HCG Cancer Centre, Bengaluru, achieves a remarkable milestone in head and neck cancer treatment with low-dose immunotherapy in pilot study.
Dr BS Ajaikumar and Dr Satheesh CT who led the pilot study. (Supplied)
“I wasn’t able to eat or swallow anything. But after just one round of chemotherapy, I am able to eat idlis and rice,” said a head and neck cancer patient, who was diagnosed with Stage 3 (B) of the disease at the HCG Cancer Centre in Bengaluru.
And it is not just this patient, but as many as 12 patients with locally-advanced carcinoma of the buccal mucosa — inner cheek cancer.
So what have the doctors at this hospital done differently to get a tumour to shrink by 90 percent with just one cycle of chemotherapy?
Dr Satheesh CT, Consultant, Medical and Hemato-Oncology, and Director of Clinical Trials at HCG Cancer Centre, Bengaluru, and his team recently (in April) found that low-dose immunotherapy drug Nivolumab with neoadjuvant chemotherapy (NACT) had demonstrated remarkable efficacy in patients who were diagnosed with locally-advanced carcinoma of the buccal mucosa.
Head and neck cancer regions. (National Cancer Institute)
Observing this, the HCG Cancer Centre in Bengaluru decided to study this in a total of 12 cases between the age group of 54 to 76 years. The patients were administered 40 mg of Nivolumab immunotherapy every two weeks, as opposed to the full dose of 3 mg per kg of body weight.
“Interestingly, we found that all 12 patients experienced significant tumour reduction, by over 90 percent, in just three months, providing a possible economical and side-effect-free therapy through low dose immunotherapy,” Dr Satheesh explained to South First.
With a legacy of innovation and a commitment to value-based care since its founding in 1989, the team at HCG — after the successful pilot study on low-dose immunotherapy Nivolumab with neoadjuvant chemotherapy — has now decided to launch an expansive study, aimed at further exploring the advantages of this approach in head and neck cancers.
Dr Satheesh’s team for the pilot study includes Dr Lohith Reddy, Consultant Radiation Oncologist and Clinical Director — AI and Radiomics; Dr Krithikaa Sekar, Consultant Radiation Oncologist; Dr Mithua Ghosh, Director —Genomics; Dr Veena, Clinical Director — Pathology.
Announcing the success rate and expansion of the pilot study, Dr BS Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited, said that a multicentric study spanning multiple HCG centres across India will be conducted soon.
A sample size of 100 head and neck cancer patients is being identified from Bengaluru, Cuttack, and Ahmedabad HCG centes for the study.
As part of the study, 50 patients will be administered only neoadjuvant chemotherapy, while the other 50 will be administered a low-dose immunotherapy drug along with chemotherapy. The cost of full dose of immunotherapy runs into lakhs and the low dose has proven to be an excellent option for patients, explained doctors from HCG.
Dr BS Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited. (Supplied)
Dr Ajaikumar said that the cost of the low-dose immunotherapy drug will be borne for the 50 patients by HCG itself.
This study aspires to provide a highly effective and affordable cancer treatment option for individuals grappling with head and neck cancers.
“This multicentric, open-labeled, prospective, randomised study is poised to redefine the landscape of head and neck cancer treatment. It seeks to evaluate the effectiveness of neoadjuvant chemotherapy, combined with low-dose immunotherapy Nivolumab with the TPF regimen (docetaxel, cisplatin, and 5-fluorouracil), compared to neoadjuvant chemotherapy with the TPF regimen alone,” Dr Ajaikumar explained.
He added, “The approach holds immense potential to significantly enhance the quality of life and extend the life expectancy of patients grappling with locally-advanced carcinoma of the buccal mucosa.”
Dr Ajaikumar stated that HCG has steadfastly championed the cause of cancer care through groundbreaking innovation and value-based care. “As cancer increasingly becomes a chronic disease, we’ve witnessed a paradigm shift in treatment approaches,” he said.
