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Fengying Wu
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-052 - Comparing EGFR-TKI with EGFR-TKI plus Chemotherapy as 1st Line Treatment in Advanced NSCLC Patients with Both Mutated EGFR and Bim Polymorphism (ID 10516)
09:30 - 09:30 | Author(s): Fengying Wu
- Abstract
Background:
Not all advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutations could get benefit from 1[st] line treatment of EGFR tyrosine kinase inhibitors (TKIs). Our previous study indicated that B-cell chronic lymphocytic leukemia/lymphoma-like 11 (Bim) deletion polymorphism was about 10% and was significantly associated with a poor clinical response to EGFR-TKIs in EGFR mutation-positive NSCLC. This retrospective study compared efficacy and tolerability of the EGFR-TKI alone versus EGFR-TKI plus chemotherapy as the 1[st] line treatment in advanced NSCLC patients with both activated EGFR mutation and Bim polymorphism.
Method:
Main included criterias were patients older than 18 years, histologically confirmed stage IIIB or IV NSCLC, EGFR mutation-positive (exon 19 deletion or 21 L858R mutation) and Bim polymorphism. Patients received gefitinib 250mg orally a day or gefitinib together with up to 4 cycles of pemetrexed/gemcitabine and platinum until disease progression or unacceptable toxic effects. The primary endpoint was progression-free survival (PFS); the second endpoint included objective response rate (ORR), overall survival (OS) and toxicity.
Result:
From June 2014 to September 2016, 65 patients were enrolled into this trial. 36 of them received gefitinib, and 29 received gefitinib plus pemetrexed/gemcitabine and platinum. Median PFS was significantly longer in EGFR-TKI plus chemotherapy-treated patients than in EGFR-TKI (7.2 [95% CI 5.35-9.05] vs 4.6 [4.01-5.19] months; p=0.008). The ORR was significantly lower in EGFR-TKI than in EGFR-TKI plus chemotherapy-treated patients (38.9% vs. 65.5% p=0.046). EGFR-TKI plus chemotherapy was associated with more grade 3 or 4 hematological toxic effects than EGFR-TKI (8 neutropenia, 4 thrombocytopenia vs. no any event). Figure 1
Conclusion:
Compared with EGFR-TKI, EGFR-TKI plus chemotherapy conferred a significant higher ORR and longer PFS in advanced NSCLC patients with both activated EGFR mutation and Bim polymorphism. An open-label, multicenter, randomized, phase 2 study is ongoing to validate these results in our institute ( NCT03002844).
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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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P1.15-009 - Safety and Efficacy of Nab-Paclitaxel Monotherapy as 2nd or Later Line Setting in Pts with Extensive SCLC, a Phase II Single Arm Study (NCT02262897) (ID 9583)
09:30 - 09:30 | Author(s): Fengying Wu
- Abstract
Background:
There is still an unmet need for patients with extensive small cell lung cancer(SCLC) who failed from the previous treatment even though topotecan was approved by Food and Drug Administration as second line setting in this population. Nab-paclitaxel (nab-P) has showed promising efficacy in pancreas cancer, breast cancer and nonsmall cell lung cancer, this phase II trial try to evaluate the safety and efficacy of nab-paclitaxel (nab-P) monotherapy as the secondary or later line therapy in patients with extensive SCLC.
Method:
Main included criteria were performance status 0-2, extensive disease, failed or insensitive relapse from the previous treatment, sufficient myeloid function. Sensitive relapsed from the last line chemotherapy was excluded. Patients who met these criteria received weekly nab-paclitaxel 130mg/m2, d1,8,15, every 4 week or nab-paclitaxel of 230 mg/m2, d1 every 3 weeks. The Primary end point is objective response rate. The secondary end point included progression free survival(PFS), overall survival, and side effects.
Result:
From Sep, 2014 to Mar, 2017, 40 patients were included into this study, included 39 males, 6 never smokers, PS 1/2:27/13 with a median age of 66 years. The median line of nab-P monotherapy is 3(2-5). Among them, 30 patients received weekly nab-P and 10 received nab-P every 3 weeks. 9, 27, 4 patients were resistant, refractory and sensitive relapse to first line chemotherapy respectively. 7 patients got partial response,17 stable diseases and 16 progression disease. The objective response rate was 17.5% and disease control rate(DCR) was 60%. The median PFS was 3 months and the during of response was 5.8 months. Subgroup analysis showed that patients who were refractory or sensitive relapse to first line chemotherapy had a significant higher DCR (67.8% vs 28.5%, p=0.042) and longer PFS(3.3 vs 1.4 months, p=0.04), while similar results were found in different PS, smoking status and lines of therapy. Toxicity was mild and manageable including alopecia, neuritis, neutropenia and anemia, no grade 3/4 adverse event observed.
Conclusion:
Nab-P showed promising efficacy together with acceptable toxicity in patients with extensive SCLC who failed or insensitive relapse from the previous treatment, especially in the subgroup of refractory or sensitive relapse to first line chemotherapy, large cohort study is needed to validate these findings.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-085 - A Phase 2 Trial of Apatinib in Advanced Non-Squamous NSCLC: Updated Data and Clinical Benefit of Continuing Apatinib after Initial Progression (ID 9039)
09:30 - 09:30 | Presenting Author(s): Fengying Wu
- Abstract
Background:
Apatinib exerts anti-tumor effects by selectively inhibiting VEGFR-2. A single-arm Phase 2 study of apatinib monotherapy in advanced non-squamous NSCLC patients showed promising response across multiple therapy lines (P3.02C-025, WCLC 2016 Abstracts). Here we report the updated efficacy and safety data, as well as the clinical benefit of continuing apatinib beyond initial progression.
Method:
Forty patients with previously heavily treated advanced non-squamous NSCLC were enrolled to receive apatinib until progression, unacceptable toxicity, withdrawal or death. After study discontinuation, apatinib monotherapy or combined therapy was allowed for patients on disease progression at the discretion of the investigators and under the consent of patients.
Result:
The cutoff date was March 12, 2017. The treatment duration of apatinib was 82 (43, 127) days with a mean dosage of 477.0 ± 85.3 mg/day. Thirty-eight patients were available for tumor response evaluation, and the best overall response rate (ORR) and disease control rate (DCR) were 21.1% and 76.3%, respectively. The median progression-free (PFS) and overall survival (OS) were 3.32 (95% CI, 2.37–4.86) and 9.26 (95% CI, 5.36–not estimable) months, respectively. Common adverse events (AEs) were hand-foot-skin reaction (HFSR) (30.0%), proteinuria (27.5%), hypertension (17.5%) and aphthous stomatitis (22.5%). Severe AEs included Grade 3 HFSR (5%), hypertension (5%) and thrombocytopenia (5%). Results of preliminary subgroup analyses indicated that age, gender, PS score, treatment line and having a driver gene mutation had no significant effects on ORR, DCR and survival. After initial progression following apatinib treatment, 9 patients received apatinib alone or combined therapy with docetaxel, gefitinib or erlotinib (Table). One PR and 6 SD were achieved. Encouragingly, 8 patients had treatment duration over 4 months.Table: Patients continued apatinib alone or combined therapy after progression
No. Regimens after progression Dose of apatinib (mg) Best efficacy Treatment duration (months) Reason for discontinue treatment 1 Apatinib plus Docetaxel 500 PR 13.11 Second progression 2 Apatinib plus Gefitinib 250 SD 7.98 Lost to follow-up 3 Apatinib plus Gefitinib 375 SD 7.82 Death 4 Apatinib plus Gefitinib 500 SD 5.82 Lost to follow-up 5 Apatinib plus Erlotinib 500 SD 4.27 Lost to follow-up 6 Apatinib 375 SD 5.13 Second progression 7 Apatinib 500 NE 4.44 Second progression 8 Apatinib 250 SD 4.24 Death 9 Apatinib 500 NE 0.33 Death
Conclusion:
This updated analysis further confirmed the efficacy and safety of apatinib for heavily treated advanced non-squamous NSCLC. Continuing apatinib monotherapy or combined therapy could bring clinical benefit.
