Evaluation of Intra-abdominal and Retroperitoneal Soft Tissue Masses

2018 ◽  
Author(s):  
Jeffrey M Farma ◽  
Neha Goel
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Careful Consideration ◽  
R0 Resection ◽  
Genetic Syndromes ◽  
Intravenous Contrast ◽  
Neoadjuvant Radiotherapy ◽  
Extent Of Surgery ◽  
Soft Tissue Masses ◽  
Retroperitoneal Sarcomas ◽  
Completion Staging

Proper workup of intra-abdominal and retroperitoneal sarcomas cannot be overstated in the management of these rare tumors. In particular, evaluation should begin with a thorough history and physical examination, including careful consideration of genetic syndromes. Next, computed tomography (CT) of the abdomen and pelvis with oral and intravenous contrast should be performed to determine whether a tumor is completely resectable as complete resection is the mainstay of sarcoma management. Completion staging studies with CT of the chest should also be performed. Following imaging, a core-needle biopsy, usually an interventional radiology–guided biopsy, is performed to obtain a tissue diagnosis. In certain large, intermediate- to high-grade tumors involving other vital organs, neoadjuvant chemotherapy or neoadjuvant radiation is considered to try to decrease the tumor in the hope of improving the chance of obtaining an R0 resection and to limit the extent of surgery. Overall, it is important to remember that prior to the initiation of any therapy, all patients should be evaluated and managed by a multidisciplinary team with expertise and experience in sarcoma. This review contains 3 figures, 3 tables and 39 references Key words: biopsy, genetic testing, intra-abdominal and retroperitoneal sarcoma, neoadjuvant chemotherapy, neoadjuvant radiotherapy  

Evaluation of Intra-abdominal and Retroperitoneal Soft Tissue Masses

2018 ◽  
Author(s):  
Jeffrey M Farma ◽  
Neha Goel
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Careful Consideration ◽  
R0 Resection ◽  
Genetic Syndromes ◽  
Intravenous Contrast ◽  
Neoadjuvant Radiotherapy ◽  
Extent Of Surgery ◽  
Soft Tissue Masses ◽  
Retroperitoneal Sarcomas ◽  
Completion Staging

Proper workup of intra-abdominal and retroperitoneal sarcomas cannot be overstated in the management of these rare tumors. In particular, evaluation should begin with a thorough history and physical examination, including careful consideration of genetic syndromes. Next, computed tomography (CT) of the abdomen and pelvis with oral and intravenous contrast should be performed to determine whether a tumor is completely resectable as complete resection is the mainstay of sarcoma management. Completion staging studies with CT of the chest should also be performed. Following imaging, a core-needle biopsy, usually an interventional radiology–guided biopsy, is performed to obtain a tissue diagnosis. In certain large, intermediate- to high-grade tumors involving other vital organs, neoadjuvant chemotherapy or neoadjuvant radiation is considered to try to decrease the tumor in the hope of improving the chance of obtaining an R0 resection and to limit the extent of surgery. Overall, it is important to remember that prior to the initiation of any therapy, all patients should be evaluated and managed by a multidisciplinary team with expertise and experience in sarcoma. This review contains 3 figures, 3 tables and 39 references Key words: biopsy, genetic testing, intra-abdominal and retroperitoneal sarcoma, neoadjuvant chemotherapy, neoadjuvant radiotherapy  

P214 ESOPHAGECTOMY FOR ESOPHAGEAL CANCER IN AN UPPER GI UNIT OF THE NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS DURING THE PERIOD 2004-2019

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
K Mylonas ◽  
D Schizas ◽  
N Hashemaki ◽  
E Mpaili ◽  
V Ntomi ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Cox Regression ◽  
Gastroesophageal Junction ◽  
Recurrence Time ◽  
R0 Resection ◽  
Neoadjuvant Radiotherapy ◽  
Female Ratio ◽  
Upper Gi ◽  
All Cause Mortality

Abstract Aim To describe the clinicopathological features and outcomes of patients registered in the esophageal cancer database of an academic upper GI unit in Greece. Methods We performed a retrospective analysis of patients that underwent esophagectomy for esophageal or gastroesophageal junction (GEJ) cancer at an upper GI unit of the National and Kapodistrian University of Athens, during the period January 2004-June 2019. Time-to-event analyses were performed to explore trends in survival and recurrence. Results A total of 146 patients were identified. Mean patient age was 62.3 xxx 10.3 years. Male to female ratio was 6.3:1. Overall, Ivor-Lewis, McKeown, and left thoracoabdominal esophagectomy was performed in 98 (67.1%), 34 (23.3%), 12 (8.2%), patients, respectively. Pharyngolaryngoesophagectomy was performed in 2 (1.4%) cases. R0 resection was achieved in 142 (97.7%) patients. Postoperative complications developed in 62 (45.3%) patients. Neoadjuvant chemotherapy and radiation were administered to 35 (26.9%) and 11 (8.5%) patients, respectively. Postoperative chemotherapy and radiation were administered to 68 (54.8%) and 17 (13.7%) patients, respectively. In total, 4 (2.7%), 23 (15.8%), 30 (20.6%), 55 (37.7%) 34 (23.3%) patients were Stage 0, I, II, III, IV respectively. Among patients with available follow-up information, overall recurrence and all-cause mortality rates were 41.2% and 46.2%, respectively. Median recurrence time and median time of death were 11.3 months and 2.5 years, respectively. On multivariate Cox regression, presence of positive lymph nodes (HR: 1.1, p=0.03) was predictive of higher recurrence rates, while neoadjuvant chemotherapy had a protective effect on disease relapse (HR=0.4, p=0.04). On multivariate Cox regression, need for neoadjuvant radiotherapy (HR: 6.9, p=0.001) and recurrence (HR: 3.4, p=0.002) were independently associated with higher risk of all-cause mortality. Conclusions In this study, we explored outcomes of patients undergoing esophagectomy for esophageal and GEJ cancer in an upper GI unit in Greece over a 15-year period. Outcomes were comparable to those reported from major referral centers across the globe.

A randomized phase II study evaluating efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy for patients with resectable rectal cancer (KSCC1301).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3549-3549
Author(s):  
Kenji Katsumata ◽  
Eiji Oki ◽  
Hiroyuki Kato ◽  
Keisuke Miwa ◽  
Masahiko Sugiyama ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Severe Toxicity ◽  
Efficacy And Safety ◽  
Neoadjuvant Radiotherapy ◽  
Randomized Phase Ii

3549 Background: Neoadjuvant radiotherapy is the current standard of care for rectal cancer. However, radiation therapy is sometimes associated with short-term severe toxicity and long-term morbidity. Perioperative introduction of new chemotherapy agents without radiotherapy for locally advanced rectal cancer (LARC) may be a promising option. Several studies of combination chemotherapy with oxaliplatin plus S-1 (SOX) have reported promising efficacy and safety in patients with metastatic colorectal cancer, suggesting a potential replacement for mFOLFOX6. Methods: A randomized phase II trial was undertaken to compare the efficacy and safety of SOX and mFOLFOX6 as neoadjuvant chemotherapy for patients with LARC. Patients were randomly assigned to receive mFOLFOX6 (every 2 weeks; day 1: 400 mg/m2 bolus 5-fluorouracil [5-FU]; days 1 and 2: 2,400 mg/m2 continuous 5-FU; day1: 200mg/m2 l-LV; and day 1: 85 mg/m2 oxaliplatin) or SOX (every 3 weeks; days 1–14: 80 mg/m2 oral S-1; and day 1: 130 mg/m2oxaliplatin). The protocol period for neoadjuvant chemotherapy was 3 months. The primary endpoint was the 3-year disease-free survival rate (3y DFS), and the secondary endpoints included pathological effect, R0 resection rate, survival and safety. Results: Between September 2013 and October 2015, 110 patients were enrolled and randomized (56 received SOX and 54 received mFOLFOX6). Baseline characteristics were balanced between the two arms. The major adverse events were neutropenia, peripheral neuropathy, loss of appetite, and fatigue. The incidence of grade 3 or higher neutropenia based on the CTCAE Vers.4.0was 13.2% in the SOX group and 32.0% in the mFOLFOX6 group. The surgical completion rate was 100% for the SOX group and 96% for the mFOLFOX6 group. The incidence of grade II or more surgical site infection based on Clavien-Dindo classification (CD) was 11.3% and 4.2% for the SOX and mFOLFOX6 groups, respectively. The CD grade III anastomosis-related complications developed in 7 cases in total. Conclusions: The KSCC1301 study suggests that neoadjuvant chemotherapy without radiation is active and safe. The results of pathological response will be provided. Clinical trial information: UMIN000011486.

scholarly journals Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954

2010 ◽  
Vol 28 (35) ◽  
pp. 5210-5218 ◽  
Author(s):  
Christoph Schuhmacher ◽  
Stephan Gretschel ◽  
Florian Lordick ◽  
Peter Reichardt ◽  
Werner Hohenberger ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Preoperative Chemotherapy ◽  
Survival Benefit ◽  
Locally Advanced ◽  
Postoperative Chemotherapy ◽  
Phase Iii ◽  
R0 Resection ◽  
Resection Rate

PurposePatients with locally advanced gastric cancer benefit from combined pre- and postoperative chemotherapy, although fewer than 50% could receive postoperative chemotherapy. We examined the value of purely preoperative chemotherapy in a phase III trial with strict preoperative staging and surgical resection guidelines.Patients and MethodsPatients with locally advanced adenocarcinoma of the stomach or esophagogastric junction (AEG II and III) were randomly assigned to preoperative chemotherapy followed by surgery or to surgery alone. To detect with 80% power an improvement in median survival from 17 months with surgery alone to 24 months with neoadjuvant, 282 events were required.ResultsThis trial was stopped for poor accrual after 144 patients were randomly assigned (72:72); 52.8% patients had tumors located in the proximal third of the stomach, including AEG type II and III. The International Union Against Cancer R0 resection rate was 81.9% after neoadjuvant chemotherapy as compared with 66.7% with surgery alone (P = .036). The surgery-only group had more lymph node metastases than the neoadjuvant group (76.5% v 61.4%; P = .018). Postoperative complications were more frequent in the neoadjuvant arm (27.1% v 16.2%; P = .09). After a median follow-up of 4.4 years and 67 deaths, a survival benefit could not be shown (hazard ratio, 0.84; 95% CI, 0.52 to 1.35; P = .466).ConclusionThis trial showed a significantly increased R0 resection rate but failed to demonstrate a survival benefit. Possible explanations are low statistical power, a high rate of proximal gastric cancer including AEG and/or a better outcome than expected after radical surgery alone due to the high quality of surgery with resections of regional lymph nodes outside the perigastic area (celiac trunc, hepatic ligament, lymph node at a. lienalis; D2).

A phase 1 study of neoadjuvant chemotherapy followed by concurrent chemoradiation with gemcitabine, sorafenib, and vorinostat in pancreatic cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16268-e16268
Author(s):  
Andrew Stewart Poklepovic ◽  
Emma Charlotte Fields ◽  
Dipankar Bandyopadhyay ◽  
Mary Beth Tombes ◽  
Maciej Kmieciak ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Antitumor Activity ◽  
Drug Exposure ◽  
Phase 1 ◽  
Neoadjuvant Treatment ◽  
R0 Resection ◽  
Resection Rate ◽  
Correlative Studies ◽  
Dose Levels

e16268 Background: The multi-kinase inhibitor sorafenib (S) and HDAC inhibitor vorinostat (V) demonstrated synergism against preclinincal pancreatic cancer (PaCa) models. The combination of S & V also potently radiosensitized pancreatic cancer cells and enhanced the activity of gemcitabine (G). This led to a phase 1 trial to determine the doses and schedule appropriate for phase 2 study of S & V with weekly G and intensity modulated radiotherapy (IMRT) as neoadjuvant treatment of PaCa following chemotherapy. Methods: Using a 3+3 dose-escalation design, adult patients with resectable, borderline resectable, unresectable, and lymph node positive PaCa were enrolled to 6 dose levels. Enrolled patients had completed at least 8w of neoadjuvant chemotherapy prior to IMRT. The schedule of administration was weekly 200mg/m2 G weekly during IMRT, S & V were dosed either 3x or 5x weekly during IMRT. Primary endpoint was to identify the dose and schedule for S & V with G based chemoradiation. Key secondary endpoints included antitumor activity, R0 resection rate, OS. Correlative studies to evaluate a variety of biomarkers and Nanostring expression analysis on pre- and post-therapy tumor specimens were also performed. Results: 22 patients were enrolled and 21 treated at 6 dose levels. Due to thrombocytopenia limiting drug exposure, the trial was modified to reduce G to 200mg/m2/wk and S & V to 3 d/wk instead of 5 d/wk. 13 patients were eligible for surgery, and 9 had R0 resections. Conclusions: Our findings indicate that the study regimen was well tolerated, typical toxicities of S (hand foot syndrome) were not observed with intermittent dosing. Uncomplicated cytopenias limited drug exposure, which was improved with intermittent S&V dosing. The RP2D of the combination is S (400mg po BID 3d/wk), V (200mg po qd 3d/wk), G 200mg/m2 IV weekly, with IMRT (50.4 Gy over 28 fractions, 5d/wk). Antitumor activity was observed across dose levels, with an encouraging R0 resection rate. These results warrant further investigation of combining S and V with G and IMRT as neoadjuvant treatment of PaCa following chemotherapy. Analyses of correlative studies and OS are underway. Clinical trial information: NCT02349867. [Table: see text]

A single-arm, phase II feasibility study of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in potentially resectable gastric or gastroesophageal junction adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 96-96
Author(s):  
M. Ryu ◽  
Y. Choi ◽  
B. Kim ◽  
Y. Park ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Residual Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Phase Iii ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

96 Background: The aim of this study was to evaluate feasibility and safety of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in patients with potentially resectable adenocarcinoma of stomach or gastroesophageal junction. Methods: Forty-one patients with clinical stage T3-4N0M0 or T2-4N+M0 determined by CT, endoscopic ultrasonography, and laparoscopy were enrolled between DEC 2008 and MAR 2010. Gastrectomy with D2 lymph node dissection was conducted after 3 cycles of DOS chemotherapy. DOS chemotherapy consists of docetaxel 50 mg/m2 iv (day1), oxaliplatin 100 mg/m2 iv (day1), and S-1 40 mg/m2 po bid (days1-14) at 3 weeks interval. After curative gastrectomy, the patients were given 1 year of adjuvant chemotherapy with S-1 (40 mg/m2 D1-28, every 6 weeks). Results: All patients finished the planned neoadjuvant chemotherapy. Twenty-three (56%) patients achieved a partial response, and the remaining 18 patients had stable disease by CT scan after 3 cycles of DOS chemotherapy. No disease progression was observed during the neoadjuvant chemotherapy. A median 4.7 weeks (range, 4.0-7.6) after the start of the 3rd cycle of DOS chemotherapy, 39 (95%) patients underwent R0 resection with no pathologic residual disease in 4 (10%) patients. Hematologic toxicities were common including grade 4 neutropenia (32%), grade 3 thrombocytopenia (17%), and febrile neutropenia (10%). However, hematologic toxicities were generally transient and manageable. There were no grade 3 or 4 non-hematologic toxicities with frequency > 5% of patients. With all toxicities taken together, 21 (51%) patients experienced grade 3 or 4 toxicities (except grade 3 neutropenia). There was no treatment-related death, and surgical complications included only mild wound problem in 4 (10%) patients. Conclusions: In this study, neoadjuvant DOS chemotherapy could induce a sufficient down-staging and R0 resection of locally advanced gastric cancer with mild and manageable toxicities. A phase III randomized trial is planned for evaluating the benefit of neoadjuvant DOS chemotherapy in patients with locally advanced gastric cancer. [Table: see text]

