Full Text:   <3285>

CLC number: R9

On-line Access: 2024-08-27

Received: 2023-10-17

Revision Accepted: 2024-05-08

Crosschecked: 0000-00-00

Cited: 5

Clicked: 7224

Citations:  Bibtex RefMan EndNote GB/T7714

-   Go to

Article info.
1. Reference List
Open peer comments

Journal of Zhejiang University SCIENCE B 2007 Vol.8 No.5 P.307-313

http://doi.org/10.1631/jzus.2007.B0307


Comparison of pharmacokinetics, efficacy and toxicity profile of gemcitabine using two different administration regimens in Chinese patients with non-small-cell lung cancer


Author(s):  WANG Lin-run, LIU Jian, HUANG Ming-zhu, XU Nong

Affiliation(s):  Department of Clinical Pharmacy, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China

Corresponding email(s):   linrunw@yahoo.com.cn, hmzj2002@yahoo.com.cn

Key Words:  Gemcitabine, Non-small-cell lung cancer, Pharmacokinetics, Qualified response, Safety


WANG Lin-run, LIU Jian, HUANG Ming-zhu, XU Nong. Comparison of pharmacokinetics, efficacy and toxicity profile of gemcitabine using two different administration regimens in Chinese patients with non-small-cell lung cancer[J]. Journal of Zhejiang University Science B, 2007, 8(5): 307-313.

@article{title="Comparison of pharmacokinetics, efficacy and toxicity profile of gemcitabine using two different administration regimens in Chinese patients with non-small-cell lung cancer",
author="WANG Lin-run, LIU Jian, HUANG Ming-zhu, XU Nong",
journal="Journal of Zhejiang University Science B",
volume="8",
number="5",
pages="307-313",
year="2007",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.2007.B0307"
}

%0 Journal Article
%T Comparison of pharmacokinetics, efficacy and toxicity profile of gemcitabine using two different administration regimens in Chinese patients with non-small-cell lung cancer
%A WANG Lin-run
%A LIU Jian
%A HUANG Ming-zhu
%A XU Nong
%J Journal of Zhejiang University SCIENCE B
%V 8
%N 5
%P 307-313
%@ 1673-1581
%D 2007
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.2007.B0307

TY - JOUR
T1 - Comparison of pharmacokinetics, efficacy and toxicity profile of gemcitabine using two different administration regimens in Chinese patients with non-small-cell lung cancer
A1 - WANG Lin-run
A1 - LIU Jian
A1 - HUANG Ming-zhu
A1 - XU Nong
J0 - Journal of Zhejiang University Science B
VL - 8
IS - 5
SP - 307
EP - 313
%@ 1673-1581
Y1 - 2007
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.2007.B0307


Abstract: 
Objective: To conduct a randomized comparative trial of pharmacokinetics, efficacy and toxicity profile treatment with 1 200 mg/m2 gemcitabine using standard 30-min infusion or fixed dose rate (FDR) infusion [10 mg/(m2·min)] on days 1 and 8 plus carboplatin AUC (area under curve) 5 on day 1 in Chinese non-small-cell cancer patients. Twelve patients were enrolled in this study. Methods: Plasma gemcitabine concentrations were measured by ion-pair reversed phase high performance liquid chromatography. Antitumoral activity and toxicity of gemcitabine was assessed according to World Health Organization criteria. Results: The obtained mean parameters, such as T1/2 (elimination half time), AUC, and CL (clearance), were consistent with those reported in literature. qualified response rate in our study was 33.3% for standard arm and 50% for FDR arm. Additional 50% and 33.3% patients contracted stable disease (SD) in standard arm and FDR arm, respectively. The predominant toxicity was hematologic, and patients in the standard infusion arm experienced consistently more hematologic toxicity. Conclusion: Pharmacokinetic and clinical data in this trial support the continued evaluation of the FDR infusion strategy with gemcitabine.

Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article

Reference

[1] Abbruzzese, J.L., Grunewald, R., Weeks, E.A., Gravel, D., Adams, T., Nowak, B., Mineishi, S., Tarassoff, P., Satterlee, W., Raber, M.N., 1991. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J. Clin. Oncol., 9(3):491-498.

[2] Abratt, R.P., Bezwoda, W.R., Falkson, G., Goedhal, L., Hacking, D., Rugg, T.A., 1994. Efficacy and safety profile of gemcitabine in non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12(9):1535-1540.

[3] Anderson, H., Lund, B., Bach, F., Thatcher, N., Walling, J., Hansen, H.H., 1994. Single-agent activity of weekly gemcitabine in advanced non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12(9):1821-1826.

[4] Bhargava, P., Marshall, J.L., Fried, K., Williams, M., Lefebvre, P., Dahut, W., Hanfelt, J., Gehan, E., Figuera, M., Hawkins, M.J., Rizvi, N.A., 2001. Phase I and pharmacokinetic study of two sequences of gemcitabine and docetaxel administered weekly to patients with advanced cancer. Cancer Chemother. Pharmacol., 48(2):95-103.

