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  • American Society of Clinical Oncology (ASCO)  (9)
  • 1
    Online Resource
    Online Resource
    Models of care for serious illness: What is the evidence?
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 31_suppl ( 2017-11-01), p. 168-168
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 31_suppl ( 2017-11-01), p. 168-168
    Abstract: 168 Background: Individuals with cancer and other serious illness may benefit from specialized models of care, including palliative care. However, limited evidence exists to guide real-world implementation of such programs. We reviewed evidence supporting models of care for serious illness as part of a larger effort to develop an implementation framework for serious illness care programs. Methods: We conducted a systematic review, focusing on existing reviews and meta-analyses across a broad range of serious illness population definitions and programs. The quality of evidence was graded and results were synthesized with respect to five outcomes categories (patient and caregiver experience; care and support processes; health outcomes; health service use and costs; and operations), program components associated with success, and implementation considerations. Results: Collectively, 28 reviews were identified, reporting 743 studies, 426 of which were randomized controlled trials. The strongest and most consistent evidence was for reduced health service use and costs (e.g., reduced hospitalization and emergency department use) and for improved patient and caregiver experiences. Few reviews reported on operational outcomes. Program components most frequently reported as associated with success included targeted selection of high-risk patients; face-to-face contact; and transition management. Common recommendations for implementation (reported in 10 of 28 reviews) included attention to relationship building, inclusion of technology-enabled decision support and continuous quality improvement. Conclusions: Compelling evidence exists for improved outcomes across a range of serious illness care models and populations with palliative care needs. Policy attention to payment structures that support feasibility and sustainability of these care models is warranted. Future research might address gaps in the literature, including implementation-related factors, operational outcomes and the relative contribution of individual components associated with program success.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.31_suppl.168
    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
    Clinical activity of BLU-285 in advanced gastrointestinal stromal tumor (GIST).
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. 11011-11011
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 11011-11011
    Abstract: 11011 Background: Oncogenic mutations in KIT or PDGFRα drive 〉 85% of GIST. However, primary and acquired mutations in the activation loop of PDGFRα and KIT are not effectively treated by approved therapies. A phase 1 study (NCT02508532) was initiated in advanced GIST to assess the safety, PK and clinical activity of BLU-285, a potent, highly-selective oral inhibitor that targets KIT Exon 17 and PDGFRα D842 activation loop mutants. Methods: Adult patients (pts) with unresectable GIST, who had received ≥2 kinase inhibitors including imatinib or who had a primary PDGFRα D842 mutation regardless of prior therapy, were given BLU-285 once daily on a 4-week cycle following a 3+3 escalation design, which allowed additional accrual to dose levels demonstrated to be safe. Adverse events (AEs) per CTCAE v4.03, PK and plasma/tumor mutant DNA levels were assessed. Response was determined by RECIST 1.1 every 8 weeks. Results: At a 01JAN17 cutoff, 40 pts (21 PDGFRa/19 KIT) have been treated with BLU-285 at doses of 30-600 mg. Median number of prior kinase inhibitor regimens was 4.5 (2-12) KIT/2.5 (0-4) PDGFRα. RECIST 1.1 responses were seen across all dose levels for PDGFRα GIST and at higher dose levels for KIT GIST. Of 17 PDGFRα D842V pts with ≥1 radiographic assessment, 7 had confirmed PR (ORR 41%) and 10 had SD. Of 11 evaluable KIT pts treated at doses ≥ 135 mg, 2 had PR (1 confirmed; ORR 18%) and 5 SD. BLU-285 is rapidly absorbed (T max 2-8 h), exposure increases linearly with dose, and half-life is 〉 24 h supporting QD dosing. Most AEs were grade 1 or 2, most commonly nausea (48%), fatigue (45%), peripheral edema, periorbital edema, vomiting (30% each), diarrhea (25%), anemia, dizziness, and lacrimation (23% each). There were no grade 4 or 5 BLU-285-related AEs, dose limiting toxicities, or discontinuations. 29 pts (all 21 PDGFRα pts) remain on treatment (duration 1-14 mo). Updated results including MTD, ct-DNA and central radiographic assessments will be presented. Conclusions: Precision targeted therapy with BLU-285 demonstrates important clinical activity in pts with both PDGFRα- and KIT-mutant GIST that is resistant to available therapies. Clinical trial information: NCT02508532.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.11011
    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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  • 3
    Online Resource
    Online Resource
    A phase I study of pemetrexed in combination with docetaxel in advanced solid tumor patients.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. 2567-2567
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 2567-2567
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.15_suppl.2567
