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  • He, Jianbo  (5)
  • Yu, Qitao  (5)
  • 1
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    Online Resource
    Phase 1b/2 study of surufatinib in combination with docetaxel as second-line treatment of advanced driver-gene negative non-squamous non-small cell lung cancer (NSCLC).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e21087-e21087
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e21087-e21087
    Abstract: e21087 Background: Advanced driver-gene negative non-squamous NSCLC has few second-line treatment choices. Surufatinib is a new antiangiogenic drug that potently inhibits VEGFR1，2，3, FGFR1 and CSF-1R. The purpose of this trial was to determine the recommended phase 2 dose of surufatinib in combination with docetaxel through a phase 1b study and to further analyze the preliminary efficacy and safety of the combination therapy in patients with advanced driver-gene negative non-squamous NSCLC. Methods: Advanced driver-gene negative non-squamous NSCLC patients progressed after first-line platinum-based chemotherapy (the combination with immune checkpoint inhibitors and/or bevacizumab was allowed) were enrolled to treat with surufatinib in combination with docetaxel. Using a 3 + 3 study design in the phase 1b dose-escalation portion, patients received surufatinib at doses ranging from 200 mg/day to 300 mg/day for 21 days per cycle. Surufatinib was started at a dose of 250 mg/day and exploratory dose of 300 mg/day if no patients develop dose-limiting toxicity (DLT) in the first 3 patients in the first treatment cycle. If 2 or more of the 3 patients develop DLT, exploratory dose of 200 mg/day. Concomitant treatment with docetaxel at a dose of 60 mg/m 2 . The primary objective of the study was the recommended phase 2 dose of surufatinib in combination with docetaxel. The secondary objective was the preliminary efficacy and safety. Results: At data cut-off (December 31, 2022), we recruited 9 patients in phase 1b portion. Three patients were enrolled in the surufatinib 250 mg/day dose cohort. Among them, 2 developed DLT (1 patient with grade 3 oral mucositis and 1 patient with grade 3 elevated blood bilirubin) which did not recur with a reduction of dosage to 200 mg/day. A total of 6 patients were enrolled in the 200 mg/day dose cohort and 1 patient developed DLT (grade 3 diarrhoea). The recommended phase 2 dose was established as surufatinib 200 mg/day combined with docetaxel 60 mg/m 2 .At present, there were 3 patients enrolled in phase 2. Among the 12 patients enrolled in this study, 1 patient was lost and 11 patients were assessable for treatment efficacy and safty. The objective response rate (ORR) was 27.2% (3/11) and the disease control rate (DCR) was 100%. The median progression free survival (PFS) was 5.8 months (95% CI = 2.1-9.4). The most common treatment-related adverse events (AEs) were diarrhoea (33.3%), neutropenia (41.7%), hypertension (25%), and anaemia (33.3%). Common grade 3 AEs included diarrhoea (16.7%), neutropenia (33.3%) and anaemia (16.7%), with no unexpected treatment-related AEs (TRAEs). Conclusions: Surufatinib in combination with docetaxel was an effective second-line treatment for patients with advanced driver-gene negative non-squamous NSCLC. The clinical benefit was encouraging, and the safety profile was acceptable. Clinical trial information: ChiCTR2100047313 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e21087
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Pd-1/Pd-L1 Inhibitors Plus Anti-Angiogenic Agents with or Without Chemotherapy Versus Pd-1/Pd-L1 Inhibitors Plus Chemotherapy as Second or Later-Line Treatment for Patients with Advanced Non-Small Cell Lung Cancer: A Real-World Retrospective Cohort Study
    Elsevier BV ; 2022
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.4213240
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
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  • 3
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    PD-1/PD-L1 inhibitors plus anti-angiogenic agents with or without chemotherapy versus PD-1/PD-L1 inhibitors plus chemotherapy as second or later-line treatment for patients with advanced non-small cell lung cancer: A real-world retrospective cohort study
    Frontiers Media SA ; 2022
    In:  Frontiers in Immunology Vol. 13 ( 2022-12-7)
    Details
    In: Frontiers in Immunology, Frontiers Media SA, Vol. 13 ( 2022-12-7)
    Abstract: The aim of this study was to assessment the efficacy and safety of Programmed cell death protein 1 (PD-1)/Programmed cell death-Ligand protein 1 (PD-L1) inhibitors plus anti-angiogenic agents with or without chemotherapy versus PD-1/PD-L1 inhibitors plus chemotherapy as second or later-line treatment for patients with advanced non-small cell lung cancer. Methods In this study, pre-treatment clinical and laboratory indicators from 73 patients with advanced non-small cell lung cancer were retrieved for retrospective analysis. According to the therapy regimes they received, the patients were separated into groups, PD-1/PD-L1 inhibitors plus chemotherapy group (PC group), PD-1/PD-L1 inhibitors plus anti-angiogenic agents’ group (PA group), PD-1/PD-L1 inhibitors plus anti-angiogenic agents plus chemotherapy group (PAC group). Cox’s proportional hazards regression model and Kaplan-Meier (KM) curves were used to assess the connection between treatment regimens and progression free survival (PFS) and overall survival (OS). In addition, the association of treatment regimens with the risk of disease progression and death was evaluated by subgroup analysis. Results The average age of the enrolled patients was 58.2 ± 10.2 years and 75.3% were male. Multivariate analyses showed that patients in PA group (Disease progression: HR 0.4, P=0.005. Death: HR 0.4, P=0.024) and PAC group (Disease progression: HR 0.3, P=0.012. Death: HR 0.3, P=0.045) had a statistically significant lower hazard ratio (HR) for disease progression and death compared to patients in PC group. Kaplan-Meier analysis showed that patients in PA group (mPFS:7.5 vs.3.5, P=0.00052. mOS:33.1 vs.21.8, P=0.093) and PAC group (mPFS:5.1 vs.3.5, P=0.075. mOS:37.3 vs.21.8, P=0.14) had a longer PFS and OS compared to patients in PC group. In all the pre-defined subgroups, patients in PA and PAC groups showed a decreasing trend in the risk of disease progression and death in most subgroups. The patients in PA group (DCR:96.3% vs.58.3%, P=0.001) and PAC group (DCR:100% vs.58.3%, P=0.019) had a better disease control rate (DCR) than patients in PC group. Conclusion PD-1/PD-L1 inhibitors plus anti-angiogenic agents with or without chemotherapy were superior to PD-1/PD-L1 inhibitors plus chemotherapy as second or later-line treatment in patients with advanced non-small cell lung cancer.
    Type of Medium: Online Resource
    ISSN: 1664-3224
    URL: Article
    DOI: 10.3389/fimmu.2022.1059995
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2606827-8
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  • 4
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    The efficacy and safety of EGFR-TKI combined with chemotherapy in NSCLC patients with EGFR co-mutation with other oncogenic alterations.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e21077-e21077
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e21077-e21077
    Abstract: e21077 Background: Previous studies indicated primary resistance to EGFR-TKIs might occur in EGFR co-mutation with other oncogenic alterations. However, the optimal therapeutic regimen for advanced NSCLC with EGFR co-mutation was still unknown. This respective observation study aimed to assess the efficacy and safety of the combination therapy with EGFR-TKI and chemotherapy in this sub-population. Methods: In this retrospectively study, from March 2017 to November 2019 advanced NSCLC patients with EGFR mutation detected using next-generation sequencing targeting 59 genes were screened for eligibility. We included patients of EGFR co-mutation with other oncogenic alterations receiving EGFR-TKI monotherapy or TKI plus chemotherapy as first-line therapy. The primary outcome was objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Disease control rate (DCR) and safety profile were considered to be the secondary endpoints. Results: Total 48 patients were enrolled. Among patients with concomitant mutation, the combination of chemotherapy with TKI was found to prolong mPFS (12.5 vs 7.3 months; HR, 0.38; 95%CI: 0.17-0.81; P = 0.012) compared with TKI monotherapy, with a trend of longer mOS (27.0 vs 22.4 months; HR, 0.40; 95%CI: 0.15-1.05; P = 0.062) and higher ORR (68.4% vs 44.8%, P = 0.113). The DCR were 100% in combination group and 93.1% in monotherapy group (P = 0.99). A proportion of 13.8% patients reported grade≥3 treatment-related adverse events in monotherapy group and 36.8% in combination group. Conclusions: EGFR co-mutation with other oncogenic alterations associated with poor treatment outcome with EGFR-TKI monotherapy. The combination of EGFR-TKI and chemotherapy was effective in this sub-population and side-effects were tolerable. The outcomes of this study should be confirmed by prospective clinical trials in future.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e21077
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 5
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    The Effect of PD-1 Inhibitor Combined with Chemotherapy on the Level of Peripheral Blood T Lymphocytes among Patients with Non-Small-Cell Lung Cancer and Its Relationship with Prognosis
    Hindawi Limited ; 2022
    In:  Computational and Mathematical Methods in Medicine Vol. 2022 ( 2022-9-7), p. 1-7
    Details
    In: Computational and Mathematical Methods in Medicine, Hindawi Limited, Vol. 2022 ( 2022-9-7), p. 1-7
    Abstract: Objective. To explore the effect of combined treatment of PD-1 inhibitor and chemotherapy on the level of peripheral blood T lymphocytes in non-small-cell lung cancer (NSCLC) patients and its relationship with prognosis. Methods. Retrospective analysis was conducted on 150 NSCLC patients treated in Guangxi Medical University Affiliated Tumor Hospital from June 2018 to September 2020, including 77 patients treated with PD-1 inhibitor combined with chemotherapy as the observation group (OG) and 73 patients with chemotherapy alone as the control group (CG). Therapeutic efficacy, immune function indexes, serum tumor markers, incidence of adverse reactions during hospitalization, 1-year survival rate, and life quality after 6 months of treatment were observed and compared between two groups. Results. Compared to the CG, the therapeutic effect of OG was evidently better. Six months after treatment, levels of CD4+/CD8+, NK cells, and CD4 + in two groups were elevated markedly, and indexes of OG were notably and comparatively higher than those in the other group. After treatment, OG was observed with a marked decline regarding levels of CYFRA21-1, CEA, and CA125 compared to those in the CG; and there was no notable difference in terms of adverse reaction occurrence between two groups, but the 1-year survival rate and 6-month life quality in OG over ranked those in CG. Conclusion. For NSCLC patients, the PD-1 inhibitor given on the basis of chemotherapy can further improve the clinical efficacy and improve immune function and long-term survival rate of patients on the premise of ensuring the safety of treatment, which is worth promoting in clinical practice.
    Type of Medium: Online Resource
    ISSN: 1748-6718 , 1748-670X
    URL: Article
    DOI: 10.1155/2022/1679191
    Language: English
    Publisher: Hindawi Limited
    Publication Date: 2022
    detail.hit.zdb_id: 2256917-0
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