Evidence map›Paper›PMID 38129716›Full record

Trial reportMedical oncology (Northwood, London, England)2023

Repurposing pantoprazole in combination with systemic therapy in advanced head and neck squamous cell carcinoma: a phase I/II randomized study.

Vanita Noronha, Vijay Patil, Nandini Menon, Devanshi Kalra, Ajaykumar Singh, Minit Shah, Supriya Goud, Kunal Jobanputra, Kavita Nawale, Srushti Shah and 11 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Medical oncology (Northwood, London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 23% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

21 authors at 5 institutions in 3 countries.

Vanita NoronhaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Vijay PatilDepartment of Medical Oncology, P D Hinduja Hospital & Medical Research Centre, Khar & Mahim, India.
Nandini MenonDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Devanshi KalraDepartment of Clinical Operations, ImmunoAdoptive Cell Therapy Private Limited, R-977, Rabale Navi, Mumbai, 400701, India.
Ajaykumar SinghDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Minit ShahDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Supriya GoudDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Kunal JobanputraDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Kavita NawaleDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Srushti ShahDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Oindrila Roy ChowdhuryDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Vijayalakshmi MathrudevDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Shweta JogdhankarDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Madhu Yadav SinghDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Ashish SinghDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Supriya AdakDepartment of Clinical Operations, Senior Clinical Study Monitor, DAVA Oncology LP, 2700 W Plano Pkwy, Plano, TX, 75075, USA.
Mayuri SandeshDepartment of Clinical Medicine, Danish Center for Particle Therapy, Aarhus University Hospital, 8200, Aarhus, Denmark.
R ArunkumarDepartment of Cardiothoracic and Vascular Surgery, JIPMER, Puducherry, India.
Suman KumarDepartment of Radiodiagnosis, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Abhishek MahajanDepartment of Radiodiagnosis, The Clatterbridge Cancer Centre NHS Foundation Trust, University of Liverpool, Liverpool, UK.
Kumar PrabhashDepartment of Medical Oncology, Solid Unit, Tata Memorial Hospital, Homi Bhabha National Institute, Parel, Mumbai, 400012, India. kumarprabhashtmh@gmail.com.ORCID http://orcid.org/0000-0001-8858-5004
Homi Bhabha National Institute · INAarhus University · DKJawaharlal Institute of Post Graduate Medical Education and Research · INP. D. Hinduja Hospital and Medical Research Centre · INUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pantoprazole decreases the acidity of the tumor microenvironment by inhibiting proton pumps on the cancer cell. This possibly leads to increased sensitivity to cytotoxic therapy. We conducted a phase I/II randomized controlled trial in adult patients with head and neck squamous cell carcinoma (HNSCC) planned for first-line palliative chemotherapy. Patients were randomized to chemotherapy + / - intravenous (IV) pantoprazole. The primary endpoint in phase I was to determine the maximum safe dose of intravenous pantoprazole, whereas it was progression-free survival (PFS) in phase II. The dose of IV pantoprazole established in phase I was 240 mg. Between Nov'18 and Oct'20, we recruited 120 patients in phase II, 59 on pantoprazole and 61 on the standard arm. Median age was 51 years (IQR 43-60), 80% were men. Systemic therapy was IV cisplatin in 22% and oral-metronomic-chemotherapy (OMC) in 78%. Addition of pantoprazole did not prolong PFS, which was 2.2 months (95% CI 2.07-3.19) in the pantoprazole arm and 2.5 months (95% CI 2.04-3.81, HR, 1.14; 95% CI 0.78-1.66; P = 0.48) in the standard arm. Response rates were similar; pantoprazole arm 8.5%, standard arm 6.6%; P = 0.175. Overall survival was also similar; 5.6 months (95% CI 4.47-8.51) in the pantoprazole arm and 5.4 months (95% CI 3.48-8.54, HR 1.06; 95% CI 0.72-1.57; P = 0.75) in the standard arm. Grade ≥ 3 toxicities were similar. Thus, pantoprazole 240 mg IV added to systemic therapy does not improve outcomes in patients with advanced HNSCC.

Indexed as

Carcinoma, Squamous CellHead and Neck NeoplasmsAdultAntineoplastic Combined Chemotherapy ProtocolsCisplatinFemaleHumansMaleMiddle AgedPantoprazoleSquamous Cell Carcinoma of Head and NeckTumor MicroenvironmentCisplatinPantoprazoleHead and neck squamous cell carcinoma (HNSCC)PantoprazolePhase I/II RCTSystemic therapy

Identifiers

PMID38129716
OpenAlexW4390046013

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.