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  • American Society of Clinical Oncology (ASCO)  (8)
  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 28 ( 2013-10-01), p. 3585-3591
    Abstract: To investigate the effectiveness of a centralized, nurse-delivered telephone-based service to improve care coordination and patient-reported outcomes after surgery for colorectal cancer. Patients and Methods Patients with a newly diagnosed colorectal cancer were randomly assigned to the CONNECT intervention or usual care. Intervention-group patients received standardized calls from the centrally based nurse 3 and 10 days and 1, 3, and 6 months after discharge from hospital. Unmet supportive care needs, experience of care coordination, unplanned readmissions, emergency department presentations, distress, and quality of life (QOL) were assessed by questionnaire at 1, 3, and 6 months. Results Of 775 patients treated at 23 public and private hospitals in Australia, 387 were randomly assigned to the intervention group and 369 to the control group. There were no significant differences between groups in unmet supportive care needs, but these were consistently low in both groups at both follow-up time points. There were no differences between the groups in emergency department presentations (10.8% v 13.8%; P = .2) or unplanned hospital readmissions (8.6% v 10.5%; P = .4) at 1 month. By 6 months, 25.6% of intervention-group patients had reported an unplanned readmission compared with 27.9% of controls (P = .5). There were no significant differences in experience of care coordination, distress, or QOL between groups at any follow-up time point. Conclusion This trial failed to demonstrate substantial benefit of a centralized system to provide standardized, telephone follow-up for postoperative patients with colorectal cancer. Future interventions could investigate a more tailored approach.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 23 ( 2014-08-10), p. 2496-2502
    Abstract: To investigate the efficacy and safety of aerobic training (AT) in patients with cancer with medically stable heart failure (HF). Patients and Methods A retrospective analysis of 90 patients with cancer who have HF and who were randomly assigned to AT (n = 47) or guideline-based usual care (UC; n = 43) was performed. AT consisted of three supervised sessions per week at 20 to 45 minutes per session at 60% to 70% of heart rate reserve for 12 weeks followed by home-based sessions for 4 to 12 months. The primary end point was all-cause mortality and hospitalization. Secondary end points were other clinical events, safety, and change in exercise capacity (VO 2peak ) and health-related quality of life (HRQOL). Results Median follow-up was 35 months. In intention-to-treat (ITT) analyses, all-cause mortality or hospitalization at 2 years was 74% in the AT group compared with 67% in the UC group (adjusted hazard ratio [HR], 1.11; 95% CI, 0.69 to 1.77; P = .676). The incidence of cardiovascular mortality or cardiovascular hospitalization was significantly higher in the AT group compared with the UC group (41% v 67%; adjusted HR, 1.94; 95% CI, 1.12 to 3.16; P = .017). There were no differences in any VO 2peak or HRQOL end points. In post hoc analyses based on adherence to AT, all-cause mortality and hospitalization was 66% in adherent patients (≥ 90 minutes per week) compared with 84% in nonadherent patients ( 〈 90 minutes per week). Conclusion In ITT analyses, AT did not improve clinical outcomes in patients with cancer who had HF. Post hoc analyses suggested that patients not capable of adhering to the planned AT prescription may be at increased risk of clinical events.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 12000-12000
