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Jie Wang
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EP1.14 - Targeted Therapy (ID 204)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.14-49 - A Phase IIIb Open-Label Study of Afatinib in EGFR TKI-Naïve Patients with EGFRm+ NSCLC: Exploratory Biomarker Analysis (Now Available) (ID 1265)
08:00 - 18:00 | Presenting Author(s): Jie Wang
- Abstract
Background
The safety and efficacy of EGFR TKIs in patients with EGFR mutation-positive (EGFRm+) NSCLC have previously been demonstrated. Here, we present results of a biomarker analysis from a subset of patients in a Phase IIIb study of afatinib in EGFR TKI-naïve patients with locally advanced/metastatic EGFRm+ NSCLC. The aim was to explore the relationship between tumor mutation type, and patients’ response to afatinib in terms of efficacy and tolerability.
Method
Patients with EGFR TKI-naïve EGFRm+ NSCLC received 40 mg/day afatinib until lack of clinical benefit (determined by investigator). The primary endpoint was incidence of serious adverse events (SAEs). Secondary endpoints were number of patients with drug-related AEs, and time to symptomatic progression (TTSP). Further endpoints included progression-free survival (PFS). For biomarker analysis, peripheral blood samples were collected during scheduled visits from patients entering the study at Beijing Cancer Hospital. DNA extracted from samples collected at Visit 3 and baseline was analyzed for EGFR and pre-specified non-EGFR mutations, respectively, using an amplification-refractory mutation system.
Result
In total, 64 patients were included in the biomarker analysis. Baseline characteristics: Chinese, 100%; female, 70.3%; mean age, 57.4 years; EGFR mutations: L858R, 50%; Del19, 42.2%. All patients experienced ≥1 drug-related AE, most commonly (grouped terms; any grade/≥3): diarrhea (n=63/9, 98.4%/14.1%) and rash or acne (n=52/5, 81.3%/7.8%). SAEs were reported for 15 patients (23.4%), most commonly cerebral infarction (n=3, 4.7%), malignant neoplasm progression, CNS metastases (both n=2, 3.1%). Median TTSP was 13.5 months (95% CI: 10.9, 18.0). At baseline, 19 of 42 patients analyzed (45.2%) had additional non-EGFR mutations; 17 (89.5%) progressed/died. Median PFS was 8.1 months in these patients, versus 12.5 months for patients with EGFR-only mutations (HR, 1.72; 95% CI 0.88, 3.36; p=0.1054). At Visit 3, mutation status had changed from EGFRm+ to EGFR mutation-negative in 33 of 40 patients analyzed (82.5%). Of these, 29 (87.9%) progressed/died; median PFS was 11.0 months versus 5.5 months for patients who remained EGFRm+ (HR, 1.25; 95% CI: 0.47, 3.30; p=0.6556).
Conclusion
In this analysis, safety data were consistent with the known safety profile of afatinib. Median PFS was twice as long in patients who became EGFR mutation-negative compared with those who remained EGFRm+; however, the difference was not statistically significant. There was no significant difference in PFS for patients with additional non-EGFR versus those with EGFR-only mutations. This exploratory analysis suggests that afatinib has clinical benefit for patients with EGFRm+ NSCLC across all the subgroups assessed.
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JCSE01 - Joint IASLC-CSCO-CAALC Session (ID 63)
- Event: WCLC 2019
- Type: Joint IASLC-CSCO-CAALC Session
- Track:
- Presentations: 2
- Now Available
- Moderators:Chunxue Bai, Tony Mok, Yi-Long Wu, Qing Zhou, Nan Wu
- Coordinates: 9/07/2019, 07:00 - 11:15, Toronto (1985)
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JCSE01.09 - A Phase II Umbrella Study of Camrelizumab in Different PD-L1 Expression Cohorts in Pre-Treated Advanced/Metastatic Non-Small Cell Lung Cancer (Now Available) (ID 3423)
07:00 - 11:15 | Author(s): Jie Wang
- Abstract
- Presentation
Abstract
Background
The role of PD-L1 expression in 2nd line and beyond non-small cell lung cancer (NSCLC) remains controversial. Camrelizumab (SHR-1210) is a potent anti-PD-1 monoclonal antibody and has shown promising activity in NSCLC in Phase I studies. We report results from the SHR-1210-201 study (NCT03085069), a phase II umbrella study of camrelizumab monotherapy in different PD-L1 expression cohorts in Chinese patients with previously treated advanced or metastatic NSCLC.
