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Z. Chen



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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.05 - Research and progress of vascular targeted therapy in the postoperative adjuvant chemotherapy for lung cancer (ID 732)

      16:35 - 16:40  |  Author(s): Z. Chen

      • Abstract
      • Presentation
      • Slides

      Background
      Postoperative adjuvant chemotherapy is extensively received due to its extension of the time to recurrence and enhancement of survival rate in non-small cell lung cancer (NSCLC). However, it has reached the plateau at current, the beneficial cases are few, and drug-resistance and over-treatment phenomena are present in most of patients, hence it is necessary to seek a new postoperative adjuvant chemotherapy to improve the survival rate. Angiogenesis is one premise of malignant tumors to occur, develop and metastasize, but vascular endothelial growth factor (VEGF) is one of the most important tumors in the process of neovascularization. Under normal conditions, VEGF is hardly expressed in a lot of normal tissues in vivo, while highly expressed in the tumors like osteosarcoma, bladder cancer, breast cancer and colorectal cancer. Recombinant human endostatin (endostar) can significantly intervene the angiogenesis-promoting effect to block the nutritional supply of tumors and inhibit tumor proliferation or metastasis. We compare the curative effect of endostar plus adjuvant chemotherapy and adjuvant chemotherapy alone in the treatment of patients with completely resected NSCLC at stage IB-IIIA.

      Methods
      This is an open, multicenter, randomized (1:1) study, stratified by gender, stage and histology. Completely resected pts (stage IB to IIIA) were randomized to receive adjuvant NP plus Endostar (Vinorelbine 25mg/m2 on d1 and d8 plus Cisplatin 75 mg/m2 on d1, and iv plus Endostar 7.5mg/m2 per day iv for consecutive 14 days. Every 21 days as one cycle for 4 cycles) or NP regimen alone. The primary endpoint was disease-free survival (DFS). Secondary endpoints included tumor response rate, overall survival and safety.

      Results
      250 pts (1:1) were included between 07/2007 and 06/2009. Two arms were well-balanced with regard to age, gender, histology, staging, and resection type. The follow-up time is 42 months. The two groups had no significant difference in the incidence of toxicity reaction. Endostatin plus NP can prolong the DFS of patients with complete resectable NSCLC at stage IIIA (19.33±3.73m vs 17.10±9.68m) with high security, but no statistical difference. Cases with high expression of VEGF showed a better DFS than cases with low expression in Endostatin plus NP group (48.45±3.52m vs 40.18±4.54m, P < 0.05). The level of peripheral circulating endothelial progenitor cells (EPCs) in NSCLC patients is significantly higher than that in healthy volunteers. EPCs level was associated with NSCLC stage. The EPCs levels after treatment significantly decreased than that before treatment (P=0.014) in beneficiaries of NP or NP plus with endostar. The time to progression (TTP) was longer in patients with lower levels of EPCs (<0.35%) before chemotherapy or endostatin treatment (P<0.001).

      Conclusion
      This preliminary result showed vascular targeted therapy in postoperative adjuvant therapy of lung cancer has a good application prospect. VEGF and EPCs play important roles in the development of lung cancer. Deep studies should be taken for the other related molecular targets in the future.

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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-016 - A single arm, multi-center, phase II study of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA non-small cell lung cancer (CTONG 1101, NCT01297101): preliminary result (ID 2041)

      09:30 - 09:30  |  Author(s): Z. Chen

      • Abstract

      Background
      The optimal treatment for stage IIIA non-small cell lung cancer (NSCLC) disease is not well established with only 15% of 5-year survival rate, probably due toalready micro-metastatic lesion at the diagnosis. Thus, neoadjuvant therapy might be a good choice for IIIA NSCLC patients. The treatment modality of EGFR (TKI) intercalated with chemotherapy has been demonstrated to significantly improve objective response rate (ORR), progression free survival(PFS) and overall survival (OS) in advanced NSCLC patients with or without activating EGFR mutations. The objective of this study is to assess the efficacy and safety profile of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA NSCLC.

      Methods
      This is a single arm, multi-center, clinical phase II trial. Patients with untreated stage IIIA bulky N2 NSCLC and ECOG PS 0/1 were enrolled to received up to 2 cycles of gemcitabine 1,000 mg/m[2] on days 1 and 8 and cisplatin 75 mg/m[2] on day 1 or carboplatin AUC=5 d1, followed by oral erlotinib (150 mg, once a day) on days 15 to 28 as neoadjuvant therapy. A repeat computed tomography (CT) scan evaluated the response after induction therapy and eligible patients would undergo surgical resection. The primary endpoint was ORR, and secondary endpoints included pCR, resection rate, DFS (disease free survival) and OS , safety, QoL and biomarker analyses. Subgroup analysis of ORR by EGFR mutation status was also performed

      Results
      Between March 2011 and December 2012, a total of 39 patients were enrolled in the study, in which 36 patients (92.3% ITT population) have completed 2-cycle neoadjuvant treatment. According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, 18 patients achieved partial response (PR) (ORR=46.2%) and 18 patients achieved stable disease (SD) (DCR=92.3%); 22(56.4%) patients underwent resection with 18 R0 (46.2%), 2 R1(5.1%),1 R2(2.6%),1 NE(2.6%). Fifteen patients have had EGFR mutation test, with 7 EGFR mutation and 8 EGFR wild type. ORR in patients with EGFR mutations and wild type was 85.7%(6/7) vs. 50%(4/8), respectively. Common toxicities included myelosuppression (38.5%), rash (28.2%), neutropenia (5.1%), alanine transaminase (ALT) elevation(5.1%), diarrhea(5.1%) , fatigue(2.6%) and alopecia(2.7%) . Five (12.8%) patients suffered from CTCAE ≥3. No CTCAE ≥4 complications were recorded perioperatively.

      Conclusion
      Two cycles of intercalated administered gemcitabine/cisplatin with erlotinib as an induction treatment is a feasible and efficacious approach for stage IIIA NSCLC, which provides evidence for the further investigation.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-044 - Overall Survival analysis results of TFINE Study (CTONG 0904): Different Dose Docetaxel plus Cisplatin as First-line Chemotherapy and Then Maintenance Therapy with Single Agent Docetaxel for Advanced non-Small Cell Lung Cancer (ID 2524)

      09:30 - 09:30  |  Author(s): Z. Chen

      • Abstract

      Background
      Docetaxel (75mg/m[2]) has been reported as first-line and maintenance treatment for Western population with advanced NSCLC. Different doses of docetaxel (60mg/m[2]) are currently delivered in Asian population. Pharmacogenomics alterations in taxanes disposition in different ethnic groups may explain this difference. TFINE study was to evaluate the efficacy, safety, and tolerability of Docetaxel in the maintenance setting, and to identify the preferable dose of docetaxel in Asian population. TFINE study demonstrated significant superiority in tolerability and similar efficacy for dose of 60mg/m2 of Docetaxel versus that of 75mg/m2 in first-line Chinese advanced NSCLC patients. And maintenance treatment with docetaxel significantly prolonged PFS compared with BSC. Here we report Overall Survival (OS) data from TFINE (ClinicalTrials.gov NCT01038661).

      Methods
      Previously untreated patients, aged between 18 and 75 years, histologically or cytologically confirmed advanced NSCLC with PS of 0-1 were included. Patients were initially randomized (R1, 1:1) to receive cisplatin (75mg/m2) plus docetaxel of 75 mg/m2 or 60mg/m2 for 4 cycles. Patients with disease control after the initial treatment were subsequently randomized (R2, 1:2) to best supportive care (BSC) or maintenance docetaxel of 60mg/m2 for up to 6 cycles. Genomic DNA was prospectively collected from all enrolled patients. The primary endpoint was PFS since R2, and the secondary endpoints included ORR, overall survival (OS), and toxicity. OS was defined as the time lasting from R2 to death of any cause. The subgroup analysis about OS included gender, historical category, smoking, ECOG PS. The maintenance treatments of every patient were recorded.

      Results
      This randomized study was undertaken in 15 centers in China. Between Dec 2009 and Aug 2011, a total of 382 patients were enrolled to R1 and 179 patients (46.8%) were enrolled to R2 (61 vs. 118). The median follow-up time for OS was 23.5 months (range 20.5, 28.1 months) for patients receiving BSC and 24.4 months (range 22.6, 25.3 months) for patients receiving maintenance docetaxel of 60mg/m2 for up to 6 cycles. Median OS of BSC group (13.7months, [95%CI:12.0, 15.7]) was not significantly different from that of docetaxel group(12.3months,[95%CI:11.2,14.1]) (p=0.77). No difference was found in the subgroup analysis. Post-discontinuation therapy was given at the discretion of the investigator. Numerically more patients in BSC group (n=35, 57.4%) received second-line treatments, including docetaxel, EGFR-TKI or pemetrexed, than those in maintenance group (n=56, 45.5%), although the difference is statistically insignificant (p=0.13). The failure observation of PFS gains translating into OS gains is partially related to post-progression therapy. Preliminary pharmacogenomics analysis demonstrated the CYP3A5*3C(6986 AG/GG) genotype associated with poor PFS and ABCB1:2677 GG genotype demonstrated less neutropenia in Chinese NSCLC patient treated with Docetaxel/DDP regiment, which did not correlated with OS.

      Conclusion
      Although there is no significant benefit in terms of OS with Docetaxel maintenance treatment, our finding for better tolerability suggest that Decetaxel maintenance treatment could be of some benefit to patients with advanced non-small cell lung cancer.