Difference between revisions of "Malignant solid neoplasm, MSI-H or dMMR"
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=All lines of therapy= | =All lines of therapy= | ||
==Pembrolizumab monotherapy {{#subobject:e0d17a|Regimen=1}}== | ==Pembrolizumab monotherapy {{#subobject:e0d17a|Regimen=1}}== | ||
| − | === | + | ===Variant #1, q2wk dosing {{#subobject:87f9c7|Variant=1}}=== |
| + | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| + | !Study | ||
| + | ![[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/ Le et al. 2017 (KEYNOTE-016)] | ||
| + | |style="background-color:#91cf61"|Phase II | ||
| + | |- | ||
| + | |} | ||
| + | ''Note: this was an expansion to a CRC-specific trial.'' | ||
| + | ====Immunotherapy==== | ||
| + | *[[Pembrolizumab (Keytruda)]] 10 mg/kg IV once on day 1 | ||
| + | |||
| + | '''14-day cycles''' | ||
| + | |||
| + | ===Variant #2, q3wk, adult dosing {{#subobject:7b36e9|Variant=1}}=== | ||
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
| + | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| + | !Study | ||
| + | ![[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | |- | ||
| + | |[http://ascopubs.org/doi/full/10.1200/jco.2016.34.4_suppl.tps787 Le et al. 2016 (KEYNOTE-164)] | ||
| + | |style="background-color:#91cf61"|Phase II | ||
| + | |- | ||
| + | |[http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5514 Schellens et al. 2017 (KEYNOTE-158)] | ||
| + | |style="background-color:#91cf61"|Phase II | ||
| + | |- | ||
| + | |} | ||
| + | ''Note: this is the FDA-approved adult pembrolizumab dose and schedule based on a pooled analysis of 5 non-randomized trials, of which two were prospective: KEYNOTE-158 and KEYNOTE-164.'' | ||
| + | ====Immunotherapy==== | ||
| + | *[[Pembrolizumab (Keytruda)]] 200 mg IV once over 30 minutes on day 1 | ||
| + | |||
| + | '''21-day cycle for up to 2 years''' | ||
| + | |||
| + | ===Variant #3, q3wk, pediatric dosing {{#subobject:392a4b|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 | ||
| Line 19: | Line 60: | ||
|- | |- | ||
|[http://ascopubs.org/doi/full/10.1200/jco.2016.34.4_suppl.tps787 Le et al. 2016 (KEYNOTE-164)] | |[http://ascopubs.org/doi/full/10.1200/jco.2016.34.4_suppl.tps787 Le et al. 2016 (KEYNOTE-164)] | ||
| + | |style="background-color:#91cf61"|Phase II | ||
| + | |- | ||
| + | |[http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5514 Schellens et al. 2017 (KEYNOTE-158)] | ||
|style="background-color:#91cf61"|Phase II | |style="background-color:#91cf61"|Phase II | ||
|- | |- | ||
|} | |} | ||
| − | ''Note: this is the FDA-approved pembrolizumab dose and schedule based on a pooled analysis of 5 non-randomized trials | + | ''Note: this is the FDA-approved pediatric pembrolizumab dose and schedule based on a pooled analysis of 5 non-randomized trials, of which two were prospective: KEYNOTE-158 and KEYNOTE-164.'' |
====Immunotherapy==== | ====Immunotherapy==== | ||
| − | * | + | *[[Pembrolizumab (Keytruda)]] 2 mg/kg (maximum dose of 200 mg) IV once over 30 minutes on day 1 |
| − | |||
'''21-day cycle for up to 2 years''' | '''21-day cycle for up to 2 years''' | ||
===References=== | ===References=== | ||
| − | #'''Abstract:''' Dung T. Le, Takayuki Yoshino, Dirk Jäger, Thierry Andre, Johanna C. Bendell, Ruixue Wang... SoonMo Peter Kang, Minori Koshiji, Luis A. Diaz. KEYNOTE-164: Phase II study of pembrolizumab (MK-3475) for patients with previously treated, microsatellite instability-high advanced colorectal carcinoma. J Clin Oncol | + | # '''Abstract:''' Dung T. Le, Takayuki Yoshino, Dirk Jäger, Thierry Andre, Johanna C. Bendell, Ruixue Wang... SoonMo Peter Kang, Minori Koshiji, Luis A. Diaz. KEYNOTE-164: Phase II study of pembrolizumab (MK-3475) for patients with previously treated, microsatellite instability-high advanced colorectal carcinoma. J Clin Oncol [http://ascopubs.org/doi/full/10.1200/jco.2016.34.4_suppl.tps787 abstract TPS787] and [http://ascopubs.org/doi/full/10.1200/JCO.2016.34.15_suppl.TPS3631 abstract TPS3631]; [https://clinicaltrials.gov/show/NCT02460198 NCT02460198 at ClinicalTrials.gov] |
