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  • 1
    Online Resource
    Online Resource
    Single agent activity of ZW25, a HER2-targeted bispecific antibody, in heavily pretreated HER2-expressing cancers.
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 15_suppl ( 2018-05-20), p. 2500-2500
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. 2500-2500
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.15_suppl.2500
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Ground ice at the Phoenix Landing Site: Stability state and origin
    American Geophysical Union (AGU) ; 2009
    In:  Journal of Geophysical Research Vol. 114 ( 2009-12-17)
    Details
    In: Journal of Geophysical Research, American Geophysical Union (AGU), Vol. 114 ( 2009-12-17)
    Type of Medium: Online Resource
    ISSN: 0148-0227
    URL: Article
    DOI: 10.1029/2009JE003417
    Language: English
    Publisher: American Geophysical Union (AGU)
    Publication Date: 2009
    detail.hit.zdb_id: 2033040-6
    detail.hit.zdb_id: 3094104-0
    detail.hit.zdb_id: 2130824-X
    detail.hit.zdb_id: 2016813-5
    detail.hit.zdb_id: 2016810-X
    detail.hit.zdb_id: 2403298-0
    detail.hit.zdb_id: 2016800-7
    detail.hit.zdb_id: 161666-3
    detail.hit.zdb_id: 161667-5
    detail.hit.zdb_id: 2969341-X
    detail.hit.zdb_id: 161665-1
    detail.hit.zdb_id: 3094268-8
    detail.hit.zdb_id: 710256-2
    detail.hit.zdb_id: 2016804-4
    detail.hit.zdb_id: 3094181-7
    detail.hit.zdb_id: 3094219-6
    detail.hit.zdb_id: 3094167-2
    detail.hit.zdb_id: 2220777-6
    detail.hit.zdb_id: 3094197-0
    SSG: 16,13
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Maternal and postnatal high-fat diet consumption programs energy balance and hypothalamic melanocortin signaling in nonhuman primate offspring
    American Physiological Society ; 2017
    In:  American Journal of Physiology-Regulatory, Integrative and Comparative Physiology Vol. 313, No. 2 ( 2017-08-01), p. R169-R179
    Details
    In: American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, American Physiological Society, Vol. 313, No. 2 ( 2017-08-01), p. R169-R179
    Abstract: Maternal high-fat-diet (HFD) consumption during pregnancy decreased fetal body weight and impacted development of hypothalamic melanocortin neural circuitry in nonhuman primate offspring. We investigated whether these impairments during gestation persisted in juvenile offspring and examined the interaction between maternal and early postnatal HFD consumption. Adult dams consumed either a control diet (CTR; 15% calories from fat) or a high-saturated-fat diet (HFD; 37% calories from fat) during pregnancy. Offspring were weaned onto a CTR or HFD at ~8 mo of age. Offspring from HFD-fed dams displayed early catch-up growth and elevated body weight at 6 and 13 mo of age. Maternal and postnatal HFD exposure reduced the amount of agouti-related peptide fibers in the paraventricular nucleus of the hypothalamus. Postnatal HFD consumption also decreased the amount of agouti-related peptide fibers in the arcuate nucleus of the hypothalamus. Postnatal HFD was associated with decreased food intake and increased activity. These results support and extend our previous findings of maternal diet effects on fetal development and reveal, for the first time in a nonhuman primate model, that maternal HFD-induced disturbances in offspring body weight regulation extended past gestation into the juvenile period. Maternal HFD consumption increases the risk for offspring developing obesity, with the developmental timing of HFD exposure differentially impacting the melanocortin system and energy balance regulation. The present findings provide translational insight into human clinical populations, suggesting that profound health consequences may await individuals later in life following intrauterine and postnatal HFD exposure.
