Metastatic colorectal cancer- third line therapy and beyond

References

• Baretti M, Le DT. DNA mismatch repair in cancer. Pharmacol Ther [Internet]. 2018;189:45–62. Available from: https://www.sciencedirect.com/science/article/pii/S0163725818300676
   PubMed Web of Science ®Google Scholar
• Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science (80). 2017;357(6349):409–413. doi: 10.1126/science.aan6733
   PubMed Web of Science ®Google Scholar
• Venderbosch S, Nagtegaal ID, Maughan TS, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: a pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS studies. Clin Cancer Res An Off J Am Assoc Cancer Res. 2014 Oct;20(20):5322–5330.
   PubMed Web of Science ®Google Scholar
• Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med [Internet]. 2015;372(26):2509–2520. doi: 10.1056/NEJMoa1500596
   PubMed Web of Science ®Google Scholar
• Le DT, Kim TW, Van Cutsem E, et al. Phase II open-label study of pembrolizumab in treatment-refractory, microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: KEYNOTE-164. J Clin Oncol Off J Am Soc Clin Oncol. 2020 Jan;38(1):11–19.
   PubMed Web of Science ®Google Scholar
• Muro K, Chung HC, Shankaran V, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol [Internet]. 2016 Jun 1;17(6):717–726. doi: 10.1016/S1470-2045(16)00175-3
   PubMed Web of Science ®Google Scholar
• Marabelle A, Le DT, Ascierto PA, et al. Efficacy of pembrolizumab in patients with noncolorectal high microsatellite instability/mismatch repair-deficient cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol Off J Am Soc Clin Oncol. 2020 Jan;38(1):1–10.
   PubMed Web of Science ®Google Scholar
• Marcus L, Lemery SJ, Keegan P, et al. FDA approval summary: pembrolizumab for the treatment of microsatellite instability-high solid tumors. Clin Cancer Res [Internet]. 2019 Jul 1;25(13):3753–3758. doi: 10.1158/1078-0432.CCR-18-4070
   PubMed Web of Science ®Google Scholar
• Overman MJ, McDermott R, Leach JL, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol [Internet]. 2017;18(9):1182–1191. Available from: https://www.sciencedirect.com/science/article/pii/S1470204517304229
   PubMed Web of Science ®Google Scholar
• Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2018 Mar;36(8):773–779.
   PubMed Web of Science ®Google Scholar
• André T, Lonardi S, Wong KYM, et al. Nivolumab plus low-dose ipilimumab in previously treated patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: 4-year follow-up from CheckMate 142. Ann Oncol Off J Eur Soc Med Oncol. 2022 Oct;33(10):1052–1060.
   PubMed Web of Science ®Google Scholar
• Lenz H-J, Van Cutsem E, Luisa Limon M, et al. First-line nivolumab plus low-dose ipilimumab for microsatellite instability-High/Mismatch repair-deficient metastatic colorectal cancer: the phase II CheckMate 142 study. J Clin Oncol Off J Am Soc Clin Oncol. 2022 Jan;40(2):161–170.
   PubMed Web of Science ®Google Scholar
• FDA. FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer. 2017. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-nivolumab-accelerated-approval-msi-h-or-dmmr-colorectal-cancer
   Google Scholar
• FDA. FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer [Internet]. 2018. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ipilimumab-msi-h-or-dmmr-metastatic-colorectal-cancer
   Google Scholar
• André T, Shiu K-K, Kim TW, et al. Pembrolizumab in microsatellite-instability-high advanced colorectal cancer. N Engl J Med. 2020 Dec;383(23):2207–2218.
   PubMed Web of Science ®Google Scholar
• Casak SJ, Marcus L, Fashoyin-Aje L, et al. FDA approval summary: pembrolizumab for the First-line treatment of patients with MSI-H/dMMR advanced unresectable or metastatic colorectal carcinoma. Clin Cancer Res An Off J Am Assoc Cancer Res.2021 Sep;27(17):4680–4684.
