Pemetrexed and cisplatin in patients with advanced gastric cancer: a Korean cancer study group multicenter phase II study.
BACKGROUND
Pemetrexed is a multitargeted antifolate enzyme inhibitor, which has activity against a variety of tumors, including advanced gastric cancer (AGC). The aim of this study was to assess efficacy and safety of pemetrexed plus cisplatin (PemCis) combination in the treatment of AGC in Korean patients.


METHODS
This was a multicenter, single arm, open label study. Patients with no prior palliative chemotherapy received pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) day 1, every 3 weeks plus folic acid and vitamin B(12) supplementation. Response rate was assessed according to response evaluation criteria in solid tumors (RECIST) criteria.


RESULTS
Of the 50 patients evaluable for efficacy, 13 had partial response for an overall response rate of 26% (95% CI, 14.6-40.3%) and 15 (30%) had stable disease. Median time to progression was 2.8 months (95%CI, 2.2-4.4 months), and median overall survival was 6.6 months (95% CI, 4.8-10.4 months). Of the 51 patients evaluable for safety, the most frequent NCI-CTC grade 3/4 toxicities were neutropenia in 49% of patients (25% of cycles) and anorexia in 10% of patients (4% of cycles).


CONCLUSIONS
PemCis has a modest activity and acceptable toxicity profile in patients with AGC. Clinical trials with different combinations and dose regimens are, therefore, warranted.
Kim
Yeul Hong
YH
Department of Internal Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.
Chung
Hyun Cheol
HC
Kang
Won Ki
WK
Park
Sook Ryun
SR
Kim
Chul Soo
CS
Kim
Tae-Yue
TY
Shin
Sang Won
SW
Park
Byung-Joo
BJ
Cha
Soo Jin
SJ
Bang
Yung-Jue
YJ
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D007723:Korea; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D000068437:Pemetrexed; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D002945:Cisplatin