bluuebunny/crossref_metadata_2025_split huggingface dataset:
PS02.104: CLINICAL STUDY OF PROSPECTIVE RANDOMIZED CONTROLLED TRIALS ON ADJUVANT THERAPIES IN TREATMENT OF RESECTABLE PIB-III (PT2–4AN0–1M0) ESOPHAGEAL SQUAMOUS CELL CARCINOMA
Authors: Zheng Bin , Chen Maohui , Wu Canxing , Zeng Taidui , Zhang Shuliang , Zheng Wei , Chen Chun 
Published: September 2018

Abstract

Background
Esophageal squamous cell carcinoma (ESCC) patients have relatively poor prognosis after operation. The study was designed to analyse the effect of surgery alone, surgery with adjuvant chemotherapy and surgery with chemoradiotherapy on prognosis in the patients with pathologic stage pIB-III (pT2–4aN0–1M0) who received radical esophagectomy.

Methods
We carried out the prospective randomized study. In this study, we analyzed 104 patients who had undergone minimally invasive esophagectomy for thoracic ESCC and been assessed as pathological stage pIB-III (pT2–4aN0–1M0) from January 2013 to October 2015 in our institute. 48 patients are treated with surgery alone (S group),33 patients received surgery and adjuvant chemotherapy (CT group), and 23 patients received surgery and adjuvant chemoradiotherapy (CRT group). We do the follow up for all the patients, collect the clilnical, patholigical data of them, and analyze the overal survival (OS) and disease-free survival (DFS) of them.

Results
The basic clinical characteristics of three groups were comparable. The average age was (52.1 ± 9.7) years old. The median follow‐up period was 39 months. The 3-year OS of the patients in the S group, CT group, and CRT group were 37.5%,18.8%, 65.2%, respectively. According to the follow-up data, both the 3-year OS and the 3-year DFS of the patients in the CRT group were better than those of the patients in the S group and CT group group (P < 0.05). However, the incidence rates of side effects and complications in CRT group were higher than those in S group and CT group, without signicant differences. One patient died in S group in perioperative period, because of postoperaive pulmonary embolism, and no patients died in CT group and CRT group in peri-treatment period.

Conclusion
Our prospective, randomized controlled trial showed that surgery with adjuvant chemoradiotherapy could improve 3-year OS and DFS compared with treatment of surgery alone or surgery with adjuvant chemotherapy.The side effects and complications of surgery with adjuvant chemoradiotherapy were acceptable. However, because our study enrolled limited patients, and the follow-up time was not long enough, we need to collect more patients and longer follow-up to further comfirm our conclusion.

Disclosure
All authors have declared no conflicts of interest.
PS02.107: OUTCOMES FOLLOWING DIFFERENT NEOADJUVANT CHEMORADIATION REGIMENS FOR LOCALLY ADVANCED ESOPHAGEAL CANCER
Authors: Shen Robert , Collins William , Yahn Colten , Allen Mark , Blackmon Shanda , Cassivi Stephen , Nichols Iii Francis , Wigle Dennis 
Published: September 2018

Abstract

Background
The objective of this study was to analyze the induction therapy regimens employed since publication of CROSS Trial in patients treated with locally advanced EGJ cancer in terms of toxicity, complications, survival and recurrence.

Methods
Retrospective chart review all patients in single institution prospective database who had neoadjuvant CRT→Surgery 2012–2015. Complications during CRT and after surgery graded using National Cancer Institute CTCAE. Cox-proportion hazard ratios were used to compare the primary outcomes of overall survival (OS) and disease-free survival (DFS).

Results
288 patients, 237 men and 51 women were identified. 246 were adenocarcinoma, 38 squamous cell carcinoma, and 4 had other histologic types. 4 distinct neoadjuvant regimens were observed: 50.4 Gy radiation with 5-fluorouracil and cisplatin (N = 22), CROSS regimen (41.4 Gy with carboplatin & paclitaxel) (N = 44), 50.4 Gy with carboplatin and paclitaxel (N = 152), and ‘Other’ which include 27 distinct regimens (N = 70). There were no differences in treatment related complications or postoperative complications between regimens. There was no difference in pathologic complete response rate, OS, or DFS between regimens.

