Malignancy grading is no better than conventional histopathological grading in small squamous cell carcinoma of tongue and floor of mouth: retrospective study in 128 patients.

There is an ongoing debate about the predictive value of histopathological parameters in oral cancer. In the past decades, the emphasis was on the possible added value of the so-called malignancy grading system. In a retrospective study on 128 previously untreated patients with a T1 or T2 squamous cell carcinoma of the tongue and the floor of the mouth, the value of the classical Broders' grading system and the malignancy grading system were compared with regard to various outcome measures such as regional metastasis, local recurrence and 5-year survival. The results show that neither of the histological grading systems has a strong predictive value and that none is superior to the other.

The status of the deep surgical margins in tongue and floor of mouth squamous cell carcinoma and risk of local recurrence; an analysis of 68 patients.

The objective of this study is to retrospectively assess the clinical relevance, i.c. the event of a local recurrence, in patients surgically treated for tongue and floor of mouth squamous cell carcinoma when tumour cell are observed histopathologically at a distance of less than 0.5 cm. Furthermore, the pattern of invasion and the presence or absence of perineural spread were recorded. A total of 68 patients, surgically treated because of a tongue or floor of mouth squamous cell carcinoma, were examined. Patients in whom any degree of epithelial dysplasia was observed in the mucosal surgical margins had been excluded beforehand. Local recurrence occurred in 2 out of 30 patients with a free surgical margins >0.5 cm and in 3 out of 38 patients with a free surgical margin <0.5 cm, the difference being not statistically significant. Apparently, the presence of tumour cells within a distance of less than 0.5 cm, but not into the deep surgical margin, does not necessarily seem to require additional treatment. The pattern of invasion and the presence or absence of perineural spread were not significantly related with local recurrence either.

The clinical relevance of epithelial dysplasia in the surgical margins of tongue and floor of mouth squamous cell carcinoma: an analysis of 37 patients.

BACKGROUND: The clinical relevance of the presence of epithelial dysplasia in the margins of surgically removed oral squamous cell carcinoma is still unclear. METHOD: In a retrospective study, the presence of mild or moderate epithelial dysplasia in the surgical margins of tongue and floor of mouth squamous cell carcinoma was examined histologically. Patients with tumor cells within 0.5 cm of the surgical margins were excluded. Also patients with severe dysplasia were excluded, as this is usually regarded as carcinoma in situ. Patients that received postoperative irradiation were also excluded. Only patients who completed a follow-up period of five years were included. All together, a total number of 37 patients fulfilled the inclusion criteria. RESULTS: Epithelial dysplasia was observed in 7 out of the 37 patients. Five of these patients, and two of the 30 patients with no dysplasia, had a local recurrence (P < 0.01). CONCLUSION: The presence of mild or moderate epithelial dysplasia in the margins of surgically removed oral squamous cell carcinoma carries a significant risk for the development of local recurrence. However, it should be noted that this study was of a retrospective nature and that the group of patients with epithelial dysplasia in the surgical margins was rather small. On the other hand, the inclusion criteria were somewhat strict, by limiting the oral subsite to tongue/floor of mouth, by excluding patients in whom tumors cell were found within 0.5 cm of the surgical margins and by excluding patients who received postoperative radiotherapy, amongst others.

Desogestrel, a new progestational compound, and the liver.

The short- and long-term effects on the liver of oral contraceptive preparations containing the new progestational compound 13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol (desogestrel) and ethinylestradiol (EE) were studied in multicentre efficacy trials. The following combinations (desogestrel/EE content per daily tablet in micrograms) were investigated: 150/30, 125/50, 100/50 and 75/50, to be taken once daily for 21 days, and a normophasic preparation containing 7 tablets with 50 micrograms EE and 15 tablets containing 125 micrograms desogestrel and 50 micrograms EE. Liver function parameters (SGOT, SGPT, alkaline phosphatase and total bilirubin) were monitored in the serum of 1856 women for periods of up to 36 treatment cycles. The incidence of values (single and combined) above the upper normal limits before treatment was 3.3%. A combination of values above upper normal limits before treatment was observed in 31 women (1.6%). In practically all cases values normalized during treatment; no deterioration was observed. During treatment a combination of values above the upper normal limits was observed in 30 women (having normal pretreatment values); they were distributed over the various preparations and unrelated to the period of contraceptive treatment. The values normalized in the majority of women during the course of treatment. This study shows that with oral contraceptive combinations containing desogestrel and EE (30 or 50 micrograms) liver function is not affected.

PIP: The short and longterm effects on the liver of oral contraceptives (OCs) containing the new progestational compound 13-ethyl-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-ol (desogestrel) and ethinyl estradiol (EE) were studied in multicenter efficacy trials. The following combinations (desogestrel/EE content/daily tablet in mcg) were investigated: 150/30, 125/50, 100/50, and 75/50 to be taken once daily for 21 days and normophasic preparation containing 7 tablets with 50 mcg EE and 15 tablets containing 125 mcg desogestrel and 50 mcg EE. Liver function parameters (SGOT, SGPT, alkaline phosphatase, and total bilirubin) were monitored in the serum of 1856 women for periods of up to 36 treatment cycles. The incidence of values (single and combined) above the upper normal limits before treatment was 3.3%. A combination of values above upper normal limits before treatment was observed in 31 women (1.6%). In practically all cases, values normalized during treatment; no deterioration was observed. During treatment, a combination of values above upper normal limits was seen in 30 women (with normal pretreatment values); these were distributed over the various preparations and unrelated to period of contraceptive treatment. Values normalized in the majority of women during treatment. This study shows that with OCs containing desogestrel and EE (30 or 50 mcg), liver function is not affected. (author's modified)

[Effect of hormonal contraceptives containing 0.05 mg ethinyl estradiol and 0.125 mg desogestrel in normophasic regimen (Oviol)]. / Wirkung eines hormonalen Kontrazeptivum mit 0,05 mg Ethinylestradiol und 0,125 mg Desogestrel in normophasischer Einnahmefolge (Oviol).