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Epidemiology, prevalence, and prognosis of multiple malignancies of a subpopulation of a large German cancer center.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e13634-e13634
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e13634-e13634
    Abstract: e13634 Background: Cancer patients have an increased risk of developing secondary primary neoplasia (SPN) compared to the general population. These multiple primary malignancies (MMs) represent an increasing challenge for patients and physicians. So far, little is known about risk factors, patient characteristics, and survival. The study’s purpose was to obtain an overview of the occurrence and distribution of MMs and the outcome and prognosis of affected patients reporting to a large cancer center in Germany. Methods: The cancer registry data base of the Charité Comprehensive Cancer Center was queried for patients, which had their first cancer diagnosis between 01.01.2009 - 31.01.2010 and consecutively developed at least one more primary cancer within the follow-up period till 31.03.2019. For defining MM the rules from the Surveillance, Epidemiology, and End Results (SEER) Program were used. General tumor and patient characteristics as well as outcome were analyzed. Results: In total, 231 patients (155 male; 76 female) were included in the final analysis. Out of the 231 patients, 203 (87.9 %) presented with 2 primary tumors, 27 patients (11.7 %) with 3 and 1 patient (0.4%) with more than three. MMs occurred mostly in patients 〉 65 years (59.3%) and between 50-64 years (30.3%). According to the SEER definition 75.3% of the patients had metachronous and 24.7% had synchronous MMs. Most male patients presented initially with cancer of the bladder and the urinary tract (20.6%) and developed SPN in the prostate and the testicles (53.1%). The second most common initial cancer in this cohort was cancer of the prostate and testicles (18.1%) and the subsequent developed SPN was cancer of the bladder and the urinary tract (28.6%). For female patients the most common initial diagnosis was breast cancer (32.9%) followed by breast cancer as SPN in 60%. Overall, most frequent SPN were cancer of the prostate and testicles (13.4%), cancers of the lung and trachea (12.6%), and breast cancer (10.4%). Most patients (37.7%) developed the SPN within the 1st year and 28.6% after 5 years or later. Patients with synchronous MMs had a more than 40 months shorter OS than patients with the metachronous MM (79.00 ± 14.58 months vs. 122.00 ± 9.66 months). Conclusions: We could show that most MMs develop within the first year but that there is another peak after 5 years. However, it is still unclear how often SPN are misinterpreted as progressive disease. Therefore, further analyses and close follow-up are necessary.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e13634
    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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    Molecular analysis of the randomized phase II/III study of the anti-IGF-1R antibody dalotuzumab (MK-0646) in combination with cetuximab (Cx) and irinotecan (Ir) in the treatment of chemorefractory KRAS wild-type metastatic colorectal cancer (mCRC).
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 3531-3531
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 3531-3531
    Abstract: 3531 Background: Previously reported results of this randomized study demonstrated that the addition of dalotuzumab (Dz) worsened the PFS and OS of chemofractory mCRC patients receiving Cx and Ir (Watkins et al; ASCO 2011). Comprehensive molecular analysis has been undertaken retrospectively to identify possible predictors of Cx resistance and Dz response. Methods: Quantitative RT-PCR for IGF-1, IGF-2, immunohistochemistry for IGF-1R and microarray expression profiling was conducted on archival tumor tissue. All patients had received Cx and Ir with either placebo (n=107), weekly Dz (n=112), or 2 weekly Dz (n=110). Results: Data from 292 and 206 patients was successfully obtained by RT-PCR or microarray respectively. Within the placebo arm, high IGF-1 expression was found to be associated with resistance to Cx (IGF-1-/IGF-1+; PFS 6.7/3.7 months, OS 15.5/9.6 months). High IGF-1 expression was associated with benefit from the addition of weekly Dz (placebo/weekly Dz; PFS 3.7/5.7 months, OS 9.6/18.2 months). By contrast the addition of Dz was not effective in tumors with high IGF-2 expression (placebo/weekly Dz; PFS 8.4/2.7 months). Microarray analysis revealed distinct populations that differentially correlated with Cx and Dz response. An epithelial phenotype appeared more associated with Cx response, whereas a mesenchymal phenotype more associated with Dz response. Rectal cancers showed greater association with increased IGF-1 expression, EMT gene signature and Dz response. Conclusions: These data support IGF-1 and IGF-2 as potential biomarkers for response to Dz therapy and high IGF-1 as a marker of resistance to Cx therapy. Based on these data Dz is being further evaluated in a molecularly selected population of mCRC. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.3531
    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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  • 6
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    Impact of Azacitidine Before Allogeneic Stem-Cell Transplantation for Myelodysplastic Syndromes: A Study by the Société Française de Greffe de Moelle et de Thérapie-Cellulaire and the Groupe-Francophone des Myélodysplasies
