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육종(GIST 포함): 국가별 치료 선택지

이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.

선택지 정리됨고형암최종 확인 2026.06

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • Active surveillance; surgery in selected abdominal-wall sporadic cases failing observation; medical therapies including chemotherapy, tyrosine kinase inhibitors, and gamma secretase inhibitors; local ablative treatments including cryotherapy or radiotherapy; pain control/supportive care[1]Standard option (per Desmoid Tumor Research Foundation)Familial adenomatous polyposis context noted by source; no treatment biomarker required; Initial observation and escalation after progression/symptoms or failure of observation, depending on tumor location and familial/sporadic context. · DTRF is a patient-advocacy source summarizing guideline approaches, not a regulator. Specific therapy availability and sequencing vary by country and specialist team. Confidence/conflicts: Medium-high for consensus-framework summary; regulator-specific drug availability must be captured separately.
  • Afamitresgene autoleucel (Tecelra); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[2]FDA accelerated approvalHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and tumor MAGE-A4 antigen expression for afamitresgene autoleucel; synovial sarcoma often has translocation biology in pediatric NCI PDQ context; Adults with unresectable or metastatic synovial sarcoma after prior chemotherapy and required HLA/MAGE-A4 testing for Tecelra; localized/advanced STS surgery/radiation/chemotherapy context from NCI. · FDA approval is accelerated and biomarker/device-gated; it does not imply eligibility, availability at every center, or insurance coverage. NCI PDQ STS sections are broad evidence summaries and not personalized recommendations. Confidence/conflicts: High for FDA accelerated approval and biomarker requirements; no current EMA/UK equivalent approval inferred.
  • Crizotinib (Xalkori)[3]FDA-approvedALK-positive; Unresectable, recurrent, or refractory ALK-positive IMT in adults and in pediatric patients age 1 year and older. · This FDA page verifies U.S. regulatory status only. It does not establish payer coverage, sequencing relative to surgery or other systemic therapy, or suitability for ALK-negative IMT. Confidence/conflicts: High for FDA approval scope and age/setting language; no conflict identified.
  • Eribulin mesylate (Halaven); surgery; radiation therapy; chemotherapy; histology-specific systemic therapy context[4]FDA-approvedNo biomarker required by fetched sources; Unresectable or metastatic liposarcoma after prior anthracycline-containing regimen for eribulin; localized/advanced/recurrent adult STS contexts for surgery/radiation/systemic options. · Eribulin is liposarcoma-specific in the FDA label, but the NCI PDQ STS treatment categories are broader STS guidance and not a personalized recommendation. Exact histologic subtype and prior therapy matter. Confidence/conflicts: High for eribulin FDA label/news and NCI STS categories; current Halaven label refresh remains a gap.
  • Nirogacestat (Ogsiveo)[5]FDA-approvedNo biomarker required by fetched FDA approval notice; Adults with progressing desmoid tumors requiring systemic treatment; DeFi trial enrolled progressing desmoid tumors not amenable to surgery. · FDA approval notice does not determine insurance coverage, local formulary access, or individual eligibility. FDA lists common adverse reactions and reproductive/ovarian toxicity concerns in the approval summary; dosing details are not reproduced here for patient-facing catalog use. Confidence/conflicts: High for FDA-approved U.S. indication; no claim about personal suitability or coverage.
  • Pexidartinib (Turalio); vimseltinib (Romvimza)[6]FDA-approvedCSF1R pathway targeted by pexidartinib and vimseltinib; no biomarker test requirement stated in fetched FDA approval notices; Adult symptomatic TGCT where surgery is not appropriate or may cause worsening functional limitation/severe morbidity. · FDA notes pexidartinib has a boxed warning for serious and potentially fatal liver injury and is available only through a REMS program. FDA approval notices do not establish payer coverage, local formulary access, or individual eligibility. Confidence/conflicts: High for U.S. approvals; no recommendation between approved options.
