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  • 1
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    Risk factors for hospitalization for cancer patients with SARS-CoV-2 infection.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e18753-e18753
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e18753-e18753
    Abstract: e18753 Background: Cancer patients are more susceptible to developing severe disease associated with SARS-CoV-2 infection. Herein, data from a high-volume cancer center is presented highlighting risk factors associated with hospitalization with COVID-19 disease. Methods: Cancer patients in the Levine Cancer Institute COVID19 database who were tested for SARS-CoV-2 due to clinical illness from March 1, 2020 to October 29, 2020 with 90 days follow-up are described here. Patients’ demographic and clinical information were retrospectively entered into a REDCap database from chart reviews. Differences in distributions were identified between hospitalized and non-hospitalized patients using the chi-squared test with uni- and multivariable logistic regression models. Statistical significance was set at p 〈 0.05. Results: 228 patients with SARS-CoV-2 infection were identified, of whom 103 (45%) were hospitalized. Median age was 63 years (range 28-95). Race distribution for infection showed White 65%, followed by Black 26.8% and Hispanic ethnicity 16.7% , with a similar distribution for hospital admission. Median length of stay was 10 days (range 1-91) with no readmissions within 90 days. The most common underlying malignancies were breast (29.8%), hematologic (21.1%) and genitourinary (12.3%). The most common preexisting conditions included hypertension (55.7%), diabetes (27.2%) and cardiac disease (3.9%). The most common presenting symptoms were cough (50.2%), fever (38.4%), fatigue (37.8%) and shortness of breath (36.4%). Maximum oxygen requirements for hospitalized patients were ambient air (34%), nasal canula (34%), high/medium flow nasal canula (10%), non-invasive ventilation (13%) and mechanical ventilation (10%). Case fatality rate was 10% with diagnosis of COVID-19, including 21.4% of those admitted to the hospital and 51.7% of those admitted to the ICU. Univariable logistic regression analysis showed that age, sex, prior chemotherapy, upper gastrointestinal cancers, hematologic cancers, number of medical conditions, cardiac disease, chronic lung diseases, hypertension, and diabetes increased risk of hospitalization. Table shows results of multivariate analysis. Conclusions: The COVID-19 pandemic has caused high case fatality rates in our cancer patients. We identified age, cardiac disease, hematologic malignancy and receipt of chemotherapy within 4 weeks of diagnosis as risk factors for hospitalization. These data may help in prioritizing early intervention in vulnerable subgroups to improve survival outcomes. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e18753
    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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  • 2
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    Upper respiratory tract SARS-CoV-2 viral shedding in cancer patients.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e18776-e18776
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e18776-e18776
    Abstract: e18776 Background: SARS-CoV-2 virus has been shown to persist in respiratory tract in immunocompromised patients. However, such data are lacking for both asymptomatic and symptomatic SARS-CoV-2 infection in cancer patients. We share our single center experience on duration of SARS-CoV-2 viral presence in the upper respiratory tract of cancer patients with SARS-CoV-2 infection (asymptomatic and symptomatic) detected by viral PCR. Methods: This is retrospective review of cancer patients with documented SARS-CoV-2 infection and measurement of viral shedding at Levine Cancer Institute. Testing indications were COVID-19 symptomatic illness, pre-procedural and pre-chemo testing. Prolonged shedding was defined as presence of viral RNA beyond 30 days after first positive test. To document viral clearance, patients required 2 negative SARS-CoV-2 PCR test separated by at least 24 hours and maximum 3 weeks apart either by nasopharyngeal or nasal PCR swab. Differences in distributions were identified between patients shedding virus more than 30 days and less than 30 days using uni- and multivariable logistic regression models. Statistical significance was set at p 〈 0.10 to enter the multivariable model, and p 〈 0.05 to remain. Results: Demographic data: median age 62 (range 20-93); 58.5% females; 70% White, 21% Black, and 7.4% Hispanics. Comorbidities included hypertension 43.2%, diabetes 16.7% and chronic lung disease 3.7%. Underlying malignancies were breast cancer 25%, hematologic cancer 22%, lung cancer 16% and genitourinary 11%. Chemotherapy was received by 26.5% patients within 4 weeks prior to testing. 