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Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma.

Yamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T - Cancer Chemother. Pharmacol. (2015)

Bottom Line: In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile.Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.

ABSTRACT

Purpose: Ipilimumab is designed to block cytotoxic T-lymphocyte antigen-4 to augment antitumor T cell responses. In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile. This phase II study assessed the safety of ipilimumab in Japanese patients with unresectable stage III or IV melanoma.

Methods: Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. The database lock for the original analysis was in August 2014. Overall survival, progression-free survival, and data on deaths were based on an updated, follow-up analysis (database lock April 2015).

Results: Data are reported from 20 patients. Fifteen patients (75 %) received all four doses of ipilimumab during induction. Twelve patients (60 %) had at least one drug-related adverse event (AE), and no patients discontinued due to a drug-related AE. There were no deaths related to study drug. The most common drug-related AEs were rash (n = 7), pyrexia (n = 3), increased aspartate aminotransferase (AST; n = 3), and increased alanine aminotransferase (ALT; n = 3). Twelve patients (60 %) reported immune-related AEs (irAEs); most frequent were skin (n = 9) and liver (n = 3) disorders. Grade 3 irAEs were ALT and AST elevation (n = 2) and diabetes mellitus (n = 1). Two patients had a partial response and two had stable disease, yielding a 20 % disease control rate. Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.

Conclusion: Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients. CLINICALTRIALS.

Gov identifier: NCT01990859.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier curves for overall survival (a) and progression-free survival (b)
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Fig2: Kaplan–Meier curves for overall survival (a) and progression-free survival (b)

Mentions: At 12 weeks after the last patient’s first treatment, four patients demonstrated antitumor activity (Table 4). Two patients (10 %) (1 pretreated, 1 untreated) had PR, and two patients (10 %) (both previously treated) had SD. The remaining patients had either progressive disease [13 (65 %)] or were not evaluable [3 (15 %)] due to death before week 12. Disease control rate was 20 % (95 % CI 5.7–43.7), and BORR was 10 % (95 % CI 1.2–31.7). The median OS was 8.71 months (95 % CI 3.71–not reached), and the median PFS was 2.74 months (95 % CI 1.25–2.83) (Fig. 2).Table 4


Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma.

Yamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T - Cancer Chemother. Pharmacol. (2015)

Kaplan–Meier curves for overall survival (a) and progression-free survival (b)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4612321&req=5

Fig2: Kaplan–Meier curves for overall survival (a) and progression-free survival (b)
Mentions: At 12 weeks after the last patient’s first treatment, four patients demonstrated antitumor activity (Table 4). Two patients (10 %) (1 pretreated, 1 untreated) had PR, and two patients (10 %) (both previously treated) had SD. The remaining patients had either progressive disease [13 (65 %)] or were not evaluable [3 (15 %)] due to death before week 12. Disease control rate was 20 % (95 % CI 5.7–43.7), and BORR was 10 % (95 % CI 1.2–31.7). The median OS was 8.71 months (95 % CI 3.71–not reached), and the median PFS was 2.74 months (95 % CI 1.25–2.83) (Fig. 2).Table 4

Bottom Line: In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile.Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.

ABSTRACT

Purpose: Ipilimumab is designed to block cytotoxic T-lymphocyte antigen-4 to augment antitumor T cell responses. In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile. This phase II study assessed the safety of ipilimumab in Japanese patients with unresectable stage III or IV melanoma.

Methods: Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. The database lock for the original analysis was in August 2014. Overall survival, progression-free survival, and data on deaths were based on an updated, follow-up analysis (database lock April 2015).

Results: Data are reported from 20 patients. Fifteen patients (75 %) received all four doses of ipilimumab during induction. Twelve patients (60 %) had at least one drug-related adverse event (AE), and no patients discontinued due to a drug-related AE. There were no deaths related to study drug. The most common drug-related AEs were rash (n = 7), pyrexia (n = 3), increased aspartate aminotransferase (AST; n = 3), and increased alanine aminotransferase (ALT; n = 3). Twelve patients (60 %) reported immune-related AEs (irAEs); most frequent were skin (n = 9) and liver (n = 3) disorders. Grade 3 irAEs were ALT and AST elevation (n = 2) and diabetes mellitus (n = 1). Two patients had a partial response and two had stable disease, yielding a 20 % disease control rate. Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.

Conclusion: Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients. CLINICALTRIALS.

Gov identifier: NCT01990859.

No MeSH data available.


Related in: MedlinePlus