    Type of Medium: Online Resource
    ISSN: 0363-6119 , 1522-1490
    URL: Article
    DOI: 10.1152/ajpregu.00309.2016
    Language: English
    Publisher: American Physiological Society
    Publication Date: 2017
    detail.hit.zdb_id: 1477297-8
    SSG: 12
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    table_1.docx
    Frontiers Media SA ; 2018
    In:  Frontiers in Endocrinology Vol. 9 ( 2018-4-23)
    Details
    In: Frontiers in Endocrinology, Frontiers Media SA, Vol. 9 ( 2018-4-23)
    Type of Medium: Online Resource
    ISSN: 1664-2392
    URL: Article
    URL: Article
    DOI: 10.3389/fendo.2018.00161
    DOI: 10.3389/fendo.2018.00161.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2018
    detail.hit.zdb_id: 2592084-4
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  • 5
    Online Resource
    Online Resource
    Safety profile of INT230-6, a novel intratumoral (IT) formulation, during injections into a variety of refractory deep and superficial tumors with evidence of tumor regression and immune activation.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 2602-2602
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 2602-2602
    Abstract: 2602 Background: INT230-6 is comprised of cisplatin (CIS), vinblastine (VIN) and an amphiphilic penetration enhancer which facilitates dispersion throughout tumors and diffusion into cancer cells. In preclinical experiments, INT230-6 led to necrosis and recruitment of immune cells with high rates of complete responses of injected and bystander tumors. This abstract highlights the safety and early pharmacodynamic activity of this approach. Methods: Patients with solid tumors that progressed on all standard treatments were enrolled. Dose escalation occurred by increasing number of tumors injected, loading per tumor, and total dose. INT230-6 was injected once every 2 weeks in multiple lesions for 5 sessions. Patients were monitored for safety and tolerability weekly. Pharmacokinetic(Pk) samples and peripheral blood were collected for flow cytometry and circulating cytokines. Pre and on study biopsies are ongoing. Results: 28 patients (14 unique cancer types) receiving a median of 3 prior treatments were enrolled. Doses from 0.3 ml up to-80 ml of INT230-6 were given into single lesions with some patients receiving a total of 120 mL ( = 9.7mg VIN exceeding the IV VIN dose) without significant systemic absorption or typical cytotoxic adverse events. Pk analysis suggests that systemic exposure of VIN or CIS is ~10% of injected. No DLT’s or drug-related SAE’s reported. The most frequent adverse event was grade 1 or 2 pain at injected site. Superficial tumors showed signs of response including flattening, areas of necrosis and ulceration. Tumor reduction, apparent in in both injected and bystander tumors, may indicate an abscopal effect. An increase 〉 30% in CD8 T-cells was seen in the blood of 3/9 evaluable patients. Conclusions: INT230-6 was safe and well tolerated in 〉 100 injections (28 patients) with encouraging activity and pharmacodynamic effects in advanced refractory tumors. Additional analysis of immune cells from on study biopsies will be presented. A new cohort will evaluate combination with an anti-PD1 antibody to understand if local tumor destruction can increase systemic antigen load, increase immune cell recognition and initiate a systemic immune response. Clinical trial information: NCT 03058289.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.2602
    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
    Early results of intratumoral INT230-6 alone or in combination with ipilimumab in subjects with advanced sarcomas.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 11557-11557
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 11557-11557
    Abstract: 11557 Background: Patients have limited treatment options following initial chemotherapy failure. INT230-6, a novel formulation of cisplatin (CIS) and vinblastine (VIN) with an amphiphilic cell penetration enhancer, is designed for intratumoral (IT) administration. Study IT-01 (BMS # CA184-592, NCT 03058289) evaluates INT230-6 alone or in combination with ipilimumab (IPI), an antibody to CTLA-4. INT230-6 dosing is set by a % of the volume of the tumor to be injected. The product has been shown to disperse throughout an injected tumor and diffuse into cancer cells. Cell death leads to recruitment of dendritic and T cells, the effect of which may be augmented by CTLA-4 inhibition as evidenced by increased efficacy of the combination in preclinical models. Historically, checkpoint inhibitors have limited