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Shi Qiu
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FP10 - Small Cell Lung Cancer/NET (ID 231)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP10.05 - A Prospective Phase II Study of Apatinib Plus Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer (ID 2045)
00:00 - 00:00 | Author(s): Shi Qiu
- Abstract
Introduction
Small-cell lung cancer (SCLC), which accounts for ∼15% of all lung cancers, is characterised by its rapid proliferation. The clinical outcomes of second-line and above treatments are unsatisfactory, resulting in a median progression-free survival (PFS) of less than 3 months. There is currently none targeted drugs or new chemotherapeutic drugs that can achieve breakthroughs in advanced SCLC. This study aims to observe whether apatinib in combination with chemotherapy can be a new choice for pretreated patients with advanced SCLC. This clinical trial has presented initial results in 2019 WCLC abstract 1788. This has updated the new data.
Methods
This is a prospective, single-center, single-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of advanced SCLC ((NCT03547804)). The dose of apatinib was 500mg per day in the initial protocol, and the treatment plan was adjusted due to tolerance of patients later and lower dose of apatinib 250mg once daily was applied. The dose of apatinib could be further reduced to 250mg every other day if the patient was observed with a grade 3/4 adverse effect. Chemotherapeutic agents were limited to irinotecan or docetaxel alone. The primary endpoint was the progression-free survival (PFS). The secondary endpoints included overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse events (AEs).
Results
31 patients were enrolled from March 2018 to Oct 2019. 28 patients were available for response evaluation. The ORR and DCR were 25.00% (7/28) and 100% (28/28), respectively. The median PFS and OS were 7.43 months and 12.50 months, respectively (Fig 1a-1b). For subgroup analyses, we found that limited-stage disease had a longer PFS comparied with that of extensive-stage disease (9.17m vs 4.33m, P=0.0013) (Fig 1c). There were no significant differences in efficacy in subgroups of different initial dose (500mg vs 250mg) and age (＜60y vs ≥60y). The most common treatment-related AEs were neutropenia, thrombocytopenia, hypertension, hand-foot syndrome, proteinuria, diarrhea, abnormal liver function and mucitis. However, the incidence of grade Ⅲ-Ⅳ adverse reactions was lower and the patients had a better tolerance with an initial dose of apatinib 250mg plus chemotherapy.
Conclusion
Apatinib plus single agent chemotherapy showed a promising efficacy and a good tolerance in patients with pretreated SCLC. Especially, apatinib 250mg per day was recommended in this clinical trial.
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P02 - Diagnostics and Interventional Pulmonology (ID 110)
- Event: WCLC 2020
- Type: Posters
- Track: Diagnostics and Interventional Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P02.25 - Coexistence of Invasive Adenocarcinoma, Minimally Invasive Adenocarcinoma and Atypical Adenomatous Hyperplasia: A Case Report (ID 1726)
00:00 - 00:00 | Author(s): Shi Qiu
- Abstract
Introduction
Multiple small nodular lung cancer (MSLC) refers to multiple tumor nodules on the same or different lobes of the lungs. These nodules are affected by the same germline characteristics and environmental exposure factors that occur simultaneously in one individual. Invasive adenocarcinoma (inv ADC), minimally invasive adenocarcinoma (MIA) and atypical adenomatous hyperplasia (AAH) are regarded as the “three-steps” in the evolution of lung adenocarcinoma.
Methods
A fifty-year-old Asian female patient without a history of smoking was hospitalized due to three ground-glass nodules (GGNs) in the right upper lobe of the lung, which were detected in March 2017. Three nodules revealed by chest CT were each pathologically diagnosed as ADC, MIA and AAH. To further confirm the correlations and differences among these types, we performed whole-exome sequencing on the three lesions followed by a comparative analysis at the genetic level to determine the major genes that may play an important role in the progression of these “three-steps” in lung adenocarcinoma.
