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Endometrial cancer: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Endometrial cancer clinical trial

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

European Union

  • dostarlimab (Jemperli) with carboplatin and paclitaxel[5]EMA authorisedno MMR restriction stated in current EMA indication; first-line primary advanced or recurrent endometrial cancer in adults who are candidates for systemic therapy. · EMA central authorisation does not establish member-state reimbursement or local access. Earlier EU dMMR/MSI-H restriction has been expanded, but national reimbursement may lag. Confidence/conflicts: high for EMA indication; no conflict identified.
  • dostarlimab (Jemperli) with carboplatin and paclitaxel[6]ApproveddMMR / MSI-H; primary advanced stage III/IV or recurrent dMMR/MSI-H endometrial cancer; no prior systemic postoperative/adjuvant therapy for primary advanced disease and no prior chemotherapy for recurrence in the assessed patient group. · G-BA English PDF is a courtesy translation and the German version is legally binding. Additional-benefit findings differ between primary advanced and recurrent disease groups. Confidence/conflicts: high for G-BA resolution; no conflict identified. Courtesy-translation caveat applies.
  • durvalumab (Imfinzi) with carboplatin and paclitaxel followed by durvalumab maintenance[7]ApproveddMMR for the assessed durvalumab maintenance indication; first-line adult primary advanced or recurrent dMMR endometrial cancer in the G-BA assessed group. · G-BA English PDF is a courtesy translation and the German version is legally binding. The conclusion "additional benefit not proven" is a comparative German benefit-assessment outcome, not a statement that the therapy lacks approval. Confidence/conflicts: high for G-BA resolution; no conflict identified. Courtesy-translation caveat applies.
  • durvalumab (Imfinzi) with carboplatin and paclitaxel, followed by durvalumab plus olaparib (Lynparza) maintenance[8]HAS reimbursement opinionpMMR / MSS, per HAS wording for durvalumab plus olaparib maintenance; first-line systemic therapy and maintenance in pMMR/MSS advanced or recurrent endometrial cancer. · The HAS PDF includes access and assessment context and notes earlier early-access refusal history; current prescribing/reimbursement should be verified against final French listing status. Confidence/conflicts: medium-high; indication wording is clear in the HAS PDF, while final access/listing status should be refreshed before patient-facing reuse.
  • lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda)[9]HAS reimbursement opinionno biomarker restriction stated on the HAS summary page; second-line treatment after platinum-containing therapy; not candidates for curative surgery or radiation. · HAS notes additional toxicity and quality-of-life uncertainty. This entry is a France HTA/reimbursement-pathway finding, not individualized suitability. Confidence/conflicts: high for HAS reimbursement/pathway statement; no conflict identified.
  • pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima)[10]Approvedno biomarker restriction in the G-BA indication wording; after progression on or following platinum-containing therapy; not candidates for curative surgery or radiation. · G-BA English PDF is a courtesy translation and the German version is legally binding. The document is a German benefit assessment and does not replace the EMA/German product information or individual prescribing decision. Confidence/conflicts: high for G-BA indication and additional-benefit conclusion; no conflict identified. Courtesy-translation caveat applies.
  • pembrolizumab (Keytruda) with carboplatin and paclitaxel[11]EMA authorisedno biomarker restriction stated in EMA indication; first-line primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. · EMA central authorisation does not determine national reimbursement. MMR/MSI status and local pathway details may affect treatment choice. Confidence/conflicts: high for EMA indication; no conflict identified.
  • pembrolizumab (Keytruda) with carboplatin and paclitaxel induction, followed by pembrolizumab maintenance[12]HAS reimbursement opiniondMMR and pMMR subgroups are discussed in the HAS evidence summary; adult patients with primary advanced or recurrent endometrial cancer; induction with carboplatin/paclitaxel followed by maintenance pembrolizumab. · HAS notes progression-free survival evidence and also limitations including absence of protocol-scheduled overall survival alpha-risk management and excess toxicity. Reimbursement scope and prescribing should be checked against the final French opinion. Confidence/conflicts: high for HAS opinion; no conflict identified.
  • pembrolizumab (Keytruda) with lenvatinib (Lenvima)[11]EMA authorisedno MSI/MMR restriction stated in current EMA Keytruda EPAR text for this combination; earlier company summary highlighted non-MSI-H/non-dMMR in some jurisdictions; after disease progression on or following prior platinum-containing therapy; not candidates for curative surgery or radiation. · EMA authorisation does not determine national reimbursement. Local labels/pathways should clarify biomarker requirements and whether pMMR/non-MSI-H restrictions apply nationally. Confidence/conflicts: medium-high; EMA Keytruda page supports current indication, while older jurisdiction summaries may differ in biomarker framing. No direct conflict in fetched EMA text.

