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A.L. Ortega



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.01 - Interim analysis of the Spanish Lung Cancer Group (SLCG) randomized phase II trial of thoracic radiotherapy (RT) concurrent with cisplatin (P) plus oral vinorelbine (OV) or etoposide (E) for unresectable locally advanced (LA) stage III non-small cell lung cancer (NSCLC). (GECP10/02). (ID 2658)

      10:30 - 10:35  |  Author(s): A.L. Ortega

      • Abstract
      • Presentation
      • Slides

      Background
      Chemoradiation is the standard of care for the treatment of unresectable LA-NSCLC. Cisplatin plus either etoposide or vinorelbine are two of the chemotherapy (CT) regimens widely used for the disease concurrently with radiotherapy. Oral vinorelbine is a formulation which has achieved comparable results to the IV vinorelbine. The purpose of the study is to evaluate the efficacy and safety of cisplatin when combined with etoposide or oral vinorelbine with radical radiation for the management of stage III NSCLC.

      Methods
      Patients (pts) between 18 and 75 years, with histologically proven untreated and unresectable LA stage IIIA/IIIB NSCLC, adequate bone marrow, hepatic and renal function, ECOG PS 0-1, were randomized to: Arm OV-P: OV 60 mg/m[2] D1, D8 cycle 1 and 80 mg/m[2] cycle 2 (if no grade 3-4 toxicity) plus P 80 mg/m[2] D1 every 3 weeks for 2 cycles as induction; patients without progression received OV 40 mg/m[2] D1, D8, and P 80 mg/m[2] D1 every 3 weeks for 2 more cycles (4 cycles in total). Arm E-P: E 50 mg/m[2] intravenously D1 to D5 plus P 50 mg/m[2] D1, D8 every 4 weeks for 2 cycles. Both regimens administered with concurrent RT 66 Gy in 6.5 weeks. The primary endpoint was progression free survival using RECIST 1.1, and secondary endpoints were overall response rate, overall survival, and safety profile. To guarantee an overall type-1 α error (one side) no greater than 0.05 and a type II (β) error 0.1 for the primary endpoint of PFS, a sample size of 134 pts allocated in a 1:1 ratio is planned.

      Results
      Since August 2011 77 pts have been recruited. 46 pts have been included in the interim analysis, 23 pts have been randomly allocated to each treatment arm. Patient’s characteristics were: Male 91.3%; median age 64 (range 44-75); PS1 56.5%; smokers 46.8%; adenocarcinoma 40.4% / squamous 55.3%; stage IIIA 46.8% / IIIB 53.2%. Median of months between initial diagnosis and study start was 1 (range 0.3-15.7). Safety: 118 cycles (cy) were analysed, 79 in arm OV-P and 39 in arm E-P. Hematological toxicities arms OV-P/E-P (% cy): grade (g) 3/4 neutropenia 8.9%/13.1%; g3 thrombocytopenia 0%/5.3%; g3 anemia 0%/2.6%; febrile neutropenia 3 cases on OV-P arm (all during induction CT on cy 1) and 1 case on E-P arm (during concurrent chemoradiation). Non-hematological toxicities arms OV-P/E-P (% cy): g3 esophagitis/mucositis 1.3%/15.5%; g3 infection without neutropenia 1.3%/5.1%. No treatment-related deaths were reported. There was no remarkable difference in other toxicities between both arms. 39 pts completed the treatment as per protocol, 19 in arm OV-P and 20 in arm E-P. Overall response rates were 73.7% and 50% for the OV-P and the E-P arm, respectively.

      Conclusion
      This interim analysis shows that OV-P and E-P when administered concurrently with RT have a manageable safety profile with efficacy. Safety data is consistent with other studies reported for both chemoradiation regimens. Based on these positive results for safety, accrual is ongoing. Clinical trial information EudraCT 2010-022927-31.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-052 - Phase II study of intermittent erlotinib (E) plus carboplatin (C), paclitaxel (P) and bevacizumab (B) as frontline treatment of patients (pts) with advanced non-squamous non-small cell lung cancer (nsNSCLC): AVAFAST Study. (ID 1432)

      09:30 - 09:30  |  Author(s): A.L. Ortega

      • Abstract

      Background
      To improve outcomes of nsNSCLC, investigators have empirically combined targeted therapies with conventional platinum-based regimens. The potential for combining E with cytotoxic drugs was initially investigated in two randomized phase III trials. Data from this studies showed that simultaneous EGFR-TKI/platinum combination resulted in antagonism in NSCLC. First-line sequential administration of E with chemotherapy in several studies, particularly the FAST-ACT trial, has demonstrated promising results in patients with nsNSCLC. The aim of this study is to combine E with C/P + B as per a sequential schedule in order to avoid the potential cell cycle-based antagonism between E and chemotherapy. In this study B has been added to the chemotherapy regimen since the addition of B has demonstrated improvement in response and survival, and should be considered as the most efficacious treatment for patients with nsNSCLC.

      Methods
      AVAFAST is an ongoing, open-label, multicenter, phase II study in chemo-naïve pts diagnosed with unresectable advanced, metastatic or recurrent nsNSCLC. Elegible pts also have 1 unidimensionally measurable lesion according to RECIST; age ≥ 18 years; ECOG PS ≤ 1; adequate hematological, renal and liver function; treated brain metastasis and signed informed consent. Radiological evidence of tumor invasion of major blood vessels, EGFR-mutation-positive disease, hemoptysis grade ≥2, significant cardiovascular disease or uncontrolled hypertension are exclusion criteria. Pts receive sequential combination of C (6 AUC), P (175mg/m2), B (7,5 mg/kg) on day 1, and intermittent E (150 mg) from day 5 to18 up to 4 cycles of 21 days. Pts who had not progressed after 4 cycles continue to receive B (7,5mg/kg) on day 1 until progression of disease or unacceptable toxicity. Non Progression Rate (NPR) at 12 weeks is used as the primary efficacy endpoint. Secondary endpoints include ORR, DCR, NPR at 24 weeks, PFS, OS, Safety profile and Quality of Life. 35 of planned 64 patients have been enrolled.

      Results
      not applicable

      Conclusion
      not applicable