No impact of grade ≥2 pneumonitis on patient-reported outcomes in PACIFIC

Patient-reported outcomes of the phase 3 PACIFIC trial indicated that durvalumab did not have a detrimental impact on patient quality of life (QoL) compared with placebo, irrespective of whether patients experienced grade ≥2 pneumonitis.

The phase 3 PACIFIC trial (NCT02125461) demonstrated that maintenance therapy with the immune checkpoint inhibitor durvalumab after completion of concurrent chemoradiotherapy (CRT) significantly improves progression-free and 5-year overall survival in patients with unresectable non-small cell lung cancer (NSCLC) [1,2]. Any-grade pneumonitis (including radiation-pneumonitis) was among the most common adverse events in PACIFIC, occurring in 33.9% and 24.8% of participants on durvalumab and placebo, respectively [2]. Pneumonitis predominantly occurred with low-grade severity, and a prior exploratory analysis from PACIFIC suggested treatment benefit with durvalumab was maintained regardless of the occurrence of pneumonitis [3]. A post-hoc analysis of the PACIFIC trial investigated whether the occurrence of grade ≥2 pneumonitis during the study impacted the tolerability of durvalumab from a patient perspective. Prof. Rina Hui (University of Sydney, Australia) presented the results [4].

Patient-reported outcomes were assessed with EORTC QLQ-C30 and QLQ-LC13 in 94 and 33 participants with grade ≥2 pneumonitis originally randomised to the durvalumab and placebo arm, respectively. Grade ≥2 pneumonitis typically occurred within 3 months of starting durvalumab or placebo. In both treatment arms, no clinically meaningful changes in patient-reported outcome scores were observed at weeks 16 or 24 from the start of treatment, regardless of whether participants experienced grade ≥2 pneumonitis (see Figure). In addition, time to deterioration was longer with durvalumab compared with placebo, which remained the case when adjusting for the occurrence of grade ≥2 pneumonitis.

Figure: Changes in patient-reported outcome scores in PACIFIC [4]



“These results indicate that the possibility of grade ≥2 pneumonitis should not deter physicians from using the PACIFIC regime in eligible patients,” concluded Prof. Hui. “Treatment guidelines should be followed if this adverse event occurs.”

1. Antonia SJ, et al. N Engl J Med 2017;377:1919–1929
2. Spigel DR, et al. J Clin Oncol. 2022;40(12):1301–1311.
3. Vansteenkiste JF, et al. Abstract 4480. ESMO Congress 2019, 27 September–01 October.
4. Hui R, et all. Impact of grade ≥2 pneumonitis (G2+ PNS) on patient reported outcomes (PROs) with durvalumab (D) after chemoradiotherapy (CRT) in unresectable stage III NSCLC. Abstract 118P. ELCC 2022 Virtual Meeting, 30 March–02 April.

 

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Posted on 25 May, 202215 February, 2024