Role of neoadjuvant chemotherapy in metastatic medulloblastoma: a comparative study in 92 children

Abstract Background Previous pilot studies have shown the feasibility of preoperative chemotherapy in patients with medulloblastoma, but benefits and risks compared with initial surgery have not been assessed. Methods Two therapeutic strategies were retrospectively compared in 92 patients with metastatic medulloblastoma treated at Gustave Roussy between 2002 and 2015: surgery at diagnosis (n = 54, group A) and surgery delayed after carboplatin and etoposide-based neoadjuvant therapy (n = 38, group B). Treatment strategies were similar in both groups. Results The rate of complete tumor excision was significantly higher in group B than in group A (93.3% vs 57.4%, P = 0.0013). Postoperative complications, chemotherapy-associated side effects, and local progressions were not increased in group B. Neoadjuvant chemotherapy led to a decrease in the primary tumor size in all patients; meanwhile 4/38 patients experienced a distant progression. The histological review of 19 matched tumor pairs (before and after chemotherapy) showed that proliferation was reduced and histological diagnosis feasible and accurate even after neoadjuvant chemotherapy. The 5-year progression-free and overall survival rates were comparable between groups. Comparison of the longitudinal neuropsychological data showed that intellectual outcome tended to be better in group B (the mean predicted intellectual quotient value was 6 points higher throughout the follow-up). Conclusion Preoperative chemotherapy is a safe and efficient strategy for metastatic medulloblastoma. It increases the rate of complete tumor excision and may improve the neuropsychological outcome without jeopardizing survival. Key Points 1. Preoperative chemotherapy increases the rate of complete tumor removal. 2. No additional risk (toxic or disease progression) is linked to the delayed surgery. 3. Preoperative chemotherapy could have a positive impact on the neuropsychological outcome of patients.

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MBCL-02. ROLE OF PREOPERATIVE CHEMOTHERAPY IN METASTATIC MEDULLOBLASTOMA: A COMPARATIVE STUDY IN 92 CHILDREN

Neuro-Oncology ◽

10.1093/neuonc/noaa222.478 ◽

2020 ◽

Vol 22 (Supplement_3) ◽

pp. iii387-iii387

Author(s):

Léa Guerrini-Rousseau ◽

Rachid Abbas ◽

Sophie Huybrechts ◽

Virginie Kieffer-Renaux ◽

Stéphanie Puget ◽

...

Keyword(s):

Preoperative Chemotherapy ◽

Survival Rates ◽

Treatment Strategies ◽

Pilot Studies ◽

Tumor Excision ◽

Intellectual Quotient ◽

Initial Surgery ◽

Group A ◽

Group B ◽

Complete Tumor

Abstract BACKGROUND Previous pilot studies have shown the feasibility of preoperative chemotherapy in patients with medulloblastoma, but benefits and risks compared with initial surgery have not been assessed. METHODS Two therapeutic strategies were retrospectively compared in 92 patients with metastatic medulloblastoma treated at Gustave Roussy, France, between 2002 and 2015: surgery at diagnosis (n=54; group A) and surgery delayed after carboplatin and etoposide-based preoperative therapy (n=38; group B). Treatment strategies were similar in both groups. RESULTS The rate of complete tumor excision was significantly higher in group B than in group A (93.3% versus 57.4%, p=0.0013). Post-operative complications, chemotherapy-associated side effects and local progressions were not increased in group B. Preoperative chemotherapy led to a decrease in the primary tumor size in all patients, 4/38 patients experiencing meanwhile a distant progression. The histological review of 19 matched tumor pairs (before and after chemotherapy) showed that proliferation was reduced and histological diagnosis feasible and accurate even after preoperative chemotherapy. The 5-year progression-free and overall survival rates were comparable between groups. Comparison of the longitudinal neuropsychological data showed that intellectual outcome tended to be better in group B (the mean predicted intellectual quotient value was 6 points higher throughout the follow-up). CONCLUSION Preoperative chemotherapy is a safe and efficient strategy for metastatic medulloblastoma. It increases the rate of complete tumor excision and may improve the neuropsychological outcome without jeopardizing survival.

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Neoadjuvant chemotherapy followed by extrapleural pneumonectomy (EPP) for malignant pleural mesothelioma (MPM): An Italian experience with cisplatin-based regimens

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.17022 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 17022-17022

Author(s):

A. Marino ◽

C. Pinto ◽

V. Mutri ◽

D. Galetta ◽

M. Di Bisceglie ◽

...

Keyword(s):

Neoadjuvant Chemotherapy ◽

Preoperative Chemotherapy ◽

Asbestos Exposure ◽

Vitamin Supplementation ◽

Resection Margins ◽

Extrapleural Pneumonectomy ◽

Small Series ◽

Group A ◽

Group B ◽

The Impact

17022 Background: We have evaluated the feasibility and the impact on survival of two different preoperative chemotherapy regimens in potentially resectable MPM. Methods: Eligibility criteria were: histologically confirmed MPM, stage T1–3 N0–2 M0, adequate organ function, KPS ≥80. A first group of pts (group A) received cisplatin 75 mg/m2 d1 and gemcitabine 1200 mg/m2 d1,8, every 3 weeks for 4 courses, followed by EPP and by 6 courses of adjuvant chemotherapy with mitoxantrone 10 mg/m2 d1, methotrexate 35 mg/m2 d1 and mitomycin 7 mg/m2 d1, every 3 weeks with mitomycin in alternate cycles. A second group of pts (group B) received cisplatin 75 mg/m2 d1 plus pemetrexed 500 mg/m2 d1 with full vitamin supplementation for 4 cycles. In each group, only pts with metastatic lymph nodes and/or positive resection margins underwent radiotherapy after EPP. Results: Twenty-five pts were enrolled from February 2000 to August 2005 (8 in group A and 17 in group B). Pt characteristics were: 21 (84%) males and 4 (16%) females, asbestos exposure in 16 (64%) pts, median age 64 years (range, 51–72), median KPS 100 (80–100), histological subtype: 19 (76%) epithelial, 2 (8%) sarcomatous, 3 (12%) mixed, 1 (4%) unknown; IMIG stage: 6 (24%) I, 14 (56%) II, 5 (20%) III. Clinical response to neoadjuvant chemotherapy consisted of 4 (16%) CR, 2 (8%) PR, 11 (44%) SD, 5 (20%) PD; 3 (12%) pts were not evaluable. The overall response rate (CR + PR) was 24% (95% CI: 9.4 - 45.1). Toxicity was mild in each group. Fourteen (56%) pts have undergone EPP, 5 (20%) pleurectomy and 6 (24%) pts were inoperable. Three postoperative complications and two postoperative deaths (one for controlateral pneumonia and one for ARDS) occurred after EPP. The 1-year survival rate was 60%. Long-term survivors (≥18 months) included 5 pts who had undergone EPP (18, 26, 54, 57 and 63 months) and 2 pts who had undergone pleurectomy (22 and 32 months). Conclusions: These preliminary data, albeit in a small series, suggest that preoperative chemotherapy followed by EPP is a feasible approach to be investigated in larger trials in pts with MPM. No significant financial relationships to disclose.

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The Efficacy of the Mineralcorticoid Receptor Antagonist Canrenone in COVID-19 Patients

Journal of Clinical Medicine ◽

10.3390/jcm9092943 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2943 ◽

Cited By ~ 2

Author(s):

Marco Vicenzi ◽

Massimiliano Ruscica ◽

Simona Iodice ◽

Irene Rota ◽

Angelo Ratti ◽

...

