Highlights
- •Chemoradiation alone or in combination with nimotuzumab (a humanised antibody directed against epidermal growth factor receptor (EGFR)) was evaluated in locally advanced oesophageal cancer.
- •93% of 107 patients had squamous cell carcinoma of the oesophagus.
- •Endoscopic complete response rate was increased with nimotuzumab (from 33.3% to 47.2%).
- •Median overall survival (OS) was also increased with addition of nimotuzumab, from 11.5 months to 15.9 months (HR 0.68; 95% CI: 0.44–1.07; P = 0.09).
- •No differences in terms of total FACT-G score were observed, except for the physical subscale (P = 0.03), with lower values in the control arm.
Abstract
Purpose
Chemoradiotherapy is the standard treatment for patients with inoperable locally advanced
oesophageal cancer. We sought to assess the safety and efficacy of chemoradiation
combined with nimotuzumab, a humanised antibody directed against epidermal growth
factor receptor (EGFR).
Patients and methods
Untreated patients with inoperable locally advanced oesophageal cancer and no distant
metastases were randomised to chemoradiotherapy (cisplatin and fluorouracil combined
with external beam radiation) alone or in combination with nimotuzumab. The primary
end-point was the endoscopic complete response (eCR) rate, and secondary end-points
comprised quality of life (QoL) and safety. The combined eCR and pathologic complete
response (cEPCR) and overall survival (OS) were also evaluated.
Results
We enrolled 107 patients with a mean age of 59 years, and 93% had squamous cell carcinoma.
Toxicity was manageable in both arms with no important differences in adverse events
(AEs). We performed post-treatment endoscopies in 67 patients, including 60 who had
a biopsy. In the intent-to-treat population, the eCR rates with and without nimotuzumab
were 47.2% and 33.3% (P = 0.17), respectively, and the cEPCR rates were 62.3% and 37.0% (P = 0.02), respectively. With a median follow-up of 14.7 months, the hazard ratio (HR)
for OS was 0.68 (95% confidence interval (CI): 0.44–1.07; P = 0.09) with a median OS of 15.9 months for the nimotuzumab arm and 11.5 months for
the control arm. Regarding QoL, a significant difference was observed for the physical
subscale score (P = 0.03) with lower values for the control arm.
Conclusion
Combined chemoradiotherapy plus nimotuzumab is safe for patients with locally advanced
oesophageal cancer, it appears to increase the cEPCR rate, and without compromising
QoL.
Clinical trials
Identification number: EF024-201; Trial registry: NCT01249352.
Keywords
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Article info
Publication history
Published online: November 24, 2017
Accepted:
October 2,
2017
Received in revised form:
September 25,
2017
Received:
April 19,
2017
Footnotes
☆Presented at: 2014 ASCO Annual Meeting [J Clin Oncol 32:5s, 2014 (suppl; abstr 4078)] and 2014 ESMO Annual Meeting [Annals of Oncology (2014) 25 (suppl_4): iv210–iv253. 10.1093/annonc/mdu334] as posters.
Identification
Copyright
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