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Cyramza ® (ramucirumab)
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The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1
Assessment of Patient-Focused Outcomes
Assessment Interval
Patient-focused outcomes were evaluated using ECOG PS, LCSS, and EQ-5D-5L. ECOG PS was assessed at every visit and LCSS and EQ-5D-5L at
baseline
every other cycle, and
30-day follow-up visit.2
ECOG PS Assessment
Time-to-deterioration in ECOG PS was
a prespecified exploratory endpoint
defined as the time from randomization to the first observation of ECOG PS ≥2, and
estimated with Kaplan-Meier and Cox regression.2
LCSS and EQ-5D-5L Assessment
Time-to-deterioration in LCSS was
prespecified secondary endpoint
defined as the time from date of randomization until the date of the first ≥15 mm increase from baseline, and
estimated with Kaplan-Meier and Cox regression.2
EQ-5D-5L mean scores were summarized by cycle/visit.2
Mean changes from baseline in EQ-5D-5L/LCSS scores were estimated using Mixed Effect Model Repeat Measurement regression by comparing with baseline scores.2
Patient-Reported Outcome Results
ECOG PS
The majority of patients in both arms maintained an ECOG PS of 0 or 1 until PD (92.4% in the ramucirumab plus erlotinib arm and 95.1% in the erlotinib plus placebo arm); therefore, TTD analysis was not feasible.2
LCSS and 5Q-5D-5L
Overall patient compliance for LCSS and EQ-5D-5L completion was similar between treatment arms (LCSS: 95.7% in the ramucirumab plus erlotinib arm and 96.7% in the erlotinib plus placebo arm; EQ-5D-5L: 96.1% in the ramucirumab plus erlotinib arm and 96.6% in the erlotinib plus placebo arm). Time-to-deterioration of both LCSS and ASBI was similar between treatment arms (LCSS: HR=0.96, 95% CI: 0.69-1.34; ASBI: HR=1.01, 95% CI: 0.73-1.40). Hemoptysis was the only LCSS item that was different between arms and favored the erlotinib plus placebo arm (HR=1.99, 95% CI: 1.21-3.28).2
The authors concluded that patient health-related QOL, as measured with the EQ-5D-5L, was not adversely impacted by the addition of ramucirumab to erlotinib.2
1. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5
2. Yoh K, Atagi S, Reck M, et al. Patient-focused outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus ERL in untreated EGFR-mutated metastatic NSCLC. Talk presented at: 5th Annual Meeting of the European Society of Medical Oncology Asia (ESMO Asia); November 22-24, 2019; Singapore, Singapore.
Glossary
ASBI = average symptom burden index
ECOG = Eastern Cooperative Oncology Group
EGFR = epidermal growth factor receptor
EQ-5D-5L = EuroQoL five-dimension, five-level health status questionnaire
HR = hazard ratio
LCSS = Lung Cancer Symptom Scale
NSCLC = non-small cell lung cancer
PD = progressive disease
PS = performance status
QOL = quality of life
TTD = time-to-deterioration
Datum fӧr senaste ӧversyn 2019 M11 25