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X. Song
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-009 - Combination of Angiogenesis Inhibitor and EGFR-TKIs in Advanced NSCLC Patients Who Developed Acquired Resistance (ID 2218)
09:30 - 17:00 | Author(s): X. Song
- Abstract
Background:
Several randomized clinical trials have shown that erlotinib and Bevacizumab combination improved the survival of patients with EGFR mutation-positive Non-small cell lung cancer（NSCLC）. The aim of this study was to evaluate the clinical activity of another angiogenesis inhibitor Endostar (rh-endostatin) in combination with continued EGFR-TKIs (including erlotinib, gefitinib and Icotinib) for advanced NSCLC patients who have developed acquired resistance to prior EGFR-TKIs treatment.
Methods:
Advanced NSCLC patients with disease progression who had partial or complete response to prior EGFR-TKIs treatment received 2-8cycles of Endostar plus EGFR-TKIs. Endostar was administered at a dose of 15mg q.d intravenously for 14 days, each at 3-week intervals; combined with continued EGFR-TKIs (erlotinib 150mg PO daily, or gefitinib 250mg PO daily or Icotinib 125mg PO t.i.d); until unacceptable toxicity or disease progression. The response was assessed using Southwest Oncology Group (SWOG) criteria after 6 weeks.
Results:
A total of 17 NSCLC evaluable patients were enrolled, including 9 women and 8 men. The presence of EGFR status were exon 21 L858R point mutation in 7 cases, exon 19 deletion in 5 cases, wild type in 2 cases and unknown in 3 cases. Median number of treatment cycles was four. It showed a 76.47% (13/17) disease control rate and had a prolonged stabilization of disease (>6 months). Median PFS was 6.9 Months. Treatment benefit and overall survival was noted both in activating EGFR mutation patients, EGFR stated unknown patients and even in wild type patients. One stage VI patient with EGFR wild type, developed resistance after 6 months 2nd line erlotinib treatment, received 8 cycles of Endstar and erlotinib combination, and had 46 months overall survival time. Endostar in combination with EGFR-TKIs were generally well tolerated. The most common adverse events were rash 35.29% (6/17), decreased appetite 29.41% (5/17), dry skin29.41% (5/17). No grade 3 or greater adverse events were seen in this study.
Conclusion:
Endostar with the addition of continuation of EGFR-TKIs has demonstrated promising clinical activity in NSCLC patients selected for acquired resistance to previous use of EGFR-TKIs. Treatment with this combination exhibited a good safety profile. Our results strengthen the evidence that angiogenesis inhibitor may be a valid option for NSCLC patients who have progressed on EGFR-TKIs. The optimal clinical combination and activity warrants further investigation.
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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 - 17:00 | Author(s): X. Song
- 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.
