DFS Estimates Research Articles

Survival and prognostic factors of primary retroperitoneal sarcomas after surgery: a single-center experience.

The percentage of retroperitoneal sarcomas (RPS) among all soft tissue sarcomas ranges from 10 to 15%. Surgery remains the gold standard for RPS. In this study, we analyzed the impact of surgical treatment for primary RPS on recurrence and overall mortality at a Chinese institution and identified and evaluated prognostic variables. Data from patients with RPS who underwent surgical treatment were retrospectively analyzed. The patients were treated at a single center from January 2000 to June 2018. Retrospectively collected demographic, clinicopathological, and surgical factors were examined. Overall survival (OS) and disease-free survival (DSF) were used as the primary endpoints. Predicted 5-year survival rates, encompassing both DFS and OS, were derived from the Sarculator prognostic nomogram. A total of 110 patients met the inclusion criteria. The median follow-up time after surgery for patients with primary RPS was 5.3 years. During this period, 59 patients died. The 5-year OS and DFS estimates were 63.5% and 35.3%, respectively. In a multivariate analysis, poor OS following surgical treatment of primary RPS was independently correlated with FNCLCC grade (p < 0.001) and surgical margin status (p = 0.016). FNCLCC grade (p = 0.001) and surgical margin status (p = 0.002) were also independently associated with poor DFS. The C-indices for 5-year OS and DFS survival utilizing the Sarculator prognostic nomogram were 0.71 and 0.73 respectively. The overall mortality rate of patients with RPS was considered acceptable. OS and DFS prognostic markers were established for primary RPS. Tumor grade and intraregional margins are other factors that affect survival and recurrence.

Adjuvant chemotherapy following concurrent chemoradiation (CRT) in patients with high-risk early-stage cervical carcinoma following radical hysterectomy: Results of NRG oncology/RTOG 0724/GOG-0724.

5504 Background: To assess the efficacy of adjuvant systemic chemotherapy following CRT for patients (pts) with high-risk early-stage cervical carcinoma. Methods: Pts with clinical stage IA2, IB, or IIA cervical carcinoma with at least one of the following high-risk features after radical hysterectomy: positive pelvic nodes, positive parametrium, and/or positive para-aortic nodes were stratified by intention to use brachy (yes v no), RT (Standard v IMRT); and RT dose (45 v 50.4 Gy) then randomized 1:1 to CRT or CRT and 4 cycles of adjuvant chemotherapy with paclitaxel and carboplatin (CRT + chemo). Primary endpoint was disease-free survival (DFS: death, local or regional failure, or distant mets). Reported secondary endpoints are OS (death due to any cause) and AEs (CTCAEv4). Sample size was 235 pts (50 DFS events, HR=0.47, corresponding to an increase in 4-year DFS from 80% to 90% for the CRT + chemo arm, 80% power, 1-sided log-rank α=0.05). Multivariable analysis (MVA) used Cox regression models. Results: From 9/16/2009 to 3/2/2022, this phase III international trial enrolled 236 pts, with 212 eligible/analyzed (109 CRT and 103 CRT + chemo). Median age was 46 yrs (min-max: 25-77) and median follow-up for all pts was 4.5 yrs (min-max: 0.02-12.8). Fifty-one percent of pts identified as white, 39% as Asian, and 6% Black. Most pts had squamous cell carcinoma (76%), with 18% adenocarcinoma and 5% adenosquamous. 56% of pts had open radical hysterectomy, 23% laparoscopic, and 22% robotic. Most pts had stage IB (87%) and 74% had positive pelvic nodes. Four (4%) pts on the CRT arm and 1 (1%) patient on CRT + chemo did not receive RT. The median (min-max) RT dose delivered was 50.4 Gy (7.2-60.4). Four pts (2 on each arm) did not receive concurrent cisplatin and 27 (26%) pts did not receive adjuvant carboplatin and paclitaxel on the CRT + chemo arm. Grade 3 and 4 events occurred in 36% and 7% of CRT pts; 44% and 21% in the CRT + chemo arm. There were 50 failures, 26 and 24 on the CRT and CRT + chemo arms, respectively, with 4-yr DFS estimates of 76% (90% CI: 69%, 83%) and 77% (90% CI: 70%, 84%) for the CRT and CRT + chemo arms, respectively (HR=1.05 [90% CI: 0.65, 1.68], p=0.56). Thirty-seven of 50 first failures were distant [74%], 20 (40%) and 17 (34%) in CRT and CRT + chemo arms, respectively. On MVA, factors that were statistically significant for worse DFS were receiving vaginal brachy (p&lt;0.0001), RT dose ≥50 Gy (p=0.0021), and adenocarcinoma histology (p=0.03). Pts receiving brachy had close or positive margins. The estimated 4-yrs OS is 87% (90% CI: 82%, 93%) and 89% (90% CI: 84%, 94%) for the CRT and CRT +chemo arms, respectively (HR=0.91 [90% CI: 0.49 to 1.69]; 1-sided log-rank p=0.40). Conclusions: The addition of systemic chemotherapy following CRT didn't improve DFS or OS in cervical cancer patients with high-risk factors after radical hysterectomy. Clinical trial information: NRG Oncology/RTOG 0724/GOG-0724.

