Abstract 18P
Background
Advanced/recurrent cervical cancer has limited therapeutic options, with a median progression-free survival after the failure of systemic treatments ranging between 3.5 and 4.5 months. Here, we reported our preliminary experience in the use of BYL719 (alpelisib) in advanced/recurrent cervical cancer after failure of at least 2 lines of treatment.
Methods
This is a prospective trial testing the role of alpelisib in PIK3CA mutated patients. The Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (Italy) approved this prospective investigation (IRB number 20205720).
Results
From April 2020 to September 2020, 17 consecutive patients with recurrent cervical cancer had next-generation sequencing (NGS). Patients harboring PIK3CA mutation were included in the study. Overall, six patients were included in the study. All patients had been treated with at least 2 previous lines of systemic treatment: 3 patients received >2 prior lines of treatment in the recurrent or metastatic setting; 60% had received prior bevacizumab in combination with chemotherapy. All patients started alpelisib at the daily dosage of 300 mg. Investigator-assessed confirmed objective response rate (ORR) was 33%. The disease control rate (DCR) was 100%. According to RECIST 1.1, two patients had a partial response (PR), and four patients had stable disease (SD). No complete response was observed. The mean duration of response (DOR) was 11.5 (SD 3.75) months; five patients had PR lasting for >9 months. One patient stopped the treatment at 0.82 months due to the onset of a grade 2 adverse event (AE) (skin rash). Grade 3 treatment-related AEs included: lymphoedema (n=1, 20%) and rash (n=1, 20%). No treatment-related grade 4-5 AEs occurred.
Conclusions
Alpelisb seems associated with promising anti-tumor activity in cervical cancer patients harboring PIK3CA mutation. Further prospective trials are needed to assess the safety and effectiveness of alpelisib in PIK3CA-mutated pre-treated cervical cancer.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.