[5] Carrato, A., Garcia-Gomez, J., Alberola, V., 1999. Carboplatin (CARBO) in combination with gemcitabine (GEM) in advanced non-small cell lung cancer (NSCLC). Comparison of two consecutive phase II trials using different schedules. Proc. Am. Soc. Clin. Oncol., 18:abstract 1922.

[6] Domine, M., Casado, V., Esteves, L., 2000. Phase II study of carboplatin (C)-gemcitabine (G) in advanced non-small cell lung cancer (NSCLC). Proc. Am. Soc. Clin. Oncol., 19:abstract 2107.

[7] Green, M.R., 1996. Gemcitabine safety overview. Semin. Oncol., 23(5 Suppl. 10):32-35.

[8] Grunewald, R., Kantarjian, H., Keating, M.J., Abbruzzese, J., Tarassoff, P., Plunkett, W., 1990. Pharmacologically directed design of the dose rate and schedule of 2',2'-difluorodeoxycytidine (gemcitabine) administration in leukemia. Cancer Res., 50(21):6823-6826.

[9] Guchelaar, H.J., Richel, D.J., van Knapen, A., 1996. Clinical, toxicological and pharmacological aspects of gemcitabine. Cancer Treat. Rev., 22(1):15-31.

[10] Kroep, J.R., Giaccone, G., Voorn, D.A., Smitt, E.F., Beijnen, J.H., Rosing, H., van Moorsel, C.J., van Groeningen, C.J., Postmus, P.E., Pinedo, H.M., Peters, G.J., 1999. Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non-small-cell lung cancer. J. Clin. Oncol., 17(7):2190-2197.

[11] Lund, B., Ryberg, M., Petersen, P.M., Anderson, H., Thatcher, N., Dombernowsky, P., 1994. Phase II study of gemcitabine (2',2'-difluorodeoxycytidine) given as a twice weekly schedule to previously untreated patients with non-small cell lung cancer. Ann. Oncol., 5(9):852-853.

[12] Manuel, D., Laura, G.E., Ana, L., 2002. A phase II trial of a two hour infusion of gemcitabine with carboplatin for advanced non small cell lung cancer (NSCLC). Ann. Oncol., 13(Suppl. 5):143-148.

[13] Miller, A.B., Hoogstraten, B., Staquet, M., Winkler, A., 1981. Reporting results of cancer treatment. Cancer, 47(1):207-214.

[14] Sederholm, C., 2002. Gemcitabine (G) compared with gemcitabine plus carboplatin (GC) in advanced non-small cell lung cancer: a phase III study by the Swedish Lung Cancer Study Group (SLUSG). Proc. Am. Soc. Clin. Oncol., 21:abstract 1162.

[15] Shord, S.S., Faucette, S.R., Gillenwater, H.H., Pescatore, S.L., Hawke, R.L., Socinski, M.A., Lindley, C., 2003. Gemcitabine pharmacokinetics and interaction with paclitaxel in patients with advanced non-small-cell lung cancer. Cancer Chemother. Pharmacol., 51(4):328-336.

[16] Stani, S.C., Bajetta, E., de Candis, D., 2001. Front line chemotherapy with four different schedules of gemcitabine and carboplatin in stage IV non-small cell lung cancer (NSCLC). Eur. J. Cancer, 37(Suppl. 6):abstract 192.

[17] Storniolo, A.M., Allerheiligen, S.R., Pearce, H.L., 1997. Preclinical, pharmacologic, and phase I studies of gemcitabine. Semin. Oncol., 24(2 Suppl. 7):2-7.

[18] Tempero, M., Plunkett, W., Ruiz van Haperen, V., Hainsworth, J., Hochster, H., Lenzi, R., Abbruzzese, J., 2003. Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J. Clin. Oncol., 21(18):3402-3408.

[19] Yanagihara, R.H., Beck, M., 2000. Low dose carboplatin and gemcitabine in advanced non-small cell lung cancer: an active combination with low toxicity. Pro. Am. Sol. Clin. Oncol., 19:2072-2075.

[20] Zatloukal, P., Petruzelka, L., 2002. Gemcitabine/carboplatin in advanced non-small-cell lung cancer. Lung Cancer, 38(Suppl. 2):33-36.

[21] Zatloukal, P., Petruzelka, L., Zemanova, M., 2001. Gemcitabine plus cisplatin (GCis) versus gemcitabine plus carboplatin (GCarb) in patients (pts) with non-small cell lung cancer (NSCLC) stage IIIb and IV: an interim analysis of a randomized trial. Proc. Am. Soc. Clin. Oncol., 20:abstract 1343.

Open peer comments: Debate/Discuss/Question/Opinion

<1>

Please provide your name, email address and a comment





Journal of Zhejiang University-SCIENCE, 38 Zheda Road, Hangzhou 310027, China
Tel: +86-571-87952783; E-mail: cjzhang@zju.edu.cn
Copyright © 2000 - 2024 Journal of Zhejiang University-SCIENCE