GILT—A randomised phase III study of oral vinorelbine and cisplatin with concomitant radiotherapy followed by either consolidation therapy with oral vinorelbine and cisplatin or best supportive care alone in stage III non-small cell lung cancer

2016 ◽  
Vol 192 (4) ◽  
pp. 216-222 ◽  
Author(s):  
Michael Flentje ◽  
Rudolf M. Huber ◽  
Walburga Engel-Riedel ◽  
Stefan Andreas ◽  
Jens Kollmeier ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Supportive Care ◽  
Best Supportive Care ◽  
Small Cell ◽  
Phase Iii ◽  
Consolidation Therapy ◽  
Small Cell Lung ◽  
Oral Vinorelbine ◽  
Phase Iii Study ◽  
Concomitant Radiotherapy

GILT study: Oral vinorelbine (NVBo) and cisplatin (P) with concomitant radiotherapy (RT) followed by either consolidation (C) with NVBo plus P plus best supportive care (BSC) or BSC alone in stage (st) III non-small cell lung cancer (NSCLC): Final results of a phase (ph) III study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7001-7001 ◽  
Author(s):  
Rudolf M. Huber ◽  
Walburga Engel-Riedel ◽  
Jens Kollmeier ◽  
Stefan Andreas ◽  
Susanne Staar ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Supportive Care ◽  
Best Supportive Care ◽  
Small Cell ◽  
Small Cell Lung ◽  
Oral Vinorelbine ◽  
Set Up ◽  
High Level ◽  
To Receive ◽  
Concomitant Radiotherapy

7001 Background: Concurrent chemo-radiotherapy (CT-RT) is considered as a standard in st III NSCLC. Published trials with C after CT-RT show encouraging but discordant results. This ph III was set up to assess C in st III NSCLC. Methods: Patients (pts) received NVBo 50 mg/m² D1, D8, D15 + P 20 mg/m² D1-D4 q4w / 2 cycles (cy) + RT (66 Gy / 33 Fr). C for OR+SD pts: NVBo 60-80 mg/m² D1D8 + P 80 mg/m² D1 q3w / 2 cy + BSC (Arm A) or BSC (Arm B). PFS was the primary endpoint. Results: From 07/05 to 05/09, 279 pts received CT/RT and 201 pts (72%) were randomised to receive CT+BSC or BSC as C. Toxicity (tox) G3-4 (% pt) CT-RT/ C (Arm A/B): anaemia 3.2/3.5/1.1; thrombopenia 2.5/1.2/0.6; neutropenia (N) 11.2/11.7/5.7; febrile N 1.4/1.0/0; nausea (G3) 5.0/4.7/2.9; vomiting (G3) 3.9/3.5/2.0; anorexia 3.6/1.2/3.0; dysphagia 1.8/2.3/1.0; fatigue 3.3/ 2.3/1.0; pneumonia/ pneumonitis 2.6/0/2.0; CT-RT pain 2.2; CT-RT oesophagitis 8.6; 3 toxic deaths. Conclusions: In this ph III, NVBo+P+RT reports a high level of efficacy (OR 60.7%; DCR 86.0%) and low tox. The DCR is significantly improved in pts who received C with NVBo+ P in eval pts (p=0.0084). Lung tox was not enhanced by using NVBo+P as C. However no survival advantage for C was achieved. [Table: see text]

Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. CRA8000-CRA8000
Author(s):  
C. P. Belani ◽  
T. Brodowicz ◽  
T. Ciuleanu ◽  
J. H. Kim ◽  
M. Krzakowski ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Supportive Care ◽  
Small Cell Lung Cancer ◽  
Annual Meeting ◽  
Best Supportive Care ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Study ◽  
Final Text

CRA8000 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]

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