Methods
Patients who progressed during or following platinum-based doublet chemotherapy were enrolled and assigned to one of 4 cohorts based on PD-L1 expression. Patients with EGFR or ALK genomic alterations were eligible provided they had disease progression with at least one approved tyrosine kinase inhibitor and with ≥50% PD-L1 expression in tumor. All enrolled patients received camrelizumab at 200 mg IV Q2W until loss of clinical benefit. The primary endpoint was objective response rate (ORR), other endpoints included progression-free survival (PFS) and overall survival (OS).
Results
As of Aug 1st 2018, of all the 259 patients who underwent screen, 229 cases could be pathologically evaluated. PD-L1 expression were 47.6% (109/229) in PD-L1 < 1%, 27.1% (62/229) in PD-L1 ≥1-<25%, 8.7% (20/229) in ≥25-<50% and 16.6% (38/229) in ≥50%. A total of 63.8% (146/229) patients were enrolled. 89.0% of patients had stage IV NSCLC and 54.8% had non-squamous tumor histology. ORR was 18.5% (95%CI: 12.6%–25.8%) in ITT population. Subgroup analysis showed increased PD-L1 expression was associated with better response rate (Table 1). No response was observed in patients with EGFR mutation. The responders had durable response (median: 15.1 months; 95%CI: 5.5–not reached). Median PFS was 3.2 months (95%CI: 2.0–3.4) and median OS was 19.4 months (95%CI: 11.6–not reached) (Table 1). Treatment-related adverse events (AEs) occurred in 87.7% of patients (all Grade); 20.5% had ≥G3 related AE; and 15.8% had related SAE. 21.2% of AEs led to dose interruption and 7.5% led to treatment discontinuation.Table 1 - Efficacy data in subgroups Population No of pts ORR, % (95%CI) PFS (month),
median (95%CI)
1YOS, % (95%CI) OS (month),
median (95%CI)
PD-L1<1% 74 12.2% (5.7%, 21.8%)
2.1 (1.9, 3.2) 47.1% (33.8%, 59.2%) 11.6 (7.8, NR) PD-L1 ≥1% and < 25% 31 19.4% (7.5%, 37.5%) 3.1 (1.8, 4.9) 76.7% (57.2%, 88.2%) NR (NR, NR) PD-L1 ≥25% and < 50% 11 45.5% (16.7%, 76.6%) 6.0 (1.9, NR) 81.8% (44.7%, 95.1%) NR (2.9, NR) PD-L1 ≥50% (without EGFR mutation) 25 28.0% (12.1%, 49.4%) 7.6 (3.3, 11.4) 55.2% (32.3%, 73.2%) NR (8.6, NR) PD-L1 ≥50% (with EGFR mutation) 5 0 1.7 (1.2, NR) 40.0% (5.2%, 75.3%) 10.3 (1.2, NR) ITT 146 18.5% (12.6%, 25.8%) 3.2 (2.0, 3.4) 56.6% (47.3%, 64.9%) 19.4 (11.6, NR) Abbreviation: NR, Not Reached.
Conclusion
In Chinese patients with previously treated advanced/metastatic NSCLC, camrelizumab demonstrated improved ORR, PFS, and OS compared with historical data of the 2nd line chemotherapy. The efficacy in patients with PD-L1 <1% is similar as the 2nd line mono-chemotherapy, while patients with higher PD-L1 expression derived greater benefit from camrelizumab, the ORR, PFS and OS in patients with PD-L1 ≥25% was comparable to the 1st line doublet chemotherapy in advanced NSCLC. Camrelizumab was well tolerated. This phase 2 data warrant further clinical studies of camrelizumab in NSCLC.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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JCSE01.10 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (Now Available) (ID 3424)
07:00 - 11:15 | Author(s): Jie Wang
- Abstract
- Presentation
Abstract
Background
NSCLC patients who have potentially resectable disease often subsequently relapse after surgery. New therapy that prevents relapse after surgery is desperately needed. In this study, we tested the efficacy and safety of neoadjuvant sintilimab, an anti-PD-1 antibody, for patients with resectable sqNSCLC in China.
Methods
All patients had treatment-naïve resectable sqNSCLC (stage IB-IIIA) that was confirmed by histopathology. Patients received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. An enhanced PET/CT was obtained at baseline and seven days prior to surgery. Preliminary analysis of safety profile and efficacy was planned after at least 20 patients had received operation.
