Cyclophosphamide maintenance to extend combination chemotherapy-free interval in metastatic pancreatic ductal adenocarcinoma.

Cyclophosphamide Maintenance Metastatic PDAC Pancreatic adenocarcinoma

Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
14 Aug 2023
Historique:
received: 22 05 2023
revised: 27 07 2023
accepted: 27 07 2023
medline: 17 8 2023
pubmed: 17 8 2023
entrez: 16 8 2023
Statut: aheadofprint

Résumé

Administering chemotherapy until progression to metastatic pancreatic ductal adenocarcinoma (PDAC) patients lacks of supporting evidence and causes cumulative toxicity. We explored the role of cyclophosphamide as maintenance therapy. PDAC germline BRCA1-2 wild-type patients who were progression-free after ≥6 months of any regimen and line of chemotherapy and received maintenance cyclophosphamide (mCTX) (50 mg/day), were included in the analysis. 42 patients were included in the analysis. Thirty-nine patients had progression of disease. Median PFS was 3.5 (range 1.0-31+) months. PFS rates at 6 and 12 months were 26.2% and 11.9%. At a median follow-up of 20.0 months (range 12.1-31.0 months), 20 patients died and 22 are alive. Median OS was 20.0 months (range 2.2-31.0+). OS at 6 and 12 months was 97.6% (95%CI: 93.4-100), and 73.8% (95% CI: 61.1-86.5), respectively. Only 2 patients receiving mCTX had Grade 3 toxicity. mCTX therapy yielded promising PFS and OS outcome in PDAC patients who were progression-free after induction chemotherapy, with unremarkable toxicity. Accordingly, this approach warrants further investigation.

Sections du résumé

BACKGROUND BACKGROUND
Administering chemotherapy until progression to metastatic pancreatic ductal adenocarcinoma (PDAC) patients lacks of supporting evidence and causes cumulative toxicity. We explored the role of cyclophosphamide as maintenance therapy.
METHODS METHODS
PDAC germline BRCA1-2 wild-type patients who were progression-free after ≥6 months of any regimen and line of chemotherapy and received maintenance cyclophosphamide (mCTX) (50 mg/day), were included in the analysis.
RESULTS RESULTS
42 patients were included in the analysis. Thirty-nine patients had progression of disease. Median PFS was 3.5 (range 1.0-31+) months. PFS rates at 6 and 12 months were 26.2% and 11.9%. At a median follow-up of 20.0 months (range 12.1-31.0 months), 20 patients died and 22 are alive. Median OS was 20.0 months (range 2.2-31.0+). OS at 6 and 12 months was 97.6% (95%CI: 93.4-100), and 73.8% (95% CI: 61.1-86.5), respectively. Only 2 patients receiving mCTX had Grade 3 toxicity.
CONCLUSIONS CONCLUSIONS
mCTX therapy yielded promising PFS and OS outcome in PDAC patients who were progression-free after induction chemotherapy, with unremarkable toxicity. Accordingly, this approach warrants further investigation.

Identifiants

pubmed: 37586911
pii: S1590-8658(23)00784-3
doi: 10.1016/j.dld.2023.07.033
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest Reni Michele: in the past 2 years reports travel expenses and personal honoraria for the following companies: Member and Consultant for Advisory Board or Stering Committee: Celgene, Eli-Lilly, Pfizer, Baxalta, Shire, Novocure, Novartis, Boston Biomedicals Principal Investigator for a Celgene research program Cascinu Stefano: in the past 2 years reports travel expenses and personal honoraria for the following companies: Speaker: Amgen, Bayer, Eli Lilly, Servier Advisory Boards: Amgen, Eli Lilly, Bayer, Baxter, MSD, Servier Consultant: Amgen, Baxter, Eli Lilly, Celgene, Novartis, MSD Research grant: Celgene, Eisai Peretti Umberto, Macchini Marina, Orsi Giulia, Militello Annamaria, Briccolani Assunta, Falconi Massimo declare no conflict of interest.

Auteurs

Michele Reni (M)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: reni.michele@hsr.it.

Umberto Peretti (U)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Marina Macchini (M)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Giulia Orsi (G)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Annamaria Militello (A)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Assunta Briccolani (A)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy.

Massimo Falconi (M)

Vita-Salute San Raffaele University, Milan, Italy; Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy.

Stefano Cascinu (S)

Department of Medical Oncology, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

Classifications MeSH