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S. Cinieri



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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-047 - The three-drugs regimen CPBev (Cis-platinum, Pemetrexed and Bevacizumab) is very active when used as first-line therapy for locally advanced or metastatic adenocarcinoma of the lung: final results of a phase III trial. (ID 3077)

      09:30 - 09:30  |  Author(s): S. Cinieri

      • Abstract

      Background
      During the past seven years paradigms of advanced lung cancer therapy dramatically changed; Bevacizumab and Pemetrexed, when administered separately in association with platinum salts, demonstrated to improve survival in patients with non-squamous histologies. In the aim to investigate activity and safety of a three-drugs regimen containing both these agents plus cis-platinum, we conducted a multi-institutional phase II trial.

      Methods
      Eligible criteria were: chemo-naive patients with proven histology of non-squamous non-small celle lung cancer, PS-ECOG-WHO equal or lesser than 2, adequate hematological, liver and renal functions, no previous history of hemoptysis, stage III/B or IV without brain metastases, at least one measurable lesion, no uncontrolled hypertension or other severe comorbidities, no anamnestic episodes of venous thromboembolism. We adopt a two-stage of Simon model as statistical design of the study; the main end-point was overall response rate. No maintenance therapy was allowed.

      Results
      Thirty-two patients were enrolled; their main characteristics were: male/female: 20/12, median age (years): 59, ECOG-WHO PS 0/1: 21/11. We administered 183 cycles of CPBev: main grade 3 adverse events were neutropenia (28%), emesis (19%), asthenia (9%), and hypertension (9%). In terms of overall response rate we registered 20/32 (62.5%) partial responses, 8/32 (25%) stable diseases and 4/32 (12.5%) progressive diseases, with a clinical benefit rate of 28/32 (87.5%). The median overall survival of the entire series was 16.9 months; 1 and 2-years-overall survival were respectively 61.4 and 32.1%; the median progression-free-survival was 9.3 months, with a 1 and 2-progression-free-survival of 43.2 and 7%, respectively.

      Conclusion
      On the basis of our data, we may affirm that CPBev regimen have a good toxicity profile and is extremely active iwhen administered to advanced non-squamous, non-small celle lung carcinomas. Data concerning outcome parameters seems to be very interesting: CPBev deserves to be compared to actual standard regimens in a phase III trial in this population of patients.

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-007 - First-line Pemetrexed plus Cisplatin followed by maintenance Pemetrexed vs Carboplatin-Paclitaxel plus Bevacizumab followed by maintenance Bevacizumab (ERACLE) in advanced non squamous non-small Cell Lung Cancer : a Quality of Life-oriented, multicenter randomized phase III trial of the GOIM (Gruppo Oncologico Italia Meridionale). (ID 749)

      09:30 - 09:30  |  Author(s): S. Cinieri

      • Abstract

      Background
      Chemotherapy (CT) for advanced non-squamous non-small cell lung cancer (NS-NSCLC) without oncogenic drivers remains palliative with suggested similar efficacy and survival among different regimens. Histotype, maintenance therapy (m) and quality of life (QoL) have been explored to improve patients (pts) outcome. The ERACLE trial (NCT01303926), a QoL-oriented phase III trial, was designed to compare the QoL for two CT regimens.

      Methods
      Pts with stage IIIB/IV NS-NSCLC (ECOG 0/1) were randomized (1:1) to receive first-line CT. Arm A received 6 cycles of Cisplatin (C) (75 mg/m[2])/Pemetrexed (P) (500 mg/m[2]) q3w, followed by mP (500 mg/m[2]), while Arm B received Carboplatin (Cb) AUC 6/Paclitaxel (T) 200 mg/m[2] plus Bevacizumab (Be) 15 mg/kg q3w for 6 cycles, followed by mBe 15 mg/kg. Both treatments were administered until progression, unacceptable toxicity or death. Stratification was based on Study Centre and disease stage. Co-Primary endpoints were EQ5D Index (EQ5D-I) and EQ5D-VAS (Euro-QoL questionnaire). Quality of life data were collected at three time points during the induction phase and at 12 and 18 weeks during the maintenance phase. Secondary endpoints were QoL over time, safety and activity of CT arms. A sample size of 49 pts per arm (that have not progressed during initial CT and during maintenance therapy for at least 12 weeks) would have 91% chance to have 12-point Minimal Interesting Difference (MID) between arms for EQ5D-VAS, and 87% chance to find 0.137 MID between arms for EQ5D-I. It is assumed that about 20% of pts in both arms experience progressive disease before the evaluation of the primary endpoint. The study sample was then increased to 118.

      Results
      From 1/2011 to 3/2012, 118 pts were randomized to Arm A (n=60) or Arm B (n=58). Baseline demographics were well balanced across arms; Arm A/Arm B male: 70%/77.6%, PS 0: 78.3%/79.3%, stage IV 95%/93%, smokers: 63%/52% . Seventy four pts (62,7%) received maintenance chemotherapy. Treatment differences (mean change from baseline), EQ5D-VAS = 1.82 (95%CI -8.60 to 12.24; P=0.73), EQ5D-I = 0.15 (95%CI 0.01 to 0.29), favoured arm A. Safety was as expected without relevant haematological toxicity and with a significant impact of G3/4 alopecia (p=0.002) and G 1-3 neurotoxicity in ARM B (p=0.008) during induction. Response rates were (Arm A/Arm B) partial responses 40%/51%; stable disease 48.3%/27.6%. The Hazard Ratio (HR) for Progression Free Survival Arm A/Arm B [Cox's analysis] was 0.62 (95%CI 0.41 to 0.95) p=0.03 and HR for Overall Survival Arm A/Arm B [Cox's analysis] was 0.69 (95%CI 0.61 to 1.04) p=0.08.

      Conclusion
      Arm A showed better (over the MID) health profile (EQ5D-I) as compared to Arm B. EQ5D-VAS didn’t find any significant difference between treatment arms. By assuming equal activity, the choice of a treatment for advanced NSCLC should be mainly based on QoL.