United Kingdom

  • dostarlimab plus platinum-containing chemotherapy[13]NICE recommendedmicrosatellite stable (MSS) or mismatch repair proficient (MMRp); primary advanced or recurrent endometrial cancer with MSS or MMRp when systemic treatment is suitable. · NICE recommendation is biomarker-specific for MSS/MMRp and commercial-arrangement dependent. It does not cover every molecular subtype or access route. Confidence/conflicts: high for NICE recommendation; no conflict identified.
  • pembrolizumab (Keytruda) with carboplatin and paclitaxel[14]Approvedno biomarker restriction stated in NICE TA1092 recommendation; untreated primary advanced or recurrent endometrial cancer. · NICE notes the summary of product characteristics recommends pembrolizumab use for no longer than 2 years in this setting. This is an NHS England appraisal context and does not determine devolved/private access. Confidence/conflicts: high for NICE recommendation; no conflict identified.
  • pembrolizumab (Keytruda) with lenvatinib (Lenvima)[15]NICE recommendedno biomarker restriction in the NICE TA904 overview; local marketing authorisation details should be checked; previously treated advanced or recurrent endometrial cancer after progression on or after platinum-based chemotherapy; not candidates for curative surgery or radiotherapy. · This entry uses the NICE TA904 page plus linked secondary summary for the exact recommendation wording. Confirm the current NICE recommendation text and commercial arrangement before patient-facing reuse. Confidence/conflicts: medium-high; NICE appraisal existence is clear, with exact recommendation wording supported by secondary summary. No conflict identified.

Japan

  • carboplatin (Paraplatin)[16]PMDA-approved (Japan)treatment of endometrial cancer; the list entry does not specify line of therapy. · The PMDA list is an approval ledger, not a full clinical guideline; local package insert, regimen partner drugs, reimbursement, and hospital protocol need confirmation before patient-facing display. Confidence/conflicts: high for existence of Japan approval; no conflicting source identified. Specific regimen/line details not supplied by this source.
  • durvalumab (Imfinzi)[16]PMDA-approved (Japan)advanced or recurrent endometrial cancer. · The PMDA list entry confirms the approval category but does not provide full regimen details or biomarker restrictions. Use the current Japanese electronic package insert and treating-center formulary for details. Confidence/conflicts: high for Japan approval existence; no source conflict identified. Biomarker and line details require label-level refresh. Availability/reimbursement outside the approving regulator not established.
  • olaparib (Lynparza) maintenance after chemotherapy including durvalumab[16]PMDA-approved (Japan)proficient mismatch repair (pMMR), per PMDA safety information wording; maintenance therapy after chemotherapy including durvalumab for advanced or recurrent pMMR endometrial cancer. · PMDA Safety Information No. 428 is an English reference translation and states the Japanese original prevails in case of inconsistency. It also flags hepatic impairment precautions, which should be reviewed in the official Japanese package insert. Confidence/conflicts: high for pMMR maintenance indication and Japan approval; no conflict identified. English translation caveat noted. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda) with lenvatinib (Lenvima)[17]PMDA-approved (Japan)not MSI-H or dMMR, per PMDA Keytruda label wording; disease progression following prior systemic therapy in any setting; not candidates for curative surgery or radiation. · The fetched PMDA document is a Keytruda prescribing-information PDF; confirm the current Japanese electronic labels for both Keytruda and Lenvima and local reimbursement before patient-facing reuse. Confidence/conflicts: high for label wording in fetched PMDA document; no conflict identified. Current-label refresh remains useful because oncology indications evolve.