  • Surgery; multiagent chemotherapy including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, and etoposide contexts; pulmonary metastasectomy context where source discusses metastatic disease[7]Standard option (per NCI PDQ)No biomarker required by fetched NCI source; histologic response/necrosis after chemotherapy is discussed as a treatment-stratification research factor; Localized and metastatic osteosarcoma/UPS of bone contexts in NCI PDQ; surgery and perioperative multiagent chemotherapy. · NCI PDQ is an evidence summary, not personalized medical advice. Regimen choice, timing, resectability, metastatic-site surgery, age, organ function, and clinical-trial availability require specialist team discussion. Confidence/conflicts: High for NCI PDQ treatment framework; no drug-specific FDA approval claim made.
  • Surgery; radiation therapy; chemotherapy including doxorubicin/ifosfamide contexts; pazopanib (Votrient)[8]FDA-approvedNo biomarker required by fetched sources; Localized/resectable STS settings for surgery/radiation/chemotherapy; advanced STS after prior chemotherapy for pazopanib label. · These are adult STS sources rather than leiomyosarcoma-only approvals. Pazopanib label excludes demonstrated efficacy for adipocytic STS and GIST, but does not make a leiomyosarcoma-only indication. NCI PDQ is an evidence summary, not personalized advice. Confidence/conflicts: High for broad adult STS and FDA pazopanib facts; leiomyosarcoma-specific access remains inferred only as non-adipocytic/non-GIST STS context, not recorded as a subtype-specific FDA claim.
  • avapritinib (Ayvakit)[9]FDA-approvedPDGFRA exon 18 mutation, including PDGFRA D842V; unresectable or metastatic GIST with the stated PDGFRA exon 18 mutation. · The FDA label states patient selection is based on presence of a PDGFRA exon 18 mutation and notes that an FDA-approved test for detection of exon 18 mutations was not currently available in that label.
  • entrectinib (Rozlytrek)[10]FDA-approvedNTRK gene fusion; Metastatic or unresectable NTRK fusion-positive sarcoma after standard treatment and with no other effective option; pediatric age scope expanded in 2023. · The fetched source is an NCI government summary of FDA action rather than the FDA approval page itself. The approval is tumor-agnostic, and the source emphasizes prior standard treatment plus no-effective-options criteria. Confidence/conflicts: High for the FDA approval summary and sarcoma-relevant eligibility framing; no conflicting fetched source.
  • imatinib mesylate (Gleevec)[11]FDA-approvedKIT (CD117)-positive; unresectable/metastatic malignant GIST; adjuvant treatment following complete gross resection, as stated in the FDA label. · The label ties these GIST indications to KIT (CD117)-positive disease and states that the optimal duration of adjuvant treatment is not known.
  • larotrectinib (Vitrakvi)[12]FDA-approvedNTRK gene fusion without a known acquired resistance mutation; Metastatic or surgery-morbid NTRK fusion-positive sarcoma in adults or children when no satisfactory alternative exists or after progression following treatment. · The fetched FDA page is the original accelerated-approval notice rather than a current full-label page; continued approval language applied on that notice. The approval is tumor-agnostic, so sarcoma use still depends on confirmed NTRK fusion and clinical fit rather than histology alone. Confidence/conflicts: High for FDA-cleared indication and sarcoma-relevant setting; no conflicting fetched source, with routine accelerated-approval caveat noted. FDA converted larotrectinib (Vitrakvi) from accelerated to FULL/regular tumor-agnostic approval on 10 April 2025 for NTRK gene fusion-positive solid tumors (confirmatory trials LOXO-TRK-14001, SCOUT, NAVIGATE; pooled ORR ~60%). The prior 'FDA accelerated approval'/'restricted' label is stale — upgraded to full approval. Only relevant if the sarcoma carries an NTRK gene fusion (a rare biomarker) confirmed by molecular testing; not a general sarcoma therapy.
  • nab-sirolimus (Fyarro)[13]Approvedno biomarker requirement stated in the fetched label; mTOR-pathway biology is background only; Adult locally advanced unresectable or metastatic malignant PEComa; label gives dosing until disease progression or unacceptable toxicity. · The fetched label is adult-only, does not rank FYARRO against surgery or other systemic options, and includes monitoring and dose-modification cautions for stomatitis, myelosuppression, infection, hyperglycemia/hypokalemia, pneumonitis, hemorrhage, hypersensitivity, and CYP3A4/P-gp interactions. Confidence/conflicts: High for current U.S. label status and setting; no conflicting fetched source.
  • nirogacestat (Ogsiveo)[14]FDA-approvedadult patients with progressing desmoid tumors who require systemic treatment. · FDA approval and label confirm U.S. indication scope only. The label carries substantial safety monitoring language including diarrhea, ovarian toxicity, hepatotoxicity, non-melanoma skin cancers, electrolyte abnormalities, and embryo-fetal toxicity warnings. Confidence/conflicts: high for U.S. indication and safety-monitoring scope; no conflict identified between the approval notice and label.
  • pazopanib (Votrient)[8]FDA-approvedadvanced STS after prior chemotherapy. · The FDA label states that efficacy has not been demonstrated for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors.
  • pexidartinib (Turalio)[15]FDA-approvednot biomarker-specific; adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. · The FDA label carries a boxed hepatotoxicity warning and states Turalio is available only through the TURALIO REMS Program. This is a U.S. label-access finding, not a statement that surgery is inappropriate in any individual case. Confidence/conflicts: high for U.S. indication scope and REMS/hepatotoxicity access caveats; no conflict identified.
  • regorafenib (Stivarga)[16]FDA-approvedlocally advanced, unresectable, or metastatic GIST after prior imatinib mesylate and sunitinib malate. · The fetched FDA label is the 2013 label revision that added the GIST indication and states it may not be the latest approved labeling. It supports the U.S. third-line sequencing concept, but current-label details should be refreshed before patient-facing reuse. Confidence/conflicts: high for the existence and scope of the U.S. post-imatinib/post-sunitinib GIST indication; medium-high for current-label freshness because the fetched PDF notes it may not be the latest approved labeling. No indication conflict identified.
  • repotrectinib (Augtyro)[17]FDA accelerated approvalNTRK gene fusion; Adult and pediatric age 12+ locally advanced, metastatic, or surgery-morbid NTRK fusion-positive sarcoma after progression or where no satisfactory alternative therapy exists. · This is an accelerated approval. The pivotal trial included both TRK-inhibitor-naive and TRK-pretreated cohorts, so the source supports use across both contexts when the label criteria are met, but it does not rank repotrectinib against other TRK inhibitors for a given sarcoma. Confidence/conflicts: High for FDA-cleared indication and post-progression/no-alternative setting; no conflicting fetched source.
  • ripretinib (Qinlock)[18]FDA-approvednot biomarker-gated in the fetched label beyond diagnosis of GIST; advanced GIST after 3 or more prior kinase inhibitors including imatinib. · The label specifies prior treatment with 3 or more kinase inhibitors, including imatinib; it does not frame this as an earlier-line option.
  • sunitinib malate (Sutent)[19]FDA-approvedafter disease progression on or intolerance to imatinib mesylate. · The fetched FDA label is the original 2006 label and explicitly says it may not be the latest approved labeling. It still supports the U.S. indication framework for the post-imatinib GIST setting, but current formulation/generic-label updates should be checked before patient-facing reuse. Confidence/conflicts: high for the existence and scope of the U.S. post-imatinib GIST indication; medium-high for current-label freshness because the fetched PDF is an older FDA label that notes it may not be the latest approved labeling. No indication conflict identified.
  • trabectedin (Yondelis)[20]FDA-approvedunresectable or metastatic liposarcoma or leiomyosarcoma after prior anthracycline-containing treatment. · The label is subtype-specific to liposarcoma or leiomyosarcoma and requires prior anthracycline-containing treatment.