Abstract P4-03-13: AN EVALUATION OF BREAST CANCER RECURRENCE DATA REPORTED TO THE NCI SEER PROGRAM

Abstract Background: There are currently 18.1 million cancer survivors in the U.S. and the number is expected to increase to 22.5 million in the next ten years. The increasing number of survivors also means that the population at risk for cancer recurrence will increase. Recurrence significantly impacts patients’ health outcomes because there are limited treatment options. Currently, there are limited population level recurrence data in cancer registries world-wide. Most recurrence estimates have been derived from randomized clinical trials (RCTs) where the patient population only represents 4% of all cancer patients. Since 2018 the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) program has been collecting abstract-based recurrence information. Our goal is to use the SEER recurrence data sources to develop a high-quality population-based recurrence database to disseminate to the public for future research. Measuring recurrence from population-based cohorts can enhance our understanding of what clinical, demographic, and geographic factors impact the risk of recurrence and can inform researchers on developing prevention strategies. Methods: In November 2021 we obtained a dataset that included recurrence information such as type of first recurrence (defined by the Standard for Oncology Registry Entry manual) and date of first recurrence. To evaluate the burden of breast cancer recurrence in the U.S. SEER population, we described the cohort of women diagnosed with breast cancer from 2010 to 2019. We then evaluated the patients with information on the status of recurrence including those that never experience recurrence and those that were never disease free (NDF). We measured frequencies of recurrence by multiple clinical variables such as age at diagnosis, race, stage at diagnosis, and tumor subtype. We followed patients from their date of diagnosis to the event defined by first recurrence, second primary, death, or last contact. We used the Kaplan-Meier method to estimate DFS. Results: The analytic dataset included 412,920 female breast cancer cases diagnosed between 2010 and 2019. Most women diagnosed with breast cancer were between 40 and 64 years old (53%, n=218,760), were White (78%, n= 320,555), were diagnosed with localized tumors (52%, n=213,824), were HER2 negative (HER2-) hormone receptor positive (HR+) (56%, n=230,874), and received treatment (95%, n=390,959). During the observation period, 67% (n = 278,098) of women did not have a recurrence, 3% (n=10,922) had a recurrence, and 16% (n=66,319) were NDF. After excluding patients with NDF status, we observed that the age group with the highest frequency of recurrence was 20-39 (9%). For reference, 4% of women in the 40 to 64 age group has a recurrence event during the observation period. Black women had higher recurrence (6%) compared to white women (3%). Triple negative breast cancers had the highest recurrence (9%) out of all subtypes. When we measured DFS, we observed significant differences by race, independent of tumor subtype. For example, in patients with HER2+/HR+ tumors, the percentage of patients at 120 months who did not experience a DFS event were 73.6% (95% CI, 72.3% to 74.9%) in white women and 67.5% (95% CI, 63.9% to 70.8%) in black women. Discussion &amp; Conclusion: We are reporting population-based recurrence estimates for breast cancer obtained through the SEER program. This is the largest breast recurrence database in North America. The size of the database allowed precise estimation of recurrence stratified by demographics, subtype, and extent of disease. We observe trends consistent with previous reports and have identified some novel findings that warrant further study. Our long-term goal is to assess how DFS estimates derived from a population-based cohort compares to previously published estimates which are largely derived from RCTs. Citation Format: Esmeralda Ramirez-Pena, Serban Negoita. AN EVALUATION OF BREAST CANCER RECURRENCE DATA REPORTED TO THE NCI SEER PROGRAM [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-03-13.

Long-term survival in patients with node-positive breast cancer who undergo sentinel lymph node biopsy alone after neoadjuvant chemotherapy: meta-analysis.

Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in patients with breast cancer who are initially node-positive but convert to clinically/radiologically node-negative remains controversial. The primary aim was to assess pooled 5-year disease-free (DFS) and overall (OS) survival for patients who are initially node-positive but have a negative SLNB after NACT, and do not proceed to axillary lymph node dissection (ALND). The study was performed using PRISMA guidelines. A systematic literature search of relevant databases was conducted. The Der Simonian-Laird and Cochran-Mantel-Haenszel methods were used to calculate weighted pooled estimates for OS and DFS for this group compared with patients who had NACT and proceeded to ALND after a negative or positive SLNB. Seven studies involving 915 patients who had a negative SLNB after NACT were included. Pooled estimates of 5-year DFS and OS in patients with a negative SLNB after NACT were 86 (95 per cent c.i. 82.1 to 90.3) and 93.1 (87.8 to 97.0) per cent respectively. Patients with a positive SLNB who underwent ALND had reduced 5-year DFS (OR 0.49, 95 per cent c.i. 0.35 to 0.69; P < 0.001) and OS (OR 0.41, 0.16 to 1.02; P = 0.06) compared with those who had a negative SLNB after NACT. There were no differences in DFS for patients who had a negative SLNB only compared with those undergoing ALND with a pCR (OR 1.65, 0.71 to 3.79; P = 0.24). Patients who are initially node-positive and who achieve a complete clinical/radiological axillary response after NACT with a subsequent negative SLNB have high rates of DFS and OS after 5 years. Patients with residual disease have significantly reduced DFS and further axillary treatment may still be warranted.

930MO PD-L1 expression and outcomes of pembrolizumab and placebo in completely resected stage IB-IIIA NSCLC: Subgroup analysis of PEARLS/KEYNOTE-091

In the PEARLS/KEYNOTE-091 study of completely resected stage IB (T ≥4 cm) to IIIA NSCLC (AJCC v7) following ≤4 cycles of adjuvant chemotherapy as recommended per local guidelines (NCT02504372), pembrolizumab (pembro) significantly prolonged DFS vs placebo in the ITT population at the second interim analysis (IA2) (HR 0.76; P = 0.0014). The DFS benefit in the PD-L1 TPS ≥50% population was not significant (HR 0.82; P = 0.14). We present more detailed results for the PD-L1 subgroups. Eligible patients were randomized 1:1 to pembro 200 mg or placebo Q3W for 18 doses. PD-L1 TPS <1% vs 1-49% vs ≥50% was a stratification factor. Dual primary end points were DFS in the ITT and TPS ≥50% populations. Data are from IA2 (median follow-up, 35.6 months). Of the 1177 randomized patients, PD-L1 TPS was <1% in 39.5%, 1-49% in 32.2%, and ≥50% in 28.3%. Baseline characteristics were generally balanced between the pembro and placebo arms in the ITT and TPS ≥50% populations and were generally similar in the ITT and TPS ≥50% populations. Grade 3-5 AE rates for pembro vs placebo were 34.1% vs 25.8% in the ITT and 37.8% vs 25.0% in the TPS ≥50% population; AEs led to discontinuation in 19.8% vs 5.9% and 23.2% vs 6.7%. Pembro improved DFS in the TPS ≥50%, 1-49%, and <1% subgroups (Table).Table: 930MOPD-L1 TPSPembroPbo≥50%N = 168N = 165Median (95% CI), moNR (44.3-NR)NR (35.8-NR)Estimates at 12 / 24 / 36 mo, %79.5 / 67.9 / 65.974.5 / 67.1 / 57.6HR (95% CI)0.82 (0.57-1.18)*1-49%N = 189N = 190Median (95% CI), mo44.2 (34.9-NR)31.3 (22.5-NR)Estimates at 12 / 24 / 36 mo, %80.5 / 65.4 / 54.668.2 / 54.3 / 44.8HR (95% CI)0.67 (0.48-0.92)<1%N = 233N = 232Median (95% CI), mo47.4 (35.0-NR)34.9 (25.5-NR)Estimates at 12 / 24 / 36 mo, %76.6 / 68.5 / 55.572.3 / 58.3 / 48.8HR (95% CI)0.78 (0.58-1.03)*Dual primary end point; P = 0.14. Open table in a new tab *Dual primary end point; P = 0.14. As expected, median and long-term DFS estimates in the pembro arm were numerically improved in the PD-L1 TPS ≥50% subgroup vs the 1-49% and <1% subgroups. The lack of statistically significant benefit for pembro in the TPS ≥50% population at IA2 likely results from placebo overperformance in this population and a smaller population size. DFS in the PD-L1-selected populations will be tested at the next IA. Overall, data support the benefit of pembro for completely resected stage IB-IIIA NSCLC and, if recommended, adjuvant chemotherapy, regardless of PD-L1 expression.