activity in sarcoma. Considering the large volume of drug injected and retained in the tumor, coupled with immune infiltration on biopsies, RECIST response methodology may not capture the benefits of INT230-6 treatment. Methods: IT-01 is an open-label phase 1/2 study that is enrolling adult subjects with locally advanced, unresectable or metastatic sarcoma. INT230-6 was administered IT Q2W for 5 doses alone or with IPI 3mg/kg IV Q3W for 4 doses. The study objectives are to assess the safety and efficacy of IT INT230-6 alone and in combination with IPI. Results: 16 heterogenous sarcoma subjects (13 monotherapy, 3 IPI combination) having a median of 3 prior therapies (0, 8) were enrolled to date. The INT230-6 dose was up to 145 mL (72.5 mg of CIS, 14.5 mg VIN) in a single session (an amount of each agent in excess of standard IV doses). The most common ( 〉 20%) related TEAEs in sarcoma subjects (n = 16) were localized pain (63%), fatigue (38%), decreased appetite (31%), nausea (31%), and vomiting (25%) most of which were low grade; with only grade 3 TEAE above 5% being anemia (13%). There were no related grade 4 or 5 TEAEs. In 11 evaluable monotherapy subjects, the disease control rate (DCR = CR+PD+SD) was 82%. Basket studies of sarcomas, including chordoma, with Royal Marsden Hospital index (RMHI) scores of 2 or higher report median overall survival (mOS) of 4 months. In this study 75% of monotherapy subjects had a RMHI score of 2 and preliminary estimates of mOS was 21.3 (4.67, NA) months. Pilot immunohistochemistry analysis of 5 paired (pre- and 28 days post-dose) biopsy samples showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased TILs. Conclusions: Preliminary data shows that INT230-6 administered intratumorally alone or in combination with ipilimumab is well-tolerated in this small, heterogenous sarcoma population. The preclinical cancer cell death and immune infiltration mechanism of action appears to translate to sarcoma subjects. There are early signs of efficacy, DCR and potentially OS, that need to be confirmed in randomized studies. Clinical trial information: 03058289.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.11557
    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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  • 7
    Online Resource
    Online Resource
    Pharmacodynamic, safety, and efficacy results of a phase I/II trial of intratumoral INT230-6 alone (IT-01) or in combination with pembrolizumab (PEM) (Keynote A10) in patients with advanced solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 3016-3016
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 3016-3016
    Abstract: 3016 Background: INT230-6 is comprised of cisplatin (CIS), vinblastine (VIN) and an amphiphilic penetration enhancer which facilitates dispersion throughout tumors and diffusion into cancer cells when given IT. Preclinical experiments show strong synergy with a PD1 antibody. Methods: Solid tumors pts that progressed on standard treatment were enrolled. INT230-6 dose was set by tumor volume, injected Q2weeks x 5. Escalation occurred by increasing number of tumors injected, loading per tumor, and total dose. In another arm, PEM (200mg IV Q3weeks) was combined with INT230-6. Patients were monitored for safety weekly while on INT230-6. Blood and tumors were assessed for PK and PD. Results: 46 pts (17 unique cancer types) were enrolled in the monotherapy arm and 4 pts in the PEM combo arm with a median of 3 prior treatments. Doses from 0.3 ml up to-160 ml of INT230-6 (80 mg CIS and 16mg of VIN) were injected. PK results indicate 95% of the drugs are retained in the tumor when compared to historical IV dosing. No dose limiting toxicity was reported. Two pts experienced drug-related SAE’s of tumor pain. The most frequent treatment-related AEs were: pain at injected site (48%), fatigue (40%) and nausea (33%). Most AE’s were grade 1 and 2, 17% were grade 3, and none ≥ grade 4. Several injected and non-injected tumors had 〉 30% decreases in diameter. Assessments revealed substantial reductions in tumor volume ( 〉 50%). Stable pts had a median increase of 50% in circulating CD4 and CD8 T-cells, while PD subjects showed decreases in circulating T-cells (p 〈 0.05). Dose-response suggests that monotherapy subjects receiving 〉 50% of tumors injected at dose/tumor volume ratio of 〉 1:4 (target dosing), predicts for prolonged SD with 88%(7/8) having SD ≥ 4mo, correlating with reduced tumor viability on IHC, and increase in tumor-infiltrating lymphocytes (TIL’s). Conclusions: Proof of concept was demonstrated that INT230-6 delivers high drug doses into the tumor without systemic exposure and typical cytotoxic AEs. Systemic and local immune activation was observed. INT230-6 was safe and well tolerated in 〉 175 deep tumor injections with tumor burden reduction in injected and non-injected tumors (an abscopal effect). Patients who received target dosing often had prolonged disease control post treatment. Updated safety, response and biomarker data from the monotherapy and PEM combo arm will be presented. Clinical trial information: 03058289 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.3016
