Annals of Oncology Advance Access first published online on March 10, 2009
This version published online on March 25, 2009
Annals of Oncology, doi:10.1093/annonc/mdn774
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Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer
1 Department of Medical Oncology, National Cancer Centre, Singapore
2 Department of Medical Oncology, Centre of Oncology, Maria Sklodowska-Curie, Memorial Institute, Crakow
3 Department of Chemotherapy, The Regional Hospital for Lung Diseases, Szczecin-Zdunowo, Poland
4 Central Hospital Bad Berka, Bad Berka
5 Department of Pneumo-Oncology, Hospital Grosshansdorf, Centre of Pneumology and Thoracic Surgery, Grosshansdorf, Germany
6 3rd Faculty of Medicine, Charles University, Postgraduate Medical School and Faculty Hospital Bulovka, Prague, Czech Republic
7 Oncology and Haematology Operative Unit, Carlo Poma Hospital, Mantova
8 Medical Oncology Operative Unit, Antonio Cardarelli Hospital, Naples, Italy
9 Helsinki University Central Hospital, Meilahden Sairaala Haartmaninkaku, Helsinki, Finland
10 Chang-Gung Memorial Hospital - Linkuo, Taoyuan, Taiwan
11 Department of Radiation Oncology, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa
* Correspondence to: Dr E. H. Tan, Division of Clinical Trials and Epidemiological Sciences, National Cancer Center, 11 Hospital Drive, Singapore 169610, Singapore. Tel: +8165-64368171; Fax: +8165-62772759; E-mail: tanenghuat123{at}gmail.com
Background: The study compared the efficacy of a first-line treatment with day 1 i.v. vinorelbine (NVBiv) and day 8 oral vinorelbine (NVBo) versus docetaxel (DCT) in a cisplatin-based combination in advanced non-small-cell lung cancer, in terms of time to treatment failure (TTF), overall response, progression-free survival (PFS), overall survival (OS), tolerance and quality of life (QoL).
Methods: Patients were randomly assigned to receive cisplatin 80 mg/m2 with NVBiv 30 mg/m2 on day 1 and NVBo 80 mg/m2 on day 8 every 3 weeks, after a first cycle of NVBiv 25 mg/m2 on day 1 and NVBo 60 mg/m2 on day 8 (arm A) or cisplatin 75 mg/m2 and DCT 75 mg/m2 on day 1 every 3 weeks (arm B), for a maximum of six cycles in both arms.
Results: From 2 February 2004 to 1 January 2006, 390 patients were entered in a randomised study and 381 were treated. The patient characteristics are as follows (arms A/B): metastatic (%) 80.5/84.8; patients with three or more organs involved (%) 45.3/40.8; median age 59.4/62.1 years; male 139/146; squamous (%) 34.2/33.5; adenocarcinoma (%) 41.6/39.3; median TTF (arms A/B in months) [95% confidence interval (CI)]: 3.2 (3.0–4.2), 4.1 (3.4–4.5) (P = 0.19); overall response (arms A/B) (95% CI): 27.4% (21.2% to 34.2%), 27.2% (21.0% to 34.2%); median PFS (arms A/B in months) (95% CI): 4.9 (4.4–5.9), 5.1 (4.3–6.1) (P = 0.99) and median OS (arms A/B in months) (95% CI): 9.9 (8.4–11.6), 9.8 (8.8–11.5) (P = 0.58). The median survival for squamous histology was 8.87/9.82 months and for adenocarcinoma 11.73/11.60 months for arms A and B, respectively. Main haematological toxicity was grade 3–4 neutropenia: 24.4% (arm A) and 28.8% (arm B). QoL as measured by the Lung Cancer Symptom Scale was similar in both arms.
Conclusions: Both arms provided similar efficacy in terms of response, time-related parameters and QoL, with an acceptable tolerance profile. In the current Global Lung Oncology Branch trial 3, NVBo was shown to be effective as a substitute for the i.v. formulation. This can relieve the burden of the i.v. injection on day 8 and can optimise the hospital's resources and improve patient convenience.
advanced NSCLC, chemotherapy, navelbine oral, platinum based, phase trial study
The address of the first author has been corrected.
Received for publication July 2, 2008. Revision received November 13, 2008. Accepted for publication November 18, 2008.
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