Clinical Effect of the C-Reactive Protein to Serum Albumin Ratio in Patients with Metastatic Gastric or Gastroesophageal Junction Cancer Treated with Trifluridine/Tipiracil
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethical Approval
2.2. Patients
2.3. Assessment of Treatment Response and Adverse Events after FTD/TPI Therapy
2.4. Definition of CAR
2.5. Statistical Analyses
3. Results
3.1. Patients
3.2. Relationship between CAR and Clinicopathological Factors
3.3. Median OS and PFS Based on the CAR in Patients with mGC/GEJC Treated with FTD/TPI
3.4. Univariate and Multivariate Analyses of OS and PFS
3.5. Relationship between CAR and Treatment Response to FTD/TPI Therapy
3.6. Adverse Events of FTD/TPI Therapy in the High- and Low-CAR Groups
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables | All Patients (n = 64) | CAR | p-Value | |
---|---|---|---|---|
Low (n = 27) | High (n = 37) | |||
Age | <65 | 10 (37.0) | 16 (43.2) | 0.797 |
≧65 | 17 (63.0) | 21 (56.8) | ||
Sex | Male | 11 (40.7) | 12 (32.4) | 0.600 |
Female | 16 (59.3) | 25 (67.6) | ||
ECOG PS | 0 | 20 (74.1) | 15 (40.5) | 0.022 |
1 | 6 (22.2) | 19 (51.4) | ||
2 | 1 (3.7) | 3 (8.1) | ||
Histological type | Intestinal | 12 (44.4) | 19 (51.4) | 0.621 |
Diffuse | 15 (55.6) | 18 (48.6) | ||
HER2 status | Negative | 24 (88.9) | 33 (89.2) | 1.000 |
Positive | 3 (11.1) | 4 (10.8) | ||
Macroscopic classification | Non-type 4 | 25 (92.6) | 27 (73.0) | 0.058 |
Type 4 | 2 (7.4) | 10 (27.0) | ||
Primary tumor site | GC | 21 (77.8) | 29 (78.4) | 1.000 |
EGJC | 6 (22.2) | 8 (21.6) | ||
Disease status | Unresectable | 12 (44.4) | 25 (67.6) | 0.078 |
Recurrence | 15 (55.6) | 12 (32.4) | ||
Peritoneal metastasis | − | 16 (59.3) | 14 (37.8) | 0.129 |
+ | 11 (40.7) | 23 (62.2) | ||
Hematogenous metastasis | − | 12 (44.4) | 20 (54.1) | 0.613 |
+ | 15 (55.6) | 17 (45.9) | ||
Lymphatic metastasis | − | 15 (55.6) | 22 (59.5) | 0.802 |
+ | 12 (44.4) | 15 (40.5) | ||
Number of metastatic sites | 1 | 16 (59.3) | 18 (48.6) | 0.454 |
≧2 | 11 (40.7) | 19 (51.4) | ||
Number of previous regimens | 2 | 20 (74.1) | 30 (81.1) | 0.551 |
≧3 | 7 (25.9) | 7 (18.9) | ||
Previous ICI administered | − | 10 (37.0) | 14 (37.8) | 1.000 |
+ | 17 (63.0) | 23 (62.2) | ||
Number of FTD/TPI | 1 | 5 (18.5) | 18 (48.6) | 0.018 |
≧2 | 22 (81.5) | 19 (51.4) | ||
Post-FTD/TPI therapy | − | 12 (44.4) | 30 (81.1) | 0.004 |
+ | 13 (48.1) | 7 (18.9) | ||
FTD/TPI ongoing | 2 (7.4) | 0 (0.0) |
Factors | Univariate | p-Value | Multivariate | p-Value | |||
---|---|---|---|---|---|---|---|
HR | 95% CI | HR | 95% CI | ||||
Age | <65 | 1 | |||||
≧65 | 0.74 | 0.41–1.32 | 0.30 | ||||
Sex | Male | 1 | |||||
Female | 0.62 | 0.34–1.13 | 0.12 | ||||
ECOG PS | 0 | 1 | 1 | ||||
1, 2 | 1.83 | 1.02–3.29 | 0.04 | 1.32 | 0.72–2.43 | 0.37 | |
HER2 status | Negative | 1 | |||||
Positive | 0.76 | 0.27–2.13 | 0.60 | ||||
Disease status | Recurrence | 1 | |||||
Unresectable | 0.67 | 0.37–1.23 | 0.20 | ||||
Peritoneal metastasis | - | 1 | 1 | ||||
+ | 2.57 | 1.37–4.82 | 0.003 | 1.51 | 0.76–2.98 | 0.24 | |
No. of previous regimens | 3 | 1 | |||||
≧4 | 0.90 | 0.43–1.87 | 0.77 | ||||
CAR | Low | 1 | 1 | ||||
