Difference between revisions of "Non-small cell lung cancer, KRAS-mutated"
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===Regimen {{#subobject:b495b6|Variant=1}}=== | ===Regimen {{#subobject:b495b6|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| − | !style="width: | + | !style="width: 20%"|Study |
| − | !style="width: | + | !style="width: 20%"|Years of enrollment |
| − | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ Blumenschein et al. 2015 (GSK 114653)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ Blumenschein et al. 2015 (GSK 114653)] | ||
| + | |2011-2012 | ||
|style="background-color:#1a9851"|Randomized Phase II (C) | |style="background-color:#1a9851"|Randomized Phase II (C) | ||
|Trametinib | |Trametinib | ||
|style="background-color:#ffffbf"|Did not meet primary endpoint of PFS | |style="background-color:#ffffbf"|Did not meet primary endpoint of PFS | ||
|- | |- | ||
| − | |[http:// | + | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5815037/ Jänne et al. 2017 (SELECT-1)] |
| + | |2013-2016 | ||
|style="background-color:#1a9851"|Phase III (C) | |style="background-color:#1a9851"|Phase III (C) | ||
|Docetaxel & Selumetinib | |Docetaxel & Selumetinib | ||
| Line 53: | Line 56: | ||
===References=== | ===References=== | ||
| − | # '''GSK 114653:''' Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. [https://doi.org/10.1093/annonc/mdv072 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25722381 PubMed] | + | # '''GSK 114653:''' Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. [https://doi.org/10.1093/annonc/mdv072 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25722381 PubMed] NCT01362296 |
| − | # '''SELECT-1:''' Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. [http://jamanetwork.com/journals/jama/article-abstract/2625317 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28492898 PubMed] | + | # '''SELECT-1:''' Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. [http://jamanetwork.com/journals/jama/article-abstract/2625317 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5815037/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28492898 PubMed] NCT01933932 |
[[Category:Non-small cell lung cancer regimens]] | [[Category:Non-small cell lung cancer regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Lung cancers]] | [[Category:Lung cancers]] | ||
Revision as of 22:25, 6 October 2020
| Page editor | Section editor | ||
|---|---|---|---|
 |
Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN  AmitKulkarniMD
|
 |
Travis Osterman, DO, MS Vanderbilt University Nashville, TN TravisOsterman |
Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
3 regimens on this page
3 variants on this page
|
Advanced or metastatic disease, subsequent lines of therapy
Docetaxel monotherapy
| back to top |
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Blumenschein et al. 2015 (GSK 114653) | 2011-2012 | Randomized Phase II (C) | Trametinib | Did not meet primary endpoint of PFS |
| Jänne et al. 2017 (SELECT-1) | 2013-2016 | Phase III (C) | Docetaxel & Selumetinib | Did not meet primary endpoint of PFS |
Chemotherapy
- Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 1
Supportive medications
- Per JMEI: Dexamethasone (Decadron) 8 mg PO twice per day on days -1 to 2 (3 days)
- Per Chem et al. 2006: Dexamethasone (Decadron) as follows:
- 8 mg PO once per day on days 1, 8, 15; 12 hours prior to Docetaxel (Taxotere)
- 10 mg IV once per day on days 1, 8, 15; 30 minutes prior to Docetaxel (Taxotere)
- 8 mg PO once per day on days 1, 8, 15; 12 hours after Docetaxel (Taxotere)
21-day cycles
References
- GSK 114653: Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. link to original article link to PMC article contains verified protocol PubMed NCT01362296
- SELECT-1: Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. link to original article contains verified protocol link to PMC article PubMed NCT01933932