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N. Vaissière
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MO06 - NSCLC - Chemotherapy I (ID 108)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Perez-Soler, P.M. Ellis
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside Ballroom A, Level 1
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MO06.06 - Oral vinorelbine (NVBo) and cisplatin (P) or pemetrexed (Pem) and P as first-line chemotherapy for non squamous (NS) metastatic or locally advanced non small cell lung cancer (M or LA NSCLC): Final results of a prospective randomised phase II trial (NAVoTrial 1) (ID 276)
16:15 - 17:45 | Author(s): N. Vaissière
- Abstract
- Presentation
Background
NVBo and P are an established regimen in advanced NSCLC. The approval of Pem and P in NS NSCLC recognises histology as treatment driver even if the higher chemosensitivity of NS NSCLC is recognised and reported with other chemotherapies (Ardizzoni. JNCI 2007). NVBo + P also showed better survival in NS NSCLC than in Squamous NSCLC (Tan. Ann.Oncol. 2009). The current randomised (2:1) phase II trial assessed disease control (DCR) (SD + PR + CR) of NVBo/CDDP or PEM/CDDP in NS NSCLC.Methods
Stage IIIB/IV untreated/relapsed NS NSCLC 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, non PD pts 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 patients were enrolled in 31 centers and 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.Conclusion
Both doublets reported good efficacy and acceptable tolerability. The maintenance allowed continuation of effective treatment with either oral vinorelbine or pemetrexed as single agent, with an acceptable safety with both agents. These results are sufficiently compelling to consider whether a phase III randomised non inferiority study with oral vinorelbine maintenance after induction vinorelbine/cddp could be as effective as pemetrexed maintenance. An oral maintenance may be a definite advantage over intravenous maintenance.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P3.10 - Poster Session 3 - Chemotherapy (ID 210)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:
- Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
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P3.10-013 - Open-label, randomized multicentre, phase II trial of Oral vinorelbine (NVBo) or intravenous vinorelbine (NVBiv) with cisplatin (CDDP) in patients (pts) with advanced Non Small Cell Lung Cancer (NSCLC): A Chinese experience (CA225 study) (ID 1188)
09:30 - 16:30 | Author(s): N. Vaissière
- Abstract
Background
Aim of the study: to evaluate efficacy (CR, PR) of the two formulations with CDDP in advanced NSCLC. Secondary objectives were progression-free survival (PFS), overall survival (OS) and safety.Methods
NVBo, 60 mg/m² (Arm A) and NVBiv, 25 mg/m² (Arm B) were delivered on D1, D8, repeated every 3 weeks. Doses were increased at cycle 2 (NVBo 80 mg/m[2], NVBiv 30 mg/m[2]) according to hematological tolerance. CDDP doses were 80 mg/m[2] D1 every 3 weeks in both arms. Pts received a maximum of 4 cycles in absence of progression.Results
Between 1/2008 and 6/2009, 132 pts were randomized at 6 investigational centres (cut-off date for final analysis: August, 31[st] 2012 - Arm A 67 pts, Arm B 65 pts). One patient in Arm A was not treated. Among the 131 pts analyzed by an independent panel review, PR was 25.8% (95% CI [15.8-38.0]) in Arm A and 23.1% (95% CI [13.5-35.2]) in Arm B, and disease control (PR+SD) 72.7% (95% CI [60.4-83.0]) in Arm A and 72.3% (95% CI [59.8-82.8]) in Arm B. PFS (months) was 6.2 [3.8-7.7] for Arm A and 6.2 [4.9-7.8] for Arm B. One Year Survival was 59% and 61.6 in Arm A and Arm B, respectively, Two Years Survival: 39% Arm A, 38.7% Arm B, and 30 months Survival 29.2% Arm A, 26.9% Arm B. Median dose intensity (DI): NVBo 44.7 mg/m²/week, NVBiv 15.6 mg/m²/week. Relative dose intensity (RDI): NVBo 89.3%, NVBiv 81.5%. The CDDP median DI was 24.6 mg/m[2]/week in Arm A and 24.5 mg/m[2]/week in Arm B, with a RDI of 92.1% and 91.6% respectively. Grade 3/4 neutropenia: 29 pts and 43 cycles Arm A, 56 pts and 106 cycles Arm B. Febrile neutropenia : 4 (6.1%) pts Arm A, 6 (9.2%) pts Arm B. Grade 3 anaemia : 6 (9.1%) pts and 10 cycles Arm A, 13 pts (20%) and 18 cycles Arm B, with grade 4 anaemia in 3 (4.6%) pts and 5 cycles only in arm B. The most frequent non hematological disorders were nausea (8 pts Grade 3 - 12.1% Arm A; 6 pts Grade 3 - 9.2% Arm B) and vomiting (10 pts Grade 3 - 15.2%, 1 pt Grade 4 - 1.5% Arm A; 9 pts Grade 3 - 13.8%, 1 pt Grade 4 - 1.5% Arm B). Diarrhea was reported in 15 (22.7%) and 9 (13.8%) pts in Arm A and Arm B, respectively.Conclusion
Both arms testing NVBo and NVBiv with CDDP reported similar efficacy results in term of Response Rate, PFS and OS, coupled with an optimal safety profile. NVBo is a step forward in the treatment of NSCLC since it optimises treatment convenience thanks to its oral formulation while maintaining a high level of efficacy.
