Article Text

Download PDFPDF

57 Alpelisib for recurrent PIK3CA-mutated recurrent cervcial cancer
  1. G Bogani1,
  2. A Indini2,
  3. M Bini1 and
  4. F Raspagliesi1
  1. 1Fondazione IRCCS Istituto Nazionale dei Tumori , Milano, Italy
  2. 2Policlinico di Milano, Medical Oncology, Milan, Italy


Introduction/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 BYL719 (alpelisib) in advanced/recurrent cervical cancer after failure of at least 2 lines of treatment.

Methodology The Fondazione IRCCS 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 next generation sequencing (NGS) to assess the presence of PIK3CA mutation/alteration.

Result(s)*Overall, 17 patients were tested for PIK3CA mutation/alteration. PIK3CA mutation was detected in seven (41%) patients. Six patients were included in the study; one patient was diagnosed with a synchronous tumor during the screening phase. 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.

Conclusion*Further trials are needed to assess the safety and effectiveness of alpelisib in PIK3CA-mutated recurrent/advanced cervical cancer

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.