Abstract
Original language | English |
---|---|
Article number | 100410 |
Journal | ESMO open |
Volume | 7 |
Issue number | 2 |
Early online date | 2 Mar 2022 |
DOIs | |
Publication status | Published - 1 Apr 2022 |
Keywords
- chemotherapy
- immunotherapy
- multimodality therapy
- radiation therapy
- surgery
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In: ESMO open, Vol. 7, No. 2, 100410, 01.04.2022.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer
T2 - an exploratory analysis from the PACIFIC trial
AU - Senan, S.
AU - Özgüroğlu, M.
AU - Daniel, D.
AU - Villegas, A.
AU - Vicente, D.
AU - Murakami, S.
AU - Hui, R.
AU - Faivre-Finn, C.
AU - Paz-Ares, L.
AU - Wu, Y. L.
AU - Mann, H.
AU - Dennis, P. A.
AU - Antonia, S. J.
N1 - Funding Information: This study (NCT02125461) was sponsored by AstraZeneca (no grant number). Funding Information: Medical writing support, under the direction of the authors, was provided by James Holland, PhD, of Ashfield MedComms (Macclesfield, UK), an Ashfield Health company, and was funded by AstraZeneca. CF-F is supported by a grant from the National Institute for Health Research (NIHR) Manchester Biomedical Research Center. This study (NCT02125461) was sponsored by AstraZeneca (no grant number). SS reports participating on advisory boards for AstraZeneca, Celgene, Merck Sharp & Dohme, BeiGene, Eli Lilly, and Varian Medical Systems; and institutional research grants from AstraZeneca, Varian Medical Systems, and ViewRay Inc. M? reports receiving personal fees from Janssen, Astellas, Bristol-Myers Squibb, Novartis, Pfizer, Roche, Sanofi, AstraZeneca, and MSD; and reports receiving a research grant from Janssen. DD reports receiving institutional research support from AstraZeneca, Genentech, Guardant Health, Janssen Research and Development, Bristol-Myers Squibb, G1 Therapeutics, Merck & Co, Inc. Novartis, AbbVie, ARMO Biosciences, Immunomedics, Eli Lilly, Merus NV, and Daiichi Sankyo. AV reports receiving personal fees for participating in a speakers? bureau for AstraZeneca. DV reports receiving honoraria from AstraZeneca; receiving institutional research support from AstraZeneca, Pfizer, Bristol-Myers Squibb, Merck Sharp & Dohme, and Roche; undertaking a consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MDS Oncology, Pfizer, and Roche/Genentech; and receiving travel/accommodation/expenses from AstraZeneca, Pfizer, Merck Sharp & Dohme, and Roche. SM reports receiving institutional research support from Takeda Pharmaceuticals; and receiving travel/accommodations/expenses from AstraZeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Taiho Pharmaceutical, and Ono Pharmaceutical. RH reports participating on advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Oncosec, Pfizer, Seagen, and Roche; receiving honoraria from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Oncosec, Pfizer, Seagen, and Roche; receiving research funding (paid to the institution) from AstraZeneca, Eli Lilly, Merck Sharp & Dohme, Novartis, Onosec, Roche, and Seagen; and receiving travel, accommodations, and expenses from Novartis. CF-F reports receiving honoraria from AstraZeneca; participating in a speaker's bureau and an advisory board for AstraZeneca (fees paid to institution); is a scientific committee member/chair for AstraZeneca; and reports receiving research funding and travel, accommodations, or expenses from AstraZeneca and Elekta. LP-A reports being board member of Genomica; participating in a leadership role for ALTUM Sequencing; participating in a speaker's bureau for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merk Serono, MSD Oncology, Pfizer, and Roche/Genentech; receiving honoraria from Amgen, AstraZeneca, Bayer, Blueprint Medicines, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Incyte, Ipsen, Eli Lilly, Merck Serono, Mirati Therapeutics, MSD, Novartis, Pfizer, PharmaMar, Roche/Genentech, Sanofi, Servier, Sysmex, and Takeda; receiving research funding (paid to the institution) from AstraZeneca, Bristol-Myers Squibb, Kura Oncology, Merck Sharp and Dohme, and PharmaMar; and receiving travel, accommodations, or expenses from Roche, AstraZeneca, AstraZeneca Spain, Bristol-Myers Squibb, Merck Sharp and Dohme, Eli Lilly, Pfizer, and Takeda. YLW reports receiving institutional research support from Roche, Pfizer, and Boehringer Ingelheim; receiving consultancy fees from AstraZeneca, Boehringer Ingelheim, Takeda, Roche, and Merck; and receiving honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/China, Hengrui Pharmaceutical, MSD Oncology, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi, and Merck. HM is an employee of AstraZeneca and holds stock or stock options in AstraZeneca. PAD is a former employee of AstraZeneca and holds stock or stock options in AstraZeneca. SJA reports a consulting or advisory role for AstraZeneca, Achilles Therapeutics, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, CBMG, Celsius Therapeutics, EMD Serono, G1 Therapeutics, GlaxoSmithKline, Glympse Bio, Memgen, Merck, RAPT Therapeutics, Samyang, Tarus Therapeutics, and Venn Therapeutics. Funding Information: Medical writing support, under the direction of the authors, was provided by James Holland, PhD, of Ashfield MedComms (Macclesfield, UK), an Ashfield Health company, and was funded by AstraZeneca . CF-F is supported by a grant from the National Institute for Health Research (NIHR) Manchester Biomedical Research Center. Publisher Copyright: © 2022 The Author(s)
PY - 2022/4/1
Y1 - 2022/4/1
N2 - Background: The phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC. Materials and methods: Patients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2: 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models. Results: Of 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status. Conclusions: Consistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.
AB - Background: The phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC. Materials and methods: Patients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2: 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models. Results: Of 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status. Conclusions: Consistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.
KW - chemotherapy
KW - immunotherapy
KW - multimodality therapy
KW - radiation therapy
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85125540674&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.esmoop.2022.100410
DO - https://doi.org/10.1016/j.esmoop.2022.100410
M3 - Article
C2 - 35247871
SN - 2059-7029
VL - 7
JO - ESMO open
JF - ESMO open
IS - 2
M1 - 100410
ER -