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ABSTRACT: Trials have demonstrated improvements in survival with adding paclitaxel (P) or topotecan (T) to cisplatin (C) for the treatment of advanced cervical cancer. We sought to evaluate the cost effectiveness of these regimens.
A decision model was developed based on Gynecologic Oncology Group (GOG) protocols 169 and 179. Arm 1 is 6 cycles of cisplatin. Arm 2 is 6 cycles of CP while arm 3 is 6 cycles of CT. Parameters include overall survival (OS), cost and complications. Sensitivity analyses were performed.
The incremental cost-effectiveness ratio (ICER) for C versus CP is $13,654/quality-adjusted life-year (QALY) gained. For CT compared to C, the ICER is $152,327/QALY. When compared simultaneously, CT is dominated. At a willingness to pay (WTP) threshold of $50,000/QALY, C is the preferred option but CP is acceptable. Sensitivity analyses suggest that CT would become the preferred option if it was to improve OS to 24 months (compared to 9.4 months).
In this model, CP is an acceptable alternative to cisplatin for the treatment of these patients with an increase in cost of only $13,654/QALY. The addition of topotecan did not increase survival enough to justify the increased cost.
Journal of Cancer. 01/2012; 3:454-8.
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ABSTRACT: The objective of this pilot study was to determine if the combination of CA 125, menopausal status and prealbumin can be used to accurately predict ovarian cancer in women with pelvic masses.
Preoperative serum CA 125, prealbumin and menopausal status were prospectively determined. Results were formulated into an ovarian cancer risk assessment (OCRA) score and compared with final surgical pathology.
OCRA was studied in 130 women. No cancers were found in women with a score less than 200. For all cancers, an OCRA score ≥ 200 had a sensitivity of 96%, specificity of 95% and positive predictive value of 95%. When the OCRA score of ≥ 200 was evaluated for its ability to predict ovarian cancer, the sensitivity, specificity, and positive predictive value were 100%, 83%, and 78%, respectively.
In this pilot study, OCRA was able to predict which women with pelvic masses were more likely to have ovarian cancer. The scoring system easily applied clinically and may help facilitate appropriate referral of women to gynecologic oncologists for optimal care.
European journal of obstetrics, gynecology, and reproductive biology 07/2011; 158(2):325-9. · 1.97 Impact Factor
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ABSTRACT: Radical hysterectomy is a common and effective treatment of early cervical cancer. Modern advances include the use of robotic assistance to perform equivalent minimally invasive procedures. The purpose was to compare surgical and short-term outcomes, as well as margins, between robotic-assisted laparoscopic radical hysterectomy and open radical hysterectomy.
The first 30 cases of robotically assisted type III radical hysterectomy for cervical cancer were compared with the 30 previous cases of open type III radical hysterectomy. Body mass index, length of operation, nodal yield, margins, estimated blood loss, hospital stay, and complications were all documented and compared.
The 30 patients undergoing robotically assisted laparoscopic radical hysterectomy were similar in body mass index to the women undergoing open radical hysterectomy (34 kg/m robotic, 32 kg/m open, P = 0.22). The mean operating time was 154 minutes compared with 166 minutes in the open arm (P = 0.36). The mean blood loss was 165 mL compared with 323 mL in the open arm (P = 0.001). The mean pelvic nodal yield was 25 nodes compared with 26 nodes in the open group (P = 0.45). The mean parametrial margin size was not significantly different between groups. The mean postoperative length of stay was 1.4 days compared with 2.8 days for the open cases (P < 0.001). Urinary retention was significantly more common in the robotic arm.
Radical surgery for cervical cancer can be accomplished using the da Vinci surgical system (Intuitive Surgical, Sunnyvale, Calif) with acceptable blood loss, operating time, parametrial margins, and nodal yield. Future studies need to address long-term outcomes.
International Journal of Gynecological Cancer 04/2010; 20(3):438-42. · 1.65 Impact Factor
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ABSTRACT: Vulvar Paget's disease is a relatively rare gynecologic neoplasm that is problematic because of its propensity to recur.
An 80-year-old woman was found to have recurrent Paget's disease of the vulva. She was initially diagnosed 12 years previously and had had multiple resections for the disease. She was found to have histologically proven Paget's disease and underwent a course of topical immune modulator therapy with imiquimod. Biopsy proved histologic regression of the disease progress. The patient remained without recurrence 12 months after therapy.
In select patients imiquimod may be used to treat or facilitate treatment of vulvar Paget's disease.
The Journal of reproductive medicine 11/2008; 53(10):811-2. · 0.87 Impact Factor
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ABSTRACT: Adenosarcomas are rare cervical tumors with unknown optimal treatment, which often affects young women. A 23-year-old woman was found to have a stage IB1 adenosarcoma of the cervix. She underwent a robotically assisted total laparoscopic radical trachelectomy with the placement of abdominal cerclage for the sparing of fertility.
Journal of Laparoendoscopic & Advanced Surgical Techniques 11/2008; 18(5):727-9. · 1.40 Impact Factor
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ABSTRACT: To determine whether differences exist in clinicopathologic variables or survival between women with primary carcinoma of the fallopian tube (PCFT) and with epithelial ovarian carcinoma (EOC).
University of Iowa Hospitals and Clinics (UIHC) tumor board records were analyzed from January 1, 1991, to April 30, 2001. No cases were knowingly excluded. Each case of PCFT was matched with 2 cases of EOC. Controls were the next 2 cases of EOC diagnosed at UIHC after each case of PFTC, with priority given to stage of disease, then histologic grade, followed by histology, with 1 year the limit for obtaining the closest match.
Twenty-eight cases of PCFT were found. These were matched with 56 cases of EOC. The mean age at diagnosis was significantly older for women with PCFT (67 years) vs. women with EOC (60 years) (p = 0.005). The was no difference in prediagnosis hormonal contraceptive use (p=0.38), body mass index (p = 0.5) or rate of positive nodes (p = 0.19). Kaplan-Meier analysis revealed no difference in survival between PCFT and EOC (p = 0.5).
There is no significant difference in clinical parameters or survival between patients with PCFT or EOC when matched for stage, grade and histology.
The Journal of reproductive medicine 10/2008; 53(9):691-4. · 0.87 Impact Factor
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ABSTRACT: Late radiation cystitis is one of the most difficult complications of radiation therapy for pelvic malignancies.
A 29-year-old woman with a history of cervical cancer presented with radiation-induced hemorrhagic cystitis. The patient received multiple units of packed red blood cells while undergoing several intravesical treatments, including continuous bladder irrigation, 4% formalin, 0.15% AgNO3 and Mg(OH)2 with Al(OH)3. The bleeding finally was stopped by the use of intravenous recombinant factor VIIa.
When hemorrhagic cystitis related to late radiation complications is refractory to conventional management, intravenous recombinant factor VIIa may be of benefit.
The Journal of reproductive medicine 06/2008; 53(5):360-2. · 0.87 Impact Factor
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ABSTRACT: The purpose of this study was to determine whether vascular endothelial growth factor (VEGF) expression in tumors correlates with the incidence of an elevated prothrombin time (PT), specifically an international normalized ratio (INR) > or = 1.4, in patients undergoing primary surgical cytoreduction for ovarian cancer.
INRs were obtained on all patients perioperatively. VEGF expression was determined by immunostaining of tumor specimens using published protocols.
One hundred patients underwent surgical cytoreduction. Sixty-seven percent of patients had postoperative INR of 1.4 or greater. INRs of greater than or equal to 1.8 were found in 5% of patients. INR elevation was independent of mean estimated blood loss (EBL) with the EBL in the patients with INRs > or = 1.4 not significantly different than the EBL in the patients with INRs < 1.4 (660 ml vs. 530 ml, P = 0.09). There was a significant correlation between elevated INR and tumor VEGF immunostaining (P < 0.005). All but one patient with an elevated INR had positive VEGF staining.
