Multicenter Retrospective Analysis of Second-Line Therapy after Gemcitabine Plus Nab-Paclitaxel in Advanced Pancreatic Cancer Patients
Abstract
:1. Introduction
2. Materials and Methods
2.1. Population
2.2. Evaluation of Outcomes
2.3. Statistical Analysis
3. Results
3.1. Population
3.2. Survival Outcomes and Response Rates of Second-Line Therapies in the Overall Population
3.3. Second-Line Therapies in the Overall Population
3.4. Survival Outcomes and Response Rates in Patients Receiving Oxaliplatin-Based and Irinotecan-Based Doublet Regimens in the Second-Line Setting
3.5. Survival Outcomes of First-Line Therapy in the Overall Population
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Baseline Characteristics | n (%) |
---|---|
Sex | |
female | 82 (45.4) |
male | 99 (54.6) |
Median age (years) | 64 (34-81) |
ECOG PS | |
0 | 114 (62.9) |
1 | 49 (27.1) |
2 | 11 (6.0) |
unknown | 7 (3.9) |
Tumor location | |
head | 92 (50.9) |
body-tail | 87 (48.1) |
unknown | 2 (1.2) |
CA19.9 | |
<40 U/mL | 24 (13.2) |
≥40 U/mL | 142 (78.5) |
unknown | 15 (8.3) |
BMI | |
≥25 | 42 (23.2) |
18.5–24.9 | 113 (62.5) |
<18.5 | 13 (7.2) |
unknown | 13 (7.2) |
Metastatic sites | |
liver | 130 (71.8) |
peritoneum | 43 (23.8) |
lung | 59 (32.6) |
other | 16 (8.8) |
Number of metastatic sites | |
0 | 3 (1.6) |
1 | 83 (45.9) |
2 | 59 (32.6) |
≥3 | 36 (19.9) |
Previous procedures | |
radiotherapy | 19 (10.4) |
surgery | 42 (23.2) |
Prior neoadjuvant therapy | 14 (7.7) |
Prior adjuvant therapy | 16 (8.8) |
Response | Overall Population n (%) | Oxaliplatin-Based Doublet n (%) | Irinotecan-Based Doublet n (%) |
---|---|---|---|
ORR | 18 (10.5) | 7 (13.7) | 11 (9.6) |
PR | 16 (9.3) | 7 (13.7) | 9 (7.8) |
CR | 2 (1.2) | 0 | 2 (1.7) |
DCR | 56 (32.3) | 18 (35.2) | 35 (30.7) |
SD | 38 (22.0) | 11 (21.5) | 24 (21.1) |
PR | 16 (9.3) | 7 (13.7) | 9 (7.8) |
CR | 2 (1.2) | 0 | 2 (1.7) |
Variables | PFS | OS | ||
---|---|---|---|---|
Univariate | Multivariate | Univariate | Multivariate | |
p | p | p | p | |
Sex | ||||
Male vs. female | 0.935 | 0.274 | ||
PS | ||||
0 vs. 1–2 | 0.062 | 0.077 | ||
Pancreatic tumor site | ||||
Head vs. body-tail | 0.639 | 0.318 | ||
Previous surgery | ||||
No vs. yes | 0.304 | 0.126 | ||
Previous radiotherapy | ||||
No vs. yes | 0.213 | 0.901 | ||
Site of metastasis | ||||
Liver (no vs. yes) | 0.865 | 0.051 | ||
Lung (no vs. yes) | 0.048 | 0.060 | 0.624 | |
Peritoneum (no vs. yes) | 0.123 | 0.237 | ||
Bone (no vs. yes) | 0.002 | 0.004 | 0.070 | |
BMI | ||||
≤25 vs. >25 kg/m2 | 0.099 | 0.058 | ||
CA19.9 | ||||
<40 vs. ≥40 U/mL | 0.069 | 0.172 | ||
N/L ratio | ||||
≤5 vs. >5 | 0.770 | 0.809 |
PFS | OS | |||||
---|---|---|---|---|---|---|
Characteristic | Oxaliplatin-Based Doublet Months (95%CI) | Irinotecan-Based Doublet Months (95%CI) | p | Oxaliplatin-Based Doublet Months (95%CI) | Irinotecan-Based Doublet Months (95%CI) | p |
Sex | ||||||
Male | 4.0 (2.2–6.0) | 3.2 (3.1–3.5) | 0.446 | 8.8 (8.0–9.6) | 8.0 (5.3–10.7) | 0.972 |