Overall survival in patients with FIGO stage IVA cervical cancer

ObjectiveFIGO stage IVA cervical cancer is a unique diagnosis that conveys a poor prognosis. Despite the use of PET/CT for staging, concurrent chemotherapy, and image-guided brachytherapy, overall survival (OS) in these patients is low. Treatment requires aggressive use of radiotherapy and chemotherapy. We report results of a prospective observational cohort study for patients with de novo stage IVA cervical cancer treated at a single institution. MethodsPatients with a new diagnosis of stage IVA cervical cancer treated at an academic institution between 1997 and 2020 were prospectively monitored. Staging was retroactively assigned using the 2018 FIGO staging system. All patients had a PET/CT prior to treatment and were treated with definitive intent radiotherapy with or without chemotherapy. The primary outcome of interest was OS. Secondary outcomes were local control, progression-free survival (PFS), and disease-specific survival (DSS). Results32 patients with de novo stage IVA cervical cancer were treated with definitive intent radiotherapy. Median follow-up time was 4.27 years (1.31–10.35). 22/32 (69%) of patients received brachytherapy as a part of their definitive treatment, and 28/32 (88%) received chemotherapy concurrently with radiotherapy. 14/32 (44%) of patients had no evidence of disease at last follow-up. The 5-year local control, PFS, DFS, and OS estimates were 79%, 49%, 53%, and 48%, respectively. On multivariate analysis, complete metabolic response was associated with a statistically significant improvement in PFS (HR = 0.256, 95% CI = 0.078–0.836, p = 0.024) and OS (HR = 0.273, 95% CI 0.081–0.919). ConclusionsThese data demonstrate a robust OS in patients with stage IVA cervical cancer when treated with definitive chemoradiotherapy.

Safety and Oncologic Outcomes of Percutaneous Cryoablation of Renal Cell Carcinoma Recurrences in the Ipsilateral Kidney Following Partial Nephrectomy.

To retrospectively investigate the safety and oncological outcomes of cryoablation performed on residual/recurring renal cell carcinoma (RCC) in the ipsilateral kidney following partial nephrectomy (PN). Data dealing with patients', RCC, procedure (including the length of the hospital stay), and follow-up (technical efficacy [TE], local tumor progression-free survival [LTPFS], disease-free survival [DFS], metastasis-free survival [MFS], cancer-specific survival (CSS), and overall survival [OS]) were retrospectively collected and analyzed. Between January 2008 and November 2020, 21 consecutive patients (17 [81%] men; 4 [19%] women; median age 68years; range 43-82) underwent cryoablation due to residual/recurring RCC in the PN site (15 patients) or de-novo RCC (6 patients) in the ipsilateral kidney. Median tumor size was 2.2cm (mean 2.3cm; range 0.8-4; interquartile range [IQR] 1.9-3). There were two (2/21; 10%) minor self-limiting hemorrhagic complications, both occurring in the group of patients with RCC in the PN site. Median hospital stay was 2days (mean 2.1; range 1-5; IQR 2-2). TE was 100% (21/21 patients), and 10-year estimates of LTPFS, MFS and DFS were 74.1% (95% confidence intervals [CI] 56.8-96.7%), 36.4% (95% CI 14.2-93.8%), and 43.5% (95% CI 21.9-86.4%), respectively. CSS and OS were 100% at the last available follow-up (median 56months; mean 67.4; range: 12-147; IQR:34-95). Cryoablation in patients with residual/recurring RCC following PN is safe and results in high 10-year estimates of LTPFS.

Safety and Efficacy of Tcralpha/Beta and CD19 Depleted Haploidentical Stem Cell Transplantation Following Reduced Intensity Conditioning in Children: Results of a Prospective Multicenter Phase I/II Clinical Trial

We report one year follow-up data on safety and efficacy from the first prospective, multi-center, open-label, single-arm phase I/II clinical trial of TCRalpha/beta and CD19-depleted haploidentical stem cells grafts which were generated with the CliniMACS plus System (Miltenyi Biotec, Germany) and transplanted after reduced-intensity conditioning in pediatric patients with various malignant and non-malignant diseases (www.clinicaltrialsregister.org; 2011-005562-38). 30 patients were enrolled in the pediatric cohort of the trial and received single agent MMF as short-term GVHD prophylaxis (40mg/kg/day for 30 days). The grafts were manufactured in 4 GMP sites. The kinetics of immune cell reconstitution were measured in two core labs using standardized phenotypic analyses and the MACSQuant flow cytometer (Miltenyi Biotec, Germany). We previously reported the outcome of the first 100 days. This report covers a median follow-up of 367 days.Results: Thirty patients from six hospitals were treated (13 female, 17 male; median age 7 years, range 1 - 17 years). 10 patients had ALL, 8 AML, 6 solid tumors (soft tissue sarcomas and neuroblastomas), 3 MDS/MPS, and 1 each with lysosomal storage disorder, SCID, and Wiskott Aldrich syndrome. Disease status in acute leukemias/MDS were: CR1 (n=4), relapsed/refractory (n=17). 5/6 patients with solid tumors had relapsed metastatic disease. The conditioning regimen consisted of 15 or 30 mg ATG (Fresenius/Grafalon) or 7 Gy total nodal irradiation, 160 mg/m2 fludarabine, 10 mg/kg thiotepa, and 140 mg/m2 melphalan. The median numbers of CD34+ cells, TCRab+ cells and CD20+ cells infused per kg bw were 14.6 x 106 (range, 4 - 54.9), 14 x 103 (range, 0.62 - 40.6) and 0.55 x 105 (range, 0.04 - 1.85), respectively. Main cellular components of the graft were NK and TCRgd+ cells (median 6.67 x 107 and 1.58 x 107 cells per kg bw, respectively) with consistently high log depletions of TCRab+ and CD19+ cells: 4.75 and 3.44, respectively.None of the 30 recipients developed severe acute GVHD grades III - IV. The vast majority of patients (97%) experienced no or only grade I acute GVHD despite minimal GVHD prophylaxis after transplantation. One patient had acute GVHD grade II. Chronic GVHD was observed in two out of 23 patients (9%): one with skin and one with gut/liver involvement. In both cases GVHD was extensive.Twenty-four patients were evaluable for assessment of immune reconstitution until 1 year or discontinuation. Figure 1 shows fast and stable reconstitution of T, B and NK cells. TCRab+ T cells continued to increase during the observation period up to a median value of 741 cells/µL (range, 245 - 3132), whereas TCRgd+ T cells remained stable after reaching a plateau around day 20.ADV reactivation in 16 patients contributed most to infectious complications following transplantation. Of these 6 patients developed ADV disease. Within the first year after transplantation 3 patients died of overwhelming of ADV infection. One EBV reactivation was observed but recovered completely. 8 patients experienced CMV reactivation after transplantation. 7 of 8 patients recovered. Another 2 patients had CMV reactivation prior to transplant, but recovered shortly after engraftment. No CMV disease was observed within the first year. 6 patients had bacterial sepsis but recovered. In one patient CMV reactivation continued until death due to sepsis after graft failure.At a median of 367 days (range, 14 - 809) among the 30 recipients, 16 are alive at time of last follow-up, 8 died of relapse, 3 died of ADV infection, 1 died of sepsis after graft failure and 1 died of ARDS. 1 patient is lost to follow-up. Of the 8 patients who died of relapsed disease, 4 had active disease at time of transplant, 2 were in remission and 2 had disease status not evaluable. Cumulative incidences of relapse and NRM were 27% and 16% at one year, respectively. Kaplan-Meyer estimates of overall survival and DFS were 64% and 60% at one year, respectively.Conclusion: The CliniMACS TCRab+ / CD19+ depletion system yielded a large number of CD34+ cells, NK cells and TCRgd+ cells, that could be infused safely into pediatric patients with minimal risk of severe acute and chronic GVHD. The immune reconstitution was rapid. Coupled with a reduced-intensity regimen, the overall TRM was low. However, further efforts have to be made to avoid ADV associated infections. [Display omitted] DisclosuresLang:Miltenyi Biotec GmbH: Patents & Royalties, Research Funding. Bader:Novartis, Medac, Amgen, Riemser, Neovii: Consultancy, Honoraria, Research Funding. Karitzky:Miltenyi Biotec GmbH: Employment. Holtkamp:Miltenyi Biotec GmbH: Employment. Siewert:Miltenyi Biotec GmbH: Employment. Pflitsch:Miltenyi Biotec GmbH: Employment. Handgretinger:Miltenyibiotec GmbH: Patents & Royalties: Co-patent holder of TcR alpha/beta depletion technologies, Research Funding.

Conditional disease-free survival rates and their associated determinants in patients with epithelial ovarian cancer: A 15-year retrospective cohort study.

BackgroundThe most common type of ovarian cancer (OC) is epithelial ovarian cancer (EOC) which is the most lethal gynecologic malignancy in adult women.AimThis study aimed to determine the conditional disease‐free survival (CDFS) rates and their associated determinants in patients with EOC.Methods and resultsThe clinical and demographic data of 335 patients with confirmed EOC at Motahari Clinic (Shiraz, Iran) were retrospectively reviewed and analyzed. Traditional DFS (TDFS) and CDFS were calculated using the Kaplan–Meier method and cumulative DFS estimates, respectively. To evaluate the effects of the prognostic determinants on the DFS of the patients, a multiple covariate Cox analysis using the landmarking method was applied.The 1‐ and 3‐year TDFSs were 81.1% and 47.0%, respectively, and decreased over time. At baseline, a higher stage tumor and endometrioid histology were associated with a higher risk of recurrence when compared to stage I and other histological subtypes, respectively. The hazard of recurrence for older women (age ≥55 years) was approximately twice and three times more than that of women aged <45 years at 1‐ and 3‐year landmark time points, respectively.ConclusionThe age at diagnosis, defined by a cut‐off of 55 years, was a prognostic factor for the CDFS of EOC women. Moreover, patients with advanced‐stage EOC (ASEOC) (stages III and IV) and endometrioid histology had poorer CDFSs compared to those with early‐stage EOC (ESEOC) (stages I and II) and other histological types. In ESEOC patients with age at diagnosis of >55 years, CDFS gradually decreased in 3 years after remission which should be considered for follow‐up care decision‐making.

Safety and Oncologic Outcomes of Magnetic Resonance Imaging-Guided Cryoablation of Renal Cell Carcinoma: A 10-Year Single-Center Experience.

Magnetic resonance imaging guidance has been sporadically reported for renal tumor cryoablation (CA); therefore, clinical experience with this modality is still limited.The aim of this study is to retrospectively analyze our 10-year experience with renal tumor CA performed on a 1.5 T magnetic resonance imaging unit with the intent of reporting procedural safety and oncologic outcomes. We included 143 patients (102 men; 41 women; median age, 73 years; range, 34-91 years) with 149 tumors (median size, 2.6 cm; range, 0.6-6.0 cm), treated between 2009 and 2019. Patient, tumor, procedure, and follow-up data were collected and analyzed. The Kaplan-Meier method was used to estimate local recurrence-free (LRFS), metastasis-free (MFS), disease-free (DFS), cancer-specific, and overall (OS) survival. Univariate and multivariate models were used to identify factors associated with complications, LRFS, MFS, DFS, and OS. The overall complication rate was 10.7% (16/149 tumors), with 1 major (1/149 [0.7%]; 95% confidence interval, 0.0%-3.7%) hemorrhagic complication. Other minor complications (15/149 [10.1%]; 95% confidence interval, 0.6%-16.1%) did not include any cases of injury to nearby organs. There were no factors associated with complications.Five-year estimates of LRFS (primary/secondary), MFS, DFS, cancer-specific survival, and OS were 82.8%/91.5%, 91.1%, 75.1%, 98.2%, and 89.6%, respectively. Increasing tumor size (hazard radio [HR], 1.8; P = 0.02) and intraparenchymal tumor location (HR, 5.6; P < 0.01) were associated with lower LRFS; increasing patient's age (HR, 0.5; P = 0.01), high tumor grade (HR, 23.3; P < 0.01) and non-clear-cell/nonpapillary histology (HR, 20.1; P < 0.01) with metastatic disease; and high tumor grade (HR, 3.2; P = 0.04) with lower DFS. Magnetic resonance imaging-guided CA of renal tumors is associated with acceptable morbidity and high survival estimates at 5-year follow-up. Given the absence of complications resulting from injuries to nearby organs, further studies are required to evaluate whether the potential reduced incidence of these adverse events justifies large-scale implementation of this interventional modality.

