Abstract 1801P
Background
Anlotinib, a novel multi-targeting tyrosine kinase inhibitor with anti-angiogenesis and anti-tumor growth effects, has obtained preliminary results from phase II clinical study in the third-line and further treatment of small cell lung cancer (SCLC). Safety and efficacy of anlotinib combined with etoposide and platinum-based regimens in the first-line treatment of extensive-stage SCLC (ES-SCLC) remain unknown.
Methods
This prospective, single-arm, single-center exploratory phase II clinical study enrolled treatment-naïve ES-SCLC patients. Patients were to receive anlotinib (12 mg per day, per os; days 1-14; 21 days per cycle) combined with etoposide and platinum-based chemotherapy for 4 cycles and continued anlotinib treatment until Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was progression-free survival (PFS). The secondary endpoints were safety, overall survival, objective response rate (ORR), disease control rate (DCR) and quality of life score.
Results
Presently, this study has enrolled 30 ES-SCLC patients, of whom 23 can be evaluated. Of 23 patients, twenty (87.0%) patients were male and seventeen (73.9%) were current or former smokers. All 23 patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 1 at baseline. The most common metastatic sites were liver (43.5%), bone (34.8%), brain (30.4%) and bilateral lung (30.4%). All 23 patients achieved partial response (PR), resulting in ORR and DCR of 100%. By the cutoff day (April 30th, 2020), 12 (52.2%) patients developed disease progression. The estimated median PFS was 6.3 months (95% CI, 5.0-7.7 months). Table: 1801P
| Baseline characteristic | All, No. of patients (%) (N＝23） |
| Age, years: | |
| Mean | 61 |
| Median | 64 |
| Range | 44-72 |
| Sex: | |
| Male | 20 (87.0) |
| Female | 3 (13.0) |
| Smoking history: | |
| Never-smoker | 6 (26.1) |
| Former or current smoker | 17 (73.9) |
| Family history of malignant tumors: | |
| Yes | 3 (13.0) |
| No | 20 (87.0) |
| ECOG PS at baseline: | |
| 1 | 23 (100.0) |
| Metastatic sites at baseline: | |
| Bilateral lung | 7 (30.4) |
| Brain | 7 (30.4) |
| Bone | 8 (34.8) |
| Liver | 10 (43.5) |
| Adrenal gland | 4 (17.4) |
| Supraclavicular lymph node | 4 (17.4) |
| Pleural | 5 (21.7) |
| Others | 4 (17.4) |
Conclusions
Preliminary results showed that anlotinib combined with etoposide and platinum-based regimens in the first-line treatment of ES-SCLC were effective and well tolerated.
Clinical trial identification
The trial protocol number is NCT03841136 and the release date is March 26th, 2019.
Editorial acknowledgement
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.