Difference between revisions of "Editing test page"
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| − | ==== | + | ====Biomarker eligiblity criteria==== |
*Gene: HER2 | *Gene: HER2 | ||
*Alteration: amplification | *Alteration: amplification | ||
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===References=== | ===References=== | ||
# Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20728210 PubMed] | # Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20728210 PubMed] | ||
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==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}== | ==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}== | ||
Revision as of 22:27, 8 January 2020
CF & Trastuzumab -- original
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CF & Trastuzumab: Cisplatin, Fluorouracil, Trastuzumab
Regimen
| Study | Evidence | Comparator | Efficacy |
|---|---|---|---|
| Bang et al. 2010 (ToGA) | Phase III (E) | CF | Superior OS |
Patients had overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.
CF & Trastuzumab -- modified
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CF & Trastuzumab: Cisplatin, Fluorouracil, Trastuzumab
Regimen
| Study | Evidence | Comparator | Efficacy |
|---|---|---|---|
| Bang et al. 2010 (ToGA) | Phase III (E) | CF | Superior OS |
Biomarker eligiblity criteria
- Gene: HER2
- Alteration: amplification
- Acceptable methods of measurement: IHC or FISH
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
- Trastuzumab (Herceptin) as follows:
- Cycle 1: 8 mg/kg IV once on day 1
- Subsequent cycles: 6 mg/kg IV once on day 1
21-day cycles
References
- Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. link to original article contains verified protocol PubMed
Abemaciclib & Anastrozole -- original
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Regimen
| FDA-recommended dose |
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Goetz et al. 2017 (MONARCH 3) | Phase III (E) | Anastrozole | Superior PFS |
Chemotherapy
- Abemaciclib (Verzenio) 150 mg PO twice per day
Hormonotherapy
- Anastrozole (Arimidex) 1 mg PO once per day
28-day cycles
References
- MONARCH 3: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. link to original article contains verified protocol PubMed
Abemaciclib & Anastrozole -- modified
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Regimen
| FDA-recommended dose |
| Study | Evidence | Comparator | Comparative Efficacy | Years of study |
|---|---|---|---|---|
| Goetz et al. 2017 (MONARCH 3) | Phase III (E) | Anastrozole | Superior PFS | 2014-2015 |
Chemotherapy
- Abemaciclib (Verzenio) 150 mg PO twice per day
Hormonotherapy
- Anastrozole (Arimidex) 1 mg PO once per day
28-day cycles
References
- MONARCH 3: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. link to original article contains verified protocol PubMed
Sunitinib monotherapy
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Regimen
| Study | Evidence | Comparator | Efficacy | Toxicity |
|---|---|---|---|---|
| Haas et al. 2016 (ECOG-ACRIN E2805) | Phase III (E) | 1. Placebo | Seems not superior | |
| 2. Sorafenib | Seems not superior | |||
| Ravaud et al. 2016 (S-TRAC) | Phase III (E) | Placebo | Seems to have superior DFS | More toxicity |
Preceding treatment
Chemotherapy
- Sunitinib (Sutent) 50 mg PO once per day on days 1 to 28
42-day cycles, given for up to 1 year
References
- ECOG-ACRIN E2805: Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016 May 14;387(10032):2008-16. Epub 2016 Mar 9. Erratum in: Lancet. 2016 May 14;387(10032):1998. link to original article link to PMC article PubMed
- S-TRAC: Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9. link to original article contains verified protocol PubMed
- Update: Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant sunitinib for high-risk renal cell carcinoma after nephrectomy: subgroup analyses and updated overall survival results. Eur Urol. 2018 Jan;73(1):62-68. Epub 2017 Sep 26. link to original article PubMed
BEACOPP 4+4
Variant #1, CI Ara-C (100 mg/m2)
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Rai et al. 1981 (CALGB 7421) | Phase III | 7+3d (bolus Ara-C) | Seems to have superior CR rate |
| 5+2d | Superior CR rate | ||
| 5+2d (bolus Ara-C) | Superior CR rate | ||
| Yates et al. 1982 (CALGB 7721) | Phase III | 7+3d, low-dose dauno (30 mg/m2) | Seems not superior |
| 7+3a (30 mg/m2) | Seems not superior | ||
| Preisler et al. 1987 (CALGB 7921) | Phase III | 10+3d | Seems not superior |
| TAD | Seems not superior | ||
| Wiernik et al. 1992 | Phase III | 7+3i | Seems to have inferior OS |
| Rowe et al. 2004 | Phase III | 7+3d + GM-CSF 7+3i 7+3i + GM-CSF 7+3m 7+3m + GM-CSF |
Seems not superior |
| Fernandez et al. 2009 (ECOG E1900) | Phase III (C) | 7+3d (high-dose) | Inferior OS |
| Dombret et al. 2015 (AZA-AML-001) | Phase III (C) | Azacitidine | Might have inferior OS |
Note: this was the lower bound of the allowable daunorubicin dose in AZA-AML-001.
Chemotherapy
- Cytarabine (Ara-C) 100 mg/m2/day IV continuous infusion on days 1 to 7 (total dose: 700 mg/m2)
- Daunorubicin (Cerubidine) 45 mg/m2 IV once per day on days 1 to 3
7-day course
Subsequent treatment
- Rowe et al. 2004: Patients with persistent disease at day 14 (greater than 5% blasts) underwent an identical second cycle of 7+3i
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| Efficacy | p-value | Narrative description |
|---|---|---|
| ORR > 20% | ≤ 0.01 | Likely to have true ORR >20% |
| ORR > 20% | > 0.01 and ≤ 0.10 | Might have true ORR >20% |
| ORR > 20% | > 0.10 | Potentially has true ORR >20% |
| ORR < 20% | N/A | Unlikely to have true ORR >20% |