An investigation by the Spanish Lung Cancer Group (GECP) has ratified the paradigm shift in the approach to these tumors in early stages, without metastasis, with a therapeutic strategy that increases the number of patients who are candidates for surgery by up to 93% and manages to eradicate tumor in 36.8% of cases, which favors the healing process.
The president of the GECP, the oncologist Mariano Provencio, will present the data from the NADIM II study on June 5 in an oral session within the framework of the annual meeting of the American Society of Clinical Oncology (ASCO, for its acronym in English) that It is celebrated in Chicago, this year in person after two years of pandemic.
“In Spain we have managed to initiate a paradigm shift: it is not just another drug, it is a new way of treating because we are going to be able to operate on many more patients and get many more to live”, assured the head of Oncology at the Hospital Puerta de Hierro in Madrid in a meeting with journalists.
The NADIM II study, with 86 patients from different Spanish hospitals, has tested, before surgery, a combined treatment of chemotherapy and immunotherapy (drug that stimulates the immune system against malignant cells) in a group of patients and has compared it with another treated with chemotherapy alone, but all of them with stage IIIA, the most advanced within the initial and localized lung tumors.
Improves prognosis and chance of cure
The oncologist has provided the results of an investigation that reflects that treatment prior to surgery reduces or eliminates the tumor and allows patients who were not candidates before to be operated on, thus improving the prognosis and the possibility of cure.
In addition, it means having a new strategy after 30 years without therapeutic novelties in these early-stage cancers treated conventionally, with chemotherapy and surgery when possible.
According to the study, 93% of those who received the combination of chemotherapy and immunotherapy were eligible for the operation, compared to 69% of those treated with chemotherapy alone. In addition, 36.8%, when operated, presented absence of tumor, which is called complete pathological response, compared to 6% of those treated with chemotherapy alone.
Regarding the objective response rate (both reduction and disappearance of the tumor), the data show 75% with combined treatment, compared to 48% with chemotherapy.
The Spanish Lung Cancer Group was a pioneer in the world, in 2019, with the NADIM I study that tested this combined treatment prior to surgery on a single group of patients and three years later the overall survival is more than 80%, data published in “The Journal of Clinical Oncology”.
Until now, and after 30 years without therapeutic novelties, only 30% of patients with this type of tumor in early stages survive three years, so NADIM I shows a 50% increase in survival in that period, a percentage that NADIM II intends to endorse when the study progresses over time.
In addition, none of the patients who presented complete remission of the tumor has relapsed in three years of follow-up “so we can think that we have cured them” with this new therapeutic strategy, according to Provencio.
“NADIM I created a great stir”, according to the oncologist and opened the door to other international investigations such as the “Checkmate 186” study, whose results are “consistent, although with shorter follow-up time” and in patients with earlier stages compared to the GECP investigation.
This therapeutic strategy is already approved by the FDA, the US drug regulatory agency. The specialist has shown his confidence that it will soon be authorized in Europe and in Spain, although it is already used for compassionate use in patients with larger tumors.
According to the president of the GECP, one of the challenges will be to design studies to better identify patients, since surgery could be avoided in those whose tumor disappears completely with previous treatment with chemotherapy and immunotherapy, or complementary approaches after surgery could be made for those without complete pathological response.
Meanwhile, the GECP has launched the Real NADIM study to collect data from patients in clinical practice, during the follow-up of their evolution, who present “excellent tolerance” to the side effects of the combined treatment that consists of only three cycles. before being operated on.