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  • American Society of Clinical Oncology (ASCO)  (7)
  • 1
    Online Resource
    Online Resource
    A phase II trial of older adults with metastatic breast cancer (MBC) receiving nab-paclitaxel: Melding the fields of geriatrics and oncology.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. 10035-10035
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 10035-10035
    Abstract: 10035 Background: The Institute of Medicine and ASCO identified key research priorities to improve the evidence base of older adults with cancer, including the need for therapeutic phase II trials. Here we present a phase II study of nab-paclitaxel in older patients (pts) with MBC, incorporating geriatric oncology principles in the study design. Methods: Pts age ≥65 years with MBC and 0-1 chemotherapy (CT) lines received nab-paclitaxel (100 mg/m 2 , 3 wks on, 1 wk off). Pts completed a geriatric assessment (GA) pre-CT including measures of function, comorbidity, cognition, nutrition, and psychosocial status. A CT toxicity (tox) risk score was calculated for each pt (Hurria et al. JCO 2011 and 2016). Relationships between tolerability (no. courses, hospitalizations, dose reductions, and grade (G) ≥3 tox attributed to CT) and risk score were assessed using generalized linear models, Student’s t tests, and Fisher’s exact test. Response rate (RR) and progression free survival (PFS) were evaluated. Results: 40 pts (mean age 73 [65-87]) were accrued from 06/12 to 01/16. Median no. of cycles was 6 [0-33] , RR was 35% (95% CI 21-52%) and PFS was 6.5 months (95% CI 5.5-NR). 58% (n = 23) of pts had G ≥ 3 tox and 30% (n = 12) were hospitalized due to CT. G 2/3 neuropathy and G 3/4 neutropenia occurred in 10% of pts (n = 4), with no cases of febrile neutropenia. Based on the CT tox risk score, 53% (n = 21), 38% (n = 15), and 10% (n = 4) were low, intermediate, and high risk. As a continuous variable, doubling in the risk score was associated with a reduction in courses completed of 4.5 (se = 1.4, p = 0.003). Lower mean log 2 risk scores were found in pts that did not require hospitalization (diff = -0.59, 95% CI -1.00, -0.18; p = 0.007), or did not have a dose reduction (diff = -0.46, 95% CI -0.85, -0.06; p = 0.02). G ≥ 3 tox was found in 38% of low, 73% of intermediate and 100% of high risk pts, with combined intermediate/high risk pts experiencing significantly more G ≥ 3 tox (OR 5.8, 95% CI 1.3-33.1; p = 0.01). Conclusions: This phase II trial of older pts with MBC receiving nab-paclitaxel incorporated geriatric principles in an oncology trial. Incorporating the GA and CT tox risk score can help weigh the risks and benefits of therapy in older adults. Clinical trial information: NCT01463072.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.10035
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  JCO Oncology Practice Vol. 19, No. 10 ( 2023-10), p. 907-916
    Details
    In: JCO Oncology Practice, American Society of Clinical Oncology (ASCO), Vol. 19, No. 10 ( 2023-10), p. 907-916
    Abstract: The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity. CONCLUSION Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.
