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Article: A Dramatic Response to Second-Line Nivolumab and Ipilimumab in BRAF-V600-Mutated Metastatic Melanoma.

Fedele, Dahlia / Moroso, Stefano / Turoldo, Angelo / Bazzocchi, Gabriele / Conforti, Claudio / Zalaudek, Iris / Guglielmi, Alessandra

Case reports in oncology

2024 Volume 17, Issue 1, Page(s) 161–168

Abstract: Introduction: Current treatment options for BRAF V600-mutated unresectable stage III/IV melanoma include anti-PD-1 monotherapy or combination with anti-CTLA-4 or anti-LAG-3 agents, BRAF/MEK inhibitors, and clinical trials. The strategy of combination ... ...

Abstract	Introduction: Current treatment options for BRAF V600-mutated unresectable stage III/IV melanoma include anti-PD-1 monotherapy or combination with anti-CTLA-4 or anti-LAG-3 agents, BRAF/MEK inhibitors, and clinical trials. The strategy of combination immunotherapy with nivolumab and ipilimumab has shown promising results, achieving higher response rates, longer duration of response, improved progression-free survival, and enhanced overall survival. The optimal sequence of treatments remains a topic of interest, with preliminary data suggesting a greater effectiveness of immunotherapy as the first-line approach. Preclinical trials have indicated that the efficacy of this sequence may be due to the modification of the immune environment by BRAF kinase inhibitors, leading to immune escape by tumor cells and resistance to immune checkpoint inhibitors. Case presentation: We present a case of a 72-year-old woman with high-burden metastatic melanoma who failed to respond to prior targeted therapy with BRAF/MEK inhibitors and exhibited a successful response to the second-line treatment with ipilimumab and nivolumab. We discuss the potential reasons for this positive outcome contributing to the current debate concerning treatment sequences, resistance mechanisms, and biomarkers predictive of response to immune checkpoint inhibitors in metastatic melanoma. Conclusion: We believe that in few years the therapeutic algorithms in BRAF V600-mutated unresectable stage III/IV melanoma will be more complex since they will define clearly the correct therapeutic sequences with the inclusion of new immune checkpoint inhibitor drugs and multiple predictive biomarkers of response to better select patients eligible to immunotherapy.
Language	English
Publishing date	2024-01-29
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2458961-5
ISSN	1662-6575
ISSN	1662-6575
DOI	10.1159/000535902
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Article ; Online: Pharmacology and therapeutic efficacy of capecitabine: focus on breast and colorectal cancer.

Aprile, Giuseppe / Mazzer, Micol / Moroso, Stefano / Puglisi, Fabio

Anti-cancer drugs

2009 Volume 20, Issue 4, Page(s) 217–229

Abstract: Capecitabine (N -pentyloxycarbonyl-5-deoxy-5-fluorocytidine), an oral prodrug of 5-fluorouracil, has provided compelling efficacy data for the treatment of metastatic breast cancer and stage III or IV colorectal cancer, both as monotherapy and in ... ...

Abstract	Capecitabine (N -pentyloxycarbonyl-5-deoxy-5-fluorocytidine), an oral prodrug of 5-fluorouracil, has provided compelling efficacy data for the treatment of metastatic breast cancer and stage III or IV colorectal cancer, both as monotherapy and in combination regimens. The preferential conversion of capecitabine to 5-fluorouracil in neoplastic tissues renders this fluoropyrimidine particularly appealing for clinical use. The enzyme thymidine phosphorylase, which mediates the final step of the capecitabine activation pathway, is expressed in higher concentration in neoplastic than in healthy tissues. This makes capecitabine more tumor specific than other chemotherapeutic agents. Accordingly, capecitabine is generally well tolerated. In particular, the incidence of myelosuppression and alopecia is low, and the most common side effects, hand-foot syndrome and diarrhea, are usually manageable. Given its good toxicity profile, capecitabine was assessed in combination with several chemotherapeutic or biologic agents. In addition, the observation that thymidine phosphorylase is upregulated after treatment with other anticancer drugs, namely taxanes, provided a rationale for the prominent antitumor activity recently observed for the combination of capecitabine with these agents. This review provides an evidence-based update of clinical trials investigating the role of capecitabine in the treatment of breast and colorectal cancer, with special emphasis on pharmacological and safety issues that form the basis of currently used schedules.
MeSH term(s)	Antimetabolites, Antineoplastic/adverse effects ; Antimetabolites, Antineoplastic/pharmacology ; Antimetabolites, Antineoplastic/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Breast Neoplasms/drug therapy ; Capecitabine ; Clinical Trials as Topic ; Colorectal Neoplasms/drug therapy ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Deoxycytidine/pharmacology ; Deoxycytidine/therapeutic use ; Drug Delivery Systems ; Female ; Fluorouracil/adverse effects ; Fluorouracil/analogs & derivatives ; Fluorouracil/pharmacology ; Fluorouracil/therapeutic use ; Humans ; Neoplasm Metastasis ; Prodrugs
Chemical Substances	Antimetabolites, Antineoplastic ; Prodrugs ; Deoxycytidine (0W860991D6) ; Capecitabine (6804DJ8Z9U) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2009-04
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1065301-6
ISSN	1473-5741 ; 0959-4973
ISSN (online)	1473-5741
ISSN	0959-4973
DOI	10.1097/CAD.0b013e3283293fd4
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Article ; Online: The HERBA Study: A Retrospective Multi-Institutional Italian Study on Patients With Brain Metastases From HER2-Positive Breast Cancer.