EXPERT-C: A randomized phase II European multicenter trial of neoadjuvant chemotherapy (capecitabine/oxaliplatin) and chemoradiation (CRT) with or without cetuximab followed by total mesorectal excision (TME) in patients with MRI-defined high-risk rectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 360-360 ◽  
Author(s):  
A. Dewdney ◽  
D. Cunningham ◽  
J. Tabernero ◽  
B. Glimelius ◽  
A. Cervantes ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Performance Status ◽  
Rectal Adenocarcinoma ◽  
Complete Response ◽  
R0 Resection ◽  
Wild Type ◽  
Braf Mutations ◽  
Secondary Endpoints

360 Background: We previously demonstrated the feasibility of administering neoadjuvant chemotherapy before CRT and TME in patients with MRI selected poor prognosis rectal cancer (Chua Y J et al Lancet Oncol 2010). This trial evaluates the addition of the anti-EGFR antibody cetuximab to this treatment strategy. KRAS and BRAF mutations have been established as predictive for lack of response to anti-EGFR therapy in metastatic colorectal cancer. Methods: Patients with newly diagnosed, histologically confirmed, MRI defined high risk rectal adenocarcinoma were randomised to receive 4 cycles of capecitabine 1,700mg/m2 with oxaliplatin 130mg/m2 (CAPOX) followed by CRT, 45Gy/25# + 5.4Gy/3# boost with concurrent continuous capecitabine 1,650mg/m2/day, TME and 4 cycles of adjuvant CAPOX (EXPERT) or the same regimen with the addition of cetuximab (400mg/m2 loading dose week 1, followed by 250mg/m2/week) (EXPERT-C). The primary endpoint is complete response (CR) (defined as pathological complete response or radiological complete response in patients who decline surgery) in KRAS and BRAF wild type tumours. Secondary endpoints include radiological response to CRT, CR in both KRAS wild type and mutant patients, R0 resection rates, progression free and overall survival and safety. Results: Between 2005-2008, 165 eligible patients were recruited from 15 centres (EXPERT n=81, EXPERT-C n=84). 99% of patients had performance status 0-1, 98% had ≥ T3 disease, 56% had an involved or threatened circumferential resection margin and 72% had evidence of extramural venous invasion determined by MRI. The current median follow up is 30 months. 72/81 (89%) and 79/84 (94%) of patients completed neoadjuvant CRT and 72/81 (89%) and 77/84 (92%) patients underwent curative-intent surgery on the EXPERT and EXPERT-C arms respectively. Two patients declined surgery. Conclusions: The primary and secondary endpoints will be analyzed in October 2010 and will be presented at the meeting. [Table: see text]

Efficacy and safety of hypofractionated preoperative radiotherapy in treatment of localized extremity/trunk wall soft tissue sarcoma (STS): Final results of the study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10564-10564
Author(s):  
Piotr Rutkowski ◽  
Hanna Melania Kosela ◽  
Milena Kolodziejczyk ◽  
Wirginiusz Dziewirski ◽  
Marcin Zdzienicki ◽  
...  
Keyword(s):  
Lower Limb ◽  
Preoperative Radiotherapy ◽  
Postoperative Radiotherapy ◽  
Tumor Resection ◽  
Wound Dehiscence ◽  
R0 Resection ◽  
Efficacy And Safety ◽  
Neoadjuvant Radiotherapy ◽  
Primary Tumors ◽  
Additional Surgery

