tbuckley/cabot-search huggingface dataset:
Updated results from TIGER-X, a phase I/II open label study of rociletinib in patients (pts) with advanced, recurrent T790M-positive non-small cell lung cancer (NSCLC).
Authors: Jonathan Wade Goldman, Jean-Charles Soria, Heather A. Wakelee, D. Ross Camidge, Shirish M. Gadgeel, Helena Alexandra Yu, Karen L. Reckamp, Vassiliki Papadimitrakopoulou, Maurice Perol, Sai-Hong Ignatius Ou, Shannon L. Matheny, Darrin Despain, Jeffrey D. Isaacson, Sergey Yurasov, Lindsey Rolfe, Lecia V. Sequist
Journal: Journal of Clinical Oncology (2016)

9045 Background: Rociletinib is an oral, irreversible tyrosine kinase inhibitor of mutant epidermal growth factor receptor. Previously, we reported that rociletinib is active at doses ≥ 500 mg BID in TIGER-X (NCT01526928; Sequist et al. N Engl J Med 2015;372:1700-9; Sequist et al. J Clin Oncol 2015;33(suppl):abstr 8001). Updated results from TIGER-X are presented. Methods: Investigation is ongoing with two doses (500 and 625 mg BID) at sites in Australia, Europe, and the USA. The primary endpoints are objective response rate (ORR) and duration of response (DOR). Secondary endpoints include safety and progression-free survival (PFS). Results: As of the prespecified enrollment cutoff date of July 1, 2015, 175 and 242 pts enrolled in the 500 and 625 mg BID dosing groups, respectively. Of those pts, 156 (500 mg BID) and 175 (625 mg BID) had centrally confirmed T790M-positive tumors. Additional data are presented in the Table. Conclusions: Rociletinib produces durable responses in pts with poor prognoses and advanced, recurrent, T790M-positive NSCLC, albeit at lower rates than previously reported. Investigation is ongoing to determine which dose provides the optimal benefit-risk profile. Updated data (including median PFS) will be presented at the meeting. Clinical trial information: NCT01526928. 500 mg BID 625 mg BID n (all pts) 175 242 Age, years† 63.0 64.0 Gender, female, % 73.7 63.6 ECOG Performance Status = 1, % 68.6 71.1 Asian ethnicity, % 19.4 20.2 Enrolled in North America, % 82.9 83.5 Time since diagnosis, months† 30.6 28.7 History of CNS disease, % 44.6 43.4 Treatment-related AEs ( ≥20%), % All Grades Grade ≥ 3 All Grades Grade ≥ 3 Hyperglycemia‡ 46.9 26.9 58.3 35.5 Diarrhea 41.7 1.7 49.6 5.0 Nausea 28.0 1.7 40.9 2.5 Fatigue 28.6 2.9 38.0 6.2 QTc prolongation‡ 20.6 5.1 27.7 9.5 Decreased appetite 21.1 0.6 23.6 1.7 n (intent-to-treat/T790M-positive pts) 156 175 Assessment INV IRR INV IRR Confirmed ORR, % (RECIST v1.1) 25.0 21.8 39.4 31.4 95% CI 18.4–32.6 15.6–29.1 32.1–47.1 24.6–38.9 DOR, months† 9.0 12.2 7.9 8.8 95% CI 4.6–11.0 5.0–NR 5.6–9.2 7.0–11.1 CI, confidence interval; INV, investigator; IRR, independent radiology review; NR, not reached. Data cutoff: September 18, 2015; †Median; ‡Combined terms
Plasma and cerebrospinal fluid pharmacokinetics of selumetinib in non-human primates (NHP).
Authors: Andrea M. Gross, Cynthia M. McCully, Katherine E. Warren, Brigitte C. Widemann
Journal: Journal of Clinical Oncology (2017)

e14070 Background: Selumetinib (AZD6244 hyd sulfate) is an orally bioavailable agent targeting mitogen-activated protein kinase (MEK) 1/2. Selumetinib has shown activity in children with NF1 plexiform neurofibromas and refractory low-grade gliomas. The central nervous system (CNS) penetration of selumetinib in humans is unknown. Methods: We analyzed selumetinib in the cerebrospinal fluid (CSF) of NHP as a surrogate for CNS penetration. Four adult male rhesus macaques were each given a single dose of selumetinib capsules 2.5 mg/kg (human equivalent dose 50 mg/m 2 ) by mouth on an empty stomach. Selumetinib was quantified in serial paired plasma and CSF samples from 0 to 48 hours after administration by Covance Bioanalytical Services (lower limit of quantification 0.5 ng/mL). Free selumetinib was estimated at 2.3% of total based on reported plasma protein binding of 97.7% in NHP. Pharmacokinetic parameters including area under the concentration x time curve (AUC) of selumetinib were calculated using non-compartmental methods and CSF penetration was calculated from the ratio of AUC (CSF): AUC (plasma). Results: Selumetinib was detected in plasma in all four NHPs, but in the CSF of only one NHP (ZH60). The mean (± SD) AUC 0- ∞ and half-life (t 1/2 ) in plasma were 3350 ± 489 ng•h/mL and 10.8 ± 2.5 hours, respectively. In ZH60, the CSF AUC 0- 48 hr was 10.6 ng•h/mL. The CSF penetration of total and free selumetinib in this animal was 0.4%, and 14%, respectively. The mean plasma AUC and t 1/2 were comparable to that of children (2842 ng•h/mL and 6.9 hours, respectively) at a similar dose in a phase I trial. However, the average peak concentration in children occurred at approximately 1 hour with a C max of 841 ng/mL, while the C max in NHP plasma ranged from 1 – 4 hours and averaged 198.8 ng/mL. Conclusions: The CSF penetration of oral selumetinib is limited; in one NHP it was 0.4% and 14% when corrected for plasma protein binding of selumetinib. The fact that plasma AUC 0- ∞ and half-lives in NHP were similar to previously reported human plasma PK indicates that this model may accurately reflect human CSF penetration as well.
Final results of ENLIVEN: A global, double-blind, randomized, placebo-controlled, phase 3 study of pexidartinib in advanced tenosynovial giant cell tumor (TGCT).
Authors: William D. Tap, Hans Gelderblom, Silvia Stacchiotti, Emanuela Palmerini, Stefano Ferrari, Jayesh Desai, Sebastian Bauer, Jean-Yves Blay, Thierry Alcindor, Kristen N. Ganjoo, Javier Martin Broto, Christopher W. Ryan, Dale Edward Shuster, Ling Zhang, Qiang Wang, Henry Hsu, Paul S. Lin, Sandra Tong, Andrew J. Wagner
Journal: Journal of Clinical Oncology (2018)

11502 Background: TGCT is a rare neoplasm of the joint/tendon sheath associated with colony-stimulating factor 1 (CSF-1) overexpression. No approved systemic therapy is available. Pexidartinib (Pex), a selective inhibitor of CSF-1 receptor, KIT, and FLT3-ITD, showed promising Phase 1 activity in TGCT. Two severe liver toxicity cases (1 required liver transplant, 1 associated with death) have been observed with Pex across the non-TGCT development program. Methods: Patients (pts) ≥18 yr with symptomatic TGCT, for whom surgery would be associated with potentially worse function or severe morbidity, were randomized (1:1) to Pex or placebo (Pbo) 1000 mg/d x 2 wks then 800 mg/d PO x 22 wks (Part 1). Pts completing Part 1 could continue into an open-label Pex extension (Part 2). The primary endpoint was centrally reviewed overall response rate (ORR) by RECIST at Week 25 for which the study was powered to detect a 25% difference (35% vs 10%). Results: 120 pts were treated, 61/59 on Pex/Pbo. Due to 2 cases of nonfatal, serious hepatic toxicity, the DMC halted enrollment 6 pts short of target and stopped entry of pts on Pbo into Part 2. At the end of Part 1, ORR by RECIST in the ITT population was 39.3% vs 0% (P< 0.0001); after a median 6-mo follow-up (longest 17 mos), no responders have progressed. Secondary endpoints for Pex vs Pbo were ORR by tumor volume score (55.7% vs 0%, P< 0.0001), range of motion (+15.1% vs +6.2%, P =0.0043), PROMIS physical function (+4.06 vs -0.89, P =0.0019), worst stiffness (-2.45 vs -0.28, P <0.0001), and pain response (31.1% vs 15.3%, 1-sided P= 0.032). Hepatic toxicities were more frequent with Pex (AST ≥5X ULN 11.5%, ALT ≥5X ULN 19.7%, total bilirubin ≥2X ULN 4.9%). 8 pts discontinued Pex due to hepatic effects; 4 were serious nonfatal AEs with increased bilirubin, one lasting ~7 mos. Other AEs ≥15% and more common with Pex included hair color changes, vomiting, fatigue, dysgeusia, and periorbital edema. Conclusions: Pex resulted in significantly improved ORR and clinical benefit in terms of functional outcomes. Serious liver toxicity was observed in some pts. Pex may offer a relevant treatment option for select pts. Clinical trial information: NCT02371369.
A phase I expansion study of pegargiminase, cisplatin, and pemetrexed in argininosuccinate synthetase 1-negative recurrent high grade gliomas (HGGs).
Authors: Peter Edward Hall, Rachel Lewis, Nelofer Syed, Richard Shaffer, Jane Evanson, Stephen Ellis, Matthew Williams, Xiaoxing Feng, Amanda Johnston, Jim Thomson, Fiona Harris, Raj Jena, Ramsay Khadeir, Bor-Wen Wu, John S. Bomalaski, Timothy Crook, Michael Sheaff, Simon Pacey, Nick Plowman, Peter Wojciech Szlosarek
Journal: Journal of Clinical Oncology (2018)

e14085 Background: Patients (pts) with recurrent HGGs are usually managed with alkylating chemotherapy +/- bevacizumab. However, prognosis remains poor with an overall survival (OS) of 7-9 months. Preclinically, we showed that HGGs are a target for arginine depletion with Pegargiminase (ADI-PEG20) due to epimutations of argininosuccinate synthetase (ASS1) and argininosuccinate lyase (ASL). Moreover, ADI-PEG20 disrupts pyrimidine pools in ASS1-ve HGGs, thereby impacting sensitivity to the antifolate, pemetrexed. Methods: We expanded a phase 1 trial of ADI-PEG20 with pemetrexed and cisplatin (ADIPEMCIS), which noted activity in aggressive thoracic cancers, to pts with relapsed HGGs (clinicaltrials.gov NCT02029690). Pts with ASS1-ve recurrent HGGs were enrolled (01/16 – 06/17) to receive ADI-PEG20 weekly at the maximum tolerated dose of 36 mg/m2 i.m. plus PEM 500 mg/m2 and CIS 75 mg/m2 i.v. every 3 weeks for up to 6 cycles. Pts with disease control were allowed ADI-PEG20 maintenance. The primary endpoints were safety, tolerability and preliminary estimates of activity. Additional endpoints included pharmacodynamics, immunogenicity, OS, and ASS1/ASL epimutations. Results: 10/19 ASS1-ve heavily pre-treated pts were enrolled onto ADIPEMCIS therapy. Treatment was well tolerated with the majority of adverse events (AEs) being CTCAE v4.03 grade 1-2; 7 pts (70%) had at least one grade 3 or 4 AE with neutropenia (40%) and thrombocytopenia (30%). The best response was stable disease by RECIST 1.1 and partial response (n = 1; 10%) by Response Assessment in Neuro-oncology (RANO) criteria. The median (95% CI) OS was 6.5 (1.8, 9.7) months. Plasma arginine and the anti-ADI-PEG20 antibody titer were suppressed with a reciprocal increase in citrulline. Two pts are alive and 1 continues 16 months on ADI-PEG20 as 3rd-line therapy for a de novo glioblastoma multiforme. Epimutations in ASS1 and/or ASL were detectable in pts’ tumors consistent with prior studies. Conclusions: ADIPEMCIS was well tolerated and compares favorably to historical controls in recurrent HGG. A randomized, phase II trial comparing ADIPEMCIS with alkylating drugs at first relapse is planned (ATOMIC-G). Clinical trial information: NCT02029690.
Large retroperitoneal lymphadenopathy (RPLN) and increased risk of venous thromboembolism (VTE) in patients (pts) with metastatic germ cell tumours (mGCT): A Global Germ Cell Cancer Group (G3) Study.
