Adding an immunotherapy drug to standard treatment increases median survival by 41% in women with metastatic or recurrent cervical cancer, according to an international clinical trial led by the Vall d’Hebron Oncology Institute (VHIO). The results of the trial, which are presented today in the journal The Lancet, are destined to change treatment protocols for this type of cancer, say the authors of the research.

Cervical cancer, caused in most cases by the papilloma virus, causes about 700 deaths a year in Spain, and the number of new annual diagnoses exceeds 2,300. Although papilloma vaccination is reducing its incidence, it is still the fourth leading cause of death in women globally, with 342,000 deaths and 604,000 new diagnoses annually.

The standard treatment for patients with metastatic or recurrent disease consists of combining two drugs, reports Ana Oaknin, specialist in gynecological tumors at the VHIO and principal investigator of the clinical trial. One of the drugs is a chemotherapy that destroys cancer cells. The other is an antiangiogenic that inhibits the growth of blood vessels and thus reduces the arrival of nutrients to the tumor.

The clinical trial, in which 410 patients from Europe, the United States and Japan have participated, has evaluated the effectiveness and safety of adding a third drug to the standard treatment. Specifically, atezolizumab, which makes it easier for T cells of the immune system to recognize and attack cancer cells.

The average survival in this group of patients who initially had a poor prognosis was 22.8 months with standard treatment and increased to 32.1 months with the combination of three drugs, which represents an increase of 41% It has also increased how long the cancer has been without progression, from 10.4 to 13.7 months on average, or a 32% increase.

Serious side effects affected a similar percentage of patients in both groups. Mild side effects, which have included fever, diarrhea, joint pain and rash, have been more common with the three-drug combination.

Two previous clinical trials had studied the benefits of other immunotherapy drugs in cervical cancer patients with positive results. But they were designed before treatment protocols incorporated bevacizumab to be able to inhibit the growth of blood vessels in the tumor. The study presented today in The Lancet is the first to analyze what immunotherapy brings compared to the current standard treatment.

After the publication of these results, “we hope that the European Medicines Agency and the US FDA will approve this treatment in the coming months, and that it will become the first-line treatment for patients with metastatic cervical cancer or appellant”, declares Ana Oaknin.

Looking to the future, there are ongoing clinical trials to evaluate the effectiveness of immunotherapy in the earliest stages of cervical cancer. “If it is effective in patients with metastasis or recurrent cancer, we hope that it will also be effective in other stages, but we have to prove it”, says the VHIO oncologist. In this way, the percentage of patients in whom the disease progresses could be reduced.