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Y.P. Zhang
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P1.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 233)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.04-044 - Local Diagnostic Practices for Advanced Non-Small-Cell Lung Cancer in Asia-Pacific and Russia: IGNITE Study (ID 2650)
09:30 - 09:30 | Author(s): Y.P. Zhang
- Abstract
Background:
IGNITE (a large, multicentre, interventional, non-comparative diagnostic study; NCT01788163) evaluated local diagnostic practices for patients with advanced non-small-cell lung cancer (aNSCLC) in Asia-Pacific/Russia.
Methods:
Eligible patients: local/metastatic aNSCLC; chemotherapy-naïve, newly diagnosed/recurrent disease after resection; ineligible for curative treatment. We report diagnostic assessments and epidermal growth factor receptor (EGFR) mutation test turnaround times (secondary endpoints) associated with tissue/cytology samples from patients in Asia-Pacific/Russia.
Results:
3382 patients enrolled (972 Russia). Immunohistochemistry (IHC) analysis was used to confirm diagnosis in 989/2093 (47%) and 165/949 (17%) patients in Asia-Pacific and Russia, respectively (where data were available). Where IHC was used, the markers assessed were: TTF-1 (Asia-Pacific 95% and Russia 90%); p65 (3% and 5%); and p40 (17% and 4%). EGFR mutation tests were not performed on samples from 262 patients and tested samples from 23 patients did not yield results. The most common reason for not testing was insufficient material provided to test (Asia-Pacific 93% [100/108 responses], Russia 67% [24/36]). The percentages of neoplastic cells in samples (data available: Asia-Pacific n=1042; Russia n=187) were: <20% tumour cells: Asia-Pacific 33% vs Russia 6%; 20–50% tumour cells: 28% vs 33%; and >50% tumour cells: 40% vs 61%. Considering sampling methodologies (data available: Asia-Pacific n=2410; Russia n=972), the most common sampling sites were the lungs (Asia-Pacific 68%; Russia 80%) or lymph nodes (Asia-Pacific 14%; Russia 10%); the most common sample collection method was bronchoscopy (Asia-Pacific 22%; Russia 45%; Table 1). Median EGFR mutation test turnaround time was within 2 weeks for all countries except Thailand (70 days; Table 2). Mutation test success rates were high for Asia-Pacific (99.5%) and Russia (98.7%).
Conclusion:
Diagnostic assessments, sampling methodologies and EGFR mutation testing practices vary between and within Asia-Pacific and Russia; further understanding of local practices will drive improvements and enable more patients to receive appropriate personalised treatment. Figure 1 Figure 2
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-066 - A Prospective, Randomized, Multicenter, Phase III Study, Comparing rhTPO with rhIL-11 Treating CIT - An Interim Analysis (NCT02344979) (ID 1178)
09:30 - 09:30 | Author(s): Y.P. Zhang
- Abstract
Background:
Chemotherapy-induced thrombocytopenia (CIT) has seriously hindered the application of anti-cancer drugs. Thrombopoietic factors such as recombinant human interleukin-11(rhIL-11), thrombopoietin and its derivative(recombinant human thrombopoietin, rhTPO) are routinely administrated for CIT. But there is no randomized study to compare rhTPO with rhIL-11 on efficacy and safety of thrombocytopenia prophylactic treatment before. This is the first randomized, open-label, multicenter, phase Ⅲ study to compare them in China. We tried to investigate the efficacy and safety of prophylactic administration with rhTPO or rhIL-11 to prevent CIT in advanced non-small-cell lung cancer(NSCLC) patients.
Methods:
From June 2009 to February 2015, 71 patients with advanced NSCLC who were receiving the first-line platinum-based chemotherapy suffered severe thrombocytopenia(the nadir of platelet counts＜50×10[9]/L, confirmed by two times of blood routine in different days) during 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 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). 49 patients (34 males, 15 females) were enrolled rhTPO arm and 22 patients (14 males, 8 females) were enrolled rhIL-11 arm. There were no statistical difference between two arms in terms of gender[34 males(69.4%) vs.14 males(63.6%),P＞0.05], age(58.5±9.3 yrs vs. 60.3±7.5 yrs, P＞0.05), and the nadir of platelet counts during prior chemotherapy cycle(31.4±13.1×10[9]/L vs. 28.6±12.8×10[9]/L, 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(66.6±43.1×10[9]/L vs. 53.8±40.6×10[9]/L, P＞0.05) , the maximum platelet counts (219±132×10[9]/L vs. 240±151×10[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(3.0-6.0) days, P＞0.05], time of platelet count recovered to 75×10[9]/L [Median(95%CI): 2(2-3) days vs. 3(0-4) days, P＞0.05] and to 100×10[9]/L[median(95%CI): 4(3-6) days vs. 4.5(3-8) days, P＞0.05]. Drug-related adverse events in rhTPO arm were less than that of rhIL-11 arm (5 cases(10.2%) in rhTPO arm, 7 cases(31.8%) 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. This is an interim analysis. More data is still waiting.
