Evidence map›Paper›PMID 40542713›Full record

Trial reportCancer2025

Efficacy of losartan plus modified FOLFIRINOX versus modified FOLFIRINOX in advanced pancreatic cancers: A randomized clinical trial (AFPAC Study).

Anant Ramaswamy, Prabhat Bhargava, Vikram Gota, Sujay Srinivas, Noorzia Sultana, Sarika Mandavkar, Poonam Jadhav, Khushboo Gandhi, Neha Mer, Nafisa Khan and 6 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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

9 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Anant RamaswamyDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.ORCID https://orcid.org/0000-0002-8169-4264
Prabhat BhargavaDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.ORCID https://orcid.org/0000-0002-6440-2186
Vikram GotaDepartment of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer (Homi Bhabha National Institute), Mumbai, India.
Sujay SrinivasDepartment of Medical Oncology, Bharath Hospitals, Kottayam, Kerala, India.
Noorzia SultanaDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Sarika MandavkarDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Poonam JadhavDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Khushboo GandhiDepartment of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer (Homi Bhabha National Institute), Mumbai, India.
Neha MerDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Nafisa KhanDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Manan VoraDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.ORCID https://orcid.org/0009-0002-0092-7618
Himanshu GujarathiDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Manish BhandareDepartment of GI and HPB Services, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Vikram ChaudhariDepartment of GI and HPB Services, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Shailesh V ShrikhandeDepartment of GI and HPB Services, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.
Vikas OstwalDepartment of Medical Oncology, Tata Memorial Hospital (Homi Bhabha National Institute), Mumbai, India.ORCID https://orcid.org/0000-0002-0067-4748

Funding

Lupin LtdTata Memorial Hospital
6 · The paper itself

Abstract

backgroundThe addition of angiotensin receptor blockers like losartan (L) has been shown to improve outcomes in small prospective studies of pancreatic ductal adenocarcinomas (PDAC).

methodsPatients diagnosed with treatment-naive locally advanced/metastatic PDAC with Eastern Cooperative Oncology Group performance status 0-1 and adequate end- organ function were randomly assigned (1:1) to either chemotherapy (mFOLFIRINOX or mFOLFIRINOX plus oral losartan 50 mg per day). The current unplanned analysis was conducted to identify an early signal of efficacy. Plasma TGF-β levels were measured at baseline, post cycle 1, and post cycle 4 in both arms.

resultsWith a median follow-up of 16.8 months, a total of 88 patients were randomized in the mFOLFIRINOX and mFOLFIRINOX-L arms (44 patients per arm). The number of deaths at 6 months, 6-month overall survival (OS), and median OS was 12, 72.7% (95% confidence interval [CI], 59.3-86.1), and 10.4 months versus 11, 73.2% (95% CI, 59.4-87), and 9.1 months, respectively, with a hazard ratio of 0.76 (95% CI, 0.47-1.22, p = .392). There were no differences in response rates (22% vs. 23%) between the mFOLFIRINOX and FOLFIRINOX-L arms, respectively. Nine patients (22%; n = 41) required temporary cessation of losartan due to accompanying chemotherapy-related adverse events. The trend of plasma TGF-β levels across time points was not significantly different between the two arms (ANOVA p > .05).

conclusionsThe addition of losartan to mFOLFIRINOX in the AFPAC study did not provide an early signal of efficacy in improving progression-free survival in advanced PDAC. The trial will not proceed to full accrual of phase 3 design.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalLosartanPancreatic NeoplasmsAdultAgedAged, 80 and overFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOxaliplatinTransforming Growth Factor betaFluorouracilfolfirinoxIrinotecanLeucovorinLosartanOxaliplatinTransforming Growth Factor betaangiotensin receptor blockadelosartanmFOLFIRINOXpancreatic adenocarcinoma

Identifiers

PMID40542713
PMCPMC12181980

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Registered trials

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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.