Prospective randomized phase II trial of oral vinorelbine (NVBo) and cisplatin (P) or pemetrexed (Pem) and P in first-line metastatic or locally advanced non-small cell lung cancer (M or LA NSCLC) patients (pts) with nonsquamous (non SCC) histologic type: NAVoTRIAL01—Preliminary results.

Authors

null

Jaafar Bennouna

Institut de Cancerologie de l'Ouest/Site René Gauducheau, Nantes, France

Jaafar Bennouna , Petr Zatloukal , Maciej Jerzy Krzakowski , Jens Kollmeier , Alain Riviere , Eric Dansin , Monika Serke , Adolfo G. Favaretto , Libor Havel , Stephanie Malasse , Fabienne Biville-Hedouin , Eng Huat Tan

Organizations

Institut de Cancerologie de l'Ouest/Site René Gauducheau, Nantes, France, Charles University, Faculty Hospital Bulovka and Postgraduate Medical Institute, Praha, Czech Republic, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland, Helios Clinic Emil von Behring, Berlin, Germany, Centre François Baclesse, Caen, France, Centre Oscar Lambret, Lille, France, Lungenklinik Hemer, Hemer, Germany, Istituto Oncologico Veneto, Padova, Italy, Fakultni Nemocnice Na Bulovce - Pneumology, Praha, Czech Republic, Institut de Recherche Pierre Fabre, Boulogne, France, Institut De Recherche Pierre Fabre, Boulogne, France, National Cancer Center, Singapore, Singapore

Research Funding

Pharmaceutical/Biotech Company
Background: NVBo+P is considered as a standard treatment (trt) in M or LA NSCLC. The recent approval of Pem+P as front line chemotherapy (CT) for non-SCC demonstrates that today, histology could become a “new guidance” to treat patients (pts). Phase III trial (Scagliotti. JCO 2008) showed efficacy of Pem+P in patients with non-SCC pts. Moreover, the higher chemosensitivity of non-SCC is recognised and reported with other chemotherapies (Ardizzoni.JNCI 2007). In GLOB 3 study, NVBo+P also showed better survival in adenocarcinoma (11.7m) than in SCC (8.9m) (Tan.Ann of Oncol 2009). This trial was set up to assess the efficacy of NVBo+P compared to Pem+P for pts with non-SCC histological type. The primary end-point was disease control rate (DCR) including overall response rate (ORR) and stable disease (SD). Methods: Pts were randomised to receive NVBo 80 mg/m² D1D8 (60 at Cycle 1) + P 80 mg/m² D1 q3w or Pem 500 mg/m² + P 75 mg/m² D1 q3w. After 4 cycles of trt, for pts showing a disease control, single agent as continuation maintenance (CM) was proposed until progression or toxicity. Given that Pem+P is now considered as a reference trt in non-SCC, pts were randomised on a 2/1 basis and stratified according to stage (IIIB - IV - relapse), non-SCC confirmed by histology or cytology, gender, smoking status and centre. Results: From 10/09 to 02/11, 153 pts were randomised to receive NVBo+P (102 pts) or Pem+P (51 pts). The efficacy between the 2 arms is similar: The ORR/DCR (Recist 1.1) after 4 cycles of trt are 26%/75% in the NVBo arm (100 eval pts in ITT population) and 24%/78% in the Pem arm (50 eval pts in ITT population). At the end of December 2011, 7 patients are still treated in CM: 5 pts in the NVBo arm and 2 pts in the Pem arm. Conclusions: The 2 CT regimen, NVBo+P or Pem+P have a similar efficacy in terms of ORR/DCR for pts with advanced non-SCC NSCLC. These results appear to be in line with the published data. As the analysis is currently in progress, final results including safety data, PFS and OS will be presented during the meeting.

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Abstract Details

Meeting

2012 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer - Non-small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Clinical Trial Registration Number

2009-012001-19

Citation

J Clin Oncol 30, 2012 (suppl; abstr 7575)

DOI

10.1200/jco.2012.30.15_suppl.7575

Abstract #

7575

Poster Bd #

49A

Abstract Disclosures