Background: Following
approval of ipilimumab, this observational cohort study (CA184-332) was
initiated to describe patient and disease characteristics, patterns of care,
survival, and adverse events (AEs) in advanced melanoma (AM) patients treated
with first-line ipilimumab in realworld US community practice. Methods: Adult
patients with treatment-naive AM who received ≥1 dose of ipilimumab 3 mg/kg between
April 2011 and September 2012 were retrospectively identified at US Oncology
sites. Clinical data were abstracted from patient medical records. Results:
Median age of the 157 patient cohorts was 66 years (range 21 - 91). 68.2% were
male, and 90.5% had a cutaneous primary site. At ipilimumab initiation, 80.9%
of patients had an ECOG performance status of 0 or 1; 54.1% were stage M1c;
34.4% had brain metastases; 24.8% had elevated lactate dehydrogenase, and 13.4%
were positive for BRAF mutation. All 4 cycles of ipilimumab were completed by
55.8% of patients. At a median follow-up of 8.5 months (range 2.9 - 15.0),
median overall survival was 11.5 months (95% CI: 8.9 - 16.6) and 1-year
survival was 46.7% (95% CI: 38.1 - 54.9). During ipilimumab treatment, AEs were
experienced by 63.7% of patients. The most frequent AEs were gastrointestinal
(41.4%; diarrhea in 19.1%) and skin-related (28.0%; rash in 17.8%); 17.8% of
patients had an AE that led to ipilimumab discontinuation. Conclusions: These
real-world results are consistent with those from clinical trials and provide
evidence supporting the effectiveness and safety of first-line ipilimumab 3
mg/kg monotherapy in patients with AM treated in a community practice setting.
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