Neoadjuvant PD-1 blockade in combination with chemotherapy for patients with resectable esophageal squamous cell carcinoma.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 220-220
Author(s):  
Chao Cheng ◽  
Weixiong Yang ◽  
Wenfang Chen ◽  
Sai-Ching Jim Yeung ◽  
Xiangbin Xing ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Tumor Regression ◽  
Objective Response ◽  
Neoadjuvant Treatment ◽  
R0 Resection

220 Background: Programmed death-1 (PD-1) blockade may induce tumor regression in patients with advanced esophageal squamous cell carcinoma (ESCC), but little is known about the efficacy of PD-1 blockade in neoadjuvant therapy of resectable ESCC. Methods: Under an approved clinical trial protocol, a pilot study was conducted by enrolling patients with untreated, resectable (stage II or IIIA) ESCC. After written informed consent, each patient received two 21-day cycles of neoadjuvant treatment with camrelizumab (200mg), albumin-paclitaxel (260mg/m2) and carboplatin (area under the curve = 5) followed by surgical resection about 6 weeks after the first dose. The primary end points were safety and feasibility. We also reported the objective response rate (ORR), disease control rate (DCR) and tumor pathological response. Results: Between January 19, 2020, and July 21, 2020, we assessed 35 patients for screening, of whom 20 patients were enrolled. Neoadjuvant combination of camrelizumab, carboplatin and albumin-paclitaxel had an acceptable side-effect profile, and was not associated with delays in surgery. The ORR was 85%, and the DCR was 100%. Eighteen (90%) patients were taken into the surgery, and all of them successfully underwent R0 resection. Five (5/18 = 27.8%) patients had a pathological complete response (pCR), and eight (44.4%) patients had major pathological responses (MPR).The most common treatment-related grade 1–2 adverse events were leukopenia (12, 60%), neutropenia (11, 55%) and nausea (8, 40%). Two (10%) patients suffered grade 3 neutropenia. There was no grade 4 adverse events and treatment-related deaths. Conclusions: Neoadjuvant camrelizumab plus carboplatin and albumin-paclitaxel had manageable treatment-related toxic effects, did not delay surgery. This regimen induced pCR or MPR in 72.2% of resected tumor, demonstrating its antitumor efficacy in resectable ESCC. Clinical trial information: ChiCTR2000028900.

Nivolumab in advanced esophageal squamous cell carcinoma (ATTRACTION-1/ONO-4538-07): Minimum of five-year follow-up.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 207-207
Author(s):  
Ken Kato ◽  
Yuichiro Doki ◽  
Takashi Ura ◽  
Yasuo Hamamoto ◽  
Takashi Kojima ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Disease Progression ◽  
Squamous Cell ◽  
Group Performance ◽  
Objective Response

207 Background:ATTRACTION-1/ONO-4538-07 (AT-1), an open-label, single-arm, multicenter phase 2 clinical trial conducted in Japan, evaluated the clinical activity and safety of nivolumab in patients with advanced esophageal squamous cell carcinoma (ESCC) refractory/intolerant to fluoropyrimidine-, platinum-, and taxane-based chemotherapy. We previously reported the 2-year follow-up findings of AT-1, in which nivolumab demonstrated antitumor activity with a manageable safety profile for these patients. Here we report the final findings from AT-1 at a minimum follow-up of 5 years. Methods:Patients aged ≥20 years with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 received 3 mg/kg nivolumab intravenously every 2 weeks in 6-week cycles until disease progression or unacceptable toxicity. The primary endpoint was centrally-assessed objective response rate (ORR), defined as the proportion of patients whose best overall response was either a complete or partial response. Secondary endpoints included overall survival (OS), investigator-assessed ORR, progression-free survival (PFS), change in tumor burden, time to response, time to disease progression, and duration of response. Results:Between February 25 and November 14, 2014, a total of 65 patients were enrolled. Sixty-four patients were evaluated for the efficacy, and all patients were evaluated for the safety. At the final database lock on August 6, 2020, 11 (17.2%, 95% confidence interval [CI] 9.9-28.2) of 64 patients had an objective response by central assessment. The median OS was 10.8 months (95% CI, 7.4-13.9), and the estimated 5-year OS rate was 6.3% (95% CI, 2.0-14.0). The median PFS was 1.5 months (95% CI, 1.4-2.8), and the estimated 5-year PFS rate was 6.8% (95% CI, 2.2-15.1). Treatment-related adverse events that occurred with a frequency of > 10% were diarrhea and rash. The presentation will include characteristics of long-term survivors as well as detailed efficacy and safety data of nivolumab. Conclusions:This final assessment represents the longest follow-up of patients with advanced ESCC treated with nivolumab. Nivolumab demonstrated continued long-term efficacy in these patients based on a minimum of 5-year long-term survival update of AT-1. Furthermore, no new safety signals with nivolumab were identified during long-term follow-up. These findings are consistent with those of nivolumab monotherapy for various types of cancer. Clinical trial information: No.142422.

