1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
3Division of Medical Oncology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
4Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
5Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
6Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
7Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
8Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Copyright © 2020 by the Korean Cancer Association
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Avelumab was kindly provided by Merck Korea, Seoul, Korea; an affiliate of Merck KGaA, Darmstadt, Germany, as part of an alliance between Merck KGaA and Pfizer. Merck KGaA, Darmstadt, Germany and Pfizer reviewed the manuscript for medical accuracy only before journal submission.
Response |
All patients (n=33) |
MSI high by PCR or NGS (n=21) |
||
---|---|---|---|---|
No. (%) | 95% CI (%) | No. (%) | 95% CI (%) | |
Complete response | 4 (12.1) | 0.97-23.2 | 3 (14.3) | 0-29.3 |
Partial response | 4 (12.1) | 0.97-23.2 | 3 (14.3) | 0-29.3 |
Stable disease | 18 (54.5) | 37.5-71.5 | 13 (61.9) | 41.1-82.7 |
Progressive disease | 6 (18.2) | 5.0-31.4 | 2 (9.5) | 0-22.0 |
Not assessablea) | 1 (3.0) | 0-8.8 | 0 | - |
Objective response rate | 8 (24.2) | 9.4-38.6 | 6 (28.6) | 9.3-47.9 |
Disease control rate | 26 (78.8) | 64.9-92.7 | 19 (90.5) | 77.9-103 |
Emerging Role of Immunotherapy for Colorectal Cancer with Liver Metastasis
Characteristic | No. (%) |
---|---|
Age, median (range, yr) | 60 (25-88) |
Sex | |
Male | 26 (78.8) |
Female | 7 (21.2) |
ECOG performance status | |
0 | 10 (30.3) |
1 | 23 (69.7) |
Primary tumor | |
Right-sided colon | 22 (66.7) |
Left-sided colon | 5 (15.2) |
Rectum | 6 (18.2) |
Histology | |
Well differentiated | 6 (18.2) |
Moderately differentiated | 19 (57.6) |
Poorly differentiated | 5 (15.2) |
Notassessable | 3 (9.1) |
RAS status | |
Wild | 11 (33.3) |
Mutant | 20 (60.6) |
Not done | 2 (6.1) |
BRAF status | |
Wild | 22 (66.7) |
Mutant | 4 (12.1) |
Not done | 7 (21.2) |
Sites of metastasis | |
Liver | 15 (45.5) |
Lung | 11 (33.3) |
Lymph node, abdomen | 20 (60.6) |
Peritoneum/Omentum | 9 (27.3) |
Bone | 2 (6.1) |
Family history of cancer in any first-degree relative | 7 (21.2) |
Previous chemotherapy regimen | |
FOLFOX | 24 (72.7) |
FOLFIRI | 15 (45.5) |
XELOX | 4 (12.1) |
Capecitabine | 10 (30.3) |
Others | 2 (6.1) |
Previous targeted treatment | |
Bevacizuamb | 25 (75.8) |
Cetuximab | 2 (6.1) |
Prior radiotherapy | 7 (21.2) |
Prior surgery | |
Primary site resection | 31 (93.9) |
Metastasectomy | 9 (27.3) |
Prior lines of therapy | |
1 | 16 (48.5) |
2 | 11 (33.3) |
≥ 3 | 6 (18.2) |
Response | All patients (n=33) |
MSI high by PCR or NGS (n=21) |
||
---|---|---|---|---|
No. (%) | 95% CI (%) | No. (%) | 95% CI (%) | |
Complete response | 4 (12.1) | 0.97-23.2 | 3 (14.3) | 0-29.3 |
Partial response | 4 (12.1) | 0.97-23.2 | 3 (14.3) | 0-29.3 |
Stable disease | 18 (54.5) | 37.5-71.5 | 13 (61.9) | 41.1-82.7 |
Progressive disease | 6 (18.2) | 5.0-31.4 | 2 (9.5) | 0-22.0 |
Not assessable |
1 (3.0) | 0-8.8 | 0 | - |
Objective response rate | 8 (24.2) | 9.4-38.6 | 6 (28.6) | 9.3-47.9 |
Disease control rate | 26 (78.8) | 64.9-92.7 | 19 (90.5) | 77.9-103 |
Event | All patients (n=33, 100%) |
|
---|---|---|
Any grade | Grade ≥ 3 | |
Any TRAE | 24 (72.7) | 6 (18.2) |
Myalgia | 6 (18.2) | 0 |
Chills | 5 (15.2) | 0 |
Infusion-related reaction | 5 (15.2) | 0 |
Pruritus | 5 (15.2) | 0 |
Thyroid dysfunction | 4 (12.1) | 0 |
Skin rash | 4 (12.1) | 0 |
Diarrhea | 3 (9.1) | 2 (6.1) |
Fever | 3 (9.1) | 0 |
Increased AST or ALT | 3 (9.1) | 0 |
Hypomagnesemia | 3 (9.1) | 0 |
Fatigue | 2 (6.1) | 0 |
Anorexia | 2 (6.1) | 0 |
Hyperglycemia | 2 (6.1) | 1 (3.0) |
Increased amylase or lipase | 1 (3.0) | 2 (6.1) |
Nausea | 1 (3.0) | 0 |
Sweating | 1 (3.0) | 0 |
Dry skin | 1 (3.0) | 0 |
Anemia | 1 (3.0) | 0 |
Hyperbilirubinemia | 0 (0.0) | 1 (3.0) |
ECOG, Eastern Cooperative Oncology Group; FOLFOX, 5-fluorouracil, leucovorin, and oxaliplatin; FOLFIRI, 5-fluorouracil, leucovorin, and irinotecan; XELOX, capecitabine and oxaliplatin.
MSI, microsatellite instability; PCR, polymerase chain reaction; NGS, next-generation sequencing. Lost to follow-up (n=1).
Values are presented as number (%). TRAE, treatment-related adverse event; AST, aspartate aminotransferase; ALT, alanine aminotransferase.