2023-06-29 09:40:00
The New England Journal of Medicine (NEJM) has published the NADIM II study of the Spanish Lung Cancer Group (GECP), which represents a paradigm shift when treating intermediate lung tumors without metastasis with chemotherapy and immunotherapy before surgery. , increasing survival and, in more than a third, eliminating the tumor.
X-ray of lung cancer/Courtesy photo
The publication in this scientific journal represents an endorsement of NADIM, a pioneering study worldwide, which is consolidated as the standard of treatment for these stage III tumors, and whose data was already presented in 2022 at the meeting of the American Society of Clinical Oncology. (DISGUST).
“This Spanish study published in NEJM has opened the door to a global change in the treatment of patients with lung cancer” in intermediate stages, patients considered to have a poor prognosis, he said in a statement. the president of the GECP, the oncologist Mariano Provencio who emphasizes that it is an independent academic investigation.
The strategy of treating with chemo-immunotherapy before operating increases the survival of patients by 20%, since 85% are alive two years after the trial, compared to 63% with the traditional approach, chemotherapy after surgery.
“Currently only 30% of these patients survive five years. With the NADIM scheme, this percentage could reach 70%”, assured the principal investigator and head of the Oncology Service at the Puerta de Hierro University Hospital in Madrid, who explained that the research carried out had never borne fruit before.
In addition, this therapeutic strategy achieves a complete disappearance of the tumor in 36.8% of patients, compared to 6.9%, who were treated only with chemotherapy.
“We have found a significant improvement that can lead us to the cure of a significant number of patients after decades without advances”, the specialist stressed.
Increase in patients who are candidates for surgery
93% of patients treated with chemotherapy and immunotherapy (with the drug nivolumab) were able to opt for subsequent surgery compared to 69% who did not receive prior treatment, so this strategy will allow a greater number of patients to be operated “without add a lot of toxicity” and “thus raise cure rates.”
“More than 6,000 patients can benefit from improvements in response to treatment and survival each year in Spain,” stated Dr. Mariano Provencio.
At the time of diagnosis, more than a third of patients with lung cancer have early-stage or locally advanced disease. In this context, neither surgery nor radiotherapy alone is associated with good results.
“In these cases there is usually micrometastasis in a lymph node, so the majority of patients eventually relapse, accounting for two thirds of systemic relapses,” pointed out the doctor, who points out that the Spanish study focuses on this type of patient with the greatest need. of clinical improvements.
The new therapeutic combination has been fast track approved by the US drug regulatory agency, the FDA; It has received the favorable opinion of the National Institute for Excellence in Health and Care of the United States (NICE, for its acronym in English) and its approval by the European Medicines Agency (EMA) and its subsequent authorization in Spain are pending.
HE GECP was a pioneer in initiating the investigation of this therapeutic combination before surgery by designing the NADIM pilot study with 46 patients and whose results were published in 2020 in The Lancet.
This was the starting point for the NADIM II study with 86 patients from twenty Spanish hospitals divided into two arms, one with chemotherapy-immunotherapy before surgery and the other with traditional chemotherapy after the operation.
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