Pneumologie 2019; 73(S 01)
DOI: 10.1055/s-0039-1678247
Posterbegehung (P19) – Sektion Pneumologische Onkologie
NSCLC metastasiert, Immunonkologie
Georg Thieme Verlag KG Stuttgart · New York

PACIFIC subgroup analysis: pneumonitis in stage III, unresectable NSCLC patients treated with durvalumab vs. placebo after CRT

M Faehling
1   Klinikum Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie
,
C Schulz
2   Klinikum der Universität Regensburg, Med. Klinik und Poliklinik II
,
H Laack
3   Hämatologie-Onkologie Hamburg
,
T Wolff
4   Oncoresearch Lerchenfeld Ug
,
A Rückert
5   Schwarzwald-Baar-Klinikum, Klinik für Innere Medizin II, Onkologie, Hämatologie, Immunologie, Infektiologie und Palliativmedizin
,
M Reck
6   Lungenclinic Grosshansdorf, Airway Research Center North (Arcn), Member of the German Center for Lung Research (Dzl), Onkologischer Schwerpunkt, Lungenclinic Grosshansdorf, Airway Research Center North (Arcn), Deutsches Zentrum für Lungenforschung (Dzl)
,
JR Fischer
7   Lungenklinik Löwenstein, Department of Oncology
,
M de Wit
8   Vivantes Klinikum Neukölln, Klinik für Hämatologie, Onkologie und Palliativmedizin, Innere Medizin
› Author Affiliations
Further Information

Publication History

Publication Date:
19 February 2019 (online)

Also available at
 

Background In the PACIFIC study of durvalumab vs. placebo in patients with stage III, unresectable NSCLC without progression after concurrent chemoradiotherapy (cCRT), on-treatment pneumonitis or radiation pneumonitis occurred with similar rates of grade 3/4 (durvalumab, 3.4%; placebo, 2.6%). We performed exploratory analyses to characterize time to onset/duration of pneumonitis and examine its relationship with underlying risk factors, patient characteristics and prior CRT.

Method PACIFIC (NCT02125461) was a phase 3, randomized, double-blind, all-comers study of patients with WHO PS 0/1 without progression after ≥ 2 cycles of platinum-based cCRT. Patients were randomized (2 : 1) after cCRT to durvalumab 10 mg/kg IV Q2W or placebo. Associations between pneumonitis and baseline characteristics or patient disposition were investigated.

Result 709 patients had received treatment; 33.6% on durvalumab and 24.9% on placebo had any-grade pneumonitis. Treatment exposure was similar in patients with or w/o pneumonitis. Median time to onset of pneumonitis was 55.0 days for durvalumab and placebo and median duration 64.0 and 57.0 days, respectively. Patients with pneumonitis were more likely Asian (47.9% vs. 17.6%) or have EGFR mutations (11.0% vs. 3.8%); however, pneumonitis-independent interaction with treatment was absent (Asian: 44.4% vs. 57.6%; EGFRm: 10.6% vs. 11.9%). Pneumonitis occured independent from baseline respiratory disorders, prior RT dose, or prior cisplatin/carboplatin use but was associated with greater discontinuation due to AEs (durvalumab: 25.6% vs. 10.2%; placebo: 18.6% vs. 6.8%). Previous induction CT was associated with absence of pneumonitis (durvalumab: 30.1% vs. 17.5%; placebo: 31.5% vs. 20.3%).

Conclusion Rates of pneumonitis were higher in Asian patients and those with EGFRm, irrespective of treatment. There were no differences in treatment exposure in patients based on the presence/absence of pneumonitis.

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