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Ivana G. Sullivan
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-111 - ATEZO-BRAIN, A Single-Arm Phase II Study of Atezolizumab Combined with Chemotherapy in Stage IV NSCLC Patients with Untreated Brain Metastases (ID 733)
09:45 - 18:00 | Author(s): Ivana G. Sullivan
- Abstract
Background
Brain metastases (BM) are a frequent complication in non-small cell lung cancer (NSCLC), have significant impact on quality of life and are associated with poor prognosis. Systemic therapies might be an alternative approach to whole brain radiotherapy (WBRT) to avoid cognitive-related adverse events. Immune checkpoint inhibitors (ICI) showed intracranial activity in advanced NSCLC patients with BM. However clinical data about efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy in patients with untreated BM are limited and further research in this setting is needed. We hypothesize that addition of ICI to conventional platinum-based chemotherapy may increase intracranial tumor response and provide clinically relevant benefit in terms of PFS, OS and quality of life to the patients with asymptomatic and non-previously treated BM.
Method
This is an ongoing multicenter, open-label, single-arm phase 2 study (EUDRACT: 2017-005154-11) to evaluate the efficacy and safety of atezolizumab 1200 mg combined with 4-6 cycles of carboplatin AUC 5 and pemetrexed 500mg/m2 every 3 weeks followed by maintenance with atezolizumab 1200 mg plus pemetrexed 500mg/m2 every 3 weeks in stage IV non-squamous NSCLC patients with untreated synchronous BM. Patients should have multiple and measurable BM, adequate performance status and organic function, do not harbor EGFR or ALK genomic alterations, be treatment naïve and do not have any contraindication to receive immunotherapy. Exclusion criteria consist of active neurological symptoms, dexamethasone dose ≥ 4 mg QD, prior treatment with brain radiotherapy, presence of leptomeningeal carcinomatosis, spinal or hemorrhagic metastases in the central nervous system. Primary endpoints are progression-free survival (PFS) at 12 weeks according to RANO-BM and RECIST v1.1 criteria and safety based on CTCAE v4. Both primary endpoints will be assessed in 40 patients in 15 sites using a Bayesian approach. Patients will undergo tumor assessments by body CT scan and brain MRI at baseline every 6 weeks for the first 12 weeks and thereafter tumor assessments will be performed every 9 weeks until disease progression or loss of clinical benefit. Secondary endpoints: intracranial and systemic objective response rate and duration of response. Exploratory endpoints: to assess neurocognitive function and quality of life; to determine time to neurological deterioration and time to need of salvage brain radiotherapy. Enrollment started on August 2018 and currently 12 patients have been included in the study.
Result
Clinical trial in progress
Conclusion
Clinical trial in progress
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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
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-19 - Association Between Efficacy and irAEs in Patients with Advanced Non-Small Cell Lung Cancer Receiving Immune-Checkpoint Inhibitors (ID 2020)
09:45 - 18:00 | Author(s): Ivana G. Sullivan
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard treatment in advanced non-small cell lung cancer (NSCLC). They can induce immune-related adverse events (irAEs) that may compromise treatment continuation.
We report our experience in advanced NSCLC patients receiving ICIs, the incidence of irAEs and its correlation with efficacy.
Method
267 patients with advanced NSCLC receiving ICIs in two Spanish institutions from March 2013 to August 2018 were analyzed. IrAEs were graded following CTCAE v4.0. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS) using landmark analysis.
Result
Median age was 66.1 years [26-85], 70% were male. 86 (32%) patients presented squamous and 181 (68%) non-squamous histology. Most frequent ICIs were nivolumab (44%), pembrolizumab (26%) and atezolizumab (17%), used as monotherapy (78%), in combination with chemotherapy (12%) or with anti-CTLA4 (9%). 30% patients were treated with ICIs in first line and 70% in second line or beyond. Median duration of treatment was 2.8 months [0.1-56.4].
152 patients (57%) experienced a total of 255 irAEs, and the median number of irAEs/patient was 1 [0-5]. Most frequent irAEs was skin toxicity (34%), followed by diarrhea (16%) and hypothyroidism (11%). 36 patients (14%) presented grade 3-4 irAEs and there were 5 treatment-related deaths: 4 pneumonitis and 1 hepatitis. Patients receiving ICIs in second line or beyond experienced significantly less irAEs (49%) than those treated in first line (74%) (p <0.001).
With a median follow-up time of 8.5 months [0.3-56.4], the landmark analysis showed that PFS was significantly longer in patients with irAEs: 12.4 months (95%CI, 1.9-22.9) vs 4.1 months (95%CI, 2.6-5.6) (p < 0.001). Similarly, OS among patients with irAEs was significantly higher: 28.2 months (95%CI, not calculated) vs 12.5 months (95%CI, 10.8-14.2) (p < 0.001). Disease control rate was significantly better in patients with irAEs: 77% vs 39%, odds ratio 0.20 (95%CI, 0.11-0.34) (p < 0.001). Besides, duration of response was significantly longer: 6.1 months [0.5-50] vs 2.6 months [0.2-51.9] (p < 0.001).