Conclusion
Since the publication of the CROSS Trial, there is a significant heterogenity in the neoadjuvant chemoradiation treatment regimen employed for patients with locally advanced EGJ tumors. Does not appear to be any differences in treatment related complications or postoperative complications between regimens. There was also no difference in pCR, overall survival or disease-free survival.

Disclosure
All authors have declared no conflicts of interest.
PS02.112: A RETROSPECTIVE STUDY OF NEOADJUVANT 5-FU, DOCETAXEL, AND NEDAPLATIN (UDON) COMBINATION CHEMOTHERAPY FOR ADVANCED ESOPHAGEAL CANCER
Authors: Kimura Yutaka , Shiraishi Osamu , Kawakami Hisato , Ueda Hiroto , Iwama Mitsuru , Kato Hiroaki , Okuno Tatsuya , Hiraki Yoko , Yasuda Atsushi , Shinkai Masayuki , Imano Motohiro , Imamoto Haruhiko , Nakagawa Kazuhiko , Yasuda Takkushi 
Published: September 2018

Abstract

Background
In Japan, pre-operative5-FU and cisplatin (CDDP) (FP) combination therapy has been the standard neoadjuvant chemotherapy (NAC) for advanced resectable esophageal cancer (EC), whereas the efficacy of docetaxel (DTX)-containing triplet regimen, FP plus DTX has been reported (Yamasaki M, et al, Ann Oncol 2017). However, for frail patients, such as patients with old age, chronic renal failure, poor performance status, severe commodities or malnutrition, high dose CDDP is not generally recommended in terms of toxicity. We have been developing non-CDDP-containing triplet regimen, 5-FU, DTX, and nedaplatin (NED) (UDON) on a phase I/II trial basis. This retrospective study aimed to investigate the safety and efficacy of NAC with UDON combination for advanced EC.

Methods
Eleven patients with advanced resectable EC who were unsuitable for the administration of high dose CDDP were enrolled in this study. Patients received two cycles of NAC with UDON (5-FU, 640 or 800 mg/m2, day1–5, DTX, 28 or 35 mg/m2, day1 and 15 and NED, 72 or 90 mg/m2, day1, q28) followed by esophagectomy. Primary endpoint was response rate and secondary endpoint was adverse event (AE).

Results
The median age was 73 years (range: 58–80) with eight patients being aged 70 or older. ECOG PS was 1/2: 7/4. The main location of the tumor was Ce/Ut/Mt/Lt/Ae: 1/1/7/1/1 and cStage was IIA/IIB/IIIA/IIIB/IIIC/IV: 2/2/4/0/2/1. The RR (CR + PR) was 82% (CR/PR/SD/PD: 1/8/2/0). The pathological response was grade 0/1a/1b/2/3: 2/3/3/2/1. Major grade 3 or 4 adverse events included neutropenia (27%), febrile neutropenia (27%), diarrhea (18%), enteritis (9%) and hyponatremia (27%). The postoperative morbidity included recurrent nerve palsy (36%), aspiration (27%), pneumonia (18%), anastomotic leakage (9%) and delirium (36%). There was no treatment-related death and no reoperation.

Conclusion
NAC with UDON for advanced resectable EC unsuitable for the administration of high dose CDDP might be feasible and effective. We are planning a phase II clinical study based on the present results.

Disclosure
All authors have declared no conflicts of interest.
PS02.117: OUTCOMES FOR SQUAMOUS CELL CARCINOMA OF THE OESOPHAGUS IN A WESTERN POPULATION
Authors: Madhavan Anantha , Phillips Alex , Wyatt Nicola , Navidi Maziar , Michael Griffin S 
Published: September 2018

Abstract

Background
Squamous cell carcinoma of the oesophagus comprises approximately 30% of oesophageal malignancies in the ‘west’. Different approaches in management have been advocated. In the UK patients may receive conventional neoadjuvant chemotherapy (OEO2) or neoadjuvant chemoradiotherapy (CROSS). The aim of this study was to evaluate outcomes of patients receiving potentially curative surgical treatment for squamous cell carcinoma of the oesophagus.

