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  • Tang, Pingzhang  (4)
  • Medicine  (4)
  • 1
    Online Resource
    Online Resource
    Association between calcitonin and efficacy of anlotinib in medullary thyroid carcinoma: An analysis based on the ALTER01031 trial.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 6526-6526
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 6526-6526
    Abstract: 6526 Background: Calcitonin (Ct) is the most important biomarker for medullary thyroid carcinoma (MTC). In a randomized, placebo-controlled phase IIb trial (ALTER01031, NCT02586350) for MTC, anlotinib exhibited a strong capability not only in PFS prolongation but also in decreasing Ct level. This subanalysis explored the relationship between Ct level and anlotinib efficacy in this trial. Methods: Serum Ct of patients (pts) were tested at baseline and on week 6 (after 2 treatment cycles). Correlation between changes in Ct level and changes in target lesion diameters was explored. The influence of baseline Ct level on median PFS for anlotinib treated pts was estimated. Finally, pts in anlotinib arm were divided into two subgroups based on the percentage decline of Ct levels ( 〉 50% vs. ≤50%) at week 6. Median PFS (mPFS), median OS (mOS) and objective response rate (ORR) of two groups were compared. Results: 86 of 91 enrolled pts (58 in anlotinib arm and 28 in placebo arm) were recorded their serum Ct levels at baseline and no significant difference was observed between two arms (7990.0 ng/L vs. 10891.5 ng/L, P = 0.192). After 2 treatment cycles, the Ct level decreased to 4597.5 ng/L in anlotinib arm (n = 50) while increased slightly in placebo arm (12640.0 ng/L, n = 24, P = 0.006). For 49 pts in anlotinib arm who had complete assessments at baseline and week 6, roughly linear relationship was observed between Ct levels (X-axis) and target lesion diameters (Y-axis) in percent changes from baseline to week 6 (y = 0.175x – 0.049; r = 0.352, P = 0.016, excluding 3 outliers). Pts with less baseline Ct level (≤ median value vs. 〉 median value) did not show more PFS benefit (17.7 vs. 22.4 months, P = 0.802). However, after 2 treatment cycles, a trend of better survival and higher response was observed in pts with high percentage decline of Ct level ( 〉 50%, n = 25) than those with low percentage decline (≤50%, n =25) although without statistical difference (data presented in the table below). Conclusions: In ALTER01031, anlotinib showed a strong capability in rapidly decreasing serum Ct. Lower baseline Ct level does not mean better prognosis while a rapid Ct decrease may predict improved survival and treatment response to MTC pts received anlotinib. Clinical trial information: NCT02586350 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.6526
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Exploration of associations between adverse drug reactions and clinical outcomes in anlotinib treatment against medullary thyroid carcinoma (MTC): A subgroup analysis based on the ALTER01031 trial.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e18518-e18518
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e18518-e18518
    Abstract: e18518 Background: Anlotinib demonstrated favorable efficacy in a randomized, placebo-controlled phase 2b trial (ALTER01031, NCT02586350) for MTC which was published in 2019 ASCO annual meeting. Similar with other anti-angiogenesis drugs, hand-foot syndrome (HFS), hypertension and proteinuria were the major adverse drug reactions (ADRs) observed in this trial. We explored the association between common ADRs and the clinical outcomes with anlotinib in this subanalysis. Methods: Patients in the anlotinib group of ALTER01031 were divided into different groups according to the development of ADRs including HFS, hypertension or proteinuria. Kaplan-Meier method was used to estimate median PFS (mPFS) for patients in different groups. The mPFS for patients with or without dose reduction were also evaluated. Results: A total of 62 patients received anlotinib in ALTER 01031. HFS of any grade was observed in 39 patients with a mPFS of 28.5 months, which was longer than in those without HFS (14.0 months, P = 0.079). The hazard ratio for progression was 0.540 (95% CI 0.252, 1.158) although statistical difference was not reached. Similarly, more survival benefit was also observed in 29 and 38 patients who experienced hypertension and proteinuria, with mPFS of 28.5 months and 22.4 months respectively. While the mPFS for patients without corresponding ADRs were only 17.0 months (HR = 0.648 [95% CI 0.320, 1.314], P = 0.237) and 14.0 months (HR = 0.738 [95% CI 0.331, 1.65] , P = 0.421). Median PFS had not been reached in 20 patients with dose reduction while was recorded as 17.0 months in those without (HR = 0.707 [95% CI 0.335, 1.496], P = 0.392). Conclusions: This analysis indicated a trend of greater PFS benefit for MTC patients treated with anlotinib who experienced HFS, hypertension or proteinuria although no statistical differences were observed. A possible positive association was also observed between dose reductions and better clinical outcomes. Clinical trial information: NCT02586350.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e18518
