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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

Genomic eligiblity criteria

  • Biomarker: HER2 amplification
  • Acceptable methods of measurement: IHC or FISH

Chemotherapy

21-day cycles

References

  1. 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

Chemohormonotherapy

28-day cycles

References

  1. 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
  2. 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;35:3638-3646. link to original article. PubMed ID 28968163.


Abemaciclib & Anastrozole -- modified

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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

Hormonotherapy

28-day cycles

References

  1. 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

42-day cycles, given for up to 1 year

References

  1. 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
  2. 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
    1. 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

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%