Alpelisb for the treatment of PIK3CA-mutated, recurrent/advanced cervical cancer (142)

Abstract

<b>Objectives:</b> 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 two lines of treatment. <b>Methods:</b> The Istituto Nazionale dei Tumori di Milano approved this prospective investigation. From April 1, 2020, to September 1, 2020, 17 consecutive patients with recurrent cervical cancer had next-generation sequencing (NGS). Patients harboring <i>PIK3CA</i> mutation were included in the study. <b>Results:</b> Overall, six patients were included in the study. All patients had been treated with at least two previous lines of systemic treatment: three patients received >2 prior lines of treatment in the recurrent or metastatic setting. Among the patients, 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 (<i>n</i>=1, 20%) and rash (<i>n</i>=1, 20%). No treatment-related grade 4-5 AEs occurred. <b>Conclusions:</b> Alpelisb has promising antitumor activity in <i>PIK3CA</i>-mutated cervical cancer. Further trials are needed to assess the safety and effectiveness of alpelisib in <i>PIK3CA</i>-mutated recurrent/advanced cervical cancer.