Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer

Fixed Dose Rate versus Standard Dose Rate Infusion of Gemcitabine and Cisplatin in Advanced Stage Non-Small Cell Lung Cancer

“…The median TTP was 7 months and 6 months in both arms respectively, while the median OS time was 12 months and 11 months in the standard arm and the FDR arm respectively. In other similar studies, the one-year survival rates ranged from 36% to 52%, median TTP ranged from 4 -12 months, and median OS ranged between 5 months and 11 months [9]- [14]. The superior results of our study reflects better patients' characteristics, as 60% and 46.7% of patients in the standard arm and FDR arm respectively, were stage IIIB disease.…”

“…Both treatment arms had almost equal ORR, 46.6% and 43.3% in arm A and arm B respectively. In other clinical trials that used FDR infusion of gemcitabine (10 mg/m 2 /min), ORR ranged between 20% and 47% [9]- [14]. The one-year survival rates in the present study were 50% versus 34%, p = 0.4 in the standard arm and the FDR arm respectively.…”

“…The superior results of our study reflects better patients' characteristics, as 60% and 46.7% of patients in the standard arm and FDR arm respectively, were stage IIIB disease. In other studies about 80% of patients were stage IV disease [9] [11]- [14] and enrollment of patients with brain metastases was allowed in four of these trials [9]- [12]. Ceribelli and colleagues included 24% of patients with brain metastases in their study [9].…”

“…Also, our results are consistent with Qiu et al meta-analysis, in which FDR infusion was associated with more Grade III-IV hematologic and non-hematologic toxicities [17]. Previous studies in NSCLC that investigated ted gemcitabine/cisplatin regimens with FDR gemcitabine reported GIII-IV neutropenia in the range of 15% -26% in the standard arm as compared to 30% -395% in the FDR arm, GIII-IV thrombocytopenia in the range of 3% -19% in the standard arm and 13% -18% in the FDR arm, while GIII-IV anemia ranged between 2% -8% in the standard arm and 11% -13% in the FDR arm [9] [12] [14]. Other regimens that used carboplatin instead of cisplatin had more severe GIII-IV hematologic toxicities [11]- [13].…”

“…While short infusion leaves most of the drug unmetabolized, prolonged infusion results in a higher intracellular concentration of the active metabolite, thus enhancing the e agent's efficacy [7]. The improved survival in patients with pancreatic adenocarcinoma, who received FDR infusion in a randomized phase II clinical trial [8], encouraged many researchers to investigate the feasibility and efficacy of FDR gemcitabine in NSCLC patients [9]- [14]. However, controversial results have been drawn from these trials.…”