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348919

A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN trial)

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Last updated: 03 Jan 2025

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Abstract


Background: Gemcitabine and 5 FU+folinic acid have both proved efficacy in treating patients with advanced pancreatic cancer.
Objective: In our study, we combined the two most active agents against pancreatic cancer; gemcitabine and 5FU that were given every 2 weeks to gain the maximum benefit of both drugs and avoid the toxicity that occurs very frequently with FOLFIRINOX.
Patients and Methods: This prospective phase II study included 42 patients of metastatic cancer pancreas who met the inclusion criteria
Results: The median age at diagnosis was 55 years. Males were more common (59.5%) than females. The most common site of metastasis was the liver (57.1%). Toxicity profile showed that neutropenia and thrombocytopenia were the most common forms of toxicity being high grade in 11.9% of patients. Other forms of toxicity were minimal not exceeding 5%. The overall response rate (ORR) was 33.3% with no reported complete responses. There was a significant correlation between the change of tumor markers levels (CEA, and CA 19.9) and both response and quality of life (QOL). The changes of CEA and CA19.9 levels were found to be independent predictors of progression free survival (PFS). One year OS rate was 49%. The median OS was 11.3 months, while the median PFS was 8.8 months. Response was also found to be a surrogate marker for survival.
Conclusions: Gemcitabine- 5 FU combination was a good alternative option for treating metastatic pancreatic cancer, it had good efficacy and safety profile.

DOI

10.21608/ejhm.2024.348919

Keywords

pancreatic, toxicity, Gemcitabine, carcinoma, 5 FU

Volume

95

Article Issue

1

Related Issue

46984

Issue Date

2024-04-01

Receive Date

2024-04-04

Publish Date

2024-04-01

Page Start

1,337

Page End

1,342

Print ISSN

1687-2002

Online ISSN

2090-7125

Link

https://ejhm.journals.ekb.eg/article_348919.html

Detail API

https://ejhm.journals.ekb.eg/service?article_code=348919

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11

Publication Type

Journal

Publication Title

The Egyptian Journal of Hospital Medicine

Publication Link

https://ejhm.journals.ekb.eg/

MainTitle

A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN trial)

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Article

Created At

24 Dec 2024