | Grade 3/4 |
---|---|---|
Neutropenia | 11 (26.9) | 2 (4.9) |
Anemia | 4 (9.8) | - |
Elevated AST | 1 (2.4) | 1 (2.4) |
Elevated ALT | 1 (2.4) | 1 (2.4) |
Hypomagnesemia | 2 (4.9) | - |
Fatigue | 8 (19.5) | 2 (4.9) |
Myalgia | 4 (9.8) | - |
Weight gain | 1 (2.4) | - |
Weight loss | 1 (2.4) | - |
Edema | 2 (4.9) | - |
Parotid gland swelling | 1 (2.4) | - |
Soft tissue swelling | 1 (2.4) | - |
Mucositis | 8 (19.5) | 1 (2.4) |
Anorexia | 18 (43.9) | 1 (2.4) |
Nausea | 7 (17.1) | 1 (2.4) |
Vomiting | 4 (9.8) | 1 (2.4) |
Diarrhea | 13 (31.7) | - |
Constipation | 2 (4.9) | - |
Epigastric soreness | 4 (9.8) | - |
Fever | 1 (2.4) | - |
Cough | 3 (7.3) | - |
Sputum | 1 (2.4) | - |
Rhinorrhea | 1 (2.4) | - |
Upper respiratory infection | 2 (4.9) | - |
Pneumonia | 1 (2.4) | - |
Cellulitis | 1 (2.4) | - |
Enterocolitis | 1 (2.4) | 1 (2.4) |
Insomnia | 1 (2.4) | - |
Hiccups | 1 (2.4) | - |
Hypersensitivity reaction | 7 (17.1) | - |
Pain | 4 (9.8) | 1 (2.4) |
Sensory neuropathy | 10 (24.4) | - |
Facial numbness | 1 (2.4) | - |
Nail change | 1 (2.4) | - |
Depigmentation | 1 (2.4) | - |
Alopecia | 25 (61.0) | - |
Dizziness | 2 (4.9) | - |
Pruritis | 1 (2.4) | - |
Onychodystrophy | 1 (2.4) | - |
Hard palate perforation | 1 (2.4) | - |
Nose order | 1 (2.4) | - |
Values are presented as number (%). ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Adverse events leading to treatment delay or dose reduction
Adverse events | Treatment delay (n=16) | Dose reduction (n=14) | ||
---|---|---|---|---|
|
| |||
Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
Neutropenia | 8 (19.5) | 1 (2.4) | 1 (2.4) | - |
| ||||
Fatigue | 3 (7.3) | 1 (2.4) | 1 (2.4) | 1 (2.4) |
| ||||
Hypersensitivity | 1 (2.4) | - | - | - |
| ||||
Anorexia | 3 (7.3) | 1 (2.4) | 2 (4.9) | 1 (2.4) |
| ||||
Vomiting | 3 (7.3) | 1 (2.4) | 2 (4.9) | 1 (2.4) |
| ||||
Diarrhea | 1 (2.4) | - | 3 (7.3) | - |
| ||||
Mucositis | 1 (2.4) | - | 3 (7.3) | 1 (2.4) |
| ||||
Cellulitis | 1 (2.4) | - | - | - |
| ||||
Enterocolitis | - | - | 1 (2.4) | 1 (2.4) |
| ||||
Soft tissue swelling | 1 (2.4) | - | - | - |
| ||||
Abdominal pain | - | - | 1 (2.4) | - |
| ||||
Neuropathy | - | - | 1 (2.4) | - |
| ||||
Myalgia | - | - | 1 (2.4) | - |
Values are presented as number (%).
EGOG PS, Eastern Cooperative Oncology Group performance status. The disease was confirmed in the lacrimal gland biopsy, and no other suggestive primary lesions were found in systemic workup or follow-up; So, it was finally determined as lacrimal gland origin squamous cell carcinoma, One neoadjuvant, two adjuvant, and two palliative chemotherapies, which were completed more than 6 months prior to study entry.
Values are presented as number (%). ACC, adenoid cystic carcinoma; CR, complete response; −, non-evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease. 1 of mucoepidermoid carcinoma and 1 of non-keratinizing squamous cell carcinoma.
Values are presented as number (%). ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Values are presented as number (%).