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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

Study design. BL baseline, D day, IPI ipilimumab, PD progressive disease, q3wk every 3 weeks, wk week. aPatients with PD, intolerability toxicity or who discontinued study treatment during induction entered the follow-up phase and were followed for safety and survival for ≥1 year after the last patient’s first treatment
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Fig1: Study design. BL baseline, D day, IPI ipilimumab, PD progressive disease, q3wk every 3 weeks, wk week. aPatients with PD, intolerability toxicity or who discontinued study treatment during induction entered the follow-up phase and were followed for safety and survival for ≥1 year after the last patient’s first treatment

Mentions: This was a single-arm, open-label study of ipilimumab monotherapy 3 mg/kg in untreated or previously treated Japanese patients with unresectable or metastatic melanoma (ClinicalTrials.gov, NCT01990859) (Fig. 1). Patients received four doses of ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 12 weeks. Patients with disease progression, intolerable toxicity, or who discontinued study treatment in the induction phase, entered a follow-up phase and were followed for safety and survival for at least 1 year after the last patient’s first treatment. The planned study sample size was approximately 18 treated patients.Fig. 1


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)

Study design. BL baseline, D day, IPI ipilimumab, PD progressive disease, q3wk every 3 weeks, wk week. aPatients with PD, intolerability toxicity or who discontinued study treatment during induction entered the follow-up phase and were followed for safety and survival for ≥1 year after the last patient’s first treatment
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig1: Study design. BL baseline, D day, IPI ipilimumab, PD progressive disease, q3wk every 3 weeks, wk week. aPatients with PD, intolerability toxicity or who discontinued study treatment during induction entered the follow-up phase and were followed for safety and survival for ≥1 year after the last patient’s first treatment
Mentions: This was a single-arm, open-label study of ipilimumab monotherapy 3 mg/kg in untreated or previously treated Japanese patients with unresectable or metastatic melanoma (ClinicalTrials.gov, NCT01990859) (Fig. 1). Patients received four doses of ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 12 weeks. Patients with disease progression, intolerable toxicity, or who discontinued study treatment in the induction phase, entered a follow-up phase and were followed for safety and survival for at least 1 year after the last patient’s first treatment. The planned study sample size was approximately 18 treated patients.Fig. 1

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