1 / 4

Zhao Kuai-le 1 , Hu Xi-chun 2 , Wu Xiang-hua 2 , Fu Xiao-long 1 , Fan Min 1 , Jiang Guo-liang 1

A phase I dose escalation study of Nimotuzumab in combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus. (presentation number 1026). Zhao Kuai-le 1 , Hu Xi-chun 2 , Wu Xiang-hua 2 , Fu Xiao-long 1 , Fan Min 1 , Jiang Guo-liang 1

nira
Download Presentation

Zhao Kuai-le 1 , Hu Xi-chun 2 , Wu Xiang-hua 2 , Fu Xiao-long 1 , Fan Min 1 , Jiang Guo-liang 1

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. A phase I dose escalation study of Nimotuzumabin combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus (presentation number 1026) Zhao Kuai-le1, Hu Xi-chun2, Wu Xiang-hua2, Fu Xiao-long1, Fan Min1, Jiang Guo-liang1 Fudan University Shanghai Cancer Center Shanghai 20032, China

  2. Patient eligibility (1) cytologically or histologically confirmed esophageal carcinoma; (2) age of 18–75; (3) locally advanced, stage II-IVa (AJCC, 2002); (4) performance status of ECOG 0–2; (5) no treatments prior to enrollment; (6) at least one measurable lesion on CT, MRI or esophageal barium exam; (6) normal functions of heart, lung, liver, kidney and bone marrow; (7) blood exams qualified for chemotherapy, which included hemoglobulin of ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL; and (8) informed consent signed Study design DDP: 25 mg/m2/d, d1-3, 5-FU: 1,800 mg/m2, continuous infusion in 72 h, every 4 weeks for 4 cycles; Irradiation: total dose of 61.2 Gy/34 fractions, 6.8 weeks; h-R3: weekly administration for 6 weeks, the dose escalation started with 100 mg, and followed by 200 mg and 400 mg. 3 patients will enrolled for each dose cohort.

  3. Results: Jul, 2009----Jun, 2010, 11 patients enrolled,h-R3 100mg/W=3cases, 200mg/W=4 cases, 400mg/W=4 cases, 2 patients withdrawed(200mg&400mg 1 cases, respectively)Median follow up 10.4 months(9.5-18 months). CR 22%, PR 56%, SD22%; 1 year OS 67%, LPFS 100% for 9 patients.

  4. Summary 1. h-R3 of 400 mg weekly with concurrent radiotherapy and PF regimen chemotherapy was safe and well-tolerated. Maximum tolerate dose (MTD) of h-R3 has not reached yet in this study. 2. The preliminary results of outcome were encouraging.

More Related