Authors: Ben Tran, Jose Manuel Ruiz Morales, Enrique González-Billalabeitia, Eitan Amir, Christoph Alexander Seidel, Carsten Bokemeyer, Christian Daniel Fankhauser, Thomas Hermanns, Alexey Rumyantsev, Alexey Tryakin, Margarida Brito Goncalves, Aude Fléchon, Tina Cheng, Daniel E. Castellano, Xavier Garcia del Muro, Daniel Yick Chin Heng, Phillipe Bedard
Journal: Journal of Clinical Oncology (2016)

e16058 Background: Data suggest that large RPLN significantly increase the risk of VTE in pts with mGCT receiving first line platinum based chemotherapy (chemo). This multinational G3 study aims to validate large RPLN as a risk factor for VTE and evaluate other predictive factors. Methods: Data were collected retrospectively from sequential pts with mGCT receiving first line chemo from 2000-2014 at 18 centers. Pre-defined variables of interest included IGCCCG risk classification, long axis diameter of largest RPLN, Khorana score (validated predictor for chemo associated VTE), LDH and past history VTE. VTE occurring at baseline, during chemo and within 90 days of completion were analysed. Pts receiving thromboprophylaxis were excluded. Predictive accuracy was assessed using multivariable logistic regression and discriminatory accuracy explored using area under the receiver operating curve (AUC). Results: Data from 853 pts were collected. Median age was 31 (range 10-71). Testicular primary (89%), non-seminoma histology (70%) and BEP chemo (83%) were most common. IGCCCG risk distribution was 63% good, 21% intermediate and 16% poor. VTE occurred in 13%. Compared to other cut-offs, RPLN > 3cm and Khorana score ≥ 3 provided the optimal balance between predictive and discriminatory accuracy. Univariable analyses identified statistically significant risk factors for VTE: mediastinal primary (OR 4.74, p = 0.04), poor prognosis (OR 2.83, p < 0.001), LDH 5-10xULN (OR 3.25, p < 0.001), prior VTE (OR 20.92, p < 0.001), Khorana score > 3 (OR 2.58, p = 0.002) and RPLN > 3cm (OR 2.48, p < 0.001). In multivariable analyses, only RPLN > 3cm (23% VTE, OR 2.22, p < 0.001) and poor prognosis (32% VTE, OR 2.25, p < 0.001) were statistically significant predictors of VTE. Khorana score lost statistical significance (OR 1.81, p = 0.07). RPLN > 3cm showed moderate discriminatory accuracy (AUC 0.61, p < 0.001) Conclusions: This study validates RPLN > 3cm and identifies IGCCCG poor prognosis as independent risk factors for VTE in mGCT pts receiving first line chemo. Prospective trials examining thromboprophylaxis in this high risk population are warranted.
Downregulating Notch counteracts KrasG12D-induced ERK activation and oxidative phosphorylation in myeloproliferative neoplasm
Authors: Guangyao Kong, Xiaona You, Zhi Wen, Yuan-I Chang, Shuiming Qian, Erik A. Ranheim, Christopher Letson, Xinmin Zhang, Yun Zhou, Yangang Liu, Adhithi Rajagopalan, Jingfang Zhang, Elliot Stieglitz, Mignon Loh, Inga Hofmann, David Yang, Xuehua Zhong, Eric Padron, Lan Zhou, Warren S. Pear, Jing Zhang
Journal: Leukemia (2018)
A new prognostic model for nasal-type, extranodal natural killer/T cell lymphoma.
Authors: Na Li, Li Zhang, Liqun Zou, Haolan Song, Jing Zhang, Huawei Weng, Hongyu Zhuo
Journal: Journal of Clinical Oncology (2016)

e19042 Background: Nasal type, extranodal natural killer (NK)/T-cell lymphoma (ENKTL) is a heterogeneous disorder with poor prognosis, and there are no optimal therapy and risk-based prognostic model for this population. The objective of our study was to construct a new model for risk-based stratification. Methods: We retrospectively analyzed 145 patients who were newly diagnosed with ENKTCL and treated with the “sandwich” mode of the first-line therapy. Computed tomography (CT) or magnetic resonance (MR) of nasopharynx, neck, chest, and whole abdomen or positron emission tomography/computed tomography (PET/CT) of the entire body was used to evaluate disease. Of 145 patients, 134 patients who had complete information were included in the analysis. Results: With a median follow-up duration of 36 months, 3-year overall survival (OS) rate of all patients was 74.6%. Prognostic factors for survival were the Eastern Cooperative Oncology Group (ECOG) performance status(PS) (P <0.001; relative risk, 2.334; 95% CI, 1.666 to 3.270), lymphocyte/monocyte ratio (LMR) ≤ 2.85 (P = 0.015; relative risk, 2.149; 95% CI, 1. 159 to 3.986), decreased high density lipoprotein (HDL) (P=0.034; relative risk, 1.959; 95% CI, 1.051 to 3.652) and primary tumor invasion (PTI) (P=0.009; relative risk, 4.047; 95% CI, 1.421 to 11.529). Basing on the above four factors, a new prognostic model for 134 patients was constructed: group1 (12.0%), no adverse factor; group 2(50.7%), one factor; group3 (20.2%), two factors; and group 4(17.1%), three or four factors. The 3-year OS of these groups were 100%, 79.9%, 58.5% and 21.7%, respectively. The International Prognostic Index, Korean Prognostic Index and the Prognosis Index for Peripheral T cell lymphoma, Unspecified were used for predicting these patients’ prognosis, the result showed that the discrimination was not power. Conclusions: The newly proposed model could be a useful clinical tool to risk stratify patients with nasal type,extranodal natural killer (NK)/T-cell lymphoma in the future.
