Induction pEmetrexed and cisplatin followed by maintenance pEmetrexed versus carboplatin plus paclitaxel plus bEvacizumab followed by maintenance bEvacizumab: A Quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE)

Domenico Galetta, Salvatore Pisconti, Saverio Cinieri, Giovanni Luigi Pappagallo, Vittorio Gebbia, Nicola Borsellino, Evaristo Maiello, Antonio Rinaldi, Michele Montrone, Pietro Rizzo, Nicola Marzano, Nicola Sasso, Antonio Febbraro, Giuseppe Colucci

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

In advanced nonsmall-cell lung cancer (NSCLC), substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. More recently, other topics such as histotype, maintenance therapy and quality of life have been explored to ameliorate this plateau. We present the treatment rationale and study design of the ERACLE (induction pEmetrexed and cisplatin followed by maintenance pemetRexed versus cArboplatin-paCLitaxel and bEvacizumab followed by maintenance bevacizumab) trial. Patients enrolled in the ERACLE trial are randomized between combination treatment arms: (A) cisplatin 75 mg/m 2 day 1 and pemetrexed 500 mg/m 2 day 1, every 3 weeks for six cycles followed (in responders or with stable disease) by pemetrexed 500 mg/m 2 day 1, every 3 weeks until progression; and (B) carboplatin AUC 6 day 1, plus paclitaxel 200 mg/m 2 day 1 and plus bevacizumab 15 mg/kg, every 3 weeks for six cycles followed (in responders or patients with stable disease) by bevacizumab 15 mg/kg every 3 weeks until progression. The primary objective of the study is to evaluate the difference in terms of quality of life between treatment arms. together with co-primary endpoints represented by the EuroQoL group (EQ-5D) questionnaire total score and the EQ-5D visual analog scale. Secondary endpoints are the evaluation of treatment activity and exploratory evaluation of treatment efficacy.

Original languageEnglish
Pages (from-to)402-406
Number of pages5
JournalClinical Lung Cancer
Volume12
Issue number6
DOIs
Publication statusPublished - Nov 2011

Fingerprint

Pemetrexed
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Maintenance
Quality of Life
Therapeutics
Visual Analog Scale
Area Under Curve
Bevacizumab
Drug Therapy
Survival

Keywords

  • Chemotherapy
  • EQ-5D questionnaire
  • EQ-5D visual analog scale
  • Maintenance therapy
  • Non-squamous advanced NSCLC
  • Quality of life

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Induction pEmetrexed and cisplatin followed by maintenance pEmetrexed versus carboplatin plus paclitaxel plus bEvacizumab followed by maintenance bEvacizumab : A Quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE). / Galetta, Domenico; Pisconti, Salvatore; Cinieri, Saverio; Pappagallo, Giovanni Luigi; Gebbia, Vittorio; Borsellino, Nicola; Maiello, Evaristo; Rinaldi, Antonio; Montrone, Michele; Rizzo, Pietro; Marzano, Nicola; Sasso, Nicola; Febbraro, Antonio; Colucci, Giuseppe.

In: Clinical Lung Cancer, Vol. 12, No. 6, 11.2011, p. 402-406.

Research output: Contribution to journalArticle

Galetta, Domenico ; Pisconti, Salvatore ; Cinieri, Saverio ; Pappagallo, Giovanni Luigi ; Gebbia, Vittorio ; Borsellino, Nicola ; Maiello, Evaristo ; Rinaldi, Antonio ; Montrone, Michele ; Rizzo, Pietro ; Marzano, Nicola ; Sasso, Nicola ; Febbraro, Antonio ; Colucci, Giuseppe. / Induction pEmetrexed and cisplatin followed by maintenance pEmetrexed versus carboplatin plus paclitaxel plus bEvacizumab followed by maintenance bEvacizumab : A Quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE). In: Clinical Lung Cancer. 2011 ; Vol. 12, No. 6. pp. 402-406.
@article{6e92b6105e2f490c85dc3d9081795baa,
title = "Induction pEmetrexed and cisplatin followed by maintenance pEmetrexed versus carboplatin plus paclitaxel plus bEvacizumab followed by maintenance bEvacizumab: A Quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE)",
abstract = "In advanced nonsmall-cell lung cancer (NSCLC), substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. More recently, other topics such as histotype, maintenance therapy and quality of life have been explored to ameliorate this plateau. We present the treatment rationale and study design of the ERACLE (induction pEmetrexed and cisplatin followed by maintenance pemetRexed versus cArboplatin-paCLitaxel and bEvacizumab followed by maintenance bevacizumab) trial. Patients enrolled in the ERACLE trial are randomized between combination treatment arms: (A) cisplatin 75 mg/m 2 day 1 and pemetrexed 500 mg/m 2 day 1, every 3 weeks for six cycles followed (in responders or with stable disease) by pemetrexed 500 mg/m 2 day 1, every 3 weeks until progression; and (B) carboplatin AUC 6 day 1, plus paclitaxel 200 mg/m 2 day 1 and plus bevacizumab 15 mg/kg, every 3 weeks for six cycles followed (in responders or patients with stable disease) by bevacizumab 15 mg/kg every 3 weeks until progression. The primary objective of the study is to evaluate the difference in terms of quality of life between treatment arms. together with co-primary endpoints represented by the EuroQoL group (EQ-5D) questionnaire total score and the EQ-5D visual analog scale. Secondary endpoints are the evaluation of treatment activity and exploratory evaluation of treatment efficacy.",
keywords = "Chemotherapy, EQ-5D questionnaire, EQ-5D visual analog scale, Maintenance therapy, Non-squamous advanced NSCLC, Quality of life",
author = "Domenico Galetta and Salvatore Pisconti and Saverio Cinieri and Pappagallo, {Giovanni Luigi} and Vittorio Gebbia and Nicola Borsellino and Evaristo Maiello and Antonio Rinaldi and Michele Montrone and Pietro Rizzo and Nicola Marzano and Nicola Sasso and Antonio Febbraro and Giuseppe Colucci",
year = "2011",
month = "11",
doi = "10.1016/j.cllc.2011.06.006",
language = "English",
volume = "12",
pages = "402--406",
journal = "Clinical Lung Cancer",
issn = "1525-7304",
publisher = "Elsevier Inc.",
number = "6",

