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V. Kolek
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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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P2.01-071 - TULUNG REGISTRY: Data Analysis of Patients with Non-Squamous NSCLC Treated with Bevacizumab in the Czech Republic (ID 2934)
09:30 - 17:00 | Author(s): V. Kolek
- Abstract
Background:
We conducted a systematic review of data from patients reported in the TULUNG registry (data cut-off 26-Jan-15). The TULUNG registry is Czech national oncology registry which prospectively collects data from all NSCLC patients treated with new targeted therapies in Czech Republic since 2008.
Methods:
Analysis was performed on a group of patients with non-squamous NSCLC with good performance status (PS 0-2), treated with bevacizumab. Since 2008 bevacizumab has been used for treatment in 193 patients (full record criteria met). 10 patients with incomplete records were not included to the review
Results:
In this group of patients 35.8% were female; the median age at bevacizumab treatment initiation was 60 years (range 29-83). The majority of patients were smokers and ex-smokers (37.8% and 34.7% respectively) and 91.7% of tumors were adenocarcinomas by histology. 91.7% patients were at the metastatic stage at the initiation of bevacizumab treatment, 6.2% of patients were in stage IIIb and only 2.1% of patients in stage IIIa (UICC6). The performance status was distributed between ECOG PS0 and PS1 mainly (40.9% PS0 and 58% PS1)at the initiation of the bevacizumab treatment. Majority of patients received bevacizumab treatment in the first line (96.4%). Two main chemotherapy regimens were used; carboplatin+paclitaxel (68.4%) and cisplatin+gemcitabine (9.8%). In this group of 193 patients analyzed, bevacizumab therapy was terminated in 152 (78.8%) patients at data cut-off. The most frequent reasons for termination were disease progression, in 55.9%, termination of treatment according to plan in 8.6% and death, in 7.9% of patients. Treatment with bevacizumab is ongoing in 41 (21.2%) patients. In 152 of patients with terminated treatment, the median duration of treatment was 15.6 weeks (95% CI 0.3 – 51.3). Response assessment showed CR in 0.7%, PR in 40.8% and SD in 35.5% of patients. Median progression free survival was 6.9 months (95% CI 5.8 – 8.1), median overall survival 16.7 months (95% CI 11.7 – 21.7). 1-year survival from bevacizumab treatment initiation was 67.9%. Adverse events were reported in 9.8% of patients, the most frequently reported adverse events were thromboembolic events (5.2%) and neutropenia (1.6%). Tromboembolic events were observed in 10 patients, none of these was fatal. We didn´t observe any severe episode of bleeding event.
Conclusion:
Therapy with bevacizumab in non-squamous NSCLC was active and very well tolerated. In eligible patients, only 7 patients (4.6%) had to discontinue bevacizumab therapy due to safety reasons. In patients with completed bevacizumab therapy 77.0% disease control rate was reached with a median survival of approximately 16.7 months from initiation of first line therapy with bevacizumab.
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-010 - Alisertib (MLN8237)+Paclitaxel versus Placebo+Paclitaxel for Relapsed SCLC (ID 1158)
09:30 - 17:00 | Author(s): V. Kolek
- Abstract
Background:
Small cell lung cancer (SCLC) is an aggressive malignant disease comprising approximately 14% of all lung cancers, with approximately 31,000 new diagnoses each year in the USA. SCLC has a very poor prognosis, particularly in patients presenting with extensive stage disease. Platinum-based combinations are standard first-line therapy for SCLC; however, relapse is almost universal (≥85%) and patients require further treatment in subsequent lines. Effective new targeted therapies are needed to improve the poor outcomes observed in SCLC. Alisertib is an investigational, orally available, selective inhibitor of Aurora A kinase. Alisertib has shown single-agent antitumor activity in preclinical in vivo models of SCLC and has demonstrated synergism with paclitaxel in this setting. Single-agent alisertib has demonstrated promising efficacy in patients with relapsed/refractory SCLC (Melichar B, et al. Lancet Oncol 2015;16[4]:395–405). Further, phase 1 and 2 evaluation of alisertib+paclitaxel in patients with relapsed ovarian cancer and breast cancer has suggested the antitumor activity of this combination (Falchook G, et al. Int J Gynecol Cancer 2013;23[8] Suppl_1:abstract; Coleman R, et al. Ann Oncol 2014;25[Suppl_4]:abstract 876O). Here we describe the design and objectives of an ongoing phase 2, randomized, double-blind, placebo-controlled study of alisertib+paclitaxel versus placebo+paclitaxel in patients with relapsed SCLC and previously treated with only one line of platinum-based therapy (NCT02038647).
Methods:
Approximately 166 adult patients with relapsed SCLC after standard first-line platinum-based therapy, measurable disease by RECIST v1.1, and Eastern Cooperative Oncology Group performance status 0 or 1 will be enrolled at approximately 80 sites in the USA and Europe. Patients will be randomized 1:1 (stratified by type of relapse [sensitive vs resistant/refractory] and presence of brain metastases) to receive 28-day cycles of either alisertib 40 mg or matched placebo PO twice daily on days 1−3, 8−10, and 15−17, plus paclitaxel 60 or 80 mg/m[2 ]IV, respectively, on days 1, 8, and 15, until disease progression or unacceptable toxicity. The primary endpoint of the trial is progression-free survival (PFS). Assuming a hazard ratio of 0.6 for PFS, a total of 138 progression/death events will be required to provide 85% power (two-sided alpha=0.05). Secondary endpoints include: overall and complete response rates; disease control rate; duration of response; overall survival; safety (NCI-CTCAE v4.03); alisertib pharmacokinetics; and symptom-related endpoints (symptom score, time to symptom relief, time to symptom progression). Evaluation of candidate biomarkers in tumor tissue specimens and in circulating tumor cells (CTC)/circulating tumor DNA, change from baseline in CTC numbers, and health-related quality of life (EORTC QLQ-C30/QLQ-LC13 instruments) are exploratory endpoints. As of 10 April 2015, there are 60 sites open in 6 countries with 90 patients randomized. The study continues to enroll patients.
Results:
not applicable
Conclusion:
not applicable
