medwireNews: Adding pembrolizumab to standard chemotherapy for advanced non-small-cell lung cancer (NSCLC) has no detrimental effect on quality of life (QoL) during or after treatment and results in better patient-reported outcomes than placebo, KEYNOTE-189 data show.
As previously reported by medwireNews, the primary efficacy results from the phase 3 trial found that giving pembrolizumab in combination with pemetrexed–platinum chemotherapy significantly delays disease progression and improves overall survival in patients with treatment-naïve metastatic nonsquamous NSCLC relative to placebo plus chemotherapy.
For the trial, 616 patients, who all lacked sensitizing EGFR or ALK mutations, were randomly assigned to receive intravenous pembrolizumab 200 mg (n=410) or placebo (n=206) every 3 weeks for up to 2 years (35 cycles) each in combination with four 3-week cycles of intravenous pemetrexed plus carboplatin or cisplatin, followed by pemetrexed maintenance therapy every 3 weeks.
The current analysis looked at the participants’ responses to the EORTC QoL Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) measures during (week 12) and after (week 21) chemotherapy.
At baseline, there was no significant difference in mean QLQ-C30 global health status (GHS)/QoL score between the patients who received pembrolizumab and those who received placebo, at 62.0 versus 60.6 points out of a possible 100, respectively.
As reported in The Lancet Oncology, mean QLQ-C30 GHS/QoL scores improved from baseline to week 9 in both treatment groups and then declined. By week 12, patients in the pembrolizumab group reported a mean 1.0-point increase in their score relative to baseline, whereas those in the placebo group reported a 2.6-point decrease, with no significant difference between the two groups.
By week 21, however, the mean GHS/QoL had increased by 1.3 points in the pembrolizumab group and decreased by 4.0 points in the placebo group, resulting in a significant between-group difference of 5.3 points.
Marina Garassino (Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy) and co-investigators also found that, during a median 10.5 months of follow-up, the median time to deterioration in cough, chest pain, or dyspnea was not reached with pembrolizumab and was 7.0 months with placebo. The Kaplan–Meier curves for time to deterioration of this composite endpoint began to separate after 3 months, but the difference between the two groups did not reach statistical significance by the end of follow-up.
Nonetheless, the team observed that more patients receiving pembrolizumab than placebo reported improved or stable outcomes for pain and dyspnea at week 21, whereas more patients receiving placebo than pembrolizumab reported a deterioration in these symptoms.
Garassino et al conclude: “These health-related quality-of-life findings complement those showing superior efficacy demonstrated with pembrolizumab plus chemotherapy over placebo plus chemotherapy in the KEYNOTE-189 study, and further support use of pembrolizumab plus pemetrexed–platinum as a first-line therapy for patients with metastatic non-squamous non-small-cell lung cancer without sensitising EGFR mutations or ALK translocations.”
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