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대장암: 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 2026.05

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

  • pembrolizumab (Keytruda)[1]FDA-approvedMSI-H or dMMR unresectable or metastatic colorectal cancer, first-line
  • nivolumab (Opdivo) + ipilimumab (Yervoy)[2]FDA-approvedMSI-H or dMMR unresectable or metastatic colorectal cancer
  • fruquintinib (Fruzaqla)[3]FDA-approvedRefractory metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF, and anti-EGFR therapy (if RAS wild-type)
  • encorafenib (Braftovi) + cetuximab (Erbitux)[4]FDA-approved (traditional approval)BRAF V600E metastatic colorectal cancer, with fluorouracil-based chemotherapy
  • surgery (polypectomy, local excision, partial colectomy/resection, resection with colostomy, local ablation/cryosurgery)[5]NCI PDQ: listed among standard treatment optionsColon cancer, stage-specific surgical and local-therapy options · NCI PDQ summary; not individualized eligibility.
  • radiation therapy (preoperative chemoradiation, short-course preoperative radiation, postoperative chemoradiation)[6]NCI PDQ: listed among standard treatment optionsStages II–III rectal cancer, as part of multimodality treatment · NCI professional PDQ; not individualized eligibility.
  • adagrasib (Krazati) plus cetuximab[13]FDA accelerated approvalKRAS G12C mutation determined by an FDA-approved test; after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. · FDA described the approval as accelerated approval; continued approval may depend on confirmatory evidence in prescribing information. The FDA efficacy section also notes prior VEGF inhibitor exposure if eligible in the KRYSTAL-1 trial population. Confidence/conflicts: high for FDA accelerated approval status; no conflict identified.
  • encorafenib (Braftovi) plus cetuximab and fluorouracil-based chemotherapy[4]FDA accelerated approvalBRAF V600E mutation detected by an FDA-authorized test; adult metastatic CRC; FDA approval page describes the BREAKWATER treatment-naive metastatic CRC trial population. · FDA approval requires BRAF V600E detected by an FDA-authorized test. The FDA page points to prescribing information for full details and lists important warnings/precautions; this queue entry does not provide dosing or individual eligibility. Confidence/conflicts: high for FDA approval status; no conflict identified.
  • nivolumab (Opdivo) plus ipilimumab (Yervoy); nivolumab single agent in post-chemotherapy metastatic setting[2]FDA-approvedMSI-H or dMMR; nivolumab plus ipilimumab includes first-line and all-line efficacy analyses in unresectable/metastatic MSI-H/dMMR CRC; single-agent nivolumab after progression following fluoropyrimidine, oxaliplatin, and irinotecan. · FDA approval is biomarker-restricted to MSI-H/dMMR disease. The source reports common adverse reactions and notes full prescribing information should be consulted. Confidence/conflicts: high for FDA approval scope; no conflict identified.
  • polypectomy, local excision, partial colectomy/resection with anastomosis, resection with colostomy, and selected local ablation/cryosurgery approaches[5]Standard option (per National Cancer Institute)all stages; stage 0 may include polypectomy/local excision/resection, stages I-II may include resection/anastomosis, and stage III may include resection/anastomosis followed by chemotherapy. · NCI is patient treatment information and does not determine individual surgical eligibility. Colon and rectal cancer local treatment details can differ; this cell is colon-cancer focused. Confidence/conflicts: high for NCI treatment-information scope; no conflict identified.
  • preoperative chemoradiation therapy; short-course preoperative radiation therapy followed by surgery and chemotherapy; postoperative chemoradiation therapy[6]NCI PDQ: standard optionstages II and III rectal cancer. · NCI notes rectal cancer management differs from colon cancer because of local recurrence risk, surgical technique, radiation use, and chemotherapy administration. This is treatment-information content, not individual eligibility. Confidence/conflicts: high for NCI PDQ treatment-option scope; no conflict identified.
  • rectal cancer surgery as part of multimodality treatment[6]NCI PDQ: standard optionstages II and III rectal cancer; surgery may occur after neoadjuvant therapy depending on the strategy. · NCI describes potential chronic symptoms after aggressive rectal surgery, especially if anal sphincter function is affected. Surgical approach depends on tumour location, response, and multidisciplinary planning. Confidence/conflicts: high for NCI PDQ treatment-option scope; no conflict identified.
  • surgery with or without chemotherapy or radiation therapy; systemic therapy; second-line chemotherapy; immunotherapy; palliative therapy[6]NCI PDQ: standard optionstage IV and recurrent rectal cancer. · NCI states surgery may be considered for locally recurrent, liver-only, or lung-only metastatic disease if feasible, but this does not imply any individual is a candidate. Palliative therapy is listed as an option to discuss for stage IV/recurrent disease. Confidence/conflicts: high for NCI PDQ treatment-option scope; no conflict identified.
  • trifluridine/tipiracil (Lonsurf) plus bevacizumab[14]FDA-approvedRAS wild-type status relevant to prior anti-EGFR therapy criterion; previously treated metastatic CRC after the specified prior systemic therapies. · FDA had previously approved single-agent Lonsurf for this indication in 2015; this cell records the 2023 combination approval with bevacizumab. Confidence/conflicts: high for FDA approval scope; no conflict identified.
  • tucatinib (Tukysa) plus trastuzumab[15]FDA accelerated approvalRAS wild-type, HER2-positive; progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. · FDA's trial summary states MOUNTAINEER required prior anti-VEGF therapy and, for dMMR/MSI-H tumours, prior anti-PD-1 therapy; prior anti-HER2 targeted therapy was excluded. Accelerated approval status should be distinguished from full approval. Confidence/conflicts: high for FDA accelerated approval status; no conflict identified.

