Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group—EORTC 08975

Abstract

Conclusion: Gemcitabine plus cisplatin and paclitaxel plus gemcitabine do not increase overall survival in patients with advanced NSCLC as compared with paclitaxel plus cisplatin. Treatment was well tolerated, and most QoL parameters were similar, but costs associated with the nonplatinum arm were highest.

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].…”

“…In the study by Schiller et al [22] cisplatin-gemcitabine was compared with both cisplatin-paclitaxel and carboplatin-paclitaxel, and with cisplatin-vinorelbine; in the same way cisplatin-vinorelbine was compared with cisplatin-paclitaxel and with carboplatinpaclitaxel. The same approach was adopted when analyzing the studies by Fossella et al [24], Smit et al [25], Treat et al [43], Liu et al [57], and Ohe et al [66].…”

“…All patients were chemotherapy-naïve, with the exception of the trial by Smit et al [25]-in which enrolled patients might have received adjuvant/neoadjuvant chemotherapy, provided it had finished at least 1 year prior to enrolling-and of a phase II study that excluded only patients receiving prior therapy for metastatic disease [47]. discontinued treatment early because of voluntary withdrawal or drug toxicity [32,35].…”

“…At least five randomized trials [21][22][23][24][25] have suggested that modern regimens combining a platinum agent with any third-generation drug are roughly comparable when survival is used as the primary measure of outcome. Still, in the landmark Eastern Cooperative Oncology Group E1594 study [22], evaluating cisplatin-gemcitabine, cisplatin-docetaxel, and carboplatin-paclitaxel versus a reference regimen of cisplatin-paclitaxel, the gemcitabine arm yielded a significantly longer time to progression (TTP) than in controls, and the 2-year survival rate was numerically higher.…”

A Pooled Study on Combination of Gemcitabine and Nedaplatin for Treating Patients with Non-small Cell Lung Cancer

“…This resulted in its use as a combination with platinum. Several clinical studies on new platinum-based doublets (Kelly et al, 2001;Schiller et al, 2002;Smit et al, 2003) produced similar results, but a meta-analysis suggested an absolute 1-year survival benefit of 3.9% for gemcitabinecisplatin chemotherapy when compared to other platinumcontaining regimens (Le Chevalier et al, 2005). Cisplatin is one of the most widely used platinum derivatives, however it is considered to link with significant toxicities, including severe nausea /vomiting, ototoxicity and neuropathy and renal toxicity, thus requiring adequate hydration.…”