Results
The TMB of the three lesions was relatively low, especially in AAH.(Fig 2C) The three lesions were found to share a common gene (BAGE2).(Fig 2B) We found that MAP3K14, MAP2K1, and EGFR, which are three major genes of the EGFR-MAPK pathway, may play an important role in AAH, MIA and inv ADC, respectively.(Fig 2D) The C>T alteration was the primary change observed in the three nodules of the patient. C>A was increased in the ADC nodule and decreased in the MIA nodule, but was rare in AAH.(Fig 2E, F)
Conclusion
We found that MAP3K14, MAP2K1, and EGFR were three dominant factors that exist as part of “three-steps” and that might act as new specific targets for the treatment of this disease type. However, the relationship among MAP2K1, MAP3K14 and EGFR still requires more verification in more samples.
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P79 - Immunotherapy (Phase II/III Trials) - Immunotherapy Plus Chemotherapy (ID 256)
- Event: WCLC 2020
- Type: Posters
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P79.09 - Neoadjuvant Combination Sintilimab plus Chemotherapy in Patients with Resectable Stage IIIA Non-Small Cell Lung Cancer. (ID 2013)
00:00 - 00:00 | Author(s): Shi Qiu
- Abstract
Introduction
Patients with stage IIIA non-small cell lung cancers (NSCLC) are potentially curable, however 5-year survival rate remains disappointing of 40%. The median overall survival(OS) of stage Ⅲ resectable NSCLC was only 31months, and 22 months for N2. At present, the standard treatment of neoadjuvant therapy is still platinum dual-drug chemotherapy. Antibodies that block programmed death 1 (PD-1) protein combined with chemotherapy improves survival in patients with advanced NSCLC. Sintilimab, a highly selective, fully human monoclonal antibody (mAb), blocks the interaction of PD-1 and its ligands and has demonstrated clinical benefit in various clinical studies. Therefore,it is still a question to be explored whether immunochemotherapy combined with chemotherapy can improve the pathological response rate, the disease-free survival(DFS) and OS. This study assessed the effects of the addition of Sintilimab to traditionnal neoadjuvant chemotherapy in resecrable NSCLC, aims to observe whether Sintilimab in combination with chemotherapy can be a new choice for treatment of resectable NSCLC.
Methods
This is a prospective, single-center, single-arm Phase Ⅱ clinical trial(NCT04326153). In this pilot study, patients with resectable stage ⅢA NSCLC received 2 cycles of neoadjuvant treatment （Sintilimab+Nab-paclitaxel+carboplatin) prior to surgery. Surgery must be done within the 3rd-4th week. Patients that are R0 confirmed by surgical pathology evaluation will receive 2 cycles of adjuvant treatment (Sintilimab+Nab-paclitaxel+carboplatin), and treatment of Sintilimab for six months. The primary endpoint is the rate of 24-month DFS. Secondary endpoints included major pathological response(mPR), the pathological complete response (pCR), OS, and adverse events(AEs).
Results
The ongoing trial has not reached pre-specified endpoints for analysis. At present, there are 2 patients who meet the standard have completed the operation after neoadjuvant. Patient A was diagnosed as large cell lung cancer with clinical stage ⅢA(T4N1M0). The evaluation of CT was patial response(PR)(Fig.1(a)(b)(c)(d)). The pathological response rate was 60%. Pathological stage reduced to stageⅠB(pT2aN0M0). Treat-related AE was increase of aspartate transaminase and alanine aminotransferase(grade Ⅱ CTCAE5.0 ). Patient B was diagnosed as adenocarcimoma with clinical stage ⅢA(T1bN2M0). The evaluation of CT was stable disease(SD)(Fig.1(e)(f)(g)(h)). The pathological response rate was 30%. Pathological stage reduced to stageⅡB(pT1cN1M0). Treat-related AE was leukopenia(grade Ⅱ CTCAE5.0). All adverse reactions can be returned to normal after symptomatic treatment.
Conclusion
Neoadjuvant Sintilimab plus chemotherapy showed a bright efficacy with no intolerable adverses. It may improve the downstage rate and pathologic remission rate of patients with NSCLC. Whether it can improve the DFS and OS of patients remains to be further observed with experimental data.
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P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P84.23 - The Safety and Toxicities of ALK -TKIs in ALK-Positive NSCLC: A Systematic Review and Pool Analysis (ID 2155)
00:00 - 00:00 | Author(s): Shi Qiu
- Abstract
Introduction
The anaplastic lymphoma kinase tyrosine kinase inhibitors (ALK-TKIs) including crizotinib, alectinib, ceritinib and brigatinib are available for the first-line treatment of patients with positive non-small cell lung cancer (NSCLC) and show a promising response. Selecting a treatment with acceptable toxicities and has a lower influence on the quality of life of the patient is essential. However, the analysis of the toxicity and safety profiles among different first line ALK TKIs is lacking. We performed a systemetic review to evaluate the safety and tolerability profiles of the first-line ALK inhibitors according to ALK -TKI type.
Methods
We extracted the data from prospective clinical trials searched in database and conducted a pooled analysis of severe AEs according to the type of ALK-TKIs. All statistical analyses were performed with the SPSS software.
Results
A total of 21 studies including 3418 patients were considered eligible for analysis. The frequencies of treatment-related death and AEs due to treatment withdrawn were 0.7% (24/3418) and 7.8 % (258/3308), respectively. The frequency of severe AEs in patients treated with ceritinib was significantly higher than patients treated with crizotinib, alectinib and brigatinib. One of the most common adverse events (AEs) observed with ALK inhibitors were gastrointestinal (GI) toxicities, such as nausea,vomiting and diarrhea. The frenquency of GI toxicities grade ≥ 3 in ceritinib group is significantly higher than in crizotinib group (5.6% vs. 1.2%, OR 4.825, 95% CI 2.907–8.008, P < 0.001) alectinib cohort (5.6% vs. 0.3%, OR 22.148, 95% CI 3.038–161.462, P < 0.001) and brigatinib group (5.6% vs 0.7%, OR 8.129, 95% CI 1.956–33.782, P=0.001). Hepatotoxicity of grade≥3 was significantly more frequent in patients treated with ceritinib, occured up to 24.1%(24.1% vs. 3.7%, OR 0.122, 95% CI 0.07–0.21, P < 0.001; 24.1% vs. 1.4%, OR 21.70, 95% CI 7.98–59.05, P < 0.001; 24.1% vs. 9.6%, OR 0.34 95% CI 0.27–0.42, P < 0.001). Significant difference of fatigue of grade ≥3 between ceritinib and other TKIs were detected(4.9% vs 0.9% OR 0.176, 95% CI 0.042–0.736, P=0.007; 4.9% vs0.7% OR 7.19, 95% CI 0.978–52.872, P=0.024; 4.9% vs 2.3% OR 0.46, 95% CI 0.29–0.74, P=0.001). It is more frequently in patients treated with crizotinib that occured neutropenia than any other group(12% vs 0.6% OR 21.07, 95% CI 5.2–85.2, P< 0.001; 12% vs1.1% OR 0.08, 95% CI 0.012–0.616, P=0.002; 12% vs 0% OR 1.09, 95% CI 1.08–1.11,P<0.001). Lung toxicity of grade ≥3 occured more often in brigatinib(6.1% vs 0% OR 2.46, 95% CI 2.22–2.71, P< 0.001; 6.1% vs2.8% OR 2.26, 95% CI 1.06–4.83, P=0.031; 6.1% vs 2.6% OR 2.46, 95%CI 1.33-4.54,P=0.003).
Conclusion
Attention should be focused on ALK inhibitor-related SAEs although ALK inhibitors have an acceptable safety profile with a low risk of treatment-related deaths. Statistically significant differences in some severe AEs among ceritinib, crizotinib alectinib and brigatinib were detected in this pool analysis.
