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Bertrand Routy
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MA08 - Clinical Trials in Brain Metastases (ID 906)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
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MA08.11 - Early Safety Data of a Phase I/II Combining Nivolumab and Stereotactic Brain Radiosurgery for Treatment of Brain Metastases in Patients with NSCLC (ID 14064)
16:20 - 16:25 | Author(s): Bertrand Routy
- Abstract
- Presentation
Background
Radiotherapy can stimulate the immune system through various means. Highly cytotoxic stereotactic radiosurgery (SRS) doses (>10Gy per fraction) may synergize with anti-PD1 to reduce intracranial disease progression or recurrence.
a9ded1e5ce5d75814730bb4caaf49419 Method
Within a phase I/II trial evaluating the combination of nivolumab with SRS in the treatment of brain metastases from NSCLC and RCC (NCT02978404), 8 patients were enrolled (1 RCC and 7 NSCLC) in the first trial cohort. Herein, only the NSCLC cases are reviewed. Patients were eligible if their KPS ≥70, were minimally symptomatic (RTOG neurological function <2), and had ≤10cc of untreated brain metastases. Prophylactic corticosteroids were not given. Nivolumab (240mg IV q2 weeks) was started 2 weeks prior to SRS, and administered until RECIST progression. SRS (15-20Gy in 1 fraction) was given to each brain metastasis. The aim of the first patient cohort is to estimate the tolerability of the combined treatment strategy.
4c3880bb027f159e801041b1021e88e8 Result
The median follow-up of the three male and four female patients was 2 months. Median age was 63 years (55-84 years). Five NSCLC patients completed ≥1 cycle of nivolumab and SRS, and were evaluated for tolerability of the combination. One patient elected to withdraw before the first nivolumab dose and 1 patient died prior to SRS. Median baseline brain edema and total brain metastases volumes were 0.5cc (0-46.97cc) and 1.25 cc (0.1-3.46cc), respectively. To date, the median number of nivolumab cycles administered is 4.5 (1-15). Intracranial adverse effects were limited to apraxia and paresthesias in the patient who had the largest volume of peri-tumoral brain edema at baseline (46.97cc). Nivolumab was held and dexamethasone was given for 74 days at doses >1mg/day until neurological symptoms resolved. Systemic adverse events included one patient with grade 2 arthritis necessitating a 6-week treatment delay and 51 days of prednisone ≥10mg. At last follow-up, three patients had died of extracranial disease progression, including the two patients who did not receive protocol SRS. Among the three patients evaluable for intracranial response, there was one partial response and two stable diseases. All three patients had stable extracranial disease.
8eea62084ca7e541d918e823422bd82e Conclusion
Combining SRS and immunotherapy is safe in regards to acute toxicity with a manageable side effect profile. Close monitoring may be required for patients with significant baseline brain edema. Evaluation for efficacy awaits further follow-up and completion of recruitment in the phase 2 component of the trial.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MA10 - Considerations in Immunotherapy / Real World (ID 911)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 10:30 - 12:00, Room 105
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MA10.04 - Discussant - MA 10.01, MA 10.02, MA 10.03 (ID 14611)
10:45 - 11:00 | Presenting Author(s): Bertrand Routy
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P3.08 - Oligometastatic NSCLC (Not CME Accredited Session) (ID 974)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.08-16 - Prognostic Value of PDL-1 Expression and Correlation Between Primary Tissue and Brain Metastases in Oligometastatic NSCLC (ID 13582)
12:00 - 13:30 | Author(s): Bertrand Routy
- Abstract
Background
Immunotherapy with anti-PD-1/PDL-1 agents in first-line metastatic non-small cell lung cancer (NSCLC) is chosen based on tumor cell PDL-1 expression. However, the incidence and prognostic value of PDL-1 expression in NSCLC patients with oligometastatic brain disease has never been characterized.
a9ded1e5ce5d75814730bb4caaf49419 Method
We retrospectively analyzed in our SARDO clinical database NSCLC patients with only 1-3 brain metastases (oligometastastic) treated in our University Health Care Center CHUM from 2007-2014. Samples were stained with SP263 (Ventana) antibody against PDL-1. A membranous staining of >25% was considered positive, and scoring was performed by an experienced pathologist. Kaplan-Meier survival curves of all clinical data were performed in SPSS 25.
4c3880bb027f159e801041b1021e88e8 Result
In our cohort of 39 oligometastatic NSCLC patients treated before 2014, none received immunotherapy. A total of 49 specimens (biopsy or surgical) from either the primary or metastatic site were adequate and included in the study. In 10 cases, both primary and metastatic tissue were available for correlation. Overall PDL-1 positivity was 40.8% (20/49), with a positivity of 54.5% (12/22) in primary site samples and 29.6% (8/27) in metastatic brain tissue. Correlation of PDL-1 status between primary and metastatic site in a sub-group of 10 patients was 80% (8/10). Median overall survival (mOS) was significantly shorter for PDL-1 positive patients (8 mos) compared to PDL-1 negative patients (20 mos, p=0.05). 59% (23/39) of patients were aggressively treated for the primary tumor, and 86% (31/39) were aggressively treated for metastatic brain disease. When we controlled for treatment aggressivity of the primary tumor, mOS of PDL-1 positive patients treated aggressively was significantly shorter than mOS of PDL-1 negative patients treated aggressively (15 vs 22 mos, p=0.046). When the primary lung tumor was not addressed aggressively, mOS was the same regardless of the PDL-1 status (4 vs 4 mos). Median progression free survival (mPFS) tended to be longer in PDL-1 positive patients (6.0 vs 9.8 mos, p=0.254).
8eea62084ca7e541d918e823422bd82e Conclusion
PDL-1 status is concordant between primary and metastatic tissue in 80% of cases. PDL-1 expression is an adverse prognostic factor in NSCLC patients with oligometastatic brain disease, despite treating the patients aggressively for their primary lung cancer and their brain metastasis. In the future, giving early PD1/PDL-1 to oligometastatic PDL-1 positive NSCLC patients could significantly improve their outcome.
6f8b794f3246b0c1e1780bb4d4d5dc53
