瑞戈菲尼不適合作為BRAF V600E轉移性腸癌化療失敗以後的二線方案

04-08

我已經懶得吐槽了，簡而言之就是病人使用美國2018NCCN治療方案治療BRAF V600E驅動的轉移性腸癌耐葯以後，國內醫生建議病人使用瑞戈菲尼，我覺得沒有什麼意義。

我就直接給出文獻好了，發表於2018年的The Oncologist雜誌：

Single‐Agent Regorafenib in Metastatic Colorectal Cancer Patients with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab (PREVIUM Trial)

Background.

Patients with RAS‐ or BRAF‐mutated (mut) metastatic colorectal cancer (mCRC) progressing on first‐line bevacizumab plus 5‐FU/irinotecan/oxaliplatin (FOLFOXIRI) have a poor prognosis. We aimed to assess the efficacy and safety of regorafenib in this population.

Methods.

Regorafenib was administered daily for 3 weeks of each 4‐week cycle until disease progression or other reason. The primary endpoint was 6‐month progression‐free survival (PFS).

Results.

KRAS, NRAS, or BRAF was mutated in mCRC samples in 60%, 20%, and 13% of patients, respectively. Median time from initial diagnosis of metastases to the start of regorafenib and treatment duration was 13.8 months and 7 weeks, respectively. Reasons for discontinuation included disease progression (80%), investigator decision (13%), and adverse events (AEs; 7%). Seven patients (47%) required dose reduction, mostly for asthenia (43%). The most common regorafenib‐related grade 3 AEs were asthenia (33%), dysphonia (13%), and hypertension (13%) (Table 1). There were no grade 4 toxicities. No patient was progression‐free at 6 months. Median PFS, time to progression (TTP), and overall survival (OS) were 2.2, 2.0, and 3.3 months, respectively.

Conclusion.

Although stopped prematurely for failing to accrue, in the population analyzed, regorafenib failed to demonstrate clinical activity in KRAS‐ or BRAF‐mutated mCRC with progression following first‐line with FOLFOXIRI plus bevacizumab, although tolerability was acceptable. Our trial suggests that exploring regorafenib efficacy in an earlier line of therapy should not be undertaken without better population refinement.