Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection?
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Patient Characteristics
3.2. Neoadjuvant Treatment
3.3. Surgical Procedure
3.4. Side Effects and Complications
3.5. Effect of Preoperative Therapy
3.6. Overall Survival
3.7. Predictors of Overall Survival
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Baseline Characteristics (n = 40) | |||||
---|---|---|---|---|---|
Age | |||||
Mean | 60.6 (37–82) years | ||||
Gender | |||||
Male | 22 (55.0%) pts | ||||
Female | 18 (45.0%) pts | ||||
Primary Localization | |||||
Head | 21 (52.5%) pts | ||||
Korpus | 13 (32.5%) pts | ||||
Tail | 6 (15%) pts | ||||
At Diagnosis | After Induction/Before Resection | ||||
N | % | N | % | p | |
ECOG | 0.03 | ||||
0 | 22 | 66.7 | 10 | 37 | |
1 | 10 | 30.3 | 12 | 44.4 | |
2 | 1 | 3 | 5 | 18.5 | |
n.a. | 7 | 13 | |||
ASA Score | |||||
1 | 2 | 5.7 | |||
2 | 15 | 42.9 | |||
3 | 18 | 51.4 | |||
n.a. | 5 | ||||
BMI [kg/m2] | Median 23.9 (17.2–28.7) | Median 22.6 (16.8–29.9) | |||
<18.5 | 1 | 3.7 | 1 | 2.9 | 0.25 |
18.5–24.9 | 18 | 66.7 | 23 | 67.6 | |
≥25 | 8 | 29.6 | 10 | 29.4 | |
n.a. | 13 | 6 |
Parameter | Category | N | % |
---|---|---|---|
Induction Therapy | |||
FOLFIRINOX | 23 | 57.5 | |
Nab-Paclitaxel/Gemcitabine | 7 | 17.5 | |
FOLFIRINOX ► Nab-Pac/Gem | 8 | 20 | |
Gemcitabine mono | 1 | 2.5 | |
Cisplatin/Capecitabine | 1 | 2.5 | |
Number of Applications | |||
Median | 8 (3–25) | ||
≥8 Applications | 20 | 51.3 | |
<8 Applications | 19 | 48.7 | |
n.a. | 1 | ||
Duration of neoadjuvant Therapy | |||
Median (months) | 3 (1–24) | ||
>3 months | 18 | 48.6 | |
≤3 months | 19 | 51.4 | |
n.a. | 3 | ||
Adjuvant Therapy | |||
Yes | 15 | 75 | |
No | 5 | 25 | |
n.a. | 20 | ||
Surgical Procedure | |||
PPPD | 16 | 40 | |
Whipple’s Procedure | 2 | 5 | |
Distal pancreatectomy | 13 | 32.5 | |
Total pancreatectomy | 9 | 22.5 | |
Additional resection | |||
Splenectomy | 19 | 47.5 | |
Gastrectomy (total/partial) | 2 | 5 | |
Partial hepatectomy | 3 | 7.5 | |
Resection of portal vein | 7 | 17.5 | |
Resection coeliac axis | 4 | 10 | |
Hemicolectomy | 1 | 2.5 | |
Post Op-Complications | |||
BDA-Insufficiency | 26 | 65 | |
Pancreatic fistula | 5 | 12.5 | |
Postpancreatectomy | 9 | 22.5 | |
haemorrhages | 1 | 2.5 |
Total | Folfirinox | Nab-Paclitaxel/Gem | Folfirinox ►Nab-Pac/Gem | p | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Parameter | Category | N | % | N | % | N | % | N | % | |
General Side effects | 0–2 | 15 | 48.5 | 19 | 63.2 | 5 | 60 | 7 | 0 | 0.009 |
12 | 3 | 0 | ||||||||
3–4 | 16 | 51.6 | 7 | 36.8 | 2 | 40 | 7 | 100 | ||
Neutropenia | 15 | 5 | 7 | |||||||
0–2 | 16 | 59.3 | 11 | 73.3 | 3 | 60 | 2 | 28.6 | 0.16 | |
3–4 | 11 | 40.7 | 4 | 26.7 | 2 | 40 | 5 | 71.4 | ||
Anemia | 17 | 5 | 8 | |||||||
0–2 | 26 | 86.7 | 15 | 88.2 | 4 | 80 | 7 | 87.5 | 1 | |
3–4 | 4 | 13.3 | 2 | 11.8 | 1 | 20 | 1 | 12.5 | ||
Thrombopenia | 9 | 3 | 4 | |||||||
0–2 | 15 | 93.8 | 8 | 88.9 | 3 | 100 | 4 | 100 | 1 | |
3–4 | 1 | 6.3 | 1 | 11.1 | 0 | 0 | 0 | 0 | ||
Infections | 16 | 4 | 7 | |||||||
0–2 | 24 | 88.9 | 15 | 93.8 | 4 | 100 | 5 | 71.4 | 0.2 | |
3–4 | 3 | 7.5 | 1 | 6.2 | 0 | 0 | 2 | 28.6 | ||
Diarrhea | 4 | 1 | 3 | |||||||
0–2 | 5 | 62.5 | 3 | 75 | 1 | 100 | 1 | 33.3 | 0.68 | |
3–4 | 3 | 37.5 | 1 | 25 | 0 | 0 | 2 | 66.7 | ||
