Patterns of peritoneal dissemination and response to systemic chemotherapy in common and rare peritoneal tumours treated by cytoreductive surgery: study protocol of a prospective, multicentre, observational study

Our plain-English summary of Patterns of peritoneal dissemination and response to systemic chemotherapy in common and rare peritoneal tumours treated by cytoreductive surgery: study protocol of a prospective, multicentre, observational study, by A. Bhatt, P. Rousset, D. Baratti, et al (BMJ Open, 2021).

The study

• Authors: A. Bhatt, P. Rousset, D. Baratti, D. Biacchi, N. Benzerdjeb, I. H J T de Hingh, M. Deraco, V. Gushchin, P. Kammar, D. Labow, E. Levine, B. Moran, F. Mohamed, D. Morris, S. Mehta, A. Nissan, M. Alyami, M. Adileh, S. Barat, A. Ben Yacov, K. Campbell, K. Cummins-Perry, D. Cortes-Guiral, N. Cohen, L. Parikh, S. Alammari, G. Bashanfer, A. Alshukami, K. Kundalia, G. Goswami, V.V. de Vlasakker, M. Sittig, P. Sammartino, A. Sardi, L. Villeneuve, K. Turaga, Y. Yonemura, O. Glehen
• Journal: BMJ Open
• Published: 2021;11(7):e046819
• Cited by: 9 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Introduction: Despite optimal patient selection and surgical effort, recurrence is seen in over 70% of patients undergoing cytoreductive surgery (CRS) for peritoneal metastases (PM). Apart from the Peritoneal Cancer Index (PCI), completeness of cytoreduction and tumour grade, there are other factors like disease distribution in the peritoneal cavity, pathological response to systemic chemotherapy (SC), lymph node metastases and morphology of PM which may have prognostic value. One reason for the underutilisation of these factors is that they are known only after surgery. Identifying clinical predictors, specifically radiological predictors, could lead to better utilisation of these factors in clinical decision making and the extent of peritoneal resection performed for different tumours. This study aims to study these factors, their impact on survival and identify clinical and radiological predictors.

Methods And Analysis: There is no therapeutic intervention in the study. All patients with biopsy-proven PM from colorectal, appendiceal, gastric and ovarian cancer and peritoneal mesothelioma undergoing CRS will be included. The demographic, clinical, radiological, surgical and pathological details will be collected according to a prespecified format that includes details regarding distribution of disease, morphology of PM, regional node involvement and pathological response to SC. In addition to the absolute value of PCI, the structures bearing the largest tumour nodules and a description of the morphology in each region will be recorded. A correlation between the surgical, radiological and pathological findings will be performed and the impact of these potential prognostic factors on progression-free and overall survival determined. The practices pertaining to radiological and pathological reporting at different centres will be studied.

Ethics And Dissemination: The study protocol has been approved by the Zydus Hospital ethics committee (27 July, 2020) and Lyon-Sud ethics committee (A15-128).

Trial Registration Number: CTRI/2020/09/027709; Pre-results.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

In plain English

This article was a study protocol; it reported no results. The authors set out a prospective, multicentre observational study with no study treatment. It was to include patients with peritoneal metastases from colorectal, appendiceal, gastric and ovarian cancer, and patients with peritoneal mesothelioma, who were having cytoreductive surgery (surgery to remove tumour from the abdominal lining and organs). The planned numbers were 500 colorectal, 600 ovarian, 300 appendiceal, 100 gastric and 100 peritoneal mesothelioma patients. Recruitment was planned over 2 years, followed by 5 years of follow-up. Centres were to record where disease was found in the abdomen on scans, during surgery and under the microscope. They were also to record what the tumour deposits looked like and spread to lymph nodes. For patients given chemotherapy before surgery, they were to record the tumour's response as seen under the microscope. The aim was to judge how these factors relate to outlook. The article did not discuss asbestos or how patients may have been exposed to it. The authors noted that the detailed data form might reduce compliance, and that differing treatment practices could limit the survival analyses.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Study protocol for a prospective, multicentre observational study with no therapeutic intervention; no results reported
• Who was studied: Planned: patients with biopsy-proven peritoneal metastases from colorectal, appendiceal, gastric or ovarian cancer, or with peritoneal mesothelioma, undergoing cytoreductive surgery at multiple centres. Planned sample sizes: colorectal 500, ovarian 600, appendiceal 300, peritoneal mesothelioma 100, gastric 100. Recruitment was planned for 15 September 2020 to 14 September 2022 (2 years), followed by 5 years of follow-up.
• Exposure: This was not an asbestos exposure study, and asbestos is not mentioned. The factors to be studied were disease distribution in the peritoneal cavity, pathological response to systemic chemotherapy, lymph node metastases and the morphology of peritoneal metastases, and their impact on survival. Pathological response to systemic chemotherapy was to be evaluated in patients receiving neoadjuvant chemotherapy for peritoneal metastases.
• The authors' conclusion: There are no conclusions, as this is a protocol. The authors stated that they expected the results could bear on selecting patients for surgery and on how much of the peritoneum is removed.
• Limitations the authors state:
  • The data collection format is exhaustive, which may make compliance a problem.
  • Differing treatment protocols across centres may limit evaluation of the impact on survival.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Colon cancer, Ovarian cancer.

Medical terms in this study, explained in our Lexicon: Chemotherapy, Cytoreductive Surgery, Peritoneal Cancer Index (PCI), Peritoneal Cavity, Biopsy, Ovarian Cancer, Peritoneal Mesothelioma, Overall Survival.

Related studies

• Quality of life after cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy: a prospective study of 216 patients — G. Passot, N. Bakrin, et al. (2014)
• Long-term survival outcomes of cytoreductive surgery and perioperative intraperitoneal chemotherapy: Single-institutional experience with 1225 cases — L.S. Kyang, N.A. Alzahrani, et al. (2019)
• Repeat Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy and Peritoneal Carcinomatosis — J.F. Wong, G.H. Tan, et al. (2015)
• Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in Asian patients: 100 consecutive patients in a single institution — M.C. Teo, G.H. Tan, et al. (2013)
• The results of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in 1200 patients with peritoneal malignancy — B. Moran, T. Cecil, et al. (2015)
• Long-term Survival and Propensity Score Matched Outcomes of Bilateral vs. Unilateral Diaphragm Interventions in Cytoreductive Surgery plus Intra-peritoneal Chemotherapy — B. Singh, G. Singh, et al. (2018)

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