Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer.

PURPOSE: To perform a randomized three-arm comparison of tamoxifen (TAM; 20 mg/d) and two separate doses of toremifene (TOR; 60 mg/d [TOR60] and 200 mg/d [TOR200]) in postmenopausal patients with hormone receptor-positive or -unknown metastatic breast cancer. MATERIALS AND METHODS: Six hundred forty-eight patients with hormone receptor-positive or -unknown metastatic breast cancer were randomly assigned to receive TAM (n = 215), TOR60 (n = 221), or TOR200 (n = 212). RESULTS: The combined response rates (by intent to treat) were as follows;: TAM, 44%; TOR60, 50%; and TOR200, 48%. Complete and partial response rates were as follows: TAM, 19%; TOR60, 21%, and TOR200, 23% (not statistically different). Median times to progression and overall survival were not significantly different. Adverse events (lethal, serious but nonlethal, and important but non-life-threatening) were similar in all three arms, except that patients in the TOR200 arm had a statistically significantly increased rate of nausea (37% v 26% and 26% for TOR200, TAM, and TOR60, respectively; P = .027). Quality-of-life assessments were not different among the three arms. CONCLUSION: The activity, toxicity, and side effects of TOR in postmenopausal women with hormone receptor-positive or -unknown metastatic breast cancer are similar if not equivalent to those of TAM. We detected no clear evidence of a dose-response effect for TOR. TOR60 is an effective and safe agent for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer and can be considered an alternative to TAM as first-line treatment for such patients.

Sperm morphologic features as a prognostic factor in in vitro fertilization.

To determine whether there is a prognostic value in the percentage normal sperm morphologic features in a human in vitro fertilization (IVF) program, the authors conducted a prospective study in women with bilateral tubal damage. Based on the percentage of morphologically normal spermatozoa, the patients were divided into four groups: group I, normal morphologic features between 0% and 14%; group II, 15% to 30%; group III, 31% to 45%; and group IV, 46% to 60%. One hundred ninety successful laparoscopic cycles were evaluated. In group I, 104 oocytes were obtained, of which 37% fertilized, but no pregnancy resulted; in group II, 81% of 324 oocytes were fertilized, with a pregnancy rate per embryo transfer (ET) of 22%; in group III, 82% of 309 oocytes were fertilized, with a 31% pregnancy rate; and in group IV, 91% of 69 oocytes were fertilized, with a pregnancy rate of 12%. Probability models indicated that there was a clear threshold in normal sperm morphologic features at 14%, with high fertilization and pregnancy rate in the groups with normal sperm morphologic features greater than 14%.

[The cost of treatment operable breast cancer]. / Die koste van behandeling van opereerbare borskanker.

The cost of primary treatment of operable breast cancer was investigated in 25 patients. As a result, appropriate cost-saving measures were instituted. In 1988 the total costs paid by the patients amounted to R40 690. The actual cost calculated according to the Scale of Benefits would have amounted to R175 035. The average subsidy per patient amounted to R5 373. If the minimum number of special investigations before treatment on the 258 new patients registered in 1988 had been performed an amount of R60 000 would have been saved. If the number of inpatient days could have been reduced R284 832 would have been saved. Doctor's fees, theatre fees and the cost of medicine are fixed. Long-term savings are possible only if breast cancer can be diagnosed early, if inpatient days are limited, and if all doctors and students are selective in their requests for special investigations.

Phyllode tumours of the breast. A review of 21 cases.

Twenty-one cases of phyllode tumours of the breast (9 malignant, 4 borderline and 8 benign) were reviewed. Three patients with malignant tumours developed metastases, and all died. Eight patients developed local recurrence, 6 in the malignant and borderline groups and 2 in the benign group. The classification into malignant, borderline and benign groups is a reliable guide for use when deciding on the extent of surgery. Malignant and borderline tumours require local mastectomy, while tumour excision suffices for benign disease. The customary pathological separation of malignant phyllode tumours from primary sarcoma of the breast is questioned.

Oligozoospermia: recent prognosis and the outcome of 73 pregnancies in oligozoospermic couples.

The minimum value for each of the five main semen parameters, below which conception rarely occurred or did not occur at all, was calculated in a group of 1884 couples complaining of primary and secondary infertility: 304 conceptions including first as well as consecutive conceptions, occurred. The parameters evaluated were (minimum value calculated in this study between brackets) volume (1.0 ml), sperm count ml(-1) (2.0 million), total sperm count (4.0 million), motility (10%), forward progression (2.0 MacLeod units: scale 1-4) and normal sperm morphology (3%). The pregnancy rate in the group of 308 oligozoospermic men and the minimum value of semen parameters were the cornerstones in determining the prognosis for oligozoospermic patients. A sperm count of >2.0 million ml(-1) was considered relatively adequate for eventual conception judged by the 68 of 308 (22.1%) pregnancies that occurred among oligozoospermic men in this study, provided that the other five semen parameters showed values above the minimum value. In cases where the average sperm count was <2 million ml(-1), the chances for conception became rare, viz five of 308 (1.6%). The total number of pregnancies in the group classified as oligozoospermic was 73 (23.7%). With these pregnancies there was no increase in the rate of foetal wastage and congenital abnormalities. Abortion occurred in 15.09% and ectopic pregnancy in 0.9% among first and consecutive pregnancies. One infant among the 56% boys and 44% girls was born with congenital abnormalities. Most of these infants had a normal birth mass of >2500 g.

