Gemcitabine in patients with advanced malignant melanoma or gastric cancer: phase II studies of the EORTC Early Clinical Trials Group.
BACKGROUND
Gemcitabine is a water-soluble analogue of deoxycytidine which has shown significant antitumour activity in a broad panel of slow-growing murine and human carcinomas. Objective responses have been reported in early clinical studies in breast, head and neck, non-small cell lung cancer patients. The weekly schedule was selected for disease-oriented phase II studies because of its better tolerability as compared to daily or twice-weekly schemes.


METHODS
Gemcitabine (1000 mg/m2) was given as a 30 min. infusion, weekly for three consecutive weeks, followed by one-week rest, every 4 weeks. Twenty-nine patients with locally advanced/metastatic gastric cancer and 39 patients with metastatic malignant melanoma entered the study. No prior chemotherapy for advanced disease had been given in all cases.


RESULTS
Among 26 evaluable patients with gastric cancer, 1 partial response (PR) of 9 months (4%), 11 no change (NC) and 14 tumour progression (PD) were observed. Of 33 evaluable patients with malignant melanoma, 1 patient achieved a PR for 10 months (3%), 2 had NC and 30 PD. Toxicity was similar in the two groups with moderate myelosuppression, mainly neutropenia, mild to moderate nausea and vomiting in 70% of patients and fatigue grade 1-2 in 50%.


CONCLUSIONS
At the tested schedule gemcitabine has no relevant antitumour activity in previously untreated patients with advanced malignant melanoma or gastric cancer.
Sessa
C
C
Department of Oncology, Ospedale San Giovanni, Bellinzona, Switzerland.
Aamdal
S
S
Wolff
I
I
Eppelbaum
R
R
Smyth
J F
JF
Sulkes
A
A
Ten Bokkel Huinink
W
W
Vermorken
J
J
Wanders
J
J
Franklin
H
H
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013274:Stomach Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine