Nivolumab for advanced non-small cell lung cancer patients with mild idiopathic interstitial pneumonia: A multicenter, open-label single-arm phase II trial.
Lung Cancer
; 134: 274-278, 2019 08.
Article
in En
| MEDLINE
| ID: mdl-31182249
ABSTRACT
OBJECTIVES:
The efficacy of nivolumab against metastatic non-small cell lung cancer (NSCLC) has been demonstrated; however, pneumonitis is relatively common and is a potentially life-threatening immune-related adverse event. Patients with idiopathic interstitial pneumonia (IIP) have a higher risk of pneumonitis and are generally excluded from clinical trials. Additionally, to date, a multicenter prospective trial for previously-treated NSCLC patients with IIP has not been performed. To fulï¬ll this unmet medical need, we conducted a multicenter, open-label single-arm phase II trial to evaluate the efficacy and safety of nivolumab in NSCLC patients with mild IIP. MATERIALS ANDMETHODS:
Eligible patients had previously-treated, inoperable NSCLC with mild IIPs. Mild IIP was defined as a predicted vital capacity of at least 80% and possible usual interstitial pneumonia (UIP) or inconsistent with UIP pattern by chest high-resolution computed tomography. Primary end point was the 6 months PFS rate and secondary end point was the safety of this therapy.RESULTS:
Eighteen patients were enrolled in this trial. Six months PFS rate was 56%, response rate was 39%, and disease control rate was 72%. There were no treatment-related deaths. One drug-related grade 3/4 nonhematologic event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved by corticosteroid therapy.CONCLUSIONS:
Nivolumab could be an effective therapy for NSCLC patients with mild IIPs.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Carcinoma, Non-Small-Cell Lung
/
Idiopathic Interstitial Pneumonias
/
Antineoplastic Agents, Immunological
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Nivolumab
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Lung Neoplasms
Type of study:
Clinical_trials
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Diagnostic_studies
/
Prognostic_studies
Limits:
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
Lung Cancer
Journal subject:
NEOPLASIAS
Year:
2019
Document type:
Article