Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma.
OBJECTIVE
To evaluate the efficacy and safety of gemcitabine-oxaliplatin (GEMOX) combined with huachansu (cinobufagin) injection treatment in patients with locally advanced or metastatic gallbladder carcinoma (GBC), and to assess the quality of life (QOL) of such patients.


METHODS
Twenty-five patients with locally advanced or metastatic GBC were treated with intravenous gemcitabine (1000 mg/m2) over 30 min on days 1 and 8, 2 h infusion of oxaliplatin (120 mg/ m2) on day 1, and 2-3 h infusion of huachansu (20 mL/ m2) on days -3-11, every 3-4 wk. Treatment was continued until occurrence of unacceptable toxicity or disease progression. QOL of patients was assessed by the EORTC QLQ-C30 at baseline, at the end of the first, third and sixth chemotherapy cycles, and 1 mo after the treatment.


RESULTS
Among the 25 patients with a median age of 64 years (range 42-78 years), 23 were evaluable in the study. A total of 137 cycles of therapy were performed and the median cycle was 5 (range 1-8) per patient. Out of the 23 patients whose response could be evaluated, 8 partial responses (PR) were observed (34.8%), while 7 patients (30.4%) demonstrated a stable disease (SD). The disease control rate was 65.2%. Progression of cancer was observed in 8 (34.8%) patients. The median progression-free and overall survival time was 5.8 mo (95% CI: 4.5-7.1 mo) and 10.5 mo, respectively. The therapy was well tolerated, with moderate myelosuppression as the main toxicity. Anemia grade 2 was seen in 16.0%, neutropenia grade 3 in 8.0% and thrombocytopenia grade 3 in 24.0% of patients, respectively. Non-hematologic toxicity ranged from mild to moderate. No death occurred due to toxicity. The QOL of patients was improved after chemotherapy, and the scores of QOL were increased by 10 to 20 points.


CONCLUSIONS
GEMOX combined with huachansu (cinobufagin) injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC.
Qin
Tian-Jie
TJ
Department of Medical Oncology, First Affiliated Hospital of Medical School of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, China.
Zhao
Xin-Han
XH
Yun
Jun
J
Zhang
Ling-Xiao
LX
Ruan
Zhi-Ping
ZP
Pan
Bo-Rong
BR
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002018:Bufanolides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D011788:Quality of Life; D012720:Severity of Illness Index; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D002018:Bufanolides; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; C002471:cinobufagin; D000093542:Gemcitabine
Steroids. 2006 May;71(5):392-402
16469341
J Clin Oncol. 1998 Jan;16(1):139-44
9440735
Br J Cancer. 2008 Jan 29;98(2):309-15
18182984
J Clin Oncol. 2006 Jul 1;24(19):3069-74
16809731
Ann Oncol. 2001 Oct;12(10):1403-6
11762811
J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Jul 11;838(2):86-95
16723285
BMC Cancer. 2005 Jun 12;5:61
15949047
Appl Environ Microbiol. 2004 Jun;70(6):3521-7
15184152
Ann Oncol. 2004 Sep;15(9):1339-43
15319238
World J Gastroenterol. 2006 May 7;12(17):2762-6
16718765
J Nat Prod. 2008 Jul;71(7):1268-70
18558746
Ann Oncol. 2005 Feb;16(2):279-81
15668284
J Natl Cancer Inst. 2000 Feb 2;92(3):205-16
10655437
Cancer Invest. 2003;21(5):690-4
14628426
Br J Cancer. 2004 May 4;90(9):1715-9
15150619
Zhongguo Zhong Yao Za Zhi. 2007 Feb;32(3):224-6
17432144
Chem Pharm Bull (Tokyo). 2005 Dec;53(12):1582-6
16327195
Invest New Drugs. 2004 Apr;22(2):193-8
14739669
Jpn J Clin Oncol. 2005 Feb;35(2):68-73
15709089
Am J Clin Oncol. 2003 Apr;26(2):151-4
12714886
J Clin Oncol. 2005 Apr 1;23(10):2332-8
15800324
Prostate. 2003 Feb 1;54(2):112-24
12497584
Ann Oncol. 2004 May;15(5):770-4
15111345
Br J Cancer. 2004 Apr 19;90(8):1516-20
15083178
Am J Clin Oncol. 2004 Dec;27(6):565-9
15577433
Br J Cancer. 2007 Mar 26;96(6):896-902
17325704
Semin Oncol. 2002 Dec;29(6 Suppl 20):40-5
12577232
Oncology. 2006;70(4):280-4
17047399
Hepatobiliary Pancreat Dis Int. 2005 Nov;4(4):589-92
16286269
Radiographics. 2001 Mar-Apr;21(2):295-314; questionnaire, 549-55
11259693