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 36 ( 2012-12-20), p. 4533-4540
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 36 ( 2012-12-20), p. 4533-4540
    Abstract: To investigate the impact of prior-to-transplantation azacitidine (AZA) on patient outcome after allogeneic stem-cell transplantation (alloSCT) for myelodysplastic syndrome (MDS). Patients and Methods Of the 265 consecutive patients who underwent alloSCT for MDS between October 2005 and December 2009, 163 had received cytoreductive treatment prior to transplantation, including induction chemotherapy (ICT) alone (ICT group; n = 98), AZA alone (AZA group; n = 48), or AZA preceded or followed by ICT (AZA-ICT group; n = 17). At diagnosis, 126 patients (77%) had an excess of marrow blasts, and 95 patients (58%) had intermediate-2 or high-risk MDS according to the International Prognostic Scoring System (IPSS). Progression to more advanced disease before alloSCT was recorded in 67 patients. Donors were sibling (n = 75) or HLA-matched unrelated (10/10; n = 88). They received blood (n = 142) or marrow (n = 21) grafts following either myeloablative (n = 33) or reduced intensity (n = 130) conditioning. Results With a median follow-up of 38.7 months, 3-year outcomes in the AZA, ICT, and AZA-ICT groups were 55%, 48%, and 32% (P = .07) for overall survival (OS); 42%, 44%, and 29% (P = .14) for event-free survival (EFS); 40%, 37%, and 36% (P = .86) for relapse; and 19%, 20%, and 35% (P = .24) for nonrelapse mortality (NRM), respectively. Multivariate analysis confirmed the absence of statistical differences between the AZA and the ICT groups in terms of OS, EFS, relapse, and NRM. Conclusion With the goal of downstaging underlying disease before alloSCT, AZA alone led to outcomes similar to those for standard ICT.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2012.44.3499
    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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  • 7
    Online Resource
    Online Resource
    Comprehensive 0utcomes for After Cancer Health: COACH.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS12141-TPS12141
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS12141-TPS12141
    Abstract: TPS12141 Background: The landscape for cancer survivors continues to evolve as individuals live longer following primary therapy. For some, treatment is complete; for others, active surveillance or maintenance therapy may be indicated. Individual survivorship needs are diverse, influenced by tumor and treatment type, as well as social determinants of health. Digital interventions may support survivors in achieving personalized health goals throughout survivorship. The Comprehensive Outcomes for After Cancer Health (COACH) Study (NCT05349227) explores the feasibility of a digital health coaching (DHC) program for individuals enrolled with diverse tumor types and geographic regions. Methods: COACH is a multi-center, randomized, wait-list control trial enrolling 550 individuals ≥18 years old who are within 1-year of completion of primary cancer therapy at enrollment. Up to 100 participants, will be recruited at each of 6 study sites, of which 3 are currently enrolling. Consented individuals are randomized to 6 months of DHC or 6 months of data collection only, then cross-over for follow-up to 12-months. Both groups wear an activity tracker; complete patient reported outcome measures; and provide fecal specimens. The DHC program includes weekly Health Advisor calls and supplemental delivery of evidenced-based content via text, email or mobile platform. Topics fall in health domains of physical, mental/emotional, financial, social, and sexual, and emphasize nutrition, physical activity, sleep, and screening for recurrent or de novo cancer. Feasibility for this study is defined as a retention rate greater than or equal to 70%, and acceptability will be defined as less than or equal to 20% scoring “not at all helpful.” Trends over time will be assessed using linear mixed models using time as a fixed effect, as well as any covariates and interactions of interest. Descriptive statistics will be used to evaluate exploratory endpoints. A cross-cohort end-point related to physical function as measured by the PROMIS Physical Function 10a, will also be evaluated. To date, 72 individuals have enrolled, with Nebraska as the lead site, including 71 women, with a mean age of 61.78 (Range 33-74), from the U.S. Midwest (n = 57) and Northeast (n = 15). 4 identify as African American/Black, 68 as White. 50 have a breast, 13 ovarian, 8 endometrial, 1 gastric diagnosis. Nine have completed the first 6 months of the study. The study is novel in the breadth of data collected and potential to understand variability in patient experiences and provide insights into the feasibility, acceptability, and efficacy of a DHC intervention supporting individuals after primary cancer treatment. Clinical trial information: NCT05349227 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.TPS12141
    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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  • 8
    Online Resource
    Online Resource
    89 Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma: Results from phase 3 ZIRCON study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4554-4554
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4554-4554
