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R.E. Sanborn
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MA 07 - ALK, ROS and HER2 (ID 673)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:Robert C. Doebele, J.C. Ho
- Coordinates: 10/17/2017, 15:45 - 17:30, Room 316
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MA 07.02 - Response to Ensartinib in TKI Naïve ALK+ NSCLC Patients (ID 10247)
15:45 - 17:30 | Author(s): R.E. Sanborn
- Abstract
- Presentation
Background:
Ensartinib is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1, and SLK. Ensartinib has demonstrated significant anti-tumor activity in both ALK TKI-naïve and crizotinib-resistant NSCLC patients. We report on data from ALK TKI treatment naïve patients.
Method:
Pts with advanced solid tumors and ECOG PS 0-1 were treated with ensartinib 225 mg qd on a continuous 28-day schedule. In expansion phase, pts were required to have measurable ALK+ NSCLC with tissue confirmed centrally via FISH or IHC. Asymptomatic brain metastases were allowed. Targeted NGS of cfDNA was performed retrospectively at baseline and on study and compared with tissue results.
Result:
As of 01Apr2017, 102 pts enrolled. In the ALK TKI naïve cohort, 15 (8 female, 7 male) ALK+ NSCLC pts treated at doses ≥ 200 mg evaluable for response. 4 pts had received prior chemotherapy. Median age 59 (34-80) yrs, 60% had ECOG PS 1. Partial response (PR) achieved in 13 pts (87%). Six pts had ALK detected via plasma NGS. In two patients who did not respond to ensartinib, tissue was positive via FISH and plasma was negative. Seven patients had insufficient plasma for NGS evaluation. Median PFS in the initial 13 evaluable ALK+ pts was 25.6 mos with the longest being 44+ mos. The PFS for all patients is still maturing. In 3 pts with central nervous system (CNS) target lesions and no prior radiation, 1 had a complete response (CR) and 2 had PR for an ORR of 100%. Most common drug-related AEs (>20% of pts) included rash (54%), nausea (34%), pruritus (26%), vomiting (25%), and fatigue (21%). Most AEs were Grade (G) 1-2. Most common G3 tx-related AE was rash (12 pts).
Conclusion:
Ensartinib was well-tolerated and induced responses in ALK TKI naïve ALK+ NSCLC pts, including pts with CNS lesions. Enrollment is ongoing in the phase 3 study of ensartinib vs. crizotinib in ALK TKI naïve NSCLC patients.
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MA 10 - Immunotherapy I (ID 664)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:S. Wang, Robert Pirker
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 303 + 304
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MA 10.05 - Improved Outcome for Immune Checkpoint Inhibitors (ICI) in Patients Previously Treated with Bavituximab in the SUNRISE Trial (ID 8684)
11:00 - 12:30 | Author(s): R.E. Sanborn
- Abstract
- Presentation
Background:
Bavituximab targets exposed phosphatidylserine (PS) in the tumor microenvironment, resulting in repolarization of myeloid suppressor cells/M2 macrophages to M1, production of pro-inflammatory cytokines such as IFNγ and IL-12, dendritic cell maturation, and tumor specific cytotoxic T-cell activation. SUNRISE was a Phase III trial of docetaxel with bavituximab (D+B) or placebo (D+P) in patients with treated Stage IIIb/IV non-squamous NSCLC. Recent correlative analyses from SUNRISE suggest bavituximab is more active in PD-L1 negative, immune cold tumors and thus may complement PD-1/PD-L1 ICI.
Method:
This subgroup analysis included all patients who received subsequent ICI after discontinuing SUNRISE study drug. We calculated overall survival (OS) both from randomization and start of subsequent ICI.
Result:
Ninety-three of 597 randomized patients (16%) received ICI as next line of therapy after SUNRISE assigned treatment. Baseline characteristics were balanced between the treatment groups and consistent with the ITT population. From randomization, mOS was not reached (95% confidence interval [CI], 15.2-NA) in D+B (N=46) and 12.6 months (95% CI, 10.4-17.8) in D+P (N=47) (hazard ratio [HR], 0.46; P=0.006) (Figure). From start of ICI, mOS was not reached (95% CI, 10.2-NA) in D+B and 6.2 months (95% CI, 3.9-8.7) in D+P (HR, 0.42; P=0.002). The mPFS was 6.0 months (95% CI, 3.5-6.5) in D+B and 4.4 months (95% CI, 2.6-6.3) in D+P (HR, 1.00; P=0.991). ORR was 20% vs. 13% (Odds ratio 0.6; P=0.41) for D+B and D+P, respectively. The safety profile was similar between groups and no immune related (IR) toxicities (colitis, pneumonitis, hypothyroidism) were reported.
Conclusion:
Within the limits of a subgroup analysis, a significant improvement in OS was observed for patients previously treated with D+B. Furthermore, bavituximab has not been associated with IR toxicities and might serve as a useful drug in combination with ICI for the treatment of immune cold tumors. Figure 1
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P1.07 - Immunology and Immunotherapy (ID 693)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.07-019 - Immune Cell Infiltrates in Non-Small Cell Lung Cancer and Interleukin-22 Expression (ID 9238)
09:30 - 16:00 | Author(s): R.E. Sanborn
- Abstract
Background:
In non-small cell lung cancer (NSCLC) the TNM staging remains standard for prognostic assessment and therapy decisions. Nevertheless, stage-specific outcomes vary significantly, indicating a need for additional prognosticators.Lymphocytic infiltrates are found in 6-11% of NSCLC patients and associated with a significant increase in disease-free and overall survival (OS). We now want to assess T cells and PD-L1[+] cells in tissue microarrays (TMAs) cored at the invasive margin (IM) and tumor center (CT) via multispectral imaging. We asked the question of their link to interleukin-22 (IL-22). Furthermore, we want to elucidate the role of IL-22 in prognosis, therapy response and recurrence.
Method:
TMAs were generated from formalin-fixed paraffin embedded tissue of 89 curatively resected patients with stage IA-IIIA NSCLC. TMAs included each 3 cores from CT and IM, selected from areas with the most dense lymphocytic infiltrates. Immunolabelling followed mIHC technique for PD-L1, CD8, CD3, FoxP3, CD163 and Cytokeratin. IL-22 expression was analyzed by immunohistochemistry (double-staining: IL-22, CD3).
Result:
We could show that the ratio of CD8[+] cells in CT compared to IM is significantly higher in stage I than stage II/III NSCLC. A similar pattern was seen for CD3[+], but not for ratios of PD-L1[+], FoxP3[+] or CD163[+]. Based on the CT/IM ratios of CD8[+] and PD-L1[+] we established an 'Invasive Score' ranging from 0–2. A Score of 0 (low CD8, low PD-L1) had a median OS of 45 months. A score of 1 (high CD8 or PD-L1) had a median OS of 53 months. A score of 2 (high CD8 and PD-L1) had a 62% survival rate at 72-months: Combining the rate of CD8 T cell infiltrates with PD-L1 positivity in the tumor is a stronger predictor for survival than one based only on CD8 CT/IM ratio. We will now combine these results with the IL-22 expression and present the respective progression free and OS data.
Conclusion:
Multispectral assessment of CD8 and PD-L1 performed on “hot-spots” NSCLC does show a clear correlation with clinical outcome: A tumor-controlling immune response appears to be associated with the permeability of the tumor to CD8 cells. This is consistent with other reports that immune infiltrates are associated with improved outcome. Current studies are seeking to verify these findings in a larger cohort of patients with NSCLC. *Authors Stump and Reu contributed equally to this study. Supported by the Harder Family, Lynn and Jack Loacker, Robert W. Franz, Wes and Nancy Lematta, the Murdock Trust and Providence Medical Foundation.
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P2.13 - Radiology/Staging/Screening (ID 714)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.13-009 - Results of Low-Dose CT Lung Cancer Screening at a Non-University Tertiary Hospital System in Oregon, USA (ID 9398)
09:30 - 16:00 | Author(s): R.E. Sanborn
- Abstract
Background:
Since the National Lung Screening Trial (NLST), doubt has been expressed as to whether the results could be replicated in a community setting. We aim to document our experience over 3.5 years and over 3000 CT scans.
Method:
The Providence Cancer Center in Portland Oregon initiated a lung cancer screening program in 2013 that included 7 hospitals (2 non-university tertiary medical centers and 5 community hospitals). Lung cancer screening candidates were referred by primary care providers from Noverember 2013 through May 2017. Candidates were screened using NLST criteria. Initially, shared decision making was provided by the team, but in 2015 transitioned to the PCP. Dedicated radiologists at the tertiary centers read all CTs and assigned Lung-RADS assessment categories. All Lung-RADS category 4 scans were reviewed by a multidisciplinary team of thoracic surgery, pulmonary, radiology and oncology to generate management recommendations. The navigator recorded all imaging, procedures, pathology, staging and complications. This individual ensured follow-up scans were completed.
Result:
2983 patients were referred. 353 were not eligible and 529 declined participation. 1950 underwent initial CT screening. 178 were presented at the multidisciplinary conference. Additional imaging included 1160 follow CT scans and 75 PET scans. Invasive diagnostic procedures included bronchoscopy (27) and CT-guided biopsy (19). Thoracic surgical procedures included pneumonectomy (1); lobectomy (21); segmentectomy or wedge resection (10). 55 cancers were diagnosed. 40 non-small cell lung cancers were found including 26 stage I; 5 stage II; 4 stage III and 5 stage IV. 6 small cell lung cancers were diagnosed including limited stage (3) and extensive stage (3). Lung cancer rate was 2.4%. 9 extra-thoracic malignancies were diagnosed including thyroid, renal cell (4), breast, colon, liver and prostate. The intervention rate was 5.6% with 46 major procedures (surgery) and 64 minor procedures (bronchoscopy, CT-guided biopsy, EUS, EGD). Adverse event rate was low and included pneumothorax (8) with 4 requiring chest tube, intra-operative bleeding requiring thoracotomy (1) and post-operative bleeding requiring repeat thoracoscopy (1). There was one death in a post-operative lobectomy patient.
Conclusion:
Low-dose CT screening for lung cancer can be done with low intervention and complication rates in a non-university setting using a systematic, multidisciplinary approach. This large group of screened patients demonstrates a stage shift toward early stage lung cancers with complication rates approximating those of the NLST. Our data contradict the argument that lung cancer screening cannot be done successfully and safely in the community.