Results
As of Jan. 28, 2019, 22 patients (20 males and 2 females) with sqNSCLC received two doses of sintilimab followed by radical resection. The median age was 61.5 yr (range, 48 to 70). Six (27.3%) and four (18.2%) patients experienced neoadjuvant treatment emergent adverse events (TEAEs) and neoadjuvant treatment-related AEs (TRAEs), respectively. Most of the TEAEs and TRAEs were grade 1 or 2. Three patients achieved radiological partial response: an ORR of 13.6% based on RECIST 1.1. Ten patients (45.5%) achieved a major pathologic response (MPR, ≤10% viable tumor cells), including four (18.2%) had complete pathologic response (no viable tumor cell). There was a direct correlation between pathological response and decrease in the standardized uptake values (SUV) in the primary tumor. Among nine patients with > 30% decrease of SUV, eight had MPR, compared with no MRP response in the 11 patients with ≤30% decrease of SUV.
Conclusion
Neoadjuvant sintilimab for sqNSCLC patients was tolerable and the 45.5% MRP rate is encouraging. A decrease in SUV may be predictive of pathologic response after PD-1 therapy in sqNSCLC.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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OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)
- Event: WCLC 2019
- Type: Oral Session
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:Christine Lee Hann, Makoto Nishio
- Coordinates: 9/08/2019, 13:30 - 15:00, Hilton Head (1978)
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OA03.02 - Effect of Anlotinib in Advanced Small Cell Lung Cancer Patients Previously Received Chemoradiotherapy: A Subgroup Analysis in ALTER 1202 Trial (Now Available) (ID 1698)
13:30 - 15:00 | Author(s): Jie Wang
- Abstract
- Presentation
Background
The ALTER 1202 trial showed significant improvement in progress-free survival and well tolerant with anlotinib in advanced small cell lung cancer (SCLC) patients received at least two lines chemotherapy. Here, we reported the effect of anlotinib in patients previously received chemoradiotherapy.
Method
The ALTER 1202 was a randomized, double-blind phase 2 trial conducted at 11 centers in China. Patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled and randomized in a 2:1 ratio to receive either anlotinib or placebo until tumor progression or unacceptable toxicity. The subgroup analysis assessed the effect of anlotinib in patients with previous concurrent, sequential and alternate chemoradiotherapy. The primary outcome was progressive-free survival (PFS). The secondary outcomes were overall survival (OS), objective response rate, disease control rate and safety. Data are reported as per the 30 June 2018, data cutoff date. This trial is registered with ClinicalTrials.gov, number NCT03059797.
Result
Between March 30, 2017 and June 8, 2018, a total of 120 patients who met all eligibility criteria were randomly assigned to the anlotinib group (82 patients) or placebo group (38 patients). And 46 patients in anlotinib group and 22 patients in placebo group previously received chemoradiotherapy. Among them, the median PFS was 5.49 months (95% confidence interval [CI], 2.83 to 6.47) with anlotinib versus 0.69 months (95% CI, 0.66 to 0.76) with placebo (hazard ratio [HR], 0.14; 95% CI, 0.07 to 0.28; P<0.0001). Meanwhile, anlotinib significantly prolonged OS compared with placebo (9.49 months [95% CI, 7.29 to 12.68] versus 2.56 months [95% CI, 0.49 to 5.22]; HR, 0.46 [95% CI, 0.22 to 0.98]; P=0.0388) in patients previously received chemoradiotherapy. The most common adverse events were hypertension (39.13%), weight loss (39.13%), hypertriglyceridemia (36.96%) and leukopenia (30.43%). While, the most common grade 3 or worse adverse events were hypertension (15.22%), hypertriglyceridemia (10.87%), γ-glutamyl-transferase increased (8.70%).
Conclusion
Anlotinib improved PFS and OS in advanced SCLC patients previously received chemoradiotherapy and was well tolerated.
