Autoimmune cytopenia

Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Forde et al. 2022 (CheckMate 816)	2017-2019	Phase 3 (C)	1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab	Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

• CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
• Paclitaxel (Taxol) 175 or 200 mg/m² IV once on day 1

21-day cycle for 3 cycles

Subsequent treatment

• Complete resection

References

1. CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528

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Section editors
	Shruti Chaturvedi, MD, MSCI Baltimore, MD LinkedIn		Benjamin Tillman, MD Nashville, TN

2 regimens on this page 2 variants on this page

This is an umbrella category that includes Felty's syndrome (autoimmune neutropenia), autoimmune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), and Evan's syndrome (AIHA & ITP). Please see the respective page(s) for disease-specific therapies. This page includes regimens that were used more broadly.

Relapsed or refractory

Alemtuzumab monotherapy

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Regimen

Study	Evidence	Efficacy
Willis et al. 2001	Phase II	ORR: 71%

Immunosuppressive therapy

• Alemtuzumab (Campath) as follows:
  • Test dose: 1 mg IV over 60 minutes once
  • Days 1 to 10: 10 mg IV over 4 hours once per day

10-day course

References

1. Willis F, Marsh JC, Bevan DH, Killick SB, Lucas G, Griffiths R, Ouwehand W, Hale G, Waldmann H, Gordon-Smith EC. The effect of treatment with Campath-1H in patients with autoimmune cytopenias. Br J Haematol. 2001 Sep;114(4):891-8. link to original article contains verified protocol PubMed

Sirolimus monotherapy

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Regimen

Study	Evidence
Bride et al. 2015	Phase II

Immunosuppressive therapy

• Sirolimus (Rapamune) 2 to 2.5 mg/m2/day PO
  • See manuscript for recommended dose adjustments

6-month course, extended for those with a favorable response

References

1. Bride KL, Vincent T, Smith-Whitley K, Lambert MP, Bleesing JJ, Seif AE, Manno CS, Casper J, Grupp SA, Teachey DT. Sirolimus is effective in relapsed/refractory autoimmune cytopenias: results of a prospective multi-institutional trial. Blood. 2016 Jan 7;127(1):17-28. Epub 2015 Oct 26. link to original article link to PMC article contains protocol PubMed