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[Tamoxifen or tamoxifen in combination with chemotherapy in adjuvant therapy of breast carcinoma. Results of a multicenter randomized study] Tamoxifen nebo tamoxifen v kombinaci s chemoterapií v adjuvantní lécbe karcinomu prsu. Vysledky multicentrické randomizované studie.
Sbornik Lékarsky. 2001; 102(1):65-76.Between April 1994 and May 1997 103 breast cancer patients (pts), pT1c-3a, pN0-1, M0, were randomised after surgery to adjuvant tamoxifen (20 mg per day) or to tamoxifen plus CMF (C 500 mg/m2, M 40 mg/m2 and F 600 mg/m2 on days 1st and 8th q 28 day) in 6 cycles. The median age (49-72 years, median 58), tumour size, number of involved lymphnodes (0-3), estrogens receptor status, grade (I-III) and type of operation were well balanced among the 50 pts on tamoxifen and the 53 pts on tamoxifen plus CMF pts, preferably postmenopausal. Results. Grade of toxicity according to WHO criteria was not higher than two in both arms. Toxicity both haematological and non-haematological was higher in the group treated with chemotherapy (0 vs 32 resp. 20%) except weight gain +5% (52% in both group). After median follow-up of 42 mos five recurrences in tamoxifen and seven in tamoxifen plus CMF pts were observed (p=NS). The projected 3-y DFS is 92% for tamoxifen and 88% for tamoxifen plus CMF (p=NS). The 3-y OS is 88% for tamoxifen and 80% for tamoxifen plus CMF pts (p=NS). Conclusions. Both regimens are equally effective with higher toxicity in the group with combined chemo- and hormonal therapy. (author's)
WASHINGTON MEMO. 1992 Nov 12; (17):2-3.In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than >30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is <.5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not coerced to use it.
SCIENCE. 1992 Jun 26; 256:1754.Depo-Provera (DP) was unanimously recommended for approval as a contraceptive by a Food and Drug Administration (FDA) advisory committee. This had happened once before in the mid-1970s, but Congress raised concerns about DP's possible link to cervical cancer. DP has been in use for 20 years as a treatment for uterine cancer. DP is an injectable progesterone analog that induces infertility for 3 months in 99% of the women who use it. It is already in use in 90 countries and has annual sales of US$100 million. The 4 annual shots cost US$120 and is an economical alternative to Norplant. There are still many unanswered questions about its safety. A recent WHO study found that it increased breast cancer by 21%, which was almost statistically significant. However, in the <34 age group breast cancer was twice as common, which is statistically significant. DP was found to increase the number of breast cancer cases by 5.6/100,00; but, it reduced the number of uterine cancer cases by 19.2/100,000. A New Zealand Hospital study found that DP use reduced bone density by 7.5% in the lumber spine and 6.5% in the neck of the femur. Critics charge that Upjohn has had 20 years to compile data but has failed to do so. There is little or no data about its effect on developing fetuses, osteoporosis, or the mechanism that causes breast cancer. All these areas were recommended for follow-up study by the FDA advisory committee.
Family Planning Perspectives. 1992 Jan-Feb; 24(1):43-4.1 hospital in Nairobi, Kenya; Mexico City, Mexico, and Chiang Mai, Thailand and 2 hospitals in Bangkok, Thailand took part in a WHO sponsored collaborative study to examine the association between depomedroxyprogesterone acetate (DMPA) and breast cancer. The researchers compared 1979-1988 data on 869 hospitalized women with breast cancer with 11,890 hospitalized women with unrelated conditions. 12.5% of cases and 12.2% of controls had ever had an injection of DMPA. Overall ever users had no significant increased risk of breast cancer (relative risk [RR], 1.2) In addition, risk did not rise with duration. Nevertheless current users who began receiving DMPA within the past 4 years did have a significantly higher risk (RR 2.6). On the other hand, current users who began receiving DMPA >5 years earlier were not at increased risk at all. For example, the RR for those who began 8-12 years earlier was 0.8 and for those who began >12 years earlier was 0.5. Further even though the current users <35 years old who began receiving DMPA within the past 4 years were >2 times as likely to have breast cancer than their corresponding counterparts who did not use DMPA (RR 2.2), the risk according to duration was not significant. The researchers listed some possible reasons for the discrepancies. They concluded that there is only a weak association between DMPA and breast cancer--comparable to that between oral contraceptives and breast cancer. In New Zealand, a case control study of 30 25-51 year old women who used DMPA for at least 5 years showed that long term use of DMPA significantly reduced bone density. For example, for DMPA users, the spine and femoral neck bone densities were 8% and 7% respectively lower than the premenopausal controls. The researchers found the same effect even when they restricted the analysis to nonsmokers.