Keyword(s):

Survival Rate ◽

Receptor Antagonist ◽

Positive Impact ◽

Ventilatory Support ◽

Continuous Administration ◽

Pharmacological Management ◽

Group A ◽

Group B ◽

The Impact ◽

Free Rate

Background: In COVID-19 patients, aldosterone via angiotensin-converting enzyme-2 deregulation may be responsible for systemic and pulmonary vasoconstriction, inflammation, and oxidative organ damage. Aim: To verify retrospectively the impact of the mineralcorticoid receptor antagonist canrenone i.v. on the need of invasive ventilatory support and/or all-cause in-hospital mortality. Methods: Sixty-nine consecutive COVID-19 patients, hospitalized for moderate to severe respiratory failure at Fondazione Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca’ Granda Ospedale Maggiore Policlinico of Milan, received two different therapeutic approaches in usual care according to the personal skills and pharmacological management experience of the referral medical team. Group A (n = 39) were given vasodilator agents or renin–angiotensin–aldosterone system (RAAS) inhibitors and group B (n = 30) were given canrenone i.v. Results: Among the 69 consecutive COVID-19 patients, those not receiving canrenone i.v. (group A) had an event-free rate of 51% and a survival rate of 64%. Group B (given a mean dose of 200 mg/q.d. of canrenone for at least two days of continuous administration) showed an event-free rate of 80% with a survival rate of 87%. Kaplan–Meier analysis for composite outcomes and mortality showed log rank statistics of 0.0004 and 0.0052, respectively. Conclusions: The novelty of our observation relies on the independent positive impact of canrenone on the all-cause mortality and clinical improvement of COVID-19 patients ranging from moderate to severe diseases.

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Fluorouracil and leucovorin with or without interferon alfa-2b in advanced colorectal cancer: analysis of a prospective randomized phase III trial. Hellenic Cooperative Oncology Group.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.10.2682 ◽

1996 ◽

Vol 14 (10) ◽

pp. 2682-2687 ◽

Cited By ~ 28

Author(s):

P A Kosmidis ◽

N Tsavaris ◽

D Skarlos ◽

D Theocharis ◽

E Samantas ◽

...

Keyword(s):

Colorectal Cancer ◽

Advanced Colorectal Cancer ◽

Positive Impact ◽

Performance Status ◽

Final Analysis ◽

Interferon Alfa ◽

Phase Iii ◽

Psychological Reactions ◽

Group A ◽

Group B

PURPOSE To investigate if double modulation of fluorouracil (5-FU) with leucovorin (folinic acid [FA]) and interferon alfa-2b (IFN 2b) improves responses and survival in comparison to single modulation of 5-FU with FA. PATIENTS AND METHODS One hundred six patients with histologically confirmed advanced colorectal cancer, measurable disease, and without previous chemotherapy were prospectively randomized into two groups. Patients in group A received 5-FU 450 mg/m2 as an intravenous bolus in the midinfusion of FA weekly. FA was given at a dose of 200 mg/m2 in 500 mL 0.9% normal saline solution in 2-hour infusion. Patients in group B received exactly the same regimen plus IFN 2b 5 million units subcutaneously three times weekly. RESULTS All patients were well balanced in both groups regarding age, sex, performance status, number, and site of metastasis. One hundred two patients were assessable. All patients have died. There was no difference in response between the two groups (7.8% v 9.8%). Median survival was 10.1 months in group A, and 7.2 months in group B (P = .00189). Median time to progression was 8.4 and 5.2 months, respectively (P = .00196). Overall, better performance status and older age had a positive impact on survival. Toxicity was the most important and catastrophic aspect of this study. Patients who received IFN 2b had significantly worse anemia, neutropenia, diarrhea, anorexia, weight loss, flu-like syndrome, and psychological reactions. CONCLUSION Based on this final analysis, the addition of IFN 2b to the combination of 5-FU and FA enhances toxicity and contributes to decreased survival.

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Optimization of the Staged scheme for the Treatment of complicated (OTA C3) Tibial Pilon Fractures

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000204 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0002

Author(s):

Zhang Hui

Keyword(s):

Operative Time ◽

Stage I ◽

Stage Ii ◽

Operative Strategy ◽

Tibial Pilon ◽

Initial Surgery ◽

Group A ◽

Definitive Surgery ◽

Group B ◽

Pilon Fractures

Category: Ankle, Ankle Arthritis, Arthroscopy, Bunion, Hindfoot, Lesser Toes, Midfoot/Forefoot, Trauma Introduction/Purpose: To explore and evaluate the optimization operative strategy reported on our results using a direct approach with posterior malleolar plating in combination with staged anterior? xation in complex pilon fractures. Methods: 43 patients were diviede into group A (23 cases, posterior plating and external? xator for stage I, ORIF through anterior approach for stage II)and group B(20 cases, closed reduction and external? xator for stage I, ORIF through anterior- posterior approach for stage II) between 2013 and 2014. With an average follow-up of 16.6 months, Results: The statistics showed that there were statistically significant differences (P<0.05)between two groups in the time before definitive surgery and the operative time of the stage II surgery, but in the time before initial surgery and the operative time of the initial surgery(P>0.05). The AOFAS and MLFAS scores in the group A were better than (P < 0.05) the Group B. 4 patients in the group A had some evidence of symptomatic arthrosis compared with 6 in the group B. The rate of tourniquet paralysis for the group A was 4.35% versus 35% (P < 0.05) for the Group B. Conclusion: The optimization operative strategy offers direct visualization for reduction, and allows the anterior components to be secured to a stable posterior fragment at a later date. The staged strategy not only obtains the leg fascia chamber decompression, also shortens the waiting time for operation, reduces reduction difficulties in definitive operation.

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Palonosetron compared to ondansetron in the prevention of chemotherapy-induced nausea and vomiting: Activity, safety, and cost-effectiveness evaluation

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e20573 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e20573-e20573 ◽

Cited By ~ 1

Author(s):

G. Bernardo ◽

R. Palumbo ◽

M. Frascaroli ◽

A. Bernardo ◽

A. Losurdo ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Positive Impact ◽

Cost Effective ◽

Complete Response ◽

Pharmacoeconomic Evaluation ◽

Nausea And Vomiting ◽

Group A ◽

Group B

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.

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CEA as a prognostic factor in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10705 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10705-10705

Author(s):

N. Valeri ◽

N. Battelli ◽

C. Mariotti ◽

A. Santinelli ◽

W. Siquini ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Advanced Breast Cancer ◽

Locally Advanced Breast Cancer ◽

Locally Advanced ◽

Advanced Breast ◽

Breast Cancer Patients ◽

Ca 15.3 ◽

Group A ◽

Group B

10705 Background: CEA and CA 15.3 are most commonly used to evaluate disease progression in metastatic and recurrent breast cancer. Only few significant studies showed a potential predictive role of CEA and CA 15.3 in adjuvant or neoadjuvant setting. We evaluated the correlation between tumour markers level at diagnosis and outcome in locally advanced breast cancer patients treated with neoadjuvant chemotherapy. Methods: Patients with locally advanced breast cancer (T > 3.5 cm and T4) at diagnosis entered the study. All patients had to have initial negative staging (chest X-ray, abdominal ultrasonography, bone scintigraphy and CT scan), whereas all patients who developed metastatic disease in sites which were uncertain during initial staging were excluded. Tumour markers at diagnosis were considered negative if CEA was inferior to 5 ng/ml and CA 15.3 inferior to 35 U/ml. All patients received neoadjuvant chemotherapy (4–6 cycles with regimens containing Anthracyclines and Taxanes or FEC). Most of patients underwent radical mastectomy followed by sequential radiation therapy and adjuvant chemotherapy and/or hormonotherapy in hormonal responsive patients. Results: Fifty-three patients entered the study. At a median follow up of 73 months, 35 patients were disease free after adjuvant treatment (group A), whereas 18 patients developed metastatic disease during follow-up (group B). At diagnosis 14 patients had CA 15.3 greater than 34 U/ml (7 in group A and 7 in group B), 6 patients had CEA greater than 5 ng/ml (1 in group A and 5 in group B) and 18 patients had CEA or CA 15.3 greater than normal values (7 in group A and 11 in group B).We analyzed DFS and OS in patients with normal (CEA < 5 ng/ml, CA15.3 < 35 U/ml) and elevated (CEA ≥ 5 ng/ml, CA 15.3 ≥ 35 U/ml) tumour markers at diagnosis; DFS (p = 0.001) and OS (p = 0.03) were significantly reduced in patients with elevated CEA at diagnosis; differences were not statistically significant for CA 15.3 (p > 0.05). Conclusions: CEA levels before neoadjuvant treatment could represent an important prognostic factor and may influence the choice of treatment in locally advanced breast cancer patients . No significant financial relationships to disclose.

