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Survival of Patients with Metastatic Melanoma Treated with Ipilimumab after PD-1 Inhibitors: A Single-Center Real-World Study
by
, , and
Sofia Verkhovskaia
1,
Rosa Falcone
1,
Francesca Romana Di Pietro
1,
Maria Luigia Carbone
2,*,
Tonia Samela
3,
Marie Perez
4,
Giulia Poti
1,
Maria Francesca Morelli
1,
Albina Rita Zappalà
1,
Zorika Christiana Di Rocco
1,
Roberto Morese
1,
Gabriele Piesco
1,
Paolo Chesi
1,
Paolo Marchetti
1,
Damiano Abeni
3,
Cristina Maria Failla
5,† and
Federica De Galitiis
1,† 1
Department of Oncology, Istituto Dermopatico dell'Immacolata IDI-IRCCS, 00167 Rome, Italy
2
Clinical Trial Center, Istituto Dermopatico dell'Immacolata IDI-IRCCS, 00167 Rome, Italy
3
Epidemiology Units, Istituto Dermopatico dell'Immacolata IDI-IRCCS, 00167 Rome, Italy
4
Department of Histopathology, Istituto Dermopatico dell'Immacolata IDI-IRCCS, 00167 Rome, Italy
5
Experimental Immunology Laboratory, Istituto Dermopatico dell'Immacolata IDI-IRCCS, 00167 Rome, Italy
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Cancers 2024, 16(19), 3397; https://doi.org/10.3390/cancers16193397
Submission received: 5 August 2024
/
Revised: 27 September 2024
/
Accepted: 2 October 2024
/
Published: 4 October 2024
(This article belongs to the Special Issue Role of Immune Checkpoint Inhibitors or Targeted Therapy in the Treatment of Patients with Melanoma Volume II)
Simple Summary
This research was conducted to evaluate the impact of ipilimumab treatment in patients with metastatic melanoma when monotherapy with PD-1 inhibitors has failed. In particular, the aim was to evaluate the efficacy of ipilimumab in this setting based on the presence or absence of BRAF or NRAS mutations. The present study could allow us to understand when salvage treatment with ipilimumab would have the best impact, although an analysis on a larger patient cohort would be necessary.
Abstract
Background: When monotherapy with PD-1 inhibitors in metastatic melanoma fails, there are currently no standard second-line choices. In case of the unavailability of clinical trials, ipilimumab represents a possible alternative treatment. Methods: We collected data of 44 patients who received ipilimumab after the failure of PD-1 inhibitors from July 2017 to May 2023 at our Institute. Overall survival (OS), progression-free survival (PFS), and post-progression survival (PPS) based on BRAF or NRAS mutation status, sex, and the presence of brain metastases were estimated using the Kaplan–Meier method. Cox regression was used to evaluate independence in multivariate analysis. The objective response rate (ORR) was estimated based on RECIST 1.1. Results: Among the 44 patients enrolled in this study, 28 BRAF-wildtype, 9 BRAF-mutated, and 7 NRAS-mutated patients were identified. OS analysis showed a significant difference between wildtype and BRAF- or NRAS-mutated patients: 23.2 months vs 5.3 and 4.59, respectively, p = 0.017. The presence of brain metastases and BRAF or NRAS mutation were independent factors for mortality in multivariate analysis. Conclusions: In case of failure to enroll patients in innovative clinical trials, second-line ipilimumab still represents an effective therapy in patients with metastatic wildtype melanoma and in the absence of brain metastases.
Keywords:
melanoma; immunotherapy; BRAF; NRAS; ipilimumab