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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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-106 - Clinical Features and Tumor Immune Microenvironment Related to Acquired Resistance to EGFR-TKI in NSCLC Patients with EGFR Mutation (ID 2343)
09:45 - 18:00 | Author(s): Jie Wang
- Abstract
Background
First generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) provide significant clinical benefit in advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation. However, patients with initial response to EGFR-TKI ultimately develop acquired resistance to EGFR-TKI treatment, which approximately 50% resistant patients develop second EGFR T790M mutation. New treatment strategy for NSCLC patients harboring EGFR T790M mutation has been available. For those EGFR T790M negative patients, chemotherapy is currently the standard treatment. However, the efficacy of immunotherapy in EGFR T790M mutation NSCLC patients is unknown. Our study focused on the relationship between the clinical features and EGFR T790M mutation status, and the tumor immune microenvironment change before and after acquired resistance to EGFR-TKI in NSCLC patients with EGFR mutation.
Method
In this study, we retrospectively evaluated 89 patients with EGFR mutation who received first generation EGFR-TKIs treatment at the First Affiliated Hospital of Zhejiang University between February 2012 and July 2018. All patients were performed second biopsy after acquired resistance to EGFR-TKI. EGFR T790M mutation, epithelial-mesenchymal transition (EMT) and tumor-infiltrating CD4 and CD8 lymphocytes (TILs) in 13 patients with paired biopsy specimens before and after resistance to EGFR-TKI were measured by next generation sequencing (NGS) and immunohistochemistry analyses respectively.
Result
Among the 89 eligible patients, EGFR T790M mutation rate was 59.6% (53/89). EGFR T790M mutation was not related with age, gender, smoking status, tumor stage, performance status, but related to the initial EGFR mutation type (EGFR exon 19 deletion or exon 21 L858R mutation). Patients with EGFR exon 19 deletion had significantly higher T790M mutation rate than that with exon 21 L858R mutation (p=0.025). Interestingly, among 11 patients with family cancer history, 10 patients acquired T790M mutation. Furthermore, patients with T790M mutation had longer progression-free survival (PFS) compared to T790M-negative patients (75.5% vs 63.9%, P<0.05). In the small cohort of 13 patients, 6 patients developed EMT after acquired resistance. TILs according to the CD4+ and CD8+ lymphocyte density were not significantly changed in all 13 patients before and after acquired resistance.
Conclusion
Our findings indicate that patients with EGFR exon 19 deletion、longer PFS or family cancer history may have higher possibility to develop second EGFR T790M mutation after resistance to EGFR-TKI treatment. The incidence of EMT was higher than we expected, providing further research and clinical treatment ideas. There is no change in TILs after resistance to EGFR-TKI in patients with or without EGFR T790M mutation, but this need further study due to the limited samples in this study.
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P1.01-61 - A Phase II Umbrella Study of Camrelizumab in Different PD-L1 Expression Cohorts in Pre-Treated Advanced/Metastatic Non-Small Cell Lung Cancer (ID 1633)
09:45 - 18:00 | Author(s): Jie Wang
- Abstract
Background
The role of PD-L1 expression in 2nd line and beyond non-small cell lung cancer (NSCLC) remains controversial. Camrelizumab (SHR-1210) is a potent anti-PD-1 monoclonal antibody and has shown promising activity in NSCLC in Phase I studies. We report results from the SHR-1210-201 study (NCT03085069), a phase II umbrella study of camrelizumab monotherapy in different PD-L1 expression cohorts in Chinese patients with previously treated advanced or metastatic NSCLC.
Method
Patients who progressed during or following platinum-based doublet chemotherapy were enrolled and assigned to one of 4 cohorts based on PD-L1 expression. Patients with EGFR or ALK genomic alterations were eligible provided they had disease progression with at least one approved tyrosine kinase inhibitor and with ≥50% PD-L1 expression in tumor. All enrolled patients received camrelizumab at 200 mg IV Q2W until loss of clinical benefit. The primary endpoint was objective response rate (ORR), other endpoints included progression-free survival (PFS) and overall survival (OS).
Result
As of Aug 1st 2018, of all the 259 patients who underwent screen, 229 cases could be pathologically evaluated. PD-L1 expression were 47.6% (109/229) in PD-L1 < 1%, 27.1% (62/229) in PD-L1 ≥1-<25%, 8.7% (20/229) in ≥25-<50% and 16.6% (38/229) in ≥50%. A total of 63.8% (146/229) patients were enrolled. 89.0% of patients had stage IV NSCLC and 54.8% had non-squamous tumor histology. ORR was 18.5% (95%CI: 12.6%–25.8%) in ITT population. Subgroup analysis showed increased PD-L1 expression was associated with better response rate (Table 1). No response was observed in patients with EGFR mutation. The responders had durable response (median: 15.1 months; 95%CI: 5.5–not reached). Median PFS was 3.2 months (95%CI: 2.0–3.4) and median OS was 19.4 months (95%CI: 11.6–not reached) (Table 1). Treatment-related adverse events (AEs) occurred in 87.7% of patients (all Grade); 20.5% had ≥G3 related AE; and 15.8% had related SAE. 21.2% of AEs led to dose interruption and 7.5% led to treatment discontinuation.
Table 1 - Efficacy data in subgroups Population No of pts ORR, % (95%CI) PFS (month),
median (95%CI)
1YOS, % (95%CI) OS (month),
median (95%CI)
PD-L1<1% 74 12.2% (5.7%, 21.8%)
2.1 (1.9, 3.2) 47.1% (33.8%, 59.2%) 11.6 (7.8, NR) PD-L1 ≥1% and < 25% 31 19.4% (7.5%, 37.5%) 3.1 (1.8, 4.9) 76.7% (57.2%, 88.2%) NR (NR, NR) PD-L1 ≥25% and < 50% 11 45.5% (16.7%, 76.6%) 6.0 (1.9, NR) 81.8% (44.7%, 95.1%) NR (2.9, NR) PD-L1 ≥50% (without EGFR mutation) 25 28.0% (12.1%, 49.4%) 7.6 (3.3, 11.4) 55.2% (32.3%, 73.2%) NR (8.6, NR) PD-L1 ≥50% (with EGFR mutation) 5 0 1.7 (1.2, NR) 40.0% (5.2%, 75.3%) 10.3 (1.2, NR) ITT 146 18.5% (12.6%, 25.8%) 3.2 (2.0, 3.4) 56.6% (47.3%, 64.9%) 19.4 (11.6, NR) Abbreviation: NR, Not Reached.
Conclusion
In Chinese patients with previously treated advanced/metastatic NSCLC, camrelizumab demonstrated improved ORR, PFS, and OS compared with historical data of the 2nd line chemotherapy. The efficacy in patients with PD-L1 <1% is similar as the 2nd line mono-chemotherapy, while patients with higher PD-L1 expression derived greater benefit from camrelizumab, the ORR, PFS and OS in patients with PD-L1 ≥25% was comparable to the 1st line doublet chemotherapy in advanced NSCLC. Camrelizumab was well tolerated. This phase 2 data warrant further clinical studies of camrelizumab in NSCLC.
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P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.18-06 - Efficacy and Safety of Neoadjuvant PD-1 Blockade with Sintilimab in Resectable Non-Small Cell Lung Cancer (ID 2999)
09:45 - 18:00 | Author(s): Jie Wang
- Abstract
Background
Non-small cell lung cancer (NSCLC) patients with potentially resectable disease most would experience relapse after surgery. New strategy preventing recurrence is in urgent need. In the current study, we first evaluated the safety and efficacy of neoadjuvant sintilimab in Chinese patients with resectable NSCLC.
Method
Patients with treatment-naïve resectable NSCLC (stage IB-IIIA) received two cycles of sintilimab (200 mg IV) on Day 1 and 22. Surgery was performed between Day 29-43. The tumor imaginations were obtained at baseline and within seven days prior to surgery. The primary endpoint was safety, and efficacy endpoints include disease free survival, rate of major pathologic response (MPR, ≤10% viable tumor cells) and objective response rate (ORR). Expression of programmed death ligand 1 (PD-L1) in baseline biopsy tissues and surgical samples were investigated. (Registration Number: ChiCTR-OIC-17013726).
Result
A total of 40 patients with NSCLC were enrolled, among which 32 (80%) were male; 33 (82.5%) had squamous-cell carcinoma; 35 (87.5%) had stage IIA to IIIB disease; and 33 (82.5%) were former or current smokers. As of June 15th, 2019, all of the patients received 2 doses of sintilimab, and 37 patients underwent radical resection. Among 40 patients, 18 (45%) patients experienced neoadjuvant treatment-related adverse events (TRAEs). Two (5%) patient experienced grade 3-4 neoadjuvant TRAE. One treatment related surgery delay was reported because of grade 1 hyperthyroidism. None of the patients has confirmed recurrence to date. Among 37 patients, 8 patients achieved radiological partial response (PR), resulted in an ORR of 21.6% regarding RECIST 1.1. Fifteen (40.5%) patients achieved MPR, and 6 (16.2%) patients had complete pathologic response (cPR) (Figure 1). There’s no correlation between baseline characteristics and MPR (Table 1). Maximum standardized uptake values (SUVmax) reduction of primary tumor after sintilimab treatment was significantly corelated with pathological response (correlation coefficient = 0.86, p <0.00001). However, there was no significant correlation between decrease in sum of lesion diameter (SLD) and pathological response (correlation coefficient = 0.21, p = 0.2104). Squamous cell carcinoma showed a better MPR (15/33, 45.5%) compared with adenocarcinoma (0/6 0%). Baseline PD-L1 expression of stromal cells was correlated with pathological regression (p= 0.0471). In 18 patients with post-surgery pathologically positive lymph nodes, heterogeneity of response between primary tumor and lymph nodes were found by comparing MPR, change of SUVmax and SLD.
Conclusion
Neoadjuvant sintilimab for Chinese NSCLC patients was well tolerated and the 40.5% MRP rate is encouraging. A SUVmax reduction may be more predictive of pathologic response than decrease in SLD after neoadjuvant PD-1 therapy in NSCLC. Heterogeneity exists between primary tumor and lymph nodes.
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P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.12-11 - Quality of Life in ALTER1202 Trial of Anlotinib as Third-or Further Line Therapy for Advanced Small Cell Lung Cancer (SCLC): A Post-Hoc Analysis (ID 1300)
10:15 - 18:15 | Author(s): Jie Wang
- Abstract
Background
Anlotinib significantly improved progress-free survival of advanced small cell lung cancer (SCLC) patients in ALTER1202 trial. In this post-hoc analysis, we assessed the effect of anlotinib on health-related quality of life in ALTER1202 trial.
Method
In the randomised, phase 2, multicentre ALTER1202 trial, patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled from 11 centers in China. Eligible patients were randomly assign (2:1) to receive anlotinib or placebo. Health-related quality of life was assessed by EQ-5D scores. Patients filled out questionnaires at screening period and the end of each treatment cycle.
Result
Between March 30, 2017 and June 8, 2018, a total of 120 patients were enrolled. There were 119 patients with completed questionnaires at screening period, and 106 patients completed questionnaires at the end of the first treatment cycle (76 in anlotinib group, 30 in placebo group). EQ-5D scores had no significant difference between baseline and the end of the first treatment cycle in patients with anlotinib (0.85 versus 0.85, P=0.706). The median EQ-5D VASscores were 80.0 versus 85.0 in anlotinib and placebo group respectively (P=0.323) at screening period, and 90.0 versus 82.5 at the end of the first treatment cycle (P=0.273). The change of EQ-5D VAS scores from baseline to the end of the first treatment cycle was statistically significant (P=0.001) in patients with anlotinib compared to patients with placebo.
Conclusion
This post-hoc analysis showed that anlotinib maintained health-related quality of life in advanced SCLC patients.
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P2.12-26 - The Impact of Anlotinib for Relapsed SCLC Patients with Brain Metastases: A Subgroup Analysis of ALTER 1202 (ID 489)
10:15 - 18:15 | Author(s): Jie Wang
- Abstract
Background
ALTER1202 trial (NCT03059797), a multicentre, randomized, double-blind phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed SCLC patients as 3rdor further line treatment. Here, we performed a comparative analysis for patients with brain metastases in the placebo and anlotinib arms.
Method
Eligible either limited- or extensive-stage SCLC pts who failed ≥2 lines of chemotherapy (n=120) were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoint was PFS. This subgroup analysis was based on patients with brain metastases at baseline.
Result
There are 30 pts with brain metastases in anlotinib and placebo groups (n=21 vs 9). Anlotinib significantly improved PFS (3.84 vs 0.76 months; HR = 0.15; 95% CI, 0.04–0.51; P = 0.0005) and OS (6.08 vs 2.56 months; HR = 0.26; 95% CI, 0.09–0.73; P = 0.0061) comparing to placebo in patients with brain metastases at baseline. In anlotinib group, loss of appetite (47.62%), loss of weight (42.86 %), leukopenia (38.10%) and hypertriglyceridemia (38.10%) were the most common adverse events (AEs); then, in placebo group were emesis (44.44%) and loss of appetite (33.33 %).
Conclusion
For patients with brain metastases in ALTER1202 trial, significant improvement in OS and PFS were found in anlotinib treated group with a manageable safety profile.
