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Y. Zhao
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P1.15 - SCLC/Neuroendocrine Tumors (ID 701)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.15-016 - The Study of Population Pharmacokinetics and Individualized Dosage of Lobaplatin-Based Regimens in Elderly Patients with Small Cell Lung Cancer (ID 9766)
09:30 - 09:30 | Author(s): Y. Zhao
- Abstract
Background:
Elderly patients with SCLC have limited treatment options and poor survival. Lobaplatin(LBP) is a representative of the third-generation platinum compound, which has showed significant efficacy and favorable toxicity for SCLC. Therefore, we adopt population pharmacokinetic methods to explore the pharmacokinetics and its correlation with adverse reactions, and to make individualized dosing regimens of lobaplatin for elderly SCLC patients.(ChiCTR-OPN-15006057)
Method:
SCLC patients aged≥65 years and creatinine clearance(Ccr) ≥60ml/min were divided into two arms, receiving four cycles of lobaplatin regimens according to Ccr. LBP was administrated at dose of 30mg/m[2 ]in Arm A(Ccr≥80ml/min) or 20mg/m[2] in Arm B(60ml/min≤Ccr＜80ml/min). Four blood samples were randomized collected from each patient in the first cycle. For the subsequent cycles, only one blood sample were collected. The primary endpoint was plasma concentrations at different time points after administration of LBP. The secondary endpoints were PFS, OS, ORR, DCR and safety.
Result:
Between January 2014 and July 2016, 100 patients(30 with limited stage and 70 with extensive stage disease) were enrolled into the study at 7 institutions in China. There were 51 patients in Arm A and 49 patients in Arm B. The median PFS and OS for Arm A and B were 155 days vs.170 days, 306 days vs. 272 days, respectively. The ORR and DCR were 50% vs. 51.22%, 88.64% vs. 90.24% respectively. Grade III/IV AEs incidence of Arm A and B were 60.8% vs. 51.0%. In terms of population pharmacokinetic, we can get the following conclusions by computer simulation that if the total doses of LBP are fixed, the exposure levels of lobaplatin in the body have great differences when the body surface areas(BSA) are different. If administrated according to the BSA, the AUC differences of individual with different BSA are little, and there is only about 8% AUC differences between the two arms. As administrated in accordance with the protocol, the AUC of Arm B is about 39% lower than that of Arm A. If dose of LBP in Arm B was increased from 20 mg/m2 to 27 mg/m2, the AUC difference between the two groups was only 3%.
Conclusion:
When Ccr≥60 ml/min, it’s necessary to administration on the basis of BSA. It’s reliable and safe to use LBP-based regimens to treat elderly patients with SCLC. Lobaplatin may offer an alternative choice for Chinese elderly patients with advanced SCLC.
