Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy)

Anna Maria Di Giacomo, Riccardo Danielli, Luana Calabrò, Erica Bertocci, Chiara Nannicini, Diana Giannarelli, Angelo Balestrazzi, Francesco Vigni, Valentina Riversi, Clelia Miracco, Maurizio Biagioli, Maresa Altomonte, Michele Maio

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Aim of study: To evaluate the feasibility of ipilimumab treatment for metastatic melanoma outside the boundaries of clinical trials, in a setting similar to that of daily practice. Methods: Ipilimumab was available upon physician request in the Expanded Access Programme for patients with life-threatening, unresectable stage III/IV melanoma who failed or did not tolerate previous treatments and for whom no therapeutic option was available. Induction treatment with ipilimumab 10 mg/kg was administered intravenously every 3 weeks, for a total of 4 doses, with maintenance doses every 12 weeks based on physicians' discretion and clinical judgment. Tumors were assessed at baseline, Week 12, and every 12 weeks thereafter per mWHO response criteria, and clinical response was scored as complete response (CR), partial response (PR), stable disease (SD), or progressive disease. Durable disease control (DC) was defined as SD at least 24 weeks from the first dose, CR, or PR. Results: Disease control rate at 24 and 60 weeks was 29.6% and 15%, respectively. Median overall survival at a median follow-up of 8.5 months was 9 months. The 1- and 2-year survival rates were 34.8% and 23.5%, respectively. Changes in lymphocyte count slope and absolute number during ipilimumab treatment appear to correlate with clinical response and survival, respectively. Adverse events were predominantly immune related, manageable, and generally reversible. One patient died from pancytopenia, considered possibly treatment related. Conclusion: Ipilimumab was a feasible treatment for malignant melanoma in heavily pretreated, progressing patients. A sizeable proportion of patients experienced durable DC, including benefits to long-term survival.

Original languageEnglish
Pages (from-to)467-477
Number of pages11
JournalCancer Immunology, Immunotherapy
Volume60
Issue number4
DOIs
Publication statusPublished - Apr 2011

Fingerprint

Italy
Melanoma
Therapeutics
Survival
Physicians
Pancytopenia
Lymphocyte Count
ipilimumab
Survival Rate
Clinical Trials
Neoplasms

Keywords

  • Advanced melanoma
  • Compassionate use
  • Cytotoxic T-lymphocyte antigen 4
  • Immunotherapy
  • Ipilimumab
  • Monoclonal antibody

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Immunology
  • Immunology and Allergy

Cite this

Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy). / Di Giacomo, Anna Maria; Danielli, Riccardo; Calabrò, Luana; Bertocci, Erica; Nannicini, Chiara; Giannarelli, Diana; Balestrazzi, Angelo; Vigni, Francesco; Riversi, Valentina; Miracco, Clelia; Biagioli, Maurizio; Altomonte, Maresa; Maio, Michele.

In: Cancer Immunology, Immunotherapy, Vol. 60, No. 4, 04.2011, p. 467-477.

Research output: Contribution to journalArticle

Di Giacomo, AM, Danielli, R, Calabrò, L, Bertocci, E, Nannicini, C, Giannarelli, D, Balestrazzi, A, Vigni, F, Riversi, V, Miracco, C, Biagioli, M, Altomonte, M & Maio, M 2011, 'Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy)', Cancer Immunology, Immunotherapy, vol. 60, no. 4, pp. 467-477. https://doi.org/10.1007/s00262-010-0958-2
Di Giacomo, Anna Maria ; Danielli, Riccardo ; Calabrò, Luana ; Bertocci, Erica ; Nannicini, Chiara ; Giannarelli, Diana ; Balestrazzi, Angelo ; Vigni, Francesco ; Riversi, Valentina ; Miracco, Clelia ; Biagioli, Maurizio ; Altomonte, Maresa ; Maio, Michele. / Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy). In: Cancer Immunology, Immunotherapy. 2011 ; Vol. 60, No. 4. pp. 467-477.
@article{c5c41d24f2304ce3af991b596887f138,
title = "Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy)",
abstract = "Aim of study: To evaluate the feasibility of ipilimumab treatment for metastatic melanoma outside the boundaries of clinical trials, in a setting similar to that of daily practice. Methods: Ipilimumab was available upon physician request in the Expanded Access Programme for patients with life-threatening, unresectable stage III/IV melanoma who failed or did not tolerate previous treatments and for whom no therapeutic option was available. Induction treatment with ipilimumab 10 mg/kg was administered intravenously every 3 weeks, for a total of 4 doses, with maintenance doses every 12 weeks based on physicians' discretion and clinical judgment. Tumors were assessed at baseline, Week 12, and every 12 weeks thereafter per mWHO response criteria, and clinical response was scored as complete response (CR), partial response (PR), stable disease (SD), or progressive disease. Durable disease control (DC) was defined as SD at least 24 weeks from the first dose, CR, or PR. Results: Disease control rate at 24 and 60 weeks was 29.6{\%} and 15{\%}, respectively. Median overall survival at a median follow-up of 8.5 months was 9 months. The 1- and 2-year survival rates were 34.8{\%} and 23.5{\%}, respectively. Changes in lymphocyte count slope and absolute number during ipilimumab treatment appear to correlate with clinical response and survival, respectively. Adverse events were predominantly immune related, manageable, and generally reversible. One patient died from pancytopenia, considered possibly treatment related. Conclusion: Ipilimumab was a feasible treatment for malignant melanoma in heavily pretreated, progressing patients. A sizeable proportion of patients experienced durable DC, including benefits to long-term survival.",
keywords = "Advanced melanoma, Compassionate use, Cytotoxic T-lymphocyte antigen 4, Immunotherapy, Ipilimumab, Monoclonal antibody",
author = "{Di Giacomo}, {Anna Maria} and Riccardo Danielli and Luana Calabr{\`o} and Erica Bertocci and Chiara Nannicini and Diana Giannarelli and Angelo Balestrazzi and Francesco Vigni and Valentina Riversi and Clelia Miracco and Maurizio Biagioli and Maresa Altomonte and Michele Maio",
year = "2011",
month = "4",
doi = "10.1007/s00262-010-0958-2",
language = "English",
volume = "60",
pages = "467--477",
journal = "Cancer Immunology and Immunotherapy",
issn = "0340-7004",
publisher = "Springer Science and Business Media Deutschland GmbH",
number = "4",

}

TY - JOUR

T1 - Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy)

AU - Di Giacomo, Anna Maria

AU - Danielli, Riccardo

AU - Calabrò, Luana

AU - Bertocci, Erica

AU - Nannicini, Chiara

AU - Giannarelli, Diana

AU - Balestrazzi, Angelo

AU - Vigni, Francesco

AU - Riversi, Valentina

AU - Miracco, Clelia

AU - Biagioli, Maurizio

AU - Altomonte, Maresa

AU - Maio, Michele

PY - 2011/4

Y1 - 2011/4

N2 - Aim of study: To evaluate the feasibility of ipilimumab treatment for metastatic melanoma outside the boundaries of clinical trials, in a setting similar to that of daily practice. Methods: Ipilimumab was available upon physician request in the Expanded Access Programme for patients with life-threatening, unresectable stage III/IV melanoma who failed or did not tolerate previous treatments and for whom no therapeutic option was available. Induction treatment with ipilimumab 10 mg/kg was administered intravenously every 3 weeks, for a total of 4 doses, with maintenance doses every 12 weeks based on physicians' discretion and clinical judgment. Tumors were assessed at baseline, Week 12, and every 12 weeks thereafter per mWHO response criteria, and clinical response was scored as complete response (CR), partial response (PR), stable disease (SD), or progressive disease. Durable disease control (DC) was defined as SD at least 24 weeks from the first dose, CR, or PR. Results: Disease control rate at 24 and 60 weeks was 29.6% and 15%, respectively. Median overall survival at a median follow-up of 8.5 months was 9 months. The 1- and 2-year survival rates were 34.8% and 23.5%, respectively. Changes in lymphocyte count slope and absolute number during ipilimumab treatment appear to correlate with clinical response and survival, respectively. Adverse events were predominantly immune related, manageable, and generally reversible. One patient died from pancytopenia, considered possibly treatment related. Conclusion: Ipilimumab was a feasible treatment for malignant melanoma in heavily pretreated, progressing patients. A sizeable proportion of patients experienced durable DC, including benefits to long-term survival.

AB - Aim of study: To evaluate the feasibility of ipilimumab treatment for metastatic melanoma outside the boundaries of clinical trials, in a setting similar to that of daily practice. Methods: Ipilimumab was available upon physician request in the Expanded Access Programme for patients with life-threatening, unresectable stage III/IV melanoma who failed or did not tolerate previous treatments and for whom no therapeutic option was available. Induction treatment with ipilimumab 10 mg/kg was administered intravenously every 3 weeks, for a total of 4 doses, with maintenance doses every 12 weeks based on physicians' discretion and clinical judgment. Tumors were assessed at baseline, Week 12, and every 12 weeks thereafter per mWHO response criteria, and clinical response was scored as complete response (CR), partial response (PR), stable disease (SD), or progressive disease. Durable disease control (DC) was defined as SD at least 24 weeks from the first dose, CR, or PR. Results: Disease control rate at 24 and 60 weeks was 29.6% and 15%, respectively. Median overall survival at a median follow-up of 8.5 months was 9 months. The 1- and 2-year survival rates were 34.8% and 23.5%, respectively. Changes in lymphocyte count slope and absolute number during ipilimumab treatment appear to correlate with clinical response and survival, respectively. Adverse events were predominantly immune related, manageable, and generally reversible. One patient died from pancytopenia, considered possibly treatment related. Conclusion: Ipilimumab was a feasible treatment for malignant melanoma in heavily pretreated, progressing patients. A sizeable proportion of patients experienced durable DC, including benefits to long-term survival.

KW - Advanced melanoma

KW - Compassionate use

KW - Cytotoxic T-lymphocyte antigen 4

KW - Immunotherapy

KW - Ipilimumab

KW - Monoclonal antibody

UR - http://www.scopus.com/inward/record.url?scp=79953784382&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79953784382&partnerID=8YFLogxK

U2 - 10.1007/s00262-010-0958-2

DO - 10.1007/s00262-010-0958-2

M3 - Article

C2 - 21170646

AN - SCOPUS:79953784382

VL - 60

SP - 467

EP - 477

JO - Cancer Immunology and Immunotherapy

JF - Cancer Immunology and Immunotherapy

SN - 0340-7004

IS - 4

ER -