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. 2021 Dec 27;61:156–167. doi: 10.1016/j.breast.2021.12.016

Table 2.

Additional guidance for patients who do not respond to initial hyperglycemia treatment.

Hyperglycemia Severity (CTCAE v4.03) [14] Initial Treatment Recommendations Additional Treatment Recommendations Recommended Alpelisib Dose Modifications
Grade 2:
FPG or fasting FSBG >160–250 mg/dL (>8.9–13.9 mmol/L) or random BG/FSBG consistently >200 mg/dL (>11.1 mmol/L)
  • •

    Overnight fasting, low carbohydrate meal, and exercise are always the first step

  • •

    Start or maximize metformin

  • •

    Add SGLT2i or other secondary antihyperglycemia medication (Table 1)
  • •
    If FSBG values remain >200 mg/dL after 1 week on metformin and SGLT2i, add an SU or meglitinide (counsel patients on symptoms of hypoglycemia)
    • o
      Alternatively, consider changing to a different second-line antihyperglycemia medicationa
    • o
      Consider additional carbohydrate restriction to <60 g/day
  • •

    If FPG does not resolve to ≤ grade 1 within 21 days after appropriate treatment with antihyperglycemia medication, reduce alpelisib by 1 dose level
Grade 3:
FPG or fasting FSBG >250–500 mg/dL (>13.9–27.8 mmol/L) or random BG/FSBG consistently >300 mg/dL (>16.7 mmol/L) OR persistent grade 2
  • •

    Overnight fasting, low carbohydrate meal, and exercise are always the first step

  • •

    Start/maximize metformin; add/continue SGLT2i or other secondary antihyperglycemia medication; add/continue tertiary SU/meglitinide (Table 1)
  • •
    If grade 3 hyperglycemia persists, start SC insulina, either:
    • o
      Once-daily basal insulin at 0.1–0.2 units/kg SC per day and increase to achieve goal of fasting FSBG <160 mg/dL, or
    • o
      Prandial rapid-acting insulin sliding scale before meals (do not initiate/continue SU/meglitinide)
  • •
    Following appropriate antihyperglycemia treatment:
    • o
      If FPG ≤ grade 1 within 3–5 days, resume alpelisib at 1 lower dose level
    • o
      If FPG not ≤ grade 1 within 3–5 days, consult an endocrinologist
    • o
      If FPG not ≤ grade 1 within 21 days, permanently discontinue alpelisib
Grade 4:
FPG or fasting FSBG >500 mg/dL (>27.8 mmol/L) or random BG/FSBG consistently >400 mg/dL (>22.2 mmol/L) OR persistent grade 3
  • •

    Overnight fasting, low carbohydrate meal, and exercise are always the first step

  • •

    Start/maximize metformin; add/continue SGLT2i or other secondary antihyperglycemia medication; add/continue tertiary SU/meglitinide (Table 1)
  • •
    If grade 4 hyperglycemia persists, start SC insulina, either:
    • o
      Once-daily basal insulin at 0.1–0.2 units/kg SC per day and increase to achieve goal of fasting FSBG <160 mg/dL, or
    • o
      Prandial rapid-acting insulin sliding scale before meals (do not initiate/continue SU/meglitinide)
  • •
    Recheck FPG within 24 h
    • o
      If FPG is confirmed at grade 4 and confounding factors could be excluded, permanently discontinue alpelisib

BG, blood glucose; BID, twice daily; CTCAE, Common Terminology Criteria for Adverse Events; FPG, fasting plasma glucose; FSBG, fingerstick blood glucose; GA, glycated albumin; OD, once daily; SC, subcutaneous; SGLT2i, sodium-glucose co-transporter 2 inhibitor; SU, sulfonylurea.

a

Refer to Table 1 for recommended secondary or tertiary antihyperglycemia medications and dosages, and insulin regimens.