Female | 3.5 (0.6–6.5) | 3.3 (3.0–3.7) | 0.901 | 11.9 (7.8–16) | 8.5 (6.9–10.1) | 0.550 |
PS | ||||||
0 | 4.0 (1.4–6.7) | 3.6 (2.8–4.5) | 0.323 | 11.0 (8.1–14.0) | 9.1 (7.3–10.9) | 0.843 |
1–2 | 2.8 (1.7–4.1) | 2.8 (2.5–3.2) | 0.871 | 6.8 (5.2–8.5) | 5.9 (3.6–8.3) | 0.905 |
Pancreatic tumor site | ||||||
Head | 5.3 (3.9–6.9) | 3.3 (2.9–3.6) | 0.532 | 10.3 (6.3–14.3) | 8.0 (6.3–9.7) | 0.211 |
Body-tail | 3.1 (2.2–4.1) | 3.5 (3.0–4.0) | 0.085 | 9.1 (7.2–11.1) | 8.9 (1.2–6.7) | 0.355 |
Previous surgery | ||||||
Yes | 5.1 (1.1–9.2) | 3.7 (2.6–4.9) | 0.450 | 10.3 (7.7–13.1) | 10.0 (6.9–13.2) | 0.621 |
No | 3.8 (2.6–4.9) | 3.2 (3.0–3.5) | 0.855 | 9.2 (7.4–11.1) | 7.7 (6.2–9.3) | 0.417 |
Previous radiotherapy | ||||||
Yes | 7.1 (3.2–11.1) | 4.5 (1.1–7.8) | 0.813 | 12.7 (4.2–21.2) | 9.1 (7.9–10.6) | 0.679 |
No | 3.5 (2.6–4.4) | 3.2 (3.1–3.4) | 0.428 | 9.2 (6.4–11.9) | 8.0 (6.6–9.4) | 0.789 |
Site of metastasis | ||||||
Liver | 3.5 (2.5–4.4) | 3.3 (2.9–3.9) | 0.361 | 9.2 (7.5–10.9) | 7.7 (6.6–8.9) | 0.831 |
Lung | 3.0 (2.5–3.6) | 3.0 (2.6–3.5) | 0.903 | 8.8 (4.8–12.9) | 9.3 (7.1–11.6) | 0.889 |
Peritoneum | 2.8 (2.3–3.5) | 2.9 (2.6–3.4) | 0.554 | 6.6 (5.0–8.2) | 7.7 (4.7–10.9) | 0.676 |
Bone | 1.7 (-) | 2.1 (1.0–3.4) | 0.321 | 2.6 (-) | 7.7 (2.2–13.4) | 0.145 |
BMI | ||||||
≤25 kg/m2 | 3.5 (1.9–5.1) | 3.2 (2.9–3.6) | 0.751 | 9.1 (5.8–12.5) | 8.0 (6.8–9.2) | 0.792 |
>25 kg/m2 | 4.0 (1.8–6.3) | 3.7 (0.6–7.0) | 0.415 | 10.3 (4.1–16.7) | 10.0 (7.0–13.1) | 0.639 |
CA19.9 | ||||||
<40 U/mL | 6.5 (5.5–7.5) | 4.0 (2.8–5.2) | 0.857 | 14.8 (13.0–16.7) | 7.4 (4.9–9.9) | 0.959 |
≥40 U/mL | 3.5 (2.4–4.6) | 3.2 (3.0–3.5) | 0.482 | 9.6 (8.0–11.3) | 8.6 (7.4–9.9) | 0.827 |
N/L ratio | ||||||
≤5 | 3.8 (2.6–5.1) | 3.3 (3.2–3.6) | 0.364 | 10.3 (7.8–12.9) | 8.0 (6.4–9.7) | 0.564 |
>5 | 6.4 (6.3–6.6) | 2.8 (2.6–3.2) | 0.384 | 12.2 (7.0–17.5) | 7.7 (3.6–11.8) | 0.816 |
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Merz, V.; Cavaliere, A.; Messina, C.; Salati, M.; Zecchetto, C.; Casalino, S.; Milella, M.; Caffo, O.; Melisi, D. Multicenter Retrospective Analysis of Second-Line Therapy after Gemcitabine Plus Nab-Paclitaxel in Advanced Pancreatic Cancer Patients. Cancers 2020, 12, 1131. https://doi.org/10.3390/cancers12051131
Merz V, Cavaliere A, Messina C, Salati M, Zecchetto C, Casalino S, Milella M, Caffo O, Melisi D. Multicenter Retrospective Analysis of Second-Line Therapy after Gemcitabine Plus Nab-Paclitaxel in Advanced Pancreatic Cancer Patients. Cancers. 2020; 12(5):1131. https://doi.org/10.3390/cancers12051131
Chicago/Turabian StyleMerz, Valeria, Alessandro Cavaliere, Carlo Messina, Massimiliano Salati, Camilla Zecchetto, Simona Casalino, Michele Milella, Orazio Caffo, and Davide Melisi. 2020. "Multicenter Retrospective Analysis of Second-Line Therapy after Gemcitabine Plus Nab-Paclitaxel in Advanced Pancreatic Cancer Patients" Cancers 12, no. 5: 1131. https://doi.org/10.3390/cancers12051131