In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .
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.
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 r and omly 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 r and omised 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 re sources and improve patient convenience
In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .