Virtual Library
Start Your Search
F.M. Du
Author of
-
+
P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P3.02c-093 - A Prospective, Randomized, Multicenter, Phase Ⅲ Study, Comparing rhTPO with rhIL-11 Treating CIT (NCT02344979) (ID 4891)
14:30 - 14:30 | Author(s): F.M. Du
- Abstract
Background:
Chemotherapy-induced thrombocytopenia (CIT) is a common dose limiting toxicity of clinical chemotherapy drugs, which may lead to reduced dose chemotherapy or delay chemotherapy time, and even terminate chemotherapy treatment. This is the first randomized, open-label, multicenter, phase Ⅲ study to compare the efficacy and safety of prophylactic treatment for thrombocytopenia in China. We tried to investigate the efficacy and safety of preventive application with rhTPO or rhIL-11 to protect against CIT in advanced non-small-cell lung cancer (NSCLC) patients.
Methods:
From June 2009 to July 2016, 108 patients with NSCLC who were receiving the first-line platinum-based chemotherapy suffered from severe thrombocytopenia(the nadir of platelet counts＜50×10[9]/L) during the prior chemotherapy cycle. They were randomized to rhTPO arm or rhIL-11 arm in the following chemotherapy cycle, and the chemotherapy regimens and drug doses were consistent with that in the prior and following cycle (GC Gemcitabine 1000-1250 mg/m[2], D1 and D8; Carboplatin dosing by AUC value=5, D1; Q3W) or GP (Gemcitabine 1000-1250 mg/m[2], D1 and D8; Cisplatin 75 mg/m[2], D1; Q3W). 77 patients (56males, 21 females) were enrolled in rhTPO arm and 31 patients (18 males, 13 females) were enrolled in rhIL-11 arm. There were no statistical difference between two arms in terms of gender, age and the nadir of platelet counts during prior chemotherapy cycle(P＞0.05). rhTPO (15000U/d) was injected subcutaneously on the 2[nd], 4[th], 6[th], 9[th ]Day after the initiation of chemotherapy, and IL-11(3mg/d) was injected subcutaneously per day from Day 9 to Day15 after the initiation of chemotherapy. Blood routines were conducted to test before chemotherapy initiation and the 3[th], 5[th], 7[th], 9[th], 11[th], 13[th], 15[th], 17[th], and 21[th] day after chemotherapy. Toxicity and efficacy were monitored.
Results:
In the following chemotherapy cycle there were no statistical difference between rhTPO arm and rhIL-11 arm on the following indexes: the nadir of platelet counts(62.6±39.4×10[9]/L vs. 52.8±36.8×10[9]/L, P＞0.05) , the maximum platelet counts (223.5±127.3×10[9]/L vs. 245.8±158.7×10[9]/L, P＞0.05) , duration of platelet counts less than 50×10[9]/L[Median (95%CI): 4.0(3.0-5.0) days vs. 4.5(3.0-9.0) days, P＞0.05], time of platelet count recovered to 75×10[9]/L [Median(95%CI): 5(3-7) days vs. 6(4-8) days, P＞0.05] and to 100×10[9]/L[median(95%CI): 6(6-8) days vs. 6(5-9) days, P＞0.05]. Drug-related adverse events in rhTPO arm were less than those of rhIL-11 arm (5 cases (6.49%) in rhTPO arm, 8 cases (25.8%) in rhIL-11 arm, P<0.05).
Conclusion:
Although there is no statistical difference on efficacies, prophylactic administration of rhTPO is safer and more convenient than that of rhIL-11 in advanced NSCLC patients.
