A randomized double blind placebo controlled multicenter study of mesalazine for the prevention of acute radiation enteritis.

BACKGROUND AND PURPOSE: Symptoms of acute radiation enteritis (ARE), dominated by diarrhea, occur in more than 70% of patients receiving pelvic irradiation. Eicosanoids and free radicals release have been implicated in the pathogenesis. Mesalazine (5-ASA) is a potent inhibitor of their synthesis in the mucosa and could therefore be of some interest in preventing ARE. PATIENTS AND METHODS: The study was performed in six radiotherapy units in France who agreed on standardized irradiation procedures. One hundred and fifty-three patients planned for external beam radiotherapy to the pelvis > or = 45 Gy for prostate (n = 97) or uterus (n = 54) cancer were randomized on a double blind basis to receive prophylactic 5-ASA (4 g/day Pentasa) or placebo. Patients with concomitant chemotherapy were excluded. Prostate and uterus cancers were chosen since these centropelvic tumors require a similar radiotherapy protocol during the first step of treatment and involve a comparable volume of small intestine. The symptoms of ARE and their severity were assessed every week during irradiation, and 1 and 3 months after its end. All patients followed a low fiber and low lactose diet. End points were diarrhea, use of antidiarrheal agents, abdominal pain, and body weight. Effficacy was evaluated using intention to treat. RESULTS: (means +/- SD) Groups did not differ for age (mean 64 +/- 9 years), sex, tumor site, or irradiation procedure. During irradiation, diarrhea occurred in 69% and 66% of the 5-ASA and placebo groups, respectively (chi2, P = 0.22). Curves of survival without diarrhea did not differ between groups (logrank P = 0.09). Severity of diarrhea did not differ between groups except at d15 where it was significantly more severe in the 5-ASA group (ANOVA P = 0.006). Duration of diarrhea did not differ (22 +/- 15 days in both groups, P = 0.88). Abdominal pain was less frequently reported in the 5-ASA group at d28 (34% vs. 51%, P = 0.048). Use of antidiarrheal agents and body weight did not differ between groups. CONCLUSION: Mesalazine 4 g/day did not decrease the symptoms of ARE.

Ductal carcinoma in situ of the male breast. Analysis of 31 cases.

From 1970 to 1992, 31 pure ductal carcinoma in situ (DCIS) of the male breast treated in 19 French Regional Cancer Centres were reviewed. They represent 5% of all breast cancers treated in men in the same period. The median age was 58 years, but 6 patients were younger than 40 years. TNM classification (UICC, 1978) showed 12 T0 (discovered only by bloody nipple discharge), 10 T1, 5 T2 and four unclassified tumours (Tx). 11 patients (35.5%) had clinical gynecomastia, and three (10%) had a family history of breast cancer. 6 patients underwent lumpectomy, and 25 mastectomy. Axillary dissection was performed in 19 cases. 6 cases received postoperative irradiation. 15 out of 31 lesions were of the papillary subtype, pure or associated with a cribriform component. The size of the 12 measured lesions varied from 3 to 45 mm. All lymph nodes sampled were negative. With a median follow-up of 83 months, 4 patients (13%) presented a local relapse (LR), respectively, at 12, 27, 36 and 55 months. 3 of these patients had been initially treated by lumpectomy. In one case LR was still in situ, but already infiltrating in the 3 others. Radical salvage surgery was performed in 3 cases, but one patient developed metastases and died 30 months later. The last patient was treated by multiple local excisions and tamoxifen. One 43-year-old patient developed a contralateral DCIS and three others developed a metachronous cancer. The aetiology and risk factors of male breast cancer remain unknown. Gynecomastia, which implies an imbalance between androgen and oestrogen, may be a predisposing factor. As in women, DCIS in the male breast has a good prognosis. Total mastectomy without axillary dissection is the basic treatment. Frequently, the first symptom is a bloody nipple discharge. The age of occurrence is younger than for infiltrating carcinoma, suggesting that DCIS is the first step in the development of breast cancer.

[Results of postoperative cervical node irradiation in carcinoma of the pharyngo-larynx. A study of the cooperative group of radiotherapists]. / Résultats de l'irradiation ganglionnaire cervicale postopératoire dans les carcinomes du pharyngolarynx. Etude du groupe coopérateur des radiothérapeutes de centre.

From 1981 to 1985, 428 patients presenting with an epidermoid carcinoma of the hypopharynx and/or larynx were treated with a curative intent by surgical resection and postoperative irradiation. Two-thirds of the tumours were T3 and 60% of patients presented with a clinical node involvement. The rates of local failure were 8%, 18% and 13%, respectively, for cancers of the larynx, of the piriform sinus and of the posterior wall; the rates of regional failure were 8%, 23% and 13%, respectively. There is no head and neck site with either a high or low risk of recurrence after resection, but the capsular rupture remains a factor of poor prognosis. The survival rate at 5 years of the whole series is 38%, for laryngeal localisation it reaches 62%. The risk of metastases is related to the node involvement and the interval between surgery and irradiation.

[Cancer of the breast in men. 106 cases]. / Cancer du sein chez l'homme. 106 observations.

In a retrospective and multicentre study 106 cases treated from 1970 to 1985 were analysed. The patients' median age was 64 years. TNM classification showed 20 T1, 48 T2, 2 T3, 32 T4 and 4 Tx. Twenty one patients had clinical gynaecomastia; 99 underwent surgery and 85 radiotherapy; 32 received adjuvant chemotherapy or hormonal therapy. The main histological type was ductal infiltrating carcinoma; 82 axillary dissections were performed, and positive lymph nodes were found in 67 percent of the cases. Hormone receptors were positive in 15 out of 20 measured cases. Five and 10 years overall survival rates (Kaplan-Meier) were 57 and 37 percent, and corrected survival rates 68 and 55 percent respectively. The main prognostic factor remains the clinical size of the tumour (T) and histologically axillary node status (pN). Eleven patients developed a second metachronous cancer. The aetiology of male breast cancer is a poorly known as that of female breast cancer. Nevertheless, imbalance among oestrogens and androgens due to metabolic, infectious or pharmacological causes is probably responsible, at least in part, for this cancer. An on-going multicentre prospective national trial tries to address this question.

Tangier disease apolipoprotein A-I compared with normal plasma A-I using monoclonal antibodies.

The molecular defect in Tangier disease is unknown. We have compared the electrophoretic and immunoreactive properties of Tangier disease and normal apolipoprotein A-I using four monoclonal antibodies. We verified that the molecular weight, pI and CNBr-cleaved fragments of Tangier disease and normal apolipoprotein A-I were not different, excluding the possibility that dimers, aggregates or fragments of apolipoprotein A-I could be responsible for its rapid catabolism in this disease.

[Cerebral irradiation as adjuvant therapy in the treatment of small cell carcinoma of the lung (author's transl)]. / Intérét de l'irradiation cérébrale adjuvante dans le traitement des cancers pulmonaires a petites cellules.

The authors present the results of a non randomized study of 33 patients suffering from small cell carcinoma of the lung. After a similar course of monthly chemo-therapy (Endoxan Oncovin, Natulan, CCNU) and mediastinal irradiation in a dose of 30 grays in 10 fractions over two weeks, 14 patients were given adjuvant cerebral irradiation, the 19 others made up the control group (30 grays to the brain overall in 10 fractions over two weeks). With a minimum follow up for 12 months, 42% of the control group had evidence of cerebral secondaries, as opposed to none in the irradiated group with any neurological signs whatsoever. The indisputable efficacy of adjuvant cerebral irradiation contrasts with the absence of any significant improvement in survival time : 2 patients are alive and in complete remission, 1 in each group, while the mean survival was 12.3 and 11.7 months respectively. This is explained by the continued occurrence of extra-cerebral metastatic deposits such as the liver or mediastinum where the efficacy of systemic therapy remains uncertain. The therapeutic approach is currently orientated in two directions : - to raise the dose delivered to the mediastinum even if it appears radiologically normal. - to continue research into new chemo-therapeutic combinations more specifically active at the hepatic level.