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Chengping Hu
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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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EP1.14-37 - Anlotinib-Induced Broncho-Pericardial/Pleural Fistula in Patients Suffering from Lung Cancer (First Report) (Now Available) (ID 374)
08:00 - 18:00 | Author(s): Chengping Hu
- Abstract
Background
Anlotinib is an small molecule inhibitor of multiple receptor tyrosine kinases, with inhibitory effects on tumor angiogenesis, and approved in China for treatment of patients with non-small cell lung cancer (NSCLC) who have undergone progression after≥2 lines of chemotherapy. The occurrence of bronchial fistula related to anlotinib has not been reported yet. We presented 2 cases of NSCLC patients with bronchial fistula after treatment with anlotinib.
Method
Case 1: A 69-year-old male diagnosed central squamous cell lung carcinoma(CSCLC) of the left (stage IV) on July 2018, who refused chemotherapy but treated with anlotinib for 3 months, aggravated with short breath, with CT indicating broncho-pericardial fistula. After catheter was set into pericardium and drained for 5 days, CT showed significant reduction of gas and pericardium partially conglutinated.
Case 2: 63-year-old male diagnosed CSCLC of the right (EGFR 19del) in 2016, with a history of diabetes, who successively received 2 lines of chemotherapy, target therapy, radiotherapy, shifted to anlotinib in August 2018 for 4 months, then aggravated with coughing pyohemosputum and fever, with CT indicating broncho-pleural fistula. After performed a closed thoracic drainage and anti-bacterium therapy, the patient improved and drainage decreased.
Result
Two cases developed bronchial fistula during the treatment of anlotinib alone, suggesting that the adverse effects mainly related to the antiangiogenics effect of it and causing ischemic necrosis. Other possible factors include: ①central lung cancer,②squamous cell carcinoma,③cachexia,④multi-line treatment,⑤long diameter of tumor≥5cm) and cavity formation,⑥radiotherapy,⑦accompanied with underlying diseases easy to complicated with infection, such as diabetes.
Conclusion
Although the incidence of bronchial fistula caused by anlotinib in NSCLC is extremely rare, it seriously affects the quality of life and overall survival of patients. Therefore, we need to use it selectively and make a close observation of the high-risk patients.
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OA04 - Immuno Combinations and the Role of TMB (ID 126)
- Event: WCLC 2019
- Type: Oral Session
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:Solange Peters, Martin Reck
- Coordinates: 9/08/2019, 15:15 - 16:45, Copenhagen (1980)
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OA04.03 - A Randomized Phase 3 Study of Camrelizumab plus Chemotherapy as 1<sup>st</sup> Line Therapy for Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (Now Available) (ID 1682)
15:15 - 16:45 | Author(s): Chengping Hu
- Abstract
- Presentation
Background
Platinum-based chemotherapy remains 1st line therapy for advanced non-small cell lung cancer (NSCLC) without oncogenic drivers in China. Camrelizumab (SHR-1210, a potent anti‒PD-1 monoclonal antibody) has shown promising activity in multiple malignancies. Here, we report interim analysis results on efficacy and safety of camrelizumab plus carboplatin/pemetrexed as 1st line treatment in Chinese advanced/metastatic non-squamous NSCLC patients with negative oncogenic drivers.
Method
In this open-label, randomized, multicenter phase 3 study (SHR-1210-303), patients with advanced/metastatic, non-squamous NSCLC with negative EGFR or ALK were stratified by sex and smoking history (≥ 400/year versus ˂ 400/year) and were randomly assigned (1:1) to receive 4 to 6 cycles of carboplatin (AUC=5) plus pemetrexed (500 mg/m2) with or without camrelizumab (200 mg), followed by pemetrexed with or without camrelizumab as maintenance therapy up to disease progression or intolerable toxicity. Treatment was given every 3 weeks. Crossover to camrelizumab monotherapy was permitted for patients in the chemotherapy arm who had confirmed disease progression. The primary endpoint was PFS per blinded independent central review according to RECIST v1.1. Secondary endpoints included ORR, DCR, DoR and OS. Data of subgroup analysis will be reported. Clinical Trials.gov number: NCT03134872.
Result
Between May 12, 2017 and Jun 6, 2018, 419 patients were randomized, among whom 205 received camrelizumab plus chemotherapy and 207 received chemotherapy treatment. After a median follow-up of 11.9 months, median PFS was 11.3 months (95% CI 9.5‒not reached) in camrelizumab plus chemotherapy arm and 8.3 months (95% CI 6.0‒9.7) in chemotherapy arm (HR 0.61 [95% CI 0.46‒0.80], p=0.0002). ORR, DCR, DoR and OS with camrelizumab plus chemotherapy were superior to chemotherapy (Table 1). Grade 3/4 adverse events occurred in 66.8% of patients in camrelizumab plus chemotherapy arm and 51.2% of patients in chemotherapy arm. There were 5 treatment-related deaths in camrelizumab plus chemotherapy arm and 4 in chemotherapy arm.
Table 1. Responses per blinded independent central review and overall survival in the total study population Camrelizumab plus chemotherapy
(n=205)Chemotherapy alone
(n=207)p-value Objective response rate 60.0% (53.0‒66.8) 39.1% (32.4‒46.1) p<0.0001 Disease control rate 87.3% (82.0‒91.6) 74.4% (67.9‒80.2) p=0.0009 Duration of response (months) 17.6 (11.6‒NR) 9.9 (8.5‒13.8) p=0.0356 Overall survival (months) NR (17.1‒NR) 20.9 (14.2‒NR) p=0.0272 Data are shown in % (95% CI) or median (95% CI). NR: not reached.
Conclusion
First-line camrelizumab plus chemotherapy shows substantial clinical benefit in patients with advanced/metastatic non-squamous NSCLC with negative EGFR or ALK in terms of PFS, ORR, and OS and acceptable safety profiles. The combination should become novel standard 1st line therapy for this population.
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