A real-world analysis of the effectiveness of pembrolizumab by type of associated treatment in patients with metastatic cervical cancer: Added value of bevacizumab.

A Alberto Farolfi (IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy) C Chiara Casadei C Caterina Gianni (Milena Urbini, PhD, Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Thomas F. Eleveld, PhD, Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Maurizio Polano, PhD, Experimental and Clinical Pharmacology Unit, IRCCS Centro di Riferimento Oncologico di Aviano (CRO), Aviano, Italy; Emanuela Scarpi, PhD, Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Cecilia Menna, MD, and Caterina Gianni, MD, Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Ferdinand W. Janssen, MSc, Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Giuseppe Schepisi, MD, Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Giorgia Gurioli, PhD, Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei ...) E Eleonora Paoletti (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) M Michela Palleschi (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) D Daniela Montanari (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) G Giulia Miserocchi (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) G Gema Hernández (TriNetX Europe, Madrid, Spain) N Nicola Gentili (9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy) M Marita Mariotti (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) S Sara Testoni (Data Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy) G Giandomenico Di Menna (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) F Francesca Rusconi (TriNetX Europe, Milan, Italy) A Alice Andalò (9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy) F Filippo Merloni (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) M Marianna Sirico (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) R Roberta Maltoni L Lorenzo Cecconetto (IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy) S Samanta Sarti (IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy) A Antonino Musolino (IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, Italy)

Abstract

5531 Background: Pembrolizumab (pembro) showed a statistical significant survival benefit in persistent, recurrent, or metastatic cervical cancer (CC) when added to chemotherapy. In this real-world study we aimed to evaluate if the effectiveness of pembro may vary according to the type of platinum used or by the incorporation of bevacizumab (bev). Methods: The analysis was conducted with the TriNetX Global Collaborative Network. In our study, we defined different cohort of patients by type of platinum (cisplatin or carboplatin) and bev use (yes or no). First, we compared 597 CC patients treated cisplatin with 1.080 CC patients treated with carboplatin, in addition to paclitaxel and pembro. After this analyses, we evaluated the addition of bev (701 patients) to a platinum-based regimen compared to a cohort of patients treated without bev (562 patients). A propensity score matching (PSM) was used to balance the cohorts by age, race, previous radiotherapy, body mass index and treatment (bev for first analyses and cisplatin for the second). Subsequently, a COX analyses, adjusted for the same factors, was used in unmatched cohorts to validate our results. Hazard ratio (HR) was used to compare the overall survival (OS) and the development of fistulae, bowel perforation or pulmonary embolism (PE) in the matched cohorts. Results: PSM generated 583 pairs of CC patients treated with cisplatin (mean age of 50.6, +/-12.6 standard deviation, SD) or carboplatin (mean age of 50.2, +/-12.7 SD). Median OS was not statistical different between the groups (HR 0.92, 95% CI 0.75-1.28), confirmed also by the Cox model (HR 0.95, 95% CI 0.79-1.15). Among the 386 matched pairs of CC patients treated with (mean age of 53.8, +/-13.1 SD) or without bev (mean age of 53.8, +/-13.4 SD), median OS was 35.7 months versus 20.1 months (HR 0.64, 95% CI 0.49–0.84, p = 0.001), without differences in the rate of fistulae (HR 0.77, 95% CI 0.50-1.18), but an increased risk in bowel perforation (HR 3.08, 95% CI 1.01-9.38, p = 0.037) and a lower risk of PE (HR 0.57, 95% CI 0.35-0.93, p = 0.022). In multivariate analyses, bev significantly reduced the risk of death (HR 0.75, 95% CI 0.61-0.94, p = 0.01). Conclusions: The survival rates associated with immunotherapy treatment in our real-world study are consistent with those reported in previous studies. Specifically, we showed that the effectiveness of pembro is not influenced by the type of platinum used. However, the addition of bev may extend OS in patients with CC, without increasing the risk of fistulae or PE.

Article Details

Volume / Issue Vol. 43, Issue 16_suppl
Published June 01, 2025
Pages 5531-5531
ISSN 0732-183X
Publisher Lippincott Williams & Wilkins

Journal Info

Journal of Clinical Oncology

Lippincott Williams & Wilkins

ISSN: 0732-183X Health Sciences

Authors (20)

A

Alberto Farolfi

IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy

C

Chiara Casadei

C

Caterina Gianni

Milena Urbini, PhD, Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Thomas F. Eleveld, PhD, Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Maurizio Polano, PhD, Experimental and Clinical Pharmacology Unit, IRCCS Centro di Riferimento Oncologico di Aviano (CRO), Aviano, Italy; Emanuela Scarpi, PhD, Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Cecilia Menna, MD, and Caterina Gianni, MD, Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Ferdinand W. Janssen, MSc, Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Giuseppe Schepisi, MD, Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy; Giorgia Gurioli, PhD, Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei ...

E

Eleonora Paoletti

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

M

Michela Palleschi

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

D

Daniela Montanari

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

G

Giulia Miserocchi

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

G

Gema Hernández

TriNetX Europe, Madrid, Spain

N

Nicola Gentili

9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy

M

Marita Mariotti

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

S

Sara Testoni

Data Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy

G

Giandomenico Di Menna

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

F

Francesca Rusconi

TriNetX Europe, Milan, Italy

A

Alice Andalò

9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy

F

Filippo Merloni

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

M

Marianna Sirico

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

R

Roberta Maltoni

L

Lorenzo Cecconetto

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

S

Samanta Sarti

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy

A

Antonino Musolino

IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, Italy