    Abstract: 4554 Background: Conventional tools (eg, CT, MRI, biopsy) have limitations for characterizing renal mass histology; approx. 25% of patients with an indeterminant renal masses (IDRM) 〈 4cm undergo surgery for benign disease. Accurate noninvasive techniques to risk stratify the IDRM remains an unmet need. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), an enzyme highly expressed in clear cell renal carcinoma (ccRCC). Radiolabeled 89 Zr-DFO-girentuximab is highly specific for CAIX and can aid differentiation between ccRCCs and other renal lesions. ZIRCON evaluated the performance of 89 Zr-DFO-girentuximab PET/CT for detection of ccRCC. Methods: In this open label, multicenter trial, patients with an IDRM (≤7cm; cT1) who were scheduled for partial nephrectomy within 90 days from planned 89 Zr-DFO-girentuximab administration were eligible. Enrolled patients received a single dose IV (37 MBq±10%; 10mg girentuximab) on Day 0 and underwent PET/CT imaging on Day 5 (±2d). Blinded central histology review determined ccRCC status. The co-primary objectives were to evaluate both the sensitivity and specificity of 89 Zr-DFO-girentuximab PET/CT imaging in detecting ccRCC in patients with IDRM, using histology as the standard of truth. Key secondary objectives included sensitivity and specificity of TLX250-CDx PET/CT imaging in the subgroup of patients with IDRM ≤4cm (cT1a). Other secondary objectives included positive and negative predictive values, and evaluation of safety and tolerability. The Wilson 95% confidence intervals (CI) lower bound for sensitivity and specificity had to be 〉 70% and 68% respectively for ≥2 independent readers to declare the study successful. Results: 300 patients received 89 Zr-DFO-girentuximab (mean age, 62±12y; 71% Male). Of 288 patients with central histopathology of surgical samples, 193 (67%) had ccRCC, and 179 (62%) had cT1a. Of 284 evaluable patients, the average across all 3 readers for sensitivity and specificity was 86% [80%, 90%] and 87% [79%, 92%] resp. for coprimary, and 85% [77%, 91%] and 90% [79%, 95%] resp. for key secondary endpoints. For all evaluable patients, positive and negative predictive values were ≥ 91.7% and ≥ 73.7%, resp. PET+ ccRCC had higher mean CAIX expression compared with PET- ccRCC patients (p 〈 0.05). Sensitivity and specificity were consistent with masses ≤2cm (n=46) of which, 26 were ccRCC+, 13 ccRCC−, and 3 unevaluable at central histopathology. Of 263 adverse events (AEs) in 124 patients, 2 AEs of mild intensity were treatment related. Conclusions: ZIRCON study confirms 89 Zr-DFO-girentuximab PET/CT is a well-tolerated and accurate modality for noninvasive identification of ccRCC in IDRM. This tool could be included in the diagnosis/management of patients with IDRM, limiting unnecessary treatment of benign lesions. Clinical trial information: NCT03849118 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4554
    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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  • 9
    Online Resource
    Online Resource
    Development of a serious illness care model implementation framework.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 31_suppl ( 2017-11-01), p. 161-161
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 31_suppl ( 2017-11-01), p. 161-161
    Abstract: 161 Background: Care of individuals with cancer and other serious illness is complex and often results in unmet needs and high costs. Despite growing national interest in innovative care models for serious illness that improve quality and reduce costs, limited information is available to guide health care organizations from program innovation to implementation. Methods: With funding from the Gordon and Betty Moore Foundation, we sought to develop a flexible serious illness care model implementation framework to inform program development, replication, and scaling across a broad range of serious illness populations and settings. A draft framework was developed, guided by review of white papers and peer reviewed evidence and of existing serious illness care programs. Expert panelists—representative of serious illness care providers, policy experts, payers, and researchers—were recruited to review and provide feedback in two rounds of group discussion and additional 1:1 interviews. Results: The resulting framework implementation process begins with setting a vision and completing a local needs assessment. We present a range of evidence-based options for each facet of care model implementation (e.g., possible business models, target populations, services, and outcomes) to guide healthcare organizations in adapting serious illness programs to their local context. Key considerations for encouraging program success include leveraging existing programs and resources, recruiting strong program leaders, engaging staff, assembling experienced multidisciplinary care teams, building strong relationships among team members and with patients/caregivers, and establishing processes for program evaluation and continuous quality improvement. Conclusions: Our framework reflects a growing landscape of care models for cancer and other serious illness, offering a range of potential approaches to program implementation. Next steps include dissemination, framework impact assessment, creating a simulator for payment models, and piloting framework for use with future programs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.31_suppl.161
    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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