Nausea | 6 | 3 | 6 | |||||||
0–2 | 15 | 93.8 | 6 | 100 | 2 | 66.7 | 5 | 83.3 | 0.66 | |
3–4 | 2 | 13.3 | 0 | 0 | 1 | 33.3 | 1 | 16.7 | ||
Neurological side effects | 0–2 | 13 | 81.3 | 10 | 70 | 3 | 100 | 3 | 100 | 0.52 |
7 | 3 | 3 | ||||||||
3–4 | 3 | 18.8 | 3 | 30 | 0 | 0 | 0 | 0 |
At Diagnosis | After Induction Therapy | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Parameter | Category | N | % | Mean | IQR | N | % | Mean | IQR | p |
CA 19-9 (U/mL) | 4358.3 | 64.8–830 | 138.5 | 12.1–65.4 | 0.001 | |||||
≤37 U/mL | 5 | 16.1 | 15 | 44.1 | ||||||
37–400 U/mL | 14 | 45.2 | 17 | 50 | ||||||
>400 U/mL | 12 | 38.7 | 2 | 5.9 | ||||||
n.a. | 9 | 6 | ||||||||
CA 19-9 trend (-%) | 29 | 44.7 | 18–94.75 | |||||||
CEA (ng/mL) | 10.5 | 2.5–7 | 3.5 | 2–5.3 | 0.16 | |||||
≤5 ng/ml | 15 | 65.2 | 18 | 69.2 | ||||||
>5 ng/ml | 8 | 34.8 | 8 | 30.8 | ||||||
n.a. | 17 | 14 | ||||||||
c/pT Status | 0.001 | |||||||||
0 | 0 | 0 | 5 | 12.5 | ||||||
1 | 0 | 0 | 8 | 20 | ||||||
2 | 3 | 8.1 | 11 | 27.5 | ||||||
3 | 14 | 37.8 | 10 | 25 | ||||||
4 | 20 | 54.1 | 6 | 15 | ||||||
n.a. | 3 | 0 | ||||||||
pN Status | ||||||||||
0 | 21 | 52.5 | ||||||||
1 | 19 | 47.5 | ||||||||
c/pM Status | 0.18 | |||||||||
0 | 30 | 78.9 | 35 | 87.5 | ||||||
1 | 8 | 21.6 | 5 | 12.5 | ||||||
n.a. | 2 | 0 | ||||||||
R Status | ||||||||||
0 | 18 | 46.2 | ||||||||
1 | 21 | 53.8 | ||||||||
n.a. | 1 |
Parameter | Category | OS (Months) | p | HR | 95%CI | p |
---|---|---|---|---|---|---|
CA 19-9 at diagnosis | ≤37 vs. >37 U/ml | 29 vs. 19 | 0.02 | 3.44 | 1.14–10.36 | 0.028 |
CA 19-9 after induction | ≤37 vs. >37 U/mL | 26 vs. 18 | 0.043 | 2.23 | 0.99–5.03 | 0.054 |
<400 vs. ≥400 U/mL | 24 vs. 7 | 0.001 | 17.2 | 2.38–124.45 | 0.005 | |
CEA after induction | ≤5 vs. >5 ng/ml | 25 vs. 18 | 0.047 | 2.67 | 0.96–7.48 | 0.061 |
BMI after induction | >25 vs. ≤25 | 15 vs. 24 | 0.01 | 0.36 | 0.15–0.83 | 0.017 |
pN status | 0 vs. 1 | 25 vs. 15 | 0.003 | 2.99 | 1.39–6.41 | 0.005 |
pT status | 0–1 vs. 2–4 | 43 vs. 19 | 0.008 | 3.09 | 1.26–7.62 | 0.014 |
Pn | 0 vs. 1 | 35 vs. 19 | 0.058 | 2.46 | 0.92–6.56 | 0.072 |
Neoadjuvant protocoll | FOLFIRINOX vs. other | 20 vs. 20 | 0.88 | 0.95 | 0.46–1.97 | 0.89 |
Nab-Pac/Gem vs. other | 20 vs. 20 | 0.54 | 0.77 | 0.33–1.81 | 0.55 | |
FOLFIRINOX ► Nab-Pac/Gem vs. other | 18 vs. 20 | 0.22 | 1.86 | 0.68–5.11 | 0.23 | |
Number of neoadjuvant applications | ≤5 vs. >5 | 15 vs. 20 | 0.033 | 0.41 | 0.17–0.98 | 0.044 |
Adjuvant therapy | no adjuvant therapy vs. adjuvant therapy | 10 vs. 25 | 0.001 | 0.21 | 0.08–0.55 | 0.002 |
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Rosumeck, N.; Timmermann, L.; Klein, F.; Bahra, M.; Stintzig, S.; Malinka, T.; Pelzer, U. Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection? Medicina 2021, 57, 77. https://doi.org/10.3390/medicina57010077
Rosumeck N, Timmermann L, Klein F, Bahra M, Stintzig S, Malinka T, Pelzer U. Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection? Medicina. 2021; 57(1):77. https://doi.org/10.3390/medicina57010077
Chicago/Turabian StyleRosumeck, Nathalie, Lea Timmermann, Fritz Klein, Marcus Bahra, Sebastian Stintzig, Thomas Malinka, and Uwe Pelzer. 2021. "Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection?" Medicina 57, no. 1: 77. https://doi.org/10.3390/medicina57010077