Pertuzumab, trastuzumab and taxane-based treatment for visceral organ metastatic, trastuzumab-naïve breast cancer: real-life practice outcomes.

PURPOSE: In this study, we aimed to describe the real-life practice outcomes of pertuzumab-trastuzumab-taxane (PTT) combination in visceral organ metastatic, trastuzumab-naive breast cancer (BC) patients. METHODS: This study was conducted by Turkish Oncology Group and included 317 patients' data from 36 centers. RESULTS: Median age was 51 (22-82). Median PFS was 28.5 months, while median OS was 40.3 months. Patients with brain metastases (n: 13, 4.1%) had worse PFS (16.8 m vs. 28.5 m; p = 0.002) and OS (26.7 m vs. 40.3 m; p = 0.009). Patients older than 65 years of age (n: 42, 13.2%) had significantly lower OS results (19.8 m vs. 40.3 m; p = 0.01). Two hundred sixty-eight patients (86.7%) received docetaxel while 37 patients (11.7%) received paclitaxel. PFS and OS were similar between taxane groups. In eight patients (2.5%), 5-40% ejection fraction decrement from baseline was detected without any clinical sign of heart failure. CONCLUSIONS: Our RLP trial included only visceral metastatic, trastuzumab-naïve BC patients including cases with brain involvement who received PTT combination in the first-line treatment. Regardless of negative prognostic characteristics, our results are in parallel with pivotal trial. Further strategies for brain metastasis should be developed to improve outcomes despite encouraging results with PTT treatment. Taxane selection can be personalized and endocrine maintenance may further improve outcomes after taxanes were discontinued. To our knowledge, this is the largest scale real-life clinical practice study of pertuzumab-trastuzumab-taxane therapy to date.

Use of ornidazole in fractionated radiotherapy: dose tolerance, serum and tumour tissue concentration.

Sensitizing and neurotoxic effect of ornidazole, was tested in a double-blind randomized study in patients with carcinoma of the cervix and larynx. Ornidazole or placebo were given orally, two times weekly, for 3 weeks. Dose was 2.5 g/m2 for each administration. Total dose given was 15 g/m2. Radiation therapy was given 3 h after the drug administration. Ornidazole was well tolerated in the majority of the patients. No neurotoxic side effects, such as peripheral neuropathy or convulsion, were observed with a total dose of up to 30 g. Dizziness, somnolence and nausea were the prominent acute side effects, seen mostly (70%) in women. In the placebo group this rate was 17% (p less than 0.01). No important side effect was observed in men receiving ornidazole. Serum concentration of ornidazole reached the maximum level in 2-4 h after oral administration and ranged (23 patients) from 65.1 to 139.8 micrograms/ml. Mean half-life was 15.6 +/- 2.8 h. Peak concentration in tumour tissue was achieved 1-3 h after the administration, ranging from 13.0 to 78.0 micrograms/g. Tumour concentration of ornidazole ranged from 14 to 93% of the serum concentration at the time of irradiation.

An educational intervention on promotion of breast feeding complemented by continuing support.

The study, aiming to document the effect of continued support for mothers on frequency of exclusive breast feeding, was carried out by inclusion of breast feeding counselling in the context of well-baby care. One hundred and forty-six mothers who had been exposed to two educational sessions on breast feeding after delivery were given appointments to bring their baby to the paediatric hospital for well-baby care. The mother-infant pairs were followed by the same two residents for 4 months. Mean number of visits was six. A conscious effort was made during all visits to influence the mothers and their close relatives towards exclusive breast feeding. It was observed that in a large proportion of the infants, breast milk was being supplemented with water at the time of the first visit and no further effort was made to change this traditional behaviour. Comparison of the results with a group of mothers who had been exposed to similar educational sessions after delivery but without further support showed a striking increase in frequency of exclusive breast feeding (breast milk and water) in the supported group.

PIP: Researchers enrolled at least 96 primiparous women infant pairs in Instanbul, Turkey into a study intended to examine the effect of continued support of mothers on an educational model to promote exclusive breast feeding. Both the study group and the control group were exposed to the same educational sessions on breast feeding. The mothers received an appointment card during the 1st home visit for a follow up visit at the University Children's Hospital at 2 weeks. The same physician saw the same group of infants monthly for 4 months. The physicians discussed breast feeding and infant feeding with mother for 5-15 minutes. Further they encouraged mothers to telephone or visit whenever a problem occurred. They also suggested bringing a close family member with them, especially the mother in law. Indeed close relatives accompanied mothers on 90% of the visits. The deeply rooted tradition of supplementing breast milk with water manifested itself in 47.9% of the cases at 1 week. Since this was so deeply rooted, the researchers considered breast milk and water as exclusive breast feeding. 85.4% of the study group practiced exclusive breast feeding at 1 month compared to 60.9% for the control group. Even though the percentage of those in the study group who exclusively breast fed was lower at 4 months (60.9%), it was well above the comparable percentage for the control group (5%). Moreover by 4 months only 4.2% of case infants were completely weaned compared to 34.8% of the control infants. These results indicate that continuing support for mothers who breast feed plays an key role in promotion of breast feeding. Further it is preferable if the continuing support comes from the same health worker.

An educational intervention on promotion of breast feeding.

This study was designed to search for an effective method to promote exclusive breast feeding among Turkish city women delivering in hospitals. Four hundred and forty-two primiparae with uncomplicated deliveries and with healthy infants with birthweights of greater than 2500 g were exposed to a group educational session on breast feeding after birth, followed by one repeat session at home. Four hundred and ninety-nine women served as controls. All homes were visited monthly for 6 months by independent observers and data relevant to the feeding of the infants were collected. Weight measurements of 176 infants were taken at age 4 months. The study and control mothers were similar in sociodemographic characteristics which reflected a low socio-economic/educational background but relatively good housing conditions. Although significant differences in frequency of exclusive breast feeding were found between the study and control groups, the impact of the intervention was much lower than our expectations and short-lived. Type of feeding was not related to sex or birthweight of the infant, nor to maternal variables. Weight at age 4 months was within normal limits and similar in the study and control groups. It was concluded that lack of up-to-date information on infant feeding was the main obstacle to breast feeding in urban groups in Turkey, and that the impact of an educational intervention limited to the first week after delivery was lost within the first 2 months.

PIP: Between August 1986-December 1988, researchers enrolled at least 941 primiparous women infant pairs at a social security obstetric hospital in Instanbul, Turkey into a study intended to examine an educational model to promote exclusive breast feeding. Neither changes in hospital routine nor a continuing support program accompanied the short term intervention. Cases watched a video on oral rehydration therapy and domestic hygiene geared toward diarrhea prevention while in the hospital. They also watched a video on breast feeding followed by a discussion on breast feeding. On days 5-7, health students made home visits to discuss breast feeding and left a booklet on breast feeding. The controls only watched the film on diarrhea. Their home visits on days 5-7 centered on domestic hygiene and baby care. Health students visited each subject once a month for 6 months. Most mothers intended to breast feed (83.2%). More educated mothers (88%) originally planned to breast feed their infants than mothers with limited (81.5%) or no education (69.7%; p.01). By the end of the 1st week, only 47.1% of the cases and 12.4% of the controls were exclusively breast feeding. Supplements consisted on nonmilk liquids. Many mothers stated that they did not produce enough milk so they had to supplement. MOreover the number of cases exclusively breast feeding fell dramatically so that by the 3rd month almost no mother infant pairs practiced exclusive breast feeding. Still cases were significantly more likely to breast feed in the 1st 2 months than controls. Despite little change in behavior, most case mothers felt that the educational session influenced them and they learned the breast is best. In conclusion, the main obstacle was insufficient up to date information available to mothers, relatives, and health personnel.