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Influence of Eastern Cooperative Oncology Group performance status (ECOG PS), tumor size and age on patient outcomes after anlotinib treatment: A subgroup analysis based on ALTER01031 trial for medullary thyroid carcinoma (MTC).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 6527-6527
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 6527-6527
    Abstract: 6527 Background: Anlotinib is a newly developed TKI achieved a nearly 2-fold PFS prolongation in a randomized, placebo-controlled phase 2b trial (NCT02586350) for MTC, the results of which were firstly published in 2019 ASCO annual meeting. This subanalysis examined the influence of baseline demographic (ECOG PS score, age) and tumor size on efficacy in this study. Methods: Kaplan-Meier method was applied to estimate the median PFS (mPFS) for subgroups of patients (pts) received anlotinib or placebo based on ECOG PS score (0 vs. 1), median tumor lesion diameter ( 〈 67 vs. ≥67mm) and age ( 〈 55 vs. ≥55 years old). Results: 91 eligible pts were randomly assigned in a 2:1 ratio to receive anlotinib or placebo. The numbers of pts in each subgroup were summarized in the table below. In placebo arm, mPFS did not differ significantly between pts with ECOG PS 0 and 1 (11.3 vs. 11.1months; HR = 0.895 [95% CI 0.347, 2.312], P = 0.821) or between pts with tumor lesion diameter 〈 67mm and ≥ 67mm (7.0 vs. 11.1 months; HR = 1.168 [95% CI 0.463, 2.945], P = 0.737). Conversely, pts in anlotinib arm with ECOG PS 0 obtained more PFS benefits (34.6 vs. 14.0 months; HR = 0.331 [95% CI 0.163, 0.671] , P = 0.002). Similarly, anlotinib treated pts with tumor lesion diameters 〈 67mm achieved a longer mPFS (Not reached vs. 14.0 months, HR = 0.567 [95% CI 0.280, 1.147], P = 0.111). Consistent with that has been verified in differentiated thyroid cancer, high age predicted poor prognosis as mPFS were 14.3 months and 6.8 months in pts 〈 55 and ≥ 55 years old respectively in placebo arm (HR = 0.322 [95% CI 0.116, 0.893], P = 0.007).). Anlotinib treatment exhibited PFS improvement to pts in both age groups but higher PFS prolongation was observed in pts 〈 55 years old (22.4 vs. 14.0 months; HR = 0.720 [95% CI 0.321, 1.614], P = 0.381). Conclusions: This analysis showed that for pts in placebo arm, PFS was similar regardless of functional status (ECOG PS) or tumor size while older pts had higher progression risk. Treatment with anlotinib exhibited greater PFS benefits for pts with better functional status (ECOG PS = 0), younger age or lower tumor burden. These results indicated that it is reasonable to start anlotinib treatment at a relative earlier disease stage before the worsen of ECOG PS, increase of tumor size or ageing. Clinical trial information: NCT02586350 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.6527
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial
    American Association for Cancer Research (AACR) ; 2021
    In:  Clinical Cancer Research Vol. 27, No. 13 ( 2021-07-01), p. 3567-3575
    Details
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 27, No. 13 ( 2021-07-01), p. 3567-3575
    Abstract: Medullary thyroid cancer (MTC) accounts for about 2% of all thyroid cancer, but has a relatively poor prognosis compared with differentiated thyroid cancer. Anlotinib is a novel multitarget tyrosine kinase inhibitor targeting VEGFR, PDGFR, FGFR, and c-Kit. This multicenter, randomized, double-blind, placebo-controlled phase IIB study (ALTER 01031 and NCT02586350) was conducted to investigate the efficacy and safety of anlotinib in MTC. Patients and Methods: Patients with histopathologically confirmed, unresectable locally advanced or metastatic MTC were enrolled and randomly assigned in a 2:1 ratio to receive anlotinib (12 mg once daily from day 1 to 14 every 3 weeks) or placebo. Patients in placebo group were allowed to receive open-label anlotinib after disease progression. The primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Results: Ninety-one patients were enrolled. At data cutoff date, the median PFS was significantly prolonged in the anlotinib group than in the placebo group (20.7 months vs. 11.1 months, P = 0.029; HR, 0.53; 95% confidence interval, 0.30–0.95). The ORR of anlotinib treatment was 48.4%. The incidence of treatment-related adverse events (TRAE) was 100% and 89.7% in the anlotinib and placebo groups, respectively. The most common TRAEs of all grades in the anlotinib group were palmar–plantar erythrodysesthesia syndrome (62.9%), proteinuria (61.3%), and hypertriglyceridemia (48.4%). Conclusions: Anlotinib demonstrates its efficacy and safety in this phase IIB trial for the treatment of MTC and may become a new choice for this rare disease, especially for Chinese patients.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    URL: Article
    DOI: 10.1158/1078-0432.CCR-20-2950
    RVK:
    XA 36791
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
    detail.hit.zdb_id: 1225457-5
    detail.hit.zdb_id: 2036787-9
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