Camrelizumab combined with paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma (ESPRIT): A phase Ⅱ, single-arm, exploratory research.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16033-e16033
Author(s):  
Jianqun Ma ◽  
Jinfeng Zhang ◽  
Yingnan Yang ◽  
Dayong Zheng ◽  
Xiaoyuan Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Neoadjuvant Therapy ◽  
Squamous Cell ◽  
Radical Surgery ◽  
Objective Response ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Therapeutic Effects

e16033 Background: Camrelizumab has been approved as a standard therapy in the second-line treatment of esophageal squamous cell carcinoma (ESCC). This study aimed to explore the efficacy and safety of camrelizumab combined with commonly used neoadjuvant chemotherapy (paclitaxel and platinum) in neoadjuvant treatment of ESCC. Methods: In this single-arm, phase Ⅱ study, patients with advanced ESCC who were expected to receive neoadjuvant therapy followed by radical surgery were recruited. The patients received 2-4 cycles of camrelizumab (200mg, iv, q3w) in combination with paclitaxel (155mg/m2, iv, q3w) and nedaplatin (80mg/m2, iv, q3w) as neoadjuvant therapy, and the therapeutic effects were determined every 2 cycles. The radical surgery was performed on patients whose tumors were evaluated as resectable. The primary endpoint was pCR, and the secondary endpoints were objective response rate (ORR) and disease control rate (DCR). Results: From May 2020 to January 2021, 24 patients with a median age of 60.5 years (50-73) were enrolled. Among them, 21 patients were available for efficacy analysis, of which 1 achieved complete response (CR), 7 achieved partial response (PR), and 13 had stable disease (SD). The ORR was 38.1% and DCR was 100%. The tumor in 10 patients shrank significantly after neoadjuvant therapy and these patients preferred radiotherapy instead of surgery as the radical therapeutic method. 2 patients abandoned surgery because of personal reasons. 2 patients were in the process of neoadjuvant therapy and had not undergone surgery yet. The remaining 7 patients underwent radical surgery and 4 patients (57.14%) achieved pCR (pT0N0M0). The main treatment-related grade 3/4 adverse event (AE) was neutropenia (1/21). All the AEs were manageable. The average intraoperative blood loss was 221mL and the average hospitalization time after operation was 12.7 days (range 8-19 days). No anastomotic leakage and treatment-related death occurred. Conclusions: Camrelizumab in combination with paclitaxel and platinum as a neoadjuvant therapy was well tolerated. The pCR rate of 57.14% was higher than the expected 40%. This encouraging result promoted us to continue this phase Ⅱ study. Clinical trial information: ChiCTR2000033761.

scholarly journals Anti-PD1/PDL1 antibodies plus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma

2020 ◽  
Author(s):  
Jiong Qian ◽  
Wu Lin ◽  
Haohao Wang ◽  
Chenyu Mao ◽  
Haiping Jiang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Trials ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Objective Response ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Abstract Background: Patients with advanced esophageal squamous cell carcinoma (ESCC) have a poor prognosis with few treatment options. Immunotherapy was suggested as a promising treatment for ESCC from some clinical trials. Here we collected clinical results from 23 patients who were received anti-PD1/PDL1 antibodies (mAbs) plus chemotherapy as first line therapy with advanced ESCC, to analyze this combined therapy’s efficacy on advanced ESCC. Methods: Results of 23 Patients started treatment from December 15th, 2017 to September 27th, 2019 (12 patients were enrolled in phase II clinical trials, 11 patients were treated by physician’s choice regiment) of anti-PD1/PDL1 antibodies (mAbs) plus chemotherapy on advanced ESCC as first line treatment were collected. Regiments were either anti-PD1 or anti-PDL1 mAbs plus traditional chemotherapy (cisplatin/5-fluorouracil (5-FU), Paclitaxel/ cisplatin, Paclitaxel/carboplatin or Paclitaxel/ 5-FU) every 3 weeks for six cycles, followed by maintenance therapy with anti-PD1/PDL1 mAbs. Objective response and safety profiles were observed as well as progression-free survival(PFS), overall survival(OS) and duration of response. Results: Of the 23 patients, 18 (78.3%) responded to treatment: 15 partial and 3 complete response. 4 patients had stable disease and 1 patient had progressive disease. The median time to response was 1.4 months (range, 1.4 months – 2.8 months). Treatment-related adverse events occurred in all patients but 3-4 grade immune-mediated adverse events occurred in only one patient. As of April 10th, 2020, the Objective response rate was 78.3%, the median PFS was 15.5 months and the median OS was 21.5 months. No treatment-related deaths were observed. Conclusions: Anti-PD1/PDL1 antibodies plus chemotherapy as the first-line treatment for advanced ESCC showed promising results with manageable adverse events and worthy of further study.

scholarly journals Neoadjuvant camrelizumab plus chemotherapy in treating locally advanced esophageal squamous cell carcinoma patients: a pilot study

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Peng Yang ◽  
Xiao Zhou ◽  
Xuefeng Yang ◽  
Yuefeng Wang ◽  
Tao Sun ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Pilot Study ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Neoadjuvant Therapy ◽  
Squamous Cell ◽  
Locally Advanced ◽  
R0 Resection ◽  
Resection Rate

Abstract Background Camrelizumab (a PD-1 inhibitor) has been used as a potential therapy in unresectable advanced esophageal squamous cell carcinoma (ESCC) along with adjuvant treatment in locally advanced ESCC, exhibiting an acceptable efficacy and safety profile. This pilot study was designed to further investigate the clinical value and tolerance of neoadjuvant camrelizumab plus chemotherapy in locally advanced ESCC. Methods A total of 16 patients with locally advanced ESCC were recruited. Patients received 2 cycles of neoadjuvant therapy including 2 doses of camrelizumab concurrent with 2 cycles of paclitaxel plus carboplatin followed by surgery 4 weeks afterward. Then, the treatment response after neoadjuvant therapy, R0 resection rate, tumor regression grade (TRG), and pathological complete remission (pCR) rate were measured. Besides, adverse events were documented. At last, progression-free survival (PFS) and overall survival (OS) were assessed. Results Generally, objective remission rate (ORR) was 81.3% whereas disease control rate (DCR) was 100% after neoadjuvant therapy. Concerning TRG grade, 31.3, 37.5, 18.8, and 12.5% patients reached TRG0, TRG1, TRG2, and TRG3, respectively. Then, pCR rate and R0 resection rate were 31.3 and 93.8%, respectively. Besides, mean PFS and OS were 18.3 months (95%CI: (16.2–20.5) months) and 19.2 months (95%CI: (17.7–20.7) months), respectively, with a 1-year PFS of 83% and OS of 90.9%. Adverse events included white blood cell decrease (37.5%), neutrophil decrease (31.3%), reactive cutaneous capillary endothelial proliferation (37.5%), and nausea or vomiting (25.0%), which were relatively mild and manageable. Conclusion Neoadjuvant camrelizumab plus chemotherapy exhibits good efficacy and acceptable tolerance in patients with locally advanced ESCC.

Preoperative chemotherapy combined with PD-1 inhibitor in locally advanced operable or potentially resectable esophageal squamous cell carcinoma: A real world study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16010-e16010
Author(s):  
Puyuan Wu ◽  
Tao Wang ◽  
Baojun Chen ◽  
Minke Shi ◽  
Yong Zhou ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Preoperative Chemotherapy ◽  
Squamous Cell ◽  
Real World ◽  
Tumor Response ◽  
Objective Response ◽  
Locally Advanced ◽  
R0 Resection

e16010 Background: Preoperative therapy of esophageal squamous cell carcinoma (ESCC) is stepping into the era of combined therapy with PD-1 inhibitor after the success of PD-1 antibodies in the first-line and second-line treatment for advanced ESCC. This single center study retrospectively analyzed the efficacy and safety of preoperative chemotherapy combined with PD-1 antibody in patients with locally advanced operable or potentially resectable ESCC in the real world. Methods: The study enrolled operable or potentially resectable locally advanced ESCC patients treated with preoperative chemotherapy combined with PD-1 inhibitor in our center from April 2020 to December 2020. The treatment regimen were 2 to 4 cycles of paclitaxel liposome (135̃175 mg/m2) or albumin paclitaxel (180mg/m2) plus nedaplatin (75mg/m2) or lobaplatin (30mg/m2) combined with PD-1 inhibitors (toripalimab 13/20, sintilimab 3/20, pembrolizumab 2/20, camrelizumab 1/20, tislelizumab 1/20) with standard therapeutic dose followed by tumor response assessment and surgery. The primary end point were safety, tumor response and complete pathological response (pCR) rate. Results: A total of 20 patients including 17 males and 3 females, of which median age was 65 and 85% were stage III-IVA (AJCC 8th), were included in the study. Of all the patients, 18 patients accomplished 2 cycles of therapy and had safety assessment, 13 patients underwent surgery, 2 patients were waiting for operations and 2 patients achieving partial response rejected surgery and were prepared for radical chemoradiotherapy. Treatment-related adverse events exceeding grade 3 levels included leukopenia 5.6% (1/18), neutropenia 16.7% (3/18), thrombocytopenia 5.6% (1/18), and immune hepatitis 5.6% (1/18). There was no severe surgery-related complication. Objective response rate (ORR) was 70.6% (12/17), and disease control rate (DCR) was 100% (17/17). R0 resection rate was 92.3% (12/13), the pCR rate was 15.4% (2/13), and 61.5% (8/13) of the patients had downstaged to the ypT1-2N0M0 I stage. One patient finally reached a pCR after switching to preoperative chemoradiotherapy because of progression after treatment of chemotherapy and PD-1 inhibitor. Conclusions: Preoperative chemotherapy combined PD-1 inhibitor treatment was well tolerated and had high efficacy in locally advanced operable and potential resectable ESCC. Since the study included some potentially resectable patients with late staging, the pCR rate may be lowered. The further study aims to find the efficient biomarker including PD-L1 expression and CD8+ T cell infiltration. Moreover, well-designed randomized prospective trials for better evidence are required.

scholarly journals GASC1-Adapted Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma: A Prospective Clinical Biomarker Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Ruinuo Jia ◽  
Youjia Mi ◽  
Xiang Yuan ◽  
Dejiu Kong ◽  
Wanying Li ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Neoadjuvant Chemotherapy ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Tumor Regression ◽  
Objective Response ◽  
Tumor Regression Grade ◽  
Potential Biomarker ◽  
Significant Difference

Neoadjuvant chemotherapy (NCT) is a standard care for esophageal squamous cell carcinoma (ESCC), but the efficacy is unsatisfactory. Cancer stem cells (CSCs) play key roles in chemotherapy resistance. Gene amplified in squamous cell carcinoma 1 (GASC1) is a neoteric gene in stemness maintaining of ESCC. We aimed to reveal whether GASC1 could be a predictive biomarker for NCT in ESCC. ESCC patients (T2-4N0-2M0) were evaluated for GASC1 expression using immunohistochemical staining and classified as GASC1-low group (GLG) and GASC1-high group (GHG). NCT was delivered in two cycles and then the surgery was completed. Primary endpoints were tumor regression grade (TRG) and objective response rate (ORR); secondary endpoints were radical surgical resection (R0) rate and three-year overall survival (OS). 60 patients were eligible with evaluable outcomes: 24 in GHG and 36 in GLG. Between GHG and GLG, TRG1, TRG2, TRG3, and TRG4 were 0 : 16.7%, 20.8% : 41.7%, 58.3% : 36.1%, and 20.8% : 5.6%, respectively (P=0.006); ORR and R0 rate were 33.3% : 69.4% (P=0.006) and 75% : 94.4% (P=0.046), respectively; the median OS was 20 : 32 (months) (P=0.0356). No significant difference in the three-year OS was observed between GHG and GLG: 29.2% : 41.7% (P=0.24). Furthermore, the GASC1 expression level was associated with poor OS independent of other factors by univariate and multivariate analyses. Therefore, GASC1 might be a potential biomarker to predict NCT efficacy for ESCC.

scholarly journals Concurrent chemoradiotherapy with S-1 compared with concurrent chemoradiotherapy with docetaxel and cisplatin for locally advanced esophageal squamous cell carcinoma

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Elderly Patients ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Concurrent Chemoradiotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Grade 3

Abstract Background This retrospective study was to assess and compare the toxicity and efficacy of concurrent chemoradiotherapy (CCRT) with S-1 or docetaxel and cisplatin in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods Patients with locally advanced ESCC who received CCRT with S-1 (70 mg/m2 twice daily on days 1–14, every 3 weeks for 2 cycles, S-1 group) or docetaxel (25 mg/m2) and cisplatin (25 mg/m2) on day 1 weekly (DP group) between 2014 and 2016 were retrospectively analyzed. Radiotherapy was delivered in 1.8–2.0 Gy per fraction to a total dose of 50–60 Gy. Treatment-related toxicities (Common Terminology Criteria for Adverse Events version 4.0), response rate, and survival outcomes were compared between groups. Results A total of 175 patients were included in this study (72 in the S-1 group and 103 in the DP group). Baseline characteristics were well balanced between the two groups. The incidence of grade 3–4 adverse events were significantly lower in the S-1 group than that of the DP group (22.2% vs. 45.6%, p = 0.002). In the DP group, elderly patients (> 60 years) had a significantly higher rate of grade 3–4 adverse events than younger patients (58.1% vs. 31.3%, p = 0.01). The objective overall response rate (complete response + partial response) was 68.1% in the S-1 group, and 73.8% the DP group (p = 0.497). The 3-year overall survival was 34.7% in the S-1 group, and 38.8% in the DP group (p = 0.422). The 3-year progression free survival in the DP group was higher than that in the S-1 group but without significant difference (33.0% vs. 25.0%, p = 0.275). Conclusion CCRT with S-1 is not inferior to CCRT with docetaxel and cisplatin and is better tolerated in in elderly patients with locally advanced ESCC.

659 AN SINGLE-ARM OPEN-LABEL PHASE II STUDY OF CAMRELIZUMAB PLUS APATINIB AS SECOND-LINE TREATMENT FOR ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Feng Wang ◽  
Qingxia Fan ◽  
Junsheng Wang ◽  
Tao Wu ◽  
Yonggui Hong ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Objective Response ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line

