Difference between revisions of "Non-small cell lung cancer, ROS1-positive"
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Warner-admin (talk | contribs) m (Text replacement - "?Regimen |limit=10000|format=sum}} regimens" to "?Regimen |limit=10000|format=sum}} regimens") |
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Advanced or metastatic disease, ROS1 inhibitor-naive= | =Advanced or metastatic disease, ROS1 inhibitor-naive= | ||
| + | |||
| + | ==Ceritinib monotherapy {{#subobject:fe3892|Regimen=1}}== | ||
| + | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
| + | |- | ||
| + | |[[#top|back to top]] | ||
| + | |} | ||
| + | ===Regimen {{#subobject:47c6e4|Variant=1}}=== | ||
| + | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| + | !Study | ||
| + | ![[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | ![[Levels_of_Evidence#Efficacy|Efficacy]] | ||
| + | |- | ||
| + | |[http://ascopubs.org/doi/full/10.1200/JCO.2016.71.3701 Lim et al. 2017] | ||
| + | | style="background-color:#91cf61" |Phase II | ||
| + | | style="background-color:#bfd3e6" |ORR: 67% (95% CI, 48-81) | ||
| + | |- | ||
| + | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Ceritinib (Zykadia)]] 750 mg PO once per day on an empty stomach | ||
| + | |||
| + | '''28-day cycles''' | ||
| + | |||
| + | ===References=== | ||
| + | # 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. [http://ascopubs.org/doi/full/10.1200/JCO.2016.71.3701 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28520527 PubMed] | ||
==Crizotinib monotherapy {{#subobject:be5391|Regimen=1}}== | ==Crizotinib monotherapy {{#subobject:be5391|Regimen=1}}== | ||
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|} | |} | ||
===Regimen {{#subobject:e9c195|Variant=1}}=== | ===Regimen {{#subobject:e9c195|Variant=1}}=== | ||
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
!Study | !Study | ||
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|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ Shaw et al. 2014] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264527/ Shaw et al. 2014] | ||
| − | |style="background-color:#91cf61"| | + | | style="background-color:#91cf61" |Non-randomized |
|style="background-color:#bfd3e6"|ORR: 72% (95% CI, 58-84) | |style="background-color:#bfd3e6"|ORR: 72% (95% CI, 58-84) | ||
|- | |- | ||
|} | |} | ||
| + | ''Note: this was an expansion cohort of a phase I study.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Crizotinib (Xalkori)]] 250 mg PO BID | *[[Crizotinib (Xalkori)]] 250 mg PO BID | ||
| Line 41: | Line 70: | ||
===References=== | ===References=== | ||
# 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] | # 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] | ||
| + | |||
| + | =Investigational agents= | ||
| + | ''Drugs with some degree of promising activity in clinical trials.'' | ||
| + | *[[Entrectinib (RXDX-101)]] | ||
| + | *[[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 12:41, 26 April 2018
| Section editor | |
|---|---|
 |
Travis Osterman, DO, MS Nashville, TN Twitter: TravisOsterman |
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
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Lim et al. 2017 | Phase II | ORR: 67% (95% CI, 48-81) |
Chemotherapy
- Ceritinib (Zykadia) 750 mg PO once per day on an empty stomach
28-day cycles
References
- 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
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence | Efficacy |
|---|---|---|
| Shaw et al. 2014 | Non-randomized | ORR: 72% (95% CI, 58-84) |
Note: this was an expansion cohort of a phase I study.
Chemotherapy
- Crizotinib (Xalkori) 250 mg PO BID
28-day cycles
References
- 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
Investigational agents
Drugs with some degree of promising activity in clinical trials.