162 patients were identified median duration of 18 days (range 4-90 days). Of these, 76% patients were tested for non-symptomatic indication with median duration of shedding 17 days (range 6-80) and 23% were tested for clinical symptoms with median duration of shedding 29 days (range 4-90) (p = 〈 0.001); 50% of patients never developed symptoms, whereas 35% patients with non-symptomatic testing indication, subsequently developed symptoms. Viral clearance by day 30, day 45, day 60 and day 90 was 78%, 93%, 97% and 100% respectively. Univariate analysis did not show difference between patients with prolonged shedding vs those shedding less than 30 days for age, gender, race, ethnicity, underlying malignancy, co-morbidities including body mass index, diabetes, chronic lung conditions, hypertension, or receipt of cytotoxic chemo. Multivariable analysis showed that presence of symptoms at any point during SARS-CoV-2 infection (OR 5.9, 95% CI 2.4-14.5, p 〈 0.001) was associated with prolonged shedding. Conclusions: Symptomatic SARS-CoV-2 infection is associated with prolonged viral shedding in cancer patients. Cancer patients can have asymptomatic SARS-CoV-2 infection. More studies are warranted to understand viral kinetics and its clinical implications in cancer patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e18776
    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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  • 3
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    The myeloma-developing regimens using genomics (MyDRUG) master protocol.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. TPS8057-TPS8057
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. TPS8057-TPS8057
    Abstract: TPS8057 Background: Multiple myeloma (MM) is the second most prevalent blood cancer, representing approximately 1% of all cancers. Although overall survival has improved in recent years due to new approved agents, the vast majority of MM patients (pts) ultimately stop responding to treatment. Moreover, about a quarter of MM pts characterized as “high risk” experience limited benefit from existing treatments. Seminal genomic sequencing research efforts, such as the MMRF CoMMpass study, have highlighted that a large number of MM cases harbor potentially actionable oncogenic molecular alterations and published reports on small numbers of cases suggest that Precision Medicine (PM) interventions clinically targeting such actionable drivers may benefit MM pts. These results suggest that PM approaches in MM are possible and should be further studied clinically. To that end, we have launched MyDRUG, a master protocol aimed at developing new myeloma regimens based on individual pt’s genomics. Methods: This study is a Phase I-II, multicenter master protocol in functional high risk MM patients (i.e patients having progressed from baseline treatment within 18 months without maintenance or 3 years on maintenance) with 1-3 prior lines of therapy. Patients are screened for actionable genomic alterations on the CLIA-grade MI-ONCOSEQ platform. Patients with actionable alterations are assigned to the appropriate targeted agent used in combination with a backbone regimen ixazomib, pomalidomide and dexamethasone (IPd), whereas patients without such alterations go on an immune arm (see Table). Inclusion criteria include measurable disease (as measured by M-protein and FLC) and acceptable hematologic and metabolic functions. A maximum of 12 evaluable pts will be accrued onto the phase I portion of each arm and an additional 21 evaluable phase II pts will be accrued onto each arm for a total of 27 evaluable pts at the MTD combination dose. The primary objective of the study is to evaluate ORR per IMWG consensus criteria. Secondary objectives are to assess adverse events (AEs), progression-free survival, and overall survival (OS). Experimental correlative aims include assessing molecular or clonal response, molecular and immune signatures of resistance/response, MRD. Clinical trial information: NCT03732703. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.TPS8057
    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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  • 4
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    Primary analysis of the randomized phase II trial of bortezomib, lenalidomide, dexamthasone with/without elotuzumab for newly diagnosed, high-risk multiple myeloma (SWOG-1211).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 8507-8507
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 8507-8507
