Evidence map›Paper›PMID 34757489›Full record

Trial reportSurgical endoscopy2022

Patient-reported outcomes during repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for isolated unresectable colorectal peritoneal metastases in a multicenter, single-arm, phase 2 trial (CRC-PIPAC).

Robin J Lurvink, Koen P Rovers, Emma C E Wassenaar, Checca Bakkers, Jacobus W A Burger, Geert-Jan M Creemers, Maartje Los, Floortje Mols, Marinus J Wiezer, Simon W Nienhuijs and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Surgical endoscopy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03246321 (Repetitive Electrostatic Pressurised Intraperitoneal Aerosol Chemotherapy With Oxaliplatin), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT03246321 phase2completednot on this map

Repetitive Electrostatic Pressurised Intraperitoneal Aerosol Chemotherapy With Oxaliplatin (ePIPAC-OX) as a Palliative Monotherapy for Isolated Unresectable Colorectal Peritoneal Metastases: Protocol of a Multicentre, Open-label, Single-arm, Phase II Study (CRC-PIPAC)

TypeinterventionalSponsorKoen RoversRan2017 to 2019Enrolled20ConditionsColorectal Neoplasms, Peritoneal Neoplasms, Appendiceal Neoplasms, Peritoneal CarcinomatosisArmsrepetitive ePIPAC-OX
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. PIPAC for Gastrointestinal Malignancies.Journal of clinical medicine · 2023
    Review
  7. Review
  8. 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

12 authors at 4 institutions in 1 country.

Robin J Lurvink *Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.ORCID http://orcid.org/0000-0002-2692-0994
Koen P Rovers *Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Emma C E WassenaarDepartment of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
Checca BakkersDepartment of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Jacobus W A BurgerDepartment of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Geert-Jan M CreemersDepartment of Medical Oncology, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Maartje LosDepartment of Medical Oncology, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
Floortje MolsDepartment of Research and Development, Netherlands Comprehensive Cancer Organization, Utrecht, The Netherlands.
Marinus J WiezerDepartment of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
Simon W NienhuijsDepartment of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Djamila BoermaDepartment of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
Ignace H J T de HinghDepartment of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands. ignace.d.hingh@catharinaziekenhuis.nl.
St. Antonius Ziekenhuis · NLNetherlands Comprehensive Cancer Organisation · NLRadboud University Nijmegen · NLTilburg University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment.

methodsIn this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m

resultsTwenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure.

conclusionsPatients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure.

trial registrationClinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426.

Indexed as

Colorectal NeoplasmsPeritoneal NeoplasmsAbdominal PainAerosolsFatigueHumansOxaliplatinPatient Reported Outcome MeasuresAerosolsOxaliplatinAntineoplastic agentsColorectal neoplasmsOxaliplatinPatient-reported outcome measuresPeritoneal neoplasmsQuality of life

Identifiers

PMID34757489
PMCPMC9085665
OpenAlexW3211528296

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.