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  • American Society of Clinical Oncology (ASCO)  (13)
  • 2020-2024  (13)
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  • American Society of Clinical Oncology (ASCO)  (13)
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  • 2020-2024  (13)
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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 18 ( 2020-06-20), p. 2062-2076
    Abstract: There is no consensus on the best choice of an alternative donor (umbilical cord blood [UCB], haploidentical, one-antigen mismatched [7/8] –bone marrow [BM], or 7/8-peripheral blood [PB] ) for hematopoietic cell transplantation (HCT) for patients lacking an HLA-matched related or unrelated donor. METHODS We report composite end points of graft-versus-host disease (GVHD)–free relapse-free survival (GRFS) and chronic GVHD (cGVHD)–free relapse-free survival (CRFS) in 2,198 patients who underwent UCB (n = 838), haploidentical (n = 159), 7/8-BM (n = 241), or 7/8-PB (n = 960) HCT. All groups were divided by myeloablative conditioning (MAC) intensity or reduced intensity conditioning (RIC), except haploidentical group in which most received RIC. To account for multiple testing, P 〈 .0071 in multivariable analysis and P 〈 .00025 in direct pairwise comparisons were considered statistically significant. RESULTS In multivariable analysis, haploidentical group had the best GRFS, CRFS, and overall survival (OS). In the direct pairwise comparison of other groups, among those who received MAC, there was no difference in GRFS or CRFS among UCB, 7/8-BM, and 7/8-PB with serotherapy (alemtuzumab or antithymocyte globulin) groups. In contrast, the 7/8-PB without serotherapy group had significantly inferior GRFS, higher cGVHD, and a trend toward worse CRFS (hazard ratio [HR], 1.38; 95% CI, 1.13 to 1.69; P = .002) than the 7/8-BM group and higher cGVHD and trend toward inferior CRFS (HR, 1.36; 95% CI, 1.14 to 1.63; P = .0006) than the UCB group. Among patients with RIC, all groups had significantly inferior GRFS and CRFS compared with the haploidentical group. CONCLUSION Recognizing the limitations of a registry retrospective analysis and the possibility of center selection bias in choosing donors, our data support the use of UCB, 7/8-BM, or 7/8-PB (with serotherapy) grafts for patients undergoing MAC HCT and haploidentical grafts for patients undergoing RIC HCT. The haploidentical group had the best GRFS, CRFS, and OS of all groups.
    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
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 353-353
    Abstract: 353 Background: Pre-clinical and retrospective clinical data support an interaction of metformin (MET) and radiotherapy. Thus, MET may represent a cost-effective means to improve radiotherapy outcomes. We sought to investigate whether MET increases time to progression (TTP) when combined with salvage radiation therapy (SRT) in men with recurrent prostate cancer after radical prostatectomy (RP). Methods: Non-diabetic men with biochemical recurrence after RP were enrolled into an open label, randomized, phase 2 study in 17 hospitals in Switzerland, France, and Germany. The randomization (1:1) was stratified by Gleason score ( 〈 8 vs ≥8), surgical margin status (R0 vs R1), PSA at randomization (PSA 〉 0.5 vs ≤ 0.5 ng/mL), ADT use, and evidence of local recurrence. Following randomization, patients received either prostate bed SRT (70Gy) or prostate bed SRT (70Gy) + MET. MET 850mg PO QD was given for 4 weeks before SRT, then 850mg PO QD for 48 weeks. The primary endpoint was TTP. Secondary endpoints were progression-free survival, undetectable PSA under normal testosterone levels, 50% PSA response, clinical progression-free