New VIG Regimen Is Called Highly Active in Sarcoma

LISBON, Portugal--A new regimen that employs escalating dosesof etoposide (VePesid) and ifosfamide (Ifex), together with G-CSF(Neupogen), appears to be among the most active combinations testedto date in adult soft-tissue sarcoma, according to a report fromthe Scandinavian Sarcoma Group.

The key to success with the so-called VIG regimen, said Dr. G.Saeter of the Norwegian Radium Hospital, Oslo, is to take advantageof the phase-specificity of etoposide by giving the drug as a3-day continuous infusion rather than as a bolus. "We believethat etoposide is an underrated drug in soft-tissue sarcoma, whichhas previously been used incorrectly," Dr. Saeter said atthe European Society of Medical Oncology congress.

In this prospective phase II study, more than 90 patients withhistologically proven sarcomas, most of whom had metastatic disease,received etoposide, 600 mg/m² over 72 hours, and ifosfamide,1,500 mg/m²/day for 3 days, every 3 weeks, along with G-CSF,5 mcg/kg on days 4 through 15. The protocol allowed for successive10% dose escalations, up to a maximum of 130%, provided that whiteblood cell nadirs were greater than 1.5 and platelet nadirs weregreater than 70 at defined time points.

Response Rate of 42%

The VIG regimen elicited a total response rate of 42%, with amedian duration of response of 8.5 months in patients who didnot undergo surgery. "Interestingly, we saw no responsesamong patients with liver disease, but when we looked at patientswith high-grade lesions outside the liver, the total responserate was 62%," Dr. Saeter said. Overall 3-year survival was26%.

Relative to earlier studies that did not use growth factor, G-CSFdrastically reduced the incidence of grade IV neutropenia andneutropenic fever. "We were able to escalate the dose inhalf of the courses, as compared with 13% of courses in a pilotstudy," Dr. Saeter said.