    Abstract: 12000 Background: Patients with AML receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). We sought to examine the effect of integrated palliative and oncology care on QOL, mood, post-traumatic stress (PTSD) symptoms, and EOL outcomes in patients with AML. Methods: We conducted a multi-site randomized trial of integrated palliative and oncology care (n = 86) versus usual oncology care (n = 74) for patients with AML undergoing intensive chemotherapy. Patients assigned to the intervention were seen by palliative care clinicians at least twice per week during their hospitalization for induction chemotherapy and all subsequent hospitalizations. Patients completed the Functional Assessment of Cancer Therapy-Leukemia, the Hospital Anxiety and Depression Scale, and the PTSD Checklist to assess their QOL, mood, and PTSD symptoms at baseline, weeks 2, 4, 12, and 24. The primary endpoint was QOL at week-2. We used analysis of covariance and mixed linear effect models, controlling for baseline scores, to assess the effect of the intervention on patient-reported outcomes. Results: Between 1/2017 and 7/2019, we enrolled 160/235 (68.1%) of eligible patients. Compared to those receiving usual care, intervention patients reported better QOL (107.59 vs. 116.45, P = 0.039) and lower depression (7.20 vs. 5.68, P = 0.021), anxiety (5.94 vs. 4.53, P = 0.018), and PTSD symptoms (31.69 vs. 27.79, P = 0.009) at week 2. Intervention effects were sustained up to week 24 for QOL (B = 2.35, P = 0.048), depression (B = -0.42, P = 0.039), anxiety (B = -0.38, P = 0.042), and PTSD symptoms (B = -1.43, P = 0.002). Among deceased participants, those receiving the intervention were more likely to report discussing their EOL care preferences with their clinicians (75.0% vs. 40.0%, P = 0.009) and less likely to receive chemotherapy in the last 30 days of life (34.9% vs. 65.9%, P = 0.008). There was no difference in hospice utilization or hospitalization at the EOL. Conclusions: The integrated palliative and oncology care model for patients with AML receiving intensive chemotherapy led to substantial improvements in patients’ QOL, psychological distress, and EOL care. Thus, palliative care should be considered a new standard of care for patients with AML. Clinical trial information: NCT02975869 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 9055-9055
    Abstract: 9055 Background: Treatment options remain limited in malignant pleural mesothelioma refractory to pemetrexed +/- platinum. TRC102 (methoxyamine hydrochloride) is a novel biochemical inhibitor of the BER pathway. Available data support the hypothesis that TRC102 bound DNA is a substrate for topoisomerase II, which cleaves TRC102-bound DNA sites to produce strand breaks in cancer cells that cause cellular apoptosis and enhance the cytotoxic effects of chemotherapy. Methods: This was a parallel cohort trial of a Phase I of TRC102 in combination with cisplatin (CDDP) and pemetrexed in patients with advanced solid tumors (Arm A) and a Phase II of TRC102 with pemetrexed in patients with mesothelioma refractory to platinum and pemetrexed (Arm B). Results: In Arm A dose escalation, 16 pts (11M/5F) were treated; 9 evaluable through 3 TRC102 dose levels (50, 75, and 100 mg/day, PO), with CDDP 60 mg/m 2 and pemetrexed 500 mg/m 2 (levels 1- 3); and 5 evaluable at TRC102 100 mg/day PO, CDDP 75 mg/m 2 , pemetrexed 500 mg/m 2 (level 4). Cycles were every 21 days. There were no DLT’s, establishing level 4 as the RP2D. The only grade 4 treatment-related AE was thrombocytopenia on cycle 22 (level 2). Cycle 1 grade 3 AEs were 1 hypophosphatemia (level 1) and 1 leukopenia (level 2). There were 3 PRs (all parotid salivary gland tumors). Median PFS (95%CI) = 7.1% (1.4 – 15.5) mos. Arm B was designed as the first stage of a two stage Gehan design trial of patients with mesothelioma who had progressed on or recurred within 6 months of pemetrexed + platinum frontline treatment. 14 pts were treated with TRC102 50 mg/day D1-4 and pemetrexed 500 mg/m 2 every 21 days. There were 2 PRs (both in epithelioid cancer of which 1 was confirmed), meeting the pre-specified criteria for continued interest ( 〉 0/14). mPFS (95% CI) was 4.3 (1.4 - 6.8) mos. 8 pts had stable disease for at least 1 cycle (4 stable at cycles 6, 9, 10 and 12). There were 1 grade 4 neutropenia and 5 grade 3 AE’s (1 each – anemia, neutropenia, leukopenia, fatigue, hyponatremia). Conclusions: TRC102 in combination with CDDP and pemetrexed exhibited antitumor activity, particularly in salivary gland tumors, and a tolerable safety profile at the doses tested. The combination of TRC102 and pemetrexed demonstrated activity in malignant mesothelioma that progressed on prior pemetrexed. Additional studies are warranted to confirm preliminary signals of activity. Clinical trial information: NCT02535312.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4164-4164
