Author of

• 17493

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  P2.02 - Poster Session with Presenters Present (ID 462)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Locally Advanced NSCLC
  • Presentations: 2
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17505

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    P2.02-012 - Long-Term Survival of Phase II of Full-Dose Oral Vinorelbine Combined with Cisplatin & Radiotherapy in Locally Advanced NSCLC (ID 4708)

    14:30 - 14:30  |  Author(s): J. Casal Rubio
    • Abstract

    Background:
    Chemo-radiotherapy is the standard of care for the treatment of inoperable locally advanced non-small cell lung cancer (LA-NSCLC). Cisplatin (P) plus vinorelbine is one of the chemotherapy (CT) regimens widely used concurrently with radiotherapy (RT). Since oral vinorelbine (oV) has achieved comparable results to the IV formulation, the optimal dose for the oV administration with P and concurrent RT is still being investigated. The aim of this study is to evaluate the efficacy and safety of full-dose oV combined with P and radical RT for LA-NSCLC patients (pts).
    
    Methods:
    Untreated pts between 18-70 years (y), with histologically proven inoperable LA-NSCLC (supraclavicular lymph node involvement excluded), V20<30%, adequate bone marrow, respiratory, hepatic and renal function, and ECOG PS0-1; received 4 cycles (cy) of oV 60 mg/m[2] D1 & 8 plus P 80 mg/m[2] D1, every 3 weeks, plus 2Gy/day of RT started on D1 of 2[nd] cy (total dose 66Gy). Primary endpoint was overall response rate (ORR) by RECIST 1.1. Secondary endpoints were: progression free survival (PFS), overall survival (OS) & safety profile. To guarantee a type-1 () error (one side) no greater than 0.05 and a type II (β) error 0.1 for the primary endpoint, a sample size of 45 eligible pts was planned. EudraCT 2009-010436-17.
    
    Results:
    Forty-eight pts were included between 02/2010-12/2011. Median age 61y [34-72], male 90%, PS1 58%; smokers 52%; squamous 63%; stage IIIB 54%. Main G3-4 toxicities (% cy) were: neutropenia 33%, febrile neutropenia 14.6%, anemia 12.5%, thrombocytopenia 16.6%, & esophagitis 12.5%. Two treatment-related deaths during the 1[st] cy. RT was administered to 87.5% of pts; 7.1% received less than 60Gy and 23.8% had delays due to adverse events. The ORR was 77.3% (2 complete responses). With a median follow-up of 28.2 months (m) [0.5-70.6], 33 pts (68.8%) have progressed and 32 (66.7%) have died. Median PFS and OS were 11.8m (CI~95%~ 7.2-16.5) and 29.8m (CI~95%~ 21.4-38.1), respectively. PFS at 1y was 48.8% pts (CI[95%] 33.9-63.7%). OS at 1 and 2y were 72.7% (CI95% 60-85.4%) and 57.3% (C95% 43-71.6%), respectively.
    
    Conclusion:
    This long-term analysis confirms the good efficacy results of the administration of full doses of oral vinorelbine combined with cisplatin and concurrent RT in patients with LA-NSCLC.
    
    

  • 17522

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    P2.02-029 - Concomitant ChemoRadiotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study from the Galician Lung Cancer Group (ID 4492)

    14:30 - 14:30  |  Author(s): J. Casal Rubio
    • Abstract
    • Slides

    Background:
    Concomitant platinum-based ChemoRadiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced Non-Small Cell Lung Cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of concomitant CT-RT with cisplatin (C) and intravenous and oral vinorelbine (V) and thoracic radiotherapy.
    
    Methods:
    31 chemo-naive patients with histologically confirmed inoperable locally advanced NSCLC, stage IIIA (T4 or N2)/IIIB, PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 30%) were included in concomitant CT-RT with: C 80 mg/m2 day 1 and intravenous V 25 mg/m2 day 1 and oral V 25 mg/m2 day 8 for three cycles, during conformal thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall survival (OS); secondary objectives were progression free survival (PFS), response rate (RR) and toxicity. Median follow-up: 18,1 months.
    
    Results:
    The patients characteristics were: mean age 59,6 years (44-75); male/female: 26/5; ECOG PS 0/1: 5/26; adeno/squamous/large cell carcinoma: 15/12/4; stage IIIA 16 patients and stage IIIB 15 patients. 28 patients were evaluable for response (3 patients in treatment) and 31 for toxicity. RR: 3 CR, 18 PR (RR 75%; 95% CI: 59-91), 5 SD (17.8%) and 2 PD (7.2%). The median PFS was 12 months (95% CI:6-18) and median OS was 28 months (95% CI:21-34). The PFS at 1/3 years were 47%/20% and the OS at 1/3 years were 77%/45%. Main toxicities (NCI-CTC 4.0) per patient in CT-RT (89 cycles of chemotherapy, 2.9 per patient; mean doses RT: 65,4 Gys) grade 1-2/3-4 (%) were: neutropenia 32/22.5; anemia 39/10; thrombocytopenia 13/0; nausea/vomiting 31/3; fatigue 29/0; esophagitis 39/6 and pneumonitis 16/0; hospitalizations was necesary in 9 patients: febrile neutropenia in 3 patients and grade 3 esophagitis in 2 patients.
    
    Conclusion:
    Concomitant CT-RT with Cisplatin and intravenous and oral Vinorelbine during thoracic radiotherapy is a feasible treatment option for inoperable locally advanced stage III NSCLC, showing good clinical efficacy and tolerability with acceptable long-term survival.
    
    

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