He further explained, “Head and neck cancer cases form a substantial portion of our patient population and despite our holistic approach, combating the recurrence and spread of these cancers has proven to be a formidable challenge. With today’s announcement, we embark on a transformative journey in head and neck cancer treatment. This study has the potential to be a game-changer in this field, underscoring HCG’s commitment to advancing research and academia in India, solidifying our position as a leader in this vital healthcare domain.”
Low-dose immunotherapy plays a crucial role in the treatment of head and neck cancer cases by harnessing the body’s immune system to fight cancer cells.
Low-dose immunotherapy, often using drugs like Nivolumab, helps bolster the patient’s immune response against cancer cells. It does so by blocking certain proteins on the surface of immune cells and cancer cells, allowing the immune system to recognise and attack cancer more effectively.
Dr Satheesh CT, Consultant — Medical and Hemato-Oncology and Director of Clinical Trials at HCG Cancer Centre, Bengaluru. (Supplied)
Also, it is often used in combination with traditional treatments like chemotherapy and radiation therapy.
“This combination approach is known as neoadjuvant therapy, where immunotherapy is given before the main cancer treatment. It can help shrink tumours, making them more responsive to subsequent therapies,” said Dr Satheesh.
“All the 12 patients at HCG, who were part of the pilot study, have shown shrinkage of tumours and they will eventually be operated on surgically. The shrinkage helps in easy removal of the tumour,” he explained.
Importantly, low-dose immunotherapy regimens typically result in fewer side effects compared to full-dose immunotherapy. This is especially significant in head and neck cancer cases, where traditional treatments like chemotherapy can lead to significant side effects such as nausea, fatigue, and weakened immune function.
Low-dose immunotherapy aims to provide effective treatment with a milder side effect profile, improving the patient’s overall quality of life during treatment. Also, by enhancing the body’s natural defenses against cancer, low-dose immunotherapy has the potential to extend the survival rates of head and neck cancer patients, particularly those with advanced-stage disease.
When the HCG’s clinical research team observed the data and the nature of cancer cases coming to the hospital, they found that nearly 35 percent of the cancer cases are head and neck cancers. Out of 100 cancer cases they diagnosed, 35 of them had head and neck-related cancer.
Of this, they found that 75.2 percent of them had hot tumours and 24.8 percent had cold tumours. Dr Satheesh explained that hot and cold tumours refer to the level of immune activity within the tumour microenvironment.
Hot vs cold tumours. (Charles River Laboratories)
To simplify, hot tumours are like fortresses with strong defense soldiers. When cancer invades, the defense team inside the fortress quickly recognises the enemy and fights it off effectively. This means that in hot tumours, the body’s defenses are actively fighting and stopping the cancer. Treatments like immunotherapy can be used to help the defense team further.
But, in cold tumours, they are like fortresses with a weak or sleepy defense team. When cancer invades, the defense team inside the fortress doesn’t notice or doesn’t do a good job of stopping the cancer.
“HCG’s head and cancer patients’ data showed that nearly 72 percent had hot tumours and, hence, the immunotherapy method seems to be working in these patients. We want to expand the study further and check if this will help in all patients exhibiting this. If it is proved, it’s going to be a breakthrough treatment option,” explained Dr Ajaikumar, who’s expecting a positive outcome from the study.
A team of doctors have been identified from HCGs centres across the country and they will be working as principal investigators for the study. Their job would be to also find the patients with these specifications.
The study will be run through the ethical committee and the scientific committee. Also, permissions and consent from the patients will be sought before starting the study, which is expected to begin in the next four months.
While the preliminary results are awaited in about 10 months from the commencement of the study, “we are immensely optimistic about the potential benefits of merging low-dose immunotherapy with neoadjuvant chemotherapy for head and neck cancers. This will be a breakthrough research coming from an Indian hospital. India has always aped the West but this study will surely be a remarkable one,” said Dr Ajaikumar.
Head and neck cancers present a significant global health concern, comprising 4.5 percent of total worldwide cancer cases with a mortality rate of 4.6 percent. This burden is especially pronounced in Asia, particularly in India, where head and neck cancers account for nearly 35 percent of all cancer cases among individuals aged 40-60 years.
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