• Vitamin D Deficiency and Risk for Sepsis
• Effects on Healthcare of the U.S. Government Shutdown
• Exercise Seems as Effective as Drugs for Some Common Condition
• Long-Term Follow-up from WHI: No Role for Hormone Therapy in Chronic Disease Prevention
• Inappropriate Antibiotic Prescribing for Sore Throat Remains High
• Estradiol Safer Than Conjugated Equine Estrogens in Terms of Thrombosis
• New Drug Approved for Menopausal Symptoms
• Diet, Exercise or Both are Better for Knee Osteoarthritis?
• FDA Approves First Drug for Early Stage Breast Cancer
• Certain Whole Fruits Linked to Lower diabetes Risk
• Spironolactone Plus Metformin for PCOS: Are They Really Better When Used Together?
• Relief of Symptomatic Vulvovaginal Atrophy
• Can Watching TV at Night Affect Your Mood?
• Study Identifies Women Who May Be Less Prone to Breast Cancer With Hormone Therapy
• Calcium-Channel Blockers Might Be Associated with Excess Breast Cancer Risk
• Pregnancy and Breast Cancer
MM: In this study 81% of the participants were white. People of color have a tendency to have lower Vitamin D levels and are therefore at even greater risk of sepsis and associated problems. With all the attention that national healthcare has been getting, it is my opinion that the cost of this and all healthcare could be greatly diminished with a more concentrated effort to monitor and improve deficient levels of vitamin D. Unfortunately, this approach is too reasonable and too cost effective so it is likely to be doomed before it would ever have an opportunity to be successful
Crit Care Med 2013 Aug 26
Vitamin D Deficiency and Risk for Sepsis
A large observational study showed a 1.6- to 2.5-fold increased risk for sepsis and a 1.6-fold increased risk for mortality among patients with vitamin D levels ≤15 ng/mL.
Vitamin D is known to have effects on human immunity — for example, by preventing excessive cytokine release and activating the innate immune system. Studies investigating vitamin D's role in infectious diseases have yielded conflicting results but were often limited by the small number of patients studied. To investigate the effect of vitamin D deficiency on the risk and course of sepsis, researchers reviewed records of patients admitted to a medical or surgical intensive care unit (ICU) at either of two medical centers in Boston between March 1, 1998, and January 5, 2011.
Data were analyzed for 3386 adults (mean age, 65.9) with vitamin D measurements available from <1 year before hospitalization. Fifty-six percent of the patients were women, 81% were white, and 67% had medical diagnoses; 69% of vitamin D measurements occurred <6 months before ICU admission. The mean vitamin D level was 29.4 ng/mL.Sepsis — according to International Classification of Diseases, 9th edition (ICD-9) definitions — was diagnosed in 568 (16.8%) of these patients. The risk for this condition was 1.6-fold higher in patients with vitamin D levels ≤15 ng/mL than in those with normal levels (≥30 ng/mL). For every 5-ng/mL increase in preadmission vitamin D level, the odds of developing sepsis decreased by 4%. Among patients with sepsis, the adjusted risks for in-hospital, 30-day, and 90-day mortality were all 1.6-fold higher in individuals with preadmission vitamin D levels <30 ng/mL than in those with higher levels.
In a subanalysis involving 444 patients, the risk for severe sepsis or septic shock — defined according to conference guidelines — was 2.5-fold higher in individuals with vitamin D levels ≤15 ng/mL than in those with levels ≥30 ng/mL. For every 5-ng/mL increase in preadmission vitamin D level, the odds of developing severe sepsis or septic shock decreased by 19%.
Comment: This large study clearly shows vitamin D deficiency to be a risk factor for sepsis. Patients with such deficiency should therefore receive vitamin D supplementation not only to prevent osteoporosis, but also as a protective measure against infections. However, whether vitamin D supplementation has any benefit for patients without deficiency remains unclear.
Citation(s): Moromizato T et al. Association of low serum 25-hydroxyvitamin D levels and sepsis in the critically ill. Crit Care Med 2013 Aug 26; [e-pub ahead of print].
(http://dx.doi.org/10.1097/CCM.0b013e31829eb7af)
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Effects on Healthcare of the U.S. Government Shutdown
By Kelly Young
The U.S. government shut down on Tuesday. Here is a quick sampling of how healthcare is affected:
- The FDA will continue emergency work involving human safety, such as high-risk recalls, and civil and criminal law enforcement. But regular inspections and lab research are on hold.
- The CDC is unable to run its influenza-tracking program. Tracking of other infectious diseases is also on hold.
- The CDC published this week's MMWR ahead of schedule and won't resume publication until the shutdown ends.
- The National Institutes of Health Clinical Center will not be accepting new patients for clinical trials. Ongoing clinical trials will continue.
- Enrollments in the new health insurance exchanges
(http://www.healthcare.gov or 800-318-2596), which began on Tuesday and are the source of much of the political rancor, were not halted by the shutdown because they rely on different streams of funding.
http://www.usa.gov/shutdown.shtml
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Exercise Seems as Effective as Drugs for Some Common Condition
By Joe Elia
The effect of exercise on reducing mortality compares favorably with that of drug therapies for several common disorders, a BMJ study suggests.
Researchers examined some 300 trials to assess the mortality benefits of drugs versus exercise interventions in the secondary prevention of coronary disease, stroke rehabilitation, heart failure treatment, and diabetes prevention.
They found no statistically significant difference between drugs and exercise in lowering the odds ratios for mortality from coronary disease. Heart failure mortality showed a benefit of diuretics over exercise. Exercise bested drugs in stroke rehabilitation. And in prediabetes, neither drugs nor exercise was more effective at reducing mortality.
The authors say their findings highlight the lack of data on the question of exercise versus drugs. They note that the "lopsided nature of modern medical research may fail to detect the most effective treatment for a given condition if that treatment is not a prescription drug."
http://www.bmj.com/content/347/bmj.f5577
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MM: Once again we see that non-Bio-Identical Hormones have little long-term benefit and that benefit is out-weighed by potential long-term harm. Unfortunately, although there is no data to indicate that Bio-identical hormones share these characteristics, it is likely that they will be lumped into the same category. The next article discusses this a bit further.
Long-Term Follow-up from WHI: No Role for Hormone Therapy in Chronic Disease Prevention
By Amy Orciari Herman
Conjugated equine estrogens, either alone or with medroxyprogesterone acetate, should not be used to prevent chronic diseases in postmenopausal women, Women's Health Initiative researchers conclude in JAMA.
Examining 13 years of data from the WHI randomized trials, the researchers found that the overall risks of CEE plus medroxyprogesterone acetate outweighed the benefits: for every 10,000 women treated per year, there were six additional coronary events and nine more strokes, pulmonary emboli, and breast cancers — with six fewer colorectal cancers and hip fractures and one fewer endometrial cancer and death (net: 20 additional adverse events). The risk-benefit profile with CEE alone was more favorable, but there were still four additional adverse events.
Women aged 50 to 59 using CEE alone seemed to fare the best.
Andrew Kaunitz, an OB/GYN with NEJM Journal Watch, said the findings "remind us that the risk:benefit ratio of menopausal hormone therapy for the treatment of bothersome vasomotor symptoms is most favorable when initiated in younger rather than older menopausal women, and for estrogen-only compared with estrogen-progestin therapy."
http://jama.jamanetwork.com/article.aspx?articleid=1745676
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Inappropriate Antibiotic Prescribing for Sore Throat Remains High
By Amy Orciari Herman
Antibiotics were prescribed in an estimated 60% of ambulatory sore throat visits across the U.S. from 1997 through 2010 — greatly exceeding the 10% of visits that should actually require penicillin — researchers report in JAMA Internal Medicine.
The researchers examined data on some 8200 adult visits for throat pain, representing an estimated 92 million visits nationwide during the study period. The antibiotic prescribing rate remained high throughout the study. Penicillin, the antibiotic of choice when treatment is required, was prescribed at 9% of visits. Azithromycin was prescribed increasingly, reaching 15% of visits by 2010.
The cost of unnecessary antibiotic prescribing was "conservatively" $500 million, the researchers estimate.
Paul Sax, an infectious diseases specialist with NEJM Journal Watch, said the findings emphasize "the seemingly intractable link that patients and providers have between sore throat and the need for antibiotics, with negative consequences both for the individual patient and to society."
http://jama.jamanetwork.com/article.aspx?articleid=1746111
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Estradiol Safer Than Conjugated Equine Estrogens in Terms of Thrombosis
By Amy Orciari Herman
Conjugated equine estrogens (CEEs) are associated with a higher thrombosis risk than estradiol among postmenopausal women, according to a case-control study in JAMA Internal Medicine.
Using data from a large HMO in Washington state, researchers matched some 180 menopausal women who experienced venous thrombosis, myocardial infarction, or stroke while using oral CEEs or estradiol with 200 menopausal estrogen users without such events. After multivariable adjustment, current CEE use was associated with twice the risk for venous thrombosis relative to estradiol use. MI risk was also higher with CEEs, but this didn't reach statistical significance. There was no association between estrogen formulation and stroke.
Plasma tests among controls revealed that CEE users had increased resistance to activated protein C, "providing biologic support" for the elevated thrombosis risk observed, the researchers note.
Andrew Kaunitz, an OB/GYN with NEJM Journal Watch, points out that CEEs can be 20 times as expensive as estradiol. He says: "For menopausal women choosing to use oral estrogen formulations, estradiol appears a wise choice from a price as well as safety perspective."
http://archinte.jamanetwork.com/article.aspx?articleid=1741892
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MM: Does it make sense that the FDA has approved a new combination estrogen that contains what is almost universally accepted to be the most dangerous potential hormone treatment available?
New Drug Approved for Menopausal Symptoms
The FDA has approved Duavee to treat moderate-to-severe symptoms of menopause and to prevent postmenopausal osteoporosis, Reuters reports. The drug is a combination of the selective estrogen-receptor modulator bazedoxifene and conjugated equine estrogen
http://www.reuters.com/article/2013/10/03/us-pfizer-ligand-bazedoxifene-idUSBRE9920WI20131003
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JAMA 2013 Sep 25; 310:1263
Diet, Exercise or Both are Better for Knee Osteoarthritis?
Diet and exercise together best achieve physiological and functional improvements.
Drug therapy often is ineffective for alleviating knee osteoarthritis (OA), and surgical treatment generally is not appropriate for mild-to-moderate cases, so lifestyle modifications still are the foundation of treatment. To assess the relative benefits of diet and exercise, researchers randomized 454 patients (mostly sedentary women; mean age, 66; mean body-mass index, 34 kg/m2) with mild-to-moderate knee OA to diet-induced weight loss, exercise, or both. The diet intervention was a combination of meal-replacement shakes and a low-fat diet plan designed to achieve calorie deficits of 800 to 1000 kcal daily. The exercise intervention consisted of thrice-weekly supervised 1-hour sessions of combined aerobic walking and strength training for 6 months, followed by a home-based program if participants wished.
At 18 months (completed by 88% of participants), mean weight loss was greater in the diet-plus-exercise and diet groups than in the exercise group (10.6 kg and 8.9 kg vs. 1.8 kg), as were reductions from baseline in interleukin-6 levels (a measure of inflammation). Diet-plus-exercise participants reported less pain and better function than did those in the diet-alone and exercise-alone groups.
Comment:When patients ask whether diet or exercise is better to help with the pain and functional effects of knee osteoarthritis, the answer is both. Exercise alone performed least well on almost all measures but appears to leverage the benefits of diet-induced weight loss. As with most trials of this nature, the structure and monitoring received by participants far exceed that generally available in most primary care practices.
Citation(s): Messier SP et al. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial. JAMA 2013 Sep 25; 310:1263.
(http://dx.doi.org/10.1001/jama.2013.277669)
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FDA Approves First Drug for Early Stage Breast Cancer
By the Editors
Perjeta (pertuzumab), a monoclonal antibody already approved for use in HER2-positive metastatic breast cancer, has received FDA approval for use in early-stage disease. It's the first drug approved for early-stage, preoperative breast cancer.
The new indication is intended for patients with HER2-positive, locally advanced, inflammatory, or early-stage cancer. The agency says pertuzumab should be used in combination with trastuzumab and other chemotherapy before surgery.
An advisory committee recommended approval 2 weeks ago, and the FDA announced its decision on Monday.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370393.htm
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MM: This study supports my contention that pure, whole foods may be beneficial but the practice of juicing may be potentially damaging. I frequently hear from people about how they have been juicing but in spite of "doing everything 'right'", they are gaining weight or having intestinal problems or other inflammatory conditions are being aggravated. Bottom line is that people should have a varied diet of frest fruits and vegetables but refrain from juicing as this alters the glycemic index of these foods and may cause/aggravate more problems than it helps.
Certain Whole Fruits Linked to Lower diabetes Risk
By Amy Orciari Herman
Adults who frequently consume certain whole fruits, including apples, grapes, and blueberries, have a significantly lower risk for type 2 diabetes than those who eat little fruit, according to a BMJ study.
Three cohorts of U.S. healthcare professionals, comprising nearly 190,000 adults without diabetes at baseline, regularly completed food-frequency questionnaires. During some 3.5 million person-years of follow-up, over 12,000 developed type 2 diabetes.
The risk for diabetes was significantly reduced with every three servings per week of blueberries (hazard ratio, 0.74), grapes and raisins (0.88), apples and pears (0.93), bananas (0.95), and grapefruit (0.95). Consumption of fruit juice, on the other hand, was associated with increased risk (hazard ratio for one or more servings/day: 1.21).
"These results support recommendations on increasing consumption of a variety of whole fruits, especially blueberries, grapes, and apples, as a measure for diabetes prevention," the researchers conclude.
http://www.bmj.com/content/347/bmj.f5001
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J Clin Endocrinol Metab 2013 Sep; 98:3599
Spironolactone Plus Metformin for PCOS: Are They Really Better When Used Together?
Study suggests combination therapy had better efficacy for management of polycystic ovary syndrome, but many questions remain.
Although management of polycystic ovary syndrome (PCOS) is generally directed at relieving bothersome symptoms and preventing endometrial abnormalities resulting from anovulation, attention has shifted toward insulin-sensitizing agents (particularly metformin) to alleviate metabolic disturbances leading to obesity, type 2 diabetes mellitus, dyslipidemia, hypertension, and cardiovascular disease. Metformin and spironolactone can reduce menstrual irregularity and hirsutism; thus, investigators in India evaluated the efficacy of the two agents (metformin 1000 mg daily and spironolactone 50 mg daily) given separately or together in a randomized, open-label, 6-month trial involving 198 women with PCOS.
At 6 months, frequency of menstrual periods had increased, and hirsutism, total serum testosterone, and area under the curve for insulin and glucose during oral glucose tolerance tests had diminished significantly in all three groups. These favorable changes were significantly greater for the combination than for either agent separately. Adverse events were no more likely in the combination group than in the others.
Comment: Although these results might be construed as showing that metformin plus spironolactone is superior to either agent separately, I remain unconvinced and would not generally use this combination for treatment of women with polycystic ovary syndrome. The authors note that sexually active women were advised to use barrier contraception. However, the potential for spironolactone to feminize a male fetus if inadvertently used during pregnancy warrants more-effective contraception. I have never prescribed — and would not recommend prescribing — spironolactone for any woman with PCOS without ensuring her use of effective contraception; furthermore, hormonal contraception by itself is effective in suppressing hirsutism. The short duration of this study does not permit us to conclude that the spironolactone/metformin combination is any more efficacious than either agent alone in the long term. Larger studies of alternative treatment modalities (including hormonal contraception) for women with PCOS are warranted.
Citation(s): Ganie MA et al. Improved efficacy of low-dose spironolactone and metformin combination than either drug alone in the management of women with polycystic ovary syndrome (PCOS): A six-month, open-label randomized study. J Clin Endocrinol Metab 2013 Sep; 98:3599.
(http://dx.doi.org/10.1210/jc.2013-1040)
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Menopause 2013 Sep; 20:888
Relief of Symptomatic Vulvovaginal Atrophy
NAMS has developed a comprehensive approach to management.
The North American Menopause Society (NAMS) has released an updated position statement that addresses a common consequence of estrogen loss in menopausal women: vulvovaginal atrophy (VVA). Almost half of postmenopausal women have reported experiencing vaginal symptoms including dryness, irritation, and pain with intercourse, but very few understand the relation of these symptoms to menopause or discuss them with a healthcare provider. The NAMS statement includes information about the evaluation, diagnosis, and treatment of VVA.
Highlights of the recommendations are as follows:
- First-line treatments for symptomatic VVA include lubricants and long-acting vaginal moisturizers.
- For persistent or moderate-to-severe VVA, low-dose vaginal or systemic estrogen therapy represents standard treatment.
- The recently approved oral selective estrogen-receptor modulator ospemifene may be used for dyspareunia.
- Progestins are generally not indicated in the setting of low-dose vaginal estrogen (however, safety data beyond 1 year are lacking)
- Whether or not vaginal estrogen is being used, vaginal spotting or bleeding in a postmenopausal woman with an intact uterus requires further evaluation.
Comment: Given that many women now live one third of their lives after menopause, their quality of life must be better recognized and addressed. This position statement provides a comprehensive approach to evaluation and management of vulvovaginal atrophy, a common and vexing problem. Although vaginal estrogen is most commonly prescribed for sexual discomfort caused by VVA, this class of medications also reduces urinary urgency and recurrent urinary tract infections associated with the condition. Accordingly, all women should be queried about vaginal symptoms and educated about VVA.
Citation(s): Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause 2013 Sep; 20:888.
(http://dx.doi.org/10.1097/GME.0b013e3182a122c2)
http://www.ncbi.nlm.nih.gov/pubmed/23985562?access_num=23985562&link_type=
MED&dopt=Abstract
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J Neurosci 2013 Aug 7; 33:13081
Can Watching TV at Night Affect Your Mood?
Depressive and anhedonic behaviors and altered neuronal structures are found in animals exposed to blue or white light at night.
As light is the most potent zeitgeber, could nighttime exposure to light alter circadian rhythms and mood that are entrained to environmental light-dark cycles? For 1 month at night, female hamsters were exposed to darkness, dim blue light (wavelength peak, ~480 nm), dim white light (broad spectrum, including blue), or dim red light (wavelength, >600 nm).
Blue or white light exposure, compared with darkness, led to more depressive and anhedonic behaviors (e.g., immobility in the forced swim test, decreased preference for sucrose) and lower spine density on hippocampal neurons. In a separate experiment, brief nighttime exposure to blue or white light induced more c-Fos activity in the suprachiasmatic nucleus than red light or darkness.
Comment: Intrinsically photosensitive retinal ganglion cells (ipRGCs), which contain melanopsin, signal the suprachiasmatic nucleus to regulate circadian rhythms and limbic regions like the hippocampus. Because melanopsin is sensitive to blue but not red light, blue light led to greater effects on mood, apparently mediated by reduction by ipRGCs in hippocampal signaling and alterations of gene expression that could modify brain-derived neurotrophic factor activity. Common sources of blue light such as television and computer screens, even at the relatively low intensities in this study (150 lux), might induce changes in mood and circadian rhythms, especially in vulnerable individuals such as depressed people. Patients with persistent depression therefore might be advised not to spend too much time at night with their computers or TVs.
Citation(s): Bedrosian TA et al. Nocturnal light exposure impairs affective responses in a wavelength-dependent manner. J Neurosci 2013 Aug 7; 33:13081.
(http://dx.doi.org/10.1523/JNEUROSCI.5734-12.2013)
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Study Identifies Women Who May Be Less Prone to Breast Cancer With Hormone Therapy
By Amy Orciari Herman
Black women, obese women, and those with less dense breasts may use hormone therapy (HT) "with minimal excess breast cancer risk," researchers conclude in the Journal of the National Cancer Institute.
Using the national Breast Cancer Surveillance Consortium, researchers studied more than 1.6 million screening mammograms, including 9300 cancer diagnoses. Some 44% of women reported being HT users, 42% were nonusers, and the rest had unknown HT status.
Overall, breast cancer incidence was higher among HT users than nonusers (5.78 vs. 5.46 cases per 1000). The increased risk was observed in whites, Asians, and Hispanics, but not in blacks. In addition, leaner women and those with denser breasts faced greater breast cancer risk with HT. Ultimately, the association between HT and breast cancer was greatest for underweight or lean women with extremely dense breasts (odds ratio, 1.49), while the association was "essentially absent" for obese women with fatty breasts.
http://jnci.oxfordjournals.org/content/early/2013/08/26/jnci.djt207.abstract
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JAMA Intern Med 2013 Aug 5
Calcium-Channel Blockers Might Be Associated with Excess Breast Cancer Risk
Other antihypertensives did not show this effect.
Several small studies have suggested an association between calcium-channel blocker (CCB) use and excess risk for breast cancer; other studies, particularly those with short follow-up, have shown no relation. To understand these conflicting results, investigators identified 1907 women (age range, 55–74) with breast cancer (invasive ductal or invasive lobular carcinomas) from a surveillance registry; cases were age-matched to 856 controls without breast cancer from a community population. Breast cancer patients were more likely to have family histories of breast cancer, be current alcohol users and smokers, and be current users of combined estrogen-progestin hormone therapy.
After adjustment for potentially confounding clinical and demographic variables, risk for both ductal and lobular breast cancer was about 2.5 times higher among current long-term CCB users (≥10 years) than among women who never used antihypertensive medications. Researchers found no excess risk associated with use of other classes of antihypertensives or short-term (<10 years) CCB use.
Comment: That calcium-channel blockers stand out compared with other classes of antihypertensives strengthens the association between CCBs and breast cancer, but no known biological mechanism accounts for these findings. An editorialist notes that calcium-channel blockers are the ninth most commonly prescribed drug class in the U.S. and would represent a major modifiable risk factor for breast cancer if these results were confirmed. These findings are worrisome but do not lead yet to specific clinical recommendations.
Citation(s): Li CI et al. Use of antihypertensive medications and breast cancer risk among women aged 55 to 74 years. JAMA Intern Med 2013 Aug 5; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.9071)
Coogan PF. Calcium-channel blockers and breast cancer: A hypothesis revived. JAMA Intern Med 2013 Aug 5; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.9069)
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J Clin Oncol 2013 Jul 10; 31:2532
Pregnancy and Breast Cancer
Chemotherapy was safe for the fetus when administered in the second and third trimesters.
One of the most clinically challenging and personally heart-wrenching situations occurs when confronting a pregnant woman with a new diagnosis of cancer. Though uncommon, breast cancer in pregnancy accounts for up to 3% of all new breast cancer diagnoses. Optimal management can be complicated by limitations on the types of imaging, systemic therapy, and radiation therapy that can be administered without teratogenic effects on the fetus. Consequently, some patients consider terminating the pregnancy. However, with a team of experienced breast cancer specialists (medical oncologist, surgeon, and radiation oncologist), most pregnant patients with early-stage disease can be managed without compromising either the pregnancy or the prognosis of the breast cancer, but relatively little data is available to reassure clinicians and patients.
To provide such data, investigators conducted a multicenter, registry study in which 311 pregnant breast cancer patients (median age, 33), mostly from Belgium and Germany, were compared with 865 nonpregnant breast cancer patients (median age, 41). Either neoadjuvant or adjuvant chemotherapy was administered to 200 patients during the second or third trimester using actual body weight to calculate body surface area (BSA) and subsequent dosing of chemotherapy. The analysis was adjusted for age, disease stage, tumor grade, hormone receptor status, human epidermal growth factor 2 status, and type of systemic therapy received.
At median follow-up of 61 months, the 5-year disease-free survival rate was estimated to be similar in pregnant versus nonpregnant patients (65% and 71%, respectively; hazard ratio, 1.34; P=0.14), as was the 5-year overall survival rate (78% and 81%; HR, 1.19; P= 0.51). Earlier than normal delivery occurred, but no fetal malformations were reported, reaffirming that chemotherapy is safe if administered in the second and third trimesters.
Comment: This report adds to the body of evidence, largely retrospective in nature, that breast cancer can be managed successfully during pregnancy without compromising outcome during pregnancy. These data reassure patients and clinicians that systemic therapy administered during the second and third trimesters of pregnancy does not seem to affect the health of the fetus. Pregnant women diagnosed with breast cancer should be referred to centers with a multidisciplinary team experienced in the management of such patients.
Citation(s): Amant F et al. Prognosis of women with primary breast cancer diagnosed during pregnancy: Results from an international collaborative study. J Clin Oncol 2013 Jul 10; 31:2532.
(http://dx.doi.org/10.1200/JCO.2012.45.6335)
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