}

TY - JOUR

T1 - Induction pEmetrexed and cisplatin followed by maintenance pEmetrexed versus carboplatin plus paclitaxel plus bEvacizumab followed by maintenance bEvacizumab

T2 - A Quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE)

AU - Galetta, Domenico

AU - Pisconti, Salvatore

AU - Cinieri, Saverio

AU - Pappagallo, Giovanni Luigi

AU - Gebbia, Vittorio

AU - Borsellino, Nicola

AU - Maiello, Evaristo

AU - Rinaldi, Antonio

AU - Montrone, Michele

AU - Rizzo, Pietro

AU - Marzano, Nicola

AU - Sasso, Nicola

AU - Febbraro, Antonio

AU - Colucci, Giuseppe

PY - 2011/11

Y1 - 2011/11

N2 - In advanced nonsmall-cell lung cancer (NSCLC), substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. More recently, other topics such as histotype, maintenance therapy and quality of life have been explored to ameliorate this plateau. We present the treatment rationale and study design of the ERACLE (induction pEmetrexed and cisplatin followed by maintenance pemetRexed versus cArboplatin-paCLitaxel and bEvacizumab followed by maintenance bevacizumab) trial. Patients enrolled in the ERACLE trial are randomized between combination treatment arms: (A) cisplatin 75 mg/m 2 day 1 and pemetrexed 500 mg/m 2 day 1, every 3 weeks for six cycles followed (in responders or with stable disease) by pemetrexed 500 mg/m 2 day 1, every 3 weeks until progression; and (B) carboplatin AUC 6 day 1, plus paclitaxel 200 mg/m 2 day 1 and plus bevacizumab 15 mg/kg, every 3 weeks for six cycles followed (in responders or patients with stable disease) by bevacizumab 15 mg/kg every 3 weeks until progression. The primary objective of the study is to evaluate the difference in terms of quality of life between treatment arms. together with co-primary endpoints represented by the EuroQoL group (EQ-5D) questionnaire total score and the EQ-5D visual analog scale. Secondary endpoints are the evaluation of treatment activity and exploratory evaluation of treatment efficacy.

AB - In advanced nonsmall-cell lung cancer (NSCLC), substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. More recently, other topics such as histotype, maintenance therapy and quality of life have been explored to ameliorate this plateau. We present the treatment rationale and study design of the ERACLE (induction pEmetrexed and cisplatin followed by maintenance pemetRexed versus cArboplatin-paCLitaxel and bEvacizumab followed by maintenance bevacizumab) trial. Patients enrolled in the ERACLE trial are randomized between combination treatment arms: (A) cisplatin 75 mg/m 2 day 1 and pemetrexed 500 mg/m 2 day 1, every 3 weeks for six cycles followed (in responders or with stable disease) by pemetrexed 500 mg/m 2 day 1, every 3 weeks until progression; and (B) carboplatin AUC 6 day 1, plus paclitaxel 200 mg/m 2 day 1 and plus bevacizumab 15 mg/kg, every 3 weeks for six cycles followed (in responders or patients with stable disease) by bevacizumab 15 mg/kg every 3 weeks until progression. The primary objective of the study is to evaluate the difference in terms of quality of life between treatment arms. together with co-primary endpoints represented by the EuroQoL group (EQ-5D) questionnaire total score and the EQ-5D visual analog scale. Secondary endpoints are the evaluation of treatment activity and exploratory evaluation of treatment efficacy.

KW - Chemotherapy

KW - EQ-5D questionnaire

KW - EQ-5D visual analog scale

KW - Maintenance therapy

KW - Non-squamous advanced NSCLC

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=80155214519&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80155214519&partnerID=8YFLogxK

U2 - 10.1016/j.cllc.2011.06.006

DO - 10.1016/j.cllc.2011.06.006

M3 - Article

C2 - 21831718

AN - SCOPUS:80155214519

VL - 12

SP - 402

EP - 406

JO - Clinical Lung Cancer

JF - Clinical Lung Cancer

SN - 1525-7304

IS - 6

ER -