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
| Autor: | Petr Zatloukal, R. P. Abratt, J. Rolski, H. Riska, C.P. Schneider, U. Gatzemeier, Ying-Huang Tsai, Eng Huat Tan, G. Carteni, E. Aitini, T. Grodzki |
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| Rok vydání: | 2009 |
| Předmět: |
Oncology
Male medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Administration Oral Docetaxel Kaplan-Meier Estimate Neutropenia Vinorelbine Vinblastine Disease-Free Survival Drug Administration Schedule Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Medicine Humans Progression-free survival Prospective Studies Lung cancer Prospective cohort study Infusions Intravenous Survival analysis Chemotherapy business.industry Hematology medicine.disease Combined Modality Therapy Survival Analysis Treatment Outcome Quality of Life Female Taxoids Cisplatin business medicine.drug Follow-Up Studies |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 20(7) |
| ISSN: | 1569-8041 |
| Popis: | 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/m 2 with NVBiv 30 mg/m 2 on day 1 and NVBo 80 mg/m 2 on day 8 every 3 weeks, after a first cycle of NVBiv 25 mg/m 2 on day 1 and NVBo 60 mg/m 2 on day 8 (arm A) or cisplatin 75 mg/m 2 and DCT 75 mg/m 2 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. |
| Databáze: | OpenAIRE |
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