Cisplatin plus gemcitabine on days 1 and 4 every 21 days for solid tumors: result of a dose-intensity study.

BACKGROUND: Three and 4-week cisplatin-gemcitabine schedules have shown similar dose-intensity (DI) and activity in non-small-cell lung cancer (NSCLC). The 3-week schedule is generally preferred because it enables better treatment compliance. To improve DI and compliance further, we delivered gemcitabine plus cisplatin over 4 days every 21 days. METHODS: Patients with any stage NSCLC or epithelial neoplasms and an ECOG PS < or = 2 were given gemcitabine 1000 mg/m(2) on days 1 and 4 plus cisplatin 70 mg/m(2) on day 2 of a 21-day cycle. Minimax design was used and a received DI for gemcitabine of > or = 580 mg/m(2)/wk was considered successful. RESULTS: Thirty-nine patients (34 NSCLC, 5 epithelial neoplasias) were enrolled. SWOG grade 3-4 neutropenia and thrombocytopenia were observed in 17.9% and 12.8% of patients, respectively. Nonhematological toxicity was minimal. Twenty-eight (18%) of 158 cycles required dose modifications and/or delays. Twenty-five patients received a gemcitabine dose intensity of > or = 580 mg/m(2)/wk. The received DIs were 601.8 mg/m(2)/wk for gemcitabine and 21.0 for cisplatin, with a relative DIs of 90.3% and 90.1%, respectively. The response rate of 27 evaluable patients with NSCLC was 44% (95% confidence interval [CI], 25.3 to 62.7%). CONCLUSIONS: The shorter schedule of gemcitabine on days 1 and 4 plus cisplatin on day 2 produces an effective DI and a toxicity profile comparable to that of weekly regimens.

Endometrial evaluation with transvaginal ultrasound during hormone therapy: a prospective multicenter study.

OBJECTIVE: To assess the value of endometrial thickness as a marker of endometrial abnormality risk during hormone therapy (HT) and to study the correlation between abnormal bleeding and abnormal endometrial histology in patients with thick endometrium. DESIGN: Prospective multicenter study. SETTING: University and general hospitals outpatient centers. PATIENT(S): Postmenopausal women (702) on HT. INTERVENTION(S): Biendometrial thickness was measured by transvaginal sonography (TVS) between day 5 and day 10 after the last P intake and, when present, after the end of the menstrual-like bleeding. MAIN OUTCOME MEASURE(S): Hysteroscopy and biopsy were performed within 5 days from TVS on all patients with an endometrial thickness >4.5 mm (precision scale 0.5 mm). RESULT(S): Endometrial thickness >4.5 mm was observed in 20.5% of patients. One hundred sixteen hysteroscopies and biopsies were performed. Hyperplasia, polyps, and endocavitary fibroids were detected in 15%, 24%, and 8% of cases, respectively. The positive predictive value of TVS examination was 47%. Endometrial thickness was the only variable significantly and independently associated with histologic abnormalities and endocavitary fibroids. Abnormal bleeding occurred in 17.1% of patients. Among 17 patients detected with thick endometrium and hyperplasia, 8 cases showed abnormal bleeding. CONCLUSION(S): Sonographic endometrial thickness of 4.5 mm provides a sensitive tool to select HT patients who might benefit from hysteroscopy and biopsy. Abnormal bleeding is not a sensitive sign of hyperplasia in patients with thick endometrium.