JAMA Dermatology reports what they believe to be the complete regression of squamous cell skin cancers after combined systemic and direct intratumoral injection of the 9-valent HPV vaccine.
Squamous cell carcinoma is the second-most-common form of skin cancer. Evidence suggests the human papilloma virus plays a role in the development of some types of this skin cancer.
Two years ago, a 97-year-old woman whose right leg was covered with squamous cell tumours went to see dermatologist Dr Anna Nichols, at Sylvester Comprehensive Cancer Centre. Surgery is the standard of care for most patients with skin cancer. “She was not a candidate for surgery because of the sheer number and size of her tumours. She wasn’t a candidate for radiotherapy, again for the same reasons,” said Nichols, an assistant professor at the University of Miami Miller School of Medicine.
In 2017, a case report by Nichols showed the HPV vaccine Gardasil reduced the number of new basal and squamous cell skin cancers in two patients. Dr Tim Ioannides, a voluntary faculty member at UM, suggested using the vaccine as an off-label treatment by directly injecting it into the tumours.
Since her patient had no other options, Nichols offered her the treatment. It is considered an “off-label” use because Gardasil is only approved for the prevention of cervical, anal, vulvar and vaginal cancers caused by the human papilloma virus.
“I think we had a really reasonable expectation and good data that this was actually going to, at the very least, do no harm to this patient, and possibly provide some benefit,” said Ioannides. “To have this type of result in such an advanced patient I think was beyond all our expectations.”
The patient was first given two doses of the 9-valent HPV vaccine in her arm, six weeks apart. A few weeks later Nichols directly injected several but not all of the patient’s tumours. The direct intra-tumoral injections were given four times over 11 months.
“All of her tumours completely resolved 11 months after the first direct tumour injection, and she has had no recurrence,” Nichols said. “It has been about 24 months now since we started with the treatment.”
“They decided to try it and it worked. It killed them all off,” said the patient, who is now looking forward to celebrating her 100th birthday this fall.
Importance: Squamous cell carcinoma (SCC) is the second most common form of skin cancer, and its incidence is increasing. When surgical management is not an option, finding a safe and efficacious treatment is a challenge. Mounting evidence suggests that the human papillomavirus (HPV) is involved in the pathogenesis of some SCCs.
Objective: To assess whether the 9-valent HPV vaccine could be an effective treatment strategy for cutaneous SCC.
Design, Setting, and Participants: A woman in her 90s with multiple, inoperable cutaneous basaloid SCCs was successfully treated at a university-based outpatient dermatology clinic with a combination of systemic and intratumoral delivery of the 9-valent HPV vaccine from March 17, 2016, through February 27, 2017, and then followed up through May 21, 2018.
Main Outcomes and Measures: Reduction in tumor size and number after a combination of systemic and intratumoral administration of the HPV vaccine.
Results: All tumors resolved 11 months after the first intratumoral injection of the vaccine. The patient remained free of tumors at the end of follow-up.
Conclusions and Relevance: This is the first report, to our knowledge, of complete regression of a cutaneous malignant tumor after combined systemic and direct intratumoral injection of the 9-valent HPV vaccine. This report suggests that the HPV vaccine may have therapeutic utility for SCCs in patients who are poor surgical candidates, have multiple lesions, or defer surgery.
Anna J Nichols, Adrianna Gonzalez, Emily S Clark, Wasif N Khan, Alyx C Rosen, Wellington Guzman, Harold Rabinovitz, Evangelos V Badiavas, Robert S Kirsner, Tim Ioannides