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JCSE01 - Joint IASLC-CSCO-CAALC Session (ID 63)
- Event: WCLC 2019
- Type: Joint IASLC-CSCO-CAALC Session
- Presentations: 1
- Now Available
- Moderators:Chunxue Bai, Tony Mok, Yi-Long Wu, Qing Zhou, Nan Wu
- Coordinates: 9/07/2019, 07:00 - 11:15, Toronto (1985)
JCSE01.11 - Efficacy and Safety of Sintilimab with Anlotinib as First-Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) (Now Available) (ID 3425)
07:00 - 11:15 | Author(s): Wei Zhang
Given the synergy effect of immunotherapy and anti-angiogenic therapy in advanced NSCLC, FDA approved atezolizumab plus bevacizumab and chemotherapy as first-line treatment. However, chemo-free first-line strategy of PD-1/PD-L1 inhibitor combining angiogenesis modulator remains to be explored. This is the first trial evaluating sintilimab (anti-PD-1) plus anlotinib (multi-target TKI against tumor angiogenesis and proliferation) in treatment-naive advanced NSCLC patients and is one arm of Phase I anlotinib-based trial (NCT03628521).
Treatment-naive, stage IIIB/IV NSCLC patients aged 18-75 with ECOG PS 0-1 were eligible. Patients with EGFR, ALK or ROS1 mutations were excluded. Participants were given intravenous sintilimab (200mg q3w) and oral anlotinib (12mg/d 2 weeks on/1 week off) until progression or unacceptable toxicity. The primary endpoints were ORR and safety. The secondary endpoints included DCR, PFS and OS. AEs were graded according to CTCAE v4.0.
From September-2018 to February-2019, 22 patients were enrolled. Most were male (95.5%), former/current smokers (63.6%) and squamous cell histology (54.5%). 4 had baseline brain metastases. All patients have received at least once tumor assessment as of Jul-3th-2019. Among all, 16 achieved confirmed PR, 6 achieved SD, ORR was 72.7% (49.8%, 89.3%) and DCR was 100% (84.6%, 100%). 6 month PFS rate is 93.8% (95%CI: 63.23%, 99.10%). Overall, sintilimab and anlotinib was well tolerated. 6 (27.3%) had grade 3 and above treatment related adverse event (TRAE). The most common TRAE included fecal occult blood, hyperuricemia, hyponatremia, foot-hand syndrome, etc. 21 patients had baseline PD-L1-evaluated and 18 patients got TMB status (details in table). Notably, 5 of 6 SD patients developed cavities inside, suggesting a synergetic anti-tumor effect from combination regimen.
ConclusionIn this interim analysis, sintilimab plus anlotinib showed high ORR (72.7%) and DCR (100%) with tolerable safety profile, supporting worthy of further development from this convenient chemo-free regimen in first line setting.
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P1.17 - Treatment of Early Stage/Localized Disease (ID 188)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
P1.17-05 - What Is the Optimal Number of Examined Lymph Node in Stage IA Non-Small Cell Lung Cancer? (ID 681)
09:45 - 18:00 | Author(s): Wei Zhang
1.To find out the optimal number of examined lymph nodes (ELNs) in stage IA non-small cell lung cancer (NSCLC). 2.To figure out whether there was a turning point beyond which ELNs might have adverse effects on survival.Method
Using the Surveillance, Epidemiology, and End Results registry (SEER) database, we selected all NSCLC patients diagnosed with stage IA (T1N0M0) from 1995 to 2015. Cases from 1995 to 2005 were as analytical data set (group 1) and those from 2006-2015 as validation data set (group 2).The overall survival (OS) of patients with different ELNs was compared statistically by SPSS. The optimal cut point of ELNs was calculated by X-Tile and verified by univariable and multivariable analyses. Propensity score matching (PSM) was done by R software 3.5.2.Result
In total, we extracted 57481 stage IA NSCLC patients (group 1, n = 20814; group 2, n = 36667). The PSM of Group 1 and Group 2 were balanced based on sex, age and race. In both groups, we divided patients into 3 subgroups, recorded as ELN = 0, 1≤ ELNs < n and ELNs≥ n. ELN = 0 had the highest risk of death in each subgroup (all p < 0.001). From n = 6 to n = 16, OS was significantly different between 1 ≤ ELNs < n, and ELNs ≥ n. But from n = 17 to n = 30, OS was the same between 1 ≤ ELNs < n and ELNs ≥ n. When dividing patients into ELNs = 0, 1-2, 3-5, 6-9, 10-29, ≥ 30,serial improvement in OS was seen with increasing ELNs, up to ELNs = 6-9, and beyond which there was little further incremental survival benefit. The survival curve of ELNs ≥ 30 even had an obvious trend to drop down.Conclusion
For stage IA NSCLC, we suggested resecting 6-9 LNs was enough, and no more than 16 LNs. More than 16 ELNs did not improve survival and more than 30 ELNs might have a detrimental effect on survival.