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Marco Perna
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EP1.04 - Immuno-oncology (ID 194)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.04-02 - Predictors of Lung Toxicity in First Line Pembrolizumb for Advanced NSCLC: An Interim Analysis of PRELUTOX Study (ID 1951)
08:00 - 18:00 | Author(s): Marco Perna
- Abstract
Background
Pembrolizumab, an anti-PD–1 antibody, is an immuno-checkpoint inhibitor (ICI) approved for advanced disease in frontline setting if PDL1 is ≥ 50%, in second line if PDL1 is >1%. ICIs are associated with immune-related adverse events (irAE), including pneumonitis or interstitial lung disease (ICI–ILD): the mechanisms that lead to irAE are not entirely known. Clinical trials found an incidence of ICI–ILD of 3 to 5% but in recent studies it is greater, with fatal cases described. Reports about real incidence, risk factors, features of pneumonitis are still few. We designed a prospective observational study in this setting of patients in order to predict pulmonary toxicity by clinical -radiological and respiratory functional variables.
Method
PRELUTOX is a prospective observational study. Our purpose is to enroll at least 50 patients in 2 years. Inclusion criteria: locally advanced or metastatic NSCLC whit PD-L1 expression ≥ 50%, with no EGFR or ALK-ROS1 mutations. Exclusion criteria: previous chemotherapy or thoracic radiotherapy; active infections or systemic autoimmune disease; interstitial lung diseases; prior pneumonitis requiring systemic steroids; immunosuppressive or corticosteroid treatment; renal or hepatic failure. Aims of our study: incidence of ICI – ILD; features of all patients including pulmonary function and comorbidities, especially the respiratory ones; features of patients who develop pneumonitis with greater attention to the HRCT pattern. Patients perform therapy and radiological exams according to routine clinical practice; pulmonary function tests (PFTs) at the beginning of Pembrolizumab and every three months
Result
This is an interim analysis. 33 patients have been recruited from May 2018 to March 2019. Patients characteristics are summarized in table 1.
ILD occurred in one patient with thoracic massive involvement (incidence 3%) with an HRCT pattern of organizing pneumonia. He presented progressive worsening of the obstructive ventilatory defect and drastic reduction of diffusing capacity, associated with severe hypoxemia
Conclusion
In literature incidence of ICI-ILD seems to be higher for NSCLC compared with other cancers: this may be related to the underlying lung status (exposure to tobacco, COPD and the thoracic tumor burden). PFTs have been described in several studies for their capacity to predict lung toxicity. In our preliminary data, during Pembrolizumab therapy, if toxicity does not occur, airways obstruction parameters and lung volumes seem to remain constant and related to the respiratory comorbidity (COPD). The same appears for diffusing capacity. Finally we suppose that the thoracic tumor burden could be related to the risk of lung toxicity but the study is still ongoing.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-41 - Immunotherapy Concomitant to Radiotherapy: A Multicentric Retrospective Study on 179 Patients with Advanced Non-Small Cell Lung Cancer (Now Available) (ID 647)
09:45 - 18:00 | Author(s): Marco Perna
- Abstract
Background
Immunotherapy (IT) has enhanced the treatment armamentarium for aNSCLC. Radiobiological studies and initial clinical reports suggest a potential synergistic effect of radiotherapy (RT) and IT. Aim of the study is to investigate the safety of cytoreductive RT (palliative or ablative) delivered in association with Nivolumab (NIVO), Pembrolizumab (PEM) or Atezolizumab (ATE) in aNSCLC setting.
Method
We analyzed 179 consecutive pts affected by aNSCLC treated with a combination of RT and IT with NIVO/PEM or ATE from January 2015 to February 2019. One hundred eighteen patients were male and 61 female. Mean age was 65 (range 38-81). Adenocarcinoma was diagnosed in 101 of patients, while squamous cell carcinoma constituted 43.6% of our population. Eleven patients received IT as first line therapy, while the other 168 pts received at least a first line of systemic therapy before IT. One hundred thirty patients received NIVO, 42 PEM and 7 ATE. Concerning RT, 109 patients were treated before first cycle of IT (within 40 days), 49 pts during IT and the remaining 21 received RT immediately after the last IT session (within 40 days) due to disease progression (DP).
Result
After a mean follow up (FUP) of 24.1 months (range 3-142), 63/179 patients were still alive. During FUP 115 patients (62.4%) experienced DP after RT-IT. One and 3-year Overall Survival were 60.3%±3.8%SE and 26,7%±4,5%SE, respectively. RT was delivered in 96 cases to bone metastasis, in 49 to brain mts, in 11 to lung nodules, in 12 to lymph nodes, in 6 to surrenalic gland and in 5 pts to other sites. RT was delivered to 109 patients as a pure palliative treatment (8-36 Gy in 1-12 fractions), to 49 pts using stereotactic ablative doses (18-54 Gy in 1-5 fractions) and to 21 with high dose moderately-hypofractionated schedules(24-51 Gy in 3-17 fractions) . In 107 patients, RT was planned using a 3D conformal approach, while in 72 an inverse planning system was used (IMRT/VMAT/Tomotherapy). Mean number of IT administrations was 11 (2-58). No patient had an interrumption of systemic therapies during or after RT. Severe acute toxicities (Grade 3 by 4.0 CTCAE scale) were reported only in three cases because of the RT treatment: 1 case of radiodermitis and two lung toxicities. Known systemic side effects from IT were observed in 44 pts, 12 of whom with ≥G3 : 6 pneumonitis, 3 colitis, 2 thyroid toxicities, 1 oesophageal toxicity, 1 pt asthenia.
Conclusion
RT and IT with checkpoint inhibitor NIVO/PEM/ATE represent a safe, well tolerated and efficient multimodal treatment in aNSCLC, with the available data suggesting also potential, synergistic effects on local and systemic disease in aNSCLC pts even when non-radical RT doses are prescribed. Ongoing studies set out to understand the optimal timing, RT doses and ideal combination between RT and IT in aNSCLC.
