1247P - Randomised phase II trial of oral vinorelbine (N) and cisplatin (P) or pemetrexed and c (PC) in first line advanced non squamous (NSCC) non small ce...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Eng Huat Tan
Authors E.H. Tan1, L. Havel2, M.J. Krzakowski3, J. Kollmeier4, R. Gervais5, E. Dansin6, M. Serke7, S. Malassé8, F. Biville-Hedouin9, J. Bennouna10
  • 1Dept. Medical Oncology, National Cancer Institute, Singapore/SG
  • 2Pneumology- Budinova 2, Fakultni Nemocnice Na Bulovce, Phaha/CZ
  • 3Lung & Thoracic Tumors Dept, MSC Memorial Cancer Centre and Institute Maria Sklodowska Curie, PL 02.781 - Warsaw/PL
  • 4Oncology/pneumology, Helios Clinic Emil von Behring, 14165 - Berlin/DE
  • 5Pneumology, Centre François Baclesse, Caen/FR
  • 6Pneumology, Centre Oscar Lambret, 59020 - Lille/FR
  • 7Lungenklinik Hemerdes Deutschen Gemeinschafts-Diakonieverbandes GmbH, DE-58675 - Hemer/DE
  • 8Statistical Department, Institut de Recherche Pierre Fabre, 92654 - Boulogne Billancourt/FR
  • 9Medical Affairs Oncology, Institute de Recherche Pierre Fabre, 92654 - Boulogne Billancourt CEDEX/FR
  • 10Oncology/ Pneumology, Institut de Cancerologie de l’Ouest-site René Gauducheau, Nantes/FR

Abstract

Background

Individualized treatments in NSCLC are now based on molecular and/or histological data. This randomized trial (2/1) was set up to assess the efficacy of NC compared to PC for pts with nSCC. The primary end-point was disease control rate (DCR) including overall response rate (ORR) and stable disease (SD).

Methods

Pts received N60-80 mg/m2 D1, D8 + C80 mg/m2 D1 or P500 mg/m2 + C75 mg/m2 D1 for 4 cycles q3w; pts with DCR received single agent continuation maintenance (CM) until progression or toxicity.

Results

From 10/09 to 02/11, 151 pts were treated with NC or PC.

ITT = 151 NCn = 100 PCn = 51
Male/Stage IV (%) 62.0/87.0 64.7/88.2
Median age (y, range) 61.0 (38.4-75.1) 63.8 (40.3-75.5)
Combination: (%) ITT(95% CI)
DCR 75.0 (65.3-83.1) 74.5 (60.4-85.7)
ORR 21.0 (13.5-30.3) 23.5 (12.8-37.5)
Combination + CM:(%) ITT (95% CI) n= 53 n = 33
DCR 75 (65.3-83.1) 76.5 (62.5-87.2)
ORR 24 (16.0-33.6) 31.4 (19.1-45.9)
Median PFS ITT (m,range) 4.2 (3.6-4.7) 4.2 (3.2-5.6)
PFS ITT at 6/12/18m (%) 33.0/10.3/5.5 27.5/7.4/2.5
Median OS ITT (m,range) 10.6 (7.8-12.1) 10.8 (7.0-14.5)

Related toxicities G3/4 (%pts) NC/PC during Combination: anemia 9.0(G3)/8.2, leucopenia 26.0/10.2, neutropenia 44.0/18.3, febrile neutro 2.0/2.0, thrombocytopenia 0/6.1, fatigue(G3) 7.0/3.9, hyperglycemia 4.0/7.8, nausea(G3) 5.0/0, vomiting(G3) 7.0/2.0, stomatitis(G3) 0/2.0, pneumonia(G3) 0/2.0, deep vein thrombosis(G3) 0/2.0, pulmonary embolism(G4) 0/2.0. During Maintenance: anemia 5.0/4.1, leucopenia 2.0/10.2, neutropenia 11.0/20.4, febrile neutro 3.8/0, fatigue (G3) 3.8/0, stomatitis(G3) 1.9/ 3.0, pain 3.8/6.0, Respiratory disorders 0/4.0, deep vein thrombosis (G3)0/2.0. Deaths potentially related to CT 2/1.

Conclusions

NC and PC had similar efficacy. In the present economic context, the acquisition cost of the two platinum based doublets should be considered in the treatment decision making of pts with advanced nSCC NSCLC.

Disclosure

S. Malassé: Statistician of the study Employment for the sponsor.

F. Biville-Hedouin: Medical Project Manager of the study Employment for the sponsor.

All other authors have declared no conflicts of interest.