Difference between revisions of "Non-small cell lung cancer, ROS1-positive"

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{| class="wikitable" style="text-align:center; width:50%;"
 
{| class="wikitable" style="text-align:center; width:50%;"
 
!colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c"|'''Section editor'''
 
!colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c"|'''Section editor'''
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===References===
 
===References===
 
# '''PROFILE 1001:''' Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406766 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25264305 PubMed]
 
# '''PROFILE 1001:''' Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406766 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25264305 PubMed]
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=Advanced or metastatic disease, ROS1 inhibitor-exposed=
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==Lorlatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
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|[[#top|back to top]]
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===Regimen {{#subobject:9134b2|Variant=1}}===
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{| class="wikitable" style="width: 100%; text-align:center;"
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!style="width: 50%"|Study
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!style="width: 50%"|[[Levels_of_Evidence#Evidence|Evidence]]
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|-
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30680-0/fulltext Shaw et al. 2017 (B7461001)]
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| style="background-color:#ffffbe" |Phase I, <20 pts in this subgroup
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====Chemotherapy====
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*[[Lorlatinib (Lorbrena)]] 100 mg PO once per day
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'''Continued indefinitely'''
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===References===
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# '''Phase 1:''' Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. Epub 2017 Oct 23. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30680-0/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29074098 PubMed]
  
 
=Additional resources=
 
=Additional resources=
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''Drugs with some degree of promising activity in clinical trials.''
 
''Drugs with some degree of promising activity in clinical trials.''
 
*[[Entrectinib (RXDX-101)]]
 
*[[Entrectinib (RXDX-101)]]
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*[[Lorlatinib (PF-06463922)]]
 
  
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Thoracic cancers]]
 
[[Category:Thoracic cancers]]

Revision as of 02:34, 5 November 2018

Section editor
TravisOsterman.jpg
 Travis Osterman, DO, MS
Nashville, TN
Twitter: TravisOsterman
LinkedIn

Note: these are biomarker-specific regimens, please see the main NSCLC page for other regimens.

6 regimens on this page
8 variants on this page


Advanced or metastatic disease, ROS1 inhibitor-naive

Ceritinib monotherapy

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Regimen

Study Evidence Efficacy
Lim et al. 2017 Phase II ORR: 67% (95% CI, 48-81)

Chemotherapy

28-day cycles

References

  1. Lim SM, Kim HR, Lee JS, Lee KH, Lee YG, Min YJ, Cho EK, Lee SS, Kim BS, Choi MY, Shim HS, Chung JH, La Choi Y, Lee MJ, Kim M, Kim JH, Ali SM, Ahn MJ, Cho BC. Open-label, multicenter, phase II study of ceritinib in patients with non-small-cell lung cancer harboring ROS1 rearrangement. J Clin Oncol. 2017 Aug 10;35(23):2613-2618. Epub 2017 May 18. link to original article contains verified protocol PubMed

Crizotinib monotherapy

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Variant #1, standard-dose

FDA-recommended dose
Study Evidence Efficacy
Shaw et al. 2014 (PROFILE 1001) Non-randomized ORR: 72% (95% CI, 58-84)

Note: this was an expansion cohort of a phase I study.

Chemotherapy

28-day cycles

Variant #2, 200 mg BID

FDA-recommended dose

Note: this is the FDA-recommended dosing for "moderate" hepatic impairment.

Chemotherapy

Continued indefinitely

Variant #3, 250 mg/d

FDA-recommended dose

Note: this is the FDA-recommended dosing for "severe" hepatic or renal impairment.

Chemotherapy

Continued indefinitely

References

  1. PROFILE 1001: Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. Epub 2014 Sep 27. link to original article link to PMC article contains verified protocol PubMed

Advanced or metastatic disease, ROS1 inhibitor-exposed

Lorlatinib monotherapy

back to top

Regimen

Study Evidence
Shaw et al. 2017 (B7461001) Phase I, <20 pts in this subgroup

Chemotherapy

Continued indefinitely

References

  1. Phase 1: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. Epub 2017 Oct 23. link to original article contains protocol PubMed

Additional resources

Investigational agents

Drugs with some degree of promising activity in clinical trials.

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