A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Patients’ Characteristics
2.2. Definition of Inflammatory Nutritional Factors and Organ Function
2.3. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Comparison of OS and PFS between the Elderly and Non-Elderly Groups
3.3. Safety and Efficacy of Nal-IRI+5-FU/LV Therapy in Elderly and Non-Elderly Groups
3.4. ROC Curves Analysis for Identifying Eligible Cases in the Elderly Group
3.5. Distributions of CAR and NLR between Eligible and Ineligible Patients in the Elderly Group
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Elderly n = 32 (%) | Non-Elderly n = 53 (%) | p-Value |
---|---|---|---|
Age (years) | 78.5 (75–88) | 65 (48–74) | − |
Median [range] | |||
Sex | 17/15 (53/47) | 32/21 (60/40) | 0.65 |
Male/Female | |||
ECOG PS | 9/23 (28/72) | 20/33 (38/62) | 0.48 |
0/≥1 | |||
BMI | 20.3 (15.9–25.6) | 20.5 (13.7–35.1) | − |
Median [range] | |||
ALBI score | −2.38 (−2.90–−1.52) | −2.57 (−3.29–−1.17) | 0.02 |
Median [range] | |||
CCR | 52.5 (35.1–95.6) | 78.9 (26.4–175.2) | <0.01 |
Median [range] | |||
Location | 13/12/7 (41/38/21) | 29/16/8 (55/30/15) | 0.56 |
Head/body/tail | |||
Status | 7/25 (22/78) | 4/49 (7/93) | 0.09 |
Locally/recurrence or unresectable | |||
No. of metastatic site | 1.5 (0–4) | 2 (0–4) | 0.01 |
Median [range] | |||
Liver metastasis | 11/21 (34/66) | 35/18 (66/34) | 0.01 |
Yes/No | |||
Lung metastasis | 10/22 (31/69) | 19/34 (36/64) | 0.81 |
Yes/No | |||
Peritoneum metastasis | 12/20 (38/62) | 23/30 (43/57) | 0.65 |
Yes/No | |||
Ascites | 9/23 (28/72) | 22/31 (42/58) | 0.25 |
Yes/No | |||
No. of previous regimens | 23/9 (72/28) | 24/29 (45/55) | 0.02 |
1/≥2 | |||
Previous irinotecan regimen | 2/30 (6/94) | 18/35 (34/66) | <0.01 |
Yes/No | |||
Dose reduction at initiation | 15/17 (47/53) | 6/47 (11/89) | <0.01 |
Yes/No |
Elderly | Non-Elderly | |||||
---|---|---|---|---|---|---|
CTCAE Grade | p-Value | |||||
Any Grade (%) | Grade 3–4 (%) | Any Grade (%) | Grade 3–4 (%) | Any Grade (%) | Grade 3–4 (%) | |
Hematologic | ||||||
Neutropenia | 11 (34%) | 10 (31%) | 14 (26%) | 11 (21%) | 0.47 | 0.31 |
Anemia | 1 (3%) | 1 (3%) | 3 (6%) | 3 (6%) | 1.00 | 1.00 |
Platelet decreased | 1 (3%) | 0 | 1 (2%) | 1 (2%) | 1.00 | 1.00 |
Non-hematological | ||||||
Febrile neutropenia | 1 (3%) | 1 (3%) | 0 | 0 | 0.38 | 0.38 |
Anorexia | 11 (34%) | 0 | 12 (23%) | 1 (2%) | 0.31 | 1.00 |
Nausea | 3 (9%) | 0 | 10 (19%) | 0 | 0.35 | 1.00 |
Diarrhea | 11 (34%) | 1 (3%) | 12 (23%) | 1 (3%) | 0.31 | 1.00 |
Fatigue | 6 (18%) | 0 | 10 (19%) | 0 | 1.00 | 1.00 |
Edema | 0 | 0 | 2 (4%) | 0 | 0.52 | 1.00 |
Infusion reaction | 0 | 0 | 1 (2%) | 1 (2%) | 1.00 | 1.00 |
Infection | 0 | 0 | 1 (2%) | 0 | 1.00 | 1.00 |
AST/ALT Elevation | 0 | 0 | 3 (6%) | 1 (2%) | 0.29 | 1.00 |
Cholangitis | 1 (3%) | 0 | 1 (2%) | 1 (2%) | 1.00 | 1.00 |
Hypokalemia | 1 (3%) | 1 (3%) | 1 (2%) | 1 (2%) | 1.00 | 1.00 |
Hyponatremia | 1 (3%) | 1 (3%) | 2 (6%) | 0 | 1.00 | 0.38 |
Mucositis oral | 1 (3%) | 0 | 1 (2%) | 0 | 1.00 | 1.00 |
Constipation | 1 (3%) | 1 (3%) | 1 (2%) | 0 | 1.00 | 0.38 |
Hiccups | 1 (3%) | 0 | 0 | 0 | 0.38 | 1.00 |
Confusion | 1 (3%) | 1 (3%) | 0 | 0 | 0.38 | 0.38 |
Alopecia | 1 (3%) | 0 | 1 (2%) | 0 | 1.00 | 1.00 |
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Ikoma, T.; Matsumoto, T.; Boku, S.; Yasuda, T.; Masuda, M.; Ito, T.; Nakamaru, K.; Yamaki, S.; Nakayama, S.; Hashimoto, D.; et al. A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer. J. Clin. Med. 2023, 12, 3477. https://doi.org/10.3390/jcm12103477
Ikoma T, Matsumoto T, Boku S, Yasuda T, Masuda M, Ito T, Nakamaru K, Yamaki S, Nakayama S, Hashimoto D, et al. A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer. Journal of Clinical Medicine. 2023; 12(10):3477. https://doi.org/10.3390/jcm12103477
Chicago/Turabian StyleIkoma, Tatsuki, Toshihiko Matsumoto, Shogen Boku, Tomoyo Yasuda, Masataka Masuda, Takashi Ito, Koh Nakamaru, So Yamaki, Shinji Nakayama, Daisuke Hashimoto, and et al. 2023. "A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer" Journal of Clinical Medicine 12, no. 10: 3477. https://doi.org/10.3390/jcm12103477
APA StyleIkoma, T., Matsumoto, T., Boku, S., Yasuda, T., Masuda, M., Ito, T., Nakamaru, K., Yamaki, S., Nakayama, S., Hashimoto, D., Yamamoto, T., Shibata, N., Ikeura, T., Naganuma, M., Satoi, S., & Kurata, T. (2023). A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer. Journal of Clinical Medicine, 12(10), 3477. https://doi.org/10.3390/jcm12103477