Anlotinib combined with etoposide as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC): Updated results from a phase II trial.

Abstract

e20610 Background: Existing maintenance treatment strategies for patients with ES-SCLC experiencing no progression after the standard first-line chemotherapy are limited. Anlotinib combined with etoposide as maintenance treatment in ES-SCLC after the standard first-line EP chemotherapy showed encouraging efficacy and good tolerability. This is an update of the phase II study (ChiCTR1800019421). Methods: Patients with histologically confirmed ES-SCLC who have not progressed after the standard first-line EP chemotherapy received anlotinib (12 mg, day 1 to 14 of a 21-day cycle) combined with etoposide (50 mg, QD, day 1 to 14 of a 21-day cycle, up to 6 cycles) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety. Results: Between April 2019 and October 2021, we screened 31 patients and enrolled 27 patients in this trial. At data cut-off (January 7, 2022), 20 (74%) patients had discontinued the trial, and 7 (26%) patients remained on treatment. The median follow-up time reached 12.9 months. Among 27 evaluable patients, there was 9 partial response, 17 stable disease and 1 disease progression, resulting in the objective response rate 33.3% and disease control rate 96.3%. The median PFS was 8.9 months (95%CI: 5.4-12.3). The median OS was 13.6 months (95%CI: 9.6-17.6). The most common grade 1-2 adverse events (AEs) were anorexia (9 of 27, 33.3 %), hypertension (8 of 27, 29.6 %) and fatigue (7 of 27, 25.9 %). The most common grade 3-4 AEs were anorexia (4 of 27, 14.8%), hypertension (2 of 27, 7.4%) and hand and foot skin reaction (2 of 27, 7.4 %). Nine patients had to adjust treatment dosage. Conclusions: This updated results have confirmed the combination of anlotinib and etoposide showed significant efficacy and favorable safety profile. The combination may represent a new treatment option as maintenance treatment in patients with ES-SCLC having not progressed after the standard first-line EP chemotherapy. The further exploration is ongoing. Clinical trial information: ChiCTR1800019421.