仿單連結:中文仿單

<<2023/8/10大腸直腸癌 即時照護網>>

洛滿舒膜 Sotorasib (LUMAKRAS)

#機轉

Sotorasib 是一種口服標靶藥物(KRAS G12C 的抑制劑)。

其機轉，是抑制具有 KRAS G12C 突變的癌細胞。

KRAS G12C 是一種腫瘤特有、突變致癌形式的 RAS GTP 酶 (KRAS)，在大腸直腸癌，約2-4%。

目前，現有臨床試驗資料，建議帶有KRAS G12C突變的轉移性結腸直腸癌病患可以考慮使用。

LUMAKRAS 的建議劑量為每日一次口服 960 mg (八顆 120 mg 藥錠)。

#臨床建議(個人):

1.可以考慮 70-80 % 劑量試試。

2.需與 Anti-EGFR 藥物併用才效果好(單用效果不佳)。

3.與化學藥物併用，是一種或許有用的藥物組套。

4.需高度經臨床考量。

#不良作用(舉例):

=嚴重

肺炎，非感染性肺炎，肝毒性，腹瀉，心臟功能，胃潰瘍。

=常見

腹瀉，噁心，嘔吐，便祕，腹痛，肝毒性，肌肉骨骼疼痛，關節疼痛，疲勞，水腫，食慾下降，皮疹，胰臟酶，電解質，尿蛋白，血球，凝血功能。

#處理:

處理不良反應時 , 可能需要調降劑量 、暫停或終止治療。

HWT @ 日期: 2023/08/10

#參考資料

根據臨床試驗，應該與化學藥物併用，是一種或許有用的藥物組套。

CodeBreaK 101 Soto (960 mg PO daily) plus Pmab (6 mg/kg IV Q2W) and standard-dose FOLFIRI (IV Q2W).

Key eligibility criteria were KRAS G12C-mutated mCRC and ≥1 prior treatment for metastatic disease.

Results:

As of November 30, 2022,

Treatment-related adverse events (TRAEs) of any grade occurred in 32 (97.0%) pts; 1 pt discontinued the full regimen due to grade 3 ALT increase. Fifteen (45.5%) had grade ≥ 3 TRAEs (most commonly dermatologic; n = 5). There were no fatal TRAEs. Safety findings were consistent with known profiles of Soto, Pmab, and FOLFIRI.

No clinically meaningful PK interaction was observed between Soto and irinotecan.

Of 31 pts evaluable for response, confirmed ORR (all partial responses) was 58.1% (95% CI: 39.1, 75.5). The 2 pts with prior Soto achieved partial response (n = 1) and stable disease (n = 1). Disease control rate was 93.5% (95% CI: 78.6, 99.2). With median follow-up of 5.7 and 7.4 months, respectively, progression-free and overall survival data are not yet mature. Fully enrolled data will be presented.