Jeffrey F. Hines

Asian-Pacific Islander race independently predicts poor outcome in patients with endometrial cancer☆

OBJECTIVE The Department of Defense health care system provides access to care without respect to age, race, or socioeconomic status. We sought to determine the effect of race as a predictor of survival in patients with endometrial cancer treated in the Department of Defense medical system. METHODS Information on patients with endometrial carcinoma was extracted from the Department of Defense centralized tumor registry for the period 1988 to 1995. Data included age at diagnosis, military status, race, tumor histology, grade, FIGO surgical stage, adjuvant therapies, and disease-free survival. The chi(2) test was used for analysis of prognostic factors and adjuvant treatments between racial groups. Actuarial survival curves were calculated by using the method of Kaplan and Meier and compared by the log-rank test. Variables found to be significant on univariate analysis (P < 0.05) were entered into a multivariate Cox regression analysis. RESULTS Of 1811 patients meeting criteria for the study, racial distribution was 90% Caucasian, 4.4% African-American, and 5.5% Asian-Pacific Islander. African-Americans had more advanced stages of disease compared to Caucasians (P < 0.001). Both African-Americans and Asian-Pacific Islanders had higher grade tumors and less favorable histologic types than Caucasians (P < 0.05). The extent of adjuvant therapies was similar for racial groups. African-Americans and Asian-Pacific Islanders had significantly worse 5-year disease-free survivals than Caucasians (P = 0.007). Additional poor prognostic factors included age >60 years, grade, unfavorable histology, and stage. On multivariate analysis age >60 years, stage, and Asian-Pacific Islander race remained significant prognostic factors. CONCLUSION African-Americans and Asian-Pacific Islanders had worse survivals than Caucasians. After controlling for imbalances in clinicopathologic factors, Asian-Pacific Islander race was found to be a newly identified poor prognostic factor.

Pure primary osteosarcoma of the ovary presenting as an extensively calcified adnexal mass: A case report and review of the literature

A case of primary ovarian osteosarcoma is reported with a review of the literature. A perimenopausal woman presented with a calcific adnexal mass seen on abdominal radiography, surgical exploration revealed no gross evidence of metastatic disease. Adjuvant chemotherapy was administered due to the reported aggressiveness of this rare tumor. Following eight courses of cisplatin-doxorubicin combination chemotherapy, the patient is without evidence of disease. A differential diagnosis for extensively calcified adnexal masses is provided. Additionally, a rationale for adjuvant chemotherapy is discussed.

A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube

OBJECTIVE To determine the safety and efficacy of the novel combination of docetaxel, oxaliplatin, and bevacizumab as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube after initial debulking surgery. METHODS Eligible patients (stage IB-IV) were treated with 6 cycles of oxaliplatin (85 mg/m(2)), docetaxel (75 mg/m(2)), and bevacizumab (15 mg/kg) every 3 weeks, followed by single-agent bevacizumab 15 mg/kg every 3 weeks to complete one year of therapy. The primary endpoint was 12-month progression-free survival (PFS). RESULTS A total of 132 patients (80 with measurable disease at baseline; 52 with non-measurable, evaluable disease at baseline) enrolled and received study treatment. At diagnosis, 76.5% of patients had stage III disease and 20% had stage IV. 62.9% were optimally cytoreduced. The most common grade 3/4 adverse events were neutropenia (42.4%), leukopenia (13.6%), hypertension (8.3%), fatigue (6.1%), and nausea (6.1%). One patient (0.8%) had a fatal gastrointestinal perforation. The best overall confirmed response rate (complete response+partial response [measurable disease subgroup]) was 58.6% (95% CI 49%, 67%). CA-125 response rates for the measurable and non-measurable disease subgroups were 83.0% and 81.5%, respectively. The 12-month PFS rate for the measurable disease subgroup was 65.7% (95% CI 53.4%, 76.7%); median PFS was 16.3 (95% CI 12.6, 19.6) months. Median overall survival was 47.3 (95% CI 34.1, upper limit not applicable) months. CONCLUSIONS This novel treatment regimen may provide a promising therapeutic approach for women with ovarian, primary peritoneal, or fallopian tube carcinoma. No unanticipated safety concerns were identified.

Phase III trial of induction gemcitabine or paclitaxel plus carboplatin followed by paclitaxel consolidation in ovarian cancer

OBJECTIVE The safety and efficacy of gemcitabine plus carboplatin (GC) or paclitaxel plus carboplatin (TC) induction regimens with or without paclitaxel consolidation therapy were assessed in ovarian cancer (OC). METHODS Patients with stage IC-IV OC were randomized to either GC (gemcitabine 1,000 mg/m(2), days 1 and 8, plus carboplatin area under the curve [AUC] 5, day 1) or TC (paclitaxel 175 mg/m(2) plus carboplatin AUC 6, day 1) every 21 days for up to six cycles. Patients with complete response (CR) were allowed optional consolidation with paclitaxel 135 mg/m(2) every 28 days for ≤ 12 months. Patients without CR received single-agent crossover therapy at induction doses/schedules until CR, disease progression (PD), or unacceptable toxicity. PD or death in 636 patients was required to compare induction arms with 80% statistical power for progression-free survival (PFS), the primary endpoint. RESULTS Randomized induction therapy was received by 820 of 919 patients enrolled; 352 patients with CR received paclitaxel consolidation whereas 155 patients without CR received single-agent crossover therapy. PFS was similar for GC and TC (median, 20.0 and 22.2 months, respectively; P=.199). Despite high censoring rates (>52%), overall survival was longer for TC (median, 57.3 versus 43.8 months for GC; P=.013). Controlling for patient characteristics including performance status, residual tumor size, and tumor stage, there was no statistical difference in a multivariate analysis (HR=1.22; 95% CI=0.99-1.52; P=.067). CONCLUSIONS GC does not improve PFS over TC as first-line induction chemotherapy in OC. Although favoring TC, overall survival analyses were limited by the study design and high censoring rates.

Comparative assessment of hypercoagulability in women with and without gynecologic malignancies using the thromboelastograph coagulation analyzer

The hypercoagulability status of women with and without gynecologic malignancies was compared using the thromboelastograph coagulation analyzer. Blood specimens from 25 women with newly diagnosed gynecologic malignancies and from 21 age-matched controls were analyzed. Hypercoagulability is defined by a short R value (min), a short K value (min), an elevated maximum amplitude (MA) value (mm), and a broad α-angle (°). A two-tailed, two-sample t-test was used for statistical analysis. When compared with specimens from age-matched controls, specimens from women with gynecologic malignancies demonstrated values consistent with hypercoagulability. The specific parameters are presented as a mean (± SD). Patients with gynecologic malignancies were found to have a short R value (7.1 ± 2.1 vs. 11.8 ± 1.8 min; P < 0.001), a short K value (3.1 ± 0.9 vs. 4.6 ± 0.9 min; P < 0.001), a prolonged MA value (64.7 ± 5.4 vs. 58.8 ± 6.1 mm; P = 0.001), and a greater α-angle (70.6 ± 5.3 vs. 61.6 ± 4.9°; P < 0.001). Detection of hypercoagulability as measured by thromboelastography is statistically more common among women with gynecologic malignancies compared with age-matched controls. Future studies may address the use of thromboelastography to identify patients at risk for gynecologic malignancies.