    Abstract: 4164 Background: Pancreatic cancer (PC) is largely refractory to immune checkpoint blockade (ICB) in genomically unselected patients (pts). Synergistic effects of combined ICB and radiotherapy have been suggested in varied solid tumors. Few studies have evaluated this approach in pts with PC. We sought to evaluate the safety and efficacy of PD-L1 inhibitor durvalumab (D) and SABR after induction chemotherapy, in LA and BR PC. Herein, we present phase II data from two cohorts. Methods: A multi-institutional, non-randomized phase 1/2 trial of SABR and D was conducted at Cedars-Sinai Medical Center (CS) and Memorial Sloan Kettering (MSK). Key eligibility: ECOG 0-1; unresectable PC, with stable/responding disease following 2-3 cycles gemcitabine and nab-paclitaxel (GnP) or 4-6 months (m) FOLFIRINOX (FFX). CS enrolled pts with BR and LA PC; MSK enrolled pts with LA PC only. All pts received SABR between dose 1 and 2 of D, with slight variation in ablative radiation techniques (CS: 33Gy/5#; MSK: MRI adaptive ablative radiation, 50Gy/5#). D dosed on day 1: 750mg x 4 doses Q14 days, and subsequently Q2 or Q4 weeks x 1 year total, or until resection, progression of disease (POD), or limiting toxicity. Primary endpoint: 6-month progression free survival (6 m PFS). Secondary endpoints: rate of downstaging to resectability, objective response by RECIST v1.1, duration of response, PFS, Overall Survival (OS). PFS and OS estimated from consent date using Kaplan-Meier method. Association between surgery and outcomes was analyzed as a time dependent covariate in univariate Cox regression models for OS and PFS. To assess immunogenomic biomarkers of response, pre- and on-treatment tissue, blood and microbiome samples were gathered. Results: Between 08/2017 and 05/2022, N= 36 enrolled. Median age 67.5 years (range 48-79), 39% (14/36) female. Performance Status: N=12 (33%) ECOG 0; N= 24 (67%) ECOG 1. Median duration chemotherapy: 3.5 m (range 1.4, 5.8). Staging: N=31 (86%) LA; N=5 (14%) BR. N = 9 (25%) underwent resection; all R0. Conversion to resection was not associated with PFS (HR 0.45; 95% CI 0.17, 1.17, p=0.1) or OS (HR 0.69; 95% CI 0.26, 1.84, p=0.5). Survival and response data summarized in table. Toxicities of special interest: Grade 3 treatment-related: in N= 7; diarrhea N= 2; elevated AST/ALT N= 2; lipase/amylase elevation, N=1; nausea N=1. Grade 4: amylase elevation N=1. Conclusions: D and SABR after induction chemotherapy in LA and BR PC is safe, had an encouraging 6-m PFS of 69% and favorable R0 resection rate, warranting further evaluation. Immuno-genomic biospecimen analyses underway. Clinical trial information: NCT03245541 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 15_suppl ( 2016-05-20), p. 7512-7512
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 725-725
    Abstract: 725 Background: Immune checkpoint blockade (ICB) has a modest signal in the treatment of patients with genomically unselected pancreatic cancer (PDAC). Synergistic effects of combined radiotherapy and ICB are postulated. Preliminary results of a phase 1/2 trial of anti-PD-L1 antibody durvalumab (D) and SABR in locally advanced (LA) and borderline resectable PDAC (Tuli, AACR; 2019; Abstr B58), noted SABR and D to be safe and tolerable following induction chemotherapy. We sought to further evaluate the tolerability and efficacy of D and SABR, in LA PDAC. Methods: A single-arm, open-label phase 2 trial was conducted at Memorial Sloan Kettering (MSK). Key eligibility: histologically confirmed LA unresectable PDAC, with stable or