High | 4.48 | 2.24–8.97 | <0.001 | 3.56 | 1.67–7.55 | <0.001 |
Factors | Univariate | p-Value | Multivariate | p-Value | |||
---|---|---|---|---|---|---|---|
HR | 95% CI | HR | 95% CI | ||||
Age | <65 | 1 | |||||
≧65 | 0.68 | 0.40–1.16 | 0.16 | ||||
Sex | Male | 1 | |||||
Female | 0.66 | 0.39–1.13 | 0.13 | ||||
ECOG PS | 0 | 1 | |||||
1, 2 | 1.56 | 0.92–2.65 | 0.10 | ||||
HER2 status | Negative | 1 | |||||
Positive | 1.37 | 0.61–3.07 | 0.44 | ||||
Disease status | Recurrence | 1 | |||||
Unresectable | 0.78 | 0.45–1.33 | 0.36 | ||||
Peritoneal metastasis | - | 1 | 1 | ||||
+ | 1.78 | 1.04–3.05 | 0.04 | 1.28 | 0.72–2.28 | 0.41 | |
No. of previous regimens | 3 | 1 | |||||
≧4 | 0.80 | 0.42–1.51 | 0.49 | ||||
CAR | Low | 1 | 1 | ||||
High | 2.67 | 1.53–4.66 | <0.001 | 2.42 | 1.33–4.41 | 0.004 |
Tumor Response Data | Low-CAR (n = 27) | High-CAR (n = 37) | p-Value |
---|---|---|---|
Best response | |||
Complete response (CR) | 2 (7.4) | 0 (0.0) | 0.18 |
Partial response (PR) | 4 (14.8) | 2 (5.4) | |
Stable disease (SD) | 8 (29.6) | 8 (21.6) | |
Progressive disease (PD) | 12 (44.4) | 25 (67.6) | |
Not evaluated (NE) | 1 (3.7) | 2 (5.4) | |
Overall response rate (ORR) | 6 (22.2) | 2 (5.4) | 0.07 |
Disease control rate (DCR) | 14 (51.9) | 10 (27.0) | 0.06 |
Low-CAR (n = 27) | High-CAR (n = 37) | p-Value | |
---|---|---|---|
Total adverse events | 22 (81.5) | 29 (78.4) | 1.000 |
Anorexia | 9 (33.3) | 17 (45.9) | 0.440 |
Decreased neutrophil count | 14 (51.9) | 7 (18.9) | 0.008 |
Fatigue | 0 (0.0) | 9 (24.3) | 0.008 |
Diarrhea | 1 (3.7) | 3 (8.1) | 0.632 |
Decreased platelet count | 1 (3.7) | 1 (2.7) | 1.000 |
Anemia | 0 (0.0) | 1 (2.7) | 1.000 |
Biliary tract infection | 0 (0.0) | 1 (2.7) | 1.000 |
Febrile neutropenia | 1 (3.7) | 0 (0.0) | 0.422 |
Hyponatremia | 1 (3.7) | 0 (0.0) | 0.422 |
Myalgia | 0 (0.0) | 1 (2.7) | 1.000 |
Peripheral sensory neuropathy | 0 (0.0) | 1 (2.7) | 1.000 |
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Hashimoto, I.; Kano, K.; Onuma, S.; Suematsu, H.; Nagasawa, S.; Kanematsu, K.; Furusawa, K.; Hamaguchi, T.; Watanabe, M.; Hayashi, K.; et al. Clinical Effect of the C-Reactive Protein to Serum Albumin Ratio in Patients with Metastatic Gastric or Gastroesophageal Junction Cancer Treated with Trifluridine/Tipiracil. J. Pers. Med. 2023, 13, 923. https://doi.org/10.3390/jpm13060923
Hashimoto I, Kano K, Onuma S, Suematsu H, Nagasawa S, Kanematsu K, Furusawa K, Hamaguchi T, Watanabe M, Hayashi K, et al. Clinical Effect of the C-Reactive Protein to Serum Albumin Ratio in Patients with Metastatic Gastric or Gastroesophageal Junction Cancer Treated with Trifluridine/Tipiracil. Journal of Personalized Medicine. 2023; 13(6):923. https://doi.org/10.3390/jpm13060923
Chicago/Turabian StyleHashimoto, Itaru, Kazuki Kano, Shizune Onuma, Hideaki Suematsu, Shinsuke Nagasawa, Kyohei Kanematsu, Kyoko Furusawa, Tomomi Hamaguchi, Mamoru Watanabe, Kei Hayashi, and et al. 2023. "Clinical Effect of the C-Reactive Protein to Serum Albumin Ratio in Patients with Metastatic Gastric or Gastroesophageal Junction Cancer Treated with Trifluridine/Tipiracil" Journal of Personalized Medicine 13, no. 6: 923. https://doi.org/10.3390/jpm13060923