Maurice Pérol1, Tudor-Eliade Ciuleanu2, Oscar Arrieta3, Kumar Prabhash4, Konstantinos N Syrigos5, Tuncay Goksel6, Keunchil Park7, Ruben Dario Kowalyszyn8, Joanna Pikiel9, Conrad R Lewanski10, Michael Thomas11, Shaker Dakhil12, Joo-Hang Kim13, Nina Karaseva14, Sergey Yurasov15, Annamaria Zimmermann16, Pablo Lee17, Gebra Cuyun Carter18, Martin Reck19, Federico Cappuzzo20, Edward B Garon21. 1. Léon-Bérard Cancer Centre, Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr. 2. Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania. Electronic address: tudor@iocn.ro. 3. Instituto Nacional de Cancerologia, Mexico City, Mexico. Electronic address: cogar@servidor.unam.mx. 4. Tata Memorial Hospital, Mumbai, India. Electronic address: kprabhash1@gmail.com. 5. Oncology Unite GPP, Sotiria General Hospital, Athens, Greece. Electronic address: ksyrigos@med.uoa.gr. 6. Ege University School of Medicine, Izmir, Turkey. Electronic address: tuncaygoksel@gmail.com. 7. Samsung Medical Center, Seoul, South Korea. Electronic address: keunchil.park@samsung.com. 8. Centro de Investigaciones Clínicas, Clínica Viedma, S.A., Argentina. Electronic address: kowar@rnonline.com.ar. 9. Wojewodzkie Centrum Onkologii, Gdansk, Poland. Electronic address: joanna.pikiel@post.pl. 10. Charing Cross Hospital, London, UK. Electronic address: Conrad.lewanski@imperial.nhs.uk. 11. 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. 12. Cancer Center of Kansas, Wichita, KS, USA. Electronic address: shaker.dakhil@cancercenterofkansas.com. 13. Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea. Electronic address: kjhang@yuhs.ac. 14. City Clinical Oncology Dispensary, St. Petersburg, Russia. Electronic address: nkaraseva06@mail.ru. 15. Eli Lilly and Company, Bridgewater, NJ, USA. Electronic address: sergey.yurasov@imclone.com. 16. Eli Lilly and Company, Indianapolis, IN, USA; LungenClinic Grosshansdorf, German Center for Lung Research, Grosshansdorf, Germany. Electronic address: zimmermann_annamaria_hayden@lilly.com. 17. LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: pablo.lee@imclone.com. 18. Eli Lilly and Company, Indianapolis, IN, USA; LungenClinic Grosshansdorf, German Center for Lung Research, Grosshansdorf, Germany. 19. LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de. 20. Istituto Toscano Tumori, Livorno, Italy. Electronic address: f.cappuzzo@googlemail.com. 21. David Geffen School of Medicine at UCLA/Translational Research in Oncology-US Network, Los Angeles, CA, USA. Electronic address: egaron@mednet.ucla.edu.
Abstract
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 receiveRAM+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. 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.
RCT Entities:
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 27.3mm (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. 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.
Authors: Bruno Kovic; Xuejing Jin; Sean Alexander Kennedy; Mathieu Hylands; Michal Pedziwiatr; Akira Kuriyama; Huda Gomaa; Yung Lee; Morihiro Katsura; Masafumi Tada; Brian Y Hong; Sung Min Cho; Patrick Jiho Hong; Ashley M Yu; Yasmin Sivji; Augustin Toma; Li Xie; Ludwig Tsoi; Marcin Waligora; Manya Prasad; Neera Bhatnagar; Lehana Thabane; Michael Brundage; Gordon Guyatt; Feng Xie Journal: JAMA Intern Med Date: 2018-12-01 Impact factor: 21.873
Authors: E Charton; B Cuer; F Cottone; F Efficace; C Touraine; Z Hamidou; F Fiteni; F Bonnetain; M-C Woronoff-Lemsi; C Bascoul-Mollevi; A Anota Journal: Qual Life Res Date: 2019-11-27 Impact factor: 4.147
Authors: Manuel Cobo; Vanesa Gutiérrez; Rosa Villatoro; Jose Manuel Trigo; Inmaculada Ramos; Omar López; María Ruiz; Ana Godoy; Irene López; Macarena Arroyo Journal: Lung Cancer (Auckl) Date: 2017-07-12
Authors: Edward B Garon; Katherine B Winfree; Cliff Molife; Zhanglin Lin Cui; Edurne Arriola; Benjamin Levy; Tarek Mekhail; Maurice Pérol Journal: Support Care Cancer Date: 2020-04-21 Impact factor: 3.603
Authors: Edward B Garon; Giorgio Vittorio Scagliotti; Oliver Gautschi; Martin Reck; Michael Thomas; Lara Iglesias Docampo; Haralabos Kalofonos; Joo-Hang Kim; Steven Gans; Odd Terje Brustugun; Sergey V Orlov; Gebra Cuyun Carter; Annamaria H Zimmermann; Ana B Oton; Ekaterine Alexandris; Pablo Lee; Katharina Wolff; Victoria Jennifer Stefaniak; Mark A Socinski; Maurice Pérol Journal: ESMO Open Date: 2020-01