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The efficacy of neoadjuvant treatment in locally advanced rectal cancer with dMMR.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.4_suppl.615 ◽

2019 ◽

Vol 37 (4_suppl) ◽

pp. 615-615 ◽

Cited By ~ 1

Author(s):

Yanhong Deng ◽

Jianwei Zhang

Keyword(s):

Rectal Cancer ◽

Neoadjuvant Chemotherapy ◽

Locally Advanced ◽

Neoadjuvant Treatment ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Group A ◽

Tumor Downstaging ◽

Group B ◽

Group D

615 Background: The incidence of Mismatch repair gene deficiency (dMMR) was about 15% in colorectal cancer, but mostly in right side colon cancer, while in locally advanced rectal cancer, it is very rare. As is known, adjuvant chemotherapy with 5FU alone was not recommended in stage II colon cancer with dMMR or MSI. However, in locally advanced rectal cancer with dMMR or MSI, the efficacy of neoadjuvant treatment with 5FU was not yet known. Methods: We enrolled patients with locally advanced rectal cancer from three prospective clinical trials, including the FOWARC study (N = 309), the mFOLFOXIRI neoadjuvant chemotherapy trial (N = 106) and the total neoadjuvant treatment with FOLFOX and radiotherapy (N = 129). From the 544 patients, 35 (6.4%) patients were dMMR, 133 patients with unknown status of MMR. Among the 35 patients, 10 patients received 5FU concurrent with radiotherapy (group A), nine patients underwent FOLFOX concurrent with radiation (group B), and 12 patients received FOLFOX neoadjuvant chemotherapy alone (group C). Another four patients underwent mFOLFOXIRI neoadjuvant chemotherapy alone (group D), including one patient with nivolumab as neoadjuvant treatment after chemotherapy. Results: Totally, 4 (11.4%) patients achieved pathologic complete response, and 13 (37%) patients had tumor downstaging to ypT0-2N0M0 (stage 0-I). In group A, the pCR rate was 10% (1/10), the tumor downstaging rate was 20% (2/10); In group B, the pCR rate was 33.3% (3/9), the tumor downstaging rate was 55.6% (5/9); In group C, the tumor downstaging rate was 41.7% (5/12). In group D, only one patient achieved pCR, and it is the one who received nivolumab as neoadjuvant treatment. Conclusions: The efficacy of neoadjuvant in locally advanced rectal cancer seemed not affected by the MMR status. But further study was needed.

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The Role of HE4, a Novel Biomarker, in Predicting Optimal Cytoreduction After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

International Journal of Gynecological Cancer ◽

10.1097/igc.0000000000000944 ◽

2017 ◽

Vol 27 (4) ◽

pp. 696-702 ◽

Cited By ~ 7

Author(s):

Francesco Plotti ◽

Giuseppe Scaletta ◽

Stella Capriglione ◽

Roberto Montera ◽

Daniela Luvero ◽

...

Keyword(s):

Ovarian Cancer ◽

Neoadjuvant Chemotherapy ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Advanced Ovarian Cancer ◽

Debulking Surgery ◽

Gynecology And Obstetrics ◽

Group A ◽

Group B

ObjectivesThis study aimed to evaluate serum human epididymis protein 4 (HE4) changes during neoadjuvant chemotherapy (NACT) to establish HE4 predebulking surgery cutoff values and to demonstrate that CA125, HE4, and computed tomography (CT) taken together are better able to predict complete cytoreduction after NACT in advanced ovarian cancer patients.MethodsFrom January 2006 to November 2015, patients affected by epithelial advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III–IV), considered not optimally resectable, were included in this prospective study. After 3 cycles of NACT, all patients underwent debulking surgery and were allocated, according to residual tumor (RT), into group A (RT = 0) and group B (RT > 0). Serum CA125, HE4, and CT images were recorded during NACT and compared singularly and with each other in term of accuracy, sensitivity, specificity, and positive and negative predictive value.ResultsA total of 94 and 20 patients were included in group A and group B, respectively. The HE4 values recorded before debulking surgery correlated with RT. The identified HE4 cutoff value of 226 pmol/L after NACT was able to classify patients at high or low risk of suboptimal surgery, with a sensitivity of 75% and a specificity of 85% (positive predictive value, 0.87; negative predictive value, 0.70). The combination of CA125, HE4, and CT imaging resulted in the best combination with a sensitivity of 96% and a specificity of 92% (positive predictive value, 0.96; negative predictive value, 0.94).ConclusionsThe novel biomarker HE4, in addition to CA125 and CT, is better able to predict the RT at debulking surgery and the prognosis of patients.

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Feasibility study of preoperative chemotherapy for patients with advanced esophageal cancer with or without naso-gastric ED tube for enteral feeding.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.184 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 184-184

Author(s):

Takashi Ogata ◽

Hiroaki Osakabe ◽

Shinsuke Nagasawa ◽

Masato Nakazono ◽

Kentaro Hara ◽

...

Keyword(s):

Esophageal Cancer ◽

Nutritional Status ◽

Cancer Patients ◽

Preoperative Chemotherapy ◽

Oral Intake ◽

Hematologic Toxicity ◽

Advanced Esophageal Cancer ◽

Group A ◽

Grade 3 ◽

Group B

184 Background: Advanced esophageal cancer patients sometimes have a difficulty to swallow food. On the other hand, standard treatment for resectable advanced esophageal cancer patients is surgery after 2 course preoperative chemotherapy of CDDP-5-FU (JCOG 9907). So we usually use naso-gastric ED tube for patients with difficulty of oral intake during preoperative chemotherapy to administrate adequate nutrition. But there is no report of the safety of this trial. Methods: The aim of this study is to clarify the safety of using ED tube during preoperative chemotherapy and compare the nutritional status between using ED tube or not. From Jan 2012 to June 2017, 122 patients were undergone esophagectomy with 2 course of preoperative chemotherapy, and 14 patients were treated with ED tube for nutrition(Group A) and 108 patients without ED tube(Group B). We evaluated the changes of nutritional status and postoperative complication as an indicator of safety. Results: Changes before and after preoperative chemotherapy(GroupA/B): average of body weight: 53.1→50.8/58.1→57.0, BMI: 20.0→19.2/22.0→21.6, TP: 6.7→6.9/7.3→6.9, alb: 3.5→3.8/4.3→4.2, pre-alb: 20.1→21.7/24.8→23.4, RBP: 2.77→3.33/3.15→3.23. Adverse events during chemotherapy: 1 case of Grade 3 hematologic toxicity and 1 case of Grade 2 non-hematologic toxicity were found at Group A(14.2%), and 11 cases of Grade 3 hematologic toxicity and 8 cases of Grade 2 non-hematologic toxicity were found at Group B(17.61%)(p = 0.758). Postoperative complications (clavien-dindo classification, Grade3 or more): 2 cases were observed at Group A(14.2%), and 21 cases were observed at Group B(19.4%)(p = 0.62). Conclusions: Preoperative chemotherapy with ED tube for nutrition was safe and effective to maintain the preoperative nutritional status.

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