Comparing Paclitaxel/5-Fluorouracil Versus Cisplatin/5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer (ESO-Shanghai 1): A Randomized, Multicenter, Phase III Clinical Trial

2018 ◽  
Author(s):  
Yun Chen ◽  
Jinjun Ye ◽  
Weixin Zhao ◽  
Jialiang Zhou ◽  
Chaoyang Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Esophageal Squamous Cell Cancer ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Multicenter Phase

Nimotuzumab plus paclitaxel and cisplatin as first-line treatment for esophageal squamous cell cancer: A single center prospective clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4097-4097 ◽  
Author(s):  
Xiaodong Zhang ◽  
Ming Lu ◽  
Xicheng Wang ◽  
Jie Li ◽  
Yan Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Esophageal Squamous Cell Cancer ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Local Advanced ◽  
First Line Treatment

4097 Background: The aim of this present phase II study is to explore the safety and efficacy of paclitaxel (T), cisplatin (C), and nimotuzumab (N), a humanized anti-EGFR monoclonal antibody combination (TCN) as first-line treatment in advanced esophageal squamous cell cancer (ESCC). Methods: Patients with histologically confirmed advanced ESCC, measureable tumor, and no prior chemotherapy and radiotherapy except adjuvant treatment were enrolled. Patients were given cisplatin 60mg/m2, paclitaxel 175mg/m2per 21 days for at least 2 cycles. The nimotuzumab was given 200mg weekly. Radiotherapy was admitted for patients with unresectable local advanced disease after 4 cycle of TCN treatment. The primary endpoints were safety and objective response rate (ORR). The secondary endpoints were progression-free survival (PFS) and over-all survival (OS). The expression of EGFR and ERCC1 were also analyzed by histoimmunochemical staining. Results: Between Mar. 2011 and Dec. 2012, 55 patients with advanced ESCC were enrolled and 53 (96.4%) were eligible for evaluation. The ORR was 54.7% (29/53) and the DCR was 94.3% (50/53). The expression of EGFR and ERCC1 were detected in 46 and 31 patients respectively. The ORR had no relation to both the expression of EGFR (55.3% vs 62.5%, p=0.71) and ERCC1 (41.7% vs 58.3%, p=0.47). As a median follow-up of 15months, the median PFS was 10.5 months (95% CI 8.7 to 12.3 months).The TCN combination treatment was well tolerated and the most common adverse events were alopecia (86.8%), leukopenia (84.9%), anorexia (84.9%), vomiting (73.6%), fatigue (73.6%), pain (66.0%), and anaemia (39.6%). And 18 (34%) patients had Grade 3 to 4 leukopenia. The median OS have not yet been reached. Conclusions: In this study, the ORR, DCR and PFS are superior to previous published studies. The addition of anti-EGFR treatment of nimotuzumab to standard chemotherapy was well tolerated with no serious AEs. But the expression of EGFR by IHC could not predict the outcome of nimotuzumab treatment. A phase III study of TCN followed by radiotherapy in unresectable local advanced ESCC had been designed to explore the survival benefits. Clinical trial information: NCT01336049.

scholarly journals Radiomics Signature Facilitates Organ-Saving Strategy in Patients With Esophageal Squamous Cell Cancer Receiving Neoadjuvant Chemoradiotherapy

2021 ◽  
Vol 10 ◽  
Author(s):  
Yue Li ◽  
Jun Liu ◽  
Hong-xuan Li ◽  
Xu-wei Cai ◽  
Zhi-gang Li ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Esophageal Squamous Cell Cancer ◽  
Clinical Model ◽  
Clinical Variables ◽  
Treatment Plans ◽  
Radiomics Signature

After neoadjuvant chemoradiotherapy (NCRT) in locally advanced esophageal squamous cell cancer (ESCC), roughly 40% of the patients may achieve pathologic complete response (pCR). Those patients may benefit from organ-saving strategy if the probability of pCR could be correctly identified before esophagectomy. A reliable approach to predict pathological response allows future studies to investigate individualized treatment plans.MethodAll eligible patients treated in our center from June 2012 to June 2019 were retrospectively collected. Radiomics features extracted from pre-/post-NCRT CT images were selected by univariate logistic and LASSO regression. A radiomics signature (RS) developed with selected features was combined with clinical variables to construct RS+clinical model with multivariate logistic regression, which was internally validated by bootstrapping. Performance and clinical usefulness of RS+clinical model were assessed by receiver operating characteristic (ROC) curves and decision curve analysis, respectively.ResultsAmong the 121 eligible patients, 51 achieved pCR (42.1%) after NCRT. Eighteen radiomics features were selected and incorporated into RS. The RS+clinical model has improved prediction performance for pCR compared with the clinical model (corrected area under the ROC curve, 0.84 vs. 0.70). At the 60% probability threshold cutoff (i.e., the patient would opt for observation if his probability of pCR was >60%), net 13% surgeries could be avoided by RS+clinical model, equivalent to implementing organ-saving strategy in 31.37% of the 51 true-pCR cases.ConclusionThe model built with CT radiomics features and clinical variables shows the potential of predicting pCR after NCRT; it provides significant clinical benefit in identifying qualified patients to receive individualized organ-saving treatment plans.

