Pembrolizumab/Axitinib combination is approved as first-line therapy in mRCC. The aim of this study is to evaluate outcomes of PAXI combo in the real-world in Italy.
This is a prospective study including patients diagnosed with mRCC who received combination as first-line therapy in recruiting Italian Centers.
Data about patient characteristics, safety and outcome were collected.
170 pts have been treated from December 2020 to September 2023. The majority had clear-cell histology (83%). Sarcomatoid feature was present in 33%of available cases. About one half of patients (55%) had synchronous metastasis. In 58% of cases nephrectomy was performed, of which 27% were cytoreductive and 4% were deferred nephrectomies. Lung metastases were identified in 106 patients (62%), bone and liver involvement in 66 and 29 patients (38.8% and 17.1%) respectively. Stratifying by IMDC criteria, 32 patients (18.8%) were at favorable-risk, 106 (62.4%) at intermediate-risk, and 32 (18.8%) at poor-risk. At time of analysis, treatment was ongoing in 49% of patients. Progression occurred in 45% of patients. Median PFS was 19.2 months (95% CI: 15-NR). With a median follow-up of 19.3 months (range 1.3-34.5), at 24-months and 36-months landmark analysis 62% (95% CI, 53-70) and 58% (95% CI, 47-69) of treated patients are still alive respectively. Disease control rate was achieved in 84.6% of patients: 4.3% reached a complete response, 52% had a partial response and 28.8% a stable disease. Primary progression was observed in 15.3% of patients. In the multivariate analysis, the prognostic significance of age ≥ 65 years, non-clear cell histology, IMDC score, and adverse events and gender interaction as predictors of worse OS were confirmed.
This is the first available prospective study on first-line Pembrolizumab/Axitinib combination in real world scenario. Our findings support the effectiveness and safety of first-line this combination in mRCC and reveal that gender emerged as a prognostic factor in relation to the occurrence of adverse events.
Clinical genitourinary cancer. 2024 Sep 14 [Epub ahead of print]
Annalisa Guida, Alessio Gili, Claudia Mosillo, Marco Maruzzo, Eleonora Lai, Francesco Pierantoni, Davide Bimbatti, Umberto Basso, Giuseppe Fornarini, Sara Elena Rebuzzi, Fabio CalabrĂ², Linda Cerbone, Claudia Caserta, Grazia Sirgiovanni, Debora Serafin, Orazio Caffo, Sarah Scagliarini, Sergio Bracarda
Dipartimento di Oncologia, Azienda Ospedaliera Santa Maria of Terni, Terni, Italy; Dipartimento di Oncologia, Oncology 1 Unit, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy. Electronic address: ., Department of Life Sciences, Health and Health Professions, link campus university Rome, Italy., Dipartimento di Oncologia, Azienda Ospedaliera Santa Maria of Terni, Terni, Italy., Dipartimento di Oncologia, Oncology 1 Unit, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy., Dipartimento di Oncologia, Oncology 3 Unit, Istituto Oncologico Veneto IOV - IRCCS, Castelfranco Veneto, Italy., Dipartimento di Oncologia, Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Dipartimento di Oncologia, Medical Oncology Unit, Ospedale San Paolo, Savona, Italy; Department of Internal Medicine and Medical Specialties, University of Genoa, Genoa, Italy., Department of Oncology, San Camillo Forlanini Hospital, Rome, Italy., Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Santa Chiara Hospital, Pisa, Italy., Department of Medical Oncology, Medical Oncology, Santa Chiara Hospital, Trento, Italy., Dipartimento integrato oncoematologico e toraco-polmonare, UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy.