By Marta Garde RicoteChicago, June 3 (EFE).- Chemotherapy’s reign as the standard treatment against aggressive breast cancer could be nearing its end: a therapy developed by a team of Spanish researchers demonstrates that a tailored strategy, closely following each step of the disease’s progression, may circumvent its necessity.
This new approach decides on the use of chemotherapy based on the patient’s response, reduces the toxicity levels in the body, results in fewer side effects, and introduces a new paradigm in clinical practice.
“All patients have a very good prognosis, but we have managed that a third did not need to undergo chemotherapy,” Dr. Javier Cortés, director of the International Breast Cancer Center and co-founder of the oncological clinical research company MEDSIR, which has propelled the trial, explained to Agencia EFE.
Their Phase II PHERGain study was applied to 356 individuals with early-stage localized HER2+ breast cancer, ranging from stages I to III. This particularly aggressive form of cancer usually mandates chemotherapy as a default treatment, but for the first time, this was not the starting point.
“We have started to see that antibodies are better than chemotherapy. There are probably patients who only need antibodies and not chemotherapy. This is what we are demonstrating,” Antonio Llombart-Cussac, another author of the study and co-founder of MEDSIR, told Agencia EFE.
To put it in football terms, it’s like starting with the reserve players and only bringing out the best, or in this case, the most aggressive treatments when necessary, Cortés clarified at the annual congress of the American Society of Clinical Oncology (ASCO) in Chicago, where their findings were presented.
Their trial, conducted between June 2017 and April 2019, involved researchers from 45 centers across seven European countries – Spain, France, Belgium, Germany, Italy, Portugal, and the United Kingdom.
Their innovative approach wasn’t always welcomed: “In some countries, the regulators did not understand the design, even if the clinicians from that country explained it to them 100 times,” Llombart-Cussac recounted.
95.4% (255) of the patients in the group that did not default to chemotherapy remained recurrence-free after three years of follow-up, and among those who were treated without chemotherapy throughout the trial, nearly 30%, that percentage increased to almost 99%.
The work of PHERGain, spearheaded by Dr. José Pérez, is far from over. There are plans to follow up at the 5- and 7-year marks, and a PHERGain II is already in the pipeline.
“It’s the exact same strategy, but with smaller tumors. We believe we’ll be able to cure more than 60% of these patients without any need for aggressive treatment. It’s in the recruitment phase and will conclude next year,” stressed Llombart-Cussac, head of the Arnau de Vilanova Hospital in Valencia.
They argue it is impossible to predict which type of patient will be able to avoid chemotherapy altogether or minimize it because it will depend on her response. What can be generalized is that if oncologists decide to use this strategy on a group of patients, “a third” of that group will not receive chemotherapy, Cortés affirmed.
MEDSIR’s Executive Director, María Campos, added that the private company, which also has a U.S. branch, was founded in 2012 specifically to address “the need for more intelligently designed studies.”
It offers “a much more agile model, not dependent on operations like service organizations. Trials are faster and, most importantly, they are focused on patient needs, not solely on the pharmaceutical industry,” Campos concluded. EFE