European Union

  • fruquintinib (Fruzaqla)[11]EMA-authorised (central marketing authorisation)Metastatic colorectal cancer after available standard therapies and progression on or intolerance to trifluridine–tipiracil or regorafenib
  • pembrolizumab (Keytruda)[12]EMA-authorised (central marketing authorisation)MSI-H or dMMR colorectal cancer (first-line metastatic and post-fluoropyrimidine unresectable or metastatic) · Multi-indication EPAR; consult the EPAR product information for the colorectal indication.
  • bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy[16]EMA authorisedmetastatic carcinoma of the colon or rectum. · EMA EPAR confirms the central EU indication; it does not specify individual eligibility or member-state reimbursement. Biosimilar and brand-specific access may vary by country. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • cetuximab (Erbitux) with irinotecan-based chemotherapy; cetuximab with FOLFOX first line; cetuximab single agent after oxaliplatin- and irinotecan-based therapy failure when irinotecan-intolerant[17]EMA authorisedEGFR-expressing, RAS wild-type; metastatic CRC; first-line FOLFOX combination, irinotecan-based combination, or later-line single-agent context as specified. · EMA indicates use in EGFR-expressing, RAS wild-type disease. Central authorisation is not the same as member-state reimbursement. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • encorafenib (Braftovi) plus cetuximab[18]HAS reimbursement opinionBRAF V600E mutation; after prior systemic therapy; HAS describes it as a second and later-line treatment for metastatic CRC with BRAF V600E mutation. · HAS notes regular dermatological monitoring because of skin-cancer risk and recommends multidisciplinary discussion for patients with ECOG score 2 or more because data were not available in that group. Confidence/conflicts: high for HAS reimbursement scope; no conflict identified.
  • encorafenib (Braftovi) plus cetuximab[19]EMA authorisedBRAF V600E mutation; metastatic CRC after prior systemic therapy. · EMA central authorisation does not establish reimbursement or access in individual EU member states. The EPAR indication is for BRAF V600E mutation-positive disease. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • fruquintinib (Fruzaqla)[20]HAS reimbursement opinionprior anti-EGFR therapy criterion applies when relevant; no positive biomarker subgroup is created by this cell; previously treated mCRC after available standard therapies and progression on or intolerance to trifluridine-tipiracil or regorafenib. · HAS deemed clinical benefit moderate and clinical added value absent in the current pathway; the reimbursed scope is restricted and includes ECOG 0-1. Confidence/conflicts: high for HAS reimbursement scope; no conflict identified.
  • fruquintinib (Fruzaqla)[21]Approvedprior anti-EGFR therapy criterion applies where relevant; mCRC after available standard therapies and progression on or intolerance to trifluridine/tipiracil or regorafenib. · Courtesy translation only; German original is legally binding. G-BA notes trifluridine/tipiracil was not sold in Germany in this context footnote, so local pathway details need review. Confidence/conflicts: high for G-BA courtesy-translation scope; German original is legally binding. No conflict identified.
  • nivolumab (Opdivo) plus ipilimumab[22]ApprovedMSI-H or dMMR; first-line unresectable or metastatic dMMR/MSI-H colorectal cancer. · Courtesy translation only; German original is legally binding. "Additional benefit not proven" is a G-BA comparative-benefit conclusion and should not be read as non-approval. Confidence/conflicts: high for G-BA courtesy-translation scope; German original is legally binding. No conflict identified.
