Durvalumab extends PFS without worsening quality of life in advanced lung cancer
Durvalumab extended PFS without worsening symptoms or quality of life among patients with locally advanced, unresectable stage III lung cancer, according to patient-reported outcomes from the phase 3 PACIFIC trial presented at International Association for the Study of Lung Cancer World Conference on Lung Cancer.
“It is indeed pleasing to see that adding durvalumab [Imfinzi, AstraZeneca] for 12 months after chemoradiation did not compromise quality of life,” Rina Hui, MBBS, FRACP, PhD, senior staff specialist in medical oncology at Westmead & Blacktown Hospitals and clinical senior lecturer at The University of Sydney in Australia, said during a press conference. “Along with the positive efficacy and safety data from PACIFIC, patient-reported outcomes findings further support the clinical value of durvalumab and the use in this earlier stage non-small cell lung cancer.”
Interim efficacy and safety results of the PACIFIC study — previously presented at ESMO —showed durvalumab, a PD-L1 inhibitor, conferred superior median PFS compared with placebo (16.8 months vs. 5.6 months).
“PACIFIC is important because up until now, the 5-year survival rate for patients with stage III non-small cell lung cancer confining the disease within the chest has only been 15%,” Hui said.
The trial — conducted at 235 centers in 26 countries — included 709 patients with a WHO performance status of 0 or 1 who received at least two cycles of platinum-based chemoradiation therapy. Patients were enrolled regardless of PD-L1 status.
Researchers randomly assigned 473 patients to 10 mg/kg IV durvalumab every 2 weeks and 236 patients to placebo. Treatment continued for up to 1 year.
To determine patient outcomes, researchers administered questionnaires via the EORTC 30-item Quality of Life (QLQ-C30) and lung cancer module (QLQ-LC13) at baseline, weeks 4 and 8, followed by every 8 weeks until week 48, and then every 12 weeks until disease progression. The researchers analyzed variations in symptoms from baseline, time to deterioration and odds of improvement
“We believe it is important to hear from the patient perspective,” Hui said.
More than 80% of patients completed up to 48 weeks of questionnaires.
Analyses showed no statistically significant differences between treatment groups in adjusted mean changes from baseline for dyspnea, cough, chest pain, fatigue, global health status/quality of life and physical functioning.
Researchers observed clinically relevant improvements from baseline to 48 weeks for dysphagia in the durvalumab group (mean change, –14.2) and placebo group (–14.8), as well as alopecia in both groups (–22.1 and –21.4).
“These improvements were likely due to resolution of toxicity related to prior chemoradiation, which all patients received before the study,” Hui said.
Researchers observed no differences in median time to deterioration between the groups, with the exception of “other pain,” which appeared significantly longer for the durvalumab group (9.2 months vs. 5.6 months; HR = 0.72; 95% CI, 0.58-0.89).
The improvement rate for appetite loss was 26.1% in the durvalumab group compared with 24.9% in the placebo group (OR = 1.72; 95% CI, 1.04-2.85).
“Patients’ quality of life was maintained with durvalumab compared with active survivors after chemoradiation,” Hui said. “Changes from baseline for key symptoms was minimum in both arms.” – by Melinda Stevens
Hui R, et al. Abstract 10762. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer; Oct. 15-18, 2017; Yokohama, Japan.
Disclosures: HemOnc Today could not confirm relevant financial disclosures at the time of publication.