Pg. Rose et al., PROLONGED ORAL ETOPOSIDE AS 2ND-LINE THERAPY FOR PLATINUM-RESISTANT AND PLATINUM-SENSITIVE OVARIAN-CARCINOMA - A GYNECOLOGIC-ONCOLOGY-GROUPSTUDY, Journal of clinical oncology, 16(2), 1998, pp. 405-410
Purpose: A phase II trial was conducted to determine the activity of p
rolonged oral etoposide in platinum resistant and platinum-sensitive o
varian carcinoma. Patients and Methods: platinum-resistant disease was
defined as progression on platinum-based chemotherapy or recurrence w
ithin 6 months of completing therapy. The starting dose was 50 mg/m(2)
/d (30 mg/m(2)/d for prior radiotherapy) for 21 days, every 28 days. A
dose escalation to a maximum dose of 60 mg/m(2)/d was prescribed. Res
ults: Of 99 patients entered, 97 were assessable for toxicity and 82 w
ere assessable for response. Among 41 platinum-resistant patients a 26
.8% response rate (7.3% complete response [CR] and 19.5% partial respo
nse [PR] rate) occurred. The median response duration was 4.3 months (
range, 1.3 to 8.7), median progression-free interval (PFI) was 5.7 mon
ths (range, 0.8 to 30.8+), and median survival time was 10.8 months (r
ange, 1.9 to 45.8). Twenty five of 41 platinum-resistant patients had
also previously received paclitaxel; of which eight (32%) responded. A
mong 41 platinum-sensitive patients, a 34.1% response rate (14.6% CR a
nd 19.5% PR rate) occurred. The median response duration was 7.5 month
s (range, 1.9 to 15.2+), median PFI was 6.3+ months (range, 0.9 to 20.
4), and median survival time was 16.5+ months (range, 0.9 to 34.8). Of
97 patients assessable For toxicity, grade 3 or 4 hematologic toxicit
y was common, with leukopenia occurring in 41.2% (grade 3, 29%; grade
4, 12%), neutropenia in 45.4% (grade 3, 20%; grade 4, 25%), thrombocyt
openia in 9% (grade 3, 5%; grade 4, 4%), and anemia in 13.4%. Three tr
eatment-related deaths occurred: two from neutropenic sepsis and one f
rom thrombocytopenic bleeding after an overdose. One patient developed
leukemia. Conclusion: This regimen is active in platinum-resistant an
d platinum-sensitive ovarian carcinoma. Additionally, the regimen is a
ctive in paclitaxel-resistant ovarian carcinoma. (C) 1998 by American
Society of Clinical Oncology.