The infertile couple. Part II. Examination and evaluation of semen.

Most laboratories in South Africa have their own methods for examining and evaluating semen. This situation contributes towards conditions unfair to patients and undesirable for physicians dealing with infertility. The technique of obtaining semen specimens for examination is described. All tests that should be done as a routine and according to international standards, as carried out at Tygerberg Hospital, are described, with special reference to pitfalls in the examination and evaluation of semen. An urgent plea to maintain international methods, standards and terminology and for adequate specific training of technologists in the field of andrology is made.

The infertile couple: Part I. Schedule of management.

The regimen for the management of couples who complain of infertility is presented as it is practised at Tygerberg Hospital. The doctor-patient relationship, the importance of the patient's comprehansion of the specific treatment regimen and why it should be adhered to are stressed. Special investigations are discussed and certain pitfalls in the management of infertile couples are pointed out. Controversy still exists with regard to many aspects of the management. Decisions about when to start with infertility investigations, whom the couple should consult, whether they should be examined as a couple or separately, and how long they should receive treatment are dealth with.

Sex and infertility. Part I. Prevalence of psychosexual problems and subjacent factors.

Data on 514 couples with psychogenic factors affecting their sex lives and fertility showed that the most prevalent problems were lack of sex education, consequences of premarital sex and the problem of infertility per se. These factors contributed to psychosexual problems of which the general prevalence was 42% (10.5% women, 13.2% men and 18.3% both husband and wife). The high prevalence of psychosexual problems emphasises the importance of the inclusion of extensive training in sex counselling in the curricula of medical students and the urgent need for sex counselling facilities at training hospitals.

Sex and infertility. Part II. Influence of psychogenic factors and psychosexual problems.

In a study of 514 couples ignorance about sex because of a complete lack of or inadequate sex education resulted in an unfavourable attitude towards sexual behaviour which adversely affected their fertility. Sexual activities which gave rise to feelings of guilt, fear or anguish had a dramatic effect on fertility; most important were premarital intercourse, criminal and therapeutic abortion, illegitimate children and prostitution. Psychosexual problems were found to have a direct influence on intercourse, as the results of post-coital tests showed. In 18.3% of cases severe psychosexual problems caused infertile couples to use lubricating substances to facilitate intercourse; this had a deleterious effect on penile penetration and on the migration of spermatozoa in the cervical mucus.

Tumour excision plus continuous tamoxifen compared with modified radical mastectomy in patients over 70 years of age with operable breast cancer.

Between 1985 and 1991, we randomly assigned 77 women over the age of 70 years with stage I-3a breast cancer to undergo a modified radical mastectomy or tumour excision followed by tamoxifen. Median follow-up was 45 months. Patients treated by tumour excision and tamoxifen had a significantly better survival (P = 0.04). The disease-free survival of the tumour excision and tamoxifen group was close to significantly better (P = 0.10). Only two patients in the tamoxifen group required an axillary dissection on follow-up for progressive nodal enlargement. Two patients underwent a local mastectomy for locally recurrent disease. We conclude that tumour excision followed by continuous tamoxifen is an acceptable, safe alternative to a modified radical mastectomy in patients over 70 years of age.

Breast-conserving treatment for stage I and II cancer. Tumour excision, axillary dissection, peri-operative interstitial irradiation, with or without peri-operative chemotherapy, followed by breast irradiation--the Tygerberg Hospital experience.

Since 1984 breast-conserving treatment has been the treatment of choice for patients at Tygerberg Hospital with early breast cancer. Peri-operative interstitial brachytherapy in breast cancer is described in detail. In the 221 patients treated (225 breasts), 197 breasts received iridium implants and 26 patients received peri-operative chemotherapy (POPFAC). There were 6 recurrences in treated breasts, 3 within the booster area and 3 outside. There were 5 salvage mastectomies, and 1 patient was treated by excision and radiotherapy. Metastases developed in 27 patients. Two patients underwent mastectomy for severe radiation changes and 7 developed postoperative wound infection after POPFAC. Five patients, who had re-excisions and prolonged seroma formation, developed delayed wound infection after POPFAC. Five patients, who had re-excisions and prolonged seroma formation, developed delayed wound infection. The importance of mammography, patient selection, tumour-free margins and radiation dosage are discussed.

Analysis of prognostic factors in 568 patients treated for breast cancer by surgery.

The Tygerberg Breast Clinic serves a heterogeneous population, and it is therefore possible to analyse prognostic factors influencing survival and to identify any possible differences between these groups. From 1978 to 1985, 568 breast cancer patients (52% white and 48% colored) were treated surgically in Tygerberg Hospital. Stage for stage, all patients received identical treatment. Colored patients were seen at a younger age, with more advanced disease, had lower estrogen receptor values, and more nodes involved. Cox's regression analysis of age, receptor value, stage, nodal involvement, race, menopausal status, treatment, and study period in the evaluation of disease-free survival and overall survival confirmed stage and lymph node status as prognostic factors. Estrogen receptor status, menopausal status, age at presentation, treatment, study period, and race did not enter the regression, except in stage I, where race was a variable. A target group for directing educational intervention is identified.