10564 Background: The primary treatment of STS is surgical resection combined with pre- or postoperative radiotherapy. Conventional fractionation in neoadjuvant radiotherapy is 50Gy (fractions: 2Gy/day). Radiobiological studies shown that alpha/beta ratios of some sarcoma cells are below 10Gy, what is rationale for hypofractionation. Aim of the study was to assess the efficacy and safety of hypofractionated radiotherapy in preoperative setting in patients with STS treated in one institution. Methods: 220 patients (median age 54years) participated in this prospective study (2006-2010). Median follow up is 34 months. 140 patients (64%) had high grade (G3) tumors, median size -9cm (45% ≥10cm), 68% on lower limb. 137 patients (62.2%) had primary tumors. Preoperative radiotherapy 5x5 Gy per 5 consecutive days was applied, with immediate tumor resection. Results: R0 resection was possible in 79%. 61 patients died (3-year overall survival OS 72%), 91 (41%) had disease relapse. Local recurrence (LR) was found in 20% of the patients (3-year LR-free survival 80%). Negative prognostic factors for LR were: tumor size ≥10cm (p=0.037), grade 3 (p=0.0041) and primary vs. recurrent tumor with borderline significance. LRs had significant impact on OS (p=0.0001). 101 patients (46%) had any kind of complications, majority on lower limb (early: 17.2% prolonged healing of the wound >1month, 12.7% -wound dehiscence, 4% -prolonged punctures of lymph fluid, 2.7% -acute skin toxicity; late: 0.9% -severe fibrosis with contracture, 11% -prolonged edema. 2.7% -bone fracture), but only 6.3% required additional surgery. Conclusions: In this non-selected group of advanced STS use of hypofractionated preoperative radiotherapy was associated with similar local control (80%) when compared to previously published studies. The early toxicity is tolerable, with small rate of late complications. Presented results warrants evaluation in randomized trial.

Multicenter phase II trial of neoadjuvant chemotherapy with mFOLFOX6 for stage II/III rectal cancer with a T3/T4 tumor FACT trial.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 713-713
Author(s):  
Toshiyuki Enomoto ◽  
Yoshihisa Saida ◽  
Kazuhiro Takabayashi ◽  
Jiro Nagao ◽  
Junichi Koike ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Postoperative Complications ◽  
Neoadjuvant Chemotherapy ◽  
Cancer Patients ◽  
Response Rate ◽  
Disease Free Survival ◽  
Stage Ii ◽  
R0 Resection ◽  
Free Survival ◽  
Disease Free

713 Background: The efficacy and safety of neoadjuvant chemotherapy with mFOLFOX6 for stage II/III rectal cancer patients with a T3/T4 tumor is still unknown. Methods: Inclusion criteriain this study are as follows: Stage II/III (Ra/Rb) rectal cancer patients with a T3/T4 tumor. The primary endpoint is preoperative response rate, and the secondary endpoints are histological effect, R0 resection rate, pCR rate, down-staging rate, neoadjuvant therapy completion rate, toxicity, the incidence of postoperative complications, and 3-year disease-free survival. Computed tomography was performed after 4 courses of mFOLFOX6. Patients with disease progression (DP) underwent resection of the primary lesion, while those without DP received another 2 courses of treatment. Treatment was discontinued when resection was not possible in patients with DP. Results: Registered patients totaled 53 with a mean age of 60 (38–77). The number of patients with T3 and T4 tumors was 42 and 10, and patients at stages II and III were 10 and 42, respectively. One patient withdrew due to consent retraction. Median relative dose intensity of mFOLFOX6 therapy was 93.2% for L-OHP, 5-FU, and l-LV. Treatment completion was achieved in 96.2% and 84.6% for 4 and 6 courses, respectively, and withdrawal was due to patient’s discretion, not adverse events. Preoperative response rate was 51%. Surgery was performed in 78.8% of patients. Serious (grade ≥3) toxicity included neutropenia (n=5), leukopenia (n=1), thrombocytopenia (n=1), febrile neutropenia (n=1), nausea (n=1), vomiting (n=1), and peripheral neuropathy (n=2). The rates of R0 resection, pCR, and sphincter preservation were 91.0%, 10.3%, and 82.9%. The down staging rate was calculated as 2%. The median follow-up after surgery was 18.0 months. Median DFS was 17.3 months, and 1-year disease-free survival was 78.8%. Median OS was 22.0 months, and 1-year overall survival was 95.7%. Postoperative complications included suture failure (n=3), wound infection (n=2), pneumonia (n=1), and intestinal obstruction (n=1). Conclusions: Neoadjuvant chemotherapy using mFOLFOX6 is a safe and efficacious treatment option for rectal cancer, especially locally advanced disease. Clinical trial information: UMIN000006583.

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