Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study
| Autor: | Nicolas, Girard, Jair, Bar, Pilar, Garrido, Marina C, Garassino, Fiona, McDonald, Françoise, Mornex, Andrea R, Filippi, Hans J M, Smit, Solange, Peters, John K, Field, Daniel C, Christoph, Anne, Sibille, Rainer, Fietkau, Vilde D, Haakensen, Christos, Chouaid, Ben, Markman, T Jeroen N, Hiltermann, Alvaro, Taus, William, Sawyer, Allison, Allen, Pratibha, Chander, Muriel, Licour, Benjamin, Solomon |
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| Přispěvatelé: | Translational Immunology Groningen (TRIGR) |
| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: |
Pulmonary and Respiratory Medicine
Humans Antineoplastic Agents Immunological/therapeutic use Carcinoma Non-Small-Cell Lung/drug therapy Chemoradiotherapy Cohort Studies Ligands Lung Neoplasms/drug therapy Progression-Free Survival Retrospective Studies Consolidation therapy Immunotherapy Locally advanced NSCLC PD-L1 inhibition Real-world data Oncology |
| Zdroj: | Journal of thoracic oncology, vol. 18, no. 2, pp. 181-193 Journal of Thoracic Oncology, 18(2), 181-193. ELSEVIER SCIENCE INC |
| ISSN: | 1556-0864 |
| Popis: | Introduction: The phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III NSCLC and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program. Here, we report treatment characteristics and a preplanned analysis of real-world progression-free survival (rwPFS).Methods: PACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every 2 wk) within an early access program between September 2017 and December 2018. The primary end points are investigator-assessed rwPFS and overall survival (analyzed by Kaplan–Meier method).Results: As of November 30, 2020, the full analysis set comprised 1399 patients from 11 countries (median follow-up duration, 23.5 mo). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% confidence interval: 19.1–24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 versus 19.3 mo) and among patients with programmed cell death-ligand 1 expression greater than or equal to 1% versus less than 1% (22.4 versus 15.6 mo). Overall, 16.5% of the patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis or interstitial lung disease.Conclusions: Consolidation durvalumab after definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was longer among patients who received concurrent versus sequential CRT and patients with higher programmed cell death-ligand 1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors. |
| Databáze: | OpenAIRE |
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