妊娠期与哺乳期乳腺癌临床实践指南(2025版)

中华医学会外科学分会乳腺外科学组

中国实用外科杂志 ›› 2025, Vol. 45 ›› Issue (12) : 1392-1396.

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中国实用外科杂志 ›› 2025, Vol. 45 ›› Issue (12) : 1392-1396. DOI: 10.19538/j.cjps.issn1005-2208.2025.12.09
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妊娠期与哺乳期乳腺癌临床实践指南(2025版)

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Clinical practice guidelines for breast cancer during pregnancy and lactation (2025 edition)

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中华医学会外科学分会乳腺外科学组. 妊娠期与哺乳期乳腺癌临床实践指南(2025版)[J]. 中国实用外科杂志. 2025, 45(12): 1392-1396 https://doi.org/10.19538/j.cjps.issn1005-2208.2025.12.09
Chinese Society of Breast Surgery, Chinese Society of Surgery, Chinese Medical Association. Clinical practice guidelines for breast cancer during pregnancy and lactation (2025 edition)[J]. Chinese Journal of Practical Surgery. 2025, 45(12): 1392-1396 https://doi.org/10.19538/j.cjps.issn1005-2208.2025.12.09
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参考文献

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Gkekos L, Lundberg FE, Humphreys K, et al. Worse histopathology and prognosis in women with breast cancer diagnosed during the second trimester of pregnancy[J]. ESMO Open, 2024, 9(4):102972.DOI:10.1016/j.esmoop.2024.102972.
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中华医学会外科学分会乳腺外科学组. 中国妊娠期与哺乳期乳腺癌临床实践指南(2022版)[J]. 中国实用外科杂志, 2022, 42(2):146-150.DOI:10.19538/j.cjps.issn1005-2208.2022.02.05.
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Roesch E, Maggiotto A, Valente SA. Multidisciplinary management of pregnancy-associated breast cancer[J]. JCO Oncol Pract, 2025, 21(3):313-321.DOI:10.1200/OP-24-00453.
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Amant F, Loibl S, Neven P, et al. Breast cancer in pregnancy[J]. Lancet, 2012, 379(9815):570-579. DOI: 10.1016/S0140-6736(11)61092-1.
Breast cancer staging and treatment are possible during pregnancy, and should be defined in a multidisciplinary setting. Tumour biology, tumour stage, and gestational stage at diagnosis determine the appropriate approach. Surgery for breast cancer is possible during all trimesters of pregnancy. Radiotherapy is possible during pregnancy but, dependent on the fetal dose received, can result in poor fetal outcomes. The decision to give radiotherapy should be made on an individual basis. Evidence increasingly supports administration of chemotherapy from 14 weeks' gestation onwards. New breast cancer treatments might be applicable to pregnant patients, but tamoxifen and trastuzumab are contraindicated during pregnancy. Cancer treatment during pregnancy will decrease the need for early delivery and thus prematurity, which is a major concern in management of breast cancer in pregnancy.Copyright © 2012 Elsevier Ltd. All rights reserved.
[5]
吴克瑾. 从多学科协作入手加强妊娠期乳腺癌个案管理[J]. 中华外科杂志, 2020, 58(2):95-98.DOI:10.3760/cma.j.issn.0529-5815.2020.02.004.
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Ferrigno Guajardo AS, Vaca-Cartagena BF, Mayer EL, et al. Taxanes for the treatment of breast cancer during pregnancy: An international cohort study[J]. J Natl Cancer Inst, 2024, 116(2):239-248.DOI:10.1093/jnci/djad219.
The addition of taxanes to anthracycline-based chemotherapy is considered standard of care in the treatment of breast cancer. However, there are insufficient data regarding the safety of taxanes during pregnancy. The aim of this study was to describe the incidence of obstetric and neonatal adverse events associated with the use of taxane-containing chemotherapy regimens for the treatment of breast cancer during pregnancy.This is a multicenter, international cohort study of breast cancer patients treated with taxanes during pregnancy. A descriptive analysis was undertaken to synthetize available data.A total of 103 patients were included, most of whom were treated with paclitaxel and anthracyclines given in sequence during gestation (90.1%). The median gestational age at taxane initiation was 28 weeks (range = 12-37 weeks). Grade 3-4 adverse events were reported in 7 of 103 (6.8%) patients. The most common reported obstetric complications were intrauterine growth restriction (n = 8 of 94, 8.5%) and preterm premature rupture of membranes (n = 5 of 94, 5.3%). The live birth rate was 92 of 94 (97.9%), and the median gestational age at delivery was 37 weeks (range = 32-40 weeks). Admission to an intensive care unit was reported in 14 of 88 (15.9%) neonates, and 17 of 70 (24.3%) live births resulted in small for gestational age neonates. Congenital malformations were reported in 2 of 93 (2.2%).Obstetric and neonatal outcomes after taxane exposure during pregnancy were generally favorable and did not seem to differ from those reported in the literature with standard anthracycline-based regimens. This study supports the use of taxanes during gestation when clinically indicated.© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.
[7]
Loibl S, Jr AH, Bachelot T, et al. ESMO expert consensus statements on the management of breast cancer during pregnancy(PrBC)[J]. Ann Oncol, 2023, 34(10):849-866.DOI:10.1016/j.annonc.2023.08.001.
The management of breast cancer during pregnancy (PrBC) is a relatively rare indication and an area where no or little evidence is available since randomized controlled trials cannot be conducted. In general, advances related to breast cancer treatment outside pregnancy cannot always be translated to PrBC, because both the interests of the mother and of the unborn should be considered. Evidence remains limited and/or conflicting in some specific areas where the optimal approach remains controversial. In 2022, the European Society for Medical Oncology (ESMO) held a virtual consensus-building process on this topic to gain insights from a multidisciplinary group of experts and develop statements on controversial topics that cannot be adequately addressed in the current evidence-based ESMO Clinical Practice Guideline. The aim of this consensus-building process was to discuss controversial issues relating to the management of patients with breast cancer during pregnancy. The virtual meeting included a multidisciplinary panel of 24 leading experts from 13 countries and was chaired by S. Loibl and F. Amant. All experts were allocated to one of four different working groups. Each working group covered a specific subject area with two chairs appointed: 1. Breast cancer during pregnancy: incidence, epidemiology, biology and pathology. Diagnostic work up, Staging and Risk assessment, prognosis (Chairs: Vincent Vandecaveye, Fedro Peccatori) 2. Clinical pharmacology of systemic agents during pregnancy. Management of localized disease and (neo) adjuvant therapies. Management of systemic disease (Chairs: Giuseppe Curigliano, Peter Schmid) 3. Obstetric care and fetal/newborn follow-up and outcomes, metastases to fetus. Management of pregnancy during anticancer therapy. Lactation. Psychological support (Chairs: Elyce Cardonick, Mathilde van Gerwen) Planning, preparation and execution of the consensus process was conducted according to the ESMO standard operating procedures.Copyright © 2023. Published by Elsevier Ltd.
[8]
Loibl S, Schmidt A, Gentilini O, et al. Breast cancer diagnosed during pregnancy: Adapting recent advances in breast cancer care for pregnant patients[J]. JAMA Oncol, 2015, 1(8):1145-1153.DOI:10.1001/jamaoncol.2015.2413.
Breast cancer during pregnancy (BCP), although rare, is becoming more common and treatment should be as similar as possible to that for nonpregnant young patients with breast cancer. A group of specialists convened to review current guidelines and provide guidance on how recent advances in breast cancer diagnosis and treatment can be adapted for pregnant patients. The majority of patients with BCP will be considered for treatment during the pregnancy. Premature delivery should be avoided whenever possible. Most treatments, including sentinel lymph node biopsy, systemic therapy with taxanes, platinum agents, or dose-dense treatment can be safely given during pregnancy, after careful risk/benefit assessment for mother and child. Chemotherapy is contraindicated during the first trimester because of a higher risk of fetal malformations but is feasible in the second and third trimesters. Other treatments such as radiation therapy or anti-human epidermal growth receptor 2 treatment are in general not indicated during pregnancy but might be considered in some instances. Patient data should be collected in a systematic way whenever possible.
[9]
Shachar SS, Gallagher K, McGuire K, et al. Multidisciplinary management of breast cancer during pregnancy[J]. Oncologist, 2017, 22(3):324-334.DOI:10.1634/theoncologist.2016-0208.
