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Clinical Trials in Gastroesophageal Cancer

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A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Clinical Research of Cancer".

Deadline for manuscript submissions: closed (23 February 2024) | Viewed by 3608

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Dr. Sheraz Rehan Markar

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Guest Editor

Nuffield Department of Surgery, University of Oxford, Oxford OX1 2JD, UK
Interests: esophageal cancer; gastric cancer; surgery

Special Issue Information

Dear Colleagues,

Clinical trials underpin modern clinical practice for patients with gastroesophageal cancer. Multimodality therapy remains the mainstay of treatment for gastroesophageal cancer, with the evidence for its effectiveness coming largely from recent clinical trials integrating immunotherapy into the therapeutic repertoire. However, clinical trials of gastroesophageal cancer are notoriously challenging, as several pitfalls are associated with the design and delivery of these trials in a complex cohort of patients with a highly heterogenous tumor. The field is developing even further as we move towards trials with a greater degree of international collaboration that include the introduction of novel endpoints, surgical and radiological quality assurance and the utilization of machine learning algorithms, warranting a Special Issue in this area.

We invite the submission of papers detailing clinical trials in gastroesophageal cancer, along with articles in the following areas:

- Clinical trials concerning the diagnosis or management of gastroesophageal cancer.

- Challenges to undertaking trials in gastroesophageal cancer.

- Quality assurance of interventions concerning gastroesophageal cancer.

- Future prospects for clinical trials of gastroesophageal cancer.

Dr. Sheraz Rehan Markar
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cancers is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

esophageal cancer
gastric cancer
oncology
surgery
clinical trials
diagnostics
treatment

Published Papers (4 papers)

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Research

12 pages, 852 KiB

Open AccessArticle

Perioperative Chemotherapy for Gastro-Esophageal or Gastric Cancer: Anthracyclin Triplets versus FLOT

by Julie F. M. Geerts, Charlène J. van der Zijden, Pieter C. van der Sluis, Manon C. W. Spaander, Grard A. P. Nieuwenhuijzen, Camiel Rosman, Hanneke W. M. van Laarhoven, Rob H. A. Verhoeven, Bas P. L. Wijnhoven, Sjoerd M. Lagarde and Bianca Mostert

Cancers 2024, 16(7), 1291; https://doi.org/10.3390/cancers16071291 - 26 Mar 2024

Viewed by 540

Abstract

Background: The FLOT4-AIO trial (2019) showed improved survival with perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) compared to anthracyclin triplets in gastric cancer treatment. It is unclear whether these results extend to real-world scenarios in the Netherlands. This study aimed to compare outcomes of perioperative FLOT to anthracyclin triplets in a real-world Dutch gastric cancer population. Methods: Patients diagnosed with resectable (cT2-4a/cTxN0-3/NxM0) gastric or gastro-esophageal junction carcinoma between 2015–2021 who received neoadjuvant FLOT or anthracyclin triplets were selected from the Netherlands Cancer Registry. The primary outcome was overall survival (OS), analyzed through multivariable Cox regression. Secondary outcomes included pathological complete response (pCR), neoadjuvant chemotherapy cycle completion, surgical resection rates, and adjuvant therapy. Results: Adjusted OS showed no significant survival benefit (HR = 0.88, 95% CI 0.77–1.01, p = 0.07), even though the median OS was numerically improved by 8 months with FLOT compared to anthracyclin triplets (48.1 vs. 39.9 months, p = 0.16). FLOT patients were more likely to undergo diagnostic staging laparoscopies (74.2% vs. 44.1%, p < 0.001), had higher rates of completing neoadjuvant chemotherapy (OR = 1.35, 95% CI 1.09–1.68, p = 0.007), receiving adjuvant therapy (OR = 1.34, 95% CI 1.08–1.66, p = 0.08), and achieving pCR (OR = 1.52, 95% CI 1.05–2.20, p = 0.03). No significant differences were observed in (radical) resection rates. Conclusion(s): Real-world data showed no significant OS improvement for FLOT-treated patients compared to anthracyclin triplets, despite more staging laparoscopies. However, FLOT patients demonstrated higher rates of neoadjuvant therapy completion, proceeding to adjuvant therapy, and increased pCR rates. Therefore, we recommend the continued use of neoadjuvant FLOT therapy in the current clinical setting. Full article

(This article belongs to the Special Issue Clinical Trials in Gastroesophageal Cancer)

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10 pages, 456 KiB

Open AccessArticle

Estimating the Time Toxicity of Contemporary Systemic Treatment Regimens for Advanced Esophageal and Gastric Cancers

by Neha Y. Agrawal, Rajat Thawani, Corbin P. Edmondson and Emerson Y. Chen

Cancers 2023, 15(23), 5677; https://doi.org/10.3390/cancers15235677 - 30 Nov 2023

Viewed by 771

Abstract

(1) Background: The purpose of this study was to evaluate the time toxicity, or time spent in health care, of immunotherapy- versus chemotherapy-based regimens for metastatic esophageal and gastric cancers. (2) Methods: A literature search was conducted, and 18 phase III clinical trials of immune checkpoint inhibitors were selected for analysis. Health care days were calculated based on the number of days associated with receiving therapy and the adverse events reported in the clinical trials. Both the number of health care days and the median overall survival were compared among chemotherapy-only, immunotherapy-only, and chemo-immunotherapy regimens across this cohort of drug registration trials. (3) Results: The estimated median number of health care days was 37 (range of 7–52) days, or 1.2 (range of 0.2–1.7) months, compared to a median survival of 10.2 months across these 18 studies. For the chemotherapy-only regimens, the median number of health care days was 39 (range of 21–51) days, and for chemo-immunotherapy, it was 39 (range of 30–52) days. The immunotherapy-only regimens had fewer days, a median of 28 (range of 24–41), p < 0.05, compared to the other two arms. (4) Conclusions: The chemo-immunotherapy regimens did not add time toxicity compared to chemotherapy alone. The immunotherapy-only regimens had lower time toxicity compared to chemotherapy alone. In the setting of decreased time toxicity and improved overall survival, further development of immunotherapy-based regimens could improve outcomes in advanced esophageal and gastric cancers. Full article

(This article belongs to the Special Issue Clinical Trials in Gastroesophageal Cancer)

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10 pages, 1609 KiB

Open AccessArticle

Quality of Life and Independent Factors Associated with Poor Digestive Function after Ivor Lewis Esophagectomy

by Valerian Dirr, Diana Vetter, Thomas Sartoretti, Marcel André Schneider, Francesca Da Canal and Christian A. Gutschow

Cancers 2023, 15(23), 5569; https://doi.org/10.3390/cancers15235569 - 24 Nov 2023

Viewed by 785

Abstract

Transthoracic esophagectomy results in a radical change in foregut anatomy with multiple consequences for digestive physiology. The aim of this study was to identify factors associated with poor functional outcomes by assessing multiple dimensions of digestive performance and health-related quality of life (HRQL). Patients with cancer-free survival after Ivor Lewis esophagectomy were included. Four functional syndromes (dysphagia, gastroesophageal reflux disease (GERD), delayed gastric conduit emptying (DGCE), and dumping syndrome (DS)) and HRQL were assessed using specifically designed questionnaires. Patient outcomes were compared with healthy controls. Independent factors associated with poor digestive performance were identified through multivariable analysis. Sixty-five postoperative patients and 50 healthy volunteers participated in this study. Compared with controls, patients had worse outcomes for dysphagia, GERD, DS, and HRQL, but not for DGCE. A multivariate analysis showed a significant correlation of reduced digestive performance with ASA score, squamous cell carcinoma, open or hybrid surgical approach, and (neo)adjuvant therapy. In contrast, no individual patient factor was found to be associated with dumping syndrome. Digestive function and HRQL are substantially impaired after Ivor Lewis esophagectomy for cancer. Comorbid patients undergoing multimodal treatment and open access surgery for squamous cell carcinoma have the highest risk of poor functional outcome. Full article

(This article belongs to the Special Issue Clinical Trials in Gastroesophageal Cancer)

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12 pages, 642 KiB

Open AccessArticle

Long-Term Survival Associated with Direct Oral Feeding Following Minimally Invasive Esophagectomy: Results from a Randomized Controlled Trial (NUTRIENT II)

by Tessa C. M. Geraedts, Teus J. Weijs, Gijs H. K. Berkelmans, Laura F. C. Fransen, Ewout A. Kouwenhoven, Marc J. van Det, Magnus Nilsson, Sjoerd M. Lagarde, Richard van Hillegersberg, Sheraz R. Markar, Grard A. P. Nieuwenhuijzen and Misha D. P. Luyer

Cancers 2023, 15(19), 4856; https://doi.org/10.3390/cancers15194856 - 5 Oct 2023

Viewed by 886

Abstract

Advancements in perioperative care have improved postoperative morbidity and recovery after esophagectomy. The direct start of oral intake can also enhance short-term outcomes following minimally invasive Ivor Lewis esophagectomy (MIE-IL). Subsequently, short-term outcomes may affect long-term survival. This planned sub-study of the NUTRIENT II trial, a multicenter randomized controlled trial, investigated the long-term survival of direct versus delayed oral feeding following MIE-IL. The outcomes included 3- and 5-year overall survival (OS) and disease-free survival (DFS), and the influence of complications and caloric intake on OS. After excluding cases of 90-day mortality, 145 participants were analyzed. Of these, 63 patients (43.4%) received direct oral feeding. At 3 years, OS was significantly better in the direct oral feeding group (p = 0.027), but not at 5 years (p = 0.115). Moreover, 5-year DFS was significantly better in the direct oral feeding group (p = 0.047) and a trend towards improved DFS was shown at 3 years (p = 0.079). Postoperative complications and caloric intake on day 5 did not impact OS. The results of this study show a tendency of improved 3-year OS and 5-year DFS, suggesting a potential long-term survival benefit in patients receiving direct oral feeding after esophagectomy. However, the findings should be further explored in larger future trials. Full article

(This article belongs to the Special Issue Clinical Trials in Gastroesophageal Cancer)

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