Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: The ANICE-PaC study
Fernández, A. ; Salgado, M. ; García, A. ; Buxò, E. ; Vera, R. ; Adeva, J. ; Jiménez-Fonseca, P. ; Quintero, G. ; Llorca, C. ; Cañabate, M. ; López, L.J. ; Muñoz, A. ; Ramírez, P. ; González, P. ; López, C. ; Reboredo, M. ; Gallardo, E. ; Sanchez-Cánovas, M. ; Gallego, J. ; Guillén, C. ; Ruiz-Miravet, N. ; Navarro-Pérez, V. ; De La Cámara, J. ; Alés-Díaz, I. ; Pazo-Cid, R.A. (Universidad de Zaragoza) ; Carmona-Bayonas, A.
Resumen: 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.
Idioma: Inglés
DOI: 10.1186/s12885-018-5101-3
Año: 2018
Publicado en: BMC CANCER 18, 1 (2018), 1185 [11 pp]
ISSN: 1471-2407
Factor impacto JCR: 2.933 (2018)
Categ. JCR: ONCOLOGY rank: 121 / 229 = 0.528 (2018) - Q3 - T2
Factor impacto SCIMAGO: 1.336 - Cancer Research (Q1) - Oncology (Q1) - Genetics (Q1)
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Exportado de SIDERAL (2020-01-17-21:52:28)
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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.
Idioma: Inglés
DOI: 10.1186/s12885-018-5101-3
Año: 2018
Publicado en: BMC CANCER 18, 1 (2018), 1185 [11 pp]
ISSN: 1471-2407
Factor impacto JCR: 2.933 (2018)
Categ. JCR: ONCOLOGY rank: 121 / 229 = 0.528 (2018) - Q3 - T2
Factor impacto SCIMAGO: 1.336 - Cancer Research (Q1) - Oncology (Q1) - Genetics (Q1)
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Exportado de SIDERAL (2020-01-17-21:52:28)
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Notice créée le 2019-01-25, modifiée le 2020-01-17