Nivolumab better maintains quality of life and symptom control vs docetaxel in advanced NSCLC
Nivolumab better preserved health-related quality of life and symptom control than docetaxel in patients with previously treated advanced nonsquamous non-small cell lung cancer (NSCLC), according to additional data from the CHECKMATE 057* trial presented at the recent European Society for Medical Oncology Asia 2016 Congress (ESMO Asia 2016) held in Singapore.
The open-label phase III CHECKMATE 057 study has previously demonstrated a better overall survival (OS), the primary endpoint, at 1 year with the anti-PD-1 monoclonal antibody nivolumab, which also showed a favourable safety profile, compared with docetaxel in NSCLC patients who had progressed despite previous treatment with platinum-based chemotherapy.
Being presented were the data from additional endpoints on patient reported outcomes (PROs) based on the EuroQoL-5 dimensions (EQ-5D) tool, which is a generic measure of health status; and lung cancer symptom scale (LCSS), a lung cancer-specific measure of symptom burden which includes the average symptom burden index (ASBI) and the 3-item global index (3-IGI). [ESMO Asia 2016, abstract 442O]
“Compared with the baseline [score] for EQ-5D, there was predominantly a maintenance of the general health status for the group of patients who received nivolumab compared with the slight deterioration for patients who had received docetaxel,” said Dr Martin Reck of Lung Clinic Grosshansdorf at Airway Research Center North in Grosshansdorf, Germany.
Although there were no differences within or between treatment arms using the index-based scoring of EQ-5D (EQ-5D utility index), Kaplan-Meier analysis of data from the visual analogue scale (EQ-5D VAS) indicated that the time to deterioration in general health status separated from 4 months onwards in favour of nivolumab (hazard ratio [HR], 0.76, 95 percent confidence interval [CI], 0.59–0.98).
In addition, analyses of mean changes from baseline in symptom burden as measured by the LCSS ASBI and 3-IGI revealed a reduction in symptom burden and improvement in quality of life favouring nivolumab over docetaxel, which emerged at the first common assessment at week 12 and persisted throughout the entire assessment period up to week 54. The differences in ASBI were significant at weeks 12, 24, 30, and 42, whereas for the 3-IGI at weeks 24 and 30.
The time to deterioration for ASBI was also longer with nivolumab than with docetaxel (HR, 0.65, 95 percent CI, 0.49–0.85) based on Kaplan-Meier analysis, with separation of the curves between treatment arms occurring as early as 2 months after initiating treatment.
“Symptom improvement observed with the LCSS occurred earlier than global health status improvement seen with the EQ-5D VAS,” noted Reck, saying both measures indicated benefit prior to separation of the OS curves.
He also pointed out that the updated 2-year OS rate continued to be better with nivolumab than with docetaxel (median OS, 12.2 vs 9.5 months; HR, 0.75, 95 percent CI, 0.63–0.91), consistent with previous finding from the 1-year survival data.
The updated tolerability data after 2 years also indicated better tolerability for nivolumab, with a lower rate of grade 3–4 adverse events (11 percent vs 54 percent) and a lower number of adverse events of any grade which led to treatment discontinuation (6 percent vs 15 percent) compared with docetaxel.
“In addition to this clear signal of objective efficacy, now we have also seen supportive data for the symptomatic efficacy ... a trend towards a better maintenance in the general health status ... a better impact on symptom burden ... and a better control of symptom burden [based on the EQ-5D VAS and the LCSS],” said Reck.