Recurrent VTE in cancer patients treated with anticoagulation.
Authors: Michael Blake Streiff, Dejan Milentijevic, Keith McCrae, Daniel Yannicelli, Jonathan Fortier, Winnie W. Nelson, François Laliberté, Concetta Crivera, Patrick Lefebvre, Jeff Schein, Alok A. Khorana
Journal: Journal of Clinical Oncology (2016)

10024 Background: Limited information exists on the efficacy of different anticoagulants for VTE treatment in cancer patients. This study aims to compare the VTE recurrence rates of most frequently prescribed anticoagulants in US. Methods: Healthcare claims from the Humana database were used to identify newly-diagnosed cancer patients with a first VTE between 1/1/2013 and 05/31/2015 who initiated LMWH, warfarin or rivaroxaban (insufficient data for other anticoagulants). Patients were observed for the duration of their eligibility or until the end of data. VTE recurrences were defined as hospitalizations with a primary diagnosis of VTE. As a sensitivity analysis, outpatients with a primary diagnosis of VTE and confirmatory imaging were added to the recurrence definition. Kaplan-Meier rates at 6 and 12 months and Cox proportional hazards models were used to compare the LMWH, warfarin, and rivaroxaban cohorts. Inverse probability of treatment weights based on propensity score was used to adjust for confounding. Results: A total of 2,428 patients (rivaroxaban: n = 707; LMWH: n = 660; warfarin; n = 1,061) were included. Median duration on initial LMWH, warfarin, and rivaroxaban treatments was 1.0, 3.5 and 3.0 months, respectively. Compared to LMWH, VTE recurrence rates were lower for rivaroxaban at 6 month (13.2% vs. 17.1%; p = 0.06) and 12 months (16.5% vs. 22.2%; p = 0.03). Recurrent VTE was 28% less likely with initial rivaroxaban than LMWH (HR [95%CI]: 0.72[0.52-0.95]; p < 0.03). Initial rivaroxaban was associated with significantly fewer recurrent VTE than warfarin at 6 months (13.2% vs. 17.5%; p < 0.02) and 12 months (15.7% vs. 19.9%; p < 0.02). Rivaroxaban users were 26% less likely to suffer recurrent VTE than warfarin users (HR [95%CI]: 0.74; [0.56-0.96], p < 0.03). In the sensitivity analysis, rivaroxaban users also had fewer recurrent VTE than LMWH and warfarin users. Conclusions: In an analysis of real world healthcare claims data in cancer patients, rivaroxaban was associated with a lower risk of recurrent VTE than LMWH or warfarin perhaps reflecting the shorter duration of treatment with LMWH and poor warfarin control.
Aortic Wall Inflammation Predicts Abdominal Aortic Aneurysm Expansion, Rupture, and Need for Surgical Repair
Authors: David Newby, Rachael Forsythe, Olivia McBride, Jennifer Robson, Alex Vesey, Roderick Chalmers, Paul Burns, O James Garden, Scott Semple, Marc Dweck, Calum Gray, Tom MacGillivray, Chengjia Wang, Yolanda Georgia Koutraki, Neil Mitchard, Annette Cooper, Edwin van Beek, Graham McKillop, Weiyang Ho, Liz Fraser, Hayley Cuthbert, Peter Hoskins, Barry Doyle, Noel Conlisk, Wesley Stuart, Colin Berry, Giles Roditi, Laura Murdoch, Richard Holdsworth, Emma Scott, Lynsey Milne, Fiona Strachan, Fiona Wee, Katherine Oatey, Catriona Graham, Gordon Murray, Garry Milne, Marise Bucukoglu, Kirsteen Goodman, Jakub Kaczynski, Anoop Shah, Andrew Tambyraja, Julie Brittenden, Graeme Houston, Robert Lambie, John Norrie
Journal: Circulation (2017)

