A phase I dose escalation study of Nimotuzumab in combination with concurrent chemoradiation

for patients with locally advanced squamous cell carcinoma of esophagus

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

(presentation number 1026)

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 designStudy 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.

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.

Results: Jul, 2009----Jun, 2010, 11 patients enrolled,h-R3 100mg/W=3 cases, 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.

Results: Jul, 2009----Jun, 2010, 11 patients enrolled,h-R3 100mg/W=3 cases, 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.

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.

Summary