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J Immunother Cancer. 2014 Jun 18;2:17. doi: 10.1186/2051-1426-2-17. eCollection 2014.

Optimizing immune-related tumor response assessment: does reducing the number of lesions impact response assessment in melanoma patients treated with ipilimumab?

Author information

1
Department of Radiology, Brigham and Women's Hospital and Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA.
2
Department of Medical Oncology and Department of Medicine, Dana-Farber Cancer Institute and Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA.
#
Contributed equally

Abstract

BACKGROUND:

Investigate the impact of the reduction of the number of target lesions on immune-related response assessment in advanced melanoma patients treated with ipilimumab.

METHOD:

Ninety patients (53 males, 37 females; age range: 25-87) with advanced melanoma treated with ipilimumab in two clinical trials were studied. Tumor measurements during trial allowing up to 5 lesions per organ and 10 lesions in total were retrospectively reviewed. A second set of tumor measurements allowing up to 2 lesions per organ and 5 lesions in total was generated. Immune-related response assessments by two measurements were compared.

RESULTS:

The number of target lesions was significantly reduced when up to 2 per organ and 5 in total lesions were allowed (Wilcoxon P < 0.0001). The immune-related response assessment using reduced number of lesions was highly concordant with assessment using the original number of lesions (Spearman r for the percent change on 1(st)-3(rd) follow-up: 0.860-0.970; κw for best immune-related response: 0.908). Median time-to-progression was 26.9 months (95%CI: 9.1-∞) by both assessments. Interobserver agreement of measurements was high for both assessments, with the concordance correlation coefficient above 0.98.

CONCLUSION:

Reduction of the number of target lesions did not significantly affect immune-related response assessment or the measurement variability in advanced melanoma patients treated with ipilimumab. Using up to 2 per organ and 5 in total target lesions is proposed to assess immune-related response, while it is important to keep other novel features of immune-related response criteria such as confirmation of progression and inclusion of new lesion measurements.

KEYWORDS:

Immune-related response criteria; Immunotherapy; RECIST; Tumor response

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