Evidence map›Paper›PMID 34387765›Full record

ArticleAnnals of surgical oncology2022

PIPAC for the Treatment of Gynecologic and Gastrointestinal Peritoneal Metastases: Technical and Logistic Considerations of a Phase 1 Trial.

Mustafa Raoof, Gautam Malhotra, Adrian Kohut, Michael O'Leary, Paul Frankel, Thuy Tran, Marwan Fakih, Joseph Chao, Dean Lim, Yanghee Woo and 10 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Annals of surgical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
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  6. Neoplastic appendiceal mucinous lesions: a narrative review of the literature from an oncologist's perspective.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 6 institutions in 2 countries.

Mustafa RaoofDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA. Mraoof@coh.org.
Gautam MalhotraDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Adrian KohutDivision of Gynecologic Oncology, Department of Surgery, City of Hope Comprehensive Cancer Center (COH), Duarte, CA, USA.
Michael O'LearyDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Paul FrankelBiostatistics Core, City of Hope Beckman Research Institute, Duarte, CA, USA.
Thuy TranDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Marwan FakihDepartment of Medical Oncology, COH, Duarte, CA, USA.
Joseph ChaoDepartment of Medical Oncology, COH, Duarte, CA, USA.
Dean LimDepartment of Medical Oncology, COH, Duarte, CA, USA.
Yanghee WooDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Isaac B PazDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Michael LewDepartment of Anesthesiology, COH, Duarte, CA, USA.
Mihaela C CristeaDepartment of Medical Oncology, COH, Duarte, CA, USA.
Lorna Rodriguez-RodriguezDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Yuman FongDivision of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA.
Andrew BlakelyNational Institute of Health, Bethesda, MD, USA.
Richard WhelanNorthwell Cancer Center, New York, NY, USA.
Marc A ReymondTuebingen Universitaet, Tübingen, Germany.
Amit MercheaMayo Clinic, Jacksonville, FL, USA.
Thanh H DellingerDivision of Gynecologic Oncology, Department of Surgery, City of Hope Comprehensive Cancer Center (COH), Duarte, CA, USA. tdellinger@coh.org.
City Of Hope National Medical Center · USCity of Hope · USBeckman Research InstituteMayo Clinic in Florida · USNorthwell Health · USUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeritoneal metastases (PM) from ovarian, gastric, appendiceal, or colorectal origin can be treated via cytoreductive surgery with or without the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) for selected patients. Unfortunately, not all patients are candidates for aggressive surgical debulking. For these patients, pressurized intraperitoneal aerosolized chemotherapy (PIPAC) has emerged as an alternative method for intraperitoneal (IP) chemotherapy administration. This report presents the design and implementation of the first phase 1 trial to evaluate the safety and efficacy of PIPAC in the United States.

methodsThis is an ongoing prospective phase 1 clinical trial of PIPAC for patients who have histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with PM and have progressed to at least one evidence-based chemotherapeutic regimen. The trial has two clinical arms. The patients in arm 1 have gynecologic and gastric malignancies treated with IP cisplatin and doxorubicin, and the arm 2 patients have colorectal and appendiceal malignancies treated with intravenous fluorouracil and leucovorin followed by IP oxaliplatin. All the patients are monitored for dose-limiting toxicities and adverse events.

resultsPractical and technical considerations for the phase 1 PIPAC trial are presented. These considerations include patient selection, operating room setup, and technical details for successful aerosolized chemotherapy delivery. The phase 1 study results will be reported separately at completion of the trial.

conclusionsThe PIPAC treatment is a feasible, minimally invasive approach that permits IP delivery of chemotherapy. Once completed, the ongoing phase 1 trial will help to provide safety and initial efficacy data.

Indexed as

Peritoneal NeoplasmsFemaleHumansProspective Studies

Identifiers

PMID34387765
OpenAlexW3191239987

What OpenQuestion holds

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Read underepoch 390

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.