The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: Results from the phase 3 SQUIRE trial

Martin Reck, Mark A. Socinski, Alexander Luft, Aleksandra Szczesna, Mircea Dediu, Rodryg Ramlau, György Losonczy, Olivier Molinier, Christian Schumann, Richard J. Gralla, Philip Bonomi, Jacqueline Brown, Victoria Soldatenkova, Nadia Chouaki, Coleman Obasaju, Patrick Peterson, Nick Thatcher

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Introduction: Necitumumab, a second-generation, recombinant human immunoglobulin G1 epidermal growth factor receptor antibody in the phase 3 SQUIRE trial (NCT00981058), increased survival benefit for patients randomized to receive necitumumab plus gemcitabine-cisplatin compared with those who received gemcitabine-cisplatin. Here we characterize health-related quality of life (HRQoL) and tolerability results. Methods: A total of 1093 patients with stage IV squamous non-small cell lung cancer were randomized 1:1 to receive necitumumab (800 mg absolute dose intravenously [IV]) plus gemcitabine-cisplatin (gemcitabine = 1250 mg/m2 IV on days 1 and 8; cisplatin = 75 mg/m2 IV on day 1) or gemcitabine-cisplatin alone (every 21 days) for up to six cycles. Patients receiving necitumumab plus gemcitabinecisplatin without disease progression continued necitumumab until progression. HRQoL was measured by Eastern Cooperative Oncology Group performance status, the Lung Cancer Symptom Scale (LCSS), and the European Quality of Life Five-Dimensions questionnaire. Efficacy and LCSS outcomes were analyzed using the baseline maximum severity score of the LCSS. Tolerability was measured in terms of exposure to the study treatment and adverse events. Hospitalization rates were collected. Results: Most patients in both study arms similarly maintained Eastern Cooperative Oncology Group performance status and comparable LCSS and European Quality of Life Five-Dimensions questionnaire assessments. Patients with a higher baseline LCSS had a greater survival benefit on the necitumumab arm. Chemotherapy exposure was similar in both treatment arms; 51% of patients on the necitumumab plus gemcitabine-cisplatin arm continued on single-agent necitumumab. The most frequent grade 4 adverse events were neutropenia (6.1% versus 7.9%) and thrombocytopenia (3.2% versus 4.3%) in the necitumumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin arms, respectively. Hospitalizations were slightly higher with necitumumab plus gemcitabine-cisplatin (36.4%) than with gemcitabine-cisplatin (34.0%). Conclusions: The addition of necitumumab to gemcitabinecisplatin was well tolerated, did not negatively affect HRQoL or toxicity, and particularly benefited patients with more severe baseline symptoms or lower HRQoL.

Original languageEnglish (US)
Pages (from-to)808-818
Number of pages11
JournalJournal of Thoracic Oncology
Volume11
Issue number6
DOIs
StatePublished - 2016

Fingerprint

gemcitabine
Cisplatin
Quality of Life
Lung Neoplasms
Hospitalization
necitumumab
Survival

Keywords

  • EQ-5D
  • Health-related quality of life
  • Lung Cancer Symptom Scale
  • Necitumumab
  • Tolerability

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life : Results from the phase 3 SQUIRE trial. / Reck, Martin; Socinski, Mark A.; Luft, Alexander; Szczesna, Aleksandra; Dediu, Mircea; Ramlau, Rodryg; Losonczy, György; Molinier, Olivier; Schumann, Christian; Gralla, Richard J.; Bonomi, Philip; Brown, Jacqueline; Soldatenkova, Victoria; Chouaki, Nadia; Obasaju, Coleman; Peterson, Patrick; Thatcher, Nick.

In: Journal of Thoracic Oncology, Vol. 11, No. 6, 2016, p. 808-818.

