A real-world analysis of the effectiveness of pembrolizumab by type of associated treatment in patients with metastatic cervical cancer: Added value of bevacizumab.
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
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (20)
Alberto Farolfi
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy
Chiara Casadei
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 ...
Eleonora Paoletti
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Michela Palleschi
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Daniela Montanari
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Giulia Miserocchi
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Gema Hernández
TriNetX Europe, Madrid, Spain
Nicola Gentili
9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy
Marita Mariotti
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Sara Testoni
Data Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Giandomenico Di Menna
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Francesca Rusconi
TriNetX Europe, Milan, Italy
Alice Andalò
9Instituto Romagnolo per lo Studio dei Tumori, Meldola, Italy
Filippo Merloni
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Marianna Sirico
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Roberta Maltoni
Lorenzo Cecconetto
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Samanta Sarti
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy
Antonino Musolino
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, Italy