Although breast cancer during pregnancy (BCDP) is rare (occurring with only 0.4% of all BC diagnoses in female patients aged 16-49 years), management decisions are challenging to both the patient and the multidisciplinary team.Experts in breast cancer at the University of North Carolina conducted a targeted literature search regarding the multidisciplinary treatment approaches to BCDP: medical, surgical, and radiation oncology. Supportive care, including antiemetic agents, and imaging approaches were also reviewed.Review of the literature revealed key points in the management of BCDP. Surgical management is similar to that in nonpregnant patients; pregnant patients may safely undergo breast-conserving surgery. Recommendations should be tailored to the individual according to the clinical stage, tumor biology, genetic status, gestational age, and personal preferences. Anthracycline-based chemotherapy can be safely initiated only in the second and third trimesters. The rate of congenital abnormalities in children exposed to chemotherapy is similar to the national average (approximately 3%). Dosing of chemotherapy should be similar to that in the nonpregnant patient (i.e., actual body surface area). Antihuman epidermal growth factor receptor 2 therapy, radiation, and endocrine treatment are contraindicated in pregnancy and lactation. Care should include partnership with obstetricians. The literature regarding prognosis of BCDP is mixed.To maximize benefit and minimize risk to the mother and fetus, an informed discussion with the patient and her medical team should result in an individualized treatment plan, taking into account the timing of the pregnancy and the stage and subtype of the breast cancer. Because BCDP is rare, it is essential to collect patient data in international registries. 2017;22:324-334 IMPLICATIONS FOR PRACTICE: Breast cancer during pregnancy is a major ethical and professional challenge for both the patient and the multidisciplinary treatment team. Although the oncologic care is based on that of the non-pregnant breast cancer patient, there are many challenges from regarding the medical, surgical and radiation oncology and obstetrical aspects of care that need to be considered to deliver the safest and best treatment plan to both the mother and developing fetus.© AlphaMed Press 2017.
[10]
Ray JG, Vermeulen MJ, Bharatha A, et al. Association between MRI exposure during pregnancy and fetal and childhood outcomes[J]. JAMA, 2016, 316(9):952-961.DOI:10.1001/jama.2016.12126.
Fetal safety of magnetic resonance imaging (MRI) during the first trimester of pregnancy or with gadolinium enhancement at any time of pregnancy is unknown.To evaluate the long-term safety after exposure to MRI in the first trimester of pregnancy or to gadolinium at any time during pregnancy.Universal health care databases in the province of Ontario, Canada, were used to identify all births of more than 20 weeks, from 2003-2015.Magnetic resonance imaging exposure in the first trimester of pregnancy, or gadolinium MRI exposure at any time in pregnancy.For first-trimester MRI exposure, the risk of stillbirth or neonatal death within 28 days of birth and any congenital anomaly, neoplasm, and hearing or vision loss was evaluated from birth to age 4 years. For gadolinium-enhanced MRI in pregnancy, connective tissue or skin disease resembling nephrogenic systemic fibrosis (NSF-like) and a broader set of rheumatological, inflammatory, or infiltrative skin conditions from birth were identified.Of 1 424 105 deliveries (48% girls; mean gestational age, 39 weeks), the overall rate of MRI was 3.97 per 1000 pregnancies. Comparing first-trimester MRI (n = 1737) to no MRI (n = 1 418 451), there were 19 stillbirths or deaths vs 9844 in the unexposed cohort (adjusted relative risk [RR], 1.68; 95% CI, 0.97 to 2.90) for an adjusted risk difference of 4.7 per 1000 person-years (95% CI, -1.6 to 11.0). The risk was also not significantly higher for congenital anomalies, neoplasm, or vision or hearing loss. Comparing gadolinium MRI (n = 397) with no MRI (n = 1 418 451), the hazard ratio for NSF-like outcomes was not statistically significant. The broader outcome of any rheumatological, inflammatory, or infiltrative skin condition occurred in 123 vs 384 180 births (adjusted HR, 1.36; 95% CI, 1.09 to 1.69) for an adjusted risk difference of 45.3 per 1000 person-years (95% CI, 11.3 to 86.8). Stillbirths and neonatal deaths occurred among 7 MRI-exposed vs 9844 unexposed pregnancies (adjusted RR, 3.70; 95% CI, 1.55 to 8.85) for an adjusted risk difference of 47.5 per 1000 pregnancies (95% CI, 9.7 to 138.2).Exposure to MRI during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood. Gadolinium MRI at any time during pregnancy was associated with an increased risk of a broad set of rheumatological, inflammatory, or infiltrative skin conditions and for stillbirth or neonatal death. The study may not have been able to detect rare adverse outcomes.
[11]
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology:Breast Cancer(Version 4.2025)[EB/OL].(2025-04-17)[2025-10-09]. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
[12]
Peccatori FA, Azim HA, Orecchia R, et al. Cancer,pregnancy and fertility: ESMO clinical practice guidelines for diagnosis,treatment and follow-up[J]. Ann Oncol, 2013, 24(suppl 6):vi160-70.DOI:10.1093/annonc/mdt199.
[13]
American College of Obstetricians and Gynecologists. ACOG Committee Opinion No.775: Nonobstetric surgery during pregnancy[J]. Obstet Gynecol, 2019, 133(4):e285-e286.DOI: 10.1097/AOG.0000000000003183.
The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice acknowledges that the issue of nonobstetric surgery during pregnancy is an important concern for physicians who care for women. Because of the difficulty of conducting large-scale randomized clinical trials in this population, there are no data to allow for specific recommendations. It is important for a physician to obtain an obstetric consultation before performing nonobstetric surgery and some invasive procedures (eg, cardiac catheterization or colonoscopy) because obstetricians are uniquely qualified to discuss aspects of maternal physiology and anatomy that may affect intraoperative maternal-fetal well-being.
[14]
Amant F, Vandenbroucke T, Verheecke M, et al. Pediatric outcome after maternal cancer diagnosed during pregnancy[J]. N Engl J Med, 2015, 373(19):1824-1834.DOI:10.1056/NEJMoa1508913.
[15]
中国人体健康科技促进会生育力保护与保存专业委员会, 国际妇科内分泌学会中国妇科内分泌学分会.. 妊娠期乳腺癌患者生育力保护专家共识[J]. 中国临床医生杂志, 2022, 50(7):772-777.DOI:10.3969/j.issn.2095-8552.2022.07.006.
[16]
Loibl S, Han SN, von Minckwitz G, et al. Treatment of breast cancer during pregnancy: An observational study[J]. Lancet Oncol, 2012, 13(9):887-896.DOI:10.1016/S1470-2045(12)70261-9.
Little is known about the treatment of breast cancer during pregnancy. We aimed to determine whether treatment for breast cancer during pregnancy is safe for both mother and child.We recruited patients from seven European countries with a primary diagnosis of breast cancer during pregnancy; data were collected retrospectively if the patient was diagnosed before April, 2003 (when the registry began), or prospectively thereafter, irrespective of the outcome of pregnancy and the type and timing of treatment. The primary endpoint was fetal health for up to 4 weeks after delivery. The registry is ongoing. The study is registered with ClinicalTrials.gov, number NCT00196833.From April, 2003, to December, 2011, 447 patients were registered, 413 of whom had early breast cancer. Median age was 33 years (range 22-51). At the time of diagnosis, median gestational age was 24 weeks (range 5-40). 197 (48%) of 413 women received chemotherapy during pregnancy with a median of four cycles (range one to eight). 178 received an anthracycline, 15 received cyclophosphamide, methotrexate, and fluorouracil, and 14 received a taxane. Birthweight was affected by chemotherapy exposure after adjustment for gestational age (p=0·018), but not by number of chemotherapy cycles (p=0·71). No statistical difference between the two groups was observed for premature deliveries before the 37th week of gestation. 40 (10%) of 386 infants had side-effects, malformations, or new-born complications; these events were more common in infants born before the 37th week of gestation than they were in infants born in the 37th week or later (31 [16%] of 191 infants vs nine [5%] of 195 infants; p=0·0002). In infants for whom maternal treatment was known, adverse events were more common in those who received chemotherapy in utero compared with those who were not exposed (31 [15%] of 203 vs seven [4%] of 170 infants; p=0·00045). Two infants died; both were exposed to chemotherapy and delivered prematurely, but both deaths were thought not to be related to treatment. Median disease-free survival for women with early breast cancer was 70·6 months (95% CI 62·1-105·5) in women starting chemotherapy during pregnancy and 94·4 months (lower 95% CI 64·4; upper 95% CI not yet reached) in women starting chemotherapy after delivery (unadjusted hazard ratio 1·13 [95% CI 0·76-1·69]; p=0·539).Although our data show that infants exposed to chemotherapy in utero had a lower birthweight at gestational age than did those who were unexposed, and had more complications, these differences were not clinically significant and, since none of the infants was exposed to chemotherapy in the first trimester, were most likely related to premature delivery. Delay of cancer treatment did not significantly affect disease-free survival for mothers with early breast cancer. Because preterm birth was strongly associated with adverse events, a full-term delivery seems to be of paramount importance.BANSS Foundation, Biedenkopf, Germany and the Belgian Cancer Plan, Ministry of Health, Belgium.Copyright © 2012 Elsevier Ltd. All rights reserved.
[17]
Annane K, Bellocq JP, Brettes JP, et al. Infiltrative breast cancer during pregnancy and conservative surgery[J]. Fetal Diagn Ther, 2005, 20(5):442-444.DOI:10.1159/000087114.
Mastectomy is considered as the standard therapy for gestational breast cancer. Since radiation therapy is harmful for the fetus, conservative surgery is rarely used during pregnancy. Among 16 patients with gestational breast cancer, 10 and 6 were treated with conservative surgery and mastectomy, respectively. No local recurrences occurred with a median follow-up time of 87 months. Among the 10 patients treated with conservative surgery, 3 chose therapeutic abortion and 7 opted to continue their pregnancy. Concerning these 7 fetuses, there were no congenital anomalies, nor growth restriction. All children were normal physically and neurologically. We concluded that conservative breast surgery may be an alternative to mastectomy in the treatment of gestational breast cancer and is safe for the fetus.Copyright (c) 2005 S. Karger AG, Basel.
[18]
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 171: Management of preterm labor[J]. Obstet Gynecol, 2016, 128(4):e155-e164. DOI: 10.1097/AOG.0000000000001711.
\n Preterm birth is the leading cause of neonatal mortality and the most common reason for antenatal hospitalization\n \n (1–4)\n \n. In the United States, approximately 12% of all live births occur before term, and preterm labor preceded approximately 50% of these preterm births\n \n (5, 6)\n \n. Although the causes of preterm labor are not well understood, the burden of preterm births is clear—preterm births account for approximately 70% of neonatal deaths and 36% of infant deaths as well as 25–50% of cases of long-term neurologic impairment in children\n \n (7–9)\n \n. A 2006 report from the Institute of Medicine estimated the annual cost of preterm birth in the United States to be $26.2 billion or more than $51,000 per premature infant\n \n (10)\n \n. However, identifying women who will give birth preterm is an inexact process. The purpose of this document is to present the various methods proposed to manage preterm labor and to review the evidence for the roles of these methods in clinical practice. Identification and management of risk factors for preterm labor are not addressed in this document.\n
[19]
Germann N, Goffinet F, Goldwasser F, et al. Anthracyclines during pregnancy: Embryo-fetal outcome in 160 patients[J]. Ann Oncol, 2004, 15(1):146-150.DOI: 10.1093/annonc/mdh013.
Anthracyclines are essential for the treatment of malignancies observed in pregnant patients. Knowledge of the potential side-effects of chemotherapy on the developing fetus is essential for patient counseling.We collected information concerning patients treated with anthracyclines during pregnancy from a review of literature between 1976 and 2001 and our experience. The events analyzed were malformations, fetal death and spontaneous abortion. A chi(2) test with a Yates correction was used to compare the distribution of severe events.A total of 160 patient pregnancies were analyzed. The fetal outcome was frequently normal (73%). Abnormalities included malformations (3%), fetal death (9%), spontaneous abortion (3%), fetal complications (8%) and prematurity (6%). Fetal death was often directly consecutive to maternal death (40%). Unfavorable fetal outcome was significantly more frequent in leukemia patients (P = 0.001). In patients with solid tumors, the first trimester was significantly associated with more complications (P = 0.029). The risk of severe fetal toxicity was increased 30-fold when the dose of doxorubicin per cycle exceeded 70 mg/m(2) (P = 0.037).Anthracyclines may induce embryo-fetal toxicity. Nevertheless the risk seems low, especially after the first trimester and using doses of doxorubicin below 70 mg/m(2).
[20]
Amant F, Van Calsteren K, Halaska MJ, et al. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: An observational study[J]. Lancet Oncol, 2012, 13(3):256-264.DOI:10.1016/S1470-2045(11)70363-1.