Examination of Tumor Regression Grading Systems in Breast Cancer Patients Who Received Neoadjuvant Therapy

Neoadjuvant therapy is a common form of treatment in locally advanced breast cancer (LABC) patients. Besides some guidelines for grading regression, a standardized general scheme is not yet available. The aim of our study was to compare the prognostic impact of different regression grading systems, namely the TR/NR, Chevallier, Sataloff, Denkert-Sinn, Miller-Payne, NSABP-B18, Residual Disease in Breast and Nodes and Residual Cancer Burden (RCB) on disease-free (DFS) and overall survival (OS). Data of 746 breast cancer patients treated in neoadjuvant setting between 1999 and 2019 have been included. The different regression grades and follow-up data were collected from medical charts. Statistical analysis included the Kaplan-Meier method, log-rank test and multivariate Cox regression. The average patient age was 55 years. The DFS and OS estimates of patients with complete pathological regression and residual in situ carcinoma have been significantly more favorable than those having partial regression or no signs of regression (pDFS<0.001, pOS < 0.001). Significant differences were found between DFS estimates of classes with partial regression and without regression defined by RCB. Concerning DFS estimates, the RCB classification (p = 0.019), while regarding OS data the y-stage (p = 0.011) and the nodal status (ypN; p = 0.045) were significant prognosticators by multivariate Cox regression. Regression grading systems help the evaluation of regression in LABC patients treated with neoadjuvant therapy. Of the several grading systems compared, the RCB classification makes the best distinction between the outcomes of the different classes, therefore we recommend the inclusion of RCB into the histopathological findings.

Abstract P2-08-25: The 5-years conditional disease free survival and overal survival for breast cancer patients in Korea

Abstract Background: Most of breast cancer patients survive for a long-term period. The existing assessment of survivors’ prognosis has had some limitations in breast cancer because it is based on an evaluation at the time of diagnosis. Conditional survival reflects change over time after diagnosis and treatment of cancer. Conditional disease-free survival (CDFS) and conditional overall survival (COS) can provide more accurate prognosis to breast cancer patients. In this study, we aimed to determine 5-years CDFS and COS according to disease-free period after diagnosis and treatment of breast cancer in Korea. Method: We retrospectively reviewed clinical data of 5664 patients aged 16 to 86 who underwent curative surgery for breast cancer between January 2000 and December 2008 at Samsung Medical Center, a single tertiary hospital in Korea. The CDFS and COS rates were based on cumulative DFS and OS estimates up to 15 years using the Kaplan-Meier method. Results: At baseline, each 5-years DFS and OS were 88.0% and 93.8%. For patients who kept disease free status from 1 to 9 years after surgery, the 5-years CDFS rates were calculated as 88.7%, 90.7%, 91.6%, 91.1%, 91.5%, 91.0%, 89.5%, 86.1% and 86.1%, respectively. The 5-year COS rates of the patients who had survived from 1 to 9 years after surgical treatment were calculated as 92.6%, 92.1%, 91.2%, 91.0%, 89.4%, 85.6%, 80.7%, 75.3%, and 73.0%, respectively. Conclusion: Our study showed that 5-years CDFS and COS for most patients who have breast cancer in Korea seemed to be good prognosis for a long time. However, cancer recurrence tended to occur after a long period postoperatively. Further study is required to identify risk factors associated with recurrence after several years in Korean breast cancer patients. Citation Format: Jee Hyun Ahn, Seok Jin Nam, Seok Won Kim, Jeong Eon Lee, Byung-Joo Chae, Se Kyung Lee, Jai Min Ryu, Jonghan Yu. The 5-years conditional disease free survival and overal survival for breast cancer patients in Korea [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-08-25.

A Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post Infusion of T -Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells with Post Transplant Cyclophosphamide

Phase II trial evaluating the Efficacy and Safety of Sargramostim Post Infusion of T -Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells with Post-Transplant Cyclophosphamide Background: T-replete HLA mismatched haploidentical transplantation (Haplo) with post-transplant cyclophosphamide (PTCY) is widely used for patients lacking a suitably matched donor. Patients who receive haplo with PTCY usually start growth factor support (G-CSF) on day +5 for neutropenia prophylaxis. G-CSF is a specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage. Granulocyte-macrophage colony-stimulating factor (GM-CSF) on the other hand, is not restricted to neutrophils because it also affects monocytes and eosinophils and plays a central role in antifungal host response. In a prior randomized study among 206 matched allogeneic HCT patients (wang et al, J Clin Oncol. 2015;33(34):3999-4006), neutropenia prophylaxis with GM-CSF +/- G-CSF had significantly lower 100-day TRM, lower 100-day cumulative mortality, lower infection related mortality and lower 600-day invasive fungal disease related mortality compared to G-CSF. Given the increase number of HLA mismatched haplos with PTCY performed each year and the high risk of infectious complications associated with this type of transplant, we suggest that GM-CSF administration post haplo and PTCY can yield similar count recovery rate to GCSF with a potential of lowering risk of infectious complications. Endpoints : The primary endpoint is to establish equivalent effectiveness of sargramostim to a matched control cohort of G-CSF treated patients in time to neutrophil engraftment (ANC&gt;500 x 3 days) post haplo with PTCY. Secondary endpoints: estimates of OS, DFS, relapse rate, GVHD and TRM. Donor chimerism at days 30, 60, 100 and 6 months post-transplant. Incidence and grade of cytokine release syndrome between day 0 and 30. Incidence of infectious complications and infection related mortality at day 100. Immune profiling assay "CYTOF" will be measured at days 30, 60, 90 and 180 for functional and phenotypic immune analysis. Other secondary endpoints include length of hospital stay and charges-based cost comparison during the first 100 days between sargramostim and G-CSF matched controls. All primary and secondary endpoints will be reported for the study group and compared to a matched control cohort from our database containing patients who received haplo with PTCY using G-CSF for neutropenia prophylaxis. A set of 20 patients, who are not on the Sargramostim study and receiving haplo transplant with G-CSF at the same time of the study accrual period, will be consented for immunoprofiling assay at days 30, 60, 100 and 180. Methods: Patients aged 18-78 years with an available 5/10-8/10 HLA- matched related donor with high risk hematological malignancy with adequate organ function will be enrolled for the study. Patients will receive Sargramostim 250mg/m2 /day subcutaneous starting day +5 post haplo/PTCY and continue till ANC&gt;1000x 3 days or &gt;1500x 1 day. If grade 3 or 4 adverse reactions occur, reduce dose by 50% or temporarily discontinue the dose until the reaction abates. Conditioning regimens to be used include previously published and currently used at our center (Flu/Cy/TBI, Flu/high dose TBI or Flu/Mel). Treatment will be in the outpatient setting and admissions if clinically indicated. Sample Size Determination : Time to ANC&gt;500 will be evaluated between the prospectively enrolled patients and matched historical controls. Based on the data of haplo transplants done at Northside in 2010-2016, the standard deviations (SD) was 3 days for time to ANC500. The correlation in measurements between prospective patient and matched control is conservatively assumed to be 0.1. SD for differences between matched pairs would be 3.55 days for time to ANC500. To control the type I error to be 5%, the 90% paired t confidence interval for difference in time to ANC500 should be constructed and its upper boundary will be compared to the non-inferiority margin 2 days. The size of 35 prospective patients provides the power 90% for concluding that time to ANC500 for Sargramostim is no more than 2 days longer than historical controls. The actual enrollment size is decided to be 38 to accommodate 10% of drop off rate. Enrollment: The study is expect to start enrolling patients October 2019. Disclosures No relevant conflicts of interest to declare.

387P - 5-years conditional disease free survival and overall survival for breast cancer patients in South Korea

BackgroundMost of breast cancer patients survive for a long-term period. The existing assessment of survivors’ prognosis has had some limitations in breast cancer because it is based on an evaluation at the time of diagnosis. Conditional survival reflects change over time after diagnosis and treatment of cancer. Conditional disease-free survival (CDFS) and conditional overall survival (COS) can provide more accurate prognosis to breast cancer patients. In this study, we aimed to determine 5-years CDFS and COS according to disease-free period after diagnosis and treatment of breast cancer in Korea. MethodsWe retrospectively reviewed clinical data of 5664 patients aged 16 to 86 who underwent curative surgery for breast cancer between January 2000 and December 2008 at Samsung Medical Center, a single tertiary hospital in Korea. The CDFS and COS rates were based on cumulative DFS and OS estimates up to 15 years using the Kaplan-Meier method. ResultsAt baseline, each 5-years DFS and OS were 88.0% and 93.8%. For patients who kept disease free status from 1 to 9 years after surgery, the 5-years CDFS rates were calculated as 88.7%, 90.7%, 91.6%, 91.1%, 91.5%, 91.0%, 89.5%, 86.1% and 86.1%, respectively. The 5-year COS rates of the patients who had survived from 1 to 9 years after surgical treatment were calculated as 92.6%, 92.1%, 91.2%, 91.0%, 89.4%, 85.6%, 80.7%, 75.3%, and 73.0%, respectively. ConclusionsOur study showed that 5-years CDFS and COS for most patients who have breast cancer in Korea seemed to be good prognosis for a long time. However, cancer recurrence tended to occur after a long period postoperatively. Further study is required to identify risk factors associated with recurrence after several years in Korean breast cancer patients. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

182PD - Utility of the CPS+EG scoring system in triple-negative breast cancer treated with neoadjuvant chemotherapy

182PD - Utility of the CPS+EG scoring system in triple-negative breast cancer treated with neoadjuvant chemotherapy

Prevalence, disease-free (DFS) and overall (OS) survival of contemporary high-risk renal cell carcinoma (RCC) patients eligible for adjuvant checkpoint inhibitor trials: A RECUR database analysis.

636 Background: Designing adjuvant trials is challenging because of uncertainties of prevalence and outcome of high-risk RCC despite use of validated risk scores. Methods: RECUR is a European multicenter database capturing patient and tumour characteristics, recurrence patterns and survival of all patients treated with (partial) nephrectomy for non-metastatic RCC from 2006 to 2011 at each participating center. We evaluated prevalence, DFS and OS of RCC according to eligibility criteria of adjuvant trials IMMotion 010 (NCT03024996, IM), Checkmate 914 (NCT03138512, CM), Keynote-564 (NCT03142334, KN) and RAMPART (NCT03288532, RP), which all predominantly recruited high-risk clear cell RCC patients. Results: Of 2669 relevant patients in RECUR, 424(15.9%), 681(25.5%), 579(21.7%) and 1221(45.7%) met eligibility criteria for IM, CM, KN and RP respectively (p &lt; 0.001). Median DFS and OS estimates (Kaplan-Meier) in RECUR corresponding to each trial placebo arm were 37.5 (95%CI 30.4–44.6) and 89.6 (95%CI 76.1–103.0) months for IM, 89.4 (95%CI 66.1–112.7) and 96.2 (95%CI 79.8–112.6) months for CM, 62.6 (95% CI39.6–85.6) and 86.6 (95%CI 74.3–98.9) months for KN and finally at 144 months (DFS not reached) and 123.8 (95% CI 110.1 – 137.4) months for RP. Additionally, at pairwise analysis of evaluated trials, DFS estimates were significantly different between all trials (p &lt; 0.001) except between CM and KN (p = 0.125), while OS estimates did not differ significantly between all trials except between RP and the other three trials (p = 0.002). Conclusions: Percentages of eligible high-risk RCC patients in RECUR were low to moderate and, together with estimated placebo arm DFS and OS, varied due to differences in trial eligibility criteria. These differences may impact on the results and interpretation of the trials.

Long-term analysis of transorally resected p16 + Oropharynx cancer: Outcomes and prognostic factors.

We observed high survival in a previous report of a p16-positive, oropharyngeal carcinoma (OPC) cohort treated primarily with transoral laser microsurgery (TLM) ± adjuvant therapy and followed for ≥ 12 months. To address long-term outcomes of primary transoral surgery for this unique disease, we present an updated analysis of our cohort with extended follow-up. A prospectively assembled TLM cohort of 171 OPC patients was analyzed for disease-free, disease-specific, and overall survival (disease-free survival [DFS], disease-specific survival [DSS], overall survival [OS]) and functional outcomes, with a minimum follow-up of 60 months or to death. Median follow-up was 103 (60-201) months. Five-year DFS, DSS, and OS estimates were 85% (95% confidence interval [CI]: 80%-91%), 93% (95% CI: 89%-97%), and 90% (95% CI: 86%-95%). Recurrence occurred in 20 (12%; 7 locoregional, 13 distant); median time to recurrence was 18.8 months; and 90% occurred within 48 months. Age, smoking, American Joint Committee on Cancer 8th edition clinical tumor-category, pathologic tumor (pT)-category, pathologic tumor-node-metastasis (pTNM), and any adjuvant were significantly associated with disease-free survival in multivariable analyses, whereas pT-category, pN-category, TNM grouping, and angioinvasion were associated with DSS. A second primary developed in six (3.5%) patients. Indications for gastrostomy were recurrence/second primary (11), postadjuvant esophageal stenosis (6), comorbidities (3), and osteo/chondroradionecrosis (3); only seven (4%) had a gastrostomy tube in the absence of these factors, all of whom received adjuvant therapy. Two had a tracheostomy tube [chondoradionecrosis (1), recurrence (1)]. High 5-year survival and locoregional control were observed, with recurrence occurring more commonly as distant metastasis. The observed time to recurrence suggests posttreatment oncologic surveillance for at least 48 months. Identified prognosticators will inform adjuvant treatment considerations, trial planning, and patient counseling for long-term outcomes. Laryngoscope, 2018 LEVEL OF EVIDENCE: 2b Laryngoscope, 129:1141-1149, 2019.

Abstract P2-09-05: 12 years' median follow up (MFU) of BIG 1-98: Adjuvant letrozole, tamoxifen and their sequence for postmenopausal women with endocrine responsive early breast cancer

Abstract Background The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five yrs of adjuvant treatment with letrozole, tamoxifen, or their sequence in postmenopausal women with hormone-receptor–positive early breast cancer. The study is conducted by the International Breast Cancer Study Group (IBCSG) on behalf of BIG. 8010 patients (pts) were enrolled between March 1998 and May 2003, and first results demonstrating a significant DFS benefit favoring letrozole compared with tamoxifen were reported in 2005 at 25.8 months' MFU. Subsequent updates showed continuing DFS benefit and updated results published in 2011 at 8.1 yrs' MFU showed OS benefit. Industry-sponsorship of the original BIG 1-98 ended in 2010; IBCSG launched an observational, non-interventional long-term follow-up study (BIG 1-98 LTFU) to collect survival, disease status and adverse events for an additional 5 yrs. We report results from BIG 1-98 LTFU at 12 yrs' MFU. Methods The original trial includes the 8010 patients enrolled. The potential BIG 1-98 LTFU cohort consisted of 148 academic medical centers with a maximum of 6843 pts who were alive and continuing follow-up when the original study ended. Response bias was addressed using weighting class adjustments estimated using multivariable logistic regression. Unadjusted incidence rates are reported here per 1000 pt-yrs with 95% Poisson confidence intervals. An updated abstract will include adjusted incidence rates, as well as estimates of OS and DFS based on a weighted Kaplan-Meier approach. The database will close in July 2016. Results As of May 2016, 81 centers participated in the BIG 1-98 LTFU study, contributing data from approximately 3900 pts (57%) and extending MFU to 12 yrs. Compared with the potential cohort of 6843 pts, the ~3900 in the LTFU analytic cohort were more likely to be under age 65 yrs at enrollment, have node-positive disease, and have tumors that were &amp;lt; 2 cm, PgR positive (≥1%), and with no evidence of peritumoral vascular invasion. Extended adjuvant endocrine therapy for primary BC was continued in 2% of pts. Unadjusted incidence estimates of myocardial infarction increased during LTFU, while incidence of thromboembolic events and osteoporosis decreased (Table). Variations in incidence rates were noted depending on recording mechanism (e.g. registry, clinic visit, telephone, information from family). Unadjusted Incidence Rate/1000 pt-yrs (95% CI)Adverse EventDuring original studyDuring LTFUMyocardial Infarction1.7 (1.4-2.0)3.5 (2.7-4.5)Thromboembolic event6.0 (5.4-6.6)2.5 (1.8-3.3)Osteoporosis23.6 (22.5-24.9)18.2 (16.3-20.3)Bone fractures17.2 (16.2-18.3)15.0 (13.2-16.9) Overall 1845 deaths were reported; the unadjusted incidence of death was lower in the original study compared with during LTFU (21.9 vs. 26.6/1000 pt-yrs); incidence remained relatively stable for pts assigned to tamoxifen (24.9 vs. 25.2/1000 pt-yrs), and increased for pts assigned to letrozole (22.0 vs. 27.1/1000 pt-yrs). Conclusions The BIG 1-98 LTFU study has been successfully conducted. The additional data from the BIG 1-98 LTFU study provides important long-term clinical information about OS, DFS and adverse events. Citation Format: Thürlimann B, Giobbie-Hurder A, Colleoni M, Jensen M-B, Ejlertsen B, de Azambuja E, Neven P, Láng I, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Price K, Piccart-Gebhart M, Regan MM, Gelber RD, Coates AS, Goldhirsch A. 12 years' median follow up (MFU) of BIG 1-98: Adjuvant letrozole, tamoxifen and their sequence for postmenopausal women with endocrine responsive early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-09-05.

HLA-Haploidentical TCR αβ/CD19-Depleted Hematopoietic Stem Cell Transplantation in Children with Fanconi Anemia

Introduction. Allogeneic HSCT currently represents the only consolidated curative approach for Fanconi anemia (FA) patients, with best results observed in the HLA-identical sibling setting. For patients lacking an HLA-matched related or unrelated donor, haploidentical HSCT virtually assures the opportunity for nearly all patients to benefit from HSCT, offering the advantage of immediate accessibility to the transplant procedure. In order to overcome the limitation of delayed immune recovery, historically associated with this type of allograft, in the last few years we developed a novel method of ex vivo graft manipulation, consisting of the negative depletion of T-cell receptor (TCR) αβ+ T-lymphocytes and CD19 B-cells from peripheral blood stem cells (PBSC) grafts (ClinicalTrial.gov identifier: NCT01810120) (Bertaina el al., Blood 2014). Here we report our analysis in a subgroup of FA patients given TCRαβ/CD19-depleted haploidentical HSCT at our Institution.Patients and methods. Ten consecutive FA patients (6 girls and 4 boys) underwent a TCRαβ/CD19-depleted HSCT from an HLA-haploidentical relative between September 2011 and July 2015. Median age at diagnosis was 6.6 (range 2.7-22.0) years and median age at time of transplantation was 8.1 (range 4.4-22.2) years. The conditioning regimen included Cyclophosphamide 300 mg/m2/day and Fludarabine 30 mg/m2/day for 4 consecutive days (days -6 to -3), with 200 cGy single-dose TBI. Pretransplantation Fresenius® ATG was administered at a dose of 4 mg/kg/day for 3 consecutive days (days -5 to -3) in order to prevent both graft failure and graft-versus-host disease (GVHD). All patients received Rituximab 200 mg/m2 to reduce the risk of Epstein-Barr virus-related post-transplant lymphoproliferative disorders. Selective removal of TCRαβ+ and B-cells was performed on G-CSF-mobilized donor PBSC through labeling with biotinylated anti-TCRαβ antibodies and anti-CD19 antibodies, followed by incubation with anti-biotin antibodies conjugated to paramagnetic beads (CliniMACS; Miltenyi Biotec, Bergisch Gladbach, Germany). No immunosuppressive therapy was administered as post-transplantation prophylaxis against GVHD.Results. The TCRαβ/CD19-depletedgrafts contained a median of 20.40 x106/kg (range 15.80-33.40) CD34+ cells, 5.60 x106/kg (range 1.78-69.60) CD3+ lymphocytes, 0.021 x106/kg (range 0.002-0.043) TCRαβ+ lymphocytes, 5.60 x106/kg (range 1.78-69.60) TCRγδ+ lymphocytes, 0.036 x106/kg (range 0.013-0.079) CD20+ lymphocytes, and 45.30 x106/kg (range 16.2-177.0) NK cells. Engraftment with sustained full donor chimerism was achieved in 9 out of 10 patients, the cumulative incidence of graft rejection being 10% (95% CI, 0-26.8). The patient who rejected his first allograft achieved a complete engraftment after a second HSCT from one-antigen mismatched unrelated donor. No secondary graft failures were observed. The median time for neutrophil and platelet engraftment was 12 days (range, 9-15) and 9 days (range, 8-12), respectively. No patient experienced acute or chronic GVHD in the follow-up period. No transplant-related deaths occurred in our cohort. With a median follow-up of 28 months (range 13.2-39.1), the Kaplan-Meier estimates of OS and DFS were both 100%, while the EFS probability was 90% (95% CI, 47.3-98.5).Discussion. These data suggest that haploidentical HSCT after removal of TCRαβ+ and CD19+ lymphocytes is able to guarantee engraftment with excellent OS and DFS in patients affected by FA. Moreover, given the very low incidence of both acute and chronic GVHD, which has been shown to contribute to the increased risk of developing late post-transplantation malignancies in FA patients, this approach can be considered a very attractive option for FA patients in need of an allograft and lacking an HLA-identical family donor. DisclosuresNo relevant conflicts of interest to declare.

Myeloablative Allogeneic Hematopoietic Cell Transplantation Performed without Routine Inpatient Admission: A Single Center Experience of 462 Consecutive Patients

Patients undergoing allogeneic hematopoietic cell transplants (Allo-HCT) using myeloablative preparative regimens are usually admitted to an inpatient transplant unit from the start of the conditioning regimen until hematopoietic recovery (on average 25-35 days). Historically, the rationale for routine inpatient care during this period has been the facilitation of administration of parenteral medications, prevention of mold infections and the monitoring and management of acute toxicities. However, advances in supportive care and other technologies may allow outpatient management during this period. We analyzed outcomes of all consecutive patients who underwent myeloablative allo-HCT as defined by the CIBMTR (Giralt 2009, BBMT) with planned total outpatient management at our center. Patient characteristics and outcome data were prospectively entered into our institutional database from which they were extracted for this analysis. Patients were scheduled to receive their conditioning regimen and post-transplant care in our purpose-built outpatient clinic. Patients received their stem cell infusion on the inpatient unit and were planned to be discharged home the same day except patients receiving haploidentical transplants who were planned to be discharged on day +5 to accommodate the early cytokine release syndrome commonly seen in such patients (Solomon BBMT 2012). Subsequent admissions were for significant complications necessitating inpatient management only. Our technical approach to total outpatient management of myeloablative allo-HCT was as previously described (Solomon BMT 2010, 45: 468-475). Patients (n=462) were transplanted consecutively between 4/08 and 12/15. Patient characteristics were: median age 46; male (53%); race - white 79%, black 18%, Asian 2%; diagnosis- AML 42%, ALL 21%, MDS/MPS 21%, NHL/HL/CLL 13%, other 3%; donor type - MRD 48%, MUD 35%, Haplo 17%, CBT <1%; graft source- PBSC 87%, BM 12%, BM+PBSC 1%; regimen-busulfan based 60%, TBI based 39%, other 1%; DRI -low 16%, intermediate 48%, high 26%, v. high 10%; HCT-CI- 0-2 (64%), ≥3(36%). The conditioning regimen was entirely delivered in the outpatient clinic as planned in 377 patients (82%). Of 85 (18%) patients who received some of their conditioning regimen in the inpatient setting, in 42(49%) this was to receive drugs not administrable or reimbursed in the outpatient setting, and in 43(51%) it was for management of toxicity. The majority of patients were discharged within 24 hours of stem cell infusion (311 -67%) with the median day of discharge for the remaining patients being d+13 (range d+2 to d+75). Following discharge after stem cell infusion, 82 patients (18%) were never readmitted, days to readmission for the remainder were 0-5 (40%), 6-9 (24%), > 10 (18%). For readmitted patients, most frequent reasons were - febrile neutropenia 33%, mucositis 29%, and lower GI toxicity 4.5%. Median total length of inpatient stay through d+100 was 16 d (range 1-98). Fungal infections were documented in only 3 patients (1%) through d +100. With a median follow-up for surviving patients of 52 months (6-218 months), K-M estimates of survival and DFS at 1 yr are 70% and 61% and at 4 years are 52% and 47% respectively. Cumulative incidences (CI) of non-relapse mortality (NRM) and relapse at 1 yr are 17% and 21% and at 4 yrs are 24% and 29% (Fig.1). CI of acute GVHD grade 2-4 and 3-4 at 6 months were 28% and 10%. CI of moderate to severe, and severe chronic GVHD at 4 years were 30% and 12%. On multivariate analysis, receipt of any part of the conditioning regimen as inpatient was a significant negative factor for survival (HR 1.99, p<0.001), DFS (HR 1.74, p =0.001) and NRM (HR 2.06, p=0.004). These data show that myeloablative allo-HCT performed without routine inpatient admission from conditioning through neutrophil recovery is feasible with low rates of NRM and fungal infection. Median total inpatient stay through d +100 can be reduced to 16 days and nearly 20% of patients can avoid any inpatient stay through d +100. With mature follow-up outcomes appear similar or superior to those commonly reported using a traditional inpatient approach. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.