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Ọrịa Cancer Mbụ: Kedu ka Verzenio nwere ike isi nyere aka?

Mbipụta ndị nchụ nta akụkọ

Nchịkwa nri na ọgwụ ọjọọ nke United States (FDA) akwadola Eli Lilly na Companylọ ọrụ (NYSE: LLY) Verzenio® (abemaciclib), yana ọgwụgwọ endocrine (tamoxifen ma ọ bụ onye na-egbochi aromatase), maka ọgwụgwọ adjuvant nke ndị ọrịa toro eto nwere ihe nnabata hormone- Ọ dị mma (HR+), onye na-anabata epidermal growth 2 receptor (HER2-), node-positive, ọrịa ara ure mbụ (EBC) na nnukwu ihe ize ndụ nke nlọghachite yana akara Ki-67 nke ≥20% dị ka FDA kwadoro. nwalee. Ki-67 bụ akara nke mgbasawanye sel. Verzenio bụ onye mbụ na naanị ihe mgbochi CDK4/6 akwadoro maka ọnụọgụ ndị ọrịa a.

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Ka oge na-aga, nsonaazụ mkpokọta nke mmemme mmepe ụlọ ọgwụ Verzenio egosipụtala profaịlụ ihe mgbochi CDK4/6 dị iche iche, yana akara ngosi sitere na nnwale monarchE nke kwadoro ihe ngosi ọhụrụ a na HR+ HER2- ọrịa ara ure na-anọchi anya nzọụkwụ ọzọ dị mkpa maka ndị mmadụ. ndị chọrọ nhọrọ ọgwụgwọ ọhụrụ, "Jacob Van Naarden, onye isi osote onye isi ala, onye isi oche nke Loxo Oncology na Lilly na onye isi ala, Lilly Oncology kwuru. "Anyị nwere obi ụtọ na nkwado mbụ a na ọnọdụ nkwado yana ka data ndị a na -eto, anyị na -atụ anya ohere ọzọ iji soro ndị ọrụ ahụike na -arụ ọrụ ịgbasa ojiji Verzenio na ọnọdụ a."

Ọnwụnwa nke Verzenio Phase 3 monarchE bụ nke enweghị usoro (1: 1), akara mepere emepe, ndị otu abụọ, ọmụmụ ọtụtụ n'ime ụmụ nwanyị toro eto na ụmụ nwoke nwere HR+ HER2-, node-positive, jiri EBC rụọ ọrụ yana njiri mara ụlọ ọgwụ na ọrịa na-adaba na nnukwu ihe egwu. nke nlọghachi ọrịa. N'ime nnwale ahụ, a na -enye ndị ọrịa ohere ịnata Verzenio 150 mg ugboro abụọ kwa ụbọchị yana nhọrọ nke dọkịta nke usoro ọgwụgwọ endocrine ọkọlọtọ, ma ọ bụ usoro ọgwụgwọ endocrine naanị. A gwara ndị ọrịa nọ na ogwe aka ọgwụgwọ abụọ ka ha gaa n'ihu na-enweta ọgwụgwọ endocrine adjuvant ruo afọ 5-10 dịka dọkịta ha tụrụ aro ya. Isi ihe dị n'ọmụmụ ihe a bụ nlanarị ọrịa na-efe efe (IDFS) wee zute ya na nyocha obere oge akọwapụtara na ebumnuche ime ọgwụgwọ (ITT), yana mmụba dị ịrịba ama na IDFS maka ndị ọrịa ejiri Verzenio gbakwunyere. ET ma e jiri ya tụnyere ndị ejiri ET naanị gwọọ ya. N'ikwekọ na ntuziaka ọkachamara, akọwapụtara IDFS dị ka ogologo oge tupu ọrịa ara ara alọta, ọrịa kansa ọ bụla amalite, ma ọ bụ ọnwụ. 

N'inweta isi njedebe nke ọmụmụ ahụ na ọnụ ọgụgụ ndị edebanyere aha, a na-eme nyocha nke akọwapụtara nke ọma gbasara IDFS na ndị ọrịa nwere nnukwu ihe egwu na ihe gbasara ọrịa yana akara Ki-67 ≥20%. Nyocha nke otu a (N = 2,003) gụnyere ndị ọrịa nwere ≥4 nti lymph nodes (ALN), ma ọ bụ 1-3 dị mma ALN nwere ma ọ bụ ọrịa Grade 3 na/ma ọ bụ oke ụbara ≥5 cm, na ndị etuto ya nwere akara Ki-67. nke -20%. Enwekwara nkwalite ọnụ ọgụgụ dị mkpa na IDFS maka ngalaba nke mbụ akọwapụtara nke ndị ọrịa na-anata Verzenio gbakwunyere ET ma e jiri ya tụnyere ndị natara ET naanị (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Nkwado a dabere na nsonaazụ nrụpụta sitere na nyocha nke otu nta a yana ntinye ọzọ, na-eduzi post-hoc. N'ime nyocha a, Verzenio nyere yana ET gara n'ihu na -egosipụta uru bara uru na ụlọ ọgwụ, yana mbelata pasent 37 n'ihe ize ndụ nke nlọghachi ọrịa kansa ara ma ọ bụ ọnwụ ma e jiri ya tụnyere ET adjuvant naanị maka ndị ọrịa nwere nnukwu ụlọ ọgwụ na njiri mara ọrịa na Ki. -67 akara ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), yana uru zuru oke na ihe omume IDFS nke 7.1 pasent n'ime afọ atọ. Ọnụ ọgụgụ ihe omume IDFS n'oge nyocha a bụ 104 na Verzenio gbakwunyere ET ma e jiri ya tụnyere 158 na ET naanị. N'ozuzu, data nlanarị etochabeghị ma ntinye ọzọ na -aga n'ihu.

