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


Authors: Ku, G. Y.; Yuan, J.; Page, D. B.; Schroeder, S. E. A.; Panageas, K. S.; Carvajal, R. D.; Chapman, P. B.; Schwartz, G. K.; Allison, J. P.; Wolchok, J. D.
Article Title: Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting lymphocyte count after 2 doses correlates with survival
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 theMemorial Sloan-Kettering Cancer Center. METHODS: Patientswith advanced refractory melanoma were treated in a compassionate use trial with ipilimumab 10mg/kg every 3 weeks for 4 doses.Those with evidence of clinical benefit atWeek 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) ≥1000/μL after 2 ipilimumab treatments (Week 7) had a significantly improved clinical benefit rate (51% vs 0%; P = .01) andmedian OS (11.9 vs 1.4months; P < .001) comparedwith thosewith an ALC <1000/μL. 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. © 2010 American Cancer Society.
Keywords: adult; cancer survival; controlled study; treatment response; aged; aged, 80 and over; middle aged; major clinical study; fatigue; neutropenia; diarrhea; side effect; follow up; biological marker; demography; ipilimumab; melanoma; infection; pain; anemia; skin neoplasms; leukopenia; nausea; thrombocytopenia; vomiting; dehydration; tumor markers, biological; dyspnea; lymphocytopenia; pruritus; rash; confusion; antibodies, monoclonal; thrombosis; colitis; hypothyroidism; lymphocyte; retreatment; lymphocyte count; electrocorticography; trial; adrenal insufficiency; compassionate use; conjunctivitis; compassionate use trials
Journal Title: Cancer
Volume: 116
Issue: 7
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2010-04-01
Start Page: 1767
End Page: 1775
Language: English
DOI: 10.1002/cncr.24951
PUBMED: 20143434
PROVIDER: scopus
PMCID: PMC2917065
DOI/URL:
Notes: --- - "Cited By (since 1996): 12" - "Export Date: 20 April 2011" - "CODEN: CANCA" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Gary Schwartz
    364 Schwartz
  2. Jedd D Wolchok
    669 Wolchok
  3. Richard D Carvajal
    133 Carvajal
  4. Geoffrey Yuyat Ku
    92 Ku
  5. Paul Chapman
    251 Chapman
  6. Katherine S Panageas
    331 Panageas
  7. James P Allison
    129 Allison
  8. Jianda Yuan
    100 Yuan
  9. David B Page
    28 Page