Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Nov 2;3(5):515-523.
doi: 10.1200/JGO.2016.006544. eCollection 2017 Oct.

Ipilimumab in Pretreated Patients With Advanced Malignant Melanoma: Results of the South African Expanded-Access Program

Bernardo L Rapoport  1 , Daniel A Vorobiof  1 , Lydia M Dreosti  1 , Adam Nosworthy  1 , Georgina McAdam  1 , Johan P Jordaan  1 , Helen Miller-Jansön  1 , Margreet de Necker  1 , Janetta C de Beer  1 , Hennie Duvenhage  1
Affiliations

Ipilimumab in Pretreated Patients With Advanced Malignant Melanoma: Results of the South African Expanded-Access Program

Bernardo L Rapoport et al. J Glob Oncol. .

Abstract

Purpose: The primary objective of this study was to evaluate 1- and 2-year survival rates and durable remissions in pretreated patients with advanced (unresectable or metastatic) malignant melanoma treated with ipilimumab in a South African expanded-access program (SA-EAP).

Patients and methods: This multicenter, retrospective study obtained data from pretreated patients with advanced malignant melanoma who were eligible for the ipilimumab SA-EAP. Ipilimumab was administered at a dose of 3 mg/kg intravenously every 3 weeks for four cycles to adults with advanced melanoma for whom at least one line of treatment for metastatic disease had failed. Data from the medical records of 108 patients treated within the SA-EAP were collected and statistically analyzed to determine overall (OS) and progression-free survival (PFS) at 1 and 2 years.

Results: In the population of 108 patients, a median OS of 8.98 months (95% CI, 7.47 to 10.79 months) was observed. One-year OS was 36% (95% CI, 26% to 45%), and 2-year survival was observed as 20% (95% CI, 12% to 27%). The median survival without progression (ie, PFS) was 3.44 months (95% CI, 2.98 to 4.16 months), and 1- and 2-year PFS were 22% (95% CI, 14% to 29%) and 14% (95% CI, 8% to 21%), respectively. The longest recorded survival was 3.4 years. No independent prognostic variables were identified to predict for OS by multivariate Cox proportional hazards model.

Conclusion: In this multicenter South African setting, ipilimumab at a dose of 3 mg/kg was an effective treatment with long-term OS in a subset of patients with pretreated advanced malignant melanoma.

PubMed Disclaimer

Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc. Bernardo L. RapoportHonoraria: Tesaro, Merck, Bristol-Myers Squibb Consulting or Advisory Role: Tesaro, Merck, Bristol-Myers Squibb Speakers’ Bureau: Tesaro, Merck, Bristol-Myers Squibb Research Funding: Tesaro, Merck, Bristol-Myers Squibb Travel, Accommodations, Expenses: Tesaro, Merck, Bristol-Myers SquibbDaniel A. VorobiofConsulting or Advisory Role: Amgen, Roche, Bristol-Myers SquibbLydia M. DreostiHonoraria: Roche, Janssen Pharmaceuticals Consulting or Advisory Role: Roche, Janssen Pharmaceuticals, Novartis Speakers’ Bureau: Janssen Pharmaceuticals Travel, Accommodations, Expenses: Roche, Janssen Pharmaceuticals, Merck SeronoAdam NosworthySpeakers’ Bureau: Key Oncologics Travel, Accommodations, Expenses: Bristol-Myers Squibb, Janssen OncologyGeorgina McAdamNo relationship to discloseJohan P. JordaanSpeakers’ Bureau: Merck Serono Research Funding: Roche, PAREXEL International, Ipsen, Quintiles, Novartis Travel, Accommodations, Expenses: RocheHelen Miller-JansönConsulting or Advisory Role: HEXOR (Inst) Research Funding: HEXOR (Inst)Margreet de NeckerConsulting or Advisory Role: HEXOR (Inst) Research Funding: HEXOR (Inst)Janetta C. de BeerConsulting or Advisory Role: HEXOR (Inst) Research Funding: HEXOR (Inst)Hennie DuvenhageEmployment: Bristol-Myers Squibb Research Funding: Bristol-Myers Squibb

Figures

Fig 1
Fig 1
Kaplan-Meier plot of overall survival (OS) in the South African expanded-access program in (A) all patients, (B) patients who achieved complete response, (C) and patients without disease progression. Dashed lines indicate 95% CIs.
Fig 2
Fig 2
(A) Pre- (March 26, 2012; red arrow indicates tumor) and (B) post-treatment (July 17, 2013) chest x-rays. Patient remains in remission.
See this image and copyright information in PMC

References

    1. The South African National Cancer Registry Summary statistics of cancer diagnosed histologically in 2005. http://www.nioh.ac.za/assets/files/Cancer%20Tables%202005.pdf.
    1. de Vries E, Bray FI, Coebergh JW., et al. Changing epidemiology of malignant cutaneous melanoma in Europe 1953-1997: Rising trends in incidence and mortality but recent stabilizations in Western Europe and decreases in Scandinavia. Int J Cancer. 2003;107:119–126. - PubMed
    1. Cayuela A, Rodríguez-Domínguez S, Lapetra-Peralta J, et al. Has mortality from malignant melanoma stopped rising in Spain? Analysis of trends between 1975 and 2001. Br J Dermatol. 2005;152:997–1000. - PubMed
    1. Lasithiotakis KG, Leiter U, Gorkievicz R, et al. The incidence and mortality of cutaneous melanoma in Southern Germany: Trends by anatomic site and pathologic characteristics, 1976 to 2003. Cancer. 2006;107:1331–1339. - PubMed
    1. Bosetti C, La Vecchia C, Naldi L, et al. Mortality from cutaneous malignant melanoma in Europe: Has the epidemic levelled off? Melanoma Res. 2004;14:301–309. - PubMed

LinkOut - more resources