Mmeghachi omume ọjọọ sitere na monarchE kwekọrọ na profaịlụ nchekwa ama ama maka Verzenio.2 A tụlere nchekwa na nnabata na ndị ọrịa 5,591. Mmeghachi omume ọjọọ ndị a na -akọkarị (> 10%) na Verzenio gbakwunyere ET (tamoxifen ma ọ bụ onye na -egbochi aromatase), yana> 2% dị elu karịa ogwe aka ET naanị, bụ afọ ọsịsa, ọrịa, ike ọgwụgwụ, ọgbụgbọ, isi ọwụwa, ọgbụgbọ, stomatitis , agụụ na -ebelata, dizziness, ọkụ ọkụ, na alopecia.3 Ihe na -ahụkarị ụlọ nyocha (akara niile ≥10%) bụ creatinine mụbara, ọnụ ọgụgụ sel ọbara ọcha belatara, ọnụ ọgụgụ neutrophil belatara, anaemia, ọnụ ọgụgụ lymphocyte belatara, ọnụ ọgụgụ platelet belatara, ALT mụbara, AST mụbara, na hypokalemia.

Nkwado FDA a na-ewulite ihe akaebe maka Verzenio, nke akwadorolarị maka ịgwọ ụdị ọrịa ara ure HR+ HER2 ma ọ bụ metastatic. N'ikwekọ na nkwado a, FDA agbasawanyela ojiji Verzenio n'ihe ngosi niile, mgbe enyere ya yana ọgwụgwọ endocrine, ịgụnye ụmụ nwoke. Verzenio dị na mbadamba ike nke 200 mg, 150 mg, 100 mg, na 50 mg.

Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana- kwuru, "Nhazi na nsonaazụ ọmụmụ ihe ọmụmụ monarchE na-agbanwe omume ma na-anọchite anya oganihu mbụ na ọgwụgwọ adjuvant nke HR+ HER2- ọrịa cancer ara n'ime ogologo oge." Ụlọ ọrụ Farber Cancer, na onye nyocha n'ọmụmụ monarchE. “Nkwenye FDA a maka Verzenio yana yana ọgwụgwọ endocrine na mmalite ọrịa kansa ara nwere ike bụrụ ụkpụrụ nlekọta ọhụrụ maka ndị a. A na-agba anyị ume site na mbelata nke ukwuu n'ihe ize ndụ nke nlọghachi ọbụlagodi oge ọgwụgwọ afọ abụọ n'ime ndị ọrịa a, enwere m ekele na m nwere ike ịnye nke a dịka nhọrọ ọgwụgwọ nye ndị ọrịa m. ”  

“Ụmụ nwanyị na ụmụ nwoke ndị nwere nnukwu ihe ize ndụ HR+ HER2- ọrịa ara ure na-achọ ime ihe niile ha nwere ike ime iji belata ihe egwu nke ọrịa ịlọghachi, na-enwe olileanya ibi ndụ na-enweghị ọrịa kansa. Nkwado nke Verzenio na -enye nhọrọ ọgwụgwọ ọhụrụ iji nyere ha aka ime nke ahụ, ”ka Jean Sachs, onye isi ndị isi, Living Beyond Breast Cancer kwuru. "Nkwado a na -ewetara obodo ọrịa kansa ara nchekwube ọhụrụ."

A ga -ewepụta data na -akwado nkwado a na Ọktoba 14European Society for Medical Oncology (ESMO) Virtual Plenary.

Mpempe akwụkwọ maka Verzenio nwere ịdọ aka na ntị na ịkpachara anya maka afọ ọsịsa, neutropenia, ọrịa ngụgụ interstitial (ILD/pneumonitis), hepatotoxicity, venous thromboembolism, na nsị nke nwa ebu n'afọ. Kụziere ndị ọrịa ihe ịrịba ama mbụ nke oche na -adịghị ọcha ka ha malite ọgwụgwọ ọrịa afọ ọsịsa, mụbaa mmiri ọnụnụ, wee gwa onye na -ahụ maka ahụike ha. Mee nyocha ọbara zuru oke na nyocha ọrụ imeju tupu mmalite ọgwụgwọ Verzenio, kwa izu abụọ maka ọnwa abụọ mbụ, kwa ọnwa maka ọnwa abụọ na -esote yana dịka egosipụtara n'ụlọ ọgwụ. Dabere na nsonaazụ, Verzenio nwere ike ịchọ mgbanwe nha. Nyochaa ndị ọrịa maka ihe ịrịba ama na ihe mgbaàmà nke thrombosis na embolism pulmonary ma na -emeso ya dịka ahụike dabara adaba. Na -adụ ndị ọrịa ọdụ n'ihe ize ndụ nye nwa ebu n'afọ yana iji ọgwụ mgbochi dị irè.

Hụ Ozi nchekwa dị mkpa n'okpuru yana zuru Na-ezipụta Ozi n'ihi na ozi ndị ọzọ.

Pịa Ebe a iji lelee ihe ọmụma ọrịa cancer ara mbụ.

Pịa Ebe a ilele infographic ikpe nnwale nke eze.

Pịa ka ịlele foto ngwaahịa Verzenio: 50 mg100 mg150 mg200 mg.

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Banyere chepụtara

Juergen T Steinmetz kwuru

Juergen Thomas Steinmetz anọgidewo na-arụ ọrụ na njem na njem ebe ọ bụ na ọ bụ nwata na Germany (1977).
Ọ tọrọ ntọala eTurboNews na 1999 dị ka akwụkwọ akụkọ n'ịntanetị mbụ maka ụlọ ọrụ njem nlegharị anya zuru ụwa ọnụ.

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