  • nivolumab (Opdivo) plus ipilimumab (Yervoy)[23]EMA authorisedMSI-H or dMMR; first-line unresectable or metastatic dMMR/MSI-H CRC; metastatic dMMR/MSI-H CRC after prior fluoropyrimidine-based combination chemotherapy. · EMA notes prescription/specialist supervision and product-information restrictions; this cell does not verify national reimbursement or local formulary status. Biomarker restriction is central to the indication. Confidence/conflicts: high for EMA central indication; no conflict identified. Local reimbursement remains unverified.
  • nivolumab (Opdivo) plus ipilimumab (Yervoy)[24]ApprovedMSI-H or dMMR; first-line metastatic MSI-H/dMMR CRC in adults unresectable from the outset. · HAS says the clinical benefit is substantial only in the reimbursed first-line metastatic/unresectable-from-outset scope and insufficient for other marketing-authorisation situations. This is France-specific access guidance. Confidence/conflicts: high for HAS reimbursement scope; no conflict identified.
  • panitumumab (Vectibix) with FOLFOX or FOLFIRI; panitumumab monotherapy[25]EMA authorisedwild-type RAS; first-line, second-line, or post-fluoropyrimidine/oxaliplatin/irinotecan metastatic CRC settings as specified. · EMA states benefit is limited to wild-type RAS tumours. Central authorisation does not guarantee national reimbursement or local availability. Confidence/conflicts: high for EMA indication scope; no conflict identified.
  • pembrolizumab (Keytruda)[26]HAS reimbursement opinionMSI-H or dMMR; first-line metastatic MSI-H/dMMR colorectal cancer in adults initially unresectable. · HAS recommends caution in patients at high risk of progression or early death and says the therapeutic decision should follow a documented multidisciplinary team proposal. This is a France reimbursement/HTA cell, not individualized eligibility. Confidence/conflicts: high for HAS reimbursement scope; no conflict identified.
  • pembrolizumab (Keytruda)[27]ApprovedMSI-H or dMMR; first-line metastatic MSI-H/dMMR CRC in adults. · Courtesy translation only; German version is legally binding. G-BA benefit assessment does not by itself settle individual eligibility, prescribing, or payer logistics. Confidence/conflicts: high for G-BA courtesy-translation scope; German original is legally binding. No conflict identified.
  • trifluridine/tipiracil (Lonsurf) plus bevacizumab[28]ApprovedRAS wild-type status relevant where prior anti-EGFR treatment criterion applies; metastatic CRC after the specified prior therapies. · HAS found no clinical added value in the current pathway and restricted reimbursement by ECOG and prior-treatment criteria. Confidence/conflicts: high for HAS reimbursement scope; no conflict identified.
  • trifluridine/tipiracil (Lonsurf) plus bevacizumab[29]Approvedanti-EGFR prior therapy may depend on tumour context; metastatic CRC after two prior anticancer treatment regimens including the listed therapy classes. · Courtesy translation only; German original is legally binding. Treatment should be initiated and monitored by experienced oncology/gastroenterology specialists per G-BA. Confidence/conflicts: high for G-BA courtesy-translation scope; German original is legally binding. No conflict identified.
  • trifluridine/tipiracil (Lonsurf) with bevacizumab; trifluridine/tipiracil monotherapy[30]EMA authorisedanti-EGFR prior therapy criterion may depend on tumour context; source does not create a new biomarker-positive subgroup in this cell; metastatic CRC after two prior anticancer regimens for the bevacizumab combination; previously treated or not candidates for available therapies for monotherapy. · This is EMA central authorisation language. It does not verify whether the combination or monotherapy is reimbursed in Germany, France, or another member state. Confidence/conflicts: high for EMA central indication; no conflict identified. Local reimbursement remains unverified.

United Kingdom

Japan

  • fruquintinib (Fruzaqla)[32]PMDA-approved (Japan)unresectable, advanced or recurrent CRC after cancer chemotherapy. · Approval claim is MHLW-attributed in a company release and reinforced by PMDA safety-revision indication text; a full PMDA review report/current label remains preferable for detailed eligibility. PMDA revision highlights nephrotic syndrome precaution updates. Confidence/conflicts: medium-high; PMDA revision verifies indication text but not full approval review. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nivolumab (Opdivo)[33]PMDA-approved (Japan)MSI-High; unresectable, advanced or recurrent MSI-High colorectal cancer after cancer chemotherapy; the review discusses prior fluoropyrimidine, oxaliplatin, and irinotecan. · PMDA notes no Japanese colorectal cancer patients were included in Study 142 and says results should be interpreted carefully. The English translation is reference material and Japanese original prevails. Confidence/conflicts: high for PMDA review-report indication; no conflict identified. Newer nivolumab-ipilimumab Japan update remains a follow-up gap. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda)[34]PMDA-approved (Japan)MSI-High; chemotherapy-treated advanced or recurrent MSI-High solid tumors after cancer chemotherapy, limited to refractory/intolerant to standard treatments. · This PMDA English translation states Japanese original text takes precedence. The indication is tissue-agnostic MSI-High solid tumors and not a first-line metastatic CRC indication in this source. Confidence/conflicts: medium-high for PMDA review-report scope; current label should be refreshed before patient-facing use. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • trifluridine/tipiracil hydrochloride (Lonsurf)[35]PMDA-approved (Japan)unresectable advanced or recurrent colorectal cancer refractory to standard therapies. · PMDA review included conditions for approval and post-marketing/ongoing study follow-up. This cell records single-agent Lonsurf from the PMDA review report, not the later trifluridine/tipiracil plus bevacizumab regimen. Confidence/conflicts: high for PMDA historical approval scope; current combination status remains a follow-up gap. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Korea

  • nivolumab (Opdivo) plus ipilimumab (Yervoy)[36]MFDS-approved (Korea)MSI-High or dMMR; adult unresectable or metastatic MSI-High/dMMR CRC; approval based on CheckMate-8HW comparing Opdivo plus Yervoy with Opdivo alone or investigator's choice chemotherapy. · Source is a company announcement that attributes approval to MFDS; MFDS primary label/reimbursement details remain needed. It does not establish HIRA reimbursement. Confidence/conflicts: medium-high; MFDS approval is company-attributed and needs MFDS primary verification. No conflict identified.
  • pembrolizumab (Keytruda)[37]ApprovedMSI-H or dMMR positive; progressive advanced colorectal cancer after prior therapy context is listed for adjacent MSI-H/dMMR tumor indications; for CRC the HIRA line states progressive advanced, MSI-H/dMMR positive, unresectable or metastatic. · HIRA states the detailed coverage scope may differ from indications and final evaluation results may change if approved specifications or circumstances change. This is a reimbursement-committee result, not a full MFDS label. Confidence/conflicts: high for HIRA reimbursement-committee wording; exact final coverage scope remains uncertain. No conflict identified.

