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Table 3 Treatment-related adverse events

From: Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: a randomized pilot trial

System organ class preferred term, n (%)

Everolimus plus letrozole (n = 20)

FEC (n = 20)

P value (all grades)

All grades (%)

Grade 3–4 (%)

All grades (%)

Grade 3–4 (%)

Mucositis oral

15 (75.0)

1 (5.0)

1 (5.0)

0 (0.0)

< 0.001

Anemia

10 (50.0)

0 (0.0)

10 (50.0)

0 (0.0)

1

Insomnia

6 (30.0)

0 (0.0)

1 (5.0)

0 (0.0)

0.092

Fatigue

4 (20.0)

0 (0.0)

11 (55.0)

0 (0.0)

0.048

Cough

4 (20.0)

0 (0.0)

3 (15.0)

0 (0.0)

1

Aspartate/Alanine aminotransferase increased

4 (20.0)

0 (0.0)

6 (30.0)

0 (0.0)

0.716

Bullous dermatitis/Rash maculo-papular

3 (15.0)

0 (0.0)

0 (0.0)

0 (0.0)

0.23

Oropharyngeal pain

3 (15.0)

0 (0.0)

0 (0.0)

0 (0.0)

0.231

Flu like symptoms

2 (10.0)

0 (0.0)

3 (15.0)

0 (0.0)

1

Nausea

1 (5.0)

0 (0.0)

13 (65.0)

0 (0.0)

< 0.001

Diarrhea

1 (5.0)

0 (0.0)

2 (10.0)

0 (0.0)

1

Constipation

1 (5.0)

0 (0.0)

3 (15.0)

0 (0.0)

0.605

Weight loss

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Tumor pain

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Hyperlipidemia

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Pruritus

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Toxic epidermal necrolysis

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Bone pain

1 (5.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Non-cardiac chest pain

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Paresthesia

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

Laryngeal inflammation

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

1

White blood cell decreased

1 (5.0)

0 (0.0)

9 (45.0)

4 (20.0)

0.008

Vomiting

0 (0.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Stomach pain

0 (0.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Anorexia

0 (0.0)

0 (0.0)

6 (30.0)

0 (0.0)

0.02

Fever

0 (0.0)

0 (0.0)

2 (10.0)

0 (0.0)

0.487

Alopecia

0 (0.0)

0 (0.0)

9 (45.0)

0 (0.0)

0.001

Generalized edema

0 (0.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Bone marrow hypocellular

0 (0.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Palpitations

0 (0.0)

0 (0.0)

1 (5.0)

0 (0.0)

1

Hot flashes

0 (0.0)

0 (0.0)

2 (10.0)

0 (0.0)

0.487

Headache

0 (0.0)

0 (0.0)

3 (15.0)

0 (0.0)

0.231

Neutrophil count decreased

0 (0.0)

0 (0.0)

6 (30.0)

4 (20.0)

0.02

  1. Adverse events occurring in all enrolled patients were reported according to National Cancer Institute Common Toxicity Criteria (Version 4.0). Data were presented as number of patients (%). FEC Fluorouracil, epirubicin plus cyclophosphamide