Abstract
Progression-free survival was almost twice as long in patients with advanced breast cancer who received the monoclonal antibody, bevacizumab, in addition to standard paclitaxel chemotherapy, compared with those receiving paclitaxel alone.
In a large, randomized clinical trial, the addition of bevacizumab (Avastin®) has been demonstrated to increase progression-free survival by several months in women with locally recurrent or metastatic breast cancer.
“These results are good news for people with breast cancer,” enthused study author Robin Zon, Elkhart General Hospital (IN, USA). “A drug with a novel mode of action on the blood vessels within the cancer has not added side effects for patients, and those who received the test drugs kept their cancer under control for almost twice as long as patients who received the standard regimen. The next step will be introducing the new drug in patients whose breast cancer has not progressed to metastasis.”
A total of 722 patients were randomized to receive either paclitaxel (90 mg/m2 on days 1, 8 and 15 of a 4-week cycle) plus bevacizumab (10 mg/kg on days 1 and 15), or paclitaxel alone. The results of an interim analysis of 484 cases that had progressed were presented at the 5th European Breast Cancer Conference (Nice, France). Women in the paclitaxel plus bevacizumab group had an average progression-free survival of 11.4 months, compared with 6.11 months in the paclitaxel-only group. The group receiving bevacizumab demonstrated a response rate of 29.9%, compared with 13.8% of those receiving paclitaxel alone.
While it is too early to judge the effects of the drug on overall survival, there was a trend towards increased survival in women receiving bevacizumab (28.4 vs 25.2 months).
The side effects of bevacizumab appear to be relatively minor and manageable. There was a 14% greater risk of grade 3/4 hypertension and increased risks of proteinuria and bleeding in the bevacizumab group, but bevacizumab did not affect the overall quality of life of patients.
Bevacizumab is a humanized monoclonal antibody that targets the vascular endothelial growth factor, a key factor in tumor angiogenesis. The drug has already been shown to be effective when administered with chemotherapy in advanced colon cancer, and is being investigated in advanced lung cancer.
“This particular antibody is proving to have some additive effect in patients who are getting conventional anticancer therapies,” commented Gordon McVie of the European Institute of Oncology (Milan, Italy). He added, “It's still not a cure. The fact that it does something different from paclitaxel shows that the research is well worth the effort, but it's a small step. We'll need a lot more small steps before we get close to the Holy Grail of curing metastatic breast cancer.” Source: Zon R, Miller K, Wang M et al.: A randomized phase III trial of paclitaxel with or without bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: Eastern Cooperative Oncology Group trial E2100. Eur. J. Cancer (Suppl.) 4(2), 46 (2006).
FDA approves new imaging system to detect cervical precancers
The US FDA has approved the LUMA™ Cervical Imaging System for use along with coloscopy to help detect cervical precancerous lesions.
The Director of MediSpectra (MA, USA), manufacturers of the system, commented that “cervical cancer is one of the few highly preventable cancers. The early detection and removal of precancerous cervical lesions reduces the risk of developing invasive cervical cancer. The approval of this imaging system gives healthcare providers an additional tool to help detect cervical cancer precursors and identify predisease that may have been missed by a coloscopy.”
Approval was based on the results of a study in 193 women who underwent coloscopy followed by LUMA imaging. First, coloscopy was performed and the doctor identified areas on the cervix for biopsy. Then, the LUMA device was used to identify any additional areas for biopsy. Of the 50 cases of cervical precancer recorded, LUMA detected nine cases that were missed by coloscopy.
The LUMA system scans cervical tissue with a combination of fluorescence spectroscopy, white-light diffuse reflectance spectroscopy and video imaging. The scan takes 12 s, with results, presented as a colored map, available to the clinician during the examination.
Source: FDA Press Release (2006). Available at http://www.fda.gov.
in brief…
Prentice RL, Caan B, Chlebowski RT et al.: JAMA 295(6), 629–642 (2006).
Tests the hypothesis that a low-fat diet can reduce the risk of breast cancer. The study enrolled 48,835 postmenopausal women aged 50–79 years, who were randomly assigned to dietary-intervention or control groups. The dietary-intervention group were given the goal of reducing their intake of fat to 20% of their total energy intake and increasing their consumption of fruit and vegetables to five portions/day and grains to six portions/day. There was no significant difference between the groups in incidence of invasive breast cancer, although a nonsignificant trend was reported. Two separate studies reported that this dietary intervention had no significant effect on cardiovascular disease or colorectal cancer risk.
Jackson RD, LaCroix AZ, Gass M et al.: N. Engl. J. Med. 354(7), 669–683 (2006).
Demonstrates that calcium plus vitamin D supplementation increases bone mineral density but has no effect on incidence of fracture in a cohort of healthy postmenopausal women. A total of 36,282 postmenopausal women aged 50–79 years, already enrolled in the Women's Health Initiative study, were randomly assigned to receive 1000 mg elemental calcium plus vitamin D or placebo. The authors speculate that the low fracture rate in the cohort as a whole may have masked any effect of calcium plus vitamin D supplements on fracture rate.
Baum M, Hackshaw A, Houghton J et al.: Eur. J. Cancer (2006) (Epub ahead of print).
Demonstrates that the addition of goserelin to standard adjuvant therapy leads to a significant reduction in event-free and overall survival of approximately 20%. The results of four randomized trials, including a total of 2710 premenopausal women with early stage breast cancer, were analyzed after a median follow up of 5.5 years. Patients received goserelin, with or without tamoxifen, for 2 years. The drug was well tolerated.
Neoprene suit saves lives of women with obstetrical bleeding
A neoprene suit, similar to the bottom half of a wetsuit, can help to save the lives of women suffering serious bleeding during childbirth.
Researchers from the University of California, San Francisco (CA, USA) conducted a study in Egypt assessing 208 obstetrical hemorrhage patients who were treated with standard therapy plus the neoprene suit compared with 158 patients treated with standard therapy alone.
The women treated with the suit, known as a nonpneumatic anti-shock garment (NASG), lost 60% less blood and were 69% less likely to die or suffer serious morbidity.
“The NASG shows promise for management of obstetric hemorrhage, particularly in lower-resource settings,” concluded the authors.
The suit requires no training to operate and consists of five segments, which are fastened tightly using Velcro. The pressure this applies to the lower extremities and abdomen forces blood towards the heart, lungs and brain, keeping the patient alive.
“In our research, women who appeared clinically dead, with no blood pressure and no palpable pulse, were resuscitated and kept alive for up to two days while waiting for blood transfusions,” stated study director Suellen Miller.
This intervention could prove particularly useful in developing countries, where obstetrical bleeding is a leading cause of death during childbirth.
Larger studies with the suit are planned in the future.
Source: University of California, San Francisco news release (2006). Available at http://pub.ucsf.edu.
Decongestants for the treatment of pregnancy rhinitis safe in pregnancy
Pregnancy rhinitis is a common problem, with approximately one in five pregnant women affected. There has been concern that decongestant medications used to treat this condition could affect the developing fetus.
However, a study by Swedish researchers, published recently in the American Journal of Obstetrics and Gynecology, has revealed no teratogenic effect of decongestant use in pregnant women.
The investigators, from the University of Lund (Sweden), followed 2474 pregnant women who received decongestants early in pregnancy and 1771 who received decongestants later in pregnancy.
No statistically significant difference in the incidence of congential abnormalities was found between the infants born to mothers receiving decongestants during the first trimester compared with women in the general population.
In fact, decongestant use during late pregnancy was associated with a 32% decreased risk of preterm delivery, a 47% decreased risk of low birth weight and a 47% decreased risk of perinatal death.
The authors speculate that pregnancy rhinitis might be “a sign of a well-functioning placenta,” meaning that women treated for rhinitis during pregnancy may be more likely to have positive birth outomes.
Source: Kallen BA, Olausson PO: Use of oral decongestants during pregnancy and delivery outcome. Am. J. Obstet. Gynecol. 194(2), 480–485 (2006).
Asymmetrical breasts linked to higher breast cancer risk
Breast cancer risk may be increased by 50% for every 100 ml difference between a woman's left and right breast.
“It has been shown in our previous work that breast asymmetry is related to several of the known risk factors for breast cancer, and that patients with diagnosed breast cancer have more breast volume asymmetry, as measured from mammograms, than age-matched healthy women,” write Diane Scutt and colleagues.
The present retrospective, case–control study compared breast asymmetry in 252 women with normal mammograms who went on to develop breast cancer and 252 healthy controls. The incidence of breast cancer was increased by 50% for every 100 ml of breast asymmetry.
The authors hope that “asymmetrical breasts could be reliable indicators of future breast disease in women,” and feel that “this factor should be considered in a woman's risk profile.”
Women with asymmetrical breasts may be at an increased risk of developing breast cancer, according to a study by researchers at the University of Liverpool (UK).
The conditional logistic regression analysis also identified height, family history of breast cancer, age at menarche, parenchyma type and menopausal status as significant independent predictors of breast cancer.
The authors speculate that the link between breast asymmetry and cancer may be mediated by ‘disruptive’ hormonal variation during breast development.
However, experts were keen to reassure women that small differences in breast size are normal and not a cause for concern. Dr Scutt pointed out that, since the average size of a female breast in this study was 500 ml, 100 ml was a considerable asymmetry. Only one woman in the entire study had perfectly symmetrical breasts.
She added “breast asymmetry should not be considered in isolation, it is important to consider a woman's entire risk profile before assessing her breast cancer risk.”
In addition, Stephen Duffy (Cancer Research UK) commented that “this increase in risk is small compared with other risk factors such as breast density…so it does not have immediate implications for prevention or screening.”
Source: Scutt D, Lancaster GA, Manning JT: Breast asymmetry and predisposition to breast cancer. Breast Cancer Res. 8(2), R14 (2006) (Epub ahead of print).
Contraceptive injections may increase diabetes risk
The contraceptive injection depo-medroxyprogesterone acetate (DMPA) has been found to be associated with an increased risk of diabetes in Latino women with prior gestational diabetes mellitus. The increase in risk appeared to only affect women with other risk factors for diabetes, for example breastfeeding or high levels of triglycerides.
The authors recommend the following for Latino women with a history of gestational diabetes: “If breastfeeding, use a nonhormonal approach,” and if not breastfeeding “but with relatively high triglycerides, use a nonhormonal method or low-dose combination pills; try to avoid DMPA.”
The study examined 526 Latino women with prior gestational diabetes who chose to use either DMPA or combination oral contraceptives. Women electing to use DMPA had a diabetes incidence of 19.1%, compared with 11.9% in those using the combination oral contraceptive.
Source: Xiang AH, Kawakubo M, Kjos SL, Buchanan TA: Long-acting injectable progestin contraception and risk of type 2 diabetes in Latino women with prior gestational diabetes mellitus. Diabetes Care. 29(3), 613–617 (2006).
Angina more common in women than previously thought
Women experience stable angina at the same rate as men, according to a study published recently in the Journal of the American Medical Association.
“The subject of longstanding debate, angina in women occurs in the general population as commonly as in men, and its prognostic impact suggests that it should not be discounted as a benign or soft diagnosis,” warn Harry Hemingway and colleagues (University College London, UK).
The study, funded by the British Heart Association, examined the medical records of over 100,000 Finnish patients aged 49–89 years with angina.
A diagnosis of angina was associated with increased death rates in women as well as men, and diabetic women with angina had a risk of heart attack similar to men. However, women with symptoms of angina were less likely than men to have the diagnosis confirmed by angiogram or exercise electrocardiogram.
Professor Hemingway emphasized that “we need to understand why women are relatively protected from heart attack but not from angina, and ensure fair access to investigation and treatment services.” Source: Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimaki I: Incidence and prognostic implications of stable angina pectoris among women and men. JAMA 295(12), 1404–1411 (2006).
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