Real-World Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study.
Benoît Godbert, Elisa Gobbini, Chantal Decroisette, Hervé Lena, Yaacoub Khalife, Florence Brellier, Anne Fleuriet, Maeva Zysman, Thomas Egenod, Denis Moro Sibilot, Nicolas Girard
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引用次数: 0
Abstract
Introduction: Nivolumab is approved in France as monotherapy for the treatment of advanced (locally advanced or metastatic) non-small cell lung cancer (aNSCLC) after prior chemotherapy. The Lung Initiative on Sequence Therapy (LIST) study is evaluating the real-world effectiveness, safety and immunotherapy-rechallenge outcomes with nivolumab in previously treated French patients with aNSCLC.
Methods: This longitudinal, prospective, observational study enrolled patients with aNSCLC who received ≥ 1 prior line of treatment that included chemotherapy. Three patient cohorts, based on prior treatment, were assessed: immunotherapy-naïve (cohort 1; prior chemotherapy, no prior immunotherapy), and immunotherapy-experienced, including patients who discontinued prior immunotherapy for reasons other than immunotherapy-related toxicity (cohort 2) and those who discontinued because of immunotherapy-related toxicity (cohort 3). The primary endpoint was time to treatment discontinuation (TTD). Results after at least 12 months of follow-up are reported.
Results: At data cut-off (September 2024), 522 patients were enrolled. In cohort 1 (N = 280), cohort 2 (N = 197) and cohort 3 (N = 45), the 12-month TTD rate was 17.7% (95% CI 13.4, 22.5), 14.4% (95% CI 9.8, 19.8) and 16.7% (95% CI 7.3, 29.2), respectively. The main reason for nivolumab discontinuation was disease progression. Younger patients, those with better performance status (PS), longer prior immunotherapy duration and prolonged benefit with prior immunotherapy had numerically higher discontinuation-free rates. Median PFS was 3.2, 2.7 and 3.9 months (95% CI 2.7-4.1, 2.2-3.4, 2.2-7.4), and median overall survival (OS) was 12.3, 9.5 and 10.4 months (95% CI 8.6-13.7, 7.2-11.3, 7.6-20.1) in cohorts 1, 2 and 3, respectively. Any-grade treatment-related adverse events were reported in 36.1%, 25.0% and 37.0% of patients in the respective cohorts.
Conclusions: The 1-year results of LIST show consistent effectiveness and safety of nivolumab in immunotherapy-experienced patients, especially in specific subgroups. Nivolumab safety in patients with prior immunotherapy-related toxicity appeared to be consistent with its expected safety profile.
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Aims and Scope
Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
Rapid Publication
The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of clinical therapies.
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The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts.
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Oncology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
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Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision.
Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor.
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Oncology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0
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Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis.
Open Access
All articles published by Oncology and Therapy are published open access
Contact
For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.
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