Real world evidence on gemcitabine and nab-paclitaxel combination chemotherapy in advanced pancreatic cancer

Abstract

Background: In the recent phase III trial MPACT the combination of gemcitabine and nab-paclitaxel (Gem/NabP) showed increased overall survival compared to gemcitabine alone in the treatment of advanced pancreatic ductal adenocarcinoma (aPDA). Until now there has been limited information on the clinical benefit and toxicity of the combination regimen in a real world setting. In addition the value for patients with locally advanced rather than metastatic aPDA has been unclear, since the former category of patients was not included in the MPACT trial.

Methods: A multicentre retrospective observational study in the South Eastern Region of Sweden was performed, with the first 75 consecutive patients diagnosed with aPDA (both locally advanced and metastatic disease) who received first-line treatment with Gem/NabP.

Results: In the overall population median progression free survival (PFS) and overall survival (OS) were 5.2 (3.4-7.0 95% CI) and 10.9 (7.8-14.0 95% CI) months, respectively. Patients with metastatic disease displayed a median OS of 9.4 (4.9-13.9) and a median PFS of 4.5 (3.3-5.7) months whereas the same parameters in the locally advanced subgroup were 17.1 (7.6-26.6) and 6.8 (5.2-8.4) months, respectively. Grade 3-4 hematologic toxicity was recorded: Neutropenia, leukopenia, thrombocytopenia, and anaemia were observed in 23, 20, 5, and 4% of patients, respectively. Dose reductions were performed in 80% of the patients.

Conclusion: This study confirms the effectiveness and safety of first-line Gem/NabP in both locally advanced and metastatic PDA in a real world setting.

Keywords: Bone marrow toxicity; Chemotherapy; Gemcitabine; Nab-paclitaxel; Pancreatic cancer.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Regional Ethics Review Board in Linköping (diary number 2017/110–31). Based on the retrospective and non-interventional nature of the study, the absence of publication of individual data, and the fact that the vast majority of patients were either dead or in end of life by the time of data collection, the Ethics board did not consider it possible or necessary to obtain written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flowchart for inclusion and exclusion criteria. Final cohort consisted of 75 patients. Nine patients were excluded due to ‘other histology’, which in this case was primary cancer of the ovaries (n = 3), biliary tract (n = 2), papilla Vateri (n = 2), leiomyosarcoma (n = 1), and oesophagus (n = 1). Eight patients were excluded due to Gem/NabP not given as first line treatment; these had either received FOLFIRINOX (n = 4) or gembitabine (n = 1) first line, never started Gem/NabP (n = 2), or received Gem/NabP as third line treatment (n = 1)

Fig. 2

Kaplan-meier diagrams showing PFS (left column) and OS (right column) for subgroups according to stage (a, b), metastatic burden (c, d), performance status (e, f), and a previous history of non-palliative chemotherapy (g-h). P-values for log rank test are shown in each panel