MMR vaccine in the postpartum does not expose seronegative women to untoward effects.

Contesto : Lo scopo di questo studio è stato quello di valutare se la vaccinazione rosolia immediatamente dopo il parto potrebbe esporre le donne sieronegative per effetti indesiderati specifici.Metodi : 163 donne rosolia-sieronegativi hanno ricevuto il vaccino MMR nel periodo post-partum; sono stati valutati a 1 mese a 3 mesi successivi attraverso interviste telefoniche. Come controlli, abbiamo confrontato 163 donne rosolia-sieropositivi, che potrebbe avere sintomi simili per qualsiasi motivo, nello stesso arco di tempo.Risultati : A un mese di follow-up, 161 donne nel gruppo dei casi e 162 controlli hanno risposto alla nostra intervista telefonica; alle tre mesi di follow-up, 154 casi e 159 controlli. Eruzione cutanea, faringite, artralgia, linfoadenopatia cervicale, mialgia e parestesia sono state le lamentele più frequentemente riportati in entrambi i gruppi. Una differenza statisticamente significativa nella frequenza di linfoadenopatia cervicale e rash cutaneo a un mese (p = 0.028 ep = 0.005, rispettivamente) è stata osservata tra i casi ei controlli; Tuttavia, nessuna differenza significativa è stata ancora osservata nella frequenza delle manifestazioni muscoloscheletriche acute e croniche a tre mesi.Conclusioni : Non sono sostanziali differenze sono stati segnalati tra casi e controlli per quanto riguarda la frequenza di artralgia e conseguente mialgia al MMR vaccinazione in post-partum . Postpartum rosolia la vaccinazione è sicura e consigliabile in caso di necessità per evitare la circolazione del virus e la sindrome da rosolia congenita

Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study

Aims: To explore the cardiac safety of adjuvant Non-Pegylated Liposomal Doxorubicin (NPL-DOX) plus Cyclophosphamide (CTX) followed by weekly Paclitaxel, in elderly women (≥ 65 years) with high-risk breast cancer. Previously, we described no symptomatic cardiac events within the first 12 months from starting treatment. We now reported the updated results after a median follow-up 76 months. Methods: The cardiac activity was evaluated with left ventricular ejection fraction (LVEF) echocardiograms assessments, before starting chemotherapy and every 6 months, until 30 months from baseline, then yearly for at least 5 years. Results: Forty-seven women were recruited by two Units of Medical Oncology (Ethics Committee authorization CESM-AOUP, 3203/2011; EudraCT identification number: 2010-024067-41, for Pisa and Pontedera Hospitals). An episode of grade 3 CHF (NCI-CTCAE, version 3.0) occurred after 18 months the beginning of chemotherapy. The echocardiograms assessments were performed comparing the LVEF values of each patient evaluated at fixed period of time, compared to baseline. We observed a slight changed in terms of mean values at 48, 60, 72 and 84 months. At these time points, a statistically significant reduction of - 3.2%, - 4.6%, - 6.4% and - 7.1%, respectively, was observed. However, LVEF remained above 50% without translation in any relevant clinical signs. No other cardiac significant episodes were reported. To this analysis, in 13 patients (28%) occurred disease relapse and,  of them, 11 (23%) died due to metastatic disease. Eight patients died of cancer-unrelated causes. Conclusions: The combination including NPL-DOX in elderly patients revealed low rate of cardiac toxic effects. Comparative trials are encouraged

Cardiac safety of adjuvant non-pegylated liposomal doxorubicin combined with cyclophosphamide and followed by paclitaxel in older breast cancer patients

Purpose To investigate the cardiac safety of adjuvant Non-Pegylated Liposomal Doxorubicin (NPL-DOX) combined to Cyclophosphamide (CTX) and followed by weekly Paclitaxel, in older patients (≥65 years) with diagnosis of high risk breast cancer. The main end point of this prospective study was the detection of early episodes of symptomatic congestive heart failure (CHF). Methods The cardiac function was evaluated by left ventricular ejection fraction (LVEF) measurements with repeated echocardiograms, performed 2 weeks before the beginning of chemotherapy and every 6 months, until 30 months after the study entry; then yearly for at least 5 years. Results Forty-seven patients were enrolled from two Italian Divisions of Medical Oncology. Final results revealed no early episodes of symptomatic CHF within the first 12 months from the enrolment. Only two cardiac events were observed: an episode of atrial flutter after the first cycle of NPL-DOX and CTX, with a quick return to normal rhythm, and a grade 3 (scored to NCI-CTCAE, version 3.0) CHF episode, 18 months later chemotherapy start. No other relevant toxicities were reported. Conclusions This adjuvant combination including NPL-DOX in elderly patients, resulted in a low rate of cardiac toxic effects. Comparative trials should be encouraged to confirm these finding