by Vera Martinella
Also available in Italy is an innovative molecule intended for a specific subgroup of patients with the ALK mutation: they are mostly young and non-smokers. In 64% the neoplasm “has been at a standstill” for three years
A new therapy is also available in Italy which manages to block, even for several years, the progression of a lung tumor in patients who already have brain metastases: the Italian Medicines Agency (Aifa) has in fact granted reimbursement to lorlatinib for patients with ALK-positive advanced non-small cell cancer. The new drug is not intended for all people with lung cancer, but for a “restricted circle” which however has very particular characteristics: “First, patients with ALK positive tumors are on average young, mostly under 50 years of age – says Silvia Novello, full professor of Medical Oncology at the University of Turin and president of WALCE Onlus —; second, they are largely non-smokers or ex-smokers who have quit many years ago; third, many have brain metastases already at the time of diagnosis, because this subtype of lung cancer is very aggressive.”
The advantages of the new drug
Lorlatinib was specifically designed to overcome the blood-brain barrier and therefore act at a brain level, but also to be active in patients previously treated with other therapies in whom, however, the disease has managed to implement resistance mechanisms. Aifa’s authorization was, in fact, granted on two fronts: on the front line for patients (adults) with advanced non-small cell cancer, with ALK translocation, not previously treated with other drugs in the same category (i.e. tyrosine kinase inhibitors) and was already available in second line (or subsequent lines) for patients who have already received specific treatments to which they no longer respond. «The results of the CROWN study, on which the green light from Aifa was based, indicate that lorlatinib is more effective than the treatments that we have so far considered standard – explains Filippo de Marinis, director of the Division of Thoracic Oncology of the European Institute of Oncology ( Ieo) of Milan and president of the Italian Association of Thoracic Oncology (Aiot) —. The trial involved 104 hospitals in 23 countries around the world, 296 patients and the advantages obtained are many: 72% of the participants saw the brain metastases disappear and a further 10% still had an intracranial response; 64% of patients did not progress three years after starting lorlatinib (compared to 19% of those taking standard therapy up to now); the side effects are well tolerated (especially increased cholesterol and triglycerides, with weight gain) and can be managed.” The treatment is in tablets to be taken at home daily, which facilitates the good quality of life of patients, who often manage to maintain their “normality” in the family, work and social spheres.
Fundamental genetic test for everyone
Every day in Italy around 115 people discover they have lung cancer (for a total of 44 thousand new cases registered in 2023), which remains difficult to treat because more than 70% of patients are diagnosed late, when the disease is already in an advanced stage and the chances of recovery are unfortunately limited. The neoplasm, in fact, does not give obvious signs of its presence at the beginning and when it does it has generally already progressed into the metastatic phase, when things get complicated, the treatments are more complex and the chances of recovery decrease, even if today there are different innovative therapies that can significantly prolong the survival of patients. «Of the 44 thousand new CAIs per year, only around 5% are of the ALK positive type and can therefore benefit from this new drug – clarifies Novello -. Today, however, we know that there is no longer just one lung cancer, but we know different types and we have many new drugs targeted against individual mutations (in addition to ALK, EGFR, RET and others) for which it is crucial to have, right from the diagnosis, the molecular profile of each patient for increasingly personalized medicine. That is, to plan the most suitable treatment for each person, before or after surgery.” Thus the survival of patients is lengthened and the hope of being able to recover also grows, limiting the number of relapses, in those who discover the neoplasm in its early stages.
Cases increasing among women
«80% of lung cancer patients are or have been smokers for many years and cases are increasing among Italian women, in step with the spread of tobacco among women – concludes De Marinis -. Persistent cough, chest pain, hoarseness, shortness of breath even with minimal effort, phlegm with streaks of bright red blood are all alarm bells that should never be ignored.” For the early diagnosis of lung cancer, the RISP program has been active in our country since 2022, free of charge and aimed at women and men between 55 and 75 years old, current heavy smokers or former smokers for less than 15 years. If discovering a carcinoma in the early stage can save lives (the smaller the nodule, the more minimally invasive and radical the surgery can be, with a high chance of definitive recovery), equally crucial is providing support to help smokers quit: very few are Italians who use drugs useful for quitting the habit and also those who turn to expert personnel who can create an identikit of the smoker and support him in his decision to say enough. But statistics indicate that if you ask for help, your chances of succeeding increase.
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January 25, 2024 (modified January 25, 2024 | 11:11)
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