    Abstract: 8507 Background: The introduction of immunomodulatory agents, proteasome inhibitors, and autologous stem cell transplantation (ASCT) has improved outcomes for patients with multiple myeloma (MM), but those with high risk MM (HRMM) have a poor long-term prognosis. To date, no trials have addressed optimal treatment for these patients. Methods: S1211 is a randomized phase II trial (NCT01668719) comparing 8 cycles of lenalidomide, bortezomib and dexamethasone (RVd) induction followed by dose-attenuated RVd maintenance until disease progression with or without elotuzumab. Stem cell collection was allowed, but ASCT was deferred until progression. HRMM was defined by one of the following: gene expression profiling high-risk (GEP hi ), t(14; 16), t(14; 20), del(17p) or amplification 1q21, primary plasma cell leukemia (pPCL) and elevated serum LDH ( 〉 2X ULN). Median progression-free survival (PFS) was the primary end-point, using a one-sided stratified log-rank test at a one-sided significance level of 0.1. Secondary endpoints included overall response rate (ORR), adverse events (AE), serious adverse events (SAE) and OS. Response was assessed using the IMWG 2009 criteria. Results: S1211 enrolled 103 evaluable patients, RVd n = 54, RVd-Elo n = 49. 75% had ISS II/III, 47% amp1q21, 38% del17p, 12% t(14; 16), 9% GEP hi , 7% pPCL, 5% t(14; 20) and 4% elevated serum LDH (18.5% 〉 1 feature). With median follow-up of 53 months (mos.), no difference in median PFS was observed [RVd-Elo = 31 mos., RVd = 34 mos.,HR = 0.968 (80% CI = 0.697-1.344), p = 0.449]. No difference in OS was observed [RVd-Elo = 68 mos, RVd = not reached, HR = 1.279 (80% CI: 0.819, 2.000), p-value = 0.478] . 72% pts had 〉 Grade 3 AEs, no differences in the safety profile were observed except 〉 Grade 3 infections (RVd 8%, RVd-Elo 16%), 〉 Grade 3 sensory neuropathy (RVd 8%, RVd-Elo 13%). Conclusions: In the first randomized HRMM study reported to date, the addition of elotuzumab to RVd induction and maintenance did not improve patient outcomes. However, the PFS and OS seen in both arms of the study exceeded the original statistical assumptions and support the role for PI/IMiD combination maintenance therapy for this patient population. The S1211 data will serve as an important benchmark for future HRMM clinical trials. Clinical trial information: NCT01668719 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.8507
    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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  • 5
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    Phase II study of daratumumab (DARA) monotherapy in patients with ≥ 3 lines of prior therapy or double refractory multiple myeloma (MM): 54767414MMY2002 (Sirius).
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 18_suppl ( 2015-06-20), p. LBA8512-LBA8512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 18_suppl ( 2015-06-20), p. LBA8512-LBA8512
    Abstract: LBA8512 Background: DARA, a human anti-CD38 IgG1κ mAb, has single agent activity and is well-tolerated in rel/ref MM (Lokhorst HM et al. ASCO 2014). This ongoing phase 2 study (NCT01985126) evaluated DARA monotherapy in the FDA breakthrough therapy designation population: MM patients with ≥ 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or double refractory to a PI and IMiD. Preliminary results are reported. Methods: MMY2002 is a 2-part, open-label, international, multicenter study. In part 1 stage 1, 34 patients were randomized to DARA 8 mg/kg (n = 18) q4w or 16 mg/kg (n = 16) qw x 8 wk, q2w x 16 wk, then q4w in a Simon-2-stage design to determine the most effective dose. Subsequently, 90 additional patients were enrolled in the 16 mg/kg DARA group. The primary endpoint was overall response rate (ORR) by independent review (IRC). Results: Data for the 16 mg/kg DARA group are presented (n = 106). Baseline characteristics: median time since diagnosis, 4.8 y; median prior treatment lines, 5; 75% ISS ≥ 2. Refractory to: last line of therapy, 96%; last PI and IMiD, 95%; pomalidomide, 63%: carfilzomib, 48%; alkylating agents, 78%. Adverse events (AE; ≥ 20%) were fatigue (39.6%), anemia (33.0%), nausea (29.2%), thrombocytopenia (25.5%), back pain (22.6%), neutropenia (22.6%), cough (20.8%). Infusion-related reactions (IRR, 42.5%) were mainly grade 1/2 during first infusion (grade 3 4.7%; no grade 4). No patients discontinued study due to IRRs; 5 (4.7%) discontinued treatment due to AEs. None of these AEs were assessed by the investigator to be DARA-related. ORR (IRC assessed) was 29.2%, with 3 sCR, 10 VGPR, and 18 PR with a 7.4 month median duration of response. ORR was consistent across clinically relevant subgroups. Median time to progression was 3.7 months. Median overall survival has not been reached and the estimated 1-year OS rate is 65%. After a median follow up of 9.4 months 14/31 (45.2%) of responders remain on therapy. Conclusions: In a heavily pre-treated MM population (95% refractory to last PI and IMiD), DARA at 16 mg/kg showed meaningful durable single agent activity, with deep responses and a favorable safety profile. Clinical trial information: NCT01985126.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.18_suppl.lba8512
    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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  • 6
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    Randomized, open-label, phase 3 study of subcutaneous daratumumab (DARA SC) versus active monitoring in patients (Pts) with high-risk smoldering multiple myeloma (SMM): AQUILA.
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 15_suppl ( 2018-05-20), p. TPS8062-TPS8062
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. TPS8062-TPS8062
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.15_suppl.TPS8062
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 7
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    Daratumumab, pomalidomide, and dexamethasone in relapsed refractory multiple myeloma (RRMM): A comparison with contemporary clinical trials.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e20011-e20011
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e20011-e20011
    Abstract: e20011 Background: Multiple Myeloma (MM) is an incurable malignancy of terminally differentiated plasma cells. The combination of pomalidomide/dexamethasone with either daratumumab or isatuximab is FDA approved for relapsed refractory multiple myeloma (RRMM) based on randomized phase III trial data. Herein, we compare our center’s experience with published data to help identify the most appropriate patient population for this regimen outside of the context of clinical trials. Methods: We interrogated our internal plasma cell disorder database to identify all patients with RRMM at our institution who were treated with the combination of daratumumab, pomalidomide, and dexamethasone (Dara-Pd). We evaluated the best response achieved, overall response rate (ORR), progression free survival (PFS), and overall survival (OS) measured from initiation on Dara-Pd. Kaplan Meier methods were used to estimate PFS and OS curves. Fisher’s exact tests and log rank tests were used to determine the association between outcomes and variables of interest. Results: Between Dec 2015 and Dec 2020, 98 patients were identified, of which 97 were evaluable for response. Median number of prior lines of therapy was 2 (range 1-12), with 23 patients (23%) previously treated with 3 prior lines and 24 patients (25%) previously treated with ≥4 lines of therapy. Most patients were refractory to an IMiD (79.6%), a PI (65.3%), or both (56.1%). The ORR was 69.1%, 〉 VGPR rate was 33%. ORR was significantly improved for patients who received Dara-Pd after 1 line (p = 0.03), but depth of response (≥VGPR), was similar (p = 0.62). At a median follow up of 10.8 months, 1-year PFS was 76.6% in patients after 1 line, 38.8% in patients after 2-3 lines, and 35% in patients after 〉 4 lines. Overall response rates appear comparable to published phase III trials comparing the combination of Pd with or without an anti-CD38 monoclonal antibody (Table 1). While PFS was somewhat lower in our population, subset analysis showed that PFS was significantly lower in patients who were PI refractory (10.8 months vs 6 months; p = 0.014), and in patients who were both IMiD and PI refractory (20.4 months vs 6 months p = 0.01), but OS was similar in these populations. Conclusions: Our data suggests that the combination of Dara-Pd has activity in heavily pretreated patients, including patients who are both IMiD and PI refractory and remains a viable option for these patients outside the context of a clinical trial.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e20011
    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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  • 8
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    Phase II study of daratumumab (DARA) monotherapy in patients with ≥ 3 lines of prior therapy or double refractory multiple myeloma (MM): 54767414MMY2002 (Sirius).
