The addition of cetuximab to preoperative chemoradiotherapy for locally advanced esophageal squamous cell carcinoma is associated with high rate of long term survival: Mature results from a prospective phase Ib/II trial
| Autor: | Baruch Brenner, Eyal Fenig, Yulia Kundel, Aaron Sulkes, Tal Goshen-Lago, Efraim Idelevich, Ofer Purim, Nikolai Menasherov, Noa Gordon, Hanoch Kashtan |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Esophageal Neoplasms medicine.medical_treatment Cetuximab Loading dose Gastroenterology 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Survival rate Aged Cisplatin business.industry Hematology Chemoradiotherapy Esophageal cancer Middle Aged medicine.disease Radiation therapy Survival Rate Oncology 030220 oncology & carcinogenesis Adenocarcinoma Female Esophageal Squamous Cell Carcinoma business medicine.drug |
| Zdroj: | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 134 |
| ISSN: | 1879-0887 |
| Popis: | AIM This phase IB/II study evaluated the safety and efficacy of the addition of cetuximab to standard preoperative chemoradiotherapy (CRT) in locally advanced esophageal cancer (LAEC). METHODS Patients (pts) with resectable LAEC (T2-3N0-1M0, T1-3N1M0 or T1-3N0-1M1A) received an induction cycle of cisplatin 100 mg/m2, day 1, and 5-fluorouracil (5-FU) 1000 mg/m2/day, days 1-5, followed 4 weeks later by radiotherapy, 50.4 Gy, given with 2 cycles of cisplatin 75 mg/m2 and escalating doses of 5-FU, days 1-4 and 29-32. Pts received 10 weekly infusions of cetuximab, 250 mg/m2, with a loading dose, 400 mg/m2. Surgery was planned 6-8 weeks after CRT. RESULTS 64 pts were treated and 60 completed CRT. Median age was 65 years and 66% were males. Adenocarcinoma/squamous ratio was 61%/39%. Tumors were advanced: 95% T3 and 67% N1. Grade ≥3 toxicities occurred in 72%, with two (3%) toxic deaths. The 5-FU maximal tolerated dose (MTD) was 1000 mg/m2/day. Clinical complete response rate was 33%. Of the 55 operated pts, R0 resection was achieved in 51 (93%) and pathological complete response (pCR) in 18 (33%), with 8 (14%) postoperative deaths. The 5-year survival rate for all pts was 38%. Pts with squamous histology had higher pCR (55% vs 20%, p = 0.015), local control (96% vs. 74%, p |
| Databáze: | OpenAIRE |
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