Ultrasmall superparamagnetic particles of iron oxide (USPIO) detect cellular inflammation on magnetic resonance imaging (MRI). In patients with abdominal aortic aneurysm, we assessed whether USPIO-enhanced MRI can predict aneurysm growth rates and clinical outcomes.In a prospective multicenter open-label cohort study, 342 patients with abdominal aortic aneurysm (diameter ≥40 mm) were classified by the presence of USPIO enhancement and were monitored with serial ultrasound and clinical follow-up for ≥2 years. The primary end point was the composite of aneurysm rupture or repair.Participants (85% male, 73.1±7.2 years) had a baseline aneurysm diameter of 49.6±7.7 mm, and USPIO enhancement was identified in 146 (42.7%) participants, absent in 191 (55.8%), and indeterminant in 5 (1.5%). During follow-up (1005±280 days), 17 (5.0%) abdominal aortic aneurysm ruptures, 126 (36.8%) abdominal aortic aneurysm repairs, and 48 (14.0%) deaths occurred. Compared with those without uptake, patients with USPIO enhancement have increased rates of aneurysm expansion (3.1±2.5 versus 2.5±2.4 mm/year, P=0.0424), although this was not independent of current smoking habit (P=0.1993). Patients with USPIO enhancement had higher rates of aneurysm rupture or repair (47.3% versus 35.6%; 95% confidence intervals, 1.1-22.2; P=0.0308). This finding was similar for each component of rupture (6.8% versus 3.7%, P=0.1857) or repair (41.8% versus 32.5%, P=0.0782). USPIO enhancement was associated with reduced event-free survival for aneurysm rupture or repair (P=0.0275), all-cause mortality (P=0.0635), and aneurysm-related mortality (P=0.0590). Baseline abdominal aortic aneurysm diameter (P<0.0001) and current smoking habit (P=0.0446) also predicted the primary outcome, and the addition of USPIO enhancement to the multivariate model did not improve event prediction (c-statistic, 0.7935-0.7936).USPIO-enhanced MRI is a novel approach to the identification of aortic wall cellular inflammation in patients with abdominal aortic aneurysms and predicts the rate of aneurysm growth and clinical outcome. However, it does not provide independent prediction of aneurysm expansion or clinical outcomes in a model incorporating known clinical risk factors.URL: http://www.isrctn.com. Unique identifier: ISRCTN76413758.
Role of adjuvant chemotherapy in patients with locally advanced rectal carcinoma after preoperative chemoradiotherapy: Single center experience.
Authors: Mikhail Fedyanin, Alexey Tryakin, Kheda Elsnukaeva, Sergey Gordeev, Olga Sekhina, Ilya Pokataev, Valeriya Glebovskaya, Nikolay Kozlov, Arsen Rasulov, Sergei Tjulandin
Journal: Journal of Clinical Oncology (2017)

e15147 Background: Various national guidance provide different approaches in adjuvant chemotherapy for locally advanced rectal carcinoma initially treated with preoperative chemoradiotherapy. We evaluated the efficacy of adjuvant chemotherapy depending on the clinical stage of disease (prior to chemoradiotherapy) and yp stage (after surgery). Methods: Preoperative chemoradiotherapy was administered in 457 patients with locally advanced rectal carcinoma. Radiotherapy was performed in pts receiving capecitabine (64%), intravenous administration of 5-FU (16%) or combination fluoropyrimidines with oxaliplatin (20%). Adjuvant chemotherapy was administered in 98 patients (21%) (fluoropyrimidines alone (20%) or in combination with oxaliplatin (80% patients). Overall survival (OS) was the primary endpoint. Statistical analysis was performed in IBM SPSS statistics v.20 software package. Results: the mean age of patients was 56.6 years, male - 56%. Median of follow up was 42 months (2-141). Adjuvant chemotherapy did not result to better OS in any of clinical stage (p = 0.6 HR 1.1, 95% CI 0.6-2.1). However adjuvant chemotherapy tended to improve disease free survival (DFS) in stage ypT0-4N1-2M0 (р=0.1, HR=0.6, 95%CI 0.4-1.1). Subanalysis showed significant improvement of DFS in patients with ypT1-4N2M0: median of DFS in patients with adjuvant chemotherapy was 62 months, in patients from group of surveillance – 16 months (р&lt;0.01, HR=0.3, 95%CI 0.14-0.7) and a tendency to improvement of OS (table). Conclusions: Our retrospective data confirmed the results of ADORE prospective trial, and showed that adjuvant chemotherapy for locally advanced rectal carcinoma after chemoradiotherapy should be administered only in patients with residual positive lymph nodes (yp stage III). [Table: see text]