Clinical breast cancer

2019 Volume 19, Issue 4, Page(s) e501–e510

Abstract: Background: There is no sufficient evidence to establish a standard of care for patients with brain metastases (BM) from HER2: Patients and methods: Data of 154 patients were retrospectively collected at 14 Italian institutions through a specifically ...

Abstract	Background: There is no sufficient evidence to establish a standard of care for patients with brain metastases (BM) from HER2 Patients and methods: Data of 154 patients were retrospectively collected at 14 Italian institutions through a specifically designed database. Results: Median overall survival (OS) was 24.5 months. Patients receiving surgery/stereotactic radiosurgery experienced longer OS compared to those receiving whole-brain radiotherapy or no treatment (33.5 vs. 11.4 months; hazard ratio = 0.34; 95% confidence interval, 0.22-0.52; P < .001). Interestingly, whole-brain radiotherapy did not improve OS compared to no treatment (11.4 vs. 9.8 months; hazard ratio = 0.99; 95% confidence interval, 0.62-1.62; P = .99). HER2-targeted therapy was associated with better OS compared to systemic therapy without HER2-targeted therapy or no systemic therapy (27.5 vs. 5.4 months; hazard ratio = 0.26; 95% confidence interval, 0.17-0.41; P < .001). At multivariate analysis stratified by local treatments, systemic therapy, Karnofsky performance status, and neurologic symptoms significantly affected OS. Age, number of BM, steroid therapy, number of previous lines of systemic therapy, status of extracranial disease, and period of diagnosis had no significant impact on OS. Conclusion: Patients with BM from HER2
MeSH term(s)	Adult ; Aged ; Biomarkers, Tumor/metabolism ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Breast Neoplasms/therapy ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Neoplasm Recurrence, Local/metabolism ; Neoplasm Recurrence, Local/pathology ; Neoplasm Recurrence, Local/therapy ; Prognosis ; Receptors, Estrogen/metabolism ; Retrospective Studies ; Survival Rate
Chemical Substances	Biomarkers, Tumor ; Receptors, Estrogen
Language	English
Publishing date	2019-05-18
Publishing country	United States
Document type	Journal Article ; Multicenter Study
ZDB-ID	2106734-X
ISSN	1938-0666 ; 1526-8209
ISSN (online)	1938-0666
ISSN	1526-8209
DOI	10.1016/j.clbc.2019.05.006
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Zs.A 5800: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Chemotherapy versus endocrine therapy as first-line treatment in patients with luminal-like HER2-negative metastatic breast cancer: A propensity score analysis.

Bonotto, Marta / Gerratana, Lorenzo / Di Maio, Massimo / De Angelis, Carmine / Cinausero, Marika / Moroso, Stefano / Milano, Monica / Stanzione, Brigida / Gargiulo, Piera / Iacono, Donatella / Minisini, Alessandro Marco / Mansutti, Mauro / Fasola, Gianpiero / De Placido, Sabino / Arpino, Grazia / Puglisi, Fabio

Breast (Edinburgh, Scotland)

2017 Volume 31, Page(s) 114–120

Abstract: Background: According to current guidelines, endocrine therapy (ET) is recommended as first-line treatment of luminal-like metastatic breast cancer (MBC), whereas chemotherapy (CT) should be considered in presence of life-threatening disease. In daily ... ...

Abstract	Background: According to current guidelines, endocrine therapy (ET) is recommended as first-line treatment of luminal-like metastatic breast cancer (MBC), whereas chemotherapy (CT) should be considered in presence of life-threatening disease. In daily practice, CT is often used outside of this clinical circumstance. Factors influencing first-line choice and the relative impact on outcome are unknown. Methods: A consecutive series of luminal-like HER2-negative MBC patients treated from 2004 to 2014 was analyzed to test the association of disease- and patient-related factors with the choice of first-line treatment (ET vs. CT). A propensity score method was used to estimate impact of first-line strategy on outcome. Results: Of 604 consecutive luminal-like MBC patients identified, 158 cases were excluded due to unknown or positive HER2-status. Among 446 HER2-negative cases, 171 (38%) received first-line CT. On multivariate analysis, the only factors significantly associated with lower CT use were old age (OR 0.25, 95%C.I. 0.13-0.49) or presence of bone metastases only (OR 0.26, 95%C.I. 0.13-0.53). In propensity score matched population, no differences were observed between CT and ET as first-line treatment either in terms of overall survival (37.5 months and 33.4 months respectively, log-rank test, P = 0.62) or progression-free survival (13.3 months and 9.9 months respectively, log-rank test, P = 0.92). Conclusions: High percentage of patients with luminal-like MBC received CT as first-line therapy in real-life. The choice was mainly driven by age and site of metastases. With the limitations of a non-randomized comparison, no differences on patients' outcome were observed depending on the first-line strategy.
MeSH term(s)	Age Factors ; Aged ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/chemistry ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Disease-Free Survival ; Female ; Hormone Antagonists/therapeutic use ; Humans ; Middle Aged ; Multivariate Analysis ; Neoplasm Metastasis ; Propensity Score ; Receptor, ErbB-2/analysis ; Retrospective Studies ; Treatment Outcome
Chemical Substances	Antineoplastic Agents ; Hormone Antagonists ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2017-02
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article
ZDB-ID	1143210-x
ISSN	1532-3080 ; 0960-9776
ISSN (online)	1532-3080
ISSN	0960-9776
DOI	10.1016/j.breast.2016.10.021
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Zs.A 3620: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Breakthrough Cancer Pain Clinical Features and Differential Opioids Response: A Machine Learning Approach in Patients With Cancer From the IOPS-MS Study.

Pantano, Francesco / Manca, Paolo / Armento, Grazia / Zeppola, Tea / Onorato, Angelo / Iuliani, Michele / Simonetti, Sonia / Vincenzi, Bruno / Santini, Daniele / Mercadante, Sebastiano / Marchetti, Paolo / Cuomo, Arturo / Caraceni, Augusto / Mediati, Rocco Domenico / Vellucci, Renato / Mammucari, Massimo / Natoli, Silvia / Lazzari, Marzia / Dauri, Mario /

Adile, Claudio / Airoldi, Mario / Azzarello, Giuseppe / Blasi, Livio / Chiurazzi, Bruno / Degiovanni, Daniela / Fusco, Flavio / Guardamagna, Vittorio / Liguori, Simeone / Palermo, Loredana / Mameli, Sergio / Masedu, Francesco / Mazzei, Teresita / Melotti, Rita Maria / Menardo, Valentino / Miotti, Danilo / Moroso, Stefano / Pascoletti, Gaetano / De Santis, Stefano / Orsetti, Remo / Papa, Alfonso / Ricci, Sergio / Scelzi, Elvira / Sofia, Michele / Aielli, Federica / Valle, Alessandro / Tonini, Giuseppe

JCO precision oncology

2020 Volume 4

Abstract: Purpose: A large proportion of patients with cancer suffer from breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, such as optimal opioid dosages, are being investigated. In this analysis the hypothesis, we explore ... ...

