Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Patients
2.2. NAC
2.3. Data Collection
2.4. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. NAC
3.3. AEs
3.4. Perioperative and Postoperative Outcomes
3.5. Survival Outcomes
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A. G8 Screening Tool
Items | Score | |
---|---|---|
1 | Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing, or swallowing difficulties? | 0 = severe decrease in food intake |
1 = moderate decrease in food intake | ||
2 = no decrease in food intake | ||
2 | Weight loss during the last 3 months? | 0 = weight loss >3 kg |
1 = does not know | ||
2 = weight loss between 1 and 3 kg | ||
3 = no weight loss | ||
3 | Mobility | 0 = bed or chair bound |
1 = able to get out of bed/chair but does not go out | ||
2 = goes out | ||
4 | Neuropsychological problems | 0 = severe dementia or depression |
1 = mild dementia or depression | ||
2 = no psychological problems | ||
5 | BMI | 0 = BMI <19 |
1 = BMI 19 to <21 | ||
2 = BMI 21 to <23 | ||
3 = BMI ≥ 23 | ||
6 | Takes more than three mediations per day? | 0 = yes |
1 = no | ||
7 | In comparison with other people of the same age, how does the patient consider his/her health status? | 0 = not as good |
0.5 = does not know | ||
1 = as good | ||
2 = better | ||
8 | Age | 0: >85 |
1: 80–85 | ||
2: <80 | ||
Total Score | 0–17 |
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Factors | Age ≥ 75 Years (n = 23) | Age < 75 Years (n = 39) | p-Value |
---|---|---|---|
Age (years) | 79 (75–82) | 67 (37–74) | <0.0001 |
Sex (Male) | 12 (52) | 23 (59) | 0.7913 |
ASA-PS | 0.2383 | ||
1 | 0 | 4 (10) | |
2 | 18 (78) | 25 (64) | |
3 | 5 (22) | 10 (26) | |
BMI (kg/m2) | 21 (16–26) | 22 (15–32) | 0.1101 |
CCI | 0.9125 | ||
0 | 6 (26) | 12 (31) | |
1 | 9 (39) | 15 (38) | |
>2 | 8 (35) | 12 (31) | |
G8 score | 0.3957 | ||
<14 | 18 (78) | 26 (67) | |
>14 | 5 (22) | 13 (33) | |
Tumor location | 0.1164 | ||
Head | 9 (39) | 24 (62) | |
Body/tail | 14 (61) | 15 (38) | |
Resectability status | 0.5082 | ||
R | 20 (87) | 30 (77) | |
BR | 3 (13) | 9 (23) | |
Initial tumor size (mm) | 24 (13–44) | 23 (11–57) | 0.9509 |
Initial CA19-9 (U/mL) | 81 (2–4701) | 281 (2–19072) | 0.4493 |
Initial SUV-max | 5 (1.6–14.5) | 5.5 (1.6–12.7) | 0.9625 |
UGT1A1 | 0.7406 | ||
Wild | 12 (52) | 20 (51) | |
6 hetero/28 hetero | 11 (48) | 18 (46) | |
6 homo | 0 (0) | 1 (3) |
Age ≥ 75 Years (n = 23) | Age < 75 Years (n = 39) | p-Value | |
---|---|---|---|
Completion of NAC | 17 (74) | 30 (77) | >0.9999 |
Dose reduction | 21 (91) | 28 (72) | 0.1063 |
ARDI | 65.3 (44.3–100.0) | 77.0 (45.2–100.0) | 0.0665 |
Surgical resection feasible | 20 (87) | 29 (74) | 0.3381 |
Reason for not undergoing surgical resection | 0.7008 | ||
Disease progression | 2 (9) | 7 (18) | |
Poor general condition | 0 (0) | 1 (3) | |
Adverse event | 0 (0) | 1 (3) | |
Others | 1 (4) | 1 (3) |
Age ≥ 75 Years (n = 23) | Age < 75 Years (n = 39) | p-Value | ||||
---|---|---|---|---|---|---|
Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | |
Neutropenia | 18 (78) | 11 (48) | 26 (67) | 18 (46) | 0.3957 | >0.9999 |
Anemia | 21 (91) | 0 (0) | 32 (82) | 2 (5) | 0.4639 | 0.5256 |
Thrombocytopenia | 16 (70) | 0 (0) | 28 (72) | 2 (5) | >0.9999 | 0.5256 |
Febrile neutropenia | 1 (4) | 1 (4) | 1 (3) | 1 (3) | >0.9999 | >0.9999 |
AST increased | 5 (22) | 0 (0) | 21 (54) | 2 (5) | 0.0173 | 0.5256 |
ALT increased | 7 (30) | 0 (0) | 23 (59) | 2 (5) | 0.0378 | 0.5256 |
Creatinine increased | 2 (9) | 0 ( 0) | 2 (5) | 2 (5) | 0.6232 | 0.5256 |
Fatigue | 10 (43) | 2 (9) | 23 (59) | 1 (3) | 0.2962 | 0.5494 |
Nausea | 6 (26) | 0 (0) | 23 (59) | 2 (5) | 0.0177 | 0.5256 |