This evaluation is based on data obtained from a multicentre trial in which to date 953 women have used the tested oral contraceptive for a total of 15,737 cycles (average 16.5 cycles, maximum 40). The contraceptive is a combination of an estrogen (ethinylestradiol) and a progestogen (desogestrel). It is designed to be used in 28-day cycles: 22 days of tablet-taking followed by 6 tablet-free days during which a withdrawal bleeding may normally be expected to occur. On days 1-7 the dose in 50 micrograms ethinylestradiol, and on days 8-22 it is 50 micrograms ethinylestradiol + 125 micrograms desogestrel. This trial shows the described oral contraceptive to be highly effective. No pregnancies occurred when the tablets were taken as directed: one pregnancy occurred in a cycle in which two tablets were missed and in which there was also an acute bout of gastroenteritis. No serious side effects occurred, and the incidence of minor complaints which arose was lower than during a non-treated control cycle. Cycle regularity was exceptionally good. Withdrawal bleedings occurred in 97.6% of the treated cycles. Spottings occurred in 3%, and breakthrough bleedings in 2.1%. These facts combine to suggest that the tested oral contraceptive is highly effective, safe, and very acceptable.

[Clinical and biochemical results during the treatment with marvelon, a new oral contraceptive (author's transl)]. / Klinische und biochemische Resultate bei der Behandlung mit Marvelon--einem neuen steroidalen Ovulationshemmer.

Marvelon was tolerated without side effects by 338 women during 2,104 cycles. Although some errors of administration were made by patients there were no pregnancies. In contradistinction to other low dosage combination oral contraceptives this new oral contraceptive has a good control of the menstrual cycle. The incidence of clinical side effects was low. An over-suppression syndrome after the discontinuation of the treatment was not observed. Hormonal assays were done in order to investigate the difficult problems of oligomenorrhoea in adolescents with oral contraception. A marked inhibition of ovulation evident by low values of pituitary ovarian hormones was found. When the treatment was discontinued the majority of the patients showed ovulation in the first post-treatment cycle.

PIP: Marvelon was tolerated without side effects by 338 women during 2104 cycles. Although some errors of administration were made by patients, there were no pregnancies. In contradistinction to other low dose oral combination contraceptives (OCs), this new OC has a good control over the menstrual cycle. The incidence of clinical side effects was low. An oversuppression syndrone after the discontinuation of the treatment was not observed. Hormonal assays were done in order to investigate the difficult problems of oligomenorrhea in adolescents with OCs. A marked inhibition of ovulation as evidenced by low values of pituitary ovarian hormones was found. When the treatment was discontinued, the majority of the patients showed ovulation in the 1st posttreatment cycle. (author's)

Clinical trial of an oral contraceptive containing desogestrel and ethinyl estradiol.

A clinical trial involving 1,159 women who used the tested preparation for a total of 15,222 observed cycles showed an oral contraceptive containing 150 micrograms of desogestrel in combination with 30 micrograms of ethinyl estradiol to be highly effective. Desogestrel is a potent progestogen, which, at the doses used for oral contraception, is devoid of any androgenic activity. Cycle control during the trial was good. No serious side effects occurred, and the incidence of minor complaints was lower than during a nontreated control cycle.

Clinical evaluation of a new oral contraceptive, 'Pregnon'.

'Pregnon', a new oral contraceptive containing 1 mg. lynestrenol and 0.05 mg. ethinyl oestradiol, was administered cyclically to 639 women of fertile age over a total of 9,159 cycles. There were no pregnancies. In most cases the withdrawal bleeding resembled normal menstruation. The incidence of metrorrhagia was relatively low and when it did occur it was usually confined to the early treatment cycles and was of very limited duration. The objective and subjective tolerance was excellent.

PIP: Pregnon is a new low-dosage ovulation-inhibiting agent containing 1 mg of lynestrenol and .05 mg of ethinyl estradiol in each tablet. It is also marketed under the name of Pregnon 28 or Ovostat 28 in which each package contains 22 active plus 6 placebo tablets. Data were collected from Belgian clinics and evaluated by the Medical Unit of Organon in Belgium and the Netherlands. During this study, 639 women of fertile age were monitored through 9159 cycles. The maximum period of treatment was 36 cycles. Clinical and gynecological examinations were made before treatment and then every 2 or 3 months. Treatment was begun by taking the 1st tablet on the 1st day of menstruation. After taking 22 tablets there was a 6-day tablet-free interval during which withdrawal bleeding usually occurred. The intensity of the withdrawal bleeding was normal in 57.3%, slight in 41.7%, and heavy in 1%. Spotting was noted in 3.1% of the cycles and breakthrough bleeding occurred in 2.9%. Usually they occurred in the first 3 cycles. Amenorrhea was observed in 2.9% of the cycles. Body weights were relatively unchanged. Blood pressures remained the same. Side effects were headache, nausea, vomiting, breast tenderness, heavy legs, leucorrhea, nervousness, depression, and decreased libido. Only 46 patients discontinued treatment because of these drug effects yielding an acceptability level of about 93%. Since no pregnancies occurred during this study, the Pearl index was 0.