Biweekly gemcitabine and cisplatin in platinum-resistant/refractory, paclitaxel-pretreated, ovarian and peritoneal carcinoma.

OBJECTIVES: Synergism between gemcitabine and cisplatin is supported by preclinical and clinical data. The present study explores the efficacy of a biweekly regimen in platinum-resistant/refractory, paclitaxel-pretreated ovarian and peritoneal cancer. METHODS: 50 paclitaxel-pretreated patients with platinum-resistant/refractory ovarian or peritoneal carcinoma who had previously received paclitaxel chemotherapy, were treated with six cycles of gemcitabine 1000 mg/m(2) followed by cisplatin 40 mg/m(2) on days 1 and 15, repeated every 4 weeks. RESULTS: The median platinum-free interval (PFI) was 4 months while the median number of previous treatment lines was 2. Chemotherapy was well tolerated. Objective responses were observed in 31.5% of evaluable patients (n=35). CA125 response was observed in 68% of patients with elevated CA125 (n=41). Median overall survival (OS) was 13.2 months (95% Confidence Interval, CI: 10.2-16.2) while progression-free survival (PFS) was 4.9 months (95%CI: 3.5-6.4). A PFI of less than 3 months was associated with lower objective response rates (15.8% versus 50%, p=0.03). CONCLUSIONS: Biweekly gemcitabine and cisplatin is feasible for patients with platinum-resistant ovarian or peritoneal cancer and is associated with a favorable toxicity profile. In a population with recent exposure to platinum, a PFI of less than 3 months was the major factor influencing response to chemotherapy.

Young age is associated with favorable characteristics but is not an independent prognostic factor in patients with epithelial ovarian cancer: a single institution experience.

BACKGROUND: Young age has been reported to be a favorable prognostic factor in ovarian cancer. The aim of the present study was to investigate the characteristics of ovarian cancer presenting in patients aged < or =40 and assess the prognostic significance of young age. METHODS: Data from 591 consecutive ovarian cancer patients, including 37 subjects (6.3%) aged < or =40, who were treated postoperatively with platinum-based chemotherapy in our institution were retrospectively reviewed. RESULTS: In our series, age < or =40 did not show an independent association with overall (p = 0.542) or progression-free survival (p = 0.334). Nonetheless, it was correlated with low tumor grade (p = 0.009) and small volume of residual disease after primary surgery (p = 0.020), while there was a nonsignificant trend for correlation with performance status 0 (p = 0.052). Stratified analysis showed that age < or =40 was associated with improved overall survival in the subgroups of serous histology and stage IIC-IV disease; however, multivariate analyses failed to identify age as an independent predictor of survival within either subgroup (p = 0.079 and p = 0.585, respectively). CONCLUSIONS: Age < or =40 was not an independent prognostic factor in our analysis. The survival advantage of young patients may be attributed to the association with low tumor grade, more complete surgical debulking and better performance status.

Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors.

PURPOSE: Osteonecrosis of the jaw (ONJ) has been associated recently with the use of pamidronate and zoledronic acid. We studied the incidence, characteristics, and risk factors for the development of ONJ among patients treated with bisphosphonates for bone metastases. PATIENTS AND METHODS: ONJ was assessed prospectively since July 2003. The first bisphosphonate treatment among patients with ONJ was administered in 1997. Two hundred fifty-two patients who received bisphosphonates since January 1997 were included in this analysis. RESULTS: Seventeen patients (6.7%) developed ONJ: 11 of 111 (9.9%) with multiple myeloma, two of 70 (2.9%) with breast cancer, three of 46 (6.5%) with prostate cancer, and one of 25 (4%) with other neoplasms (P = .289). The median number of treatment cycles and time of exposure to bisphosphonates were 35 infusions and 39.3 months for patients with ONJ compared with 15 infusions (P < .001) and 19 months (P = .001), respectively, for patients with no ONJ. The incidence of ONJ increased with time to exposure from 1.5% among patients treated for 4 to 12 months to 7.7% for treatment of 37 to 48 months. The cumulative hazard was significantly higher with zoledronic acid compared with pamidronate alone or pamidronate and zoledronic acid sequentially (P < .001). All but two patients with ONJ had a history of dental procedures within the last year or use of dentures. CONCLUSION: The use of bisphosphonates seems to be associated with the development of ONJ. Length of exposure seems to be the most important risk factor for this complication. The type of bisphosphonate may play a role and previous dental procedures may be a precipitating factor.