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

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

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

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