    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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  • 8
    Online Resource
    Online Resource
    INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 11515-11515
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 11515-11515
    Abstract: 11515 Background: INT230-6 is a novel intratumoral (IT) agent with a dual anti-cancer mechanism (tumor cytoreduction while stimulating antigen presentation and recruitment of T-cells). The drug is comprised of cisplatin (CIS) and vinblastine (VIN) co-formulated with an amphiphilic molecule that enables drug dispersion throughout tumors and passive diffusion into cancer cells following IT delivery. In the neoadjuvant setting, a single injection can cause necrosis in 〉 95% of the tumor and recruit TILs. Combining with anti-CTLA-4 improved responses in preclinical models. Methods: INT230-6 dose is set by the tumor’s longest diameter and is proportional to the injected disease volume. INT230-6 is administered IT Q2W for 5 treatment sessions followed by maintenance every 9 weeks as monotherapy or with IPI 3mg/kg IV Q3W for 4 doses. Biopsies from injected tumors are obtained pretreatment and Day 28 for immunoprofiling. Results: 22 subjects with various advanced STS histologies with a median age of 64 and a median of 3 prior systemic therapies were enrolled (11 INT230-6 alone, 11 IPI combination). There were 178 image-guided IT INT230-6 injections (107 to deep tumors) at INT230-6 doses ranging from 5 to 242 mL (121mg CIS, 24.2mg VIN, doses which vastly exceed the usual IV doses of these drugs). PK analysis showed that 〉 95% of drug agents remain in the tumor. The most common ( 〉 25%) all-grade related adverse events (AEs) in evaluable monotherapy subjects (n = 10) were pain (80%), decreased appetite (40%), nausea (40%), anemia (30%), fatigue (30%) and vomiting (30%). Tolerability was similar for the combination with IPI. Most events were low grade. The incidence of grade 3 AEs for the INT230-6 arm was 30% and for the IPI combination was 10%. There were no related grade 4 or 5 AEs in either cohort. RECIST metrics may not accurately reflect clinical benefit with this treatment given large volumes of INT230-6 is repeatedly injected into a tumor and local inflammation may occur. Paired biopsies showed reduction in proliferating tumor cells and an increase in T-cell infiltrates. The disease control rate at the first imaging timepoint for evaluable INT230-6 subjects (n = 9) was 56% and for evaluable IPI combination (n = 5) was 80%. Abscopal effects were seen in 2 monotherapy subjects, though most uninjected tumors were not tracked. The estimated 1-year overall survival was 88% for the IPI combo and 60% for the monotherapy cohort. Conclusions: IT INT230-6 is well tolerated as monotherapy and combined with IPI. STS, which is typically not sensitive to immunotherapy, may be amenable to INT230-6 or IPI combo to create antigens and promote a systemic immune response. Preliminary efficacy using INT230-6 alone is encouraging and will be evaluated in a global phase 3 trial. Further evaluation is needed to determine whether the addition of IPI may improve patient outcomes. Clinical trial information: NCT03058289.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.11515
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 9
    Online Resource
    Online Resource
    DNA mismatch repair deficiency and hereditary syndromes in Latino patients with colorectal cancer
    Wiley ; 2017
    In:  Cancer Vol. 123, No. 19 ( 2017-10), p. 3732-3743
    Details
    In: Cancer, Wiley, Vol. 123, No. 19 ( 2017-10), p. 3732-3743
    Abstract: The landscape of hereditary syndromes and clinicopathologic characteristics among Latino/Hispanic individuals in the United States with colorectal cancer remains poorly understood. Using data from the Hispanic Colorectal Cancer Study, approximately 13% of cases in the current study appear to have mismatch repair‐deficient tumors, 61.9% of which will be confirmed to have Lynch syndrome.
