First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial

Abstract

The purpose of our study was to compare progression-free survival and quality of life (QOL) after cisplatin -gemcitabine (CG) or epirubicin -gemcitabine (EG) in chemotherapy-naive patients with unresectable non-small-cell lung cancer. Patients (n ¼ 240) were randomised to receive gemcitabine 1125 mg m À2 (days 1 and 8) plus either cisplatin 80 mg m À2 (day 2) or epirubicin 100 mg m À2 (day 1) every 3 weeks for a maximum of five cycles. Eligible patients had normal organ functions and Eastern Cooperative Oncology Group performance status p2. QOL was measured with European Organisation for Research and Treatment of Cancer QLQ-C30 and LC13 questionnaires. There were no significant differences in median progression-free survival (CG 26 weeks, EG 23 weeks), median overall survival (CG 43 weeks, EG 36 weeks), or tumour response rates (CG 46%, EG 36%). Toxicity was mainly haematologic. In the EG arm granulocytopenia occurred more frequently, leading to more febrile neutropenia. Also, elevation of serum transaminases, mucositis, fever, and decline in LVEF were more common in the EG arm. In the CG arm, more patients experienced elevated serum creatinine levels, sensory neuropathy, nausea, and vomiting. Global QOL was not different in both arms. Progression-free survival, overall survival, response rate, and QOL were not different between both arms; however, overall toxicity was more severe in the EG arm.

Survival Outcome of Inoperable Non-Small Cell Lung Cancer Patients Receiving Conventional Dose Epirubicin and Paclitaxel as First-Line Treatment

“…The response rate was 50% and median survival was 8 months in that study. Combinations of HDEpi with vinorelbine [21, 22] and gemcitabine [23] also yielded comparable response rates and survival times.…”

Health-related quality of life in patients undergoing drug therapy for advanced non-small-cell lung cancer

“…Out of these 18 trials, only 2 had HRQoL as a primary endpoint [37,50] and just 1 of these included statistical analyses of HRQoL data [37]. Of the remaining 16 trials, 8 reported statistical analysis data on lung-cancerrelated symptoms [36,[38][39][40]43,45,46,48,49].…”

“…Of these, 2 used LCSS [21,36], 12 used EORTC QLQ-C30/LC13 [37][38][39][40][41][42][43][44][45][46][47][48][49], and 4 used FACT-L [50][51][52][53][54]. Out of these 18 trials, only 2 had HRQoL as a primary endpoint [37,50] and just 1 of these included statistical analyses of HRQoL data [37].…”

First- and second-line therapy for advanced nonsmall cell lung cancer

“…All other societies recommend first-line platinum-based chemotherapy for advanced NSCLC patients. There are multiple randomised published trials on this topic [71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89][90]. In terms of survival, there is no statistically significant difference between the two types of treatment in all but one trial.…”