Methods
A retrospective review of patients who underwent treatment with curative intent for oesophageal squamous cell carcinoma between 2006 to 2016 at a single institution was performed. Patients underwent a standardised staging protocol and were assigned to the treatment modality based on the stage of the disease by a multi-disciplinary team. Outcomes were evaluated according to the treatment received.

Results
Overall 199 patients underwent curative treatment in the 10 year period. This comprised 26% of the oesophagectomies for carcinoma. Of these, 168 patients had disease which was staged T3 and above or had evidence of nodal disease. 81% of these patients received neo-adjuvant treatment, 108 receiving chemotherapy alone and 29 receiving chemoradiotherapy. The remaining 31 patients underwent surgery alone. There was no significant difference in the clinical staging between the three treatment modalities, (P = 0.25). There were 31 patients with early (T1/2 N0) cancer that underwent unimodality treatment in the form of surgery. Estimated median survival was 85 months for those that received chemotherapy and 53 months chemoradiotherapy (P = 0.45). Within the surgical group those patients with locally advanced disease (T3 + or N + ) median survival was 19 months; median survival was not reached for early cancers.

Conclusion
Both chemoradiotherapy and chemotherapy in the neoadjuvant setting combined with radical surgery enable excellent long-term outcomes to be achieved. Data from the Neo-aegis trial will hopefully inform which neoadjuvant treatment confers the greatest survival advantage.

Disclosure
All authors have declared no conflicts of interest.
PS02.121: INTENSIFIED IMRTWITH CARBOPLATIN AND PACLITAXEL IN LOCALLY ADVANCED ESOPHAGEAL CANCER: AN ANALYSIS ON EARLY OUTCOME
Authors: Innocente Roberto , Navarria Federico , Palazzari Elisa , Matrone Fabio , Farina Eleonora , Fanetti Giuseppe , Boz Giovanni , Gigante Marco , Foltran Luisa , Castoro Carlo , Ubiali Paolo , Petri Roberto , Ruol Alberto , De Paoli Antonino , Franchin Giovanni 
Published: September 2018

Abstract

Background
Evaluate safety, feasibility and efficacy of an intesified IMRT and concomitant carboplatin and paclitaxel-based chemotherapy (Carbo/Tax CT) in patients (pts) with locally advanced esophageal cancer (LAEC) treated at our Institution

Methods
We retrospectively analyzed acute toxicity (according to CTCAE 4.0 scale), compliance and response to treatment in a series of consecutive patients treated, between February 2016 and February 2018, with intensified radiotherapy (IMRT) and weekly concurrent carboplatin and paclitaxel-based chemotherapy (CT) according to the CROSS trial.

Results
Thirty-four consecutive pts, 30(88%) males and 4 (12%) females, were treated. The median age was 68.5 yrs (range 46–83) and the ECOG Performance status ranged from 0 to 2. The diagnosis was adenocarcinoma in 15 pts (44%), squamous-cell carcinoma in 18 pts (53%) and undifferentiated carcinoma in 1 pt (3%). Two pts (6%) had a T2, 26 pts (76.4%) a T3 and 6 pts (17.6%) a T4 disease, respectively; 5 pts (15%) were N0, 21 pts (62%) N1 and 8 pts (23%) N2, respectively. Tumor involved the cervical esophagus in 3 pts (9%), the thoracic esophagus in 24 pts (70.5%) and the gastroesophageal junction in 7(20.5%). All pts underwent concurrent chemoradiotherapy (CRT), with IMRT technique, consisting of 45 Gy/25 frs to PTV1 (the primary gross tumor volume and the regional nodes), a simultaneous integrated boost ranging from 52.5Gy to 54Gy to PTV2 (gross tumor volume) and weekly concurrent carboplatin (AUC2) and paclitaxel (50mg/m2). Induction CT was administered to 6 pts. All pts completed the RT schedule. The median number of CT cycles was 3 (range 1–5) and 11 pts (32%) received 4 to 5 cycles of CT. Two adverse reactions to paclitaxel were reported. There were no major non-hematological adverse effects, the most common were nausea and vomiting (10%), and dysphagia (7%). Leukopenia was reported in 20 pts (71%), G3 in 2 pts (10%) and G2 in 18 (90%), respectively. G2 anemia occurred in 2 pts while G2 thrombocytopenia was reported in 3 pts (10%). Among the 30 evaluable pts (restaging is ongoing in 4 pts) a clinical complete response (PET, endoscopy and biopsy) was observed in 11 pts (37%), 7 with adenocarcinom and 4 with squamous cell carcinoma. Partial response was observed in 11 pts (37%) and 8 (26%) showed progressive disease. Total esophagectomy with radical lymphadenectomy, performed in 11 pts, showed a pathologic complete response in 6 pts (54%).

