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. 2021 Oct 21;13(21):5277. doi: 10.3390/cancers13215277

Table 6.

Representative data on ir thyroid disorders in the setting of hematological malignancies.

Ref. Type of Study
N		 Type of Malignacy Treatment Treatment Efficacy Thyroid Immuno-
Toxicity
[164] Single-arm trial
N = 70		 R/R AML Azacitidine 75 mg/m2 days 1 to 7 IV or SC
plus nivo 3 mg/kg IV on days 1 and 14 Q 4 to 6 weeks.

  • ORR: 33%

  • CR: 22%

 No
[165] Phase 1/1 b multicenter, investigator-initiated study
N = 28 		Relapsed hematological cancer a 3 mo or more after allogeneic HSCT Ipilimumab at a dose of 3 or 10 mg/Kgr BW Q 3 weeks (4 doses), with additional doses Q 12 weeks for up to 60 weeks in case of clinical benefit. Ipilimumab led to durable responses No
[166] Phase II, open-label study
N = 121		 R/R DLBCL ineligible for auto-HSCT or after auto-HSCT failure Nivo 3 mg/kg Q 2 weeks. Median PFS:

  • 1.9 mo (auto-HSCT-failed cohort)

  • 1.4 mo (auto-HSCT-ineligible cohort)

Median OS:

  • 12.2 mo (auto-HSCT-failed cohort)

  • 5.8 mo (auto-HSCT-ineligible cohort)

 No
[167] Open-label, phase II study
N = 27		 Relapsed FL R (375 mg/m2 IV) on days 1, 8, 15, and 22 of cycle 1 and Pembro (200 mg IV) Q 3 weeks for up to 16 cycles starting on day 2 of cycle 1. Pre-planned interim analysis (N = 15):

  • ORR: 80%

  • CR: 60%

 No
[142] Single-arm phase II Study
(KEYNOTE-087)
N = 210		 R/R cHL Pembro 200 mg once every 3 weeks.

  • ORR ((95% CI): 69.0% (62.3% to 75.2%),

  • CR: 22.4% (16.9% to 28.6%)

 Hypo-thyroidism was the most common irAE with an incidence of 12.4%
[145] Multicenter, non-
comparative, phase II trial (CheckMate 205)
N = 51		 R/R cHL Nivo 240 mg IV for 4 doses, followed by 12 doses of N-AVD;
all doses Q 2 weeks.

  • Objective response rate (95% CI): 84% (71% to 93%)

  • CR: 67% (52% to 79%)

  • 9-mo modified PFS: 92%.

 Hypo-thyroidism was the most common irAE with an incidence of 16%
(No severe case)
[168] Phase 1 study
N = 23		 R/R HL after auto-HSCT, or brentuximab vedotin Nivo (at a dose of 3 mg/kgr/BW) Q 2 weeks.

  • Objective response rate: 87%

  • CR: 17%

  • PR: 70%

  • Stable disease: 13%

  • PFS (24 weeks): 86%

 Hypo-
thyroidism:
9%
(Incidence)

a Leukemia, lymphoma, multiple myeloma, or a neoplasm with myelodysplastic or myeloproliferative features. Abbreviations: AML, acute myeloid leukemia; auto, autologous; cHL, classic Hodgkin’s lymphoma; CR, complete response; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; HL, Hodgkin’s lymphoma; HSCT, hematopoietic stem-cell transplantation; irAE, immune-related adverse event; IV, intravenously; kgr/BW, kilogram of body weight; mo, months; N, number of patients; N-AVD, nivolumab plus doxorubicin, vinblastine, and dacarbazine; nivo, nivolumab; ORR, overall response rate; OS, overall survival; Pembro, pembrolizumab; PFS, progression-free survival; PR, partial response; Q, every; R, rituximab; Ref., reference; R/R, relapsed/refractory; SC, subcutaneously.