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A. Ardizzoni
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-082 - Multicenter Randomized Trial Comparing Erlotinib vs. Gemcitabine or Vinorelbine as Third-Line in Advanced EGFR-Wild-Type or Unknown NSCLC (ID 651)
09:30 - 09:30 | Author(s): A. Ardizzoni
- Abstract
Background:
In clinical practice, approximately one third of patients with advanced non-small cell lung cancer (NSCLC) is candidate at third-line treatment. Currently, only erlotinib is licensed with this indication. Recent studies (TAILOR and DELTA trials) have questioned the role of erlotinib in second-line therapy of patients with advanced EGFR wild-type NSCLC, suggesting an inferiority in survival compared to chemotherapy with docetaxel. For this reason, the use of erlotinib is gradually shifting to the third-line. However, in this setting, chemotherapy drugs, such as gemcitabine or vinorelbine, could achieve similar survival results, with limited toxicity and lower costs than erlotinib. Therefore, the objective of this study is to evaluate the efficacy of chemotherapy (gemcitabine or vinorelbine) vs. erlotinib in the treatment of patients with advanced EGFR wild-type or unknown NSCLC progressing after two lines of chemotherapy in terms of overall survival (primary end-point). The treatments will be also compared in terms of activity, quality of life, toxicity and costs (secondary end-points).
Methods:
538 patients will be enrolled from 40 clinical Italian centers and assigned by randomization to one of 2 treatment arms (chemotherapy vs. erlotinib) with a ratio of 1:1. As stratification factors will be considered: the center, histology (squamous vs. non-squamous), EGFR (wild type vs. unknown) and PS (0-1 vs. 2). Patients will be randomized to receive treatment with erlotinib 150 mg/day (control arm) or chemotherapy with gemcitabine 1000 mg/m[2] or vinorelbine 25 mg/m[2] on days 1, 8 every 21 days (experimental arm), according to investigator choice and previous treatment received. Treatments will be administered until disease progression, patient refusal, unacceptable toxicity, patient clinical deterioration or investigator decision. It was estimated that with 440 deaths from any cause the study would have 85% power to detect a hazard ratio of 0.75 at a two-sided significance level of 5%. If the superiority comparison will fail to detect a significant difference between treatments, the non-inferiority of the chemotherapy arm will be tested with a power equal to 65% against a prospectively defined margin for non-inferiority of the HR equal to 1.25.
Results:
not applicable
Conclusion:
If this study should be positive, it will follow a change in clinical practice with an improvement in life expectancy of patients with advanced NSCLC and savings in terms of economic resources for the NHS. This study (CONFERMER trial) is supported by NHS, Regione Emila Romagna. As to 14 April 2015, 44 patients were randomized.
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P3.01-089 - Nab-Paclitaxel with or without CC-486 as Second-Line Therapy for NSCLC (ABOUND.2L) (ID 719)
09:30 - 09:30 | Author(s): A. Ardizzoni
- Abstract
Background:
Many patients with advanced non-small cell lung cancer (NSCLC) will experience disease progression during first-line chemotherapy. Effective and well-tolerated second-line treatment options for this patient population are limited. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly improved the primary endpoint of overall response rate (ORR) compared with solvent-based paclitaxel plus C in patients with advanced NSCLC (33% vs 25%; P = 0.005; Socinski et al. J Clin Oncol. 2012;30:2055-2062). nab-P combined with CC-486, an oral formulation of azacitidine, resulted in promising outcomes in a phase I trial of patients with relapsed/refractory solid tumors (LoRusso et al. Mol Cancer Ther. 2013;12(11 Suppl):Abstract A120). In the open-label, multicenter phase II ABOUND.2L trial, the safety and efficacy of nab-P with or without CC-486 will be evaluated in the second-line treatment of patients with advanced nonsquamous NSCLC.
Methods:
Approximately 160 patients who have received 1 platinum-containing chemotherapy regimen for treatment of advanced disease will be randomized 1:1 to CC-486 200 mg/day on days 1 to 14 every 21 days plus nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 8 and 15 every 21 days or nab-P 100 mg/m[2] IV (30-minute infusion) on days 1 and 8 every 21 days. Key eligibility criteria include histologically or cytologically confirmed advanced nonsquamous NSCLC, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, no prior taxane therapy, no known EGFR mutation or EML4-ALK translocation, and peripheral neuropathy grade < 2. Randomization will be stratified by ECOG performance status (0 vs 1), sex, and smoking status (yes vs no). ClinicalTrials.gov identifier NCT02250326.Key Endpoints
Primary -Progression-free Survival Secondary -Disease control rate -Overall Survival -ORR -Safety Exploratory -Changes in quality of life -Healthcare resource utilization throughout the study -Correlation between pretreatment tumor characteristics and response to treatment
Results:
Not applicable
Conclusion:
Not applicable
