Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120)
ABSTRACT Objective: The PACIFIC trial established standard therapy for patients with unresectable stage III NSCLC who did not progress after platinum-based concurrent chemoradiation therapy. However, real-world data, particularly from Latin America, remain limited. The LACOG 0120 study aimed to eva...
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Sociedade Brasileira de Pneumologia e Tisiologia
2025-01-01
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| Series: | Jornal Brasileiro de Pneumologia |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-37132024000600603&lng=en&tlng=en |
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| author | Mauro Zukin Victor Gondim Andrea Kazumi Shimada Ellias Magalhães e Abreu Lima Clarissa Mathias Williams Fernandes Barra William Nassib William Junior Mônica Padoan Yuri Bittencourt Rosely Yamamura Carlos Eduardo Baston Silva Letícia de Jesus Rossato Caio de Almeida Monteiro Rafaela Gomes de Jesus Gustavo Gössling Ana Caroline Zimmer Gelatti |
| author_facet | Mauro Zukin Victor Gondim Andrea Kazumi Shimada Ellias Magalhães e Abreu Lima Clarissa Mathias Williams Fernandes Barra William Nassib William Junior Mônica Padoan Yuri Bittencourt Rosely Yamamura Carlos Eduardo Baston Silva Letícia de Jesus Rossato Caio de Almeida Monteiro Rafaela Gomes de Jesus Gustavo Gössling Ana Caroline Zimmer Gelatti |
| author_sort | Mauro Zukin |
| collection | DOAJ |
| description | ABSTRACT Objective: The PACIFIC trial established standard therapy for patients with unresectable stage III NSCLC who did not progress after platinum-based concurrent chemoradiation therapy. However, real-world data, particularly from Latin America, remain limited. The LACOG 0120 study aimed to evaluate the efficacy and safety of consolidation therapy with durvalumab in a real-world setting in Brazil. Methods: Patients with unresectable stage III NSCLC who received chemoradiotherapy followed by durvalumab consolidation therapy through an expanded access program were evaluated. The primary objective was to assess progression-free survival (PFS). Secondary endpoints included overall survival (OS), treatment compliance, and safety, with a focus on the incidence and severity of immune-mediated adverse events (NCT04948411). Results: Thirty-one patients from seven centers were evaluated. Median follow-up was 50.3 months (95% CI: 48.6-54.4). Median PFS was 9.9 months (95% CI: 7.3-52.4), with a 36 month-PFS of 34.5% (95% CI: 17.7-52.1). Median OS was 34.9 months (95% CI: 26.0-NR), and the 36 month-OS was 46.3% (95% CI: 25.7-64.6). Durvalumab was administered for a median of 17 cycles (10 to 24), with 45.2% of patients completing the planned therapy. The main reason for discontinuation was disease progression. Treatment-related adverse events of any grade occurred in 12 patients (38.7%), with grade 3 events reported in two (6.5%). Pneumonitis was observed in 4 patients (12.9%) - grade 3 in 1 patient. Conclusions: PFS was lower in this analysis compared to the PACIFIC trial; however, OS was similar, indicating comparable efficacy in a real-world setting among Brazilian patients with unresectable stage III NSCLC. No new safety concerns were identified. |
| format | Article |
| id | doaj-art-97615a0c6ce14ca4a736f2150ef3b804 |
| institution | Kabale University |
| issn | 1806-3756 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Sociedade Brasileira de Pneumologia e Tisiologia |
| record_format | Article |
| series | Jornal Brasileiro de Pneumologia |