44 patients (17%) discontinued treatment due to toxicity. Within this group, 66% patients did not progress after immunotherapy, in contrast to 29% in the rest of the population (p < 0.001).
Multivariable analysis revealed that cutaneous, endocrinological and reumathological toxicities were significantly associated with increased OS.
Conclusion
The presence of irAEs in advanced NSCLC patients treated with ICIs was associated with better outcomes. Patients who discontinued ICIs due to toxicity showed a higher disease control rate.
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P1.07 - Nursing and Allied Professionals (ID 171)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Nursing and Allied Professionals
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.07-09 - Implementation of a Nursing Program for Cancer Patients Treated with Immunotherapy by an Immunotherapy Nurse Specialist (ID 1367)
09:45 - 18:00 | Author(s): Ivana G. Sullivan
- Abstract
Background
Immunotherapy is one of the fastest-evolving areas of oncology to date including non-small cell lung cancer. Due to their mechanism of action they can produce immune related adverse effects (irAES), in which a coordinated multidisciplinary approach is essential for their management, and immunotherapy nurse practice is rapidly changing achieving an important role as a case manager.
To describe the implementation of a nursing program for cancer patients treated with immunotherapy by an immunotherapy nurse specialist. We present preliminary data that will be updated for the presentation.
Method
Before starting immunotherapy, patients receive health education that includes an explanation of the mechanism of action, prohibited medications, possible side effects and the emergency workup that must be followed in case of occurrence. Additionally, all baseline necessary procedures are revised and concomitant medication is registered. An educational booklet specifically made by the nurse is also given, which also includes the contact information of the nursing consult.
In the follow-up visits, toxicities are identified and graded according to CTCAE v4.0 and the patient's health changes are also summarized. In case of toxicity, the nurse starts the process of referral to the specialist and a close follow-up is carried out. Additionally, virtual follow-up visits and doubts and questions about immunotherapy are also answered.
Result
From August 2018 to April 2019 a total of 703 visits and 270 virtual visits have been done by the immunotherapy nurse specialist. 176 cancer patients have been visited and 100 of them had lung cancer. During this period, it has been necessary to refer patients to the specialist on 71 occasions, mostly to endocrinology, rheumatology, dermatology and pulmonology department.
Conclusion
The implementation of the immunotherapy nursing program has contributed to an improvement of early detection and management of irAEs in cancer patients receiving immunotherapy as well as a greater patient satisfaction along with a reduction of waiting time for the visit with the specialist.
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-52 - Impact of Corticosteroids and Antibiotics on Efficacy of Immune-Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer (ID 2015)
10:15 - 18:15 | Author(s): Ivana G. Sullivan
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard-of-care in advanced non-small cell lung cancer (NSCLC). Corticosteroids are frequently used in symptomatic advanced NSCLC patients, but their immunosuppressive effect may reduce the efficacy of ICIs.
Here we report our experience in patients with NSCLC and the potential impact of on-treatment use of corticosteroids and antibiotics.
Method
Medical records of 267 patients with advanced NSCLC receiving ICIs from March 2013 to August 2018 were reviewed. Corticosteroid usage at the time of initiation or during ICIs treatment and administration of antibiotics from three months before the initiation of ICIs to 3 months after treatment end were collected. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS). A multivariable analysis was performed to study the influence of clinical characteristics on treatment efficacy.
Result
146 patients (55%) received corticosteroids: 63 (43%) for the treatment of irAEs and 83 (57%) for the management of baseline conditions. Prednisone (40%) and dexamethasone (35%) were the most commonly used types of corticosteroids. Median dose of prednisone equivalent was 50mg daily [5-1250mg], 92% patients received ≥10mg of prednisone equivalent daily. Median duration of corticosteroids was 59 days [0.5-83.0].
OS was longer in the group of patients that did not receive corticosteroids or received <10mg prednisone equivalent daily: 14.7 months (95%CI, 11.1-18.3) vs 8.3 months (95%CI, 6.9-9.8) (p = 0.009). No differences in PFS were observed: 4.6 months (95%CI, 2.9-6.3) vs 4.2 months (95%CI, 2.5-5.9) (p = 0.359).
Patients receiving corticosteroids for baseline condition presented shorter median overall survival than the rest of the study population: 6.5 months (95%CI, 4.6-8.3) vs 16.5 months (95%CI, 12.1-20.8) (p <0.001). Multivariable analysis identified corticosteroids usage as an independent variable related to poorer outcomes.
141 patients (52.8%) received antibiotics. Quinolone (37%) and penicillin (33%) were the most commonly used groups of antibiotics. No correlation between the usage of antibiotics and efficacy of ICIs was found, with median OS of 10.2 months (95%CI, 6.4-13.9) vs 12.5 months (95%CI, 9.9-15.0) (p = 0.924).
Conclusion
In our series, corticosteroid use of ≥10mg of prednisone equivalent daily was associated with significantly poorer outcomes, especially when given for baseline condition. No correlation was found between antibiotics and survival. It is important to underline that the use of corticosteroids may simply identify a population with higher volume and aggressive tumors. Prudent use of corticosteroids needs to be warranted.