   PubMed Web of Science ®Google Scholar
• Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up☆. Ann Oncol [Internet]. 2023 Jan 1;34(1):10–32. doi: 10.1016/j.annonc.2022.10.003
   PubMed Web of Science ®Google Scholar
• Morris VK, Kennedy EB, Baxter NN, et al. Treatment of metastatic colorectal cancer: ASCO guideline. J Clin Oncol Off J Am Soc Clin Oncol. 2023 Jan;41(3):678–700.
   PubMed Web of Science ®Google Scholar
• Siena S, Sartore-Bianchi A, Marsoni S, et al. Targeting the human epidermal growth factor receptor 2 (HER2) oncogene in colorectal cancer. Ann Oncol [Internet]. 2018 May 1;29(5):1108–1119. doi: 10.1093/annonc/mdy100
   PubMed Web of Science ®Google Scholar
• Bertotti A, Migliardi G, Galimi F, et al. A molecularly annotated platform of patient-derived xenografts (“xenopatients”) identifies HER2 as an effective therapeutic target in cetuximab-resistant colorectal cancer. Cancer Discov. 2011 Nov;1(6):508–523.
   PubMed Web of Science ®Google Scholar
• Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Jun 1;17(6):738–746. doi: 10.1016/S1470-2045(16)00150-9
   PubMed Web of Science ®Google Scholar
• Cho H-S, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the herceptin fab. Nat. 2003;421(6924):756–760. doi: 10.1038/nature01392
   Google Scholar
• Sartore-Bianchi A, Lonardi S, Aglietta M, et al. Central nervous system as possible site of relapse in ERBB2-positive metastatic colorectal cancer: long-term results of treatment with trastuzumab and lapatinib. JAMA Oncol. 2020 Jun;6(6):927–929.
   PubMed Web of Science ®Google Scholar
• Meric-Bernstam F, Hurwitz H, Raghav KPS, et al. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019 Apr;20(4):518–530.
   PubMed Web of Science ®Google Scholar
• Gupta R, Meric-Bernstam F, Rothe M, et al. Pertuzumab plus trastuzumab in patients with colorectal cancer with ERBB2 amplification or ERBB2/3 mutations: results from the TAPUR study. JCO Precis Oncol. 2022 Oct;6(6):e2200306.
   PubMedGoogle Scholar
• Siena S, Di Bartolomeo M, Raghav K, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):779–789.
   PubMed Web of Science ®Google Scholar
• Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res An Off J Am Assoc Cancer Res. 2016 Oct;22(20):5097–5108.
   PubMed Web of Science ®Google Scholar
• Takegawa N, Tsurutani J, Kawakami H, et al. [Fam-] trastuzumab deruxtecan, antitumor activity is dependent on HER2 expression level rather than on HER2 amplification. Int J Cancer. 2019 Dec;145(12):3414–3424.
   PubMed Web of Science ®Google Scholar
• Yoshino T, Di Bartolomeo M, Raghav KPS, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): final results from a phase 2, multicenter, open-label study (DESTINY-CRC01). J Clin Oncol. 2021 May 20;39(15_suppl):3505. doi: 10.1200/JCO.2021.39.15_suppl.3505
   Web of Science ®Google Scholar
• FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer [internet]. 2023. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tucatinib-trastuzumab-colorectal-cancer
   Google Scholar
• Strickler JH, Cercek A, Siena S, et al. LBA27 - additional analyses of MOUNTAINEER: a phase II study of tucatinib and trastuzumab for HER2-positive mCRC. Ann Oncol. 2022;33(suppl_.):S1394. doi: 10.1016/j.annonc.2022.08.023
   Google Scholar
• Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun;417(6892):949–954.
   PubMed Web of Science ®Google Scholar
• Schirripa M, Biason P, Lonardi S, et al. Class 1, 2, and 3 BRAF-Mutated metastatic colorectal cancer: a detailed clinical, pathologic, and molecular characterization. Clin Cancer Res An Off J Am Assoc Cancer Res. 2019 Jul;25(13):3954–3961.
   PubMed Web of Science ®Google Scholar
• Kopetz S, Grothey A, Yaeger R, et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct;381(17):1632–1643.
   PubMed Web of Science ®Google Scholar
• Tabernero J, Grothey A, Van Cutsem E, et al. Encorafenib plus cetuximab as a new standard of care for Previously treated BRAF V600E-Mutant metastatic colorectal cancer: updated survival results and subgroup analyses from the beacon study. J Clin Oncol Off J Am Soc Clin Oncol. 2021 Feb;39(4):273–284.