survival, time to further systemic therapy, prostate cancer-specific survival, overall survival, and adverse events (AE). The trial design was powered for a HR 0.65 with planned enrollment of 170 patients. The trial was prematurely closed by the sponsor due to financial reasons. Data is reported after patients reached a minimum follow-up of 12 months after SRT and corresponds to the final analysis. Results: A total of 111 patients were randomized (106 evaluable) between 10/2017 and 11/2020. The median PSA at randomization was 0.3 ng/mL (range, 0.03-1.5 ng/mL), 19 patients (17.9%) had Gleason ≥8, 54 (50.9%) pT3 disease, and 50 (47.2%) positive surgical margins. Twenty-four patients (22.6%) used short-term ADT. Trial arms were well balanced. At a median follow-up of 27.1 months (95% CI: 26.7-27.8), a total of 16 progression events occurred. The median TTP was not reached in either treatment arm. The hazard ratio adjusted by stratification factors was 1.25 (95% CI: 0.40-3.94; one-sided 80% CI: 2.05; log-rank p=0.62). Two-year TTP was 89% (95% CI: 76%-96%) in the SRT arm vs 82% (95% CI: 67%-91%) in the SRT + MET arm. No statistically significant differences were found for the secondary endpoints. Most common AE during treatment was grade 1-2 diarrhea (24.1% SRT vs 54.6% SRT + MET). Grade 2 and 3 AE (gastrointestinal and/or urinary) were 25.9% and 3.7% with SRT vs 34.5% and 7.3% with SRT + MET (p=0.41 and p=0.68), respectively. Conclusions: Adding MET to SRT did not result in a significant improvement in TTP in non-diabetic men with recurrent prostate cancer post-RP. Because of early trial closure and fewer than expected events, the trial may have been underpowered for this endpoint. Additional correlative studies will be pursued. Clinical trial information: NCT02945813 .
    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
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 7062-7062
    Abstract: 7062 Background: Pts with R/R LBCL after first-line (1L) treatment (tx) who are unable to undergo high-dose chemotherapy (HDCT) and HSCT have poor outcomes and limited tx options. PILOT (NCT03483103) evaluated liso-cel, an autologous, CD19-directed chimeric antigen receptor (CAR) T cell product, as 2L tx in pts with R/R LBCL not intended for HSCT. Methods: Eligible pts were adults with R/R LBCL after 1L tx who were not deemed candidates for HDCT and HSCT by their physician and met ≥ 1 frailty criteria: age ≥ 70 yr, ECOG PS = 2, DLCO ≤ 60%, LVEF 〈 50%, CrCl 〈 60 mL/min, or ALT/AST 〉 2 × ULN. Bridging tx was allowed. Pts received lymphodepletion with cyclophosphamide and fludarabine, followed 2–7 days later by liso-cel at a target dose of 100 × 10 6 CAR + T cells. Cytokine release syndrome (CRS) was graded per Lee 2014 criteria and neurological events (NE) per NCI CTCAE, version 4.03. Primary endpoint was ORR per independent review committee (IRC); all pts had ≥ 6 mo follow-up (f/u) from first response. Results: Of 74 pts leukapheresed, 61 received liso-cel and 1 received nonconforming product. Common reasons for pre-infusion dropout included death and loss of eligibility (5 each). For liso-cel–treated pts, median age was 74 yr (range, 53–84; 79% ≥ 70 yr) and 69%, 26%, and 5% met 1, 2, and 3 frailty criteria, respectively; 26% had ECOG PS = 2 and 44% had HCT-CI score ≥ 3. After 1L tx, 54% were chemotherapy refractory, 21% relapsed ≤ 12 mo, and 25% relapsed 〉 12 mo; 51% of pts received bridging chemotherapy. Median (range) on-study f/u was 12.3 mo (1.2–26.5). ORR and CR rate was 80% and 54%, respectively. Median DOR and PFS was 12.1 mo and 9.0 mo, respectively. Median OS has not been reached (Table). Most frequent tx-emergent AEs (TEAE) were neutropenia (51%), fatigue (39%), and CRS (38%), with grade (gr) 