Research output: Contribution to journalArticle

Reck, M, Socinski, MA, Luft, A, Szczesna, A, Dediu, M, Ramlau, R, Losonczy, G, Molinier, O, Schumann, C, Gralla, RJ, Bonomi, P, Brown, J, Soldatenkova, V, Chouaki, N, Obasaju, C, Peterson, P & Thatcher, N 2016, 'The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: Results from the phase 3 SQUIRE trial', Journal of Thoracic Oncology, vol. 11, no. 6, pp. 808-818. https://doi.org/10.1016/j.jtho.2016.03.002
Reck, Martin ; Socinski, Mark A. ; Luft, Alexander ; Szczesna, Aleksandra ; Dediu, Mircea ; Ramlau, Rodryg ; Losonczy, György ; Molinier, Olivier ; Schumann, Christian ; Gralla, Richard J. ; Bonomi, Philip ; Brown, Jacqueline ; Soldatenkova, Victoria ; Chouaki, Nadia ; Obasaju, Coleman ; Peterson, Patrick ; Thatcher, Nick. / The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life : Results from the phase 3 SQUIRE trial. In: Journal of Thoracic Oncology. 2016 ; Vol. 11, No. 6. pp. 808-818.
@article{64fc3ae196cc4463a7a13fae7f4f3232,
title = "The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: Results from the phase 3 SQUIRE trial",
abstract = "Introduction: Necitumumab, a second-generation, recombinant human immunoglobulin G1 epidermal growth factor receptor antibody in the phase 3 SQUIRE trial (NCT00981058), increased survival benefit for patients randomized to receive necitumumab plus gemcitabine-cisplatin compared with those who received gemcitabine-cisplatin. Here we characterize health-related quality of life (HRQoL) and tolerability results. Methods: A total of 1093 patients with stage IV squamous non-small cell lung cancer were randomized 1:1 to receive necitumumab (800 mg absolute dose intravenously [IV]) plus gemcitabine-cisplatin (gemcitabine = 1250 mg/m2 IV on days 1 and 8; cisplatin = 75 mg/m2 IV on day 1) or gemcitabine-cisplatin alone (every 21 days) for up to six cycles. Patients receiving necitumumab plus gemcitabinecisplatin without disease progression continued necitumumab until progression. HRQoL was measured by Eastern Cooperative Oncology Group performance status, the Lung Cancer Symptom Scale (LCSS), and the European Quality of Life Five-Dimensions questionnaire. Efficacy and LCSS outcomes were analyzed using the baseline maximum severity score of the LCSS. Tolerability was measured in terms of exposure to the study treatment and adverse events. Hospitalization rates were collected. Results: Most patients in both study arms similarly maintained Eastern Cooperative Oncology Group performance status and comparable LCSS and European Quality of Life Five-Dimensions questionnaire assessments. Patients with a higher baseline LCSS had a greater survival benefit on the necitumumab arm. Chemotherapy exposure was similar in both treatment arms; 51{\%} of patients on the necitumumab plus gemcitabine-cisplatin arm continued on single-agent necitumumab. The most frequent grade 4 adverse events were neutropenia (6.1{\%} versus 7.9{\%}) and thrombocytopenia (3.2{\%} versus 4.3{\%}) in the necitumumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin arms, respectively. Hospitalizations were slightly higher with necitumumab plus gemcitabine-cisplatin (36.4{\%}) than with gemcitabine-cisplatin (34.0{\%}). Conclusions: The addition of necitumumab to gemcitabinecisplatin was well tolerated, did not negatively affect HRQoL or toxicity, and particularly benefited patients with more severe baseline symptoms or lower HRQoL.",
keywords = "EQ-5D, Health-related quality of life, Lung Cancer Symptom Scale, Necitumumab, Tolerability",
author = "Martin Reck and Socinski, {Mark A.} and Alexander Luft and Aleksandra Szczesna and Mircea Dediu and Rodryg Ramlau and Gy{\"o}rgy Losonczy and Olivier Molinier and Christian Schumann and Gralla, {Richard J.} and Philip Bonomi and Jacqueline Brown and Victoria Soldatenkova and Nadia Chouaki and Coleman Obasaju and Patrick Peterson and Nick Thatcher",
year = "2016",
doi = "10.1016/j.jtho.2016.03.002",
language = "English (US)",
volume = "11",
pages = "808--818",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "6",

}

TY - JOUR

T1 - The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life

T2 - Results from the phase 3 SQUIRE trial

AU - Reck, Martin

AU - Socinski, Mark A.

AU - Luft, Alexander

AU - Szczesna, Aleksandra

AU - Dediu, Mircea

AU - Ramlau, Rodryg

AU - Losonczy, György

AU - Molinier, Olivier

AU - Schumann, Christian

AU - Gralla, Richard J.

AU - Bonomi, Philip

AU - Brown, Jacqueline

AU - Soldatenkova, Victoria

AU - Chouaki, Nadia

AU - Obasaju, Coleman

AU - Peterson, Patrick

AU - Thatcher, Nick

PY - 2016

Y1 - 2016

N2 - Introduction: Necitumumab, a second-generation, recombinant human immunoglobulin G1 epidermal growth factor receptor antibody in the phase 3 SQUIRE trial (NCT00981058), increased survival benefit for patients randomized to receive necitumumab plus gemcitabine-cisplatin compared with those who received gemcitabine-cisplatin. Here we characterize health-related quality of life (HRQoL) and tolerability results. Methods: A total of 1093 patients with stage IV squamous non-small cell lung cancer were randomized 1:1 to receive necitumumab (800 mg absolute dose intravenously [IV]) plus gemcitabine-cisplatin (gemcitabine = 1250 mg/m2 IV on days 1 and 8; cisplatin = 75 mg/m2 IV on day 1) or gemcitabine-cisplatin alone (every 21 days) for up to six cycles. Patients receiving necitumumab plus gemcitabinecisplatin without disease progression continued necitumumab until progression. HRQoL was measured by Eastern Cooperative Oncology Group performance status, the Lung Cancer Symptom Scale (LCSS), and the European Quality of Life Five-Dimensions questionnaire. Efficacy and LCSS outcomes were analyzed using the baseline maximum severity score of the LCSS. Tolerability was measured in terms of exposure to the study treatment and adverse events. Hospitalization rates were collected. Results: Most patients in both study arms similarly maintained Eastern Cooperative Oncology Group performance status and comparable LCSS and European Quality of Life Five-Dimensions questionnaire assessments. Patients with a higher baseline LCSS had a greater survival benefit on the necitumumab arm. Chemotherapy exposure was similar in both treatment arms; 51% of patients on the necitumumab plus gemcitabine-cisplatin arm continued on single-agent necitumumab. The most frequent grade 4 adverse events were neutropenia (6.1% versus 7.9%) and thrombocytopenia (3.2% versus 4.3%) in the necitumumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin arms, respectively. Hospitalizations were slightly higher with necitumumab plus gemcitabine-cisplatin (36.4%) than with gemcitabine-cisplatin (34.0%). Conclusions: The addition of necitumumab to gemcitabinecisplatin was well tolerated, did not negatively affect HRQoL or toxicity, and particularly benefited patients with more severe baseline symptoms or lower HRQoL.

AB - Introduction: Necitumumab, a second-generation, recombinant human immunoglobulin G1 epidermal growth factor receptor antibody in the phase 3 SQUIRE trial (NCT00981058), increased survival benefit for patients randomized to receive necitumumab plus gemcitabine-cisplatin compared with those who received gemcitabine-cisplatin. Here we characterize health-related quality of life (HRQoL) and tolerability results. Methods: A total of 1093 patients with stage IV squamous non-small cell lung cancer were randomized 1:1 to receive necitumumab (800 mg absolute dose intravenously [IV]) plus gemcitabine-cisplatin (gemcitabine = 1250 mg/m2 IV on days 1 and 8; cisplatin = 75 mg/m2 IV on day 1) or gemcitabine-cisplatin alone (every 21 days) for up to six cycles. Patients receiving necitumumab plus gemcitabinecisplatin without disease progression continued necitumumab until progression. HRQoL was measured by Eastern Cooperative Oncology Group performance status, the Lung Cancer Symptom Scale (LCSS), and the European Quality of Life Five-Dimensions questionnaire. Efficacy and LCSS outcomes were analyzed using the baseline maximum severity score of the LCSS. Tolerability was measured in terms of exposure to the study treatment and adverse events. Hospitalization rates were collected. Results: Most patients in both study arms similarly maintained Eastern Cooperative Oncology Group performance status and comparable LCSS and European Quality of Life Five-Dimensions questionnaire assessments. Patients with a higher baseline LCSS had a greater survival benefit on the necitumumab arm. Chemotherapy exposure was similar in both treatment arms; 51% of patients on the necitumumab plus gemcitabine-cisplatin arm continued on single-agent necitumumab. The most frequent grade 4 adverse events were neutropenia (6.1% versus 7.9%) and thrombocytopenia (3.2% versus 4.3%) in the necitumumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin arms, respectively. Hospitalizations were slightly higher with necitumumab plus gemcitabine-cisplatin (36.4%) than with gemcitabine-cisplatin (34.0%). Conclusions: The addition of necitumumab to gemcitabinecisplatin was well tolerated, did not negatively affect HRQoL or toxicity, and particularly benefited patients with more severe baseline symptoms or lower HRQoL.

KW - EQ-5D

KW - Health-related quality of life

KW - Lung Cancer Symptom Scale

KW - Necitumumab

KW - Tolerability

UR - http://www.scopus.com/inward/record.url?scp=84979779392&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84979779392&partnerID=8YFLogxK

U2 - 10.1016/j.jtho.2016.03.002

DO - 10.1016/j.jtho.2016.03.002

M3 - Article

C2 - 26980471

AN - SCOPUS:84979779392

VL - 11

SP - 808

EP - 818

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 6

ER -