Abstract 1220P
Background
Docetaxel is one of the standard second-line therapies for non-small cell lung cancer (NSCLC), but the clinical outcomes are poor. Anlotinib, a novel anti-angiogenesis agent, has been demonstrated to prolong both progression-free survival (PFS) and overall survival (OS) in advanced NSCLC as third-line treatment. Here, we performed ALTER-L018 to assess efficacy and safety of anlotinib plus docetaxel vs docetaxel in EGFR-negative NSCLC progressing after first-line platinum-based chemotherapy with or without immune checkpoint inhibitors (ICIs) treatment.
Methods
In this multicenter, randomized, phase II trial (NCT03624309), EGFR-negative NSCLC patients (pts) who failed after first-line platinum-based chemotherapy (with or without ICIs) were randomly assigned (1:1) to receive anlotinib (12mg QD on day 1-14, Q3W) plus docetaxel (75mg/m2 on day 1) (group A) or docetaxel (75mg/m2 on day 1) only (group D). The primary end point was PFS, and secondary end points included OS, ORR, DCR and safety.
Results
Between Jan 14, 2019, and Apr 26, 2021, 71 pts. were available for efficacy and safety analysis (Table). Median PFS were 4.26 months (95%CI: 2.82-5.70) in group A and 1.64 months (95%CI: 0.00-3.29) in group D (HR 0.31, 95% CI: 0.17-0.59; p<0.001); median OS were 16.16 months (95%CI: 2.98-29.34) in group A and 10.85 months (95%CI: 5.78-15.92) in group D (HR 0.97, 95% CI: 0.48-2.00; p=0.943). For tumor response, ORR and DCR were 36.67% vs 7.32% (p=0.002), 83.33% vs 53.66% (p=0.009) in group A and D, respectively. The most common ≥ grade 3 adverse events that possibly or definitely related to therapy included leucopenia (5, 15%), neutropenia (2, 6%), and thrombocytopenia (1, 3%) in group A, and leukopenia (1, 2%), neutropenia (1, 2%) in group D. Table: 1220P
Demographics
| Group A (n=33) | Group D (n=42) | |
| Median age, years | 53 (40-71) | 58 (39-74) |
| Age group, years | ||
| < 60 | 25 (76%) | 26 (62%) |
| ≥ 60 | 8 (24%) | 16 (38%) |
| Sex | ||
| Men | 28 (85%) | 34 (81%) |
| Women | 5 (15%) | 8 (19%) |
| Disease stage | ||
| III | 7 (21%) | 4 (10%) |
| IV | 26 (79%) | 38 (90%) |
| ECOG PS | ||
| 0 | 11 (33%) | 9 (21%) |
| 1 | 22 (67%) | 33 (79%) |
| Histologic subtype | ||
| ADC | 23 (70%) | 26 (62%) |
| Non-ADC | 10 (30%) | 16 (38%) |
| Smoking history | ||
| Never smoker | 7 (21%) | 12 (29%) |
| Former smoker | 20 (61%) | 22 (52%) |
| Current smoker | 6 (18%) | 8 (19%) |
| Front line treatment | ||
| Platinum-based chemotherapy with ICIs | 11 (33%) | 16 (38%) |
| Platinum-based chemotherapy | 22 (67%) | 26 (76%) |
*Data Cut-off: Apr 26, 2021
Conclusions
Anlotinib plus docetaxel is a feasible choice for relapsed NSCLC progressing after first-line platinum-based chemotherapy with or without ICIs, significantly improving survival and with manageable safety.
Clinical trial identification
NCT03624309.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.