A multi-center, late phase II clinical trial of Genexol (paclitaxel) and cisplatin for patients with advanced gastric cancer.
Because of unsatisfactory treatment results with 5-fluorouracil-based palliative combination chemotherapy for advanced gastric cancer, the evaluation of new effective and well-tolerated regimens is needed. We conducted a multi-center, late phase II trial to evaluate the efficacy and safety of Genexol (a paclitaxel formulation) combined chemotherapy with cisplatin in patients with previously untreated metastatic or unresectable measurable gastric adenocarcinoma. All patients were between 18 and 75 years of age, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and had an adequate baseline major organ function. Genexol 175 mg/m(2) was administered as a 3-h infusion, followed by cisplatin 75 mg/m(2) as an intravenous infusion day 1, once every 3 weeks. Thirty-six patients were enrolled from 7 hospitals between November 2002 and April 2003. Of these, 33 patients were assessable for efficacy and 35 for toxicity. Based on an intent-to-treat analysis, 16 patients (46%) achieved a partial response, 7 (20%) stable disease, and 10 (29%) progressed, giving an overall response rate of 46% (95% CI, 29% to 63%). The median duration of response was 7.1 months (95% CI, 6.3 to 7.9 months), and the median time to progression and overall survival were 4.9 months (95% CI, 3.2 to 6.6 months) and 13.8 months (95% CI, 10.8 to 16.8 months), respectively. The major toxicity was neutropenia, with grade 3/4 intensity in 10 patients (29%). However, no febrile neutropenia occurred, and non-hematologic toxicity was usually mild. Grade 3/4 toxicities included nausea (9% of the patients), vomiting (9%), peripheral neuropathy (9%), alopecia (9%), and myalgia (6%). In conclusion, the combination of Genexol and cisplatin was found to be an active and relatively well-tolerated regimen for the treatment of advanced gastric carcinoma.
Park
Sook Ryun
SR
Department of Internal Medicine, Seoul National University College of Medicine, 28 Yongon-dong, Chongno-gu, Seoul 110-744, Korea.
Oh
Do-Youn
DY
Kim
Dong-Wan
DW
Kim
Tae-You
TY
Heo
Dae Seog
DS
Bang
Yung-Jue
YJ
Kim
Noe Kyeong
NK
Kang
Won Ki
WK
Kim
Heung-Tae
HT
Im
Seock-Ah
SA
Suh
Jae-Hong
JH
Kim
Hark-Kyun
HK
Kim
Hoon-Kyo
HK
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
D017239:Paclitaxel; D002945:Cisplatin