China

  • bevacizumab biosimilar (Byvasda)[38]NMPA-approved (China)metastatic colorectal cancer; source does not state a line of therapy. · This is a biosimilar approval report, not a complete metastatic CRC regimen or NMPA label. It does not specify combination chemotherapy partners, reimbursement, or patient selection. Confidence/conflicts: medium for NMPA-attributed biosimilar approval; NMPA primary label remains a gap. No conflict identified.
  • fruquintinib (Elunate)[39]NMPA-approved (China)metastatic colorectal cancer; line of therapy not specified in the WuXi source. Takeda global background says China approval and launch but does not provide detailed China label eligibility in the fetched lines. · Sources are company/partner announcements rather than an NMPA primary label. Do not infer reimbursement, hospital availability, or eligibility details beyond metastatic CRC approval without NMPA label verification. Confidence/conflicts: medium-high for NMPA-attributed approval and launch; NMPA primary source remains a gap. No conflict identified.
  • ipilimumab N01 injection (IBI310; Tabosun) plus sintilimab (Tyvyt)[40]NMPA-approved (China)MSI-H or dMMR; neoadjuvant therapy for resectable stage IIB to III MSI-H/dMMR colon cancer before radical surgery. · Source is an oncology news article citing Innovent, not an NMPA primary page. The setting is colon cancer specifically, not all colorectal cancer, and is neoadjuvant for resectable stage IIB to III MSI-H/dMMR disease. Confidence/conflicts: medium; NMPA primary confirmation and current label are needed. No conflict identified. Availability/reimbursement outside the approving regulator not established.

출처

  1. FDA — pembrolizumab first-line MSI-H/dMMR colorectal cancer approval · regulator approval notice
  2. FDA — nivolumab plus ipilimumab MSI-H/dMMR colorectal cancer approval · regulator approval notice
  3. FDA — fruquintinib refractory metastatic colorectal cancer approval · regulator approval notice
  4. FDA — encorafenib traditional approval BRAF V600E metastatic colorectal cancer · regulator approval notice
  5. NCI PDQ — Colon Cancer Treatment · NCI PDQ
  6. NCI PDQ — Rectal Cancer Treatment · NCI PDQ
  7. NICE TA709 — pembrolizumab for untreated metastatic MSI-high/MMR-deficient colorectal cancer · NICE technology appraisal
  8. NICE TA1065 — nivolumab plus ipilimumab for untreated unresectable/metastatic MSI-high/MMR-deficient colorectal cancer · NICE technology appraisal
  9. NICE TA1079 — fruquintinib for previously treated metastatic colorectal cancer · NICE technology appraisal
  10. NICE TA1008 — trifluridine–tipiracil with bevacizumab for metastatic colorectal cancer after 2 systemic treatments · NICE technology appraisal
  11. EMA EPAR — Fruzaqla (fruquintinib) · EMA EPAR
  12. EMA EPAR — Keytruda (pembrolizumab) · EMA EPAR
  13. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  14. U.S. Food and Drug Administration (FDA) — regulatory approval notice · regulatory approval notice
  15. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  16. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  17. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  18. Haute Autorite de Sante (HAS) — HTA/reimbursement opinion · HTA/reimbursement opinion
  19. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  20. Haute Autorite de Sante (HAS) — HTA/reimbursement opinion · HTA/reimbursement opinion
  21. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  22. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  23. European Medicines Agency (EMA) — regulatory EPAR · regulatory EPAR
  24. Haute Autorite de Sante (HAS) — HTA/reimbursement opinion · HTA/reimbursement opinion
  25. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  26. Haute Autorite de Sante (HAS) — HTA/reimbursement opinion · HTA/reimbursement opinion
  27. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  28. Haute Autorite de Sante (HAS) — HTA/reimbursement opinion · HTA/reimbursement opinion
  29. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  30. European Medicines Agency (EMA) — regulatory EPAR · regulatory EPAR
  31. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  32. Takeda Pharmaceutical Company Limited — company regulatory approval announcement · company regulatory approval announcement
  33. Pharmaceuticals and Medical Devices Agency (PMDA) — regulatory review report PDF · regulatory review report PDF
  34. Pharmaceuticals and Medical Devices Agency (PMDA) — regulatory review report PDF · regulatory review report PDF
  35. Pharmaceuticals and Medical Devices Agency (PMDA) — regulatory review report PDF · regulatory review report PDF
  36. Ono Pharmaceutical Co., Ltd. — company regulatory approval announcement · company regulatory approval announcement
  37. Health Insurance Review and Assessment Service (HIRA) — reimbursement committee result / press release · reimbursement committee result / press release
  38. The Center for Biosimilars — medical news / NMPA-attributed approval report · medical news / NMPA-attributed approval report
  39. Takeda Oncology — company regulatory background / approval announcement · company regulatory background / approval announcement
  40. OncLive — medical news / NMPA-attributed approval report · medical news / NMPA-attributed approval report

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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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.

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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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