2023-07-06 11:34:47
The combination of ‘chemo’ and immunotherapy is used to operate previously inaccessible tumors. “It represents a real advance for patients with a prognosis limited to about 15 months.”
“There is nothing to do, but we are going to try everything.” In 2017, this is what Fabio Franco, an oncologist at the Puerta de Hierro University Hospital in Madrid, told José Ramón Pérez. A five centimeter tumor next to one of his lungs put his life at risk. Surgical options were complicated by his location next to the heart. But there was an opportunity that came in the form of a clinical trial: a combination of chemotherapy and immunotherapy used before surgery to shrink the tumor mass.
José Ramón is now free of the disease and is one of the patients included in the first studies called Nadim, launched by the team led by the head of Medical Oncology at the Madrid center, Mariano Provencio. “It is a short-term therapy, only three doses of nivolumab, together with chemotherapy, that gives very little added toxicity”, explains the also president of the Spanish Lung Cancer Group (GECP).
This way of treating lung cancer presents a great opportunity for patients with a stage III tumor. “About 30% of patients are diagnosed at this stage, but with current therapeutic strategies, survival is limited. That is why we commented that Nadim’s data represent a real advance for an important group of patients with a limited prognosis despite being diagnosed in early stages. The prognosis was 15 months of progression-free survival”, emphasizes Provencio.
The latest data from Nadim II have seen the light this week in The New England Journal of Medicine (NEJM) and represents a total change in the approach to this type of tumors. This Spanish study consolidates a new way of treating early lung cancer that increases survival by 20%. So that a year more than 6,000 patients like José Ramón will be able to benefit from its impact.
After the three doses, they checked José Ramón’s tumor. It had been reduced to two centimeters and was now operable. “When they operated on me, the surgeon told me: ‘There is no tumor anymore.’ And I answered them: ‘Seriously, then why have you opened me up?’ They left me like new.”
José Ramón did not hesitate to enter the clinical trial when they asked him. “And I would do it again, because there is no doubt that they did what they could and today I can continue walking my four hours a day and hiking without problems,” says the 67-year-old who boasts of being very physically active.
“Currently only 30% of these patients survive five years. With the Nadim scheme this percentage could reach 70%. More than 6,000 patients can benefit from improvements in response to treatment and survival each year in Spain”, says the head of the study.
“The repercussion is important since we are talking about opening the door to tumor cure in this group of patients. It must be taken into account that in lung cancer this is always complicated, even when we have detected the tumor in its early stages. It will force us to change the global approach to this tumor”.
Figures that support the effort of clinical trials
But Provencio remembers that, despite today’s good news, they had to convince many that it was worth starting the trial. “In 2016, with the first Nadim, we had to convince a lot of people to support us financially to carry it out.”
Together with José Ramón, another 45 patients were included in the first Nadim. This was the first study worldwide that analyzed the benefits (feasibility, safety, efficacy and survival) of administering chemo-immunotherapy with nivolumab before surgery and nivolumab monotherapy after surgery in patients with early or local lung cancer. advanced.
The idea arose from “previous, preclinical data with mice; we saw the good synergy of both treatments. Then, we kept in mind the situation of these patients who, while potentially operable, had almost no progress in the last 30 years. And we decided to look for financing to do the study and we got it”.
The figures that emerge from the Nadim II essay are the best endorsement of this approach, in addition to the testimony of José Ramón. The work included in the scientific publication shows that more than a third (36.8%) of the patients with this new scheme achieve a complete reduction of the tumor, compared to 6.9% who were treated with chemotherapy alone.
Currently only 30% of these patients survive five years. With the Nadim scheme this percentage could reach 70%
In addition, more than eight out of ten of those diagnosed are alive at two years compared to 63% with the traditional approach. Thus, up to 93% of the patients treated with chemo-immunotherapy were eligible for subsequent surgery compared to 69% who did not receive prior treatment. In Spain, 86 patients from 20 hospital centers were recruited for the second part of the trial.
Nadim II was possible thanks to the good results that were published from the first pilot in 2020 in The Lancet. “It was a change of approach that was gestated from an independent clinical research group in Spain. The results were so spectacular (81.9% of patients alive at three years, 69.6% had no disease progression after three years, and 63% tumor-free at surgery) that we captured international interest and a worldwide study was launched in this line that validated the Nadim data and was key to the accelerated approval by the FDA of this treatment”, explains the president of the GECP.
Hence the enormous impact of the work. “This Spanish study published in NEJM It has opened the door to a global change in the treatment of patients with early lung cancer”, emphasizes Provencio, who explains that “in the United States, the FDA granted rapid approval for this treatment scheme to be available in North American hospitals The National Institute for Health and Care Excellence (NICE) has also expressed its favorable opinion, highlighting its cost-effectiveness and we hope that it will also reach Europe this year. A global change that begins and consolidates with 100% Spanish research”.
For Provencio, the important thing is that this advance reaches patients like José Ramón soon. “We already have the positive opinion of the European CHMP,” he adds, pointing out that in Spain “there are already hospitals that have incorporated it into their clinical practice given the benefits obtained.”
The president of the GECP adds that “we are not just talking about a drug. We are talking about a change in the therapeutic approach and strategy that involves many professionals: pathologists, surgeons, oncologists or radiotherapists. We have found a significant improvement that can lead us to the cure of a significant number of patients after decades without progress”
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 most patients eventually relapse, accounting for two thirds of systemic relapses,” says Dr. Provencio. Pilar Perez
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