Conclusion
Intensified IMRT with concomitant Carbo/Tax CT in pts with LAEC seems to be safe and effective. These promising results need to be confirmed in all pts evaluated in this multimodality program

Disclosure
All authors have declared no conflicts of interest.
PS02.129: BRAIN METASTASIS FROM THORACIC ESOPHAGEAL CANCER AT A SINGLE INSTITUTE
Authors: Hirao Motohiro , Tanaka Eiichi , Okita Y , Fujinaka T , Nishikawa K , Hamakawa T , Mano M , Nakamori S , Sekimoto M 
Published: September 2018

Abstract

Background
Brain metastases (BM) from esophageal cancer (EC) are rare. Despite of an advance of treatments for the patients with BM from EC, life expectancy and quality of life of these patients are still poor. We present an overview of the patients with BM from EC at a single institute.

Methods
We retrospectively identified 10 patients with BM from EC treated with surgery, radiation, or a combination of multidisciplinary therapies at Osaka National Hospital between 2003 and 2017 for stages IIb through IV of primary EC (follow-up, > 157 days). Medical records were reviewed to collect demographic and clinical information.

Results
Median age at diagnosis of BM was 63.5 years (range, 53–79 years). 9 patients were male, and 7 patients had squamous cell carcinoma of EC at the primary esophageal resection. Median overall survival from the commencements of therapy for BM was 156 days (range, 17–5404 days). The interval between the primary esophagectomy and the start of therapy for BM from EC was 298 days (range, 64–860 days). The average score of Karnofsky performance status (KPS) just before a diagnosis of BM was 75 (range, 50–90). On univariate analysis, the patients with the lower score of KPS (P = 0.01) or the shorter interval between the primary esophageal surgery and the start of therapy for BM (P = 0.06) were found to have worsened survival after the therapy for BM from EC.

Conclusion
The patients who had a poor KPS just before a diagnosis of BM, or the shorter interval between the esophagectomy for the primary EC and the start of therapy for BM, had poor prognosis.

Disclosure
All authors have declared no conflicts of interest.
PS02.132: SAFETY, ANTITUMOR ACTIVITY AND BIOMARKER OF ANTI-PD-1 ANTIBODY IN PATIENTS WITH ADVANCED ESOPHAGEAL CARCINOMA
Authors: Wang Feng , Meng Xiangrui , Fan Qingxia 
Published: September 2018

Abstract

Background
Esophageal squamous cell carcinoma (ESCC) has a poor outcome with a 5-year survival rate of only about 15–25%.Immunotherapy targeting the checkpoint programmed cell death protein 1 (PD1) has been shown to be effective in the management of melanoma, non-small cell lung cancer, and renal cell carcinoma.To assessed the safety and activity of anti-PD-1 antibody in patients with metastatic ESCC.PD-L1expression, mutation load were also assessed in this study.

Methods
A retrospective analysis of 52 patients with advanced ESCC received anti-PD-1 antibody or chemotherapy, all patients has previously received first- or multi-line chemotherapy.26 patients in the observation group received continuous treatment of anti-PD-1 antibody: Q2W with initial dose of 200mg until disease progression or intolerable toxicity. 26 patients in the control group received irinotecan intravenously on day 1 and 8 at a dose of 80 mg·m-2.During this process, efficacy and safety of anti-PD-1 antibody and irinotecan were also evaluated.

