TY - JOUR
T1 - Quality of life results from the phase 3 REVEL randomized clinical trial of ramucirumab-plus-docetaxel versus placebo-plus-docetaxel in advanced/metastatic non-small cell lung cancer patients with progression after platinum-based chemotherapy
AU - Pérol, Maurice
AU - Ciuleanu, Tudor Eliade
AU - Arrieta, Oscar
AU - Prabhash, Kumar
AU - Syrigos, Konstantinos N.
AU - Goksel, Tuncay
AU - Park, Keunchil
AU - Kowalyszyn, Ruben Dario
AU - Pikiel, Joanna
AU - Lewanski, Conrad R.
AU - Thomas, Michael
AU - Dakhil, Shaker
AU - Kim, Joo Hang
AU - Karaseva, Nina
AU - Yurasov, Sergey
AU - Zimmermann, Annamaria
AU - Lee, Pablo
AU - Carter, Gebra Cuyun
AU - Reck, Martin
AU - Cappuzzo, Federico
AU - Garon, Edward B.
N1 - Publisher Copyright:
© 2016 Elsevier Ireland Ltd.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Objectives: REVEL demonstrated that ramucirumab + docetaxel (RAM + DTX) improved overall survival, progression-free survival, and objective response rate in patients with advanced/metastatic non-small cell lung cancer with progression after platinum-based chemotherapy. This analysis examined quality of life (QoL) as assessed by the Lung Cancer Symptom Scale (LCSS) and clinician-reported functional status. Materials and Methods: The LCSS includes 6 symptom and 3 global items measured on a 0-100-mm scale higher scores represent greater symptom burden. LCSS and ECOG PS data were collected at baseline, every 3-week cycle, the summary visit, and at the 30-day follow-up. LCSS total score and Average Symptom Burden Index (ASBI) were calculated. The primary analysis compared time to deterioration (TtD) between treatment arms for all individual items and summary scores, defined as increase from baseline by ≥15 mm using the Kaplan-Meier method and Cox regression. TtD to ECOG PS ≥2 was analyzed. Results: There were 1253 patients randomized to receive RAM + DTX or placebo + docetaxel (PL + DTX). Across all assessments, LCSS compliance was approximately 75% and balanced across arms. The mean (SD) baseline LCSS total score was 27.3 mm (17.08 mm) on RAM + DTX and 29.6 mm (17.59 mm) on PL + DTX. At 30-day follow-up, mean (SD) LCSS total score was 32.0 (19.03) on RAM + DTX and 32.5 (19.87) on PL + DTX. The TtD for all LCSS scores was similar between treatment arms. Stratified HRs (95% CI) for LCSS total score and ASBI were HR = 0.99 (0.81, 1.22), p = 0.932 and HR = 0.93 (0.75, 1.15), p = 0.514 with approximately 70% of patients censored. TtD to PS ≥ 2 was similar between treatment arms (HR = 1.03 [95% CI: 0.85, 1.26], p = 0.743) with approximately two-thirds of the patients censored. Conclusion: In addition to improvement of clinical efficacy outcomes demonstrated in REVEL, these results suggest that adding ramucirumab to docetaxel did not impair patient QoL, symptoms, or functioning.
AB - Objectives: REVEL demonstrated that ramucirumab + docetaxel (RAM + DTX) improved overall survival, progression-free survival, and objective response rate in patients with advanced/metastatic non-small cell lung cancer with progression after platinum-based chemotherapy. This analysis examined quality of life (QoL) as assessed by the Lung Cancer Symptom Scale (LCSS) and clinician-reported functional status. Materials and Methods: The LCSS includes 6 symptom and 3 global items measured on a 0-100-mm scale higher scores represent greater symptom burden. LCSS and ECOG PS data were collected at baseline, every 3-week cycle, the summary visit, and at the 30-day follow-up. LCSS total score and Average Symptom Burden Index (ASBI) were calculated. The primary analysis compared time to deterioration (TtD) between treatment arms for all individual items and summary scores, defined as increase from baseline by ≥15 mm using the Kaplan-Meier method and Cox regression. TtD to ECOG PS ≥2 was analyzed. Results: There were 1253 patients randomized to receive RAM + DTX or placebo + docetaxel (PL + DTX). Across all assessments, LCSS compliance was approximately 75% and balanced across arms. The mean (SD) baseline LCSS total score was 27.3 mm (17.08 mm) on RAM + DTX and 29.6 mm (17.59 mm) on PL + DTX. At 30-day follow-up, mean (SD) LCSS total score was 32.0 (19.03) on RAM + DTX and 32.5 (19.87) on PL + DTX. The TtD for all LCSS scores was similar between treatment arms. Stratified HRs (95% CI) for LCSS total score and ASBI were HR = 0.99 (0.81, 1.22), p = 0.932 and HR = 0.93 (0.75, 1.15), p = 0.514 with approximately 70% of patients censored. TtD to PS ≥ 2 was similar between treatment arms (HR = 1.03 [95% CI: 0.85, 1.26], p = 0.743) with approximately two-thirds of the patients censored. Conclusion: In addition to improvement of clinical efficacy outcomes demonstrated in REVEL, these results suggest that adding ramucirumab to docetaxel did not impair patient QoL, symptoms, or functioning.
KW - Advanced/metastatic non-small cell lung cancer
KW - Average symptom burden index
KW - Lung cancer symptom scale
KW - Quality of life
UR - https://www.scopus.com/pages/publications/84959441334
U2 - 10.1016/j.lungcan.2016.01.007
DO - 10.1016/j.lungcan.2016.01.007
M3 - Article
C2 - 26898621
AN - SCOPUS:84959441334
SN - 0169-5002
VL - 93
SP - 95
EP - 103
JO - Lung Cancer
JF - Lung Cancer
ER -
