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 non-small-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.
authors.affiliation: Division of Medical Oncology, Giovanni Paolo II Oncology Institute, Bari, Italy. galetta@teseo.it
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.forename: Saverio
authors.initials: S
authors.lastname: Cinieri
authors.forename: Giovanni Luigi
authors.initials: GL
authors.lastname: Pappagallo
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Nicola
authors.initials: N
authors.lastname: Borsellino
authors.forename: Evaristo
authors.initials: E
authors.lastname: Maiello
authors.forename: Antonio
authors.initials: A
authors.lastname: Rinaldi
authors.forename: Michele
authors.initials: M
authors.lastname: Montrone
authors.forename: Pietro
authors.initials: P
authors.lastname: Rizzo
authors.forename: Nicola
authors.initials: N
authors.lastname: Marzano
authors.forename: Nicola
authors.initials: N
authors.lastname: Sasso
authors.forename: Antonio
authors.initials: A
authors.lastname: Febbraro
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D000068437:Pemetrexed; D011788:Quality of Life; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin