ኒዮአድጁቫንት/አድጁቫንት ፔምብሮሊዙማብ በኤፍዲኤ ተቀባይነት ያለው ከትንሽ ሴል ላልሆነ የሳንባ ካንሰር

ኖ Novምበር 2023 ፔምብሮሊዙማብ (ኬይትሩዳ፣ ሜርክ) በምግብ እና መድኃኒት አስተዳደር (ኤፍዲኤ) እንደ ኒውዮአዳጁቫንት ሕክምና ከፕላቲኒየም ከያዘው የኬሞቴራፒ ሕክምና እና ከቀዶ ሕክምና በኋላ እንደ ድህረ-ቀዶ ሕክምና ረዳት ረዳት ሕክምና ለትንሽ ሴል ሳንባ ካንሰር (NSCLC) የሚለካ እጢዎች ተቀባይነት አግኝቷል 4 ሴንቲ ሜትር ወይም ከዚያ በላይ የሆነ ዲያሜትር, ከፕላቲኒየም-የያዘ ኬሞቴራፒ ጋር ሲጣመር.

KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled trial involving 797 patients with AJCC 8th edition resectable Stage II, IIIA, or IIIB NSCLC who had not been previously treated, assessed the drug’s efficacy. Patients undergoing platinum-based chemotherapy were randomized (1:1) to receive pembrolizumab or a placebo every three weeks for four cycles (neoadjuvant treatment).

Subsequently, for a maximum of thirteen cycles (adjuvant treatment), patients were administered either continued single-agent pembrolizumab or a placebo every three weeks. The surgical window and chemotherapy specifics are available at the link to the drug label above.

የውጤታማነት ዋና የውጤት መለኪያዎች በመርማሪ የተገመገሙ ከክስተት-ነጻ መትረፍ (EFS) እና አጠቃላይ ድነት (OS) ናቸው። ፕላሴቦ ለሚቀበሉ አማካኝ ስርዓተ ክወና 52.4 ወራት ነበር (95% CI: 45.7, NE) እና በፔምብሮሊዙማብ ክንድ ላይ አልተገኘም (95% CI: የማይገመት [NE]፣ NE]፤ p-value=0.0103)። የአደጋው ጥምርታ [HR] 0.72 [95% CI: 0.56, 0.93]; p-value=0.0103]። በፕላሴቦ ክንድ ውስጥ ያለው መካከለኛ EFS 17 ወራት (95% CI: 14.3, 22.0) በፔምብሮሊዙማብ ክንድ ውስጥ ከ 17 ወራት ጋር ሲነፃፀር (95% CI: 34.1 months, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-value=0.0001)።

The adverse reactions most frequently reported by 20% or more of the patients in KEYNOTE-671 were as follows: nausea, fatigue, neutropenia, anaemia, constipation, decreased appetite, decreased white blood cell count, musculoskeletal pain, rash, congestion, vomiting, diarrhoea, and dyspnea.

A comparatively lower rate of adverse reactions prevented surgery for 6% of patients in the pembrolizumab arm who received neoadjuvant treatment, as opposed to 4.3% in the placebo arm. In addition, 3.1% of patients who received neoadjuvant treatment and surgery in the pembrolizumab arm experienced surgical delays as compared to 2.5% in the placebo arm. The safety information pertaining to the neoadjuvant and adjuvant phases can be found in the drug label link provided above.

Pembrolizumab በየ 200 ሳምንቱ በ 3 mg ወይም 400 mg በየ 6 ሳምንቱ የታዘዘ ነው። ከኬሞቴራፒ ጋር በተመሳሳይ ቀን ሲሰጥ, pembrolizumab አስቀድሞ መሰጠት አለበት.