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. 2010 Apr 1;116(7):1767-75.
doi: 10.1002/cncr.24951.

Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival

Geoffrey Y Ku  1 , Jianda Yuan, David B Page, Sebastian E A Schroeder, Katherine S Panageas, Richard D Carvajal, Paul B Chapman, Gary K Schwartz, James P Allison, Jedd D Wolchok
Affiliations
Free PMC article

Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival

Geoffrey Y Ku et al. Cancer. .
Free PMC article

Abstract

Background: : Ipilimumab is a monoclonal antibody that antagonizes cytotoxic T lymphocyte antigen-4, a negative regulator of the immune system. The authors report on advanced refractory melanoma patients treated in a compassionate use trial of ipilimumab at the Memorial Sloan-Kettering Cancer Center.

Methods: : Patients with advanced refractory melanoma were treated in a compassionate use trial with ipilimumab 10 mg/kg every 3 weeks for 4 doses. Those with evidence of clinical benefit at Week 24 (complete response [CR], partial response [PR], or stable disease [SD]) then received ipilimumab every 12 weeks.

Results: : A total of 53 patients were enrolled, with 51 evaluable. Grade 3/4 immune-related adverse events were noted in 29% of patients, with the most common immune-related adverse events being pruritus (43%), rash (37%), and diarrhea (33%). On the basis of immune-related response criteria, the response rate (CR + PR) was 12% (95% confidence interval [CI], 5%-25%), whereas 29% had SD (95% CI, 18%-44%). The median progression-free survival was 2.6 months (95% CI, 2.3-5.2 months), whereas the median overall survival (OS) was 7.2 months (95% CI, 4.0-13.3 months). Patients with an absolute lymphocyte count (ALC) > micro =1000/microL after 2 ipilimumab treatments (Week 7) had a significantly improved clinical benefit rate (51% vs 0%; P = .01) and median OS (11.9 vs 1.4 months; P < .001) compared with those with an ALC <1000/microL.

Conclusions: : The results confirm that ipilimumab is clinically active in patients with advanced refractory melanoma. The ALC after 2 ipilimumab treatments appears to correlate with clinical benefit and OS, and should be prospectively validated. Cancer 2010. (c) 2010 American Cancer Society.

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Figures

Figure 1
Figure 1
Radiographic images of a patient with a complete response are shown. Representative images were obtained (A) at baseline, (B) after completing induction with 4 treatments of ipilimumab every 3 weeks, and (C) at 9 months (before the second dose of maintenance ipilimumab). The patient was alive at the time of last follow-up without evidence of disease recurrence, 11.2 months after the initiation of protocol therapy.
Figure 2
Figure 2
Changes in the absolute lymphocyte count (ALC) with ipilimumab therapy are shown. (A) The ALC of all patients at baseline and after 1 and 2 doses of ipilimumab is shown. (B) The change in ALC for each patient with therapy is shown.
Figure 3
Figure 3
Kaplan-Meier survival curves are shown stratified by the absolute lymphocyte count (ALC) at (A) baseline and after (B) the first and (C) second ipilimumab doses.
See this image and copyright information in PMC

References

    1. American Cancer Society Cancer Facts and Figures, 2008. Available at: http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf Accessed June 30, 2009.
    1. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin-2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105–2116. - PubMed
    1. Eigentler TK, Caroli UM, Radny P, Garbe C. Palliative therapy of disseminated malignant melanoma: a systematic review of 41 randomised clinical trials. Lancet Oncol. 2003;4:748–759. - PubMed
    1. Chapman PB, Einhorn LH, Meyers ML, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17:2745–2751. - PubMed
    1. Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med. 1995;182:459–465. - PMC - PubMed

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