   PubMed Web of Science ®Google Scholar
• Prior IA, Lewis PD, Mattos C. A comprehensive survey of Ras mutations in cancer. Cancer Res. 2012 May;72(10):2457–2467. doi: 10.1158/0008-5472.CAN-11-2612
   PubMed Web of Science ®Google Scholar
• Patelli G, Tosi F, Amatu A, et al. Strategies to tackle RAS-mutated metastatic colorectal cancer. ESMO Open [Internet]. 2021 Jun 1;6(3): 100156. doi: 10.1016/j.esmoop.2021.100156
   PubMed Web of Science ®Google Scholar
• Fakih MG, Kopetz S, Kuboki Y, et al. Sotorasib for previously treated colorectal cancers with KRAS G12C mutation (CodeBreak100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan 1;23(1):115–124. doi: 10.1016/S1470-2045(21)00605-7
   PubMed Web of Science ®Google Scholar
• Ryan MB, Coker O, Sorokin A, et al. KRAS(G12C)-independent feedback activation of wild-type RAS constrains KRAS(G12C) inhibitor efficacy. Cell Rep. 2022 Jun;39(12):110993.
   PubMed Web of Science ®Google Scholar
• Amodio V, Yaeger R, Arcella P, et al. EGFR blockade reverts resistance to KRAS(G12C) inhibition in colorectal cancer. Cancer Discov. 2020 Aug;10(8):1129–1139.
   PubMed Web of Science ®Google Scholar
• Fakih M, Falchook G, Hong DS, et al. CodeBreaK 101 subprotocol H: phase Ib study evaluating combination of sotorasib (Soto), a KRASG12C inhibitor, and panitumumab (PMab), an EGFR inhibitor, in advanced KRAS p.G12C-mutated colorectal cancer (CRC) [internet]. Available from: https://www.annalsofoncology.org/article/S0923-7534(21)03184-7/fulltext
   Google Scholar
• Yaeger R, Weiss J, Pelster MS, et al. Adagrasib with or without cetuximab in colorectal cancer with mutated KRAS G12C. N Engl J Med [Internet]. 2022 Dec 21;388(1):44–54. doi: 10.1056/NEJMoa2212419
   PubMed Web of Science ®Google Scholar
• Solomon JP, Linkov I, Rosado A, et al. NTRK fusion detection across multiple assays and 33,997 cases: diagnostic implications and pitfalls. Mod Pathol [Internet]. 2020 Jan 1;33(1):38–46. doi: 10.1038/s41379-019-0324-7
   PubMed Web of Science ®Google Scholar
• Wang H, Li Z-W, Ou Q, et al. NTRK fusion positive colorectal cancer is a unique subset of CRC with high TMB and microsatellite instability. Cancer Med. 2022 Jul;11(13):2541–2549.
   PubMed Web of Science ®Google Scholar
• FDA approves larotrectinib for solid tumors with NTRK gene fusions | FDA [internet]. [cited 2021 Jul 25]. Available from: https://www.fda.gov/drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions
   Google Scholar
• FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC | FDA [internet]. [cited 2021 Jul 25]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-ntrk-solid-tumors-and-ros-1-nsclc
   Google Scholar
• Yoshino T, Mizunuma N, Yamazaki K, et al. TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 trial. Lancet Oncol. 2012 Oct;13(10):993–1001.
   PubMed Web of Science ®Google Scholar
• Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May;372(20):1909–1919.
