1148 - Safety and efficacy of ipilimumab 10 mg/kg among patients with advanced melanoma from Italy enrolled in a European compassionate use program

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Skin cancers
Biological therapy
Presenter Michele Maio
Authors M. Maio1, P. Queirolo2, A. Testori3, M. Altomonte4, M. Maur5, E. Bajetta6, P.A. Ascierto7, V. Chiarion Sileni8, A.M. Di Giacomo9, R. Ridolfi10
  • 1Division Of Medical Oncology And Immunotherapy, Azienda Ospedaliera Senese - Medical Oncology and Immunotherapy Unit, 53100 - Siena/IT
  • 2Department Of Oncology, National Institute for Cancer Research - Genova, Genova/IT
  • 3Melanoma Muscle Cutaneous Sarcoma Division, European Institute of Oncology, Milan/IT
  • 4Department Of Oncology, Azienda Ospedaliera Senese - Medical Oncology and Immunotherapy Unit, 53100 - Siena/IT
  • 5Dept. Of Hematology/oncology, Ospedale Policlinico-Modena, 41100 - Modena/IT
  • 6Medical Oncology, Istituto di Oncologia del Policlinico di Monza, IT-20052 - Monza/IT
  • 7Unit Of Medical Oncology And Innovative Therapy, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli/IT
  • 8Medical Oncology, Istituto Oncologico Veneto IOV-IRCCS, IT-35128 - Padova/IT
  • 9Azienda Ospedaliera Senese - Medical Oncology and Immunotherapy Unit, 53100 - Siena/IT
  • 10Immunoterapia E Terapia Cellulare Somatica, IRCCS-IRST Meldola, 47014 - Meldola (FC)/IT



Clinical studies of ipilimumab have shown improved survival and durable tumour responses across a spectrum of doses and schedules. Here, we evaluate the use of ipilimumab 10 mg/kg outside of clinical trials, in a setting similar to daily practice.


Ipilimumab was available upon physician request for patients (pts) aged ≥16 years with unresectable stage III/stage IV melanoma who had either failed systemic therapy or were intolerant to ≥1 systemic treatment and for whom no other therapeutic option was available. Induction therapy with ipilimumab 10 mg/kg was given on Week (wk) 1, 4, 7 and 10 with tumour assessments conducted at baseline, wk 12 and q 12 wks thereafter using modified World Health Organization criteria. Maintenance therapy with ipilimumab was available q 12 wks from wk 24 for pts with evidence of clinical benefit. Pts were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events v.3.0.


In total, 74 pts, including 11 with brain metastasis, received ≥1 dose of ipilimumab and were eligible for analysis. Of these, 43 (58.1%) completed the induction phase and 26 (35.1%) received maintenance therapy (median of 2 cycles; range: 1–13). The disease control rate was 32%, including 3 pts (4%) with a complete response, 6 (9%) with a partial response, and 13 (19%) with stable disease. Median progression-free survival (PFS) and overall survival (OS) was 3 months (mo) (95% CI: 2.3–3.7) and 7 mo (95% CI: 5.3–8.7), respectively. For pts with brain metastases, PFS and OS were 3 mo (95% CI: 2.4–3.6) and 4 mo (95% CI: 2.4–5.6). The 3-yr survival rate was 16.6%, with 11 long survivors pts (>3 yrs). Overall, 45 pts (61%) reported an AE of any grade; most commonly pruritis and diarrhoea. Eight grade 3/4 AEs were reported, including diarrhoea (n = 2), pain (including epigastric; n = 3) and one case each of fever, increased liver enzymes and pancytopenia. Most AEs were manageable through adherence to protocol-specific guidelines.


Ipilimumab is a feasible treatment option for pts who progressed on, or were unable to tolerate previous therapies, with approximately one-third of pts achieving disease control and a long-term survival benefit.


M. Maio: Advisory board and honoraria from: BMS and Roche.

P. Queirolo: Paola Queirolo served on Advisory Board of Bristol Myers Squibb, Roche-Genentech, GSK, MSD and received honoraria from Brystol Myers Squibb and Roche-Genentech.

A. Testori: I have a consultant or advisory relationship to disclose ( BMS, GSK, AMGEM advisory boards); I have honoraria to disclose (from above mentioned advisory boards); I have other remuneration to discloure ( travel expenses from oncovision and Igea).

P.A. Ascierto: Consultant or advisory relationship for: Brystol Myers - Squibb Merck Roche GSK Amgen. Honoraria to disclose from BMS, Merck, Roche.

V. Chiarion Sileni: Advisory Board and/or Honoraria from: BMS MSD Shering & Plough Roche GSK.

All other authors have declared no conflicts of interest.