title: Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial.
abstract: BACKGROUND
  Cisplatin with pemetrexed (CP) and carboplatin with paclitaxel and bevacizumab (CbTB) are standard first-line treatments for patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC). Quality of life (QoL) is a key objective in the management of advanced NSCLC. Thus, effect on QoL could be an additional factor in the choice of treatment.
  
  
  METHODS
  Patients with untreated stage IIIB/IV NS-NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2), every 3 weeks, for 6 cycles followed by maintenance pemetrexed; or carboplatin area under the curve 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, every 3 weeks, for 6 cycles followed by maintenance bevacizumab. The primary end point was the difference in QoL between the 2 treatment arms after 12 weeks of maintenance, measured using the EuroQoL 5 Dimensions-Index (EQ5D-I) and EQ5D-visual analogue scale (EQ5D-VAS).
  
  
  RESULTS
  One hundred eighteen patients were randomized to CP (n = 60) or CbTB (n = 58). Baseline characteristics were well balanced. The proportion of patients evaluable for the primary end point was lower than planned. After 12 weeks of maintenance, the difference between mean changes in EQ5D-I was 0.137, favoring CP (95% confidence interval [CI], -0.02 to 0.29, Wilcoxon P = .078), although not statistically significant; and the difference between mean changes in EQ5D-VAS was 0.97 (95% CI, -9.37 to 11.31, Wilcoxon P = .41).
  
  
  CONCLUSIONS
  Although the study was underpowered because of a small number of patients evaluable for the primary end point, QoL did not differ between treatment arms. Other factors such as comorbidities and schedule should be used when deciding on first-line treatment.
authors.affiliation: Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy. Electronic address: galetta@teseo.it.
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.affiliation: Medical Oncology Department and Breast Unit - "Sen. Perrino" Hospital Strada Statale 7 per Mesagne, Brindisi, Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: Cinieri
authors.affiliation: Medical Oncology Division, "S.G. Moscati" Hospital, Taranto, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.affiliation: Medical Oncology Division, "La Maddalena" Hospital, Palermo, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.affiliation: Thoraco-Pulmonary Medical Oncology, National Cancer Institute "Fondazione G. Pascale" - IRCCS, Napoli, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.affiliation: Medical Oncology Unit, "Buccheri-La Ferla" Hospital, Palermo, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Borsellino
authors.affiliation: Medical Oncology Division, "Casa Sollievo della Sofferenza" Hospital, Foggia, Italy.
authors.forename: Evaristo
authors.initials: E
authors.lastname: Maiello
authors.affiliation: Medical Oncology Division, "Fatebenefratelli" Hospital, Benevento, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Febbraro
authors.affiliation: Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Catino
authors.affiliation: Medical Oncology Department and Breast Unit - "Sen. Perrino" Hospital Strada Statale 7 per Mesagne, Brindisi, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Rizzo
authors.affiliation: Medical Oncology Division, "S.G. Moscati" Hospital, Taranto, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Montrone
authors.affiliation: Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Misino
authors.affiliation: Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Logroscino
authors.affiliation: Gruppo Oncologico Italia Meridionale (GOIM), Bari, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Rizzi
authors.affiliation: Clinical Trials Unit, National Cancer Institute "Fondazione G. Pascale" - IRCCS, Napoli, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.affiliation: Gruppo Oncologico Italia Meridionale (GOIM), Bari, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D000068437:Pemetrexed / Q000008:administration & dosage; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000068437:Pemetrexed; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin
keywords: Advanced NSCLC; EQ5D; Quality of life; Symptom palliation; Treatment choice