Not just in clinical trials: immunotherapy also works in daily clinical practice. This is what emerges from the results of Pacific R, the real life study that enrolled about 1,400 patients with unresectable stage III non-small cell lung cancer. Thus it was found that immunotherapy with durvalumab is effective in the control of lung cancer in patients not ‘selected’ as it happens in the studies. In 2020, about 41 thousand new cases of lung cancer were estimated in Italy, 85% of which concerns the non-small cell form, the most frequent. One third of these patients are diagnosed with stage III disease.
Random 2021
Lung cancer: combo of two drugs delays progression by 6 months, especially in smokers
by Irma D’Aria
Data from the Congresses
Durvalumab is already approved in Italy after definitive chemo-radiotherapy for patients with unresectable stage III disease and ≥1% expression of a specific protein (Pd-L1). Last June, at the American Society of Clinical Oncology (Asco) Congress, the survival benefits obtained from durvalumab were highlighted in the update of the Pacific pivotal study, with 43% of patients alive at 5 years. From the Congress of the European Society for Medical Oncology (Esmo), which took place last September, new important evidence has come. The advantages of immunotherapy are not limited to controlled clinical trials, but are concretely found in real life.
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Lo studio in ‘real life’
290 centers from 11 countries were involved, including Italy with 116 patients. Pacific R showed a progression-free survival with durvalumab of approximately 22 months. Good tolerability: only 16% of patients were forced to stop treatment due to an adverse event and 27% due to disease progression. “These are significant data, which highlight the important implications of immunotherapy for the benefit of a particular category of patients who, although candidates for recovery, for a long time did not benefit from new therapeutic opportunities – clarifies Diego Signorelli, oncologist at the Niguarda Hospital in Milan. This study confirmed the role of durvalumab as a gold standard also in daily clinical practice, therefore in a population of unselected patients with strict criteria such as those adopted in the pivotal study “.
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Patients with lung cancer locally
In fact, Pacific R was attended by patients with locally advanced unresectable lung cancer, who had previously undergone concomitant (in about 75% of cases) or sequential chemo-radiotherapy treatment, unlike those involved in the Pacific study, in which selection included the execution of chemo-radiotherapy only concurrently. Additionally, Pacific R anticipated durvalumab therapy to commence within 90 days of terminating radiotherapy, while in Pacific a maximum interval of 42 days was contemplated. “Although the work in ‘real life’ confirms the activity of durvalumab even in a diversified population and not completely overlapping with that enrolled in the registration study – clarifies Signorelli – it is important that in the clinical setting, when possible, the criteria provided for by the Therefore, concomitant chemo-radiotherapy treatment is preferred over sequential and durvalumab is administered within 42 days of the end of radiotherapy. In addition, in the pivotal study, the effectiveness of the drug was even greater for patients who had been able to start immunotherapy within 14 days from the end of the radiation treatment “.
Molecular diagnosis: this is how lung cancer treatment changes
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The importance of multidisciplinarity
One aspect on which the Pacific study invites reflection is the need for patients with locally advanced lung cancer to be evaluated from diagnosis within a multidisciplinary team. “Alongside the oncologist – concludes Diego Signorelli – the presence of figures such as the thoracic surgeon, the radiotherapist, the radiologist, the nuclear doctor, the pulmonologist and the pathologist is central. Multidisciplinarity has improved the treatment of patients with lung cancer and, especially in locally advanced disease, it is essential to guarantee the best treatment path. One possibility is also to take advantage of the important tools used during the pandemic, resorting to telemedicine where not all the specialists involved are present in the single center “.
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