Biliary tract infection | 0 (0) | 0 (0) | 4 (10) | 4 (10) | 0.2871 | 0.2871 |
Diarrhea | 8 (35) | 2 (9) | 13 (33) | 2 (5) | >0.9999 | 0.6232 |
Stomatitis | 3 (13) | 0 (0) | 7 (18) | 0 (0) | 0.7313 | >0.9999 |
Sensory neuropathy | 8 (35) | 0 (0) | 21 (54) | 0 (0) | 0.1910 | >0.9999 |
Pneumonitis | 0 (0) | 0 (0) | 1 (3) | 1 (3) | >0.9999 | >0.9999 |
Age ≥ 75 Years (n = 20) | Age < 75 Years (n = 29) | p-Value | |
---|---|---|---|
Operative procedure | 0.4981 | ||
PD | 9 (45) | 18 (62) | |
DP | 10 (50) | 10 (34) | |
TP | 1 (5) | 1 (3) | |
Vascular resection | 2 (10) | 3 (10) | >0.9999 |
Operation time (min) | 451 (280–850) | 523 (273–805) | 0.2447 |
Blood loss (mL) | 340 (25–2800) | 475 (10–4450) | 0.3098 |
pT stage | 0.7145 | ||
0 | 1 (5) | 0 (0) | |
1 | 11 (55) | 19 (66) | |
2 | 8 (40) | 8 (28) | |
3 | 0 (0) | 2 (7) | |
pN1 | 9 (45) | 6 (21) | 0.1142 |
R0 resection | 18 (90) | 25 (86) | >0.9999 |
Clavien–Dindo ≥ IIIA | 7 (35) | 16 (55) | 0.2450 |
POPF of ≥grade B | 3 (15) | 6 (21) | 0.7199 |
DGE of ≥grade B | 1 (5) | 2 (7) | >0.9999 |
Mortality | 0 (0) | 0 (0) | >0.9999 |
Postoperative hospital stay (days) | 19 (10–79) | 24 (10–70) | 0.3496 |
Adjuvant chemotherapy | 18 (90) | 27 (93) | >0.9999 |
Univariate Analysis | p-Value | Multivariate Analysis | p-Value | |||
---|---|---|---|---|---|---|
HR | 95% CI | HR | 95% CI | |||
Age (≥75 vs. <75 years) | 1.155 | 0.593–2.248 | 0.6723 | 1.247 | 0.608–2.556 | 0.5475 |
Sex (male vs. female) | 1.307 | 0.658–2.593 | 0.4443 | |||
ASA-PS (3 vs. 1/2) | 1.678 | 0.803–3.508 | 0.1687 | 3.515 | 1.422–8.691 | 0.0065 |
BMI (<22 vs. ≥22) | 1.182 | 0.613–2.277 | 0.6178 | |||
CCI (≥2 vs. <2) | 1.620 | 0.831–3.160 | 0.1566 | |||
G8 (≤14 vs. >14) | 1.586 | 0.722–3.482 | 0.2507 | |||
Tumor location (Head vs. Body/tail) | 1.404 | 0.721–2.733 | 0.3183 | |||
Resectability status (BR vs. R) | 2.663 | 1.198–5.923 | 0.0163 | |||
Initial tumor size (≥20 vs. <20 mm) | 1.442 | 0.677–3.073 | 0.3430 | |||
Initial CA19-9 (≥37 vs. <37 U/mL) | 1.855 | 0.843–4.085 | 0.1247 | 2.302 | 0.936–5.661 | 0.0695 |
Initial SUV-max (≥5 vs. <5) | 1.709 | 0.880–3.319 | 0.1137 | |||
Completion of NAC (no vs. yes) | 1.918 | 0.906–4.062 | 0.0887 | |||
Dose reduction (no vs. yes) | 1.044 | 0.456–2.388 | 0.9195 | |||
ARDI (≤70 vs. >70) | 1.585 | 0.818–3.073 | 0.1725 | |||
Surgical resection feasible (no vs. yes) | 14.603 | 5.910–36.089 | <0.0001 | 26.878 | 7.955–90.819 | <0.0001 |
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Share and Cite
Shindo, Y.; Ioka, T.; Tokumitsu, Y.; Matsui, H.; Nakajima, M.; Kimura, Y.; Watanabe, Y.; Tomochika, S.; Nakagami, Y.; Tsunedomi, R.; et al. Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer. Cancers 2024, 16, 2522. https://doi.org/10.3390/cancers16142522
Shindo Y, Ioka T, Tokumitsu Y, Matsui H, Nakajima M, Kimura Y, Watanabe Y, Tomochika S, Nakagami Y, Tsunedomi R, et al. Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer. Cancers. 2024; 16(14):2522. https://doi.org/10.3390/cancers16142522
Chicago/Turabian StyleShindo, Yoshitaro, Tatsuya Ioka, Yukio Tokumitsu, Hiroto Matsui, Masao Nakajima, Yuta Kimura, Yusaku Watanabe, Shinobu Tomochika, Yuki Nakagami, Ryouichi Tsunedomi, and et al. 2024. "Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer" Cancers 16, no. 14: 2522. https://doi.org/10.3390/cancers16142522
APA StyleShindo, Y., Ioka, T., Tokumitsu, Y., Matsui, H., Nakajima, M., Kimura, Y., Watanabe, Y., Tomochika, S., Nakagami, Y., Tsunedomi, R., Iida, M., Takahashi, H., & Nagano, H. (2024). Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer. Cancers, 16(14), 2522. https://doi.org/10.3390/cancers16142522