Lung Cancer Study Group

Clinical Trials in Lung Cancer. What is the situation in Portugal?

Do you know what a clinical trial is and what are the benefits of this type of study? Are you aware of Portugal’s participation in clinical trials in the area of ​​lung cancer?

We spoke with Dr. Fernanda Estevinho, oncologist at Hospital Pedro Hispano – Local Health Unit of Matosinhos and member of the GECP Scientific Committee, to help us highlight the important role of clinical trials at various levels and to take stock of the participation of our hospitals and centres, leaving some advice on how to monitor recruitment for these studies.

1 – What is the importance of clinical trials specifically in the area of ​​lung cancer?

Clinical trials are clinical trials involving drug intervention, and these play a key role in the development of new therapeutic options.

When we talk about an aggressive tumor such as lung cancer, it is essential to develop treatments that are increasingly targeted, more effective, associated with greater survival and symptom control, with better tolerance profiles and improved quality of life.

Basic and translational research will be the basis for identifying therapies to be studied in clinical trials, from phase I to IV. During the design and implementation of clinical trials, there is a rigorous monitoring of the entire process, and the principles of good clinical practice are followed in order to optimize benefits and reduce risks.

The benefits are reflected, from the outset, at the individual level, in the patient who has the possibility of performing an effective and innovative drug in a clinical trial; and at the population level, leading to changes in international and national guidelines, and consequently to the availability of drugs in clinical practice.

We can focus on this second point when we talk about the benefits that some clinical trials have shown: the combination of cisplatin with pemetrexed, studied in non-squamous non-small cell cancers, revealed a 19% reduction in mortality, the first therapies aimed at patients with lung cancer EGFR mutation and metastasis increased the response rate from 47% to 71%, immunotherapy as monotherapy, in patients with advanced non-small cell lung cancer, first-line increased overall survival with an HR of 66%, observing- that overall survival at 5 years has doubled. Fortunately, there have been many other therapeutic options that have recently shown benefits, and this has only been possible due to clinical trials. It should be noted that the first patients to benefit from this innovation are those who participated in them.

2 – What is your assessment of Portugal’s participation in recent years in clinical trials in the area of ​​thoracic tumors? How can we improve in this area?

We have a rich history of conducting investigator-initiated national clinical trials, such as the COIMBRA clinical trial, MUTAR, other clinical trials that studied different drug combinations, different drug delivery methods, or the number of cycles. Currently, in addition to international clinical trials, we also observe the development of some national clinical trials, at the initiative of the investigator.

However, considering the needs of our patients, the availability of clinical trials is less than desired, being lower than the offer in other countries with a history of high recruitment, such as Spain. Thus, by way of example, in Portugal, in February 2022, approximately 16 clinical trials are being recruited, and in Spain approximately 184.

This need is felt at a national level, as revealed by the survey carried out by the GECP in 2020, in which 77.1% of physicians who responded to the questionnaire stated that they would like to have a greater number of clinical trials.

As doctors, we aim to give the best treatment to each patient, with greater efficiency and improved quality of life. This search for the best therapeutic option, in many situations, and as I mentioned in the previous question, involves the search for clinical trials. In some situations, there are clinical trials with targeted and promising therapeutic options, which are not available in Portugal, with the possibility of patient displacement, with all associated inconveniences. Also within the country, this trip to a center that has a clinical trial may, after evaluation with the assistant physician, be the best option. We look forward to a future with more clinical trials and more and better therapeutic options.

3) How can local centers monitor ongoing clinical trials recruitment? What advice do you give your peers?

There are several ways to monitor and increase recruitment, from checking the inclusion criteria in group consultations to dissemination by other centres.

One of the main pieces of advice is to publicize the existence of trials through the various platforms available, for example the GECP website, as well as the centers and researchers. The mobility of patients from one center to another can allow the patient to have access to a new therapeutic option.

A second piece of advice is to create local research centers, whenever they do not exist, and to hold periodic meetings in order to monitor ongoing trials, proactively looking for new trials to initiate recruitment.

4) What, from your point of view, are the advantages of participating in clinical trials for centers, from a micro perspective, and for the country, from a more macro perspective?

If at the individual level there can be benefits such as access to new therapies, in the national context if we present a good recruitment, we will undoubtedly have more possibilities of being able to bring other clinical trials. Many of us have had the experience of finding the perfect clinical trial for our patient and that patient is only recruiting on another continent…

Likewise, worldwide, it will have the benefit of accelerating research in this area of ​​pathology, with the development of better therapeutic options in terms of survival or quality of life.

5) Do you want to leave a final comment on the role of GECP in this field?

GECP celebrated in 2021, 21 years of existence.

These are years of intense activity in the field of research, from clinical trials initiated by the researcher to real-life studies, supporting training, fostering multidisciplinarity and inter-institutional collaboration.

Clinical trials have played and will continue to play a key role in the therapeutic evolution, feeding on research and leading to the development and approval of more effective treatments that allow for a better quality of life.

In the year 2022 and beyond, we want to continue to grow hair and for our patients!

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