Abstract	Purpose: A large proportion of patients with cancer suffer from breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, such as optimal opioid dosages, are being investigated. In this analysis the hypothesis, we explore with an unsupervised learning algorithm whether distinct subtypes of BTcP exist and whether they can provide new insights into clinical practice. Methods: Partitioning around a k-medoids algorithm on a large data set of patients with BTcP, previously collected by the Italian Oncologic Pain Survey group, was used to identify possible subgroups of BTcP. Resulting clusters were analyzed in terms of BTcP therapy satisfaction, clinical features, and use of basal pain and rapid-onset opioids. Opioid dosages were converted to a unique scale and the BTcP opioids-to-basal pain opioids ratio was calculated for each patient. We used polynomial logistic regression to catch nonlinear relationships between therapy satisfaction and opioid use. Results: Our algorithm identified 12 distinct BTcP clusters. Optimal BTcP opioids-to-basal pain opioids ratios differed across the clusters, ranging from 15% to 50%. The majority of clusters were linked to a peculiar association of certain drugs with therapy satisfaction or dissatisfaction. A free online tool was created for new patients' cluster computation to validate these clusters in future studies and provide handy indications for personalized BTcP therapy. Conclusion: This work proposes a classification for BTcP and identifies subgroups of patients with unique efficacy of different pain medications. This work supports the theory that the optimal dose of BTcP opioids depends on the dose of basal opioids and identifies novel values that are possibly useful for future trials. These results will allow us to target BTcP therapy on the basis of patient characteristics and to define a precision medicine strategy also for supportive care.
Language	English
Publishing date	2020-11-04
Publishing country	United States
Document type	Journal Article
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.20.00158
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Article ; Online: Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS).

Mercadante, Sebastiano / Marchetti, Paolo / Cuomo, Arturo / Caraceni, Augusto / Mediati, Rocco Domenico / Mammucari, Massimo / Natoli, Silvia / Lazzari, Marzia / Dauri, Mario / Airoldi, Mario / Azzarello, Giuseppe / Bandera, Mauro / Blasi, Livio / Cartenì, Giacomo / Chiurazzi, Bruno / Costanzo, Benedetta Veruska Pierpaola / Degiovanni, Daniela / Fusco, Flavio / Guardamagna, Vittorio /

Advances in therapy

2016 Volume 34, Issue 1, Page(s) 120–135

Abstract: Introduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first ... ...

Abstract	Introduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here. Methods: Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity. Results: Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids. Conclusions: These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients' satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients. Funding: Molteni Farmaceutici, Italy.
MeSH term(s)	Adult ; Aged ; Algorithms ; Analgesics, Opioid/therapeutic use ; Breakthrough Pain/diagnosis ; Breakthrough Pain/drug therapy ; Breakthrough Pain/therapy ; Cancer Pain/diagnosis ; Cancer Pain/drug therapy ; Cancer Pain/epidemiology ; Cancer Pain/therapy ; Female ; Humans ; Italy/epidemiology ; Male ; Middle Aged ; Pain Management/methods ; Pain Measurement ; Patient Satisfaction ; Surveys and Questionnaires
Chemical Substances	Analgesics, Opioid
Language	English
Publishing date	2016-11-21
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-016-0440-4
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Article: Factors Influencing the Clinical Presentation of Breakthrough Pain in Cancer Patients.

Mercadante, Sebastiano / Marchetti, Paolo / Cuomo, Arturo / Caraceni, Augusto / Mediati, Rocco Domenico / Vellucci, Renato / Mammucari, Massimo / Natoli, Silvia / Lazzari, Marzia / Dauri, Mario / Adile, Claudio / Airoldi, Mario / Azzarello, Giuseppe / Bandera, Mauro / Blasi, Livio / Cartenì, Giacomo / Chiurazzi, Bruno / Costanzo, Benedetta Veruska Pierpaola / Degiovanni, Daniela /

Cancers

2018 Volume 10, Issue 6

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2018-06-01
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers10060175
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Article: A Dramatic Response to Second-Line Nivolumab and Ipilimumab in BRAF-V600-Mutated Metastatic Melanoma.

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Article ; Online: Pharmacology and therapeutic efficacy of capecitabine: focus on breast and colorectal cancer.

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Article ; Online: The HERBA Study: A Retrospective Multi-Institutional Italian Study on Patients With Brain Metastases From HER2-Positive Breast Cancer.

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Article ; Online: Chemotherapy versus endocrine therapy as first-line treatment in patients with luminal-like HER2-negative metastatic breast cancer: A propensity score analysis.

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Article ; Online: Breakthrough Cancer Pain Clinical Features and Differential Opioids Response: A Machine Learning Approach in Patients With Cancer From the IOPS-MS Study.

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Article ; Online: Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS).

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Article: Factors Influencing the Clinical Presentation of Breakthrough Pain in Cancer Patients.

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