Jaafar Bennouna1, Libor Havel2, Maciej Krzakowski3, Jens Kollmeier4, Radj Gervais5, Eric Dansin6, Monika Serke7, Adolfo Favaretto8, Aleksandra Szczesna9, Manuel Cobo10, Libero Ciuffreda11, Jacek Jassem12, Mario Nicolini13, Rodryg Ramlau14, Domenico Amoroso15, Barbara Melotti16, Teresa Almodovar17, Marcello Riggi18, Noël-Raphaël Caux19, Nathalie Vaissière19, Eng-Huat Tan20. 1. Institut de Cancérologie de l'Ouest, Nantes, France. 2. Department of Pneumology and Thoracic Surgery, University Hospital Bulovka, Prague, Czech Republic. 3. Maria Sklodowska-Curie Oncology Centre, Institute of Oncology, Chest Oncology, Warsaw, Poland. 4. Department of Pneumology, Lungenklinik Heckeshorn, Helios-Klinikum Emil von Behring, Berlin, Germany. 5. Department of Oncology, Centre François Baclesse, Caen, France. 6. Department of Oncology, Centre Oscar Lambret, Lille, France. 7. Department of Pneumology III, Lungenklinik Hemer, Hemer, Germany. 8. Veneto Institute of Oncology IOV-IRCCS, Second Medical Oncology Unit, Padova, Italy. 9. Department of Oncology, Mazowieckie Centrum ChorobPluciGruzlicy, Otwocku, Poland. 10. Department of Medical Oncology, Hospital Clinico Carlos Haya, Malaga, Spain. 11. Ospedale Molinette, Oncologia Medica, Torino, Italy. 12. Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland. 13. Ospedale Cervesi, U.O.S. di Oncologia, Cattolica, Italy. 14. Department of Oncology, Wielkopolskie Centrum Pulmonologii Torakochirurgii, Poznan, Poland. 15. Ospedale Versilia, UOC Oncologia Medica, Lido di Camaiore, Italy. 16. Department of Medical Oncology, S Orsola-Malpighi Hospital, Bologna, Italy. 17. Department of Oncology, Instituto Portugues De Oncologia, Porto, Portugal. 18. Department of Oncology, Institut de Recherche Pierre Fabre, Paris, France. Electronic address: marcello.riggi@pierre-fabre.com. 19. Department of Oncology, Institut de Recherche Pierre Fabre, Paris, France. 20. Department of Medical Oncology, National Cancer Centre, Singapore.
Abstract
BACKGROUND: The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. PATIENTS AND METHODS: Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 (arm A) or oral vinorelbine 80 mg/m(2) on days 1 and 8 (first cycle 60 mg/m(2)) and cisplatin 80 mg/m(2) on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. RESULTS: Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. CONCLUSION:Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.
RCT Entities:
BACKGROUND: The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. PATIENTS AND METHODS: Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 (arm A) or oral vinorelbine 80 mg/m(2) on days 1 and 8 (first cycle 60 mg/m(2)) and cisplatin 80 mg/m(2) on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. RESULTS: Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. CONCLUSION: Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.
Authors: Natalia Sutiman; Zhenxian Zhang; Eng Huat Tan; Mei Kim Ang; Shao-Weng Daniel Tan; Chee Keong Toh; Quan Sing Ng; Balram Chowbay; Wan-Teck Lim Journal: PLoS One Date: 2016-05-02 Impact factor: 3.240
Authors: Francesco Grossi; Piotr Jaśkiewicz; Marion Ferreira; Grzegorz Czyżewicz; Dariusz Kowalski; Libero Ciuffreda; Ramon Garcia-Gomez; Salvatore Caruso; Joaquim Bosch-Barrera; Stéphanie Gautier; Christine Ta Thanh Minh; Sébastien Henriet; Gilberto de Castro Journal: Ther Adv Med Oncol Date: 2021-07-16 Impact factor: 8.168