3 CRS in 1 pt (2%) and no gr 4/5 CRS. Any-grade NEs were seen in 31%, gr 3 in 5% (n = 3), and no gr 4/5 NEs; 7% received tocilizumab, 3% corticosteroids, and 20% both for tx of CRS/NEs. Overall, gr ≥ 3 TEAEs occurred in 79%, with gr 5 in 2 pts (both due to COVID-19). Two pts (3%) had gr 3/4 infections and 15 (25%) had gr ≥3 neutropenia at Day 29. Conclusions: In the PILOT study, liso-cel as 2L tx in pts with LBCL who met ≥ 1 frailty criteria and for whom HSCT was not intended demonstrated substantial and durable overall and complete responses, with no new safety concerns. Clinical trial information: NCT03483103. [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: 2022
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 8046-8046
    Abstract: 8046 Background: HRSMM patients (pts) have a median time to progression of 〈 2 years. ISA is a monoclonal antibody that binds to highly expressed CD38 on myeloma cells and is approved in RRMM. We designed a phase II study to test the efficacy of ISA +/- LEN in HRSMM (NCT02960555). Methods: The primary endpoint of the study was the overall response rate (ORR) after 6 months of ISA 20 mg/kg IV days 1, 8, 15, 22 cycle 1; days 1, 15 cycles 2-6; day 1 cycles 7-30 monotherapy (stage 1, n = 25) or with LEN 25 mg po daily on days 1-21 every 28 days, cycles 1-6 (stage 2, n = 36). Secondary endpoints are progression free survival (PFS), overall survival (OS) while exploratory endpoints included quality of life (QoL), flow and sequencing. Results: 61 HRSMM pts (+immunoparesis and ≥95%abnormal plasma cells in bone marrow) (stage 1 n = 25; stage 2 n = 36) were accrued 02/2017-10/2022. The study met its primary endpoint of ORR ≥ 70% after 6 cycles of therapy [Stage 2 ORR (89%) = VGPR 9 (25%), PR 23 (64%), MR 3(8%), PD 1(3%)]. Median time to response was 1 cycle. In stage 2, 17/36 (47%) patients had grade 3 treatment related adverse events (AEs): 1 pt related to ISA (myalgia, 3%) and 16 pts related to LEN (44%) [ANC decrease (36%), skin rash (8%), ALC decrease (11%), WBC decrease (8%), fatigue (6%)] and 1/36 pts a grade 4 (related to LEN) [ANC decrease 3%]. Most common grade 1-2 AEs: WBC decrease (53%), ANC decrease (56%), skin rash (28%), fatigue (39%), ALC decrease (42%), thrombocytopenia (28%), diarrhea (39%), constipation (28%). There were no grade 5 AEs. No patients dis continued treatment due to AEs. There were 3 deaths in stage 1 unrelated to therapy: 1 patient progressed to and died while on systemic AL amyloidosis therapy, one patient (with COPD) died of COVID19 while in sustained PR, one heavy smoker died of squamous cell cancer of the tongue. Pre- and post- treatment BM flow showed that ISA/LEN increased CD4+/CD8+ and effector memory cytotoxic T cells. QoL measures (n = 32; 15 in stage 1, 17 in stage 2 and 21 with both BL/after 6 months data) showed that ISA+/- LEN resulted in decreased cancer worry/anxiety and improved future perspective at 6 months compared to BL in both stages. QoL was favorable and conserved throughout treatment, suggesting minimal effects of treatment on patient assessment of well-being. For stage 1, median PFS was 49.3 months (95% CI:40.8~NA months); median OS not reached at a median f/u of 49 months (range 6.3-68 months). Stage 2 median PFS/OS is not reached. Conclusions: ISA/LEN results in high ORR without decrease in patient well-being. ISA monotherapy also results in prolonged PFS when compared to historical data. ISA/LEN therapy remodels the BM TME with increase in memory cytotoxic T cells. The results of this study give rationale for the ongoing phase 3 ITHACA evaluating ISA +/- LEN/DEX with the potential to change the standard of care in HRSMM (NCT04270409). RO and OL have equal contribution. Clinical trial information: NCT02960555 .
    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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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 12017-12017
    Abstract: 12017 Background: The 5-year survival rates for adolescents and young adults (AYA) with cancer have steadily improved, yet disparities by race/ethnicity persist. The drivers of these disparities remain unclear. Neighborhood socioeconomic deprivation has been linked to adverse health outcomes independent of the effects of individual-level measures of social determinants of health (SDOH). We evaluated the impact of neighborhood SDOH on overall survival (OS) in a diverse AYA cancer patient population treated in a single academic setting. Methods: This study utilized a multi-ethnic cohort of AYA cancer survivors (N=10,261) diagnosed between ages 15-39 seen at MD Anderson Cancer Center between 2000 and 2016. Patient demographics, zip code at presentation, cancer characteristics, and follow-up were obtained from our institutional tumor registry. Zip codes were linked to Area Deprivation Index (ADI) values, a validated neighborhood-level SDOH measure, with higher ADI representing worse SDOH. Results: The cohort included 6,361 (62%) non-Hispanic White, 1,112 (10.8%) non-Hispanic Black, and 2,133 (20.8%) Hispanic AYA cancer patients, with 655 (6.4%) of other ethnicities or missing information. The mean ADI value was significantly higher (p 〈 0.05) for Black (61.7) and Hispanic (65.3) patients, compared to White (51.2) patients. Analysis of ADI by cancer type showed significant differences, mainly driven by the significantly higher ADI in patients with cervical cancer (62.3) than other cancer types. In contrast, AYA patients diagnosed with breast cancer (53.0) and CNS tumors (52.9) resided in neighborhoods with the lowest ADI values. ADI was a significant predictor of OS overall. In multivariable models that included gender, age at diagnosis, cancer diagnosis, and race/ethnicity, risk of death for AYA cancer patients residing in neighborhoods with ADI in the highest quartile was greater than that for patients in the lowest quartile (HR: 1.09, 95% CI: 1.00-1.19, p=0.043). Conclusions: Our results in this large multi-ethnic cohort indicate that non-White AYA patients with cancer more commonly live in neighborhoods associated with higher ADI compared to their White counterparts. Even when treated in the same academic setting, AYA cancer patients with higher ADI experienced worse OS across cancers. Although the magnitude of the effect was moderate, the presence of this effect within a tertiary cancer center with existing barriers to care suggests that ADI is a meaningful risk factor impacting survival. Further analysis is warranted to determine the generalizability of these findings to the patient population more broadly. However, the results provide intriguing evidence for potential interventions aimed at supporting AYA cancer patients from disadvantaged backgrounds.
    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. 39, No. 15_suppl ( 2021-05-20), p. 5010-5010
    Abstract: 5010 Background: GC has been shown to independently prognosticate outcomes in prostate cancer. Herein, we validate the GC in a European randomized phase III trial of dose escalated SRT after RP. Methods: SAKK 09/10 (NCT01272050) randomized 350 patients with biochemical recurrence after RP to 64Gy vs 70Gy. No patients received androgen deprivation therapy (ADT) or pelvic nodal radiotherapy. A pre-specified statistical plan was developed to assess the impact of the GC on clinical outcomes. RP samples were centrally reviewed for the highest-grade tumor and those passing quality control (QC) were run on a clinical-grade whole-transcriptome assay to obtain the GC score (0 to 1; 〈 0.45, 0.45-0.6, 〉 0.6 for low-, intermediate-, and high, respectively). The primary aim of this study was to validate the GC for the prediction of freedom from biochemical progression (FFBP) using Cox multivariable analysis (MVA) adjusting for age, T-category, Gleason score, persistent PSA after RP, PSA at randomization, and randomization arm. The secondary aims were to evaluate the association of GC with clinical progression-free survival (CPFS) and use of salvage ADT. Results: Of 233 patients with tissue available, 226 passed QC and were included for analysis. The final GC cohort was a representative sample of the overall cohort, with a median follow-up of 6.3 years (IQR 6.0-7.2). GC score (continuous per 0.1 unit, score 0-1) was independently associated with FFBP (HR 1.14 [95% CI 1.03-1.25], p = 0.009). Higher GC scores were independently associated with CPFS, use of salvage ADT, and rapid biochemical failure ( 〈 18 months after SRT). High- vs. low/intermediate-GC showed a HR of 2.22 ([95% CI 1.37-3.58], p = 0.001) for FFBP, 2.29 ([95% CI 1.32-3.98] , p = 0.003) for CPFS, and 2.99 ([95% CI 1.50-5.95], p = 0.002) for use of salvage ADT. Patients with high-GC had 5-year FFBP of 45% [95% CI 32-59] vs 71% [95% CI 64-78] in low-intermediate GC. Similar estimates for GC risk groups were observed in the 64Gy vs 70Gy in GC high (5-year FFBP of 51% [95% CI 32-70] vs 39% [95% CI 20-59]) and in low-intermediate GC (75% [95% CI 65-84] vs 69% [95% CI 59-78]). Conclusions: This study represents the first contemporary randomized controlled trial in patients with recurrent prostate cancer treated with early SRT without ADT that has validated the prognostic utility of the GC. Independent of standard clinicopathologic variables and radiotherapy dose, patients with a high-GC were more than twice as likely than a lower GC score to experience biochemical and clinical progression and receive salvage ADT. This data confirms the clinical value of Decipher GC for tailoring treatment in the postoperative salvage setting.
    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: 2021
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 104-104
    Abstract: 104 Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have a lower participation rate in cancer clinical trials (CCT) than patients of high socioeconomic status (SES). Our comprehensive cancer center is notable for providing equal access to breast CCT (BCCT) through a private system (McNair) and a public safety net hospital system, Smith Clinic (SC). Our prior research has shown that SC cancer patients, who are 60% uninsured, predominantly low SES, and 〉 80% racial minorities, are 40% less likely to enroll into BCCT compared to McNair patients who are 〉 95% insured and largely White. Methods: We developed a 7-minute video with testimonies of our current patients (who are of diverse racial and linguistic backgrounds) about their BCCT experience and testimonies of our research team discussing misconceptions surrounding BCCT and biospecimen collection. The video was designed to be culturally sensitive and used simplified terms in English, Spanish, and Vietnamese. We modified a validated questionnaire by UT Health San Antonio, Institute for Health Promotion Research to assess participants’ attitudes towards CCT participation before and after watching the video. We used a Wilcoxon Signed Rank test to measure the effect of the video on a 5-point Likert scale with 5 indicating “Extremely likely”, 3 “Moderately Likely” and 1 “Not Likely at all”. The primary outcome was a shift in likelihood of participation in a CCT by 1. Other outcomes included assessing the effects of English proficiency, residing in United States (US) for at least 10 years, race, stage of breast cancer diagnosis (high risk vs. early stage vs. metastatic disease) using Chi-squared tests. With 200 survey respondents, the study had 97% power to detect the desired primary outcome. The project was supported by a Pfizer education grant. Results: A total of 200 patients (73 at McNair and 127 at SC) watched the video and completed the surveys. 93 identified as Hispanic, 50 as African American, 14 as Asian, 47 as White, and 7 as other races. The mean pre-intervention score for likelihood of willingness to participate in a CCT was 3.34 (SD 1.45) at McNair and 2.81 (SD 1.28) at SC. The mean post-intervention score was 3.89 (SD 1.28) at McNair and 3.44 (SD 1.22) at SC. While the pre- and post-intervention scores were significantly different across the two sites (p = 0.01 and p = 0.015 respectively), the study did not meet its primary objective. English proficiency, residing in US for at least 10 years, race, and stage of breast cancer diagnosis were not significantly associated with the outcome. Conclusions: Our patient education video did not improve our patients’ willingness to participate in BCCT as much as we had hoped. This suggests that a comprehensive approach is required to improve our community’s engagement and close the disparity gap in BCCT enrollment.
    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: 2022
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 6_suppl ( 2021-02-20), p. 194-194
    Abstract: 194 Background: Salvage radiotherapy (RT) is often utilized in case of biochemical progression after radical prostatectomy (RP). Here we report the outcomes of the European SAKK 09/10 randomized phase 3 trial with the aim to compare effectiveness and tolerability of conventional vs. dose-intensified salvage RT. Methods: SAKK 09/10 is an open-label, multicenter, randomized phase 3 trial performed in 24 centers in Switzerland, Germany and Belgium. Men with biochemical progression (two consecutive rises with the final PSA 〉 0.1 ng/mL or three consecutive rises) after RP with a PSA nadir of ≤ 0.4 ng/mL, with a PSA ≤ 2 ng/mL at randomization and without clinical evidence of macroscopic disease were recruited. Patients were randomly assigned to either conventional dose RT (64 Gy in 32 fractions) or dose-intensified RT (70 Gy in 35 fractions) directed to the prostate bed. Three-dimensional conformal RTor intensity-modulated RT/rotational techniques were used. The primary endpoint was freedom from biochemical progression (PSA ≥ 0.4 ng/mL and rising). Secondary endpoints included clinical progression-free survival, time to hormonal treatment, overall survival, acute and late toxicity (according to the NCI CTCAE v4.0) and quality of life (according to the EORTC QLQ-C30 and PR25). The trial was registered under NCT01272050 in clinicaltrials.gov. Results: Between 02/2011 and 04/2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175), of whom 344 aged between 48 to 75 years were assessable for the intention-to-treat population. The median PSA at randomization was 0.3 ng/mL (range, 0.03-1.61 ng/mL). At the time of data cutoff (July 3, 2020), the median follow-up was 6.2 years (IQR 5.5-7.2) and a total of 138 biochemical progression events occurred. The estimated freedom from biochemical progression rate at 6 years was 62.3% (95% CI 54.2-69.4%) and 61.3% (95% CI 53.4-68.3%) for the 64 Gy and the 70 Gy arm, respectively, and the hazard ratio adjusted by stratification factors was 1.14 (95% CI 0.82-1.60; log-rank p = 0.44). No significant difference was found for clinical progression-free survival, time to hormonal treatment and overall survival between the two arms, respectively. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21.2%) and 13 (7.9%) patients treated with 64 Gy, and in 46 (26.3%) and 7 (4%) patients with 70 Gy (p = 0.81). Lategrade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and 7 (4.2%) patients with 64 Gy, and in 35 (20%) and 4 (2.3%) patients with 70 Gy(p = 0.009). Quality of life data will be presented. Conclusions: Dose-intensified salvage RT to the prostate bed was not superior to conventional dose RT. However, dose-intensified salvage RT was associated with higher frequencies of late grade ≥ 2 gastrointestinal toxicity. Clinical trial information: NCT01272050.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
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  • 9
    Online Resource
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    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e19048-e19048
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e19048-e19048
    Abstract: e19048 Background: Cancer patients experience morbidity and mortality from infections, including COVID-19. Results are in conflict as to whether hematologic malignancy (heme) patients or solid tumor (solid) patients are at particular risk. We compared COVID-19 infection outcomes in these cohorts at our institution. Methods: Retrospective chart review of COVID-19 patients diagnosed from February 2020 to January 2021 who had a heme or solid diagnosis. We used Chi square analyses and t-tests for statistical correlations. Results: We analyzed outcomes of 146 COVID-19 episodes. Median age was 64 (25-97), 49% were female, and 24% were minorities. 49 (34%) had heme malignancy. Age, race, BMI, Karnofsky, and Charlson index (CCI) were similar for heme and solid cohorts. All-cause mortality (37 vs 15%) and COVID-induced mortality (33 vs 10%) were higher in heme vs solid, Table 1. Need for hospitalization (73 vs 46%, p = 0.009) and ICU care (31 vs 14%, p = 0.02) were worse for heme. Mean length of stay was 14.6 days and did not statistically differ for both groups. Overall risk of thrombosis was 11%. Severity of hypoxemia correlated with mortality. Compared with patients not requiring oxygen, relative risk (RR) of mortality was 3.06 (p = 0.06) for nasal cannula, 3.82 (p = 0.03) for high-flow oxygen, and 11.9 (p = 0.0008) for ventilation. Heme patients trended towards increased need of high-flow oxygen or ventilation vs solid patients, RR = 1.65 (p = 0.06). Additional mortality predictors were chemo within 6 months of COVID-19, age 〉 65, nursing home residency, CCI 〉 5, ICU care, max CRP 〉 100, ferritin 〉 1000, abs lymph count 〈 500, platelet count 〈 100, and bacteremia or C. difficile coinfection (Table). Race, gender, Appalachian status, and BMI did not predict mortality. Among the above factors, recent chemo (p=0.0001) and bacteremia (p = 0.03) were more common in heme vs solid patients. A higher proportion of heme patients received treatment for COVID-19 (51 vs 32%, p = 0.03). The most frequent therapies across the whole group were steroids (n=43), remdesivir (n=29), and azithromycin (n = 17). Conclusions: COVID-19 poses elevated mortality and morbidity risk for hematologic malignancy vs other cancer patients despite similar pre-infection demographics. Not surprisingly, need for ICU care, age, recent chemotherapy, and comorbidities elevate mortality risk in both heme and solid patients. Elevated inflammatory markers and severe lymphopenia appear to identify those patients who have immune dysregulation and greatest mortality risk. Mortality predictors.[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: 2021
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 8037-8037
    Abstract: 8037 Background: Currently approved CAR T cell therapies are generally administered as inpatient (inpt) treatment at university medical centers due to concerns about frequency, onset, severity, and management of AEs, including cytokine release syndrome (CRS) and neurologic events (NEs). We sought to characterize whether patients (pts) could be safely monitored in the outpatient (outpt) setting after receiving liso-cel, an investigational, CD19-directed CAR T cell product administered at equal target doses of CD8+ and CD4+ CAR+ T cells, across university and non-university sites in TRANSCEND NHL 001 (NCT02631044), OUTREACH (NCT03744676), and PILOT (NCT03483103). Methods: Eligible pts had R/R LBCL after systemic chemoimmunotherapy; moderately impaired organ function was allowed. For outpt infusion of liso-cel, pts were required to receive safety monitoring education, have a caregiver and stay within 1 h travel to site of care for 30 d post-treatment. All study sites had a multidisciplinary CAR T cell team and standard operating procedures for toxicity monitoring and management. Results: At data cutoff, 53 pts had received liso-cel on Study Day 1 and were monitored as outpts (university, n = 33; non-university, n = 20), including pts ≥65 y of age (n = 23) and with high tumor burden (SPD ≥50 cm 2 ; n = 16). Any grade CRS and NEs were reported in 18 (34%) and 14 pts (26%), respectively. Severe CRS and/or NEs occurred in only 2 pts (4%) and were reversible. Median (range) time to onset of CRS and NEs was 5 (2–9) and 8.5 (3–22) d, respectively. Tocilizumab and/or corticosteroids for treatment of CRS and/or NEs were required in 8 pts (15%). Overall, 30 pts (57%) required hospitalization post-treatment, with a median (range) time to hospitalization post-treatment of 5.5 (2–22) d; 9 pts (17%) were hospitalized Study Day 4 or earlier. Two pts required ICU-level care. There were no grade 5 treatment-emergent AEs. Safety in pts monitored as outpts was comparable across types of sites. Overall response rate was 81% (95% CI, 68–91). Safety and efficacy were consistent with data from inpts across the 3 studies (N = 270). Conclusions: Pts with R/R LBCL were successfully treated with liso-cel and monitored for CAR T cell-related toxicity in the outpt setting across different types of sites. Incidences of severe CRS, NEs, and early hospitalization were low; 43% of pts did not require hospitalization. A larger dataset will be presented, including comparisons of outpts vs inpts and sites of care. Clinical trial information: NCT02631044 (TRANSCEND NHL 001), NCT03744676 (OUTREACH), NCT03483103 (PILOT) .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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