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Zhiyong Ma



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    JCSE01 - Perspectives for Lung Cancer Early Detection (ID 779)

    • Event: WCLC 2018
    • Type: Joint IASLC/CSCO/CAALC Session
    • Track: Screening and Early Detection
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/23/2018, 07:30 - 11:15, Room 202 BD
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      JCSE01.22a - Tislelizumab Combined With Chemotherapy as First-Line Treatment in Chinese Patients With Advanced Lung Cancer (ID 14702)

      11:15 - 11:15  |  Author(s): Zhiyong Ma

      • Abstract

      Abstract not provided

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    MA02 - Improving Outcomes for Patients with Lung Cancer (ID 895)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 201 BD
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      MA02.06 - A Randomized, Double-Blind, Placebo-Controlled Trial of Chemotherapy Combined with Yangzheng Xiaoji in Advanced NSCLC (Now Available) (ID 13562)

      11:05 - 11:10  |  Author(s): Zhiyong Ma

      • Abstract
      • Presentation
      • Slides

      Background

      Yangzheng Xiaoji (YZXJ) is a Chinese medicine formulation made of 16 herbs and used in patients with solid cancers. The aim of this randomized, double-blind and placebo-controlled multi-center trial (YANG-1,ClinicalTrials.gov registration No. NCT02195453) is to evaluate the impact of Yangzheng Xiaoji capsule on the quality of life (QoL) and treatment-related side effects in patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with advanced NSCLC and with Eastern Cooperative Oncology Group performance status 0 to 1, who receive first-line chemotherapy (gemcitabine or pemetrexed and cisplatin), were randomized (1:1) to Yangzheng Xiaoji (YZXJ) or placebo combined with chemotherapy. The primary endpoint was QoL (Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale (LCSS)) after two or four cycles of chemotherapy. The second endpoints included overall response rate, progression free survival and toxicity.

      4c3880bb027f159e801041b1021e88e8 Result

      Between 10/2014 and 4/2017, the trial enrolled and randomized 504 patients from 25 centers in China. 397 patients received at least two cycles of chemotherapy and were included for final analysis. Baseline characteristics, including FACT-L and LCSS scores, were well balanced between two groups. The mean FACT-L scores were significantly changed in both groups from the baseline to that after chemotherapy (97.58 increase to 100.89 in YZXJ/chemotherapy arm, P<0.001; 93.83 decrease to 97.93 in placebo arm, P<0.001). The mean score of LCSS from baseline was significantly changed in YZXJ/chemotherapy groups(25.84 decrease to 22.31, P<0.001), but there was no statistical difference in the placebo group(25.59 vs. 26.45, P=0.136). The YZXJ/chemotherapy arm had a better QoL than the placebo/chemotherapy arm (FACT-L, 3.30 vs. -4.09; P<0.001) as well as improved lung cancer symptoms compared with placebo (LCSS, -3.53 vs. -0.86; P<0.001). There was no statistical difference in chemotherapy completion rate, ORR and PFS between two groups. The most common adverse events were bone marrow toxicity (70.92% vs. 67.59%) and gastrointestinal reaction (34.66% vs. 63.24%) (YZXJ vs. Placebo, P=0.441 and P<0.001, respectively). The rate of fatigue was significantly lower in YZXJ group than placebo group (4.38% vs. 30.04%, P<0.001).

      8eea62084ca7e541d918e823422bd82e Conclusion

      For patients with advanced NSCLC who received platinum-based chemotherapy, Yangzheng Xiaoji Capsule significantly improved the quality of life and symptoms, especially fatigue and gastrointestinal reaction.

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    P1.04 - Immunooncology (Not CME Accredited Session) (ID 936)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.04-36 - Tislelizumab Combined With Chemotherapy as First-Line Treatment in Chinese Patients With Advanced Lung Cancer (ID 12092)

      16:45 - 18:00  |  Author(s): Zhiyong Ma

      • Abstract
      • Slides

      Background

      Immune checkpoint inhibitors have shown efficacy in patients with NSCLC as monotherapy and in combination with chemotherapy. Tislelizumab is a humanized IgG4 monoclonal antibody to PD‑1 specifically engineered to minimize FcϒR binding on macrophages, possibly minimizing negative interactions with other immune cells. In a phase 1 study, tislelizumab was generally well tolerated and showed antitumor activity; 200mg IV Q3W was established as the recommended dose.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This multi-arm phase 2 study, consisting of safety run-in and dose-extension phases, assessed tislelizumab in combination with platinum-based chemotherapy (by tumor histology) as a potential first-line treatment for Chinese patients with lung cancer. All patients received tislelizumab at 200mg Q3W in combination with 4–6 cycles of platinum-doublet until disease progression. Nonsquamous (nsq) NSCLC patients received pemetrexed + platinum Q3W for 4 cycles followed by pemetrexed maintenance, while squamous (sq) NSCLC patients received paclitaxel + platinum (A) or gemcitabine + platinum (B) Q3W, and small-cell lung cancer (SCLC) patients received etoposide + platinum Q3W. Tumor response (RECIST v1.1) and safety/tolerability were evaluated.

      4c3880bb027f159e801041b1021e88e8 Result

      As of 21 Feb 2018, 48 patients (median age, 62 years [range: 36–75], 71% male, 71% current/former smokers) received tislelizumab treatment (median, 3 cycles [range: 1–7]); 44 patients remain on the study. Across the four cohorts, confirmed and unconfirmed partial responses were observed in 13 and 9 patients, respectively (Table). The most frequent AEs were chemotherapy-related hematologic toxicities. The most commonly reported grade ≥3 treatment-related AEs were neutropenia (20.8%) and anemia (12.5%); the most common grade 3 immune-related AEs were pyrexia (6.3%) and rash (6.3%). One sq‑NSCLC patient experienced a fatal myocarditis/myositis following one cycle of paclitaxel/cisplatin; all other treatment-related AEs were managed/resolved by study-drug interruption (n=15) or discontinuation (n=4) and appropriate treatment.

      Best Overall Response (Patients With ≥1 Post-Baseline Tumor Assessment)

      nsq-NSCLC (n=9)

      sq-NSCLC [A] (n=12 )

      sq-NSCLC [B] (n=5 )

      SCLC (n=8)

      Total

      (N=34)

      PR

      4 (44.4)

      9 (75)

      4 (80)

      5 (62.5)

      22 (64.7)

      Confirmed PR

      1 (11.1)

      4 (33.3)

      4 (80)

      4 (50)

      13 (38.2)

      Unconfirmed PR

      3 (33.3)

      5 (41.7)

      0 (0)

      1 (12.5)

      9 (26.5)

      SD

      3 (33.3)

      2 (16.7)

      1 (20)

      2 (25)

      8 (23.5)

      PD

      1 (11.1)

      0 (0)

      0 (0)

      1 (12.5)

      2 (5.9)

      NE

      1 (11.1)

      1 (8.3)

      0 (0)

      0 (0)

      2 (5.9)

      Data presented as n (%).

      Abbreviations: nsq-NSCLC, non-squamous non-small cell lung cancer; NE, not evaluable; PD, progressive disease; PR, partial response; SCLC, small cell lung cancer; SD, stable disease; sq-NSCLC, squamous non-small cell lung cancer.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Tislelizumab, in combination with platinum doublets, demonstrated preliminary antitumor activity and was generally well tolerated in patients with advanced lung cancer.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.05 - Interventional Diagnostics/Pulmonology (Not CME Accredited Session) (ID 937)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.05-24 - Clinical Characteristics and Prognostic Analysis of Multiple Primary Malignant<br /> Neoplasms in Patients with Lung Cancer (Now Available) (ID 12840)

      16:45 - 18:00  |  Author(s): Zhiyong Ma

      • Abstract
      • Slides

      Background

      To investigate the clinical characteristics, survival status and prognostic factors of multiple primary malignant neoplasm (MPMN) patients with lung cancer.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The clinical and pathological data of 14,528 lung cancer patients who were diagnosed and treated in the affiliated cancer hospital of Zhengzhou University from January 2008 to August 2015 were retrospectively analyzed.

