Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
Background Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice. Methods Retrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients’ clinical characteristics. Results All 210 eligible patients had a median age of 65.0 years (range 37–81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status ≥2. Patients received a median of four cycles of treatment (range 1–21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0–8.5), and median PFS was 5.0 months (95% CI 4.3–5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age ≥ 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0–1 vs. 2–3 (p = 0.030), baseline NLR > 3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004). Conclusions Nab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
BMC cancer - 18(2018), 1 vom: 29. Nov. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fernández, Ana [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
First-line chemotherapy |
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| Anmerkungen: |
© The Author(s). 2018 |
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| doi: |
10.1186/s12885-018-5101-3 |
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| funding: |
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SPR027706621 |
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| 100 | 1 | |a Fernández, Ana |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study |
| 264 | 1 | |c 2018 | |
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| 520 | |a Background Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice. Methods Retrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients’ clinical characteristics. Results All 210 eligible patients had a median age of 65.0 years (range 37–81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status ≥2. Patients received a median of four cycles of treatment (range 1–21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0–8.5), and median PFS was 5.0 months (95% CI 4.3–5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age ≥ 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0–1 vs. 2–3 (p = 0.030), baseline NLR > 3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004). Conclusions Nab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed. | ||
| 650 | 4 | |a Metastatic pancreatic adenocarcinoma |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Gemcitabine |7 (dpeaa)DE-He213 | |
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| 650 | 4 | |a First-line chemotherapy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Survival |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Salgado, Mercedes |4 aut | |
| 700 | 1 | |a García, Adelaida |4 aut | |
| 700 | 1 | |a Buxò, Elvira |4 aut | |
| 700 | 1 | |a Vera, Ruth |4 aut | |
| 700 | 1 | |a Adeva, Jorge |4 aut | |
| 700 | 1 | |a Jiménez-Fonseca, Paula |4 aut | |
| 700 | 1 | |a Quintero, Guillermo |4 aut | |
| 700 | 1 | |a Llorca, Cristina |4 aut | |
| 700 | 1 | |a Cañabate, Mamen |4 aut | |
| 700 | 1 | |a López, Luis Jesús |4 aut | |
| 700 | 1 | |a Muñoz, Andrés |4 aut | |
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| 700 | 1 | |a González, Paula |4 aut | |
| 700 | 1 | |a López, Carlos |4 aut | |
| 700 | 1 | |a Reboredo, Margarita |4 aut | |
| 700 | 1 | |a Gallardo, Elena |4 aut | |
| 700 | 1 | |a Sanchez-Cánovas, Manuel |4 aut | |
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