European Union

  • Eribulin (Halaven); trabectedin (Yondelis)[21]EMA authorisedNo biomarker required by fetched EMA sources; Unresectable/metastatic liposarcoma after anthracycline-containing regimen for eribulin; advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin. · EMA central authorization does not establish member-state reimbursement or access. The Halaven exact indication should be refreshed from EMA product information before patient-facing quoting. Confidence/conflicts: Medium-high; trabectedin details directly fetched from EMA page, Halaven exact indication needs product-information refresh.
  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy[22]EMA authorisedNo biomarker required by fetched EMA source; Postoperative treatment after macroscopically complete resection of high-grade resectable non-metastatic osteosarcoma in children, adolescents, and young adults. · EMA central authorization does not establish member-state reimbursement or local availability. Age range, surgical completeness, metastatic status, and chemotherapy plan are key source-stated conditions. Confidence/conflicts: High for EMA indication and age/stage/surgery constraints; member-state access unverified.
  • Nirogacestat hydrobromide (Ogsiveo)[23]EMA authorisedNo biomarker required by fetched EMA EPAR; Adult progressing desmoid tumours requiring systemic treatment. · EMA central authorisation does not establish Germany/France reimbursement timing, local prescribing restrictions, or individual eligibility. EMA notes additional monitoring status. Confidence/conflicts: High for EU central authorisation; reimbursement/access remains member-state specific.
  • Pazopanib (Votrient); trabectedin (Yondelis) broad STS context[24]EMA authorisedNo synovial sarcoma-specific biomarker requirement in fetched EMA broad STS sources; Broad advanced STS settings only; not recorded as synovial-sarcoma-specific approval. · This cell is broad STS EU context, not a synovial-specific EU approval. Member-state reimbursement and any EU TCR/cell-therapy authorization require separate verification. Confidence/conflicts: Medium for synovial sarcoma because sources are broad STS; explicit EU Tecelra-equivalent source not verified.
  • Trabectedin (Yondelis); pazopanib (Votrient)[25]EMA authorisedNo biomarker required by fetched EMA sources; Advanced soft-tissue sarcoma after anthracycline/ifosfamide failure or unsuitability for trabectedin; advanced STS label context for pazopanib pending product-information refresh. · EMA central authorization does not establish member-state reimbursement or local access. Votrient indication detail should be refreshed from product information before surfacing as leiomyosarcoma-specific. Confidence/conflicts: High for trabectedin EU facts; medium for pazopanib EU STS detail pending product-information text refresh.
  • avapritinib (Ayvakyt)[26]EMA authorisedPDGFRA D842V mutation; unresectable metastatic GIST with PDGFRA D842V mutation. · The fetched EMA page is mutation-specific and disease-setting-specific; it does not support use for all GIST or for non-metastatic resectable disease. EMA notes this is a conditional marketing authorisation. Confidence/conflicts: high for EMA mutation-specific GIST indication; no conflict identified. Member-state reimbursement remains unverified.
  • imatinib (Glivec)[27]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST; adjuvant context after surgical removal in adults at risk of recurrence. · The fetched EMA summary page does not add the KIT (CD117)-positive qualifier used in some other jurisdictions, and it frames adjuvant use around adults at risk of recurrence after surgery rather than a fixed-duration requirement. Confidence/conflicts: high for EMA central-authorisation scope on unresectable/metastatic and postoperative-risk contexts; no conflict identified. Member-state reimbursement remains unverified.
  • regorafenib (Stivarga)[28]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST after prior imatinib and sunitinib. · The EMA summary page supports a post-imatinib/post-sunitinib sequencing concept but does not provide mutation-specific selection criteria in the displayed lines. Confidence/conflicts: high for EMA post-imatinib/post-sunitinib GIST indication scope; no conflict identified. Member-state reimbursement remains unverified.
  • ripretinib (Qinlock)[29]EMA authorisednot biomarker-specified on the fetched EMA summary page beyond GIST biology involving KIT and PDGFRA; advanced GIST after three or more prior kinase inhibitors including imatinib. · The indication is late-line and does not establish earlier-line use. The fetched EMA page frames the disease as advanced and previously treated with three or more kinase inhibitors. Confidence/conflicts: high for EMA late-line advanced GIST indication; no conflict identified. Member-state reimbursement remains unverified.
  • sunitinib (Sutent)[30]EMA authorisednot biomarker-specified on the fetched EMA summary page; unresectable or metastatic GIST after imatinib treatment failure. · The fetched EMA summary page does not distinguish failure because of progression versus intolerance in the displayed lines, and it is not a first-line GIST source. Confidence/conflicts: high for EMA sequencing after imatinib failure; no conflict identified. Member-state reimbursement remains unverified.

