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
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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.
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One trial that included cisplatin plus docetaxel in the control arm did not find the intervention arm (intravenous vinorelbine and oral vinorelbine plus cisplatin) to be superior.
“one trial that included cisplatin plus docetaxel in the control arm and did not find the intervention arm to be superior (intravenous vinorelbine and oral vinorelbine plus cisplatin).69”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [69]
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- Authors
- Tan, E. H., Rolski, J., Grodzki, T., Schneider, C. P., Gatzemeier, U., Zatloukal, P., Aitini, E., Carteni, G., Riska, H., Tsai, Y. H., & Abratt, R.
- Affiliations
- National Cancer Centre Singapore (SG)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Zentralklinik Bad Berka (DE)
- LungenClinic Grosshansdorf (DE)
- Charles University (CZ)
- Azienda Ospedaliera Carlo Poma (IT)
- Helsinki University Hospital (FI)
- Chang Gung Memorial Hospital (TW)
- University of Cape Town (ZA)
- Corresponding author
- Tan, E.H.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2009-07
- Volume
- 20
- Issue
- 7
- Pages
- 1249-1256
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2128170871
- Cited by
- 64
- References
- 34
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 2 · 2021: 3 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 5 · 2016: 6 · 2015: 3 · 2014: 10 · 2013: 11 · 2012: 2
- FWCI
- 5.03
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Institut de Recherche PIERRE FABRE
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- non-small cell lung cancer, vinorelbine, docetaxel, cisplatin, first-line chemotherapy, oral vinorelbine, time to treatment failure, progression-free survival, overall survival, overall response, quality of life, treatment toxicity, metastatic lung cancer, EGFR tyrosine kinase inhibitors, bevacizumab
- MeSH terms
- Docetaxel, Vinorelbine, Administration, Oral, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Combined Modality Therapy, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Infusions, Intravenous, Lung Neoplasms, Male, Prospective Studies, Quality of Life, Vinblastine, Survival Analysis, Treatment Outcome, Disease-Free Survival, Taxoids, Kaplan-Meier Estimate
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