M. Ludovisi

Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Progressive or Recurrent Ovarian Cancer

PURPOSE We aimed at investigating the efficacy, tolerability, and quality of life (QOL) of gemcitabine (GEM) compared with pegylated liposomal doxorubicin (PLD) in the salvage treatment of recurrent ovarian cancer. PATIENTS AND METHODS A phase III randomized multicenter trial was planned to compare GEM (1,000 mg/m(2) on days 1, 8, and 15 every 28 days) with PLD (40 mg/m(2) every 28 days) in ovarian cancer patients who experienced treatment failure with only one platinum/paclitaxel regimen and who experienced recurrence or progression within 12 months after completion of primary treatment. RESULTS One hundred fifty-three patients were randomly assigned to PLD (n = 76) or GEM (n = 77). Treatment arms were well balanced for clinicopathologic characteristics. Grade 3 or 4 neutropenia was more frequent in GEM-treated patients versus PLD-treated patients (P = .007). Grade 3 or 4 palmar-plantar erythrodysesthesia was documented in a higher proportion of PLD patients (6%) versus GEM patients (0%; P = .061). The overall response rate was 16% in the PLD arm compared with 29% in the GEM arm (P = .056). No statistically significant difference in time to progression (TTP) curves according to treatment allocation was documented (P = .411). However, a trend for more favorable overall survival was documented in the PLD arm compared with the GEM arm, although the P value was of borderline statistical significance (P = .048). Statistically significantly higher global QOL scores were found in PLD-treated patients at the first and second postbaseline QOL assessments. CONCLUSION GEM does not provide an advantage compared with PLD in terms of TTP in ovarian cancer patients who experience recurrence within 12 months after primary treatment but should be considered in the spectrum of drugs to be possibly used in the salvage setting.

Preoperative local staging of endometrial cancer: transvaginal sonography vs. magnetic resonance imaging.

To compare the accuracy of transvaginal sonography (TVS) and magnetic resonance imaging (MRI) in the preoperative staging of endometrial carcinoma.

Phase II study of liposomal doxorubicin and gemcitabine in the salvage treatment of ovarian cancer

In total, 70 patients were enrolled into this phase II study, to evaluate the activity of the pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) combination in recurrent ovarian cancer patients. PLD, 30 mg m−2, was administered on day 1 by 60′ i.v. infusion, followed by GEM, 1000 mg m−2, given by 30′ i.v. on days 1 and 8; cycles were repeated every 21 days. In all, 67 patients are so far evaluable for response. Seven complete responses (10.4%, 95% CI: 3.1–17.7), 16 partial responses (23.9%, 95% CI: 13.7–34.1), 26 disease stabilisations (38.8%, 95% CI: 27.1–50.5) and 18 progressions (26.9%, 95% CI: 16.3–37.5) have been registered. Within the resistant population (n=36), the response rate was 25% (95% CI: 10.9–39.1). Within the group of platinum-sensitive patients (n=31), the response rate was 45.2% (95% CI: 27.7–62.7). A total of 443 courses are evaluable for toxicity. Grade 3–4 hematological toxicity was registered in 30 patients (42.8%), mainly represented by neutropenia (35.6%); palmar-plantar erythrodysesthesia affected 24 patients (34.2%), but it was of grade 3 in only seven of them (10%).

Sonographic features of decidualized ovarian endometriosis suspicious for malignancy

The discovery of an ovarian mass during pregnancy is often a difficult issue because of the risk related to surgical intervention during pregnancy. Moreover, ultrasound examination is often unable to provide a definitive diagnosis. A case of decidualized ovarian endometriosis is presented to highlight the challenges in this diagnosis. We report the transvaginal ultrasound findings, including color Doppler examination, magnetic resonance characteristics and tumor marker longitudinal evaluation during the first trimester of pregnancy, as well as the final histological characteristics of the lesion. Decidualization is a rare occurrence in ovarian endometriosis and must be differentiated from malignant transformation. Copyright

Imaging in gynecological disease (1): ultrasound features of metastases in the ovaries differ depending on the origin of the primary tumor

To describe the gray‐scale and color Doppler ultrasound findings of metastatic tumors in the ovary according to the origin of the primary tumor.

Transvaginal ultrasonography and magnetic resonance imaging for assessment of presence, size and extent of invasive cervical cancer

To prospectively assess the diagnostic performance of transvaginal ultrasound and magnetic resonance imaging (MRI), using histology as the gold standard, with regard to the presence, size, and extent of invasive cervical cancers and the detection of metastatic lymph nodes.

Does quantitative analysis of three-dimensional power Doppler angiography have a role in the diagnosis of malignant pelvic solid tumors? A preliminary study

To investigate the role of a simplified method for the three‐dimensional (3D) quantification of tumor vascularity in the differential diagnosis of solid pelvic masses.

Ovarian cancer arising in endometrioid cysts: ultrasound findings

To describe sonographic characteristics of malignant transformation in endometrioid cysts.

Evaluation of pemetrexed (Alimta, LY231514) as second-line chemotherapy in persistent or recurrent carcinoma of the cervix: the CERVIX 1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) Group

BACKGROUND The objective of the study was to estimate the antitumor activity of pemetrexed in patients with advanced/recurrent carcinoma of the cervix and to determine the nature and degree of toxicity. METHODS A multicenter phase II trial was conducted by the Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group. Patients with advanced/recurrent measurable carcinoma of the cervix that had failed one prior chemotherapy regimen in association or not with radiotherapy were treated with pemetrexed at a dose of 500 mg/m(2) every 21 days. All the patients had a measurable lesion according to RECIST criteria in a not previously irradiated field. RESULTS From November 2006 to September 2008, 43 patients were entered by seven member institutions of the MITO-Group. A total of 164 cycles (median 2, range 1-9) were administered. The treatment was well tolerated. More serious toxic effects (grades 3 and 4) included leukopenia in 27.9% and neutropenia in 30.2% of patients. No treatment-related deaths were reported. Six patients (13.9%) had partial responses (at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) with a median response of 7 weeks (range 3-27). Twenty-three patients (53.4%) had stable disease (less than a 50% reduction and less than a 25% increase in the sum of the products of two perpendicular diameters of all measured lesions and the appearance of no new lesions) and fourteen (32.5%) patients had progressive disease. Median progression-free survival was 10 weeks and overall survival was 35 weeks. CONCLUSION Pemetrexed showed moderate activity against advanced/recurrent cervical cancer that had failed prior chemotherapy.

Ultrasound evaluation of intra‐abdominal sites of disease to predict likelihood of suboptimal cytoreduction in advanced ovarian cancer: a prospective study

To analyze in advanced ovarian cancer patients the ability of ultrasound to evaluate the extent of intra‐abdominal disease and to predict the likelihood of suboptimal cytoreduction.