Gemcitabine–docetaxel versus cisplatin–vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin

Abstract

Background: This multicenter, randomized, phase III study compared the efficacy, including progression-free survival (PFS), and safety of gemcitabine -docetaxel (GD) combination versus cisplatin-vinorelbine (CV) in the treatment of advanced non-small-cell lung cancer (NSCLC). Results: A total of 311 patients were enrolled (155 GD and 156 CV). Neither PFS nor overall survival differed significantly between the two arms (median PFS 4.2 and 4 months; median survival 11.1 and 9.6 months; 1-year survival 46% and 42%, for GD and CV, respectively). For the GD arm compared with the CV arm, the hazard ratio for PFS was 1.04 [95% confidence interval (CI) 0.83 -1.32], and for overall survival, it was 0.90 (95% CI 0.70 -1.16). Objective response rates did not differ significantly (31% for GD, 35.9% for CV). Myelosupression, emesis and frequency of febrile neutropenia were less pronounced on the GD arm, whereas fluid retention and pulmonary events were more pronounced. The CV arm experienced a higher number of serious adverse events and a lower compliance with the protocol. There was no quality of life (QoL) difference between arms. Median time to definite impairment of health-related QoL was 153 and 168 days in GD and CV arms, respectively. Conclusions: There was no advantage in PFS with GD compared with CV; however, the CV regimen had higher rate of toxic events, mainly myelosuppression. The herein, non-platinum-containing regimen could be considered as a rational alternative to the cisplatin-based doublet.

Non–Small Cell Lung Cancer

“…188,[203][204][205][206]209,210 New agent/nonplatinum regimens are reasonable alternatives if available data show activity and tolerable toxicity (e.g., gemcitabine/docetaxel). 211 No evidence yet shows the superiority of one particular platinum-based regimen. 207,208 Maintenance Therapy: Patients should be reevaluated for tumor progression with a follow-up CT scan (i.e., after the first or second cycle).…”

“…Other carboplatinbased regimens include gemcitabine/carboplatin and docetaxel/carboplatin; 203,209,210 gemcitabine/docetaxel is another option. 211 Note that albumin-bound paclitaxel can be substituted for paclitaxel or docetaxel either for patients who have experienced hypersensitivity reactions after receiving paclitaxel or docetaxel despite premedication, or those in whom the standard premedications (i.e., dexamethasone, H2 blockers, H1 blockers) are contraindicated. 212,213 Specific targeted therapies have been developed for treating advanced lung cancer.…”

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

“…Reasons for exclusion were not stated in eight studies [30,31,40,42,43,48,57,64], whereas we were unable to assess if any exclusion criteria were applied in a trial published in Chinese only [46]. Response was assessed according to the World Health Organization standard criteria [72] in 19 trials [22,23,25,29,32,34,35,39,44,45,47,49,50,52,53,59,62,65,68], according to the Southwest Oncology Group guidelines [73] in two studies [21,24], and according to the Response Evaluation Criteria in Solid Tumors [74] in four trials [60,61,66,67].…”

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

“…In particular, among non-platinum-based chemotherapy regimens, the combination docetaxel -gemcitabine is considered one of the most promising. In fact, a randomised phase II trial and two randomised phase III trials compared this association with last generation platinum-containing doublets, docetaxel -cisplatin (Georgoulias et al, 2001) and cisplatinvinorelbine (Georgoulias et al, 2005;Pujol et al, 2005) yielding similar activity and efficacy. Therefore, the combination docetaxel -gemcitabine could be considered a regimen to test in elderly subjects, as tolerability, especially haematological toxicity, can be problematic (Georgoulias et al, 2005;Pujol et al, 2005;Manegold et al, 2006).…”