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Nobuyuki Hayashi
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P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.12-07 - Phase I Study of Amrubicin and Cisplatin with Concurrent Thoracic Radiotherapy (TRT) in Limited-Disease Small Cell Lung Cancer (LD-SCLC) (ID 47)
10:15 - 18:15 | Author(s): Nobuyuki Hayashi
- Abstract
Background
Amrubicin and cisplatin is one of active regimens for patients with extensive-disease small cell lung cancer (ED-SCLC). Combined modality of combination chemotherapy and concurrent thoracic radiotherapy has been recognized as standard treatment for LD-SCLC. This study aimed to determine the maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of amrubicin and cisplatin with concurrent TRT in LD-SCLC.
Method
Patients fulfilling the following eligibility criteria were enrolled: chemotherapy-naïve, PS0-1, age =<75, LD-SCLC, and adequate organ function. Patients received escalating doses of amrubicin on days 1, 2, and 3, under a fixed 60 mg/m2 of cisplatin on day 1. Four cycles of chemotherapy were repeated every 4 weeks. TRT of once-daily 2Gy/day commenced on day 2 of the first cycle of chemotherapy. The initial doses of amrubicin was 20 mg/m2 (level 1), and the dose was escalated to 25 (level 2) and 30 (level 3) mg/m2.
Result
Eight patients were enrolled at three dose levels. male/female=3/5; PS 0/1=4/4; median age (range) =68.5 (60-73). Two of two in level 3 experienced DLTs. The presentation of DLTs was grade4 neutropenia and leukopenia lasting more than four days. The MTD determined level 3, and level 2 was recommended for this combined modality. Evaluation of responses were 7 partial response and 1 progressive disease (response rate 87.5%) and the median overall survival time was 24.7 months, and suggested the regimen seemed to be modest activity.
Conclusion
In combined modality of this chemotherapy with TRT for LD-SCLC, MTD was amrubicin 30 mg/m2 and cisplatin 60 mg/m2, and DLTs were neutropenia and leukemia.