A phase II evaluation of ifosfamide and mesna in unresectable diffuse malignant mesothelioma. A Southwest Oncology Group study.
BACKGROUND
Malignant mesothelioma is a highly treatment-resistant neoplasm. This study represents an attempt to define an effective form of systemic therapy.


METHODS
Twenty-six patients with unresectable diffuse malignant mesothelioma were enrolled in Southwest Oncology Group (SWOG) study 8731 and treated with ifosfamide, 2 g/m2 intravenously for 4 days, and mesna 2 g/m2 intravenously for 5 days, every 3 weeks. Patients were either previously untreated with chemotherapy or had at most one prior systemic treatment.


RESULTS
Two patients, or 8% (95% confidence interval, 1-25%), achieved partial response, with response durations of 4 and 6 months. One additional patient met criteria for tumor size reduction but not duration criteria. Thirteen (50%) patients had stable disease of 4 months' median duration (range, 1-13 months). The median survival of the entire group was 6.5 months. The dose-limiting toxicity was granulocytopenia (11 patients, < or = 250/microliters).


CONCLUSIONS
Ifosfamide/mesna has modest activity in malignant mesothelioma. It could be tested using alternate dosage schedules and in combination with other agents in treating this highly resistant neoplasm.
Zidar
B L
BL
Allegheny Health, Education & Research Foundation, Pittsburgh, Pennsylvania.
Metch
B
B
Balcerzak
S P
SP
Pierce
H I
HI
Militello
L
L
Keppen
M D
MD
Berenberg
J L
JL
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D015080:Mesna / Q000008:administration & dosage / Q000009:adverse effects; D008654:Mesothelioma / Q000188:drug therapy*; D008875:Middle Aged; D010534:Peritoneal Neoplasms / Q000188:drug therapy; D010997:Pleural Neoplasms / Q000188:drug therapy; D012074:Remission Induction; D016019:Survival Analysis; D013736:Testicular Neoplasms / Q000188:drug therapy
D015080:Mesna; D007069:Ifosfamide