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Nimotuzumab-CRT improves PFS in head, neck cancers

Audrey Abella
06 Jul 2018

The addition of the EGFR inhibitor nimotuzumab to a chemoradiotherapy (CRT) regimen using cisplatin improved progression-free survival (PFS) and disease-free survival (DFS) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with CRT alone, according to data from a phase III trial presented at ASCO 2018.

A total of 536 patients with stage III/IV SCCHN (50 percent oropharyngeal cancers) were randomized 1:1 to receive weekly radical radiotherapy (66–70 Gy) and cisplatin 30 mg/m2 (CRT), either with nimotuzumab 200 mg (NCRT) or without. Median follow-up was 33.0 months. [ASCO 2018, abstract 6000]

PFS was significantly longer among NCRT vs CRT recipients (median, 60.3 vs 21.0 months, hazard ratio [HR], 0.74, 95 percent confidence interval [CI], 0.56–0.95; p=0.023), with a 2-year PFS rate of 58.9 percent vs 49.5 percent, respectively.

The addition of nimotuzumab also improved DFS in NCRT vs CRT recipients (HR, 0.75, 95 percent CI, 0.57–0.97; p=0.028), with a 2-year DFS rate of 59.2 percent and 49.0 percent, respectively.

The researchers attributed the improvements in PFS and DFS to the better local regional control that NCRT provided compared with CRT (65.1 percent vs 56.5 percent; p=0.018).

The median OS rate was 43.4 vs 31.3 months (HR, 0.85, 95 percent CI, 0.65–1.10; p=0.22) in the NCRT arm vs the CRT arm, respectively, but the researchers noted that the OS data has yet to mature and suggest a trend towards an improvement with NCRT, noted the researchers.

The rates of grade 3–5 adverse events (AEs) were similar between the NCRT and CRT arms (27.7 percent vs 29.2 percent for radiation dermatitis, 41.3 percent vs 37.7 percent for odynophagia, and 30.3 percent vs 28.8 percent for dysphagia) except for mucositis, which was higher among NCRT recipients (66.7 percent vs 55.8 percent; p=0.010). Hospitalization due to AEs was also higher with NCRT (21.6 percent vs 15.3 percent; p=0.058).

These results suggest that nimotuzumab enhanced the effect of cisplatin when combined with RT, noted the researchers. Therefore, NCRT combination may provide an alternative therapeutic option for the treatment of head and neck cancers, as other alternatives such as neoadjuvant/adjuvant chemotherapy, altered radiation schedules, or other chemotherapeutic agents added to cisplatin failed to improve outcomes, they added.

 

 

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Most Read Articles
04 Feb 2019
The carbon-chain length of saturated fatty acids appears to be an important factor in determining its role in cardiovascular health, a recent study has found.
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Olanzapine confers a modest therapeutic effect on weight compared with placebo in adult outpatients with anorexia nervosa, a study has shown. However, it does not appear to offer significant benefit for psychological symptoms.
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A latest study at ISC 2019 shows that even patients with large-core stroke damage can have a good outcome after mechanical clot removal with endovascular thrombectomy (EVT), depending on the size of the infarct and time lapses between stroke onset and treatment.
Jairia Dela Cruz, 04 Feb 2019
Treatment with secukinumab results in a higher rate of remission or low-disease activity at week 16 in patients with psoriatic arthritis as compared with placebo, according to a posthoc analysis of the FUTURE 2 study. This effect is sustained at 2 years and is evident in both tumour necrosis factor inhibitor-experienced and -naïve patients.