The sequence of chemotherapy and anti-PD-1 antibody influence the efficacy of neoadjuvant immunochemotherapy in locally advanced esophageal squamous cell cancer: A phase II study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4051-4051
Author(s):  
Lingdi Zhao ◽  
Wenqun Xing ◽  
Yonghao Yang ◽  
Yong Zhang ◽  
Baozhen Ma ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Esophageal Squamous Cell Cancer ◽  
Control Group ◽  
Chemotherapy Drugs ◽  
Grade 3 ◽  
And Control ◽  
Experimental Group

4051 Background: PD-1 blockade may result in expansion of tumor-specific T cells. However, traditional immunochemotherapy regimens usually designed to use chemotherapy drugs and anti-PD-1 antibody on the same day, which may make chemotherapy drugs kill activated T cells. The purpose of this study was to investigate the rate of pCR of chemotherapy plus anti-PD-1 therapy and the influence of sequence of chemotherapy and anti-PD-1 therapy on pCR in patients with locally advanced esophageal squamous cell cancer. Methods: Thirty esophageal squamous cell cancer patients with T3, T4, or lymph node positive were assigned into experiment group (anti-PD-1 antibody was administrated two days after chemotherapy) and control group ( anti-PD-1 antibody and chemotherapy were administrated on the same day) according to the order of enrollment. There were fifteen patients in each group. The chemotherapeutic regimen was paclitaxel and cisplatin, paclitaxel was given at the dose of 150-175mg/m2 on day 1 and cisplatin was given at the dose of 70-75mg/m2 on day 1. The anti-PD-1 antibody was toripalimab at the fixed dose of 240mg on day 3 or day 1. Operation was performed four to six weeks after the second cycle of chemotherapy combined with toripalimab. Results: From July 2019 to September 2020, a total of 30 patients completed at least one cycle of immunochemotherapy. 11 in the experimental group received operation after two cycles of neoadjuvant chemotherapy plus toripalimab. Thirteen in control groupreceived operation aftertwo cycles of neoadjuvant chemotherapy plus toripalimab. Four patients in experimental group and one in control group got pCR, the rates of pCR in experimental group and control group were 36.4% and 7.7% individually. Although the difference was not significant in statistics, the experimental group had the trend of higher pCR rate(c2= 3.092, p = 0.079). PD-L1 CPS examination before treatment was performed in fourteen patients, it was found that except one patient with PD-L1 CPS was 10, the left thirteen with PD-L1 CPS were all below one. The patient with PD-L1 CPS 10 was in control group and pCR was got in this patient. Except one patient in the experimental group had grade 3 immune-related enteritis, one patient in the control group died from immune-related myocarditis after operation, there were no more immune-related events more than grade 3. Conclusions: Toripalimab was delayed on day 3 when toripalimab plus chemotherapy was taken as neoadjuvant therapy regimen in locally advanced esophageal squamous cell carcinoma might achieve a higher pathological complete response than toripalimab and chemotherapy used on the same day. Clinical trial information: NCT 03985670.

608 RADIOMICS MODEL FACILITATES ORGAN-SAVING STRATEGY IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CANCER RECEIVING NEOADJUVANT CHEMORADIOTHERAPY

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Yue Li
Keyword(s):  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Esophageal Squamous Cell Cancer ◽  
Minimum Diameter ◽  
Clinical Model ◽  
Clinical Variables ◽  
Treatment Plans

Abstract   After neoadjuvant chemoradiotherapy(NCRT) in locally advanced esophageal squamous cell cancer(ESCC), roughly 40% of the patients may achieve pathologic complete response (pCR) of the primary tumor. Those patients may benefit from organ-saving strategy if the probability of pCR could be correctly identified before esophagectomy. A reliable approach to predict pathological response allows future studies to investigate individualized treatment plans. We aim to establish a CT-based radiomics model to predict tumor response to NCRT. Methods 121 patients with ESCC who underwent NCRT followed by esophagectomy were retrospectively collected. Radiomics features extracted from pre−/post-NCRT CT images were selected by univariate logistic (p < 0.157) and LASSO regression. A radiomics signature(RS) developed with selected features was combined with 4 clinical variables, including percentage of tumor thickness reduction, tumor adventitia type, tumor minimum diameter on post-NCRT esophagogram and age, to construct RS + clinical model with multivariate logistic regression which was internally validated by bootstrapping. Performance and clinical usefulness of RS + clinical model were assessed by receiver operating characteristic(ROC) curves and decision curve analysis, respectively, comparing with the model of clinical variables alone. Results Among the 121 patients, 51 achieved pCR(42%) after NCRT. 16 radiomics features were selected and incorporated into RS. The RS + clinical model has improved prediction performance for pCR compared with the clinical model(corrected area under the ROC curve,0.843 vs. 0.700). At the 60% probability threshold cutoff(i.e., the patient would opt for observation if his probability of pCR was >60%), net 12% surgeries could be avoided by RS + clinical model without an increase in the number of missed residual diseases, equivalent to implementing organ-saving strategy in 29.4% of the 51 true-pCR cases. Conclusion The model built with CT radiomics features and clinical variables shows the potential of predicting pCR after NCRT; it provides significant clinical benefit in identifying qualified patients to receive individualized organ-saving treatment plans.

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