title: 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.
abstract: OBJECTIVE
  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.
  
  
  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 27.3mm (17.08 mm) on RAM+DTX and 29.6mm (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Léon-Bérard Cancer Centre, Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr.
authors.forename: Maurice
authors.initials: M
authors.lastname: Pérol
authors.affiliation: Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania. Electronic address: tudor@iocn.ro.
authors.forename: Tudor-Eliade
authors.initials: TE
authors.lastname: Ciuleanu
authors.affiliation: Instituto Nacional de Cancerologia, Mexico City, Mexico. Electronic address: cogar@servidor.unam.mx.
authors.forename: Oscar
authors.initials: O
authors.lastname: Arrieta
authors.affiliation: Tata Memorial Hospital, Mumbai, India. Electronic address: kprabhash1@gmail.com.
authors.forename: Kumar
authors.initials: K
authors.lastname: Prabhash
authors.affiliation: Oncology Unite GPP, Sotiria General Hospital, Athens, Greece. Electronic address: ksyrigos@med.uoa.gr.
authors.forename: Konstantinos N
authors.initials: KN
authors.lastname: Syrigos
authors.affiliation: Ege University School of Medicine, Izmir, Turkey. Electronic address: tuncaygoksel@gmail.com.
authors.forename: Tuncay
authors.initials: T
authors.lastname: Goksel
authors.affiliation: Samsung Medical Center, Seoul, South Korea. Electronic address: keunchil.park@samsung.com.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.affiliation: Centro de Investigaciones Clínicas, Clínica Viedma, S.A., Argentina. Electronic address: kowar@rnonline.com.ar.
authors.forename: Ruben Dario
authors.initials: RD
authors.lastname: Kowalyszyn
authors.affiliation: Wojewodzkie Centrum Onkologii, Gdansk, Poland. Electronic address: joanna.pikiel@post.pl.
authors.forename: Joanna
authors.initials: J
authors.lastname: Pikiel
authors.affiliation: Charing Cross Hospital, London, UK. Electronic address: Conrad.lewanski@imperial.nhs.uk.
authors.forename: Conrad R
authors.initials: CR
authors.lastname: Lewanski
authors.affiliation: Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany. Electronic address: michael.thomas@med.uni-heidelberg.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Cancer Center of Kansas, Wichita, KS, USA. Electronic address: shaker.dakhil@cancercenterofkansas.com.
authors.forename: Shaker
authors.initials: S
authors.lastname: Dakhil
authors.affiliation: Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea. Electronic address: kjhang@yuhs.ac.
authors.forename: Joo-Hang
authors.initials: JH
authors.lastname: Kim
authors.affiliation: City Clinical Oncology Dispensary, St. Petersburg, Russia. Electronic address: nkaraseva06@mail.ru.
authors.forename: Nina
authors.initials: N
authors.lastname: Karaseva
authors.affiliation: Eli Lilly and Company, Bridgewater, NJ, USA. Electronic address: sergey.yurasov@imclone.com.
authors.forename: Sergey
authors.initials: S
authors.lastname: Yurasov
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA; LungenClinic Grosshansdorf, German Center for Lung Research, Grosshansdorf, Germany. Electronic address: zimmermann_annamaria_hayden@lilly.com.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Zimmermann
authors.affiliation: LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: pablo.lee@imclone.com.
authors.forename: Pablo
authors.initials: P
authors.lastname: Lee
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA; LungenClinic Grosshansdorf, German Center for Lung Research, Grosshansdorf, Germany.
authors.forename: Gebra Cuyun
authors.initials: GC
authors.lastname: Carter
authors.affiliation: LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Reck
authors.affiliation: Istituto Toscano Tumori, Livorno, Italy. Electronic address: f.cappuzzo@googlemail.com.
authors.forename: Federico
authors.initials: F
authors.lastname: Cappuzzo
authors.affiliation: David Geffen School of Medicine at UCLA/Translational Research in Oncology-US Network, Los Angeles, CA, USA. Electronic address: egaron@mednet.ucla.edu.
authors.forename: Edward B
authors.initials: EB
authors.lastname: Garon
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010984:Platinum / Q000008:administration & dosage / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011788:Quality of Life; D019233:Retreatment; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D010984:Platinum; D043823:Taxoids; D000096662:Ramucirumab
keywords: Advanced/metastatic non-small cell lung cancer; Average symptom burden index; Lung cancer symptom scale; Quality of life