Results
Total 52 patients were participated in the study from January 2016 to June 2017, and all of them could be evaluated for objective efficacy and safety.In observation group, ORR and DCR were 26.9% and 46.2% respectively.In control group, ORR and DCR were 23.1% and 42.3% respectively.PFS were 3.5months (95% CI, 1.3–7.9 months) and 3.1months (95% CI, 1.9–5.4 months) in observation group and in control group respectively.The differences between the 2 groups in ORR, DCR and PFS were not statistically significant(P>0.05).In observation group, treatment-related AEs occurred in 20 patients (76.92%), most commonly reactive capillary hemangiomas(76.92%), pruritus(19.23%) and hypothyroidism(11.54%).Most events were grade 1 or 2. Two(7.69%) treatment-related grade 3 events(pneumonitis) were reported, No grade 4 or grade 5 treatment-related adverse events were reported.In control group,25 patients (96.15%) experienced treatment-related adverse events,19(73.08%) treatment-related grade 3 or grade 4 events were reported.509 genes panal sequencing showed that the TMB in the group with clinical benefit (CB) was much higher than that in that without clinical benefit (NCB) (P = 0.0479).An objective response was more common in patients with PD-L1-positive tumors as defined by > 5% staining than in those with PD-L1-negative tumors.

Conclusion
In this population of ESCC patients, anti-PD-1 antibody had a manageable safety profile and promising antitumor activity.

Disclosure
All authors have declared no conflicts of interest.
PS02.137: SALVAGE ESOPHAGECTOMY AFTER DEFINITIVE CHEMORADIOTHERAPY: EXPERIENCES OF A SINGLE INSTITUTION
Authors: Guo Xufeng , Li Zhigang 
Published: September 2018

Abstract

Background
Definitive chemoradiotherapy (dCRT) is considered a standard treatment for locally advanced esophageal cancer. Despite of long-term survival of 15–20% after such treatment, locoregional recurrence occurs in around 40–60%. Further radiotherapy is often contraindicated because the maximal tolerable dose has been achieved. As for salvage chemotherapy, the treatment outcome is disappointing. Salvage surgery is another choice but its role still remains debatable. The present study was designed to evaluate the safety and efficacy of salvage esophagectomy.

Methods
18 consecutive cases of salvage esophagectomy after dCRT by a single institution were analyzed.

Results
(1) 16 males and 2 females. There were 6 cases (33.3%) and 12 cases (66.7%) of recurrent and persistent tumor after dCRT respectively; (2) All the patients were treated with McKeown operation stytle combing thoracic and abdominal lymph nodes dissection. Esophagus was replaced by stomach of 15 cases and colon of 3 cases respectively. Radical resection (R0) was performed in 12 cases, palliative resection (R2) in 6 cases. There were 4 cases of pathological complete response (pCR); (3) The incidence of postoperative complications was 61.1% (11/18), including 6 cases of pulmonary infection, 4 cases of anastomotic leak, 2 cases of incision infection, one case of respiratory insufficiency, one case of recurrent laryngeal nerve paralysis, one case of chylothorax, one case of aortic bleeding caused by empyema; (4) One patient died in perioperative period because of aortic bleeding due to empyema. The follow-up period was from 2 to 26 months, and the median follow-up time was 9 months. There were 13 patients survived and 5 patients died at the last follow-up date including one death in perioperative period, 2 cases died of local-regional recurrence and metastasis respectively.

Conclusion
Salvage esophagectomy is a treatment option for the recurrent or persistent disease after dCRT, but the incidence of postoperative complications is high. Accurate clinical staging is especially important after dCRT and ycT4, ycN + patients should be avoided. R0 resection and recurrence after long disease free period are favorable prognostic factors.

Disclosure
All authors have declared no conflicts of interest.
PS02.138: SALVAGE ESOPHAGECTOMY: SINGLE ONCOLOGICAL CENTER EXPERIENCE
Authors: Sabino Flávio , Guimaraes Marco , Eduardo Pinto Carlos , Fernandes Daniel , Felipe Pinto Luis , Albagli Rafael , Ribeiro Luciana 
Published: September 2018

Abstract

Background
Surgical resection is considering the gold standard in esophageal cancer treatment, with 15–40% cure global rates. Radical exclusive chemoradiotherapy (CRT) is used in patients with local advanced esophageal cancer or without clinical conditions for esophagectomy, with a 5-year overall survival up to 30%. However, locoregional control is poor with a 40–60% recurrence rate and salvage esophagectomy maybe an option for these patients.

Methods
Our objective is to report the experience of a single high volume oncological institution with salvage esophagectomy.
Retrospective analysis of 28 patients medical records, with esophageal cancer, submitted to Salvage Esophagectomy in Brazilian NCI after radical exclusive CRT or RT between January 1990 and December 2015.

Results
Median age was 56 years and most are male (78,5%). Esophageal middle third was the tumor principal location (50%) and histological type was squamous cell carcinoma (82%). Thoracic approach for esophagectomy was the principal surgical technique, and gastric tube the most used conduit for reconstruction (78,5%). Surgery was R0 in 83% of the cases, with a surgical morbidity of 64%. Median hospital time was 15 days (8–58) and surgical mortality 14% (4 patients), with 7% in the first 30 days. Median overall survival was 22,3 months.

Conclusion
Our results are in line with published data in the literature. Besides surgical morbidity and mortality, Salvage Esophagectomy remains de only chance of cure for patients with locoregional recurrence after radical exclusive CRT.

Disclosure
All authors have declared no conflicts of interest.
PS02.139: THE TREATMENT STRATEGY AND CLINICAL OUTCOMES FOR SALVAGE ESOPHAGECTOMY AFTER DEFINITIVE CHEMORADIOTHERAPY
Authors: Ogawa Kyohei , Narumiya Kosuke , Kudo Kenji , Yagawa Yosuke , Maeda Shinsuke , Toyoshima Yukinori , Ide Hiroko , Osugi Harushi , Yamamoto Masakazu 
Published: September 2018

Abstract

Background
Definitive chemoradiotherapy for esophageal cancer which was unresectable tumor has become common therapy. In recently, we have perform chemoradiotherapy for resectable tumor because esophagectomy for esophageal cancer is an invasive surgical procedure. But some cases were recurrent. We examined the treatment strategy and clinical outcomes of salvage esophagectomy after definitive chemoradiotherapy for esophageal cancer.

Methods
We reviewed 46 cases of subjects with esophageal cancer who underwent salvage esophagectomy after definitive chemoradiotherapy with more than 50Gy of radiation from 2000 to 2017. We exam (1) Back ground (2) Term after Chemoradiotherapy (3)Surgical approach (4) Route of reconstruction (5)Rang of lymphanodectomy (6)Complication (7)Prognosis.

Results
Age 63.0(43–79), Male: Female = 44:2, Location: Upper/Middle/Lower = 15/25/8, T1/T2/T3/T4 = 11:2:25:8 R0: R1: R2 = 35:9:2 (2) Within1 year/More than 1 year = 31/15 (3) Neck digection/Right thoracotomy: Left thoracotomy: laparotomy = 8:31:5:2 (4) Mediastinal rute/Ante/Retro = 34:9:3 (5) 1 Field:2 Field:3 Field = 11:27:8 (6) Anastleakage/Pneumonia/Abcess/Meningitis/Fluid in the thoracic cavity = 11: 9: 4: 1: 8 (7) 5-years survival rate was 36%. Hospital death was4.3%

Conclusion
There were high rate complications for salvage esophagectomy after definitive chemoradiotherapy for esophageal cancer. Patients should be carefully selected for salvage esophagectomy.Surgeons should consider the indications and techniques for esophageal surgery to increase cure rates and decrease morbidity.

Disclosure
All authors have declared no conflicts of interest.