    Type of Medium: Online Resource
    ISSN: 0008-543X , 1097-0142
    URL: Issue
    URL: Article
    DOI: 10.1002/cncr.v123.19
    DOI: 10.1002/cncr.30790
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 1479932-7
    detail.hit.zdb_id: 2599218-1
    detail.hit.zdb_id: 2594979-2
    detail.hit.zdb_id: 1429-1
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  • 10
    Online Resource
    Online Resource
    A phase 1/2 study of intratumoral INT230-6 alone (IT-01) or in combination with pembrolizumab [KEYNOTE-A10] in adult subjects with locally advanced, unresectable and metastatic solid tumors refractory to therapy.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 2592-2592
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 2592-2592
    Abstract: 2592 Background: Study IT-01 (KEYNOTE-A10) evaluates INT230-6, a novel formulation of cisplatin (CIS) and vinblastine (VIN) with an amphiphilic cell penetration enhancer designed for intratumoral (IT) administration, alone or in combination with pembrolizumab (PEM), an antibody to PD-1. INT230-6 dosing is set by a tumor’s volume. In preclinical studies, INT230-6 increases drug dispersion throughout the tumor, allows drug diffusion into cancer cells and recruits dendritic, CD4 and CD8 T cells. The addition of PEM has been shown to improve these responses in models. Phase 1 data indicated INT230-6 alone induced tumor regression in both injected and non-injected lesions. Considering the large volume of drug injected and retained in the tumor, coupled with immune infiltration on biopsies, RECIST response methodology may not capture the benefit of INT230-6 treatment. Methods: IT-01 is an open-label phase 1/2 study, currently enrolling adult subjects with solid tumors in phase 2. INT230-6 was administered IT Q2W for 5 doses alone or with PEM 200mg Q3W. The study seeks to assess the safety and efficacy of IT INT230-6 alone and in combination with PEM. Results: 67 subjects have been enrolled (58 mono and 12 INT230-6 + PEM (3 started in mono, then received combo)) having a median of 3 prior therapies (0, 10). Median age was 60 (42, 85). 20+ cancer types were accrued; breast cancer and sarcoma were the most frequent. Over 500 image guided INT230-6 IT injections were given (253 to deep tumors) at doses of 0.3 to 172mL (86 mg CIS, 17.2 mg VIN) in a single session, which are higher amounts than typical IV doses. PK shows that 95% of INT230-6 active agents remain in the tumor. The most common ( 〉 20%) related TEAEs for INT230-6 alone were localized pain (57%), nausea (36%), fatigue (29%) and vomiting (24%); with grade 3 TEAEs ( 〉 1) of localized pain (5%) and anemia (3%). The safety in the combination was similar. There were no related grade 4 or 5 TEAEs. In evaluable monotherapy subjects (n = 43), the disease control rate (DCR) was 65% vs. 100% in PEM subjects (n = 5). Given the range of dose and entering tumor burden, an exploratory analysis of dose relative to tumor burden (TB) showed that subjects receiving a dose of INT230-6 〈 50% of their reported TB (n = 30) had a mOS of 3.5 months. While in subjects receiving a dose of INT230-6 to ≥50% of TB (n = 37), mOS has not yet been reached after a median follow up of 9.5 months (HR: 0.26 (0.13,0.51)). Conclusions: INT230-6 is well tolerated when administered IT as monotherapy and combined with PEM. Given the challenge in assessing overall response rate following IT delivery, an exploratory analysis suggests prolonged survival for subjects receiving an INT230-6 dose ≥50% of their tumor burden compares favorably to the 〈 50% group and to literature accounting for prognostic factors (ECOG, LDH, # of metastatic sites). Clinical trial information: 03058289.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.2592
    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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