TY - JOUR
T1 - Dynamic change of fatigue of pemetrexed maintenance treatment in the JMEN trial
AU - Zhang, Li
AU - Belani, Chandra
AU - Zhang, Ping hai
AU - Wang, Xin
AU - Yang, Lulu
AU - Orlando, Mauro
AU - Wu, Yi long
N1 - Funding Information:
Funding for this study was provided by Eli Lilly and Company (Indianapolis, Indiana, USA). Eli Lilly was involved in study conception and design, acquisition, analysis and interpretation of data, critical revision of the report, and the decision to submit the paper for publication.
Funding Information:
Writing assistance was provided by Dr. Jarrett Coffindaffer of inVentiv Health Clinical, and editorial assistance was provided by Ms. Angela Lorio of inVentiv Health Clinical. Support for this assistance funded by Eli Lilly and Company .
Publisher Copyright:
© 2017
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/1
Y1 - 2018/1
N2 - Objectives In the JMEN trial, patients with advanced non-squamous non-small cell lung cancer (NSCLC) without progression after platinum-based first-line therapy derived extended survival, delayed disease progression, and maintained overall quality of life (QoL) from pemetrexed maintenance therapy. However, fatigue was the most common physician-reported non-hematological toxicity in the pemetrexed group. This post hoc analysis investigated dynamic change of fatigue. Materials and methods Analysis of the overall safety population with squamous and non-squamous NSCLC subgroups included Common Terminology Criteria for Adverse Events to summarize adverse event (AE) rates by cycle and AE investigator-reported severity. Worsening of fatigue, defined as +15 mm or more from baseline on a 100 mm scale, evaluated QoL using the patient-reported Lung Cancer Symptom Scale. Patients with worsening fatigue and time-to-worsening of fatigue symptoms were also analyzed. Results Drug-related fatigue occurred more frequently with pemetrexed than placebo. The drug-related grade 3/4 fatigue was also higher in the overall population on pemetrexed than with placebo. Fatigue incidence during pemetrexed maintenance after induction was not altered with cumulative exposure. Percentage of patients who experienced worsening of fatigue based on patient-reported LCSS scores was comparable between the two arms in cycles 1–10. The time-to-worsening of fatigue was similar between the pemetrexed arm and the placebo arm in the overall population; however, the East Asian subpopulation patients taking pemetrexed experienced a longer median time-to-worsening of fatigue than patients taking placebo. Conclusion Analyses suggest that despite higher incidence of any grade drug-related fatigue compared with placebo in patients with advanced NSCLC, pemetrexed maintenance does not impair patient-reported QoL.
AB - Objectives In the JMEN trial, patients with advanced non-squamous non-small cell lung cancer (NSCLC) without progression after platinum-based first-line therapy derived extended survival, delayed disease progression, and maintained overall quality of life (QoL) from pemetrexed maintenance therapy. However, fatigue was the most common physician-reported non-hematological toxicity in the pemetrexed group. This post hoc analysis investigated dynamic change of fatigue. Materials and methods Analysis of the overall safety population with squamous and non-squamous NSCLC subgroups included Common Terminology Criteria for Adverse Events to summarize adverse event (AE) rates by cycle and AE investigator-reported severity. Worsening of fatigue, defined as +15 mm or more from baseline on a 100 mm scale, evaluated QoL using the patient-reported Lung Cancer Symptom Scale. Patients with worsening fatigue and time-to-worsening of fatigue symptoms were also analyzed. Results Drug-related fatigue occurred more frequently with pemetrexed than placebo. The drug-related grade 3/4 fatigue was also higher in the overall population on pemetrexed than with placebo. Fatigue incidence during pemetrexed maintenance after induction was not altered with cumulative exposure. Percentage of patients who experienced worsening of fatigue based on patient-reported LCSS scores was comparable between the two arms in cycles 1–10. The time-to-worsening of fatigue was similar between the pemetrexed arm and the placebo arm in the overall population; however, the East Asian subpopulation patients taking pemetrexed experienced a longer median time-to-worsening of fatigue than patients taking placebo. Conclusion Analyses suggest that despite higher incidence of any grade drug-related fatigue compared with placebo in patients with advanced NSCLC, pemetrexed maintenance does not impair patient-reported QoL.
UR - http://www.scopus.com/inward/record.url?scp=85035813318&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85035813318&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2017.11.026
DO - 10.1016/j.lungcan.2017.11.026
M3 - Article
C2 - 29290253
AN - SCOPUS:85035813318
VL - 115
SP - 121
EP - 126
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -