Academic Journal
Curative immune checkpoint inhibitors therapy in patients with mismatch repair-deficient locally advanced rectal cancer: a real-world observational study
| العنوان: | Curative immune checkpoint inhibitors therapy in patients with mismatch repair-deficient locally advanced rectal cancer: a real-world observational study |
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| المؤلفون: | Tosi, F, Salvatore, L, Tamburini, E, Artale, S, Lonardi, S, Marchetti, S, Pastorino, A, Pietrantonio, F, Puccini, A, Rojas-Llimpe, F L, Vincenzi, B, Mariano, S, Negri, F, Bencardino, K, Pinto, C, Aschele, C, Siena, S |
| المساهمون: | F. Tosi, L. Salvatore, E. Tamburini, S. Artale, S. Lonardi, S. Marchetti, A. Pastorino, F. Pietrantonio, A. Puccini, F.L. Rojas-Llimpe, B. Vincenzi, S. Mariano, F. Negri, K. Bencardino, C. Pinto, C. Aschele, S. Siena |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2024 |
| المجموعة: | The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| مصطلحات موضوعية: | clinical complete response, dMMR/MSI rectal cancer, dostarlimab, immune checkpoint inhibitor, immunotherapy, locally advanced rectal cancer, Settore MEDS-09/A - Oncologia medica |
| الوصف: | Background: Sustained clinical complete remissions were reported in all of 23 mismatch repair deficient/microsatellite instable (dMMR/MSI) locally advanced rectal cancer (LARC) patients treated with dostarlimab alone in a recent phase II study. These results led to off-label use of dostarlimab or other immune checkpoint inhibitors (ICIs) in dMMR/MSI-LARC even before regulatory approval. The present study [STAR(t)-IT-REDUCE] describes the outcome of dMMR/MSI-LARC patients treated with ICI in Italy. Materials and methods: Investigator-initiated, observational, retrospective-cohort, multicentric study of ICI treatment in dMMR/MSI-LARC. Patients were eligible if treated with ≥1 ICI dose from July 2022 to December 2023 (date of approval of dostarlimab for this indication in Italy). Results: Seventeen dMMR/MSI-LARC patients (13 of 17 treatment-naïve) were eligible. Fourteen patients completed 6 months of treatment, two discontinued after four doses and one after five doses because of immune-related pneumonia, social constraints, or non-oncological bowel obstruction, respectively. Overall, 16 of 17 assessable patients [94.1%; 95% confidence interval (CI) 69.24% to 99.69%, 'ITT analysis'] achieved complete clinical response (cCR). Ten of 11 treatment-naïve patients completing 6 months of treatment had cCR (90.9%; 95% CI 57.12% to 99.52%, 'per-protocol analysis'). One patient with near-CR underwent rectal surgery and minimal residual intramucosal tumor was found. With a median follow-up of 9.5 months, no local relapse occurred. One patient developed unconfirmed lung metastases. Two grade 3 and no grade 4 adverse events were reported. Conclusion: The present STAR(t)-IT-REDUCE study documents the immunoablative and curative activity of ICI monotherapy in dMMR/MSI-LARC. Toxicity and compliance issues inherent to real-world practice are limited and do not affect achievement of initial complete tumor response but may limit response duration. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/39357124; volume:9; issue:10; firstpage:1; lastpage:6; numberofpages:6; journal:ESMO OPEN; https://hdl.handle.net/2434/1106408 |
| DOI: | 10.1016/j.esmoop.2024.103929 |
| الاتاحة: | https://hdl.handle.net/2434/1106408 https://doi.org/10.1016/j.esmoop.2024.103929 |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.ECEFF7B0 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.esmoop.2024.103929 |
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