Kartolo A1, Shah H2, Hopman W3, Fung As4, Wheatley-Price P2, Robinson A5. 1. Division of Medical Oncology, Department of Oncology, Queen's University, Canada. Electronic address: 12bak@queensu.ca. 2. Division of Medical Oncology, Department of Medicine, University of Ottawa, Canada and Ottawa Hospital Research Institute, Canada. 3. Department of Public Health Sciences, Queen's University, Canada. 4. Division of Medical Oncology, Department of Oncology, Queen's University, Canada. 5. Division of Medical Oncology, Department of Oncology, Queen's University, Canada. Electronic address: Andrew.Robinson@kingstonhsc.ca.
Abstract
AIM: To investigate the impact of PD-L1 expression status on consolidative durvalumab efficacy and safety in stage III NSCLC patients. METHODS: This retrospective, ethics board approved, multi-centre study included all patients with histologically and/or cytologically confirmed unresectable stage III NSCLC, EGFR/ALK wild-type patients who completed concurrent chemoradiation therapy (cCRT) from January 2018 to August 2020 at the Cancer Centre of Southeastern Ontario and The Ottawa Hospital Cancer Centre. PD-L1 status was grouped as ≥50% vs. 1-49% vs. <1%. Primary study endpoint was overall survival (OS). RESULTS: Of the total 63 patients, 27 (43%), 16 (25%), 8 (13%), and 12 (19%) patients in the PD-L1 ≥50%, PD-L1 1-49%, PD-L1 <1%, and PD-L1 unknown groups (reported separately), respectively. With the median follow-up of 17.0 months, our multivariable Cox analysis suggested PD-L1≥50% was independently associated with improved OS compared to PD-L1<1% group (HR 0.18, 95%CI 0.04-0.86, P = 0.03). There were no significant differences in OS outcomes between PD-L1 1-49% and PD-L1 <1% group (HR 0.36, 95%CI 0.08-1.63, P = 0.18). Any grade treatment-related pneumonitis was observed in 46% of patients. Sixty-two percent, 38%, and 18% of patients required systemic corticosteroid use, hospitalization, and permanent treatment discontinuation due to pneumonitis, respectively. CONCLUSIONS: Our multi-centre, real-world study supported the use of consolidative durvalumab in inoperable stage III PD-L1 expressing NSCLC. Pneumonitis was significant, and higher than expected. Benefit appeared greater in high PD-L1 expressing patients, consistent with the subgroup analysis from the landmark PACIFIC trial. Our results need to be interpreted with cautions due to small sample size and a relatively short follow-up duration.
AIM: To investigate the impact of PD-L1 expression status on consolidative durvalumab efficacy and safety in stage III NSCLC patients. METHODS: This retrospective, ethics board approved, multi-centre study included all patients with histologically and/or cytologically confirmed unresectable stage III NSCLC, EGFR/ALK wild-type patients who completed concurrent chemoradiation therapy (cCRT) from January 2018 to August 2020 at the Cancer Centre of Southeastern Ontario and The Ottawa Hospital Cancer Centre. PD-L1 status was grouped as ≥50% vs. 1-49% vs. <1%. Primary study endpoint was overall survival (OS). RESULTS: Of the total 63 patients, 27 (43%), 16 (25%), 8 (13%), and 12 (19%) patients in the PD-L1 ≥50%, PD-L1 1-49%, PD-L1 <1%, and PD-L1 unknown groups (reported separately), respectively. With the median follow-up of 17.0 months, our multivariable Cox analysis suggested PD-L1≥50% was independently associated with improved OS compared to PD-L1<1% group (HR 0.18, 95%CI 0.04-0.86, P = 0.03). There were no significant differences in OS outcomes between PD-L1 1-49% and PD-L1 <1% group (HR 0.36, 95%CI 0.08-1.63, P = 0.18). Any grade treatment-related pneumonitis was observed in 46% of patients. Sixty-two percent, 38%, and 18% of patients required systemic corticosteroid use, hospitalization, and permanent treatment discontinuation due to pneumonitis, respectively. CONCLUSIONS: Our multi-centre, real-world study supported the use of consolidative durvalumab in inoperable stage III PD-L1 expressing NSCLC. Pneumonitis was significant, and higher than expected. Benefit appeared greater in high PD-L1 expressing patients, consistent with the subgroup analysis from the landmark PACIFIC trial. Our results need to be interpreted with cautions due to small sample size and a relatively short follow-up duration.
Authors: Luis E Raez; Oscar Arrieta; Diego F Chamorro; Pamela Denisse Soberanis-Piña; Luis Corrales; Claudio Martín; Mauricio Cuello; Suraj Samtani; Gonzalo Recondo; Luis Mas; Zyanya Lucia Zatarain-Barrón; Alejandro Ruíz-Patiño; Juan Esteban García-Robledo; Camila Ordoñez-Reyes; Elvira Jaller; Franco Dickson; Leonardo Rojas; Christian Rolfo; Rafael Rosell; Andrés F Cardona Journal: Front Oncol Date: 2022-07-12 Impact factor: 5.738