In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e14511-e14511
Abstract:
e14511 Background: To evaluate the safety and therapeutic effect of Nimotuzumab (h-R3) in combination with radiotherapy on esophageal cancer. Methods: 42 patients with stage II (Inoperable or refused surgery) to IV (Supraclavicular lymph node metastasis only)were assigned to the phase II clinical trial during Nov. 2008 to Jul. 2010. Histopathological classification of all patients was squamous cell carcinoma. All patients received 50-70 Gy of three-dimensional conformal radiotherapy. 200mg of Nimotuzumab was administered once a week during radiotherapy. Results: There were 9, 25 and 8 patients with stage II, III and IV esophageal cancer, respectively. All patients received 50-70 Gy of radiation therapy except two. 37 patients (88.1%) received Nimotuzumab for more than 5 times. The recorded grade III toxicities (21.4% of all adverse events) included gastrointestinal toxicity, esophagitis, dermatology toxicity and hematological toxicity. Complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) were observed in 0, 22 (52.4%), 17 (40.5%) and 3 (7.1%) patients in one month after treatment. EGFR over-expression rate was 95.2%. Median survival time (MST) was 14 months. One-year and 2-year overall survival (OS) and progression-free survival (PFS) were 54.8%, 36.8% and 39.4, 33.3%, respectively. After a median follow-up time of 17 months, the local recurrence and distant metastases were observed in 18 (42.9%) and 14 (33.3%) patients, respectively. Conclusions: Nimotuzumab combined with radiotherapy were well-tolerated in patients with esophageal cancer. The incidence of grade III toxicity was 21.4%, no grade IV toxicity was observed. EGFR over-expression was found higher than in previous studies. One-year and 2-year OS and PFS were 54.8%, 36.8% and 39.4, 33.3%, respectively. Further study is needed to confirm the therapeutic efficacy of Nimotuzumab in esophageal cancer.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.e14511
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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