Maintenance chemotherapy with daily oral etoposide following salvage therapy in patients with germ cell tumors.
OBJECTIVE
To evaluate the role of maintenance daily oral etoposide (VP-16) chemotherapy for germ cell patients who had a response to salvage therapy.


METHODS
Thirty-seven patients were entered onto this trial, and 34 were fully assessable. This was as heavily pretreated patient population, with a median of two prior salvage regimens. The salvage treatment that immediately preceded oral VP-16 consisted of autologous bone marrow transplantation in 14 patients (41%), surgery in 10 (29%), and standard-dose salvage chemotherapy in 10 (29%). Daily oral VP-16 was administered at a dose of 50 mg/m2 for 21 consecutive days every 4 weeks for three cycles.


RESULTS
The major toxicity with daily oral VP-16 was leukopenia. Three patients had grade III and two grade IV leukopenia. Two of these patients had granulocytopenic fever. Other grade III toxicities included thrombocytopenia (n = 1) and mucositis (n = 2). Twenty-three patients started daily oral VP-16 while in complete remission (CR) following salvage therapy. Seventeen (74%) remain continuously disease-free, with a median follow-up time of 36 months (range, 26 to 49) from initiation of daily oral VP-16. Eleven patients started daily oral VP-16 while in partial remission (PR) following salvage therapy. Three of these 11 patients converted to CR, but all three subsequently relapsed.


CONCLUSIONS
Maintenance oral VP-16 was well tolerated in this heavily treated patient population. Results in this poor-risk population were encouraging.
Cooper
M A
MA
Department of Medicine, Indiana University Medical Center, Indianapolis 46202-52565, USA.
Einhorn
L H
LH
D000284:Administration, Oral; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D018237:Germinoma / Q000628:therapy*; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000628:therapy*; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy
D005047:Etoposide