In conclusion, development of an elevated INR (INR > or = 1.4) is common in patients undergoing primary surgical cytoreduction. Positive tumor VEGF staining is very common in patients having a postoperative coagulopathy.
Journal of Surgical Oncology 12/2007; 96(6):514-7. · 2.10 Impact Factor
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ABSTRACT: The platinum-free interval (PFI) is an important entity in the treatment of women with epithelial ovarian cancer. The purpose of this study was to determine on clinical samples whether a taxane-free interval (TFI), as defined by in vitro extreme drug resistance assay, existed in women previously exposed to platinum and taxane chemotherapy.
Records were examined from 2003 to 2006 to find all patients with epithelial ovarian cancer who had previous exposure to platinum and taxane therapy. Further examination was done to find all patients who underwent secondary cytoreduction and had their tumor submitted for extreme drug resistance assay.
Thirty-four women meeting the above criteria were found. The mean PFI was 25 months (median 18). The mean TFI was 27 months (median 20). Over 44% of the patients have been exposed to more than just a course of platinum and a course of a taxane. In patients having a PFI of >or=12 months, 38.8% had extreme drug resistance (EDR) to carboplatin and 41.9% EDR to cisplatin. Conversely, in patients having a TFI of >or=12 months, 89.7% had EDR to paclitaxel and 82.8% EDR to docetaxel.
While only a small percentage have EDR to carboplatin and cisplatin after a PFI of >or=12 months, almost 90% of patients with a TFI>or=12 months showed EDR to paclitaxel in vitro.
Gynecologic Oncology 09/2007; 106(3):538-40. · 3.89 Impact Factor
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ABSTRACT: The purpose of this study was to determine if serum prealbumin could be used to objectively determine which patients could not safely undergo cytoreductive surgery.
Patients with suspected ovarian cancer in a 24-month period underwent nutritional assessment during their preoperative workup and were followed for development of postoperative complications.
One hundred and eight of 114 patients underwent surgical cytoreduction. Of the 108 surgical patients, 88 patients had prealbumin levels <18 mg/dl and 24 patients had prealbumin levels <10 mg/dl. Postoperative complications increased with lower prealbumin levels. All complications occurred in group of patients with prealbumin <18 mg/dl (P=0.013). A significantly increased number of complications occurred in patients with prealbumin <10 mg/dl (61.5% vs. 6.4%, P<0.001, RR 9.6). All postoperative mortality in this series occurred in patients with prealbumin <10 mg/dl (23.1% vs. 0%, P<0.001). Patients whose prealbumin started low but was able to be raised to >10 mg/dl by TPN did not have significantly increased complications or EBL compared to patients whose initial prealbumin was >10 mg/dl (18.2% vs. 4.8%, P=0.95 and 570 vs. 600 ml, P=0.87).
Significantly more blood loss, morbidity, and mortality occurred in patients with abnormal preoperative prealbumin. This was especially true in patients with a prealbumin <10 mg/dl. With these significantly increased risks, patients with extremely poor nutritional status (prealbumin <10 mg/dl) may be better served by neoadjuvant chemotherapy with interval cytoreductive surgery if nutrition improves.
Gynecologic Oncology 07/2007; 106(1):128-31. · 3.89 Impact Factor
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John P Geisler
Gynecologic Oncology 04/2007; 104(3):780-1. · 3.89 Impact Factor
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Obstetrics and Gynecology 03/2006; 107(4):107S. · 4.73 Impact Factor
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ABSTRACT: To determine whether neoadjuvant cisplatin and 5-fluorouracil chemotherapy can be used to preserve the anal sphincter and/or urethra in patients with advanced vulvar cancer involving these sites.
Fourteen patients with advanced vulvar cancer (1997-2003) involving the anal sphincter and/or urethra were given 3-4 cycles of neoadjuvant chemotherapy to attempt preservation of these pelvic structures rather than undergoing a primary pelvic exenteration. Following 3 cycles, a radical vulvectomy and groin lymph node dissection were planned. All patients had lesion size documented by measurement and photograph prior to and following chemotherapy.
The median age was 63 years (range 39-88). Thirteen patients received a median of 3 cycles (range 2-4) of neoadjuvant chemotherapy. Ten patients received cisplatin and 5-fluorouracil, while three received cisplatin alone. The median time from diagnosis to surgery was 77 days (range 54-143). All patients with cisplatin and 5-fluorouracil chemotherapy underwent surgery except one patient who had a synchronous renal cell carcinoma and died prior to surgery. Patients receiving cisplatin alone showed no measurable response, while all patients receiving cisplatin and 5-fluorouracil demonstrated at least a partial response. Two patients had no residual invasive carcinoma on final pathology. All patients receiving cisplatin and 5-fluorouracil followed by surgery are disease-free, while two of three receiving cisplatin have progressive disease. The anal sphincter and urethra were conserved in all patients receiving cisplatin and 5-fluorouracil.
Neoadjuvant cisplatin and 5-fluorouracil in advanced vulvar cancer demonstrated a response rate of 100%. The anal sphincter and urethra were conserved in all patients receiving cisplatin and 5-fluorouracil. Responders are disease-free at this time. This response rate demonstrates superior activity of 5-fluorouracil in vulvar cancer and spares these patients the morbidity of exenteration or radiation.
Gynecologic Oncology 02/2006; 100(1):53-7. · 3.89 Impact Factor
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ABSTRACT: Abdominal sacral colpopexy is a commonly performed procedure for treating apical vaginal prolapse. Although complications are uncommon, they can be complex and present unique management dilemmas. We present the case and subsequent management of a woman who developed erosion of polypropylene surgical mesh into her vagina and rectum 8 years after abdominal sacral colpopexy.
Journal of Pelvic Medicine and Surgery 12/2005; 12(1):45-47.
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Gynecologic Oncology 04/2005; 96(3):906. · 3.89 Impact Factor
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Gynecologic Oncology 11/2004; 95(1):270-1. · 3.89 Impact Factor
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ABSTRACT: The purpose is to investigate the safety and efficacy of i.p. topotecan and oral etoposide as salvage treatment for patients with platinum-resistant ovarian or primary peritoneal cancer.
Patients were treated with i.p. topotecan initial dose, 1 mg/m2 on days 1 to 5, followed by oral etoposide 100 mg on days 6 to 9 of a 28-day cycle for six cycles. Dose reduction of topotecan was used for severe bone marrow suppression. Peritoneal (topotecan) and plasma (topotecan and etoposide) levels were assessed at multiple time points using high-pressure liquid chromatography.
Twenty-two patients (mean age, 61 years) with a median of 1.5 prior treatments were enrolled. Etoposide peak plasma concentrations ranged from 1.9 to 6.9 microg/mL (mean, 3.6 microg/mL). Topotecan plasma levels rose with increasing peritoneal concentration and were detectable within 1 hour but tended to decrease rapidly to below detectable levels within 24 hours. The peak plasma concentration of topotecan was 12.82 +/- 8.55 microg/mL with a plasma half-life of 6.17 +/- 2.75 hours. A total of 104 cycles was administered; 14 patients (64%) completed all six planned cycles. All patients were evaluable for toxicity, and 21 patients were evaluable for response. The most common grade 4 toxicities were neutropenia and thrombocytopenia in eight and four patients (36 and 18%), respectively. There were no treatment-related deaths. The overall response rate was 38% [complete response, three (14%); partial response, five (24%)]. Seven patients had stable disease and six progressed while on treatment.
The combination of i.p. topotecan and oral etoposide is an active and well-tolerated regimen in platinum-resistant ovarian carcinoma. Additional studies investigating topotecan in combination with etoposide are warranted.
Clinical Cancer Research 10/2004; 10(18 Pt 1):6080-5. · 7.74 Impact Factor
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ABSTRACT: Juvenile granulosa cell tumor (JGCT) of the ovary, if diagnosed at an early stage, has a favorable prognosis. Recurrences are uncommon but typically occur within the first year. The patient presented here was treated with a left oophorectomy after initial presentation. Tumor recurrence in the left adnexa, diagnosed 48 months later, was treated with cytoreductive surgery followed by chemotherapy; she remains disease free 19 months after this recurrence. Late recurrences of JGCT can occur and continued close surveillance is recommended.
American Journal of Obstetrics and Gynecology 08/2004; 191(1):366-7. · 3.47 Impact Factor
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ABSTRACT: We present two patients who developed necrotizing enterocolitis following their first cycle of chemotherapy for epithelial ovarian/peritoneal cancer. After optimal cytoreductive surgery, both women received gemcitabine as part of a chemotherapy protocol. One patient developed necrotizing enterocolitis, 1 day after chemotherapy and the other 8 days after chemotherapy. The first patient succumbed to the enterocolitis despite aggressive supportive care. The second patient succumbed despite both aggressive supportive care and surgical intervention. Pathologic review for both patients revealed a drug induced vasculitis causing necrotizing enterocolitis.
Gynecologic Oncology 03/2004; 92(2):705-7. · 3.89 Impact Factor
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ABSTRACT: hMLH1, the human MutL homologue, has been linked to microsatellite instability (MSI) in gastrointestinal tumors. However, to the authors' knowledge, the role of hMLH1, the other mismatch repair genes (MMR), and MSI in ovarian carcinoma has not been well defined. The purpose of the current study was to determine the relation between MSI of ovarian carcinoma and MMR gene expression, hMLH1 and hMSH2 hypermethylation, and hMLH1 and hMSH2 null mutations.
hMLH1 mRNA was detected by reverse transcriptase-polymerase chain reaction (RT-PCR) and amplification of cDNA using a housekeeping gene (glycerol 3-phosphate dehydrogenase) as a control for mRNA quality and quantity. Methylation-specific PCR (MS-PCR) was used to correlate methylation of the hMLH1 and hMSH2 CpG islands with mRNA expression status. Similar techniques were used to evaluate the concomitant expression of five other MMR: hMSH2, hMSH3, hMSH6, PMS1, and PMS2. Microsatellite instability was studied using the National Cancer Institute consensus markers (D2S123, D5S346, D17S250, BAT25, and BAT26) and NM23 as described previously.
One hundred twenty-five primary tumors were analyzed. High-frequency MSI (MSI-H) was found in 21 tumors (16.8%). hMLH1 mRNA was absent in 10 of these 21 tumors (47.6%). In each case, coordinated hypermethylation of both regions A and C of the promoter was identified. Microsatellite stable and low-frequency MSI tumors all were found to express not only hMLH1 but the other MMR genes as well (P < 0.001). Absence of expression of hMSH2 and the four other MMRs occurred in tumors with absent hMLH1 mRNA expression because of CpG island hypermethylation. No absence of expression of hMSH2, hMSH3, hMSH6, PMS1, or PMS2 was found to occur in tumors expressing hMLH1. None of the 11 MSI-H tumors without promoter hypermethylation demonstrated a null mutation in hMLH1 or hMSH2.
A molecular mechanism to explain > 50% of the MSI-H phenotype in ovarian carcinoma cases was demonstrated. MSI-H may occur because of MMR defects, especially hMLH1 promoter hypermethylation. Additional mechanisms are required to explain the balance between the cases of MSI-H as well as the phenomenon of MSI-L tumors.
Cancer 11/2003; 98(10):2199-206. · 4.77 Impact Factor
