Breast cancer during pregnancy a prospective and retrospective registry (GBG-20 / BIG02-03)

Heilung durch Innovation, Kompetenz und Partnerschaft

Background:
Breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. About 3% of all breast cancers are diagnosed during pregnancy. [1]

Pregnancy has a dual effect on the risk of breast cancer: it transiently increases the risk after childbirth but reduces the risk in later years. [2]
The MD Anderson Cancer Centre developed a protocol for the management of breast cancer in pregnancy and demonstrated that it is safe to treat them according to the current standard.[3] The 5-year survival rate of patients with negative axillary lymph nodes is 82% in both pregnant and non-pregnant women and 59% in node-positive patients. [4]
[1] Nulman et al. Neurodevelopment of children exposed in utero to treatment of maternal malignancy. Br J Cancer 6 (2001) 1611-18. [2] Lambe et al. Transcient increase in the risk of breast cancer after giving birth. N Engl J Med 331 (1994) 5-9. [3] Loibl et al. Breast carcinoma during pregnancy. International recommendations from an expert meeting. Cancer 106 (2006) 237-246. [4] Petrek JA, Dukoff R, Rogatko A. Prognosis of pregnancy-associated breast cancer. Cancer 67 (1991) 869-872.

Patients and Methods:

The registry is independent of the treatment and gestational age of the patients during pregnancy. Primary endpoint: - Foetal outcome 4 weeks after delivery.

Secondary endpoint: - Maternal outcome of pregnancy. - Stage of and biological characteristics of breast cancer. - Breast cancer therapy, type of surgery. - Sensitivity and specifity of diagnostic procedures. - Outcome of the newborn after 5 years of therapy. - Outcome of breast cancer 5 years after diagnosis.

Recruitment
2 0 0 accr ual n o. 18 0 16 0 14 0 12 0 10 0 8 0 6 0 4 0 2 0 0 A pr . 0 3 S e p. 0 3 Fe b. 0 4 J ul . 0 4 D ez. 0 4 M ai . 0 5 Okt . 0 5 M r z. 0 6 A ug. 0 6 Jan . 0 7 J un . 0 7 N ov . 0 7 A pr . 0 8 S e p. 0 8

From April 2003 - April 2008, 141 patients have been registered. The median age is 33 years (range 24-43 years).

Patients characteristics (n=134):

T T1 T2 T3 T4 N NN+ M M0 24.6% 47.4% 20.2% 7.9% 32.7% 2 67.3% 79.0% Histo type Ductal invasive 83.8% 3 27.2% 70.9% Her-2/neu Positive Negative Grading 1 1.9% 57.3% 42.7% Chemotherpy during pregnancy Surgery and chemotherpy Syrgery only Chemotherapy only No therapy Therapy unknow Chemotherpy after pregnancy Chemotherapy only Delivery Spontaneous delivery Operative vaginal delivery Caessarean Sectio 35.3% 13.7% 51.0% 26.2% 41.8% 31.1% 4.9% 3.3% 18.9%

M1
Mx ER/PR Negative Positive

8.0%
13.0% 56.4% 43.6%

Lobular invasive
Inflammatory Other

4.5%
5.4% 6.3%

20% of all patients have been diagnosed during the 1st, 43.8% during the 2nd and 36.2% during the 3rd trimester. The median time of delivery was 37 weeks (range 31-41 weeks). The median weight of babies, whose mother received systemic therapy, was 2740 g (range 12703740), the median weight of babies without cytotoxic therapy during pregnancy was 2723 g (range 1260-4180). The APGAR-Score was not reduced.

Cytotoxic regimes during pregnancy (n=57):

4 x AC/EC followed by texane 15 3 x CMF followed by 4 x EC 2

Regimen

6 x AC/EC

4 x AC/EC

6 x FEC

6 x CMF

15

11

The 57 patients evaluable received in the median 4 cycles during pregnancy (1-7).

The maximum given was 7 cycles. No significant differences in postpartum haemoglobin were documented.
The median haemoglobin in babies received intrauterine systemic treatment was 16.7 g/dl (range 10.4-24.9) and 16.9 g/dl (range 13.7-21.4) in babies without intrauterine chemotherapy. Maternal outcome: By April 2008 32 patient relapsed.

Conclusion:
Pregnant women with breast cancer need to be treated in a specialized team. Systemic cytotoxic treatment after the 12th gestational week is feasible.

Fetal outcome in babies, who received intrauterine chemotherapy was not different from those who did not.
Registry needs to be continued to get more valid prospective information.