التفاصيل البيبلوغرافية
| العنوان: |
Open-label, phase IIa study of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. |
| المؤلفون: |
Si, Lu1 (AUTHOR) silu15_silu@126.com, Zhang, Xiaoshi2 (AUTHOR), Shin, Sang Joon3 (AUTHOR), Fan, Yun4 (AUTHOR), Lin, Chia-Chi5 (AUTHOR), Kim, Tae Min6 (AUTHOR), Dechaphunkul, Arunee7 (AUTHOR), Maneechavakajorn, Jedzada8 (AUTHOR), Wong, Chi Sing9 (AUTHOR), Ilankumaran, Palanichamy10 (AUTHOR), Lee, Dung-Yang1,10 (AUTHOR), Gasal, Eduard10 (AUTHOR), Li, Haifu11 (AUTHOR), Guo, Jun12 (AUTHOR) |
| المصدر: |
European Journal of Cancer. Aug2020, Vol. 135, p31-38. 8p. |
| مصطلحات موضوعية: |
*ANTINEOPLASTIC agents, *CLINICAL trials, *CONFIDENCE intervals, *LACTATE dehydrogenase, *MELANOMA, *GENETIC mutation, *PATIENT safety, *SURVIVAL, *TREATMENT effectiveness, *DESCRIPTIVE statistics, *PHARMACODYNAMICS |
| مصطلحات جغرافية: |
SOUTHEAST Asia |
| مستخلص: |
This study (NCT02083354) assessed the efficacy and safety of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. Overall, 77 patients of East Asian origin (including 61 from Mainland China) with unresectable or metastatic BRAF V600-mutant cutaneous melanoma were enrolled. Prior treatment was allowed except with BRAF/MEK inhibitors. Patients received dabrafenib 150 mg twice daily and trametinib 2 mg once daily. The primary end-point was objective response rate (ORR) using Response Evaluation Criteria in Solid Tumours 1.1. Secondary end-points were duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics and safety. At data cutoff (February 23, 2018; median follow-up, 8.3 months), treatment was ongoing in 36 patients (47%). The median age was 52 years; 32% of patients had elevated lactate dehydrogenase, and 84% had received prior systemic therapy. ORR was 61% (95% confidence interval: 49.2–72.0), with four patients (5%) achieving complete response. Median DOR and PFS were 11.3 and 7.9 months, respectively. Median OS was not reached. The most common adverse event (AE) of any grade was pyrexia (56%). Grade ≥III AEs occurred in 29 patients (38%). The most common grade ≥III AEs were pyrexia (8%) and anaemia (6%). AEs led to permanent discontinuation in five patients (6.5%). Mean C max for dabrafenib and trametinib was 3560 and 11.5 ng/mL (day 1) and 2680 and 27.1 ng/mL (day 15), respectively. These results support the efficacy and tolerability of dabrafenib in combination with trametinib in East Asian patients with unresectable or metastatic BRAF V600-mutant cutaneous melanoma. • Dabrafenib-trametinib was efficacious in East Asians with advanced BRAF V600-mutant cutaneous melanoma. • Efficacy and safety of dabrafenib-trametinib in East Asians was similar to global studies. • No new safety findings were observed with dabrafenib-trametinib in East Asian patients. • Dabrafenib-trametinib could be a treatment option for East Asians with BRAF V600-mutant melanoma. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
