Influence of the toxicity from induction treatment with immunotherapy in the surgical rescue of patients with NSCLC in N2: a multicenter cohort prospective study
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Background: Lung cancer is one of the leading causes of death in the world. Thanks to scientific
progress, immunotherapy has now begun to be studied as a neoadjuvant treatment for patients
with advanced-stage non-small cell lung cancer.
Nowadays, it is being seen that immunotherapy will be the future treatment for this type of
patient. That is why it will be necessary to know what side effects are produced by the treatment
of IT (Immunotherapy) as the only therapy, in those patients who are candidates to receive a
surgical rescue after the neoadjuvant treatment and therefore be able to know what we will
face.
So far, it is important to know the immunotherapy in all its possible aspects, if we manage to
know all the side effects produced and all the possible post-surgery comorbidities, we will have
the necessary information to develop the appropriate tools to prevent everything that can
negatively influence the subsequent surgical rescue of these patients.
Objective: The main objective of this study is to establish which side effects produced by
neoadjuvant immunotherapy have an influence on the surgical rescue of patients with stage N2
(nodal extent) non-small cell lung carcinoma regardless of their T (tumor extent).
Design: A prospective multicenter cohort will be conducted. Patients with a lung carcinoma
(adenocarcinoma or squamous cell carcinoma) with an N2 extension regardless of the size of
their T and M0 (distant metastasis), according to the TNM classification, will be introduced in
this study to be carried out in the following university hospitals: Dr. Josep Trueta Hospital,
Bellvitge Hospital of Barcelona and Vall d’Hebron Hospital.
Outcomes: Our variable of interest, is the occurrence of toxicity due to treatment with
neoadjuvant immunotherapy, of patients with a potentially resectable lung carcinoma. It will be
analyzed as a nominal dichotomous qualitative variable
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