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Retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus Gemcitabine between December 2013 and June 2015 according to the routine practice. Overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.
This observational, retrospective, multicenter study included patients with metastatic pancreatic adenocarcinoma (either recurrent or de novo) from 20 Spanish hospitals, who started first-line chemotherapy with nab-paclitaxel (Abraxane®, Celgene Europe Limited) plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. The record included all adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,[15] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine. Data were retrieved from patients' medical records and lasted until death or the closure of the database on 16 March 2017. All patients signed the corresponding informed consent for their clinical data being used in this study, which was conducted in accordance with the local personal data protection law (LOPD 15/1999). The study protocol was approved by the local independent ethics committee.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine - nabpaclitaxel | Drug | efficacy and safety |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel | 2 years |
| progression free survival | Evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel | 2 years |
| Assess adverse events (per CTCAE v4.0 criteria) | Assess the adverse events (per CTCAE v4.0 criteria) associated with the use of gemcitabine and nab-paclitaxel in real world setting. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,[15] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |