Evidence map›Paper›PMID 26459175›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2016

(Ir)relevance of Metformin Treatment in Patients with Metastatic Pancreatic Cancer: An Open-Label, Randomized Phase II Trial.

Michele Reni, Erica Dugnani, Stefano Cereda, Carmen Belli, Gianpaolo Balzano, Roberto Nicoletti, Daniela Liberati, Valentina Pasquale, Marina Scavini, Paola Maggiora and 7 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 104 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 9 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 9 syntheses or guidelines pooled it, 166 citations in OpenAlex.

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44 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 2 institutions in 1 country.

Michele ReniDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. piemonti.lorenzo@hsr.it reni.michele@hsr.it.
Erica DugnaniDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Stefano CeredaDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Carmen BelliDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Gianpaolo BalzanoPancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Roberto NicolettiDepartment of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Daniela LiberatiDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Valentina PasqualeDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Marina ScaviniDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Paola MaggioraDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Valeria SordiDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Vito LampasonaDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Domenica CerauloDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Gaetano Di TerlizziDepartment of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Claudio DoglioniDepartment of Pathology, IRCCS San Raffaele Scientific Institute, Milan, Italy. Vita-Salute San Raffaele University, Milan, Italy.
Massimo FalconiPancreatic Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Vita-Salute San Raffaele University, Milan, Italy.
Lorenzo PiemontiDiabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. piemonti.lorenzo@hsr.it reni.michele@hsr.it.
San Raffaele University of Rome · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe aimed to assess the safety and efficacy of metformin for treating patients with metastatic pancreatic cancer and to identify endocrine and metabolic phenotypic features or tumor molecular markers associated with sensitivity to metformin antineoplastic action. EXPERIMENTAL

designWe designed an open-label, randomized, phase II trial to assess the efficacy of adding metformin to a standard systemic therapy with cisplatin, epirubicin, capecitabine, and gemcitabine (PEXG) in patients with metastatic pancreatic cancer. Patients ages 18 years or older with metastatic pancreatic cancer were randomly assigned (1:1) to receive PEXG every 4 weeks in combination or not with 2 g oral metformin daily. The primary endpoint was 6-months progression-free survival (PFS-6) in the intention-to-treat population.

resultsBetween August 2010 and January 2014, we randomly assigned 60 patients to receive PEXG with (n = 31) or without metformin (n = 29). At the preplanned interim analysis, the study was ended for futility. PFS-6 was 52% [95% confidence interval (CI), 33-69] in the control group and 42% (95% CI, 24-59) in the metformin group (P = 0.61). Furthermore, there was no difference in disease-free survival and overall survival between groups. Despite endocrine metabolic modifications induced by metformin, there was no correlation with the outcome. Single-nucleotide polymorphism rs11212617 predicted glycemic response, but not tumor response to metformin. Gene expression on tumor tissue did not predict tumor response to metformin.

conclusionsAddition of metformin at the dose commonly used in diabetes did not improve outcome in patients with metastatic pancreatic cancer treated with standard systemic therapy. See related commentary by Yang and Rustgi, p. 1031.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCisplatinDeoxycytidineDisease-Free SurvivalEpirubicinFemaleGemcitabineHumansKaplan-Meier EstimateMaleMetforminMiddle AgedPancreatic NeoplasmsCapecitabineCisplatinDeoxycytidineEpirubicinGemcitabineMetformin

Identifiers

PMID26459175
OpenAlexW2192618281

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.