| spelling | doaj-art-97615a0c6ce14ca4a736f2150ef3b8042025-01-21T07:39:25ZengSociedade Brasileira de Pneumologia e TisiologiaJornal Brasileiro de Pneumologia1806-37562025-01-0150610.36416/1806-3756/e20240228Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120)Mauro Zukinhttps://orcid.org/0000-0002-6439-3136Victor Gondimhttps://orcid.org/0009-0007-8592-1579Andrea Kazumi Shimadahttps://orcid.org/0000-0001-7221-3054Ellias Magalhães e Abreu Limahttps://orcid.org/0009-0007-6571-8813Clarissa Mathiashttps://orcid.org/0000-0002-6219-9858Williams Fernandes Barrahttps://orcid.org/0000-0001-8954-4212William Nassib William Juniorhttps://orcid.org/0000-0001-5008-8854Mônica Padoanhttps://orcid.org/0009-0008-5260-3141Yuri Bittencourthttps://orcid.org/0000-0002-0591-128XRosely Yamamurahttps://orcid.org/0000-0002-2823-7910Carlos Eduardo Baston Silvahttps://orcid.org/0000-0001-8520-0850Letícia de Jesus Rossatohttps://orcid.org/0000-0003-2416-6614Caio de Almeida Monteirohttps://orcid.org/0009-0004-7728-9778Rafaela Gomes de Jesushttps://orcid.org/0000-0001-6912-2995Gustavo Gösslinghttps://orcid.org/0000-0002-4361-2889Ana Caroline Zimmer Gelattihttps://orcid.org/0000-0002-5939-8071ABSTRACT Objective: The PACIFIC trial established standard therapy for patients with unresectable stage III NSCLC who did not progress after platinum-based concurrent chemoradiation therapy. However, real-world data, particularly from Latin America, remain limited. The LACOG 0120 study aimed to evaluate the efficacy and safety of consolidation therapy with durvalumab in a real-world setting in Brazil. Methods: Patients with unresectable stage III NSCLC who received chemoradiotherapy followed by durvalumab consolidation therapy through an expanded access program were evaluated. The primary objective was to assess progression-free survival (PFS). Secondary endpoints included overall survival (OS), treatment compliance, and safety, with a focus on the incidence and severity of immune-mediated adverse events (NCT04948411). Results: Thirty-one patients from seven centers were evaluated. Median follow-up was 50.3 months (95% CI: 48.6-54.4). Median PFS was 9.9 months (95% CI: 7.3-52.4), with a 36 month-PFS of 34.5% (95% CI: 17.7-52.1). Median OS was 34.9 months (95% CI: 26.0-NR), and the 36 month-OS was 46.3% (95% CI: 25.7-64.6). Durvalumab was administered for a median of 17 cycles (10 to 24), with 45.2% of patients completing the planned therapy. The main reason for discontinuation was disease progression. Treatment-related adverse events of any grade occurred in 12 patients (38.7%), with grade 3 events reported in two (6.5%). Pneumonitis was observed in 4 patients (12.9%) - grade 3 in 1 patient. Conclusions: PFS was lower in this analysis compared to the PACIFIC trial; however, OS was similar, indicating comparable efficacy in a real-world setting among Brazilian patients with unresectable stage III NSCLC. No new safety concerns were identified.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-37132024000600603&lng=en&tlng=enNon-Small-Cell Lung CancerDurvalumabConsolidation TherapyReal-World DataBrazil |
| spellingShingle | Mauro Zukin Victor Gondim Andrea Kazumi Shimada Ellias Magalhães e Abreu Lima Clarissa Mathias Williams Fernandes Barra William Nassib William Junior Mônica Padoan Yuri Bittencourt Rosely Yamamura Carlos Eduardo Baston Silva Letícia de Jesus Rossato Caio de Almeida Monteiro Rafaela Gomes de Jesus Gustavo Gössling Ana Caroline Zimmer Gelatti Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) Jornal Brasileiro de Pneumologia Non-Small-Cell Lung Cancer Durvalumab Consolidation Therapy Real-World Data Brazil |
| title | Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) |
| title_full | Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) |
| title_fullStr | Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) |
| title_full_unstemmed | Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) |
| title_short | Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120) |
| title_sort | durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage iii nsclc real world data from an expanded access program in brazil lacog 0120 |
| topic | Non-Small-Cell Lung Cancer Durvalumab Consolidation Therapy Real-World Data Brazil |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-37132024000600603&lng=en&tlng=en |
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