Weekly Chemotherapy with Cisplatin and Paclitaxel and Concurrent Radiation Therapy as Preoperative Treatment in Locally Advanced Esophageal Cancer: A Phase II Study

2010 ◽  
Vol 28 (8) ◽  
pp. 820-827 ◽  
Author(s):  
Michele Orditura ◽  
Gennaro Galizia ◽  
Vincenzo Napolitano ◽  
Erika Martinelli ◽  
Roberto Pacelli ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Preoperative Treatment ◽  
Advanced Esophageal Cancer ◽  
Weekly Chemotherapy ◽  
Locally Advanced Esophageal Cancer

Phase II cisplatin, irinotecan, cetuximab and concurrent radiation therapy followed by surgery for locally advanced esophageal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4064-4064 ◽  
Author(s):  
P. C. Enzinger ◽  
T. Yock ◽  
W. Suh ◽  
P. Fidias ◽  
H. Mamon ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Locally Advanced ◽  
Complete Response ◽  
Tumor Location ◽  
Advanced Esophageal Cancer ◽  
Early Results ◽  
Ecog Ps ◽  
Locally Advanced Esophageal Cancer

4064 Background: Weekly irinotecan, cisplatin, and concurrent radiation therapy is a well-tolerated, active regimen in locally advanced esophageal cancer. (Ilson. JCO 2003) Cetuximab, an EGFR inhibitor, is a potent radiation sensitizer in head and neck cancer. (Bonner. Proc ASCO 2004) Methods: In this phase II trial, patients (pts) with T2–4N0–1M0–1A esophageal adenocarcinoma (A) or squamous cell carcinoma (S) receive 5040 cGy/28 fractions of radiation therapy (RT) and concurrent weekly cisplatin 30mg/m2 plus irinotecan 65 mg/m2 on weeks 1, 2, 4, and 5, followed by surgery 4–8 weeks after completion of RT. Additionally, pts receive weekly infusions of cetuximab 250 mg during RT, up to one week before surgery, and for 6 months following surgery. Results: Seventeen pts have been entered: male: female = 14:3, median age 54, ECOG PS 0:1 = 6:11, A:S = 17:0, stage IIA:IIB:III:IVA = 6:1:8:2, tumor location-esophagus-mid:lower:gastroesophageal junction = 1:4:12, >10% weight loss-yes:no = 8:9. Of 17 pts entered, 15 pts have proceeded to surgery, 1 pt died from Aspergillus infection resulting in respiratory failure and sepsis, and 1 pt is pending surgery. Of the 15 pts who underwent surgery, 2 (13%) had a complete pathologic response; pathologic stage for other pts: 0 = 1, I = 3, IIA = 3, IIB = 1, III = 4, IV = 1. Grade III/IV toxicity (17 pts) was: diarrhea 9 pts, neutropenia 9 pts, febrile neutropenia 5 pts, anorexia 5 pts, vomiting 4 pts, fatigue 3 pts, mucositis 1 pt. Chemotherapy dose attenuation was required for diarrhea in 5 pts, for neutropenia in 4 pts, and for folliculitis in 1 pt. One patient was removed from study during week 6 for prolonged diarrhea/ dehydration. Due to the 2-step design of the trial, accrual is on hold pending a 3rd required pathologic CR in the first 17 patients. Conclusions: Compared to other trials of irinotecan, cisplatin, radiation therapy, and surgery in similar groups of esophageal cancer patients, early results for this combination with cetuximab suggest a lower complete response rate and higher overall toxicity. Additional data will be available at ASCO. Supported by Bristol-Myers Squibb. No significant financial relationships to disclose.

scholarly journals Toripalimab Used on the Same Day or Third Day With Chemotherapy for Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer—A Phase II Study

2021 ◽  
Author(s):  
Wenqun Xing ◽  
Lingdi Zhao ◽  
Yan Zheng ◽  
Baoxing Liu ◽  
Xianben Liu ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Control Group ◽  
Advanced Esophageal Cancer ◽  
Grade 3 ◽  
Experimental Group ◽  
Locally Advanced Esophageal Cancer

Abstract Background There is no standard neoadjuvant therapy for locally advanced esophageal cancer in China. The role of neoadjuvant chemotherapy plus immunotherapy for locally advanced esophageal cancer is still being explored. Methods This open-label, randomized phase II study was conducted at a single center between July 2019 and September 2020, 30 patients with locally advanced ESCC (T3, T4, or lymph-node positive) were enrolled. Patients were randomized according to the enrollment order at a 1:1 ratio to receive chemotherapy on day 1 and toripalimab on day 3 (experiment group) or chemotherapy and toripalimab on day 1 (control group). The chemotherapeutic regimen was paclitaxel and cisplatin. Surgery was performed 4 to 6 weeks after the second cycle of chemoimmunotherapy. The primary endpoint was pCR rate, the secondary endpoint were safety and disease-free survival. Results Thirty patients completed at least one cycle of chemoimmunotherapy; 11 in the experimental group and 13 in the control group received surgery. R0 resection was got in all these 24 patients. Four patients (36%) in the experimental group and one (7%) in the control group achieved pCR. The experimental group showed a statistically non-significant higher pCR rate (P = 0.079). PD-L1 combined positive score (CPS) examination was performed in 14 patients; one in control group had a PD-L1 CPS of 10 and pCR was achieved, while the left 13 were all ≤ 1, 11 of the 13 patients received surgery in which two (in the experimental group) got pCR. Two patients endured from ≥ grade 3 adverse events, one suffered from grade 3 immune-related enteritis after one cycle of chemoimmunotherapy and dropped off the study. Another patient died from severe pulmonary infection and troponin elevation after surgery. CONCLUSIONS Although the primary endpoint was not met, initial results of this study showed that delaying toripalimab to day 3 in chemoimmunotherapy might achieve a higher pCR rate than that on same day, and further large-sample clinical trials are needed to verify this. Trial registration: NCT 03985670, registered 10 June 2019.

Chemoradiation with or without nimotuzumab in locally advanced esophageal cancer (LAEC): A randomized phase II study (NICE trial).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 4078-4078 ◽  
Author(s):  
Gilberto Castro ◽  
Nils G Skare ◽  
Carlos J C Andrade ◽  
J.G.M. Segalla ◽  
Sergio Jobim De Azevedo ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Advanced Esophageal Cancer ◽  
Randomized Phase Ii ◽  
Locally Advanced Esophageal Cancer
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