Adding Nimotuzumab to Chemoradiation Improved Survival in Locally Advanced Head and Neck Cancer

• Study Design
• Nimotuzumab
• References

In patients with locally superior squamous cellular carcinoma of the pinnacle and neck, nimotuzumab—a humanized monoclonal antibody in opposition to the epidermal boom factor receptor—in combination with cisplatin and radiotherapy become superior to cisplatin and radiotherapy on my own in improving progression-loose survival, disease-unfastened survival, and locoregional tumor control, according to analyze conducted by way of Vijay Patil, MBBS, MD, DM, of the Tata Memorial Center in Mumbai, India, and colleagues.

These consequences have been in the beginning supplied on the 2018 ASCO Annual Meeting and have been discussed at the Best of ASCO Chicago by using Mark Agulnik, MD, Professor of Hematology and Oncology at Northwestern University Feinberg School of Medicine in Chicago, along side this yr’s different top decided on abstracts in head and neck most cancers.1,2

The median period of progression-loose survival in patients who acquired nimotuzumab become considerably longer as compared with chemoradiation therapy on my own: 60.3 months vs 21.0months. The 2-12 months progression-unfastened survival charge was also drastically progressed with nimotuzumab: 58.9% vs 49.5% (P = .022).

This was the first phase III trial of nimotuzumab. According to the investigators, “this aggregate affords a brand new healing option within the armamentarium against locally superior squamous head and neck cancer.”

Study Design

THE SINGLE-INSTITUTION segment III randomized examine became conducted in 536 patients with locally superior stage III or IV squamous head and neck most cancers who were treated with weekly Nimotuzumab similarly to radiation and cisplatin chemotherapy or chemoradiation remedy on my own. Patients were equally allotted to receive both radical radiotherapy (66–70 Gy) with weekly cisplatin (30 mg/m2) or the identical time table of chemoradiation remedy along side weekly nimotuzumab (two hundred mg).

Patients in the trial have been all 18 years or older, had a Karnofsky overall performance popularity of as a minimum 70, and had adequate organ function; the median follow-up changed into 33.zero months. The number one endpoint changed into progression-unfastened survival, and key secondary endpoints were disease-free survival, duration of locoregional tumor control, and usual survival.
With the addition of nimotuzumab: 43.4 months vs 31.three months (P = .222). The risk ratio in prefer of nimotuzumab was zero.851, suggesting a 15% reduction in the danger of death, but this was no longer statistically significant.

Grade three to five unfavorable events were similar between the two arms. However, patients within the nimotuzumab arm skilled a higher occurrence of mucositis (66.7% vs 55.8%; P = .010).

Dr. Agulnik’s Take on the Research

“CHEMORADIATION IS a not unusual remedy strategy, however it virtually desires [the addition of other strategies] to improve outcomes,” he said. “We’ve checked out neoadjuvant and adjuvant strategies, we’ve checked out altering radiation schedules, and we’ve looked at the addition of second chemotherapeutic agents to cisplatin. Most of them, however, have did not improve outcomes.”

Nimotuzumab

• Nimotuzumab is a humanized monoclonal antibody that targets the extracellular region of the epidermal growth factor receptor with high specificity, thereby blocking off ligand binding and receptor activation.
• In the United States, nimotuzumab has had Orphan Drug fame for glioma on account that 2014.
• The drug is being studied in medical trials for a whole lot of other cancers, inclusive of esophageal cancer, nasopharyngeal cancer, non–small cell lung cancer, gastric cancer, and colorectal most cancers.

“What’s dazzling is that this observe turned into randomized. It was performed in a single institute, but a superb single institute,” he said. “The delivery of radiation and cisplatin became great and properly balanced within the groups, with a excessive compliance rate. However, there may be a limitation: most people do no longer use 30 mg/m2 in remedy. Therefore, what’s the authentic relevance to a group that receives a remedy probable no longer regular with standards?” Other barriers of the take a look at, he noted, have been a low oral cavity populace and immature normal survival data.

According to Dr. Agulnik, the cumulative cisplatin dose correlates with the general survival outcome. Cisplatin at one hundred mg/m2 each three weeks for to 3 doses comes out to 200 to 300 mg/m2, and cisplatin at 40 mg/m2 weekly for six to 7 weeks equals a complete dose of 240 to 280 mg/m2. “And in this examine, at 30 mg/m2, we’re dosing underneath that at 180 to 210 mg/m2,” he said. “So, the inferior dosing of the drug probably has an effect here.” However, 200 mg/m2 is considered an ok dose of cisplatin, and almost 80% of patients in both hands had acquired it, which is slightly better than the RTOG 0522 have a look at.three

Prior research has mounted that the addition of cetuximab to radiation and cisplatin did no longer improve outcomes.3 “So, the query is, what makes this study different?” he asked. “Compared to the RTOG 0522 trial, this trial had greater [human papillomavirus]– terrible patients, greater hypopharynx sufferers, and more T3 to T4 sufferers. Patients also obtained fewer radiation interruptions and a touch bit greater cisplatin as well, despite a weekly dose of 30 mg/m2.”

Chemoradiation with concurrent cisplatin (one hundred mg/m2 every three weeks) remains the gold trendy of care in locally superior squamous mobile carcinoma of the head and neck. The addition of nimotuzumab, however, needs to be taken into consideration when weekly radiosensitization is planned.

DISCLOSURE: Drs. Patil and Agulnik pronounced no conflicts of interest.

References

1. Patil VM, Noronha V, Joshi A, et al: Results of a randomized section III study of nimotuzumab in aggregate with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in locally superior squamous mobile carcinoma of the head and neck. 2018 ASCO Annual Meeting. Abstract 6000. Presented June 3, 2018.
2. Agulnik M: Head and neck cancer. 2018 Best of ASCO Chicago. Special session. Presented August 11, 2018.
3. Ang KK, Zhang Q, Rosenthal DI, et al: Randomized segment III trial of concurrent extended radiation plus cisplatin with or without cetuximab or degree III to IV head and neck carcinoma: RTOG 0522. J Clin Oncol 32:2940-2950, 2014.

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