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Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer

Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer
Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer
Purpose: To evaluate oral topotecan as single-agent, second-line therapy in patients with ovarian cancer previously treated with a platinum-based regimen.
Patients and Methods: Patients (N = 116) received oral topotecan 2.3 mg/m2 daily for 5 days every 21 days. Eligibility criteria included histologic diagnosis of International Federation of Gynecology and Obstetrics stage III or IV epithelial ovarian cancer, bidimensionally measurable disease, prior platinum-containing chemotherapy, age >= 18 years, performance status <= 2, and life expectancy >= 12 weeks.
Results: Overall response rate was 21.6% (25 of 116 patients). Median duration of response was 25.0 weeks; median time to response was 8.4 weeks. Median time to progression was 14.1 weeks; median survival was 62.2 weeks. Grade 4 neutropenia was experienced by 50.4% of patients in 13.4% of courses administered. Grade 4 thrombocytopenia was experienced by 22.1% of patients in 5.1% of courses. Grade 3 or 4 anemia was experienced by 29.2% of patients in 8.5% of courses. Most frequent nonhematologic toxicities were predominantly (> 90%) grade 1 or 2 and included nausea, alopecia, diarrhea, and vomiting.
Conclusion: Second-line oral topotecan administered at 2.3 mg/m2 for 5 days every 21 days demonstrated activity in patients with progressive or recurrent ovarian cancer after first-line platinum-based chemotherapy. This activity was comparable to that seen in previous studies with intravenous topotecan. Grade 4 neutropenia was less frequent with oral topotecan than previously reported for intravenous topotecan. Oral topotecan is an active, tolerable, and convenient formulation of an established agent for the second-line treatment of advanced epithelial ovarian cancer and may also facilitate exploring prolonged treatment schedules.
1527-7755
3967-3975
Clarke-Pearson, D.L.
73e04ce1-f921-45e2-a019-2adea5334d15
Van Le, L.
eb7b056b-a0a2-4add-9764-8830e94bafef
Iveson, T.
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
Whitney, C.W.
85256b91-19a6-4597-a953-5302bbb250dc
Hanjani, P.
e516cfd1-a490-4571-8163-89246c995b3e
Kristensen, G.
39066b87-e802-455e-88a3-ad712f17b40f
Malfetano, J.H.
cbe28dde-de0e-482f-8a4f-5336d23bdc01
Beckman, R.A.
db43e963-03ab-4f9b-b225-d821f1d3b564
Ross, G.A.
b0f30f93-b85f-4ff0-91f0-83f59b993584
Lane, S.R.
c1dbd918-c752-4c0e-bdf5-887ff128ee7e
DeWitte, M.H.
52b19f6d-92fb-4c51-bca7-9627a2795955
Fields, S.Z.
67234d8c-6f3a-4171-b097-17ff465b011e
Clarke-Pearson, D.L.
73e04ce1-f921-45e2-a019-2adea5334d15
Van Le, L.
eb7b056b-a0a2-4add-9764-8830e94bafef
Iveson, T.
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
Whitney, C.W.
85256b91-19a6-4597-a953-5302bbb250dc
Hanjani, P.
e516cfd1-a490-4571-8163-89246c995b3e
Kristensen, G.
39066b87-e802-455e-88a3-ad712f17b40f
Malfetano, J.H.
cbe28dde-de0e-482f-8a4f-5336d23bdc01
Beckman, R.A.
db43e963-03ab-4f9b-b225-d821f1d3b564
Ross, G.A.
b0f30f93-b85f-4ff0-91f0-83f59b993584
Lane, S.R.
c1dbd918-c752-4c0e-bdf5-887ff128ee7e
DeWitte, M.H.
52b19f6d-92fb-4c51-bca7-9627a2795955
Fields, S.Z.
67234d8c-6f3a-4171-b097-17ff465b011e

Clarke-Pearson, D.L., Van Le, L., Iveson, T., Whitney, C.W., Hanjani, P., Kristensen, G., Malfetano, J.H., Beckman, R.A., Ross, G.A., Lane, S.R., DeWitte, M.H. and Fields, S.Z. (2001) Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer. Journal of Clinical Oncology, 19 (19), 3967-3975.

Record type: Article

Abstract

Purpose: To evaluate oral topotecan as single-agent, second-line therapy in patients with ovarian cancer previously treated with a platinum-based regimen.
Patients and Methods: Patients (N = 116) received oral topotecan 2.3 mg/m2 daily for 5 days every 21 days. Eligibility criteria included histologic diagnosis of International Federation of Gynecology and Obstetrics stage III or IV epithelial ovarian cancer, bidimensionally measurable disease, prior platinum-containing chemotherapy, age >= 18 years, performance status <= 2, and life expectancy >= 12 weeks.
Results: Overall response rate was 21.6% (25 of 116 patients). Median duration of response was 25.0 weeks; median time to response was 8.4 weeks. Median time to progression was 14.1 weeks; median survival was 62.2 weeks. Grade 4 neutropenia was experienced by 50.4% of patients in 13.4% of courses administered. Grade 4 thrombocytopenia was experienced by 22.1% of patients in 5.1% of courses. Grade 3 or 4 anemia was experienced by 29.2% of patients in 8.5% of courses. Most frequent nonhematologic toxicities were predominantly (> 90%) grade 1 or 2 and included nausea, alopecia, diarrhea, and vomiting.
Conclusion: Second-line oral topotecan administered at 2.3 mg/m2 for 5 days every 21 days demonstrated activity in patients with progressive or recurrent ovarian cancer after first-line platinum-based chemotherapy. This activity was comparable to that seen in previous studies with intravenous topotecan. Grade 4 neutropenia was less frequent with oral topotecan than previously reported for intravenous topotecan. Oral topotecan is an active, tolerable, and convenient formulation of an established agent for the second-line treatment of advanced epithelial ovarian cancer and may also facilitate exploring prolonged treatment schedules.

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Published date: 2001

Identifiers

Local EPrints ID: 26247
URI: http://eprints.soton.ac.uk/id/eprint/26247
ISSN: 1527-7755
PURE UUID: b2d59e92-a6a6-4cdb-9846-78902c92e6ca
ORCID for T. Iveson: ORCID iD orcid.org/0000-0002-4681-2712

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Date deposited: 21 Apr 2006
Last modified: 23 Jul 2022 01:42

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Contributors

Author: D.L. Clarke-Pearson
Author: L. Van Le
Author: T. Iveson ORCID iD
Author: C.W. Whitney
Author: P. Hanjani
Author: G. Kristensen
Author: J.H. Malfetano
Author: R.A. Beckman
Author: G.A. Ross
Author: S.R. Lane
Author: M.H. DeWitte
Author: S.Z. Fields

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