Combined treatment with avelumab and axitinib for advanced type B3 thymoma and thymic carcinoma shows promise as second-line therapy after standard treatment.  |  Medicine in 2 Minutes

Combined treatment with avelumab and axitinib for advanced type B3 thymoma and thymic carcinoma shows promise as second-line therapy after standard treatment. | Medicine in 2 Minutes

1. Patients who had never received anti-angiogenesis therapy had longer progression-free survival

2. Adverse effects of the combination of avelumab and axitinib are mild and include abdominal pain, diarrhea, nausea and vomiting.

Level of evidence assessment: 2 (Good)

Summary of the study: Type B3 thymoma and thymic carcinoma are aggressive tumors with poor survival outcomes and there are not many treatment options available for advanced or metastatic disease. This study investigated the efficacy and safety of avelumab and axitinib, an anti-PD-L1 inhibitor and an anti-angiogenesis drug, respectively. The primary outcome of interest was overall response rate (ORR) and secondary outcomes included progression-free survival (PFS) and safety. The overall response rate was 34% (11 of 32 patients), but none achieved a complete response. There were 34% of patients who had a partial response. In 66% of patients, there was a decrease in tumor size. Patients who had never received anti-angiogenesis treatment had a higher ORR (47% versus 15%). The median progression-free survival was 7.5 months. The PFS at 6 months was 61.3% and that at 12 months was 29.0%. Patients who had never received anti-angiogenesis therapy had longer PFS (10.0 months versus 4.5 months). Safety was measured by adverse events (AEs), and most patients who experienced AEs had only mild symptoms, including abdominal pain, diarrhea, nausea, and vomiting. The most common serious AE was hypertension, noted in 19% of patients. Axitinib dose reductions were required in 25% of patients due to AEs. There were no treatment-related deaths. Limitations of this study include the small study size, which limits the interpretation of subgroup analyses. Additionally, late-onset AEs may not be appreciable in this follow-up period. Despite the attention paid to the safety parameters of this treatment, it is difficult to assess the impacts on health-related quality of life. Overall, the results of this study suggest that there may be benefit for avelumab and axitinib as second-line treatment after standard platinum-based chemotherapy treatment of advanced type B3 thymoma. and metastatic and thymic carcinoma.

Click to read the study in The Lancet Oncology

Relevant reading: Avelumab plus axitinib versus sunitinib for advanced renal cell carcinoma

In depth [randomized controlled trial]: This single-arm phase 2 trial was carried out in 2 health centers in Italy. The study enrolled 32 adult patients with type B3 thymoma or thymic carcinoma whose disease had progressed despite standard chemotherapy. The ORR was 34% (90% confidence interval (CI), 21-50%). In 26 patients with sufficient tumor burden to obtain a sample, subgroup analyzes of high, low, or negative tumor PD-L1 expression showed similar ORR between subgroups (38%, 33%, and 28% respectively). The ORR was 47% (90% CI, 27-68%) in 19 patients who had not previously received anti-angiogenesis agents, compared with 15% in 13 patients who had previously received anti-angiogenic therapy ( 90% CI, 3-41%). The median duration of follow-up for PFS was 22.4 months. The median PFS was 7.5 months (90% CI, 3.7-10.0 months) while the 6-month PFS was 61.3% (90% CI, 45.3-73.9 %) and at 12 months it was 29.0% (90% CI, 16.0-43.4%). Post-hoc analysis of subgroups of patients treatment-naive with anti-angiogenesis agents showed a median PFS of 10.0 months (90% CI, 7.4-13.1 months) compared to 4.5 months for those who received (90% CI, 2.4-7.5 months; relative risk (RR) 0.56, 90% CI, 0.28-1.09). PFS was not associated with PD-L1 expression when patients were grouped by low versus high expression or negative status (PFS HR, 1.07; 90% CI 0.51- 2.26).

Picture: PD

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