Cancer chemotherapy and pharmacology · 2019
A phase I study evaluating combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer.
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Qi Saichun, Mao Ya, Jiang Mingjun
Аннотация
OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of combined nimotuzumab and neoadjuvant chemoradiotherapy followed by surgery in locally advanced esophageal cancer.
METHODS: Patients with clinically resectable, locally advanced esophageal cancer treated with neoadjuvant chemoradiotherapy plus nimotuzumab were eligible for study participation. Radiotherapy was administered in 1.8 Gy once daily for 5 days per week up to a total dose of 41.4 Gy. Weekly nimotuzumab (200 mg/week) was administered following paclitaxel and carboplatin on the same day for 5 weeks. The primary end-point was the pathological complete response (pCR) rate and the secondary end-point was the safety, progression-free survival (PFS) and overall survival (OS).
RESULTS: A total of 64 patients with a median age of 58 years were enrolled in this study. pCR was observed in 51.6% patients. Grade 3 acute toxicities were observed in 6 patients (9.4%), shown as bone marrow suppression. 7 patients experienced grade 1 transient skin rash during nimotuzumab treatment. The median PFS time and OS time were 64.6 and 68.2 months.
CONCLUSIONS: Combined nimotuzumab and neoadjuvant chemoradiotherapy for clinically resectable, locally advanced esophageal cancer showed a significant anticancer effect with tolerable toxicities.
METHODS: Patients with clinically resectable, locally advanced esophageal cancer treated with neoadjuvant chemoradiotherapy plus nimotuzumab were eligible for study participation. Radiotherapy was administered in 1.8 Gy once daily for 5 days per week up to a total dose of 41.4 Gy. Weekly nimotuzumab (200 mg/week) was administered following paclitaxel and carboplatin on the same day for 5 weeks. The primary end-point was the pathological complete response (pCR) rate and the secondary end-point was the safety, progression-free survival (PFS) and overall survival (OS).
RESULTS: A total of 64 patients with a median age of 58 years were enrolled in this study. pCR was observed in 51.6% patients. Grade 3 acute toxicities were observed in 6 patients (9.4%), shown as bone marrow suppression. 7 patients experienced grade 1 transient skin rash during nimotuzumab treatment. The median PFS time and OS time were 64.6 and 68.2 months.
CONCLUSIONS: Combined nimotuzumab and neoadjuvant chemoradiotherapy for clinically resectable, locally advanced esophageal cancer showed a significant anticancer effect with tolerable toxicities.