TY - JOUR
T1 - CPT-11 plus cisplatin in patients with advanced, untreated gastric or gastroesophageal junction carcinoma
T2 - Results of a phase II study
AU - Ajani, Jaffer A.
AU - Baker, Jackie
AU - Pisters, Peter W.T.
AU - Ho, Linus
AU - Mansfield, Paul F.
AU - Feig, Barry W.
AU - Charnsangavej, Chusilp
PY - 2002/2/1
Y1 - 2002/2/1
N2 - BACKGROUND. This Phase II study assessed the response rate and toxicity profile of the combination CPT-11 and cisplatin administered weekly to patients with untreated, advanced adenocarcinoma of the stomach or the gastroesophageal junction. METHODS. Patients with histologic proof of adenocarcinoma of the stomach or the gastroesophageal junction with adequate liver, kidney, and bone marrow functions were treated with 65 mg/m2 CPT-11 plus 30 mg/m2 cisplatin, both administered intravenously 1 day per week for 4 consecutive weeks, followed by a recovery period of 2 consecutive weeks. The response rate, time to disease progression, survival, and toxic effects were analyzed. RESULTS. Thirty-six of 38 registered patients (95%) were assessable. The median number of 6-week cycles per patient was 2.5 (range, 1-7 6-week cycles). Four patients (11%) achieved a complete response, and 17 patients (47%) had a partial response for an overall response rate of 58%. The median time to progression of carcinoma was 24 weeks, and the median survival was 9 months (range, 1-23+months). There was one treatment-related death. Major toxic effects included diarrhea, neutropenia, and fatigue. Ninety percent of all planned doses were delivered on time; however, 53 of 79 canceled or delayed weekly doses (66%) occurred in the third or fourth week of the therapy cycle. CONCLUSIONS. The combination of CPT-11 and cisplatin is active against gastric or gastroesophageal adenocarcinoma and needs to be studied further. A modification in doses and schedules may be warranted to make the regimen more tolerable to patients. The addition of other active drugs or radiation therapy to this regimen would be of interest.
AB - BACKGROUND. This Phase II study assessed the response rate and toxicity profile of the combination CPT-11 and cisplatin administered weekly to patients with untreated, advanced adenocarcinoma of the stomach or the gastroesophageal junction. METHODS. Patients with histologic proof of adenocarcinoma of the stomach or the gastroesophageal junction with adequate liver, kidney, and bone marrow functions were treated with 65 mg/m2 CPT-11 plus 30 mg/m2 cisplatin, both administered intravenously 1 day per week for 4 consecutive weeks, followed by a recovery period of 2 consecutive weeks. The response rate, time to disease progression, survival, and toxic effects were analyzed. RESULTS. Thirty-six of 38 registered patients (95%) were assessable. The median number of 6-week cycles per patient was 2.5 (range, 1-7 6-week cycles). Four patients (11%) achieved a complete response, and 17 patients (47%) had a partial response for an overall response rate of 58%. The median time to progression of carcinoma was 24 weeks, and the median survival was 9 months (range, 1-23+months). There was one treatment-related death. Major toxic effects included diarrhea, neutropenia, and fatigue. Ninety percent of all planned doses were delivered on time; however, 53 of 79 canceled or delayed weekly doses (66%) occurred in the third or fourth week of the therapy cycle. CONCLUSIONS. The combination of CPT-11 and cisplatin is active against gastric or gastroesophageal adenocarcinoma and needs to be studied further. A modification in doses and schedules may be warranted to make the regimen more tolerable to patients. The addition of other active drugs or radiation therapy to this regimen would be of interest.
KW - Adenocarcinoma
KW - Advanced disease
KW - Gastroesophageal junction
KW - Phase II trial
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U2 - 10.1002/cncr.10279
DO - 10.1002/cncr.10279
M3 - Article
C2 - 11857295
AN - SCOPUS:0036468440
SN - 0008-543X
VL - 94
SP - 641
EP - 646
JO - Cancer
JF - Cancer
IS - 3
ER -