Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study

• Published in: BMC cancer 2018-11, Vol.18 (1), p.1185-1185, Article 1185
• Main Authors: Fernández, Ana, Salgado, Mercedes, García, Adelaida, Buxò, Elvira, Vera, Ruth, Adeva, Jorge, Jiménez-Fonseca, Paula, Quintero, Guillermo, Llorca, Cristina, Cañabate, Mamen, López, Luis Jesús, Muñoz, Andrés, Ramírez, Patricia, González, Paula, López, Carlos, Reboredo, Margarita, Gallardo, Elena, Sanchez-Cánovas, Manuel, Gallego, Javier, Guillén, Carmen, Ruiz-Miravet, Nuria, Navarro-Pérez, Víctor, De la Cámara, Juan, Alés-Díaz, Inmaculada, Pazo-Cid, Roberto Antonio, Carmona-Bayonas, Alberto
• Format: Article
• Language: English
• Subjects: Adenocarcinoma; Adult; Aged; Albumins - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer metastasis; Cancer therapies; Chemotherapy; Clinical medicine; Clinical trials; Combination drug therapy; Comorbidity; Decision making; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Dosage and administration; Drug therapy; Female; First-line chemotherapy; Gemcitabine; Humans; Implants; Information processing; Male; Medical prognosis; Metastases; Metastasis; Metastatic pancreatic adenocarcinoma; Methods; Middle Aged; Nab-paclitaxel; Neoplasm Metastasis; Neoplasm Staging; Nomograms; Paclitaxel; Paclitaxel - administration & dosage; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - mortality; Pancreatic Neoplasms - pathology; Patient outcomes; Patients; Prognosis; Real-life; Retrospective Studies; Studies; Survival; Survival Analysis; Toxicity; Treatment Outcome; Tumors
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-018-5101-3

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. 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. 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  3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004). 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.