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Morgan MA, Polan ML, Melecot HH, Debru B, Sleemi A, Husain A. Experience with a low-pressure colonic pouch (Mainz II) urinary diversion for irreparable vesicovaginal fistula and bladder extrophy in East Africa. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1163-8.
INTRODUCTION AND HYPOTHESIS: We report our experience with a low-pressure colonic pouch for urinary diversion in women with irreparable vesicovaginal fistulas and bladder extrophy. METHODS: This is a case series of 35 women with irreparable vesicovaginal fistula who underwent urinary diversion and two cases performed for bladder extrophy. RESULTS: Partial or complete loss of the urethra was present in over 90% of fistula cases. Fifty-five percent had prior vaginal repairs. The median length of stay was 21 days. Median follow-up for 29 (78%) patients was 18 months. Nighttime urinary incontinence occurred in 31%. Twenty-one (91%) of 23 patients had a serum creatinine <1.5 although all patients had evidence of acidosis. Two patients died 4 years after surgery from sepsis and renal failure. CONCLUSIONS: Urinary diversion using the Mainz pouch II can be performed in the developing world with low perioperative morbidity and mortality. Acidosis and nighttime incontinence are the most common complications.
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Morgan MA, Darcy KM, Rose PG, DeGeest K, Bookman MA, Aikins JK, Sill MW, Mannel RS, Allievi C, Egorin MJ. Paclitaxel poliglumex and carboplatin as first-line therapy in ovarian, peritoneal or fallopian tube cancer: a phase I and feasibility trial of the Gynecologic Oncology Group. Gynecol Oncol. 2008 Sep;110(3):329-35.
PURPOSE: To estimate the maximum tolerated dose (MTD) of paclitaxel poliglumex (PPX) in combination with carboplatin in patients with chemotherapy-naive ovarian, primary peritoneal or fallopian tube cancer, and to assess the feasibility of administering multiple cycles of this regimen. METHODS: The first 11 patients were treated in a standard 3 + 3 dose-seeking design, with carboplatin held constant at area under the curve (AUC) of 6 and PPX at 225, 175 or 135 mg/m(2). Pharmacokinetics of PPX and carboplatin were evaluated during this dose-seeking component of the trial. MTD was defined by acute dose-limiting toxicities (DLT) in the first cycle. Twenty additional evaluable patients were treated at the estimated MTD to assess the feasibility of this regimen over >or=4cycles. RESULTS: PPX at 225 mg/m(2) resulted in DLT in 2/3 patients, and was de-escalated first to 175 mg/m(2) and then to 135 mg/m(2). PPX slowly hydrolyzed to paclitaxel and did not alter the pharmacokinetics of carboplatin. DLT within the first 4-cycles were observed in 3 patients (15%) treated at the MTD: neutropenia > 2weeks (2), febrile neutropenia (1). Nineteen patients (95%) experienced grade 4 neutropenia. Sixteen patients (80%) had at least one episode of grade 3 thrombocytopenia. Three patients (15%) had grade 2 and one had grade 3 peripheral neuropathy. Complete response by CA-125 was 75%. CONCLUSIONS: The recommended dose of PPX of 135 mg/m(2) with carboplatin (AUC = 6) in newly diagnosed ovarian cancer was feasible for multiple cycles, but hematologic toxicity was greater compared with standard carboplatin and 3-hour paclitaxel.
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Morgan
Bookman
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Greer BE, Koh WJ, Abu-Rustum N, Bookman MA, Bristow RE, Campos S, Cho KR, Copeland L, Eifel P, Huh WK, Jaggernauth W, Kapp DS, Kavanagh J, Lipscomb GH, Lurain JR, Morgan M, Morgan RJ, Powell CB, Remmenga SW, Reynolds RK, Secord AA, Small W, Teng N, National Comprehensive Cancer N. Cervical cancer. J Natl Compr Canc Netw. 2008 Jan;6(1):14-36.
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Bookman
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Morgan MA, Darcy KM, Rose PG, DeGeest K, Bookman MA, Aikins JK, Sill MW, Mannel RS, Allievi C, Egorin MJ, Gynecologic Oncology G. Paclitaxel poliglumex and carboplatin as first-line therapy in ovarian, peritoneal or fallopian tube cancer: a phase I and feasibility trial of the Gynecologic Oncology Group. Gynecol Oncol. 2008 Sep;110(3):329-35.
PURPOSE: To estimate the maximum tolerated dose (MTD) of paclitaxel poliglumex (PPX) in combination with carboplatin in patients with chemotherapy-naive ovarian, primary peritoneal or fallopian tube cancer, and to assess the feasibility of administering multiple cycles of this regimen. METHODS: The first 11 patients were treated in a standard 3 + 3 dose-seeking design, with carboplatin held constant at area under the curve (AUC) of 6 and PPX at 225, 175 or 135 mg/m(2). Pharmacokinetics of PPX and carboplatin were evaluated during this dose-seeking component of the trial. MTD was defined by acute dose-limiting toxicities (DLT) in the first cycle. Twenty additional evaluable patients were treated at the estimated MTD to assess the feasibility of this regimen over >or=4cycles. RESULTS: PPX at 225 mg/m(2) resulted in DLT in 2/3 patients, and was de-escalated first to 175 mg/m(2) and then to 135 mg/m(2). PPX slowly hydrolyzed to paclitaxel and did not alter the pharmacokinetics of carboplatin. DLT within the first 4-cycles were observed in 3 patients (15%) treated at the MTD: neutropenia > 2weeks (2), febrile neutropenia (1). Nineteen patients (95%) experienced grade 4 neutropenia. Sixteen patients (80%) had at least one episode of grade 3 thrombocytopenia. Three patients (15%) had grade 2 and one had grade 3 peripheral neuropathy. Complete response by CA-125 was 75%. CONCLUSIONS: The recommended dose of PPX of 135 mg/m(2) with carboplatin (AUC = 6) in newly diagnosed ovarian cancer was feasible for multiple cycles, but hematologic toxicity was greater compared with standard carboplatin and 3-hour paclitaxel.
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Bookman
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Fujiwara K, Armstrong D, Morgan M, Markman M. Principles and practice of intraperitoneal chemotherapy for ovarian cancer. International Journal of Gynecological Cancer. 2007 Jan-Feb;17(1):1-20.
Intraperitoneal (IP) chemotherapy has been studied for years to improve the survival of patients with ovarian cancer. Recently, the result of Gynecologic Oncology Group 172 trial comparing IP versus intravenous administration of cisplatin-based chemotherapy was published, demonstrating the improvement of survival benefit in favor of the IP arm. This trial is the third trial that showed a survival benefit on IP chemotherapy. The National Cancer Institute (NCI) and Gynecologic Oncology Group have done a meta-analysis on the results of these three US trials and other phase III trials of IP versus intravenous chemotherapy, and significant improvement of survival was shown with IP therapy. Based on this meta-analysis, NCI has released a clinical announcement encouraging the gynecological oncology community to consider IP chemotherapy as the standard treatment for optimally debulked advanced ovarian cancer patients. However, there still are controversial issues regarding the use of IP chemotherapy. It is important to understand how IP chemotherapy works to solve those issues in the future. In this review article, we discuss the principles and clinical aspects of IP chemotherapy and also discuss the current problems and future perspectives in IP chemotherapy.
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Morgan MA. Another view of "humanitarian ventures" and "fistula tourism". International Urogynecology Journal. 2007 Jun;18(6):705-7.
There are many ethical issues involved in medical missions to developing countries. The Current Opinion/Update "Humanitarian ventures or `fistula tourism?': the ethical perils of pelvic surgery in the developing world" raised many concerns about surgical trips to treat obstetric fistula. Despite a lack of experience with obstetric fistula, western surgeons may still bring surgical and public health techniques that may be of value to health systems in developing countries. Emphasis should be placed on program development and assessment first. This should include not only surgical training but also help with counseling, prevention and reintegration. Participation in clinical trials should be up to the health care personnel in the country being helped, and aide should not depend on such participation. Success will likely be determined by a national effort and integration into existing health systems, not isolated "fistula champions." The appalling situation of obstetric fistula in the twenty-first century should be a wake-up call to obstetricians/gynecologists and urologists. The dictum "first do no harm" must not evolve into "first do nothing."
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