Abstract
Background: Nimotuzumab is an
anti-epidermal growth factor receptor monoclonal
antibody which can be added to chemoradiotherapy
(CRT) to improve efficacy for management of
locally advanced squamous cell carcinoma of the
head and neck (LASCCHN). We prospectively
evaluated the efficacy and safety of nimotuzumab
with CRT for LASCCHN and compared with CRT alone.
Materials and Methods: In this prospective study,
29 LASCCHN (Stage III–IVb) patients received
Nimotuzumab plus CRT or CRT alone. Treatment
included six cycles of cisplatin (40–50 mg/week)
or carboplatin (area under the curve-based),
nimotuzumab (200 mg/week), and radiotherapy (60–70
Gy). Tumor response was evaluated as per response
evaluation criteria in solid tumors criteria. MoS
was estimated using the Kaplan–Meier method.
Toxicity and adverse events (AE's) were assessed
as per CTCAE v 4.0. Results: At 24 weeks after
completion of treatment, the tumor response rate
(complete response, partial response, stable
disease) was 53.3% and 35.7% favoring nimotuzumab
arm while progression of disease was 40% and 35.7%
in Nimotuzumab plus CRT and CRT groups,
respectively. However, the objective response rate
was 57% and 30% in favor of nimotuzumab arm. At
median follow-up of 45.5 months, MoS was 33 months
in Nimotuzumab plus CRT and 27 months in CRT
group. The 5-year survival rate was 33.3% in
Nimotuzumab plus CRT versus 7.1% in CRT group.
Nimotuzumab was observed to be safe with no
additional AE's such as hypersensitivity,
hypomagnesemia, and allergic reaction was
reported. Conclusion: Addition of Nimotuzumab to
standard CRT showed improved survival rate in
unresectable, LASCCHN patients without producing
additional toxicity.
PCN340 TREATMENT OUTCOMES IN LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF HEAD AND NECK PATIENTS WHO SUBSEQUENTLY PROGRESSED: REAL-WORLD EVIDENCE FROM EUROPE AND THE US
