Clinical Research

Changing the Oncology Treatment Paradigm For Oral Cancers

改變口腔癌的腫瘤治療模式

THE CHALLENGE
——Oral Cancer Survival Rate Has Only Improved 5% in the Last Decade and Patients Can Have a Severely Compromised Quality of Life

Oral cancers, a type of Head and Neck cancer, include the lip, tongue, gums, cheeks, the floor (bottom) of the mouth under the tongue, the hard and soft palate, sinuses, and the pharynx (throat). It is an underserved disease which is often overlooked by the medical community yet it is the 6th most common and deadliest cancer in the world. Despite advances in management of oral cancer, 50% of patients die within 5 years of diagnosis.

600,000 new cases of oral squamous cell carcinoma—the main type of oral cancer—are diagnosed worldwide each year, including 40,000 in China. In China alone, from 1990 to 2017, the number of new cases and the incidence rate for oral cancer increased by 280.0% and 79.7%, respectively; the number of deaths and mortality rose by 196.8% and 29.0%. In Hong Kong, it is the 10th leading cause of death in males.

The main risk factors for oral cancer are smoking and alcohol use. In particular, betel quid chewing is also an important risk factor in some Asian countries. Due to the rising prevalence of oral human papillomavirus (HPV), oral cancers are increasing among all populations segments. Unfortunately, often oral cancer is discovered after it has spread to lymph nodes in the neck and prognosis at this stage is significantly worse than when the cancer is only in the local oral areas.

Surgery and radiation treatment are the standard of care for oral cancers. These treatments can severely damage a patient’s ability to speak, swallow and chew. Scars, serious discomfort, decreased quality of life, and social isolation result in one of the highest suicide rates of all cancers. After standard treatments, the chances are high the cancer will return. Despite recent advances in imaging, surgery, radiation, and systemic therapies, the overall survival has only improved 5% in the last decade.

THE ANSWER
——Innovative Nano-engineered Technology Delivers Anti-cancer Agents Directly to Tumors

The Asian Fund for Cancer Research (AFCR) is committed to supporting the development of the most promising life-saving treatments. Our strong support is helping to advance a novel delivery system that can save lives of oral cancer patients. A penny-sized uniquely engineered delivery system filled with chemotherapy, biologics and other small therapeutics can be placed directly on tumor sites. The novel system ensures targeted and timely delivery of high doses of the drug at the site, sparing patients the harsh toxicities of anti-cancer agents on their body.

A pre-surgery version of the delivery system can be applied topically and rapidly kill cancer cells, shrink tumors and elicit a powerful immune response. It can be applied to pre-cancerous areas to prevent the cells from becoming an invasive cancer, thus eliminating or reducing the need for disfiguring surgery that can destroy function of the organ. The tiny delivery system can be directly applied to oral tumors (or other accessible tumors such as cervical cancer) in the neoadjuvant setting (before a main treatment) to reduce the chance of recurrence and disfiguring surgeries.

A second version of the technology can be applied after surgery to the tumor site and lymph nodes to deliver high drug doses to efficiently destroy remaining cancer cells before they proliferate further or spread.

THE IMPACT
——A Phase III Clinical Trial Will Treat Oral Cancer

The pre-surgical version of the technology has already treated patients with oral cavity cancer in a Phase I and II clinical trial. The overall response rate was 87% and over 70% reduction in tumor volume was reported. The drug remained in the local environment at high concentrations and no toxicities or severe adverse events were reported proving the safety and tolerability of the delivery system.

A Phase III clinical trial, the large and late stage testing before approval, is under planning. The trial will use both versions of the technology to treat oral squamous cell cancer. The pre-surgical version will also treat high-risk oral pre-cancer. This treatment platform presents a high impact approach that can improve and save the lives of many cancer patients in Asia and around the world.

CLINICIAL DEVELOPMENT PLAN: Future clinical study is being planned to evaluate this platform technology for different types of solid tumors and to investigate if the technology can enhance responses of cancers to immunotherapy.

HOW YOU CAN HELP
——You Can Bring Hope of Life-Saving Cancer Care

Your support of AFCR will enable scientists to develop novel, save and effective immunotherapeutic approaches to treating oral cancers. When you support AFCR, you’re funding a vision: one in which patients in Asia and throughout the world no longer live in fear of the words ‘you have cancer.’

There is no better way for you to help make this happen than to support the Asian Fund for Cancer Research. With your donation, you are saving lives.