Abstract 778P
Background
Advanced/recurrent cervical cancer has limited therapeutic options, with a median progression-free survival (PFS) after the failure of systemic treatments ranging between 3.5 and 4.5 months. Here, we reported our preliminary experience in the use of BUL719 (alpelisib) in advanced/recurrent cervical cancer after failure of at least 2 lines of treatment.
Methods
The Istituto Nazionale dei Tumori di Milano (Italy) approved this prospective investigation. From 04/01/2020 to 09/01/2020, 17 consecutive patients with recurrent cervical cancer underwent NGS to assess the presence of PIK3CA mutation/alteration.
Results
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 the 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 6.6 (SD 3.75) months; four patients had PR lasting for >6 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
Further trials are needed to assess the safety and effectiveness of alpelisib in PIK3CA-mutated recurrent/advanced cervical cancer.
Clinical trial identification
IRB number 20205720.
Editorial acknowledgement
None
Legal entity responsible for the study
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.