Russia

Thailand

  • carboplatin plus paclitaxel; other listed chemotherapy options include cisplatin, doxorubicin, and paclitaxel-based regimens[19]Standard option (per Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline)MMR-deficient tumors are noted in the guideline as a special case where chemotherapy benefit may differ; biomarker testing should be discussed; high-risk adjuvant context; first-line systemic therapy for advanced or recurrent disease when platinum-based chemotherapy is appropriate; second-line doxorubicin and weekly paclitaxel may be considered. · The guideline ties chemotherapy choice to prior treatment, disease-free interval, patient condition, risk group, and coverage constraints; it does not imply every regimen is reimbursed identically in every setting. Confidence/conflicts: high for guideline and coverage statements; no conflict identified.
  • hysterectomy-based surgery with staging as clinically indicated[19]Standard option (per Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline)molecular testing context includes p53, MMR proteins, HER2, hormone receptors, and POLE mutations when relevant; primary treatment and staging; high-risk endometrial carcinoma histology staging context. · The guideline is a practice guideline, not a personalized surgical plan; stage, histology, hospital capability, molecular testing, and operative risk determine the actual approach. Confidence/conflicts: high for Thailand guideline recommendation; no conflict identified.
  • pembrolizumab (Keytruda) or dostarlimab (Jemperli) immune checkpoint inhibitor approaches[19]Standard option (per Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline)dMMR/MSI-H for single-agent immune checkpoint inhibitor consideration; MMR status relevant for advanced/metastatic integration of immunotherapy; MSI-H/dMMR endometrial cancer after progression following platinum-based therapy for single-agent immune checkpoint inhibitor consideration; advanced/metastatic integration especially in dMMR/MSI-H tumors. · Guideline consideration is not the same as Thai national benefit coverage. The guideline specifically notes no current government healthcare-scheme coverage for immunotherapy. Confidence/conflicts: high for guideline statement and access caveat; no conflict identified.
  • pembrolizumab (Keytruda) plus lenvatinib (Lenvima); trastuzumab (Herceptin and biosimilars) with standard chemotherapy for HER2-positive serous/carcinosarcoma contexts[20]Recommended (HTA / guideline)MMR status for pembrolizumab plus lenvatinib discussion; HER2-positive disease for trastuzumab context; recurrent or advanced endometrial cancer for pembrolizumab plus lenvatinib; HER2-positive advanced endometrial cancer, particularly serous carcinoma/frontline context, for trastuzumab with standard chemotherapy. · This is an options-to-discuss guideline entry with explicit coverage caveat. It should not be presented as a routinely covered Thai benefit or as a first-line superiority claim. Confidence/conflicts: high for guideline statement and coverage caveat; no conflict identified. Pembrolizumab + lenvatinib is FDA-approved (regular approval Jul 2021, KEYNOTE-775) for advanced/recurrent endometrial cancer that is NOT MSI-H/dMMR, after progression on prior platinum-based systemic therapy and not curable by surgery/radiation. The Phase 3 LEAP-001 trial separately showed it did NOT beat chemotherapy in the FIRST-LINE setting, so it is not a substitute for upfront chemotherapy — but it remains an established post-platinum option. Trastuzumab added to carboplatin/paclitaxel is NCCN-recommended for HER2-positive serous carcinoma/carcinosarcoma. Options-to-discuss guideline entry (Thai Gynecologic Cancer Society); confirm Thai coverage and eligibility (MMR/HER2 status, prior therapy) with the oncologist.
  • vaginal brachytherapy (VBT), external beam pelvic radiation therapy (EBRT/EBPRT), and pelvic radiation with or without brachytherapy[19]Standard option (per Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline)risk group and molecular classification may affect adjuvant decisions; adjuvant treatment after surgery by risk group; locoregional recurrence after primary surgery alone when prior radiation history permits. · Radiation choice depends on risk group, lymphovascular space invasion, surgical nodal staging, prior radiation, recurrence site, and patient condition. Confidence/conflicts: high for Thailand guideline recommendation; no conflict identified.

출처

  1. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  2. Association of Cancer Care Centers summarizing FDA approval — professional oncology organization FDA approval summary · professional oncology organization FDA approval summary
  3. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  4. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  5. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  6. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / Annex XII · benefit-assessment resolution / Annex XII
  7. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / Annex XII · benefit-assessment resolution / Annex XII
  8. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion PDF · health technology assessment / reimbursement opinion PDF
  9. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  10. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment justification / Annex XII · benefit-assessment justification / Annex XII
  11. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  12. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  13. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  14. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  15. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  16. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
  17. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator-hosted prescribing information · regulator-hosted prescribing information
  18. Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
  19. Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline — national specialty-society practice guideline · national specialty-society practice guideline
  20. Journal of Gynecologic Oncology / Thai Gynecologic Cancer Society guideline — national specialty-society practice guideline · national specialty-society practice guideline

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. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.