Related Experiment Video
Updated: Jul 4, 2026

Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Dose escalation study of amrubicin in combination with fixed-dose irinotecan in patients with extensive small-cell
Fumihiro Oshita1, Haruhiro Saito, Kouzo Yamada
1Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan. foshita@kcch.jp
Background:
The combination of amrubicin (Am) and irinotecan (CPT) shows appreciable activity against small-cell lung cancer (SCLC) in vitro.
Patients And Methods:
We conducted a dose escalation study of Am in combination with CPT to determine the qualitative and quantitative toxicities and efficacy against extensive (ED) SCLC.
Results:
Thirteen previously untreated patients with ED-SCLC were treated with CPT at 60 mg/m(2) on day 1 and dose-escalated Am on days 1-3 with prophylactic granulocyte colony-stimulating factor subcutaneously on days 5-9 every 2-3 weeks. At level 3 (40 mg/m(2)/day Am), 3 of 4 registered patients experienced dose-limiting toxicity such as grade 4 neutropenic fever, and therefore, this was defined as the maximum tolerated dose. A total of 31 courses was administered at dose level 2 (35 mg/m(2)/day) in 6 patients, and grade 4 neutropenia was observed during 5 courses (16.1%). Non-hematological toxicities, except 1 course of grade 3 transfusion of red blood cells and 1 course of grade 3 transaminase elevation, were mild. Thus, dose level 2 of Am was recommended for further study. One patient achieved complete remission and 12 achieved partial remission, and the overall response rate was 100%. The median survival time was 17.4 months, and the 1-year survival rate was 76.9%.
Conclusions:
CPT at 60 mg/m(2) on day 1 and Am at 35 mg/m(2)/day on days 1-3 with granulocyte colony-stimulating factor support every 3 weeks is recommended for Japanese patients with ED-SCLC.
Related Concept Videos
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Dosage Regimen: Fixed Dose
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Treatment Resistent Cancers
