scholarly journals Oral Topotecan Hydrochloride

2020 ◽  
Author(s):  
Keyword(s):  
Oral Topotecan

Myelotoxicity of oral topotecan in relation to treatment duration and dosage: a phase I study

2010 ◽  
Vol 21 (2) ◽  
pp. 202-205 ◽  
Author(s):  
George P. Stathopoulos ◽  
Alexandros Ardavanis ◽  
Pavlos Papakotoulas ◽  
Dimitrios Pectasides ◽  
George Papadopoulos ◽  
...  
Keyword(s):  
Phase I ◽  
Treatment Duration ◽  
Phase I Study ◽  
Oral Topotecan

Absolute bioavailability studies of a new oral topotecan formulation in Chinese patients using UHPLC–MS/MS

2013 ◽  
Vol 76 ◽  
pp. 252-256 ◽  
Author(s):  
Ning Li ◽  
Xiaohong Han ◽  
Jianliang Yang ◽  
Lin Gui ◽  
Yuanyuan Song ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Absolute Bioavailability ◽  
Oral Topotecan

Phase 2 trial of prolonged administration of oral topotecan in platinum/taxane-refractory ovarian, fallopian tube, and primary peritoneal cancers

2004 ◽  
Vol 95 (1) ◽  
pp. 109-113 ◽  
Author(s):  
Maurie Markman ◽  
Kenneth Webster ◽  
Kristine Zanotti ◽  
Barbara Kulp ◽  
Gertrude Peterson ◽  
...  
Keyword(s):  
Fallopian Tube ◽  
Phase 2 ◽  
Prolonged Administration ◽  
Phase 2 Trial ◽  
Oral Topotecan

Oral Topotecan as Single-Agent Second-Line Chemotherapy in Patients With Advanced Ovarian Cancer

2001 ◽  
Vol 19 (19) ◽  
pp. 3967-3975 ◽  
Author(s):  
D. L. Clarke-Pearson ◽  
L. Van Le ◽  
T. Iveson ◽  
C. W. Whitney ◽  
P. Hanjani ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Median Time ◽  
Single Agent ◽  
Advanced Ovarian Cancer ◽  
Prolonged Treatment ◽  
Second Line ◽  
Gynecology And Obstetrics ◽  
Platinum Based Chemotherapy ◽  
Oral Topotecan

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.

Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment for Chemotherapy-Naive Patients With Extensive-Disease Small-Cell Lung Cancer

2006 ◽  
Vol 24 (13) ◽  
pp. 2044-2051 ◽  
Author(s):  
John R. Eckardt ◽  
Joachim von Pawel ◽  
Zsolt Papai ◽  
Antoaneta Tomova ◽  
Valentina Tzekova ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Open Label ◽  
Extensive Disease ◽  
Phase Iii Study ◽  
Grade 3 ◽  
Oral Topotecan

Purpose This open-label, randomized, multicenter phase III study compared oral topotecan/intravenous cisplatin (TC) with intravenous (IV) etoposide/cisplatin (PE) in patients with untreated extensive-disease small-cell lung cancer (ED-SCLC). Patients and Methods A total of 784 patients were randomly assigned to either oral topotecan 1.7 mg/m2/d × 5 with IV cisplatin 60 mg/m2 on day 5 (n = 389) or IV etoposide 100 mg/m2/d × 3 with IV cisplatin 80 mg/m2 on day 1 (n = 395) every 21 days. Results Overall survival (primary end point) was similar between groups (P = .48; median: TC, 39.3 weeks v PE, 40.3 weeks). One-year survival was 31% (95% CI, 27% to 36%) in both groups and the difference of −0.03 (95% CI, −6.53 to 6.47) met the predefined criteria of ≤ 10% absolute difference for noninferiority of TC relative to PE. Response rates were similar between groups (TC, 63% v PE, 69%). Time to progression was slightly but statistically longer with PE (log-rank P = .02; median: TC, 24.1 weeks v PE, 25.1 weeks). The regimens were similarly tolerable. Grade 3/4 neutropenia occurred more frequently with PE (84% v 59%), whereas grade 3/4 anemia and thrombocytopenia occurred more frequently with TC (38% v 21% and 38% v 23%, respectively). Lung Cancer Symptom Scale scores were statistically better with PE, but the differences were small and of debatable clinical significance. Conclusion Oral topotecan with cisplatin provides similar efficacy and tolerability to the standard (etoposide with cisplatin) in untreated ED-SCLC and may provide greater patient convenience compared with intravenous etoposide and cisplatin.

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