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 15_suppl ( 2015-05-20), p. LBA8512-LBA8512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. LBA8512-LBA8512
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.15_suppl.lba8512
    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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  • 9
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    Analysis of time to next treatment (TTNT) in melflufen and dexamethasone-treated patients (pts) with relapsed/refractory multiple myeloma (RRMM).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 8043-8043
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 8043-8043
    Abstract: 8043 Background: Melflufen is a novel peptide-conjugated alkylator potentiated by intracellular aminopeptidases, which are markedly overexpressed in MM. Melflufen + dex had encouraging activity in pts with RRMM and ≥2 prior lines of therapy in the phase 1/2 O-12-M1 study (overall response rate 31%; median overall survival of 20.7 mo; Richardson et al. ASH 2017. Abs. 3150). TTNT is used in Real World Evidence (RWE) to assist treatment decisions and support economic reimbursement modeling. We report TTNT after melflufen + dex in O-12-M1. Methods: Pts with RRMM and ≥2 prior lines of therapy, including bortezomib and lenalidomide (len) received 40 mg IV melflufen on d 1 of each 28-d cycle + 40 mg weekly dex until progressive disease (PD)/unacceptable toxicity. Pts were followed up for 2 y after PD, and TTNT was retrospectively reviewed for subsequent therapy. Results: As of 9 Nov 2017, 45 pts were treated: median age, 66 y (47-78); ISS stage II/III, 60%; high-risk cytogenetics, 44%. Pts had 4 median prior lines of therapy; 87% were refractory to last line of therapy including alkylators (24%), proteasome inhibitors (PIs; 27%), IMiDs (56%), and monoclonal antibodies (mAbs, 9%); 11% were last-line double refractory. At data cutoff, 44 pts (98%) discontinued melflufen + dex, mainly due to adverse events (40%) and PD (29%). 26 pts received subsequent therapy. Median time from start of melflufen + dex to first subsequent therapy or death, whichever occurred first, (TTNT) was 7.9 mo (95% CI: 5.7-11.0); next therapy included alkylators (27%), PIs (38%), IMiDs (58%), and mAbs (8%). Conclusions: Types of subsequent salvage therapy used after melflufen + dex were similar to studies of approved agents in RRMM; TTNT was also similar (Table). Further trials are ongoing, including melflufen + dex vs pomalidomide (pom) + dex in pts with RRMM refractory to len (Phase 3 OCEAN study; NCT03151811). Clinical trial information: NCT01897714. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.8043
    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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  • 10
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    A phase II study of bortezomib added to standard daunorubicin and cytarabine during induction therapy and to intermediate-dose cytarabine (Int-DAC) for consolidation in patients with previously untreated acute myeloid leukemia (AML) age 60-75 years: CALGB study 10502.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 6526-6526
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 6526-6526
    Abstract: 6526 Background: We conducted a clinical trial to determine the complete remission (CR) rate in older AML patients treated with bortezomib (Bz) plus daunorubicin and cytarabine induction therapy and the maximal tolerated dose (MTD) of Bz when added to Int-DAC consolidation therapy. Methods: Ninety-five adults (60-75 yrs old; median, 67) with previously untreated AML (including therapy-related and prior MDS) received Bz 1.3 mg/m 2 IV on days 1, 4, 8 and 11 with daunorubicin 60 mg/m 2 on days 1-3 and cytarabine 100 mg/m 2 by continuous IV infusion on days 1-7. Patients who achieved a CR received 2 courses of consolidation chemotherapy with cytarabine 2 gm/m 2 over 3 hours on days 1-5 (Int-DAC) with Bz administered on days 1, 4, 8 and 11. Three cohorts with escalating dose levels of Bz were tested (0.7, 1.0, and 1.3 mg/m 2 ). Dose limiting toxicities were assessed during the first cycle of consolidation. Predictors of response, including CD74 expression, were assessed. Results: The CR frequency was 65% (62/95). An additional 4% (4/95) achieved CR with incomplete platelet recovery. The CR rate according to ELN Genetic Groups was 90% (9/10) for favorable, 71% (12/17) for Int-I, 52% (17/33) for Int-II, and 46% (5/11) for adverse. Six patients had grade 3 sensory neuropathy. There were 6 treatment-related deaths during cycle 1 of induction and 2 during cycle 2. Bz plus Int-DAC proved tolerable at the highest dose tested. The median disease-free (DFS) and overall survivals (OS) for patients on this study were 8.2 and 12.1 months, respectively. Lower CD74 expression was associated with CR/CRp (p=.04) but not with DFS or OS. Conclusions: The addition of Bz 1.3 mg/m 2 IV on days 1, 4, 8, and 11 to standard “3 + 7” daunorubicin and cytarabine induction chemotherapy for AML is well tolerated and results in a remission rate at least as high as would be expected with ”3+7” alone in older patients. The maximum tested dose of Bz given in combination with Int-DAC for remission consolidation was 1.3 mg/m 2 and proved to be tolerable. Further testing of this regimen in a phase III study is planned.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.6526
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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