Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study.
OBJECTIVE
Gemcitabine is the only drug approved for single-agent therapy in advanced pancreatic carcinoma (APC). Gemcitabine-based combination chemotherapy has not yet shown promising results.


METHODS
This multicenter phase II study enrolled previously untreated patients with locally advanced and/or metastatic pancreatic adenocarcinoma. Patients received 1,000 mg/m(2) gemcitabine, 100-min infusion, day 1 and 100 mg/m(2) oxaliplatin, 2-h infusion, day 2; q2w. The primary end point was response rate (RR).


RESULTS
Thirteen study centers enrolled 48 eligible patients of which 44 were evaluable. The RR, median overall survival, and median time to progression were 18.2%, 9.4 and 5.6 months, respectively. Sixteen patients (36.4%) experienced clinical benefit. The global quality of life scores improved by 11.71. Grade 3/4 peripheral sensory neuropathy was noted (2.1%), while the most common hematologic toxicity was anemia (grade 3/4, 6.3%).


CONCLUSIONS
Gemcitabine and oxaliplatin combination chemotherapy showed a promising activity in APC patients and was well tolerated.
Lee
Kyung Hee
KH
Division of Hemato-Oncology, College of Medicine, Yeungnam University, Daegu, South Korea.
Kim
Min Kyoung
MK
Kim
Yeol Hong
YH
Ryoo
Baek Yeol
BY
Lim
Ho Yeong
HY
Song
Hong Suk
HS
Kim
Hoon Kyo
HK
Lee
Myung Ah
MA
Im
Seock Ah
SA
Chang
Heung Moon
HM
Cho
Jae Yong
JY
Zang
Dae Young
DY
Kim
Bong Seog
BS
Kim
Jun Suk
JS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine