Abstract
Objective: A single-agent topotecan has an indication for the treatment of small cell lung cancer in Japan. Previous studies demonstrated that topotecan combined with a platinum agent could provide additional antitumor efficacy. This study was to find the recommended dose of topotecan in combination with cisplatin and preferred administration sequence in untreated patients with extensive disease small cell lung cancer for Phase II study. Methods: Patients received topotecan as a 30 min infusion for 5 days in escalating doses (starting at 0.5 mg/m2/day), and cisplatin at a fixed dose of 60 mg/m2, 3 weeks cycle. This study employed the following stages: cisplatin was given before topotecan on day 1 to previously treated patients (Stage 1). After the maximum-tolerated dose level was achieved, the same schedule was applied for untreated patients (Stage 2). Subsequently, cisplatin was given after topotecan on day 5 to untreated patients (Stage 3). The recommended doses of cisplatin on day 1 and 5 schedules were estimated by considering results obtained from Stages 2 and 3, respectively. Results: A total of 34 patients were enrolled. The maximum-tolerated doses in Stages 1-3 were estimated at 0.65, 0.65, and 1.4 mg/m2, respectively. The recommended doses of cisplatin on day 1 and 5 schedules in untreated patients were determined at 0.65 and 1.0 mg/m2, respectively. The major toxicity in this combination was hematological events. Conclusions: For treatment-naive patients, the combined use of 0.65/60 mg/m2 topotecan/cisplatin with cisplatin on day 1 schedule or 1.0/60 mg/m2 topotecan/cisplatin with cisplatin on day 5 schedule is recommended for Phase II study.
| Original language | English |
|---|---|
| Pages (from-to) | 197-203 |
| Number of pages | 7 |
| Journal | Japanese Journal of Clinical Oncology |
| Volume | 41 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Feb 2011 |
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Keywords
- Cisplatin
- Combination chemotherapy
- Small cell lung cancer
- Topotecan
ASJC Scopus subject areas
- Oncology
- Cancer Research
- Radiology Nuclear Medicine and imaging
Cite this
Phase I study of topotecan and cisplatin in patients with small cell lung cancer. / Ichinose, Yukito; Seto, Takashi; Nishiwaki, Yutaka; Kiura, Katsuyuki; Sakai, Hiroshi; Yokoyama, Akira; Segawa, Yoshihiko; Ando, Masahiro; Watanabe, Koshiro.
In: Japanese Journal of Clinical Oncology, Vol. 41, No. 2, 02.2011, p. 197-203.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase I study of topotecan and cisplatin in patients with small cell lung cancer
AU - Ichinose, Yukito
AU - Seto, Takashi
AU - Nishiwaki, Yutaka
AU - Kiura, Katsuyuki
AU - Sakai, Hiroshi
AU - Yokoyama, Akira
AU - Segawa, Yoshihiko
AU - Ando, Masahiro
AU - Watanabe, Koshiro
PY - 2011/2
Y1 - 2011/2
N2 - Objective: A single-agent topotecan has an indication for the treatment of small cell lung cancer in Japan. Previous studies demonstrated that topotecan combined with a platinum agent could provide additional antitumor efficacy. This study was to find the recommended dose of topotecan in combination with cisplatin and preferred administration sequence in untreated patients with extensive disease small cell lung cancer for Phase II study. Methods: Patients received topotecan as a 30 min infusion for 5 days in escalating doses (starting at 0.5 mg/m2/day), and cisplatin at a fixed dose of 60 mg/m2, 3 weeks cycle. This study employed the following stages: cisplatin was given before topotecan on day 1 to previously treated patients (Stage 1). After the maximum-tolerated dose level was achieved, the same schedule was applied for untreated patients (Stage 2). Subsequently, cisplatin was given after topotecan on day 5 to untreated patients (Stage 3). The recommended doses of cisplatin on day 1 and 5 schedules were estimated by considering results obtained from Stages 2 and 3, respectively. Results: A total of 34 patients were enrolled. The maximum-tolerated doses in Stages 1-3 were estimated at 0.65, 0.65, and 1.4 mg/m2, respectively. The recommended doses of cisplatin on day 1 and 5 schedules in untreated patients were determined at 0.65 and 1.0 mg/m2, respectively. The major toxicity in this combination was hematological events. Conclusions: For treatment-naive patients, the combined use of 0.65/60 mg/m2 topotecan/cisplatin with cisplatin on day 1 schedule or 1.0/60 mg/m2 topotecan/cisplatin with cisplatin on day 5 schedule is recommended for Phase II study.
AB - Objective: A single-agent topotecan has an indication for the treatment of small cell lung cancer in Japan. Previous studies demonstrated that topotecan combined with a platinum agent could provide additional antitumor efficacy. This study was to find the recommended dose of topotecan in combination with cisplatin and preferred administration sequence in untreated patients with extensive disease small cell lung cancer for Phase II study. Methods: Patients received topotecan as a 30 min infusion for 5 days in escalating doses (starting at 0.5 mg/m2/day), and cisplatin at a fixed dose of 60 mg/m2, 3 weeks cycle. This study employed the following stages: cisplatin was given before topotecan on day 1 to previously treated patients (Stage 1). After the maximum-tolerated dose level was achieved, the same schedule was applied for untreated patients (Stage 2). Subsequently, cisplatin was given after topotecan on day 5 to untreated patients (Stage 3). The recommended doses of cisplatin on day 1 and 5 schedules were estimated by considering results obtained from Stages 2 and 3, respectively. Results: A total of 34 patients were enrolled. The maximum-tolerated doses in Stages 1-3 were estimated at 0.65, 0.65, and 1.4 mg/m2, respectively. The recommended doses of cisplatin on day 1 and 5 schedules in untreated patients were determined at 0.65 and 1.0 mg/m2, respectively. The major toxicity in this combination was hematological events. Conclusions: For treatment-naive patients, the combined use of 0.65/60 mg/m2 topotecan/cisplatin with cisplatin on day 1 schedule or 1.0/60 mg/m2 topotecan/cisplatin with cisplatin on day 5 schedule is recommended for Phase II study.
KW - Cisplatin
KW - Combination chemotherapy
KW - Small cell lung cancer
KW - Topotecan
UR - http://www.scopus.com/inward/record.url?scp=79251628083&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79251628083&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyq177
DO - 10.1093/jjco/hyq177
M3 - Article
VL - 41
SP - 197
EP - 203
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
SN - 0368-2811
IS - 2
ER -