responding disease following 4-6 months (m) of FOLFIRINOX (FFX), ECOG 0-2. Therapy: D and SABR; D dosed on day 1 750mg x 4 doses Q14 days, and subsequently 1500mg Q 28 days x 11 doses (1 year total), or until progression of disease (POD), or limiting toxicity. All patients received MRI adaptive ablative radiation, 50Gy in 5 fractions between doses 1 and 2 of D. Primary endpoint: 6-m progression free survival (6 m PFS) by RECIST v1.1. Secondary endpoints were Duration of Response, Overall Response Rate (ORR), CA 19-9 response, rates of downstaging/resection, and survival outcomes (overall survival (OS) and progression-free survival (PFS)) calculated from date of enrolment. OS and PFS were estimated using Kaplan-Meier method. Pre- and on-treatment tissue, blood and microbiome samples were collected to evaluate tumor-intrinsic and peripheral immunogenomic correlates of response. Results: Between 09/2020 and 05/2022, N = 18 enrolled. Median age 67.5 years (IQR; 62.5, 71.5), 28% (5/18) female. Baseline Performance Status: N = 8 (44%) ECOG 0; N = 10 (56%) ECOG 1. Tumor location: Head/uncinate N = 9 (50%), body N = 7 (39%), neck N = 2 (11%). Median # doses FFX prior to enrolment: 8.5 (IQR; 8.0- 11.0). At median follow-up of 13.8 m, 6-m PFS: 62% (95% CI 43%, 91%). Median PFS: 10.2 m (95% CI; 5.03, NA) and median OS 17.2 m (95% CI; 12.98, NA). Disease progression (any time) N = 12, of which local POD in N = 7 (58%). N = 3 completed maintenance D; N = 5 on active treatment. ORR: N = 17 (94.4%) stable disease (95% CI; 64.6%, 99.4%). Toxicity endpoints of special interest: Grade 3 ICB-related: in N = 4 patients; diarrhea N = 2; elevated AST/ALT N = 2; G3 lipase elevation N = 1; attribution uncertain. Conclusions: D and SABR following FFX in LA PDAC had an encouraging 6-m PFS of 62% (43-91%) and a tolerable safety profile. Immuno-genomic analyses of correlative biospecimens is underway. Funding support AstraZeneca. Clinical trial information: NCT03245541 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: JCO Oncology Practice, American Society of Clinical Oncology (ASCO), Vol. 18, No. 4 ( 2022-04), p. e495-e503
    Abstract: Serious Illness Conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Although behavioral interventions may prompt earlier or more frequent SICs, their impact on the quality of SICs is unclear. METHODS: This was a secondary analysis of a randomized clinical trial ( NCT03984773 ) among 78 clinicians and 14,607 patients with cancer testing the impact of an automated mortality prediction with behavioral nudges to clinicians to prompt more SICs. We analyzed 318 randomly selected SICs matched 1:1 by clinicians (159 control and 159 intervention) to compare the quality of intervention vs. control conversations using a validated codebook. Comprehensiveness of SIC documentation was used as a measure of quality, with higher integer numbers of documented conversation domains corresponding to higher quality conversations. A conversation was classified as high-quality if its score was ≥ 8 of a maximum of 10. Using a noninferiority design, mixed effects regression models with clinician-level random effects were used to assess SIC quality in intervention vs. control groups, concluding noninferiority if the adjusted odds ratio (aOR) was not significantly 〈 0.9. RESULTS: Baseline characteristics of the control and intervention groups were similar. Intervention SICs were noninferior to control conversations (aOR 0.99; 95% CI, 0.91 to 1.09). The intervention increased the likelihood of addressing patient-clinician relationship (aOR = 1.99; 95% CI, 1.23 to 3.27; P 〈 .01) and decreased the likelihood of addressing family involvement (aOR = 0.56; 95% CI, 0.34 to 0.90; P 〈 .05). CONCLUSION: A behavioral intervention that increased SIC frequency did not decrease their quality. Behavioral prompts may increase SIC frequency without sacrificing quality.
    Type of Medium: Online Resource
    ISSN: 2688-1527 , 2688-1535
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 3005549-0
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