      4c3880bb027f159e801041b1021e88e8 Result

      Of the total lung cancer patients, 2.5% (364/14,528) were MPMN cases and 3.6% (13/364) were diagnosed with 3 primary malignancies, 0.3% (1/364) with 4 primary malignancies and 96.2% (350/364) with 2 primary malignancies. Among the
      350 lung cancer patients diagnosed with 2 primary malignancies, 26.6% (93/350) had lung cancer diagnosed first (LCF) and 73.4% (257/350) had other cancers diagnosed initially (OCF), whereas synchronous MPMN (SMPMN) accounted for 21.1% (74/350) and metachronous MPMN (MMPMN) accounted for 78.9% (276/350) of cases.Detection of first primary neoplasms were at an early stage for LCF patients and the age of the first lung cancer diagnosis was 59.3 years vs 55.4 years in the OCF group (P = 0.008), whereas the onset age of second primary neoplasm diagnosis was similar in both groups (62.5 and 61.6 years, P = 0.544). The median survival times of the OCF and LCF groups were 86 months vs 58 months (P < 0.001). The median survival times of MMPMN and SMPMN patients were 94 months vs 27 months (P < 0.001).Multivariate analysis showed that SMPMN, LCF and the age of the primary cancer diagnosed first (≥ 60 years) were independent factors for inferior prognosis of patients.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Though LCF was diagnosed in earlier stages than OCF, the survival rate was inferior and the time until the development of the second primary malignancy was shorter than in the OCF group. SMPMN patients had a worse prognosis than MMPMN
      patients in both the LCF and OCF groups. Also ≥ 60 years of age at the time of the primary cancer diagnosis was an independent factor for inferior prognosis in all patients.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.13 - Targeted Therapy (Not CME Accredited Session) (ID 979)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.13-24 - <sub>Efficacy of EGFR-TKIs Compared with Chemotherapy as First-Line Therapy in Patients with EGFR Rare Mutation Advanced Lung Adenocarcinoma </sub> (Now Available) (ID 12903)

      12:00 - 13:30  |  Author(s): Zhiyong Ma

      • Abstract
      • Slides

      Background

      Clinical activity of epithelial growth factor receptor tyrosine kinase inhibitors or platinum-based chemotherapy as firstline therapy in patients with EGFR rare mutation advanced lung adenocarcinoma remains unknown, This retrospective study assesses the activity and long-term survival of the two treatment regimens.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      3856 patients diagnosed with lung adenocarcinoma from Henan Cancer Hospital received EGFR gene detection during January 2, 2012 to November 1, 2017. 1643 patients with EGFR mutation and phase IIIB/IV were identifed. Among them, 130 cases (7.9%) with EGFR rare mutations, excluded 64 patients(4 cases of patients coexist with uncommon mutations and common mutations, 17 cases of insertions in exon 20, 42 cases of T790m and T790m complex mutations, and 1 loss of follow-up), 66 cases of EGFR uncommon mutations(G719X, L861Q, S768I and compound mutations)enrolled in the evaluation of efficacy, of whom 34 patients received EGFR-TKIs alone and 32 patients received platinum-based chemotherapy as frstline therapy. All EGFR-TKIs were first-generation drugs, details were gefitinib (250 mg/day), erlotinib (150 mg/day) and eclectinib (125 mg tid/day), all patients received at least 4 weeks of EGFR-TKIs. All chemotherapy drugs were third-generation in combination with platinum, details were pemetrexed (500 mg/m2), vinorelbine (25 mg/m2 d1, 8), or gemcitabine (1000 mg/m2 d 1, 8) platinum-based chemotherapy, every 3 weeks as a treatment cycle.

      4c3880bb027f159e801041b1021e88e8 Result

      Regardless of whether EGFR-TKIs or chemotherapy, the objective response rate (ORR: 28.6% vs 36% P>0.05) and disease control rate (DCR: 82.1% vs 84% P>0.05) were similar. EGFR-TKIs showed superior progression-free survival than chemotherapy group (7.1 vs 4.9 mts; HR=0.717, P=0.166), but there was not statistically difference. However, compared with chemotherapy, we found that overall survival (OS: 14.6 vs 20.3 mts; HR=1.879, P=0.019) was significantly lower in patients with EGFR-TKIs, which was statistically significant. In multivariate analysis, first-line use of targeted therapy (HR = 0.447 P = 0.006) and smoking history (HR = 3.824 P = 0.003) were found to be a signifcant independent prognostic factor for OS in lung adenocarcinoma patients with EGFR uncommon mutation.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Compared with chemotherapy, first-line use of the first generation of EGFR-TKIs can improve the short-term efficacy of patients with EGFR rare mutation advanced lung adenocarcinoma, but longer survival in patients with first-line platinum-based chemotherapy.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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