(Endometrial Cancer) Is Carboplatin Plus Paclitaxel ± Avelumab Effective?
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- February 22, 2023
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On February 14, 2023, Sandro Pignata and colleagues at the Istituto Nazionale Tumori published in the medical journal The Lancet the efficacy and safety results of the MITO END-3 Phase 2 trial evaluating first-line carboplatin plus paclitaxel ± avelumab in patients with advanced or recurrent endometrial cancer.
Trial Design
This randomized, open-label Phase 2 trial enrolled 125 patients with advanced or recurrent endometrial cancer and randomized them to:
- Carboplatin + Paclitaxel + Avelumab group: 6–8 cycles (3-week cycles), followed by avelumab maintenance therapy (2-week cycles) until adverse events occur (N=63)
- Carboplatin + Paclitaxel group: N=62
Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall survival (OS) and safety.
Efficacy Results
Median PFS:
- Carboplatin + Paclitaxel + Avelumab group: 9.6 months
- Carboplatin + Paclitaxel group: 9.9 months
Safety Profile
Serious adverse events:
- Carboplatin + Paclitaxel + Avelumab: 24 cases / Carboplatin + Paclitaxel: 7 cases
Most common Grade 3–4 adverse event (neutropenia):
- Carboplatin + Paclitaxel + Avelumab: 31% / Carboplatin + Paclitaxel: 43%
Conclusions
Based on the MITO END-3 Phase 2 trial results, Sandro Pignata and colleagues concluded that first-line carboplatin plus paclitaxel ± avelumab in patients with advanced or recurrent endometrial cancer warrants further investigation, although dMMR status needs to be taken into consideration.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00016-5/fulltext
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