| + | # '''Abstract:''' Jan H.M. Schellens, Aurelien Marabelle, Susan Zeigenfuss, Jie Ding, Scott Knowles Pruitt, and Hyun Cheol Chung. Pembrolizumab for previously treated advanced cervical squamous cell cancer: Preliminary results from the phase 2 KEYNOTE-158 study. Journal of Clinical Oncology 35, no. 15_suppl (May 20 2017) 5514-5514. [http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5514 link to abstract] | ||
| + | # '''KEYNOTE-016:''' Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. [http://science.sciencemag.org/content/357/6349/409.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/ link to PMC article] '''contains verified protocol in supplement''' [https://www.ncbi.nlm.nih.gov/pubmed/28596308 PubMed] | ||
[[Category:MSI-H or dMMR regimens]] | [[Category:MSI-H or dMMR regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Site-agnostic regimens]] | [[Category:Site-agnostic regimens]] | ||
Revision as of 14:53, 11 May 2018
4 regimens on this page
6 variants on this page
|
Note: this is a new type of page for HemOnc.org, as all other regimen pages (except for cancer of unknown primary) are tissue-specific. The initial drug with tissue-agnostic approval is for patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
All lines of therapy
Pembrolizumab monotherapy
Variant #1, q2wk dosing
| Study | Evidence |
|---|---|
| Le et al. 2017 (KEYNOTE-016) | Phase II |
Note: this was an expansion to a CRC-specific trial.
Immunotherapy
- Pembrolizumab (Keytruda) 10 mg/kg IV once on day 1
14-day cycles
Variant #2, q3wk, adult dosing
| FDA-recommended dose |
| Study | Evidence |
|---|---|
| Le et al. 2016 (KEYNOTE-164) | Phase II |
| Schellens et al. 2017 (KEYNOTE-158) | Phase II |
Note: this is the FDA-approved adult pembrolizumab dose and schedule based on a pooled analysis of 5 non-randomized trials, of which two were prospective: KEYNOTE-158 and KEYNOTE-164.
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once over 30 minutes on day 1
21-day cycle for up to 2 years
Variant #3, q3wk, pediatric dosing
| FDA-recommended dose |
| Study | Evidence |
|---|---|
| Le et al. 2016 (KEYNOTE-164) | Phase II |
| Schellens et al. 2017 (KEYNOTE-158) | Phase II |
Note: this is the FDA-approved pediatric pembrolizumab dose and schedule based on a pooled analysis of 5 non-randomized trials, of which two were prospective: KEYNOTE-158 and KEYNOTE-164.
Immunotherapy
- Pembrolizumab (Keytruda) 2 mg/kg (maximum dose of 200 mg) IV once over 30 minutes on day 1
21-day cycle for up to 2 years
References
- Abstract: Dung T. Le, Takayuki Yoshino, Dirk Jäger, Thierry Andre, Johanna C. Bendell, Ruixue Wang... SoonMo Peter Kang, Minori Koshiji, Luis A. Diaz. KEYNOTE-164: Phase II study of pembrolizumab (MK-3475) for patients with previously treated, microsatellite instability-high advanced colorectal carcinoma. J Clin Oncol abstract TPS787 and abstract TPS3631; NCT02460198 at ClinicalTrials.gov
- Abstract: Jan H.M. Schellens, Aurelien Marabelle, Susan Zeigenfuss, Jie Ding, Scott Knowles Pruitt, and Hyun Cheol Chung. Pembrolizumab for previously treated advanced cervical squamous cell cancer: Preliminary results from the phase 2 KEYNOTE-158 study. Journal of Clinical Oncology 35, no. 15_suppl (May 20 2017) 5514-5514. link to abstract
- KEYNOTE-016: Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. link to original article link to PMC article contains verified protocol in supplement PubMed