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Current Medical Research and Opinion Volume 36, 2020 - Issue 10
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Oncology

Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small-cell lung cancer

Kiyotaka Yoha Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, JapanCorrespondence[email protected]
,
Shinji Atagib Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
,
Martin Reckc Lungen Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
,
Edward B. Garond David Geffen School of Medicine, University of California Los Angeles/TRIO-US Network, Los Angeles, CA, USA
,
Santiago Ponce Aixe Hospital Universitario, CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain
,
Denis Moro-Sibilotf Grenoble University Hospital, Grenoble, France
,
Katherine B. Winfreeg Eli Lilly and Company, Indianapolis, IN, USA
,
Bente Frimodt-Mollerh Eli Lilly and Company, Copenhagen, Denmark
,
Annamaria Zimmermanng Eli Lilly and Company, Indianapolis, IN, USA
,
Carla Visseren-Gruli Lilly Oncology, Utrecht, Netherlands
,
Kazuhiko Nakagawaj Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan
& for the RELAY investigators show all
Pages 1667-1675 | Received 30 Apr 2020, Accepted 08 Aug 2020, Published online: 28 Aug 2020

References

  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: non-small cell lung cancer, Version 2 [Internet]. 2020 [cited 2020 Feb 21]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
  • Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(Suppl 4):iv192–iv237.
  • Planchard D, Popat S, Kerr K, et al. Correction to: “metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up”. Ann Oncol. 2019;30(5):863–870.
  • Hsu WH, Yang JC, Mok TS, et al. Overview of current systemic management of EGFR-mutant NSCLC. Ann Oncol. 2018;29 (Suppl 1):i3–i9.
  • Park K, Tan E-H, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016;17(5):577–589.
  • Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454–1466.
  • Mok T, Wu YL, Ahn MJ, et al. Osimertinib or platinum–pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med. 2017;376(7):629–640.
  • Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113–125.
  • 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.
  • Kovic B, Jin X, Kennedy SA, et al. Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology: a systematic review and quantitative analysis. JAMA Intern Med. 2018;178(12):1586–1596.
  • Hollen PJ, Gralla RJ, Kris MG, et al. Quality of life assessment in individuals with lung cancer: testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer. 1993;29(Suppl 1):S51–S58.
  • Janssen MF, Birnie E, Haagsma JA, et al. Comparing the standard EQ-5D three-level system with a five-level version. Value Health. 2008;11(2):275–284.
  • Pérol M, Ciuleanu TE, Arrieta O, et al. 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. Lung Cancer. 2016;93:95–103.
  • Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009;374(9699):1432–1440.
  • Bonnetain F, Fiteni F, Efficace F, et al. Statistical challenges in the analysis of health-related quality of life in cancer clinical trials. J Clin Oncol. 2016;34(16):1953–1956.
  • Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the Lung Cancer Symptom Scale. Cancer. 1994;73(8):2087–2098.
  • Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–1736.
  • EQ-5D-5L [Internet]. EQ-5D, EuroQol Research Foundation; 2020 [cited 2020 Jan 20]. Available from: www.EuroQoL.org
  • Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–655.
  • Eisenhauer EA, Therasse P, Bogaert J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
  • van Hout B, Janssen MF, Feng YS, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–715.
  • Kaplan EL, Meier P. Nonparametric estimation of incomplete observations. J Am Stat Assoc. 1958;53(282):457–481.
  • Cox DR. Regression models and life-tables. J Royal Stat Soc Ser B. 1972;34(2):187–220.
  • Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res. 2013;19(10):2629–2636.
  • Leighl NB, Karaseva N, Nakagawa K, et al. Patient-reported outcomes from FLAURA: osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020;125:49–57.

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