Abstract   Esophageal squamous cell carcinoma (ESCC) as a common malignancy is prevalent in East Asia and in eastern and southern Africa. Although pembrolizumab, nivolumab and camrelizumab are respectively recommended as second-line treatment for advanced ESCC due to improved overall survival (OS), objective response rate (ORR) was modest. New effective treatments are needed. Hence, the study of camrelizumab plus apatinib (VEGFR2 inhibitor) as second-line treatment for advanced ESCC was performed. Methods This ongoing phase II trial (NCT03736863) in six sites in China enrolled pts aged 18-75 with unresectable locally advanced, locally recurrent, or metastatic ESCC that progressed or were intolerant after first-line chemotherapy, and an ECOG performance status of 0-1. Pts received 200 mg camrelizumab intravenously every 2 weeks and apatinib 250 mg orally once per day in 4-week cycles until disease progression, unacceptable adverse events (AEs) or withdrawal of consent. The primary endpoint was investigator-assessed ORR. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS) and OS. Results At data cutoff (Feb 28, 2021), 52 pts were enrolled, including 42 males and 50 with distant metastases, with the median age of 62 years. In the evaluable population of 39 pts, ORR without confirmation was 43.59% and DCR was 94.87%. The median duration of response was 6.9 months (95% CI 4.57–9.23). The median PFS was 6.8 month (95% CI 2.66–10.94). The 12-month overall survival was 52.2%. A total of 80.8% of pts had treatment-related AEs (TRAEs) with 46.2% of grade ≥ 3 TRAEs. The safety profile of camrelizumab and apatinib was consistent with other anti–PD-1 antibodies and angiogenesis inhibitors. Conclusion This is the first study that evaluates the combination anti–PD-1 antibody and anti-angiogenesis inhibitor as a second-line therapy for advanced ESCC. Camrelizumab plus apatinib showed encouraging clinical efficacy and acceptable safety. Further phase III randomized trials are warranted.

scholarly journals The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial

2021 ◽  
Vol 11 ◽  
Author(s):  
Xiaofei Zhang ◽  
Dashan Ai ◽  
Juanqi Wang ◽  
Yun Chen ◽  
Qi Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Lymph Nodes ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Postoperative Radiotherapy ◽  
Locally Advanced ◽  
Target Volume ◽  
Local Control Rate

BackgroundThis trial aims to explore the feasibility and safety of postoperative radiotherapy covering all regional lymph node areas for locally advanced thoracic esophageal squamous cell carcinoma patients treated with intensity-modulated radiation therapy (IMRT).MethodsThis was a single-center single-arm, phase II clinical trial initiated in 2014. Patients who were treated with radical transthoracic resection and had negative margins within 3 months and histologically confirmed esophageal squamous cell carcinoma (pT3-4 or N+, M0 determined by the 7th edition of the AJCC guidelines) were recruited in this trial. Postoperative radiotherapy was performed with a total dose of 40 Gy in 20 fractions using IMRT. Clinical target volumes (CTVs) included the tumor bed, anastomosis, bilateral supraclavicular region, mediastinal lymph nodes, left gastric lymph nodes and celiac trunk lymph nodes. The primary endpoint was the 2-year local control rate, and the secondary endpoints were overall survival (OS) and adverse events (AEs).ResultsA total of 70 eligible patients were recruited from 2014 to 2016. The 2-year local control rate, as the primary endpoint, was 67.3%. In addition, the median OS was 57.0 months, with 1-year and 3-year OS rates of 92.8% and 60.9%, respectively. Among the patients, 28/40 (40%) developed locoregional recurrence, with 25.7% involving hematogenous recurrences. All reported AEs occurred during the course of IMRT or within 6 months thereafter. None of them suffered grade 4 hematological or nonhematological AEs. Nearly all patients completed the entire course of postoperative radiotherapy, with a completion rate of 97.1%.ConclusionFor an extensive target volume, 40 Gy is feasible and shows acceptable toxicity in patients with locally advanced thoracic esophageal squamous cell carcinoma, although the local recurrence rate is relatively high. Our findings provide a basis for further exploration of high-dose radiation with extensive CTV combined with chemotherapy.Clinical Trial Registration[http://www.clinicaltrials.gov/ct2/results?cond=&term=NCT02384811&cntry=&state=&city=&dist=], identifier [NCT02384811].

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