Concurrent chemoradiotherapy with cetuximab plus twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal squamous cell carcinoma.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 4106-4106
Author(s):  
C. Hsu ◽  
C. Lin ◽  
J. C. Cheng ◽  
C. Yen ◽  
J. Lee ◽  
...  
2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 79-79
Author(s):  
C. Lin ◽  
C. Hsu ◽  
J. C. Cheng ◽  
C. Yen ◽  
H. Shiah ◽  
...  

79 Background: We investigated the efficacy and safety of adding cetuximab into twice-weekly paclitaxel/cisplatin-based concurrent chemoradiotherapy (CCRT), followed by surgery, for patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods: Patients with operable ESCC (T3N0-1M0 or T1-3N1M0 or M1a) were treated with paclitaxel (35 mg/m2 1 h on days 1 and 4/week), cisplatin (15 mg/m2 1 h on days 2 and 5/week), cetuximab (400 mg/m2 2 h on day -5, then 250 mg/m2 2 h on day 3/week) and radiotherapy (2 Gy on days 1-5/week). When the accumulated radiation dose reached 40 Gy, the feasibility of esophagectomy was evaluated for all patients. In patients for whom esophagectomy was not feasible, CCRT was continued to a radiation dose of 60-66 Gy. Results: Sixty-two patients with ESCC were enrolled, and the majority had T3N1M0 or M1a tumors by endoscopic ultrasonographic staging (94%). All patients received CCRT to 40 Gy. Forty-three patients underwent surgery, and 17 patients continued definitive CCRT to 60-66 Gy. Of the scheduled doses of paclitaxel, cisplatin, and cetuximab, 80%, 79%, and 99% were given, respectively. The intent-to-treat pathological complete response rate was 24% (15/62) (95% confidence interval: 13-35%). At the median follow-up of 13.3 months, the one-year progression-free and overall survivals were 76% and 63%, respectively. The most common grade 3/4 toxic effects were leukopenia (51%), neutropenia (15%), esophagitis (19%), and infection (12%). Grade 1, 2, and 3 skin rash occurred in 59%, 36%, and 2% of patients, respectively. Grade 1, 2, 3, and 4 hypomagnesemia occurred in 14%, 5%, 0%, and 5% of patients, respectively. Conclusions: Adding cetuximab to twice-weekly paclitaxel/cisplatin-based CCRT prior to esophagectomy is an active and tolerable treatment for locally advanced ESCC. No significant financial relationships to disclose.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4099-4099 ◽  
Author(s):  
Chia-Chi J. Lin ◽  
Chih-Hung Hsu ◽  
Jason C. Cheng ◽  
Chueh-Chuan Yen ◽  
Her-Shyong Shiah ◽  
...  

4099 Background: We investigated the efficacy and safety of adding cetuximab to twice-weekly paclitaxel/cisplatin-based concurrent chemoradiotherapy (CCRT), followed by surgery, for patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods: Patients with locally advanced ESCC (T3N0-1M0 or T1-3N1M0 or M1a by AJCC 2002) were treated with paclitaxel (35 mg/m2 1 h D1, 4/wk), cisplatin (15 mg/m2 1 h D2, 5/wk), cetuximab (400 mg/m2 2 h D-5, then 250 mg/m21 h D3/wk) and radiotherapy (2 Gy D1-5/wk). The feasibility of esophagectomy was evaluated for all patients at the accumulated radiation dose of 40 Gy. If esophagectomy was not feasible, CCRT was continued to a radiation dose of 60-66 Gy. Results: 66 patients were enrolled between Oct 2008 and Jun 2010, and 61 (94%) of them had T3N1M0 or M1a tumors by endoscopic ultrasonographic staging. All patients received CCRT to 40 Gy. Forty-three patients underwent surgery, and 17 patients continued definitive CCRT to 60-66 Gy. Of the scheduled doses of paclitaxel, cisplatin, and cetuximab, 80%, 79%, and 99% were given, respectively. The most common grade 3/4 toxic effects were leukopenia (51%), neutropenia (15%), esophagitis (19%), and infection (12%). The pathological complete response rate was 24% (intent-to-treat, 16/66) (95% confidence interval: 13-35%) and 37% (who underwent resection, 16/43). At the median follow-up of 34.6 months, the median progression-free (PFS) and overall survivals were 21.6 and 33.9 months, respectively. No KRAS codon 12/13 mutations were identified in 47 tumor samples. The median PFS for patients with two, one, and no adverse tumor biomarkers (Tau+, ERCC1+, pEGFR-) (n = 40) was 12.3 months, 27.6 months, and greater than 33.6 months, respectively (p = .087). Conclusions: Adding cetuximab to twice-weekly paclitaxel/cisplatin-based CCRT prior to esophagectomy is an active and tolerable treatment for locally advanced ESCC. Clinical trial information: NCT01034189. [Table: see text]


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  

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.


2020 ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  

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 who had locally advanced ESCC and received CCRT with S-1 (70mg/m2 twice daily on days 1-14, every 3 weeks for 2 cycles, S-1 group) or docetaxel (25mg/m2) and cisplatin (25mg/m2) on day 1 weekly (DP group) between 2014 and 2016 were retrospectively analyzed. Treatment-related toxicities, 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 in the DP group (22.2% versus 45.6%, p = 0.002). 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% versus 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.


2020 ◽  
Author(s):  
Chen Li ◽  
Lijun Tan ◽  
Xiao Liu ◽  
Xin Wang ◽  
Zongmei Zhou ◽  
...  

Abstract Background: To investigate the survival benefit of concurrent chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma during the years of intensity-modulated radiotherapy. Methods: Medical records of 1273 patients with esophageal squamous cell carcinoma who received intensity-modulated radiotherapy from January 2005 to December 2017 in the CAMS were retrospectively reviewed. 683 patients received concurrent chemoradiotherapy, 590 patients received radiotherapy alone. Propensity score matching (PSM) method was used to eliminate baseline differences between the two groups. Survival and toxicity profile were evaluated afterwards. Results: After a median follow-up time of 50.4 months (3.2-157.4 months), both overall survival and progression-free survival of the concurrent chemoradiotherapy group were better than those of the radiotherapy group, either before or after PSM. After PSM, the 1-, 3-, 5-year OS of radiotherapy and concurrent chemoradiotherapy groups were 63.3% vs 72.2%, 31.6% vs 42.2% and 28.5% vs 38.1%, respectively (p=0.003). The 1-year, 3-year and 5-year PFS rates of radiotherapy and concurrent chemoradiotherapy group were 44.3% vs 48.6%, 23.4% vs 31.2% and 15.8% vs 25.2%, respectively (p=0.002). The rates of ≥ grade 3 leukopenia and radiation esophagitis in the concurrent chemoradiotherapy were higher than those in the radiotherapy alone group (p<0.05). There was no significant difference in the probability of radiation pneumonia between the two groups (p=0.359). Multivariate logistic regression analysis showed ≥ 70 years old, female, KPS ≤ 70, stage I-II, and patients diagnosed at earlier years (2005-2010) had lower probability of receiving concurrent chemoradiation (p<0.05). Multivariate Cox analysis indicated that female, stage I-II, EQD2≥60Gy and concurrent chemotherapy were favorable prognostic factors for both OS and PFS. Conclusions: Concurrent chemotherapy can bring survival benefits to patients with locally advanced esophageal squamous cell carcinoma receiving intensity-modulated radiotherapy. For patients who cannot tolerate concurrent chemotherapy, radiation monotherapy is an effective alternative with promising results.


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