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E. Maiello



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.02 - Treatment decisions for elderly patients with advanced non-small cell lung cancer (NSCLC) in Italian clinical practice: results from the RIGHT-3 project by Italian Association of Medical Oncology (ID 3115)

      10:35 - 10:40  |  Author(s): E. Maiello

      • Abstract
      • Presentation
      • Slides

      Background
      In 2004, the Italian Association of Medical Oncology (AIOM) created the RIGHT (Research for the identification of the most effective and highly accepted clinical guidelines for cancer treatment) program. The third step of the program, RIGHT3, aimed to evaluate the concordance between AIOM lung cancer guidelines and clinical practice in Italy. Description of treatment decisions for elderly patients with advanced non-small-cell lung cancer (NSCLC) was among the indicators. According to 2009 AIOM guidelines, single-agent chemotherapy with a third-generation agent was a reasonable choice for elderly patients with advanced NSCLC, whilst evidence about use of platinum-based treatment in the elderly population was judged potentially affected by selection bias and not conclusive.

      Methods
      RIGHT3 was a retrospective observational study conducted in a sample of 53 Italian lung cancer centers, representative of 230 AIOM centers. Patients with NSCLC diagnosis who had their first visit at the oncology center during 2010 and followed-up for at least 6 months were included. Proportion of elderly patients with stage IV disease receiving chemotherapy was among the 14 indicators evaluated.

      Results
      Overall, 306 pts with stage IV NSLSC were enrolled, and 299 were evaluable. Of these, 91 (30.4%) were older than 70. In the elderly subgroup, 81 pts (89%) were treated with first-line chemotherapy. In detail, a single-agent treatment was administered in 28 (34.6%) of cases, and a combination chemotherapy in the other 53 cases (65.4%). Among pts receiving platinum-containing doublets, carboplatin was more frequently used than cisplatin: carbo-gemcitabine (16 pts), carbo-pemetrexed (12 pts), cisplatin-pemetrexed (8 pts), cisplatin-gemcitabine (7 pts), carbo-vinorelbine (4 pts) were the 5 most frequently used regimens.Thirty pts (33%) received a second-line chemotherapy: single-agent in 23 cases, combination chemotherapy in 7 cases.

      Conclusion
      First-line platinum-based combination chemotherapy was commonly used in elderly patients with advanced NSCLC in 2010 by the Italian Lung cancer centers involved. First-line single-agent treatment, recommended by AIOM 2009 guidelines as the treatment choice with highest level of evidence, was used only in a minority 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): E. Maiello

      • 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.