Gemcitabine in the treatment of advanced non2small2cell lung cancer

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1 Gemcitabine 6 : Gemcitabine ( : ) III IV (NSCLC) : :7 III IV NSCLC, III,IV mg/ m,,,, :7 7 III IV NSCLC, III,IV mg/ m,,, mg/ m,, : :,6 (PR), ( %) %[ %CI, % %],, % () III, III 6 :, (PR), ( %) 6 %[ %CI, %7 %] / III IV,7 %() III (7 %) : NSCLC, NSCLC, NSCLC : / :R7 R7 :A : - 67X() - - Gemcitabine in the treatment of advanced nonsmallcell lung cancer GUAN Zhongzhen, CHEN Ruqin, XU Guangchuan, et al. Medical Oncology Department of Cancer Center, S un Yatsen University of Medical Sciences, Guangzhou 6, China Abstract Objective :The aim of the study was to evaluate the clinical efficacy and toxicity of Gemcitabine single drug and gemcitabinecisplatin combination in advanced nonsmallcell lung cancer (NSCLC). Methods : gemcitabine singledrug study :Twentyone previously untreated NSCLC patients entered the trial from September 7 to May gemcitabine mg/ m was administeredon days, and in each day cycle. GemcitabineCisplatin combination study :Fortyeight previously untreated NSCLC patients entered the trial from October 7 to J uly Gemcitabine mg/ m was administered on days, and and Cisplatin mg/ m, on day in each day cycle. Results : Gemc itabine singledrug study :Of assessable patients, 6 achieved a partial response (PR), and among them ( %) were confirmed PR. The overall response rate was 6 %( %confidence interval [ CI ], %to %). patients can be evaluated the toxicity. A minor proportion of patients experienced mild GI reaction, leukopenia, thrombocytopenia and decreased hemoglobin levels. Only %( patient each) of the patients experience grade III leukopenia and nausea/ vom iting. One patient experienced grade III infection. The median survival of the whole group was 6 months. Gemc itabinecisplatin combination study :Of assessable patients, achieved a partial response ( PR), and among them ( %) were confirmed PR. The overall response rate was 6 %( %confidence interval [ CI ], %to 7 %). patients can be evaluated for toxicity. About / of the patients experienced grade IIIIV nausea/ vomiting and leukope nia and decreased hemoglobin. 7 %( patients) experienced grade III thrombocytopenia. The other toxicity was mild and tolerable. cycles (7 %) of gemcitabine injections were dosereduced or omitted due to toxicity. The median survival of the whole group was months. Conclusion :The singledrug gemcitabine induced an objective efficacy in ad vanced NSCLC, with modest side effects. The gemcitabinecisqlatin combination regime was effective and well tolerated in the treatment of advanced NSCLC, it could be considered as one of the recommended standard regime. Key words :Gemcitabine/ Therapeutic Use Non Small Cell Lung Cancer (NSCLC) Clinical Trial : - - :, : ( 6) (,) dfdctp ( ), (,) DNA DNA, (,6) (,) Eli Lilly, 6 ( ), 6 Anderson 7-7 China Academic Journal Electronic Publishing House. All rights reserved.

2 ,. Gemcitabine, ( PR) %,III - IV, : > %, %, ALT/ AST > (ALT, 7 AST 6 A 6-6 () : > 6, (), (),, ( ) (6) :,, (7),,,, : ( mg/ m 6 ( ) ( ) ) (CDDP), () / IIIIV,, () ( ) () ( < 6 Gy),, () (P. S) 7 () (6) (7), () ( /L, / L, Hb g/ dl,, ) (), () < > (), (IUD, ) () (CNS) ( / L) ( / L) % () ( ) (), / > < WHO ( / ) ( / ) > 7 7 < 7 % 7 * *. # ( ) () III, -7 China Academic Journal Electronic Publishing House. All rights reserved.

3 P. S., (PD), 6,,,, (), (Median Survival) 6 KaplanMeier () :WHO, : CR,PR,SD PD CR PR () CR PR, /, CR PR,CR PR < > (Confirmed) SD, PD,, (6),WHO, 6 6 :,, 66 :,, 7, (n = ), 6 :,7 77, 6 KPS7,, :,,, : ( ) 7 :III,IV,,,,,,, 6 :,, 6, 6 : - HT G - CSF / 6 :,6 PR ( %), ( %) CR 6 (SD),7 KaplanMeier % III, + ( %) / China Academic Journal Electronic Publishing House. All rights reserved. 6

4 ,. Gemcitabine 67 :,, mg/ m,, : G - CSF,7, - HT,7 mg/ m,,,, :, III CR, PR (6 %), % PR, % PR ( Confirmed PR), PR (Confirmed PR) 67 KaplanMeier,,, % mg/ m,6 ( ), Cisplatin mg/ m,,, :,,7, :,,,,, :, 76, KPS 7,,,, III, IV, 6, 6,,,,,,,,, ( ) :,,,, mg/ m DDP,7 % % %6 %, 7 ( ) (SD), (PD), 767,7,, 7 ( ), -7 China Academic Journal Electronic Publishing House. All rights reserved.

5 DDP,, 6 :,6 % PR, % PR,/ (Confirmed PR), III - IV, Gemzar + DDP,, DDP, + DDP (n = ) / ALT AST ALP 7 6 BILIRUBIN ( %) 6 7 ( ) :,DDP Gem citabine, /, (6 %) PR, ( %) Confirmed PR, 6,, DDP :,,, % PR, % PR (Confirmed PR), Castellano D, Lianes P, PazAres L, et al. A phase II study of a novel gemcitabine plus cisplatin regimen administered ev ery three weeks for advanced nonsmallcell lung cancer J. Ann Oncol,, () :7. Abratt RP, Bezwoda WR, Goedhals L, et al. Weekly gemc itabine with monthly cisplatin :effective chemotherapy for ad vanced nonsmallcell lung cancer J. J Clin Oncol, 7, () :77. Crino L, Scagliotti G, Marangolo M, et al. Cisplatingemc itabine combination in advanced nonsmallcell lung cancer :a phase II study J. J Clin Oncol, 7, () :7. GonzalezBaron M, Ordonez A, Gracia M, et al. Gemcitabine and cisplatin in advanced nonsmall cell lung cancer (NSCLC) : results from a phase II study (Meeting abstract ) J. Proc Annu Meet Am Soc Clin Oncol, 7, 6 :A67. Crino L, Mosconi AM, Scagliotti GV, et al. Gemcitabine as secondline treatment for relapsing or refractory advanced non small cell lung cancer : a phase II trial J. Semin Oncol,, ( Suppl. ) :6. 6 Fukuoka M, Takada M, Yokohama A, et al. Phase II studies of gemcitabine for nonsmall cell lung cancer in Japan J. Semin Oncol, 7, ( Suppl. 7) :S7S76. 7 She pherd FA,RP, Anderson H, et al. Gemcitabine in the treat ment of elderly patients with advanced nonsmdllcell lung cancer J. Seminars in Oncology,7, ( Suppl 7) : S7S7. : -7 China Academic Journal Electronic Publishing House. All rights reserved.