Evidence map›Paper›PMID 33544279›Full record

Trial reportAnnals of surgical oncology2021

Pressurized Intraperitoneal Aerosol Chemotherapy (Oxaliplatin) for Unresectable Colorectal Peritoneal Metastases: A Multicenter, Single-Arm, Phase II Trial (CRC-PIPAC).

Koen P Rovers, Emma C E Wassenaar, Robin J Lurvink, Geert-Jan M Creemers, Jacobus W A Burger, Maartje Los, Clément J R Huysentruyt, Gesina van Lijnschoten, Joost Nederend, Max J Lahaye and 5 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
9.4field-weighted citation impact, top 1% 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

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

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  20. PIPAC for Gastrointestinal Malignancies.Journal of clinical medicine · 2023
    Review
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

15 authors at 5 institutions in 1 country.

Koen P Rovers *Department of Surgery, Catharina Cancer Institute, Eindhoven, The Netherlands.
Emma C E Wassenaar *Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.
Robin J LurvinkDepartment of Surgery, Catharina Cancer Institute, Eindhoven, The Netherlands.
Geert-Jan M CreemersDepartment of Medical Oncology, Catharina Cancer Institute, Eindhoven, The Netherlands.
Jacobus W A BurgerDepartment of Surgery, Catharina Cancer Institute, Eindhoven, The Netherlands.
Maartje LosDepartment of Medical Oncology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Clément J R HuysentruytDepartment of Pathology, Catharina Cancer Institute, Eindhoven, The Netherlands.
Gesina van LijnschotenDepartment of Pathology, Catharina Cancer Institute, Eindhoven, The Netherlands.
Joost NederendDepartment of Radiology, Catharina Cancer Institute, Eindhoven, The Netherlands.
Max J LahayeDepartment of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Maarten J DeenenDepartment of Clinical Pharmacy, Catharina Cancer Institute, Eindhoven, The Netherlands.
Marinus J WiezerDepartment of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.
Simon W NienhuijsDepartment of Surgery, Catharina Cancer Institute, Eindhoven, The Netherlands.
Djamila BoermaDepartment of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.
Ignace H J T de HinghDepartment of Surgery, Catharina Cancer Institute, Eindhoven, The Netherlands. ignace.d.hingh@catharinaziekenhuis.nl.
Catharina Ziekenhuis · NLSt. Antonius Ziekenhuis · NLRadboud University Nijmegen · NLMaastricht University · NLThe Netherlands Cancer Institute · NL

Funding

Catharina Research Foundation 2017-5Sint Antonius Research Foundation 17-4
6 · The paper itself

Abstract

backgroundDespite its increasing use, pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) has never been prospectively investigated as a palliative monotherapy for colorectal peritoneal metastases in clinical trials. This trial aimed to assess the safety (primary aim) and antitumor activity (key secondary aim) of PIPAC-OX monotherapy in patients with unresectable colorectal peritoneal metastases.

methodsIn this two-center, single-arm, phase II trial, patients with isolated unresectable colorectal peritoneal metastases in any line of palliative treatment underwent 6-weekly PIPAC-OX (92 mg/m

resultsTwenty enrolled patients underwent 59 (median 3, range 1-6) PIPAC-OX procedures. Major treatment-related adverse events occurred in 3 of 20 (15%) patients after 5 of 59 (8%) procedures (abdominal pain, intraperitoneal hemorrhage, iatrogenic pneumothorax, transient liver toxicity), including one possibly treatment-related death (sepsis of unknown origin). Minor treatment-related adverse events occurred in all patients after 57 of 59 (97%) procedures, the most common being abdominal pain (all patients after 88% of procedures) and nausea (65% of patients after 39% of procedures). Median hospital stay was 1 day (range 0-3). Response rates were 0% (radiological), 50% (biochemical), 56% (pathological), and 56% (ascites). Median progression-free and overall survival were 3.5 months (interquartile range [IQR] 2.5-5.7) and 8.0 months (IQR 6.3-12.6), respectively.

conclusionsIn patients with unresectable colorectal peritoneal metastases undergoing PIPAC-OX monotherapy, some major adverse events occurred and minor adverse events were common. The clinical relevance of observed biochemical, pathological, and ascites responses remains to be determined, especially since radiological response was absent.

Indexed as

Colorectal NeoplasmsPeritoneal NeoplasmsAerosolsAntineoplastic Combined Chemotherapy ProtocolsHumansOxaliplatinAerosolsOxaliplatin

Identifiers

PMID33544279
OpenAlexW3127884565

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.