Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

Song, Tao; Zhang, Xuebang; Fang, Min; Zhao, Rugang; Wu, Shixiu

doi:10.1002/cam4.897

Cited by 12 publications

(7 citation statements)

References 17 publications

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“…The authors concluded that although dCRT with FOLFOX did not increase PFS and OS compared with dCRT based on 5‐FU and cisplatin, the FOLFOX regimen might be a more convenient treatment option for patients with unresectable EC. Previously, we also reported a phase II clinical trial evaluating the efficiency and safety of dCRT based on OHP and paclitaxel for patients with EC . Our results indicated that 26 (76.5%) of 34 patients finished dCRT on schedule with a median OS of 23.7 months.…”

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confidence: 58%

Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study

Chen

et al. 2019

The Oncologist

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Lessons Learned Definitive concurrent chemoradiotherapy based on oxaliplatin and endostatin was effective with the objective response rate exceeding 80%, and the treatment‐related toxicities were acceptable. The treatment compliance of the current combination was much higher, without significant reduction in survival outcomes, than historical reports. Background This phase II trial aimed at assessing the efficiency and safety of definitive concurrent chemoradiotherapy (dCRT) using oxaliplatin (OHP) and endostatin in patients with inoperable esophageal squamous cell carcinoma (ESCC). Methods Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60.0 Gy over 6 weeks. Endostatin and OHP were both intravenously administered at doses of 7.5 mg/m2 daily for 2 weeks and 135 mg/m2 on day 1, respectively, every 3 weeks. The primary endpoint was the objective response rate (ORR). Results The analysis included 37 patients. The median age was 63 years (range: 49–71 years), and all patients were stage III–IVA. Of these patients, 97.3% (36/37) completed the dCRT course with an ORR of 83.8%, including 10 (27.0%) patients with complete response and 21 (56.8%) patients with partial response. The median overall survival (OS) time was 18.5 months (95% confidence interval [CI]: 10.6–26.4) with a 2‐year OS rate of 39.6% (95% CI: 0.202–0.590). The median progression‐free survival (PFS) time was 11.5 months (95% CI: 7.6–15.4) with a 2‐year PFS rate of 20.2% (95% CI: 0.049–0.355). Grade 3 toxicities included esophagitis (five patients) and leukocytopenia (three patients). Grade 4 leukopenia was observed in one patient. Late toxicity was infrequent, and no treatment‐related death occurred. Posttreatment dysphagia scores were significantly improved when compared with baseline (p < .001). Conclusion dCRT based on OHP and endostatin resulted in high treatment compliance with manageable toxicities. This combination resulted in encouraging ORR without compromising survival outcomes. It should be validated in future clinical studies.

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confidence: 58%

Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study

Chen

et al. 2019

The Oncologist

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“…The treatment e cacy of de nitive CRT was established by some clinical trials, such as the RTOG 85 − 01 and RTOG 94 − 05 trials [10,11]. Mikhail et al reviewed 12 trials and illustrated that 2year OS of de nitive chemotherapy ranged from 18-54% and 3-year OS ranged from 22.2-64.3% [10,[12][13][14][15][16][17]. The present study reported that 2-/3-year OS were 24.8%/17.8% before matching, and 31.9%/23.8% after matching.…”

Section: Discussionmentioning

confidence: 99%

Propensity Score Analysis Comparing Survival Between Definitive Chemoradiotherapy and Esophagectomy with Adjuvant Chemoradiotherapy in Patients with Esophageal Squamous Cell Carcinoma

