Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial

Giacomo, Anna Maria Di; Ascierto, Paolo A.; Pilla, Lorenzo; Santinami, Mario; Ferrucci, Pier Francesco; Giannarelli, Diana; Marasco, Antonella; Rivoltini, Licia; Simeone, Ester; Nicoletti, Stefania Vittoria Luisa; Fonsatti, Ester; Annesi, Diego; Queirolo, Paola; Testori, Alessandro; Ridolfi, Ruggero; Parmiani, Giorgio; Maio, Michele

doi:10.1016/s1470-2045(12)70324-8

Cited by 272 publications

(161 citation statements)

References 28 publications

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“…9 The longterm follow-up analysis of these MM patients showed a median follow-up of 39.9 mo and a median OS of 12.9 mo, with 2-or 3-y survival for 33.4% and 28.5%, respectively. 10 The prospective multi-parametric immunomonitoring that was carried out for a group of MM patients enrolled in the NIBIT-M1 study allowed to identify novel immunological parameters associated with the clinical activity of the treatment.…”

Section: Discussionmentioning

confidence: 87%

“…[5][6][7][8] Of note, long-term clinical responses were achieved by the combination of IPI plus FTM in MM patients, including those with brain metastasis. 9,10 However, hallmarks of CTLA-4 blockade therapies are their unknown mechanisms of activity in vivo and that a relatively small subset (%20%) of patients can achieve a long-term survival. 11 Thus, biomarkers predictive of clinical responses from these treatments are needed to optimize patient's selection and for the possible combination with different agents.…”

Section: Introductionmentioning

confidence: 99%

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Immunological markers and clinical outcome of advanced melanoma patients receiving ipilimumab plus fotemustine in the NIBIT-M1 study

Maccalli

Giannarelli²,

Capocefalo³

et al. 2015

OncoImmunology

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Moreover, either the absence or the presence of soluble NKG2D ligands (ULBP-1 or ¡2) at baseline in the serum of MM patients enabled to discriminate subjects with long-term survival (median overall survival, (OS) D 33.6 mo for ULBP-1 and ¡2) from poor survivors (OS D 9.8 or 6.6 mo, respectively). Conversely, no significant association between the levels of soluble MICA, MICB and ULBP-3 and the clinical outcome of patients was observed. An inverse correlation between circulating levels of these molecules at baseline and frequency of either CD3 C CD4 C CD45RO C BTLA C or Th17 or CD3 C CD4 C 4-1BB C T cells occurred in patients with a favorable clinical outcome. The simultaneous monitoring of different immune parameters, though validation in a large cohort of patients is needed, allowed to identify an association between phenotypic and soluble markers representing a possible predictive immunological signature for the clinical activity of IPI plus FTM.

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Section: Discussionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Immunological markers and clinical outcome of advanced melanoma patients receiving ipilimumab plus fotemustine in the NIBIT-M1 study

Maccalli

Giannarelli²,

Capocefalo³

et al. 2015

OncoImmunology

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“…Chemotherapy 96 or radiotherapy 98 could induce a release of tumor antigens, thus increasing the antitumor activity of ipilimumab. An abscopal effect has been seen in melanoma patients, in whom radiotherapy for one lesion induced a shrinkage of non-irradiated lesions.…”

Section: Brain Metastases From Melanomamentioning

confidence: 99%

Diagnosis and treatment of brain metastases from solid tumors: guidelines from the European Association of Neuro-Oncology (EANO)

Soffietti

Abacıoğlu²,

Baumert³

et al. 2017

Neuro-Oncology

422

338

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The management of patients with brain metastases has become a major issue due to the increasing frequency and complexity of the diagnostic and therapeutic approaches. In 2014, the European Association of NeuroOncology (EANO) created a multidisciplinary Task Force to draw evidence-based guidelines for patients with brain metastases from solid tumors. Here, we present these guidelines, which provide a consensus review of evidence and recommendations for diagnosis by neuroimaging and neuropathology, staging, prognostic factors, and different treatment options. Specifically, we addressed options such as surgery, stereotactic radiosurgery/stereotactic fractionated radiotherapy, whole-brain radiotherapy, chemotherapy and targeted therapy (with particular attention to brain metastases from non-small cell lung cancer, melanoma and breast and renal cancer), and supportive care. Key wordsbrain metastases | chemotherapy | neuroimaging | neuropathology | stereotactic radiosurgery/stereotactic fractionated radiotherapy | supportive care | surgery | targeted therapy | whole-brain radiation therapy

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“…Hypophysitis was never diagnosed when ipilimumab, even at a dose of 10 mg/kg, was combined with chemotherapy in ant studies (30,44,45) except one (46). Similarly, hypophysitis was not reported in patients affected by advanced cutaneous melanoma with brain radiotherapy-pretreated metastases (47).…”

Section: Anti-ctla4-mabs and Pituitary Dysfunctionmentioning

confidence: 99%

ENDOCRINE SIDE-EFFECTS OF ANTI-CANCER DRUGS: mAbs and pituitary dysfunction: clinical evidence and pathogenic hypotheses

Torino

Barnabei

Paragliola

et al. 2013

European Journal of Endocrinology

108

103

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mAbs are established targeted therapies for several diseases, including hematological and solid malignancies. These agents have shown a favorable toxicity profile, but, despite their high selectivity, new typical side-effects have emerged. In cancer patients, pituitary dysfunction may be mainly due to brain metastases or primary tumors and to related surgery and radiotherapy. Anticancer agents may induce hypopituitarism in patients cured for childhood cancers. These agents infrequently affect pituitary function in adult cancer patients. Notably, hypophysitis, a previously very rare disease, has emerged as a distinctive side-effect of ipilimumab and tremelimumab, two mAbs inhibiting the cytotoxic T-lymphocyte antigen-4 receptor, being occasionally seen with nivolumab, another immune checkpoint inhibitor. Enhanced antitumor immunity is the suggested mechanism of action of these drugs and autoimmunity the presumptive mechanism of their toxicity. Recently, ipilimumab has been licensed for the treatment of patients affected by metastatic melanoma. With the expanding use of these drugs, hypophysitis will be progressively encountered by oncologists and endocrinologists in clinical practice. The optimal management of this potentially life-threatening adverse event needs a rapid and timely diagnostic and therapeutic intervention. Hypopituitarism caused by these agents is rarely reversible, requiring prolonged or lifelong substitutive hormonal treatment. Further studies are needed to clarify several clinical and pathogenic aspects of this new form of secondary pituitary dysfunction.European Journal of Endocrinology 169 R153-R164

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Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial

Cited by 272 publications

References 28 publications

Immunological markers and clinical outcome of advanced melanoma patients receiving ipilimumab plus fotemustine in the NIBIT-M1 study

Immunological markers and clinical outcome of advanced melanoma patients receiving ipilimumab plus fotemustine in the NIBIT-M1 study

Diagnosis and treatment of brain metastases from solid tumors: guidelines from the European Association of Neuro-Oncology (EANO)

ENDOCRINE SIDE-EFFECTS OF ANTI-CANCER DRUGS: mAbs and pituitary dysfunction: clinical evidence and pathogenic hypotheses

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