    Type of Medium: Online Resource
    ISSN: 2688-1527 , 2688-1535
    URL: Article
    DOI: 10.1200/OP.23.00185
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 3005549-0
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  • 3
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    Online Resource
    Establishing analytical and clinical similarity between HD201 and herceptin.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 579-579
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 579-579
    Abstract: 579 Background: Trastuzumab, an approved prescription drug by EMA and FDA under the name Herceptin has become the key treatment in patients with HER2 − positive breast cancer. HD201, developed by Prestige Biopharma Pte Ltd is a biosimilar candidate to Herceptin. The biosimilarity of HD201 was established based on systematic stepwise comparisons between HD201 and reference product, Herceptin. In order to confirm clinical similarity of HD201 to Trastuzumab, two clinical studies were undertaken. Methods: First, in a double-blind, randomised and parallel group study, 101 randomised healthy human subjects were subjected to a single 6 mg/kg IV dose by body weight over 90-min infusion of either HD201, EU- and US-Herceptin group by assessing pharmacokinetic (PK) and safety (TROIKA-I). The second study was a randomised, double-blind, parallel group, equivalence, multicentre clinical phase III trial (TROIKA) designed to compare the efficacy based on total pathological complete response rate (tpCR), safety, and pharmacokinetics of HD201 to EU-Herceptin in patients with HER2 positive early breast cancer. Each group of ~250 subjects were administered with either HD201 or EU-Herceptin in combination with chemotherapy in neoadjuvant followed by the antibody alone in the adjuvant phase. Results: TROIKA-I study demonstrated that HD201 was safe and well tolerated with comparable PK as EU- and US-Herceptin. Based on the neoadjuvant data from TROIKA study, the tpCR rate in the HD201 and Herceptin treatment groups was comparable and the 95% CI was included within the pre-defined margins of equivalence (Table). The incidence and severity of reported TEAEs did not imply any significant safety concerns and were comparable between both groups. In addition, the comparison of steady-state C trough between both arms in TROIKA study has established equivalence. Conclusions: The overall comparison exercise demonstrated the equivalence of HD201 to Herceptin. Clinical trial information: 2016-0040019-11 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.579
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Pilot Trial of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Gefitinib Plus Carboplatin and Paclitaxel in Patients With Stage IIIB or IV Non–Small-Cell Lung Cancer
    American Society of Clinical Oncology (ASCO) ; 2003
    In:  Journal of Clinical Oncology Vol. 21, No. 11 ( 2003-06-01), p. 2094-2100
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 21, No. 11 ( 2003-06-01), p. 2094-2100
    Abstract: Purpose: Gefitinib is an oral agent that inhibits the tyrosine kinase of the epidermal growth factor receptor. In phase I trials gefitinib was well tolerated and antitumor activity was seen in pretreated non–small-cell lung cancer (NSCLC) patients. Preclinical studies indicated enhanced effects when gefitnib was added to carboplatin or paclitaxel. This pilot trial combined gefitinib with carboplatin and paclitaxel to define the toxicities of the combination and assess drug-drug interactions in untreated advanced NSCLC patients. Patients and Methods: Initially (part 1) patients were randomly assigned to receive intermittent gefitinib with cycle 1 or 2 of chemotherapy. Thereafter (part 2), the highest dose of gefitinib that was given without dose-limiting toxicity (DLT) from part 1 was administered continuously beginning with the first cycle of chemotherapy. Three sequentially enrolled cohorts received gefitinib 250 and 500 mg (intermittently) and 500 mg (continuously). Results: We treated 24 patients; nine patients with 250 mg and 15 patients with 500 mg (nine patients continuous). Two occurrences of DLT were observed. One patient (500 mg, part 1) developed grade 3 rash and another patient (part 2) developed prolonged neutropenia. Steady-state gefitinib levels did not affect exposure to chemotherapy. In a limited sample, chemotherapy modestly increased the gefitinib area under concentration-time curve at steady-state and minimum steady-state trough concentration. Partial responses were observed in five of 24 patients. The median survival was 8 months. Conclusion: The gefitinib with carboplatin and paclitaxel regimen was generally well tolerated and no unanticipated toxicities or clinically relevant pharmacokinetic interactions were observed. Both doses of gefitinib were believed to be safe for further study with chemotherapy. This regimen was thus tested in a completed randomized phase III trial.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2003.12.008
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2003
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    HD204: Analytical biocomparability and clinical trial I progression of bevacizumab.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e15014-e15014
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15014-e15014
    Abstract: e15014 Background: Prestige Biopharma Pte Ltd is developing HD204, a biosimilar of the EU-approved and US-licensed Bevacizumab (Avastin) that is approved treatment for a variety of tumour types. Bevacizumab is a recombinant humanized monoclonal antibody (IgG1) that binds to soluble vascular endothelial growth factor (VEGF), thus prevent interaction with VEGF receptors. Due to heterogeneity nature of antibody drug, extensive characterization of antibody from physicochemical and biological properties using multiple bioanalytical assays is required. The development of HD204 from analytical biocomparability to clinical trial I are demonstrated. Methods: Analytical biocomparability in physiocochemical and biological properties of HD204 was compared to Avastin sourced from EU and US using multiple bioanalytical assays as below. Clinical phase I (SAMSON), a randomized, double-blind, single dose and 3-way parallel group was initiated recently to compare pharmacokinetic and to evaluate the safety, tolerability and immunogenicity of HD204, EU-Avastin and US-Avastin. Approximately 120 healthy human subjects (assigned to 3 treatment group) was administered with a single intravenous infusion of 1 mg/kg of either HD204, EU- and US-Avastin. Results: HD204 shows equivalent in physicochemical and biological properties compared to EU- and US-Herceptin. For phase I study, patient recruitment was completed with treatment for come patients initiated but still ongoing. Conclusions: HD204 was shown to be equivalent in all parameters in the analytical biocomparability testing. Clinical Phase 1 trial (SAMSON) is ongoing on and key data from SAMSON trial will be reported in ASCO meeting. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e15014
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    HER2 testing in breast cancer by quantitative PCR: technical and clinical considerations.
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 15_suppl ( 2015-05-20), p. e11619-e11619
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. e11619-e11619
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.15_suppl.e11619
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    HD201: Analytical biocomparability and clinical trial progression of trastuzumab.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e12505-e12505
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e12505-e12505
    Abstract: e12505 Background: Trastuzumab, an approved prescription drug by EMA and FDA under the name Herceptin has become the key treatment in patients with HER2 positive breast cancer. HD201, developed and owned by Prestige Biopharma Pte Ltd is a biosimilar product to Herceptin (Trastuzumab). The development of HD201 from analytical biocomparability to clinical trial progression are demonstrated. Methods: Analytical biocomparability in terms of physicochemical (primary, higher order structure, glycan profiles, molecular and charge variants) and biological properties (inclusive of binding to Fcγ receptors and neonatal receptor) between HD201 and EU and US-Herceptin were compared. The first human study of HD201 (clinical phase I) was designed to assess the pharmacokinetic (PK) equivalence between HD201 and EU-Herceptin. In this randomised, blinded, single-dose comparative PK study, randomised healthy human subjects were subjected to a single 6 mg/kg IV dose of HD201 and EU-Herceptin following by PK and safety evaluations. Following this, a randomised, double-blind, parallel group, equivalence, multicentre clinical phase III trial (TROIKA) was designed to compare the efficacy, safety, and pharmacokinetics of HD201 to EU-Herceptin in 500 patients with HER2+ early breast cancer. Each group of patients (250 patients) were administered with either HD201 or EU-Herceptin once every 3 weeks up to 8 cycles in combination of a neoadjuvant chemotherapy comprising of docetazel followed by an anthracycline-containing regimen. Results: HD201 shows equivalent in physicochemical and biological properties compared to EU- and US-Herceptin. Clinical phase I study demonstrated that HD201 is safe and well tolerated with comparable PK profiles as EU-Herceptin after single dose administration to healthy male adults (Pivot et al., 2018). Analysis of sub study from clinical phase III has demonstrated comparable results with EU- Herceptin in terms of patient demographic, clinical response, safety and pharmacokinetic profile. Conclusions: HD201 is demonstrated to be equivalent in analytical biocomparability and in clinical response, safety and PK profile to Herceptin in human study. Additional data for Pharmacokinetic from Troika trial will be reported in Asco meeting. Clinical trial information: 2012-000805-56.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e12505
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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