Chang

Cheng

Chen

et al. 2021

Preprint

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Background: The purpose of the current study is to compare definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy in patients with cT1-3/N0-3 esophageal squamous cell carcinoma in survival.Methods: Records from 2008 to 2014 of 4931 patients with clinical T1-3/N0-3 esophageal squamous cell carcinoma receiving definitive chemoradiotherapy or esophagectomy with adjuvant chemoradiotherapy were obtained from the Taiwan Cancer Registry. Univariable and multivariable analyses were performed and propensity score matching was used to minimize the bias. Overall survival was compared between definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy, and also in the three different clinical stages.Results: Definitive chemoradiotherapy was performed on 4381 patients, and 550 patients received esophagectomy adjuvant chemoradiotherapy. Each group produced 456 patients for comparison after propensity score matching. The 1-year, 2-year, and 3-year overall survival rates for matched patients in with definitive chemoradiotherapy group were 57.18%, 31.92%, and 23.8%. The 1-year, 2-year, and 3-year overall survival rates for matched patients treated in the esophagectomy with adjuvant chemoradiotherapy group were 72.35%, 45.74%, and 34.04%(p<0.0001). In multivariable analysis, treatment modality was an independent prognostic factor. Esophagectomy with adjuvant chemoradiotherapy provided better survival outcome than definitive chemoradiotherapy for patients with clinical stage II/III disease. As for patients with clinical stage I disease, there was no significant survival difference between definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy.Conclusions: Esophagectomy with adjuvant chemoradiotherapy provided better survival than definitive chemoradiotherapy in clinical II/III esophageal squamous cell carcinoma. However, more data are needed to conduct a convincing conclusion in clinical stage I patients.

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“…3 For unresected locally advanced ESCC, definitive concurrent chemoradiation therapy (dCCRT) is the standard treatment strategy, and has shown satisfactory clinical effects and manageable toxicities. 4 The standard regimen of dCCRT for ESCC comprises 50.4 Gy of radiation and cisplatinbased chemotherapy, and no significant difference in median survival (13.0 months vs. 18.1 months), 2-year survival (31% vs. 40%), or local/regional failure and persistence of disease (56% vs. 52%) was found between high-dose and standard-dose arms. 5,6 Based on the results of Radiation Therapy Oncology Group (RTOG) 8501, dCCRT significantly increases the survival of patients with EC (T1-3N0-1M0) compared with RT alone (5-year overall survival [OS], 26% vs. 0%, respectively).…”

Section: Introductionmentioning

confidence: 94%

Safety and efficacy of programmed cell death‐1 antibody SHR‐1210 combined with concurrent chemoradiotherapy to treat locally advanced esophageal squamous cell carcinoma: a study protocol for an exploratory single‐arm phase Ib trial

Wei

Guo

Zhang

et al. 2020

Precision Radiation Oncology

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Objective Esophageal squamous cell carcinoma (ESCC) is the most common pathological pattern in China, with poor prognosis due to its early and frequent metastasis. Definitive concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced ESCC. Studies have shown promising efficacy of immune‐checkpoint inhibitors in ESCC. This study explores the safety and efficacy of immunotherapy combined with definitive concurrent chemoradiotherapy for locally advanced ESCC. Method This study was an exploratory, open, single‐arm clinical trial involving 20 untreated patients with locally advanced ESCC. The patients were treated with eight cycles (4 weeks per cycle) of SHR‐1210 concurrently combined with 6 weeks of radiotherapy, and 4 weeks of chemotherapy and apatinib beginning from 4 weeks after the completion of radiotherapy to the end of treatment. Primary end‐points were treatment‐related adverse events, serious adverse events, and patients’ quality of life (European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (QLQ)‐C30 and QLQ‐OES18). Secondary end‐points were the objective response rate, progression‐free survival, and overall survival. Discussion This phase Ib study evaluates the tolerability and efficacy of programmed cell death‐1 antibody along with definitive concurrent chemoradiotherapy in treating locally advanced ESCC. This novel combination is expected to yield fewer side‐effects and better survival.

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Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

Cited by 12 publications

References 17 publications

Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study

Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study

Propensity Score Analysis Comparing Survival Between Definitive Chemoradiotherapy and Esophagectomy with Adjuvant Chemoradiotherapy in Patients with Esophageal Squamous Cell Carcinoma

Safety and efficacy of programmed cell death‐1 antibody SHR‐1210 combined with concurrent chemoradiotherapy to treat locally advanced esophageal squamous cell carcinoma: a study protocol for an exploratory single‐arm phase Ib trial

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