Meeting
2013 ASCO Annual Meeting
Prospective randomised 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) with nonsquamous (Non SCC) histological type. NAVoTRIAL01: Final results.
Authors
Jaafar Bennouna
Institut de Cancerologie de l’Ouest, Nantes, France
Jaafar Bennouna , Libor Havel , Maciej Krzakowski , Jens Kollmeier , Radj Gervais , Eric Dansin , Monika Serke , Adolfo G. Favaretto , Manuel Cobo , Aleksandra Szczesna , Libero Ciuffreda , Jacek Jassem , Mario Nicolini , Rodryg Ramlau , Domenico Amoroso , Barbara Melotti , Teresa Almodovar , Nathalie Vaissiere , Marcello Riggi , Eng Huat Tan
Organizations
Institut de Cancerologie de l’Ouest, Nantes, France, Fakultni Nemocnice Bulovka-Klinika Pneumologie a Hrudni Chirurgie, Praha, Czech Republic, Instytut im M. Sklodowskiej-Curie, Centrum Onkologii, Warsaw, Poland, Helios Clinic Emil von Behring, Berlin, Germany, Centre François Baclesse, Caen, France, Centre Oscar Lambret, Lille, France, Lung Clinic Hemer, Hemer, Germany, Istituto Oncologico Veneto, Padua, Italy, Complejo Hospitalario Regional Universitario Carlos Haya, Cala Del Moral, Spain, Regional Lung Diseases Hospital, Otwock, Poland, Medical Oncology Unit, Molinette Hospital, Turin, Italy, Department of Oncology and Radiotherapy, Medical University of Gdánsk, Gdánsk, Poland, Ospedale Civile Degli Infermi, Rimini, Italy, Regional Center for Lung Disease, Wielkoposkie Centrum, Poznan, Poland, Ospedale Versilia, Lido Di Camaiore, Italy, Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy, Instituto Portugues de Oncologia de Lisboa Fransico Gentil, Lisboa, Portugal, Institut de Recherche Pierre Fabre, Boulogne, France, Institut de Recherche Pierre Fabre, Boulogne Billancourt, France, National Cancer Center, Singapore, Singapore
Research Funding
Pharmaceutical/Biotech Company
Background: NVBo+P is considered as a standard treatment 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). The importance of histological types was highlighted in a phase III trial (Scagliotti. JCO 2008). 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 Oncol. 2009). This trial was set up to assess the efficacy of NVBo+P (Arm A) and Pem+P (Arm B) for pts with Non SCC histological type, evaluated in terms of Disease Control Rate (DCR) (SD+PR+CR). Methods: Pts were randomised to receive q3w NVBo 80 mg/m² D1D8 (60 at Cycle 1) + P 80 mg/m² D1 (Arm A) or Pem 500 mg/m² + P 75 mg/m² D1 (Arm B). After 4 cycles of combination, pts with DCR received single agent NVBo (Arm A) or PEM (Arm B) as maintenance until progression or toxicity. 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 11/09 to 02/11, 153 pts were randomised to Arm A (102 pts) or Arm B (51 pts). DCR after combination and maintenance was 75.0% (95% CI, 65.3 to 83.1) in Arm A and 76.5% (95% CI, 62.5 to 87.2) in Arm B. Median PFS was 4.2 (95% CI, 3.6 to 4.7) and 4.3 months (95% CI, 3.8 to 5.6) in Arm A and Arm B, respectively. Median OS was 10.2 months (95% CI, 7.8 to 11.9) and 10.8 months (95% CI, 7.0 to16.4) in Arm A and Arm B, respectively. During the combination period grade 3/4 neutropenia was 44.0% in Arm A and 18.3% in Arm B but febrile neutropenia was 2% in both arms; grade 3/4 thrombopenia was 0% and 6% in Arm A and Arm B, respectively. Conclusions: Even if the current results should be confirmed in a phase III study, the choice of a platinum-based doublet with oral vinorelbine as front-line chemotherapy could be a useful alternative in non SCC. Clinical trial information: 2009-012001-19.
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Abstract Details
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 31, 2013 (suppl; abstr 8043)
DOI
10.1200/jco.2013.31.15_suppl.8043
Abstract #
8043
Poster Bd #
32G
Abstract Disclosures
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