United Kingdom

  • Mifamurtide (Mepact) with postoperative multiagent chemotherapy; surgery and chemotherapy within UK bone sarcoma guideline context[31]NICE recommendedNo biomarker required by fetched UK sources; Post-surgery non-metastatic high-grade osteosarcoma age 2 to 30 years for mifamurtide/NICE context; bone sarcoma specialist management pathway. · NICE applies to England unless otherwise stated; exact recommendation details should be checked in TA235 before patient-facing quoting. Devolved nations, funding route, and local bone sarcoma MDT decisions remain separate. Confidence/conflicts: Medium-high; NICE overview verified but exact recommendation chapter still needs refresh for integration.
  • Nirogacestat hydrobromide (Ogsiveo)[32]ApprovedNo biomarker required by fetched MHRA/NICE sources; Adults with progressing desmoid tumours; NICE reimbursement/appraisal pathway still pending as of fetched source. · MHRA approval is regulatory and does not by itself establish NHS commissioning or NICE recommendation. NICE appraisal is in progress and should be rechecked after the expected publication date. Confidence/conflicts: High for MHRA approval; NHS access confidence limited because NICE appraisal remains in progress.
  • Regorafenib (Stivarga); ripretinib (Qinlock)[33]ApprovedNo mutation biomarker required by NICE regorafenib/ripretinib recommendation text; prior kinase inhibitor sequence is central; Regorafenib after imatinib and sunitinib; ripretinib after 3 or more kinase inhibitors including imatinib. · NICE recommendations apply to England unless otherwise stated and include commercial/patient-access arrangements. Scotland, Wales, Northern Ireland, and MHRA label detail remain separate cells. Confidence/conflicts: High for NICE England-context recommendations; no conflict identified.
  • Trabectedin (Yondelis); surgery, radiotherapy, systemic anticancer therapy categories in UK STS guideline context[34]NICE recommendedNo biomarker required by fetched sources; Advanced STS after anthracycline/ifosfamide failure or unsuitability for trabectedin; broader UK STS specialist management context. · NICE applies to England unless otherwise stated and does not establish devolved nation policy. UK STS guideline is broad STS guidance, not a leiomyosarcoma-only reimbursement decision. Confidence/conflicts: High for NICE trabectedin recommendation; broad STS guideline context is not subtype-specific reimbursement.

출처

  1. Desmoid Tumor Research Foundation (DTRF) — patient-advocacy guideline-context information · patient-advocacy guideline-context information
  2. U.S. Food and Drug Administration (FDA) — regulator accelerated approval notice · regulator accelerated approval notice
  3. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  4. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  5. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  6. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  7. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  8. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  9. U.S. Food and Drug Administration — official drug label · official drug label
  10. National Cancer Institute — national cancer agency FDA approval summary · national cancer agency FDA approval summary
  11. U.S. Food and Drug Administration — official drug label · official drug label
  12. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  13. DailyMed / National Library of Medicine — official drug label · official drug label
  14. U.S. Food and Drug Administration — official drug label · official drug label
  15. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  16. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  17. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  18. U.S. Food and Drug Administration — official drug label · official drug label
  19. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  20. U.S. Food and Drug Administration — official drug label · official drug label
  21. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  22. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  23. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  24. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  25. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  26. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  27. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  28. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  29. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  30. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  31. NICE — technology appraisal guidance overview · technology appraisal guidance overview
  32. Medicines and Healthcare products Regulatory Agency (MHRA) / GOV.UK — regulator approval press release · regulator approval press release
  33. NICE — technology appraisal guidance · technology appraisal guidance
  34. NICE — technology appraisal guidance · technology appraisal guidance

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 일부 선택지는 신속·조건부 승인 상태로, 적응증이 축소되거나 철회될 수 있습니다. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026.06.

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임상시험 및 신흥 선택지

환자가 거주하는 국가에서 아직 승인된 표준 치료가 아닌 선택지입니다 — 연구, 임상시험, 허가 외 사용, 담당 종양내과 의사가 먼저 언급하지 않을 수 있는 초기 근거입니다. 각 항목은 근거의 강도에 따라 구분됩니다. 여기에 실린 항목은 조사하고 의료진과 상의할 정보일 뿐, 효과가 입증되었거나 안전하거나 현재 이용 가능하다는 의미가 아닙니다. 임상 세부 내용은 영문이 정본입니다.

임상시험 진행 중

임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.

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국가별로 출처가 연결된 선택지와 함께, 진단명·단계·검사 결과·진료과·임상시험 검색어를 정리합니다.

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출처

공신력 있는 출처 기반

모든 선택지는 규제·평가·지침 등 공신력 있는 출처에 연결되며, 새 출처가 검증되면 계속 확장됩니다.

진료 전 정리할 정보

  • Has the tumor been confirmed as KIT (CD117)-positive GIST?
  • Is the discussion about unresectable/metastatic treatment or adjuvant treatment after resection?
  • What mutation testing or risk assessment informs whether this option is relevant?
  • Has PDGFRA exon 18 testing been performed, and does it include D842V?

임상시험 검색어

Sarcoma (incl. GIST) clinical trial