Effects of controlled ovarian stimulation on toxicity of TAC chemotherapy in early breast cancer patients

Figures & data

Table 1 Patient characteristics

Characteristics	OS (n=18)	Control (n=18)	P-value
Median age (range), years	35.2 (22–38)	30.5 (25–40)	0.005
T-classification			0.32
T1	10 (55.6%)	7 (38.8%)
T2–T4	8 (44.4%)	11 (61.1%)
N-classification			0.73
N0	12 (66.7%)	11 (61.1%)
N+	6 (33.3%)	7 (38.9%)
HR status			0.49
ER and PR negative	6 (33.3%)	8 (42.1%)
ER and/or PR positive	12 (66.7%)	10 (58.8%)
HER-2 status			0.29
Negative	17 (94.4%)	15 (83.3%)
Positive	1 (5.6%)	3 (16.7%)
Radiotherapy before CT			0.49
No	12 (66.7%)	14 (77.8%)
Yes	6 (33.3%)	4 (22.2%)
Medication
Tamoxifen + GnRH antagonist	10 (55.6%)
GnRH agonist	4 (22.2%)
GnRH antagonist	4 (22.2%)
Number of cycles
1	10 (55.6%)
2	8 (44.4%)

Abbreviations: CT, chemotherapy; ER, estrogen receptor; GnRH, gonadotropin-releasing hormone; HR, hormone receptor; OS, ovarian stimulation; PR, progesterone receptor.

Table 2 Grade I/II and grade III/IV toxicity during 6 cycles of TAC in both arms

Adverse event	OS	Control	P-value	OR (95% CI)	P-value, OR (95% CI), multivariate
Any grade
Fatigue	13	14	0.700	0.74 (0.16–3.38)
Mucositis	5	13	0.008	0.15 (0.03–0.06)	0.018, 0.13 (0.03–0.70)
Neuropathy	5	7	0.480	0.60 (0.15–2.45)
Diarrhea	8	4	0.157	2.80 (0.66–11.9)
Nausea	12	13	0.717	0.77 (019–3.19)
Vomiting	7	5	0.362	1.66 (0.41–6.71)
Eye complaints	5	9	0.171	0.39 (0.10–1.54)
Constipation	7	15	0.006	0.13 (0.27–0.61)	0.020, 0.13 (0.022–0.721)
Anemia	11	13	0.480	0.60 (0.15–2.45)
Thrombopenia	5	0	NA	NA
Leukopenia	7	4	0.278	2.23 (0.52–9.59)
Neutropenia	6	3	0.248	2.50 (0.52–12.1)
Grade III/IV
Total grade III/IV	6	5	0.717	1.30 (0.31–5.39)
Febrile neutropenia	5	2	0.206	3.08 (0.51–18.5)

Notes: All side effects were scored according CTCAE4.03. Each side effect was scored maximal once per patient during the course (the highest grade of occurrence was scored). The multivariate model has been adjusted for age.

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable; OR, odds ratio; OS, ovarian stimulation; TAC, docetaxel, adriamycin, and cyclophosphamide.

Table 3 The peak estradiol levels of distinct stimulation protocols

Protocol	N	Mean levels of estradiol (pmol/L)
Tamoxifen + GnRH antagonist	10 (55.6%)	8,046 (4,565–11,527)
GnRH agonist	4 (22.2%)	6,869 (3,758–9,979)
GnRH antagonist	4 (22.2%)	4,566 (2,170–6,962)

Abbreviation: GnRH, gonadotropin-releasing hormone.