Chemotherapy for the treatment of maternal cancers during pregnancy has become more acceptable in the past decade; however, the effect of prenatal exposure to chemotherapy on cardiac and neurodevelopmental outcomes of the offspring is still uncertain. We aimed to record the general health, cardiac function, and neurodevelopmental outcomes of children who were prenatally exposed to chemotherapy.We did an interim analysis of a multicentre observational cohort study assessing children who were prenatally exposed to maternal cancer staging and treatment, including chemotherapy. We assessed children at birth, at age 18 months, and at age 5-6, 8-9, 11-12, 14-15, or 18 years. We did clinical neurological examinations, tests of the general level of cognitive functioning (Bayley or intelligence quotient [IQ] test), electrocardiography and echocardiography, and administered a questionnaire on general health and development. From age 5 years, we also did audiometry, the Auditory Verbal Learning Test, and subtasks of the Children's Memory Scale, and the Test of Everyday Attention for Children, and we also completed the Child Behavior Checklist. This study is registered with ClinicalTrials.gov, number NCT00330447.236 cycles of chemotherapy were administered in 68 pregnancies. We assessed 70 children, born at a median gestational age of 35·7 weeks (range 28·3-41·0; IQR 3·3; 47 women at <37 weeks), with a median follow-up period of 22·3 months (range 16·8-211·6; IQR 54·9). Although neurocognitive outcomes were within normal ranges, cognitive development scores were lower for children who were born preterm than for those born at full term. When controlling for age, sex, and country, the score for IQ increased by an average 11·6 points (95% CI 6·0-17·1) for each additional month of gestation (p<0·0001). Our measurements of the children's behaviour, general health, hearing, and growth corresponded with those of the general population. Cardiac dimensions and functions were within normal ranges. We identified a severe neurodevelopmental delay in both members of one twin pregnancy.Fetal exposure to chemotherapy was not associated with increased CNS, cardiac or auditory morbidity, or with impairments to general health and growth compared with the general population. However, subtle changes in cardiac and neurocognitive measurements emphasise the need for longer follow-up. Prematurity was common and was associated with impaired cognitive development. Therefore, iatrogenic preterm delivery should be avoided when possible.Research Foundation-Flanders; Research Fund-K U Leuven; Agency for Innovation by Science and Technology; Stichting tegen Kanker; Clinical Research Fund-University Hospitals Leuven; and Belgian Cancer Plan, Ministery of Health.Copyright © 2012 Elsevier Ltd. All rights reserved.
[21]
de Haan J, Verheecke M, Van Calsteren K, et al. Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: A 20-year international cohort study of 1170 patients[J]. Lancet Oncol, 2018, 19(3):337-346.DOI:10.1016/S1470-2045(18)30059-7.
Awareness is growing that cancer can be treated during pregnancy, but the effect of this change on maternal and neonatal outcomes is unknown. The International Network on Cancer, Infertility and Pregnancy (INCIP) registers the incidence and maternal, obstetric, oncological, and neonatal outcomes of cancer occurring during pregnancy. We aimed to describe the oncological management and obstetric and neonatal outcomes of patients registered in INCIP and treated in the past 20 years, and assess associations between cancer type or treatment modality and obstetric and neonatal outcomes.This descriptive cohort study included pregnant patients with cancer registered from all 37 centres (from 16 countries) participating in the INCIP registry. Oncological, obstetric, and neonatal outcome data of consecutive patients diagnosed with primary invasive cancer during pregnancy between Jan 1, 1996, and Nov 1, 2016, were retrospectively and prospectively collected. We analysed changes over time in categorical patient characteristics, outcomes, and treatment methods with log-binomial regression. We used multiple logistic regression to analyse preterm, prelabour rupture of membranes (PPROM) or preterm contractions, small for gestational age, and admission to the neonatal intensive care unit (NICU). The INCIP registry study is registered with ClinicalTrials.gov, number NCT00330447, and is ongoing.1170 patients were included in the analysis and 779 (67%) received treatment during pregnancy. Breast cancer was the most common malignant disease (462 [39%]). Every 5 years, the likelihood of receiving treatment during pregnancy increased (relative risk [RR] 1·10, 95% CI 1·05-1·15), mainly related to an increase of chemotherapeutic treatment (1·31, 1·20-1·43). Overall, 955 (88%) of 1089 singleton pregnancies ended in a livebirth, of which 430 (48%) of 887 pregnancies ended preterm. Each 5 years, we observed more livebirths (RR 1·04, 95% CI 1·01-1·06) and fewer iatrogenic preterm deliveries (0·91, 0·84-0·98). Our data suggest a relationship between platinum-based chemotherapy and small for gestational age (odds ratio [OR] 3·12, 95% CI 1·45-6·70), and between taxane chemotherapy and NICU admission (OR 2·37, 95% CI 1·31-4·28). NICU admission seemed to depend on cancer type, with gastrointestinal cancers having highest risk (OR 7·13, 95% CI 2·86-17·7) and thyroid cancers having lowest risk (0·14, 0·02-0·90) when compared with breast cancer. Unexpectedly, the data suggested that abdominal or cervical surgery was associated with a reduced likelihood of NICU admission (OR 0·30, 95% CI 0·17-0·55). Other associations between treatment or cancer type and outcomes were less clear.Over the years, the proportion of patients with cancer during pregnancy who received antenatal treatment increased, especially treatment with chemotherapy. Our data indicate that babies exposed to antenatal chemotherapy might be more likely to develop complications, specifically small for gestational age and NICU admission, than babies not exposed. We therefore recommend involving hospitals with obstetric high-care units in the management of these patients.Research Foundation-Flanders, European Research Council, Charles University, Ministry of Health of the Czech Republic.Copyright © 2018 Elsevier Ltd. All rights reserved.
[22]
Program NT. NTP monograph: Developmental effects and pregnancy outcomes associated with cancer chemotherapy use during pregnancy[J]. NTP Monogr, 2013,2:i‑214.
[23]
Girardelli S, Bonomo B, Papale M, et al. Weekly paclitaxel for pregnancy associated breast cancer[J]. Clin Breast Cancer, 2024, 24(3):199-203.DOI:10.1016/j.clbc.2023.11.007.
[24]
Van Assche IA, Van Calsteren K, Huis In 't Veld EA, et al. Child outcomes after prenatal exposure to platinum and taxane-based chemotherapy: An unplanned interim analysis of the international network on cancer, infertility,and pregnancy study[J]. EClinicalMedicine, 2024, 78:102922.DOI:10.1016/j.eclinm.2024.102922.
[25]
Wang M, Yin Z, Miao J, et al. The fetal outcomes after neoadjuvant platinum and paclitaxel chemotherapy during pregnancy: Analysis of three cases and review of the literature[J]. Arch Gynecol Obstet, 2022, 305(1):49-54.DOI:10.1007/s00404-021-06113-8.
[26]
Pei Y, Gou Y, Li N, et al. Efficacy and safety of platinum-based chemotherapy for ovarian cancer during pregnancy: A systematic review and meta-analysis[J]. Oncol Ther, 2022, 10(1):55-73.DOI:10.1007/s40487-021-00179-9.
[27]
Lambertini M, Martel S, Campbell C, et al. Pregnancies during and after trastuzumab and/or lapatinib in patients with human epidermal growth factor receptor 2-positive early breast cancer: Analysis from the NeoALTTO(BIG 1-06)and ALTTO(BIG 2-06)trials[J]. Cancer, 2019, 125(2):307-316.DOI:10.1002/cncr.31784.
Limited data exist on the safety of using anti-human epidermal growth factor receptor 2 (HER2) targeted agents during pregnancy. To date, only retrospective studies have assessed the prognosis of patients with a pregnancy after prior early breast cancer, with no data in HER2-positive patients.The Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization (NeoALTTO) trial and the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial were randomized phase 3 trials for patients with HER2-positive early breast cancer. In both trials, pregnancy information was prospectively collected. Pregnancy outcomes were compared between patients unintentionally exposed to trastuzumab and/or lapatinib during gestation (the exposed group) and those who became pregnant after trastuzumab and/or lapatinib completion (the unexposed group). In the ALTTO trial, disease-free survival (DFS) was compared between pregnant patients and those aged 40 years or younger without a subsequent pregnancy via an extended Cox model with time-varying covariates to account for a guarantee-time bias.Ninety-two patients (12 in the exposed group and 80 in the unexposed group) had a pregnancy: 7 in the NeoALTTO trial and 85 in the ALTTO trial. Seven patients (58.3%) in the exposed group and 10 patients (12.5%) in the unexposed group opted for an induced abortion; in the unexposed group, 10 patients (12.5%) had a spontaneous abortion. No pregnancy/delivery complications were reported for the remaining cases, who successfully completed their pregnancy, with the exception of 1 fetus with trisomy 21 (Down syndrome). No significant difference in DFS (adjusted hazard ratio, 1.12; 95% confidence interval, 0.52-2.42) was observed between young patients with a pregnancy (n = 85) and young patients without a pregnancy (n = 1307).For patients with HER2-positive early breast cancer, having a pregnancy after treatment completion appears to be safe without compromising fetal outcome or maternal prognosis.© 2018 American Cancer Society.
[28]
LaFargue CJ, Dal Molin GZ, Sood AK, et al. Exploring and comparing adverse events between PARP inhibitors[J]. Lancet Oncol, 2019, 20(1):e15-e28.DOI:10.1016/S1470-2045(18)30786-1.
Ovarian cancer remains one of the most challenging malignancies to treat. Targeted therapies such as poly (ADP-ribose) polymerase (PARP) inhibitors have emerged as one of the most exciting new treatments for ovarian cancer, particularly in women with BRCA1 or BRCA2 mutations or those without a functional homologous recombination repair pathway. Perhaps the most advantageous characteristic of PARP inhibitors is their mechanism of action, which targets cancer cells on the basis of their inherent deficiencies while seemingly avoiding normally functioning cells. Although health-care providers might assume a low toxicity profile because of their specific mechanism of action, PARP inhibitors are not completely benign and overall show a class effect adverse-event profile. Further complicating this situation, three different PARP inhibitors have been approved by the US Food and Drug Administration since 2014, each with their own specific indications and individual toxicity profiles. The diversity of adverse events seen both within and across this class of drug underscores the importance of having a comprehensive reference to help guide clinical decision making when treating patients. This Review characterises and compares all toxicities associated with each PARP inhibitor, both in monotherapy and in novel combinations with other drugs, with a particular focus on potential management strategies to help mitigate toxic effects. Although the excitement surrounding PARP inhibitors might certainly be warranted, a thorough understanding of all associated toxicities is imperative to ensure that patients can achieve maximal clinical benefit.
[29]
Zagouri F, Dimopoulos MA, Andrikopoulou A. PARP inhibitors during conception and pregnancy in breast cancer[J]. Crit Rev Oncol Hematol, 2025, 210:104696.DOI:10.1016/j.critrevonc.2025.104696.
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Gougis P, Hamy AS, Jochum F, et al. Immune checkpoint inhibitor use during pregnancy and outcomes in pregnant individuals and newborns[J]. Jama Netw Open, 2024, 7(4):e245625.DOI:10.1001/jamanetworkopen.2024.5625.
With the widespread use of immune checkpoint inhibitors (ICIs), concerns about their pregnancy outcomes through maternal exposure have emerged, and clinical comparative data are lacking.
[31]
吴克瑾, 陈玉芸, 金玉春, 等. 年轻女性早期乳腺癌病人生育相关调查研究[J]. 中国实用外科杂志, 2021, 41(11):1262-1268.DOI:10.19538/j.cjps.issn1005-2208.2021.11.16.
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on Breast EP, Roberta M diFlorio-Alexander, Slanetz PJ, et al. ACR appropriateness criteria® breast imaging of pregnant and lactating women[J]. J Am Coll Radiol, 2018, 15(11S):S263-S275.DOI:10.1016/j.jacr.2018.09.013.
Breast imaging during pregnancy and lactation is challenging due to unique physiologic and structural breast changes that increase the difficulty of clinical and radiological evaluation. Pregnancy-associated breast cancer (PABC) is increasing as more women delay child bearing into the fourth decade of life, and imaging of clinical symptoms should not be delayed. PABC may present as a palpable lump, nipple discharge, diffuse breast enlargement, focal pain, or milk rejection. Breast imaging during lactation is very similar to breast imaging in women who are not breast feeding. However, breast imaging during pregnancy is modified to balance both maternal and fetal well-being; and there is a limited role for advanced breast imaging techniques in pregnant women. Mammography is safe during pregnancy and breast cancer screening should be tailored to patient age and breast cancer risk. Diagnostic breast imaging during pregnancy should be obtained to evaluate clinical symptoms and for loco-regional staging of newly diagnosed PABC. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.
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ACR Committee on Drugs and Contrast Media. ACR Manual on Contrast Media v2024[EB/OL].(2024-06-12)[2025-10-09]. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast-Media-Manual.pdf.
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Leide-Svegborn S, Ahlgren L, Johansson L, et al. Excretion of radionuclides in human breast milk after nuclear medicine examinations.Biokinetic and dosimetric data and recommendations on breastfeeding interruption[J]. Eur J Nucl Med Mol Imaging, 2016, 43(5):808-821. DOI: 10.1007/s00259-015-3253-3.
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Johnson HM, Mitchell KB. Breastfeeding and breast cancer: Managing lactation in survivors and women with a new diagnosis[J]. Ann Surg Oncol, 2019, 26(10):3032-3039.DOI:10.1245/s10434-019-07596-1.
Supporting breastfeeding is a global health priority, yet few clinical guidelines exist to guide surgical oncologists in managing lactation during or after breast cancer treatment.The literature was reviewed to identify evidence-based strategies for managing lactation during multidisciplinary breast cancer treatment or among breast cancer survivors.The majority of the evidence is from observational studies, with some higher levels of evidence, including systematic reviews and meta-analyses. Several significant gaps in knowledge remain.This review serves as a comprehensive resource of evidence-based recommendations for managing lactation in breast cancer survivors and breastfeeding women with a new breast cancer diagnosis.

基金

上海市卫生健康委员会联合上海市中医药管理局项目(ZXXT-202301)
上海市科学技术委员会项目(23ZR1408400)

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