5011 Background: Paclitaxel in combination with carboplatin is effective salvage therapy for the treatment of recurrent ovarian cancer. The purpose of this study was to evaluate the antitumor activity of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal carcinoma. Methods: Patients with measurable disease received nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 of each 28-day cycle and carboplatin AUC 5 intravenously on day 1. Patients were to be treated for at least 6 cycles. Efficacy was measured by objective response rate (ORR) per RECIST, progression-free survival (PFS), and overall survival (OS). Patients were followed every 3 months for 2 years. Results: Forty eligible patients with median age of 62 years (range 43 - 81) were enrolled; 28 patients had ovarian cancer stage IIIC, 9 had stage IIB/IIIB or IIC, and 3 had stage IV disease. Most were Caucasian (83%), most had ECOG status of 0 (88%), and all had received prior taxane/platinum chemotherapies. The median (standard deviation [STDV]) platinum-free interval was 13 (8) months. The median number of cycles with nab-paclitaxel plus carboplatin was 6 (range 3-48). Of 38 patients who were evaluable (2 did not receive treatment), 15 (39%) had a complete response (CR), 15 (39%) had a partial response (PR) for an ORR of 79%. Seven (18%) patients had stable disease (SD), 1 (3%) patient had disease progression (PD). The median (STDV) PFS was 13 (11) months and median (STDV) OS was 30 (13) months. The most common grade ≥ 3 adverse events were neutropenia (43%), fatigue (33%), hypersensitivity reaction to carboplatin (18%), anemia (10%), thrombocytopenia (5%), and nausea (5%). Of the 40 patients enrolled, 11 patients have completed 2 years of follow-up, 15 patients have died, 13 patients are still being followed, and 1 patient is still receiving treatment after more than 2 years. Conclusions: With a 97% disease control rate (CR + PR + SD), the combination of nab-paclitaxel plus carboplatin had significant antitumor activity and was reasonably tolerated in patients with platinum-sensitive recurrent ovarian cancer. No significant financial relationships to disclose.
With the advent of minimally invasive laparoscopic techniques, most gynecologic procedures for benign conditions can be performed in an outpatient setting. However, the role of such techniques in gynecologic oncology is not well defined. By reviewing the literature and presenting some new data, we attempt to elucidate the applications of operative videolaparoscopy in gynecologic oncology. Advanced laparoscopic techniques are utilized for the management of cervical cancer as well as the staging and treatment of endometrial and ovarian cancers. Such techniques are used in performing radical hysterectomy for early stage cervical cancer, pelvic and paraaortic lymphadenectomy, and second look laparoscopy following chemotherapy for ovarian cancer. Even though preliminary data are encouraging, large prospective controlled studies with long-term follow-up are necessary to better define the role and limitations of laparoscopy in the treatment of gynecologic malignancies.
We report the first case of a laparoscopic radical hysterectomy and paraaortic and pelvic lymphadenectomy to treat a stage IA2 carcinoma of the cervix. To our knowledge, a laparoscopic radical hysterectomy with laparoscopic paraaortic lymphadenectomy has not been previously described.