   PubMed Web of Science ®Google Scholar
• Xu J, Kim TW, Shen L, et al. Results of a randomized, double-blind, placebo-controlled, phase III trial of Trifluridine/Tipiracil (TAS-102) monotherapy in Asian patients with Previously treated metastatic colorectal cancer: the TERRA study. J Clin Oncol. 2018;36(4):350–358. doi: 10.1200/JCO.2017.74.3245
   PubMed Web of Science ®Google Scholar
• Salvatore L, Niger M, Bellu L, et al. Compassionate use program for trifluridine/tipiracil (TAS-102) in metastatic colorectal cancer: a real-life overview. Ann Oncol [Internet]. 2016 Oct 1;27(vi169): vi169. doi: 10.1093/annonc/mdw370.60
   Google Scholar
• Marcus L, Lemery SJ, Khasar S, et al. FDA approval summary: TAS-102. Clin Cancer Res [Internet]. 2017 Jun 14;23(12):2924–2927. doi: 10.1158/1078-0432.CCR-16-2157
   PubMed Web of Science ®Google Scholar
• Kuboki Y, Nishina T, Shinozaki E, et al. TAS-102 plus bevacizumab for patients with metastatic colorectal cancer refractory to standard therapies (C-TASK FORCE): an investigator-initiated, open-label, single-arm, multicentre, phase 1/2 study. Lancet Oncol. 2017 Sep;18(9):1172–1181.
   PubMed Web of Science ®Google Scholar
• Pfeiffer P, Yilmaz M, Möller S, et al. TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):412–420.
   PubMed Web of Science ®Google Scholar
• Tabernero J, Prager GW, Fakih M, et al. Trifluridine/Tipiracil plus bevacizumab for third-line treatment of refractory metastatic colorectal cancer: the phase 3 randomized SUNLIGHT study. J Clin Oncol. 2023;41(4_suppl):4–4. doi: 10.1200/JCO.2023.41.4_suppl.4
   Google Scholar
• Wilhelm SM, Dumas J, Adnane L, et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011 Jul;129(1):245–255.
   PubMed Web of Science ®Google Scholar
• Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet (London, England). 2013 Jan;381(9863):303–312.
   PubMed Web of Science ®Google Scholar
• Li J, Qin S, Xu R, et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619–629.
   PubMed Web of Science ®Google Scholar
• Riechelmann R, Grothey A. The role of regorafenib in metastatic colorectal cancer. Lancet Oncol. 2015;16(6):596–597. Available from: https://www.sciencedirect.com/science/article/pii/S1470204515701919
   PubMed Web of Science ®Google Scholar
• Abrahao ABK, Ko Y-J, Berry S, et al. A comparison of regorafenib and TAS-102 for metastatic colorectal cancer: a systematic review and network meta-analysis. Clin Colorectal Cancer. 2018 Jun;17(2):113–120. doi:10.1016/j.clcc.2017.10.016
   PubMed Web of Science ®Google Scholar
• Cao J, Zhang J, Peng W, et al. A phase I study of safety and pharmacokinetics of fruquintinib, a novel selective inhibitor of vascular endothelial growth factor receptor-1, -2, and -3 tyrosine kinases in Chinese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Aug;78(2):259–269.
   PubMed Web of Science ®Google Scholar
• Li J, Qin S, Xu R-H, et al. Effect of fruquintinib vs placebo on overall survival in patients with Previously treated metastatic colorectal cancer: the FRESCO randomized clinical trial. JAMA. 2018 Jun;319(24):2486–2496.
   PubMed Web of Science ®Google Scholar
• Dasari NA, Lonardi S, Garcia-Carbonero R, et al. LBA25 FRESCO-2: a global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol [Internet]. 2022 Sep 1;33:S1391–2. doi: 10.1016/j.annonc.2022.08.021
   Web of Science ®Google Scholar
• Tucker N. FDA approval sought for fruquintinib in refractory metastatic colorectal cancer treatment. 2023. Available from: https://www.targetedonc.com/view/fda-approval-sought-for-fruquintinib-in-refractory-metastatic-colorectal-cancer-treatment
   Google Scholar
• de Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2000 Aug;18(16):2938–2947.
   PubMed Web of Science ®Google Scholar
• Delisle ME, Ward MAR, Helewa RM, et al. Timing of palliative care in colorectal cancer patients: does it matter? J Surg Res. 2019 Sep;241:285–293. doi: 10.1016/j.jss.2019.04.009
   PubMed Web of Science ®Google Scholar
• Otsuka M, Koyama A, Matsuoka H, et al. Early palliative intervention for patients with advanced cancer. Jpn J Clin Oncol. 2013 Aug;43(8):788–794.
   PubMed Web of Science ®Google Scholar