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Biomedical subjects

J P Micha

Publications and source records attributed to J P Micha.

At least 19 recordsLinked to original sources
PubMed2000

A phase I trial of a 3-day topotecan Q 21 days for recurrent epithelial cancers of the ovary, fallopian tube, and peritoneum.

OBJECTIVE: This trial was undertaken to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of topotecan that can be administered for 3 days q 21 days. A 3-day schedule is more convenient and less expensive than standard 5-day dosing. METHODS: Patients with recurrent epithelial ovary, tubal, or peritoneal carcinoma were treated with escalating doses of topotecan beginning at 2.50 mg/m(2) as an outpatient days 1-3 q 21 days. Colony stimulating factors were not employed prophylactically, but could be added for grade 4 marrow toxicity. RESULTS: Twenty patients with a median age of 61 (range 46-80) and performance status of 0 or 1 were entered. All patients had received at least one prior paclitaxel/platinum regimen; 6 had received two. Ninety-one cycles were delivered (median = 6) and 98.9% were on schedule. Grade 4 neutropenia was seen in 17 of 20 patients (85%) in cycle 1 and in 38 of 91 (41.8%) total cycles. Sixteen of 20 patients (80%) started G-CSF on cycle 2. Two of 91 (2.2%) cycles had grade 4 thrombocytopenia. Four cycles (4.4%) were associated with febrile neutropenia. Two patients experienced grade 4 neurotoxicity (DLT) at 4.25 mg/m(2). Other nonhematologic toxicity was mild. CONCLUSIONS: Topotecan can be safely administered on schedule as an outpatient days 1-3 q 21 days. Neurotoxicity was the DLT when G-CSF was added; the MTD was 3.75 mg/m(2). There was minimal other nonhematologic toxicity. Neutropenia was predictable and easily managed with G-CSF. Febrile neutropenia was uncommon and thrombocytopenia was rare at the doses evaluated.

Aged↗
PubMed1998

Three-hour paclitaxel infusion and carboplatin is an effective outpatient treatment for stage III epithelial ovarian cancer.

OBJECTIVE: The aim of this study was to determine the response rate and toxicity of a 3-h paclitaxel infusion and carboplatin delivered as outpatient therapy for the treatment of stage III/IV epithelial ovarian cancer. METHODS: Thirty patients with stage III/IV epithelial ovarian cancer underwent cytoreductive surgery. The first 10 patients received adjuvant paclitaxel 150 mg/m2 via 3-h infusion on day 1 and carboplatin 5 times area under the curve on day 2 (group 1) every 28 days. The paclitaxel dose was escalated to 175 mg/m2 for the next 20 patients (group 2). chi 2 and Kaplan-Meier procedures were used for statistical analysis. RESULTS: Nine of 51 cycles in group 1 (17.6%) and 19 of 116 cycles (16.4%) in group 2 were associated with grade 4 neutropenia (P = 0.96), but only 2 of the 161 total cycles (0.01%) had fever and neutropenia. One patient in group 1 experienced grade 3 thrombocytopenia. Two patients in the entire group (7.4%) required colony-stimulating factors. One patient in group 2 (3.7%) had grade 3 neurotoxicity. With a median follow-up of 29 months for the entire group, 5 of 8 patients (62.5%) in group 1 and 14 of 19 patients (73.7%) in group 2 are alive. Median progression-free survival for group 1 and 2 is 13 and 14 months, respectively. Median overall survival has not been reached. CONCLUSIONS: Paclitaxel via 3-h infusion and carboplatin is an effective outpatient treatment for epithelial ovarian cancer that can be safely administered on schedule in the majority of patients.

Adult↗
PubMed1998

"Medically necessary" panniculectomy to facilitate gynecologic cancer surgery in morbidly obese patients.

A retrospective review of patients in our practice who underwent abdominal panniculectomy to facilitate gynecologic cancer surgery was performed. The objective of the study was to determine if panniculectomy was a safe and useful procedure in the morbidly obese gynecologic cancer patient. A total of 12 patients underwent the procedure between 1992 and 1996. Optimal pelvic oncologic surgery was accomplished in all 12 patients. All aspects of those procedures were performed by gynecologic oncologists. The Buchwalter retractor was used in all cases. The patients' weights ranged from 170 to 429 pounds, with a mean of 275 pounds. The mean body mass index was 48, with a range from 37 to 67. Four patients had a history of diabetes mellitus. Nine patients healed without wound complications. Three patients developed superficial subcutaneous wound infections/necrosis that were successfully managed with office debridement. Abdominal panniculectomy is a reasonably safe procedure that makes radical pelvic surgery possible regardless of the patient's weight. Prolonged wound bulb suction drainage may decrease the incidence of wound necrosis/infection in these high-risk patients.

Adipose Tissue↗
PubMed1998

Single-dose dexamethasone paclitaxel premedication.

Paclitaxel is one of the most active chemotherapy agents for the treatment of ovarian and other gynecologic cancers. Hypersensitivity reactions (HSR) remain one of the major clinical concerns in the use of paclitaxel. This report deals with 183 consecutive patients treated with paclitaxel chemotherapy. A total of 1010 cycles were administered. Premedication consisted of single-dose intravenous decadron, benadryl, and cimetidine administered immediately prior to chemotherapy. Four hypersensitivity reactions occurred. All patients recovered uneventfully from these reactions. Two of these patients received additional oral decadron followed by the standard premedication and were successfully retreated with multiple courses of paclitaxel therapy without reaction. Our findings confirm other reports that paclitaxel chemotherapy hypersensitivity reactions can be decreased with a single-dose intravenous decadron premedication regimen and that patients who do have paclitaxel HSRs may be safely retreated with paclitaxel.

Adult↗
PubMed1998

Primary surgical cure of stage III-B cervical carcinoma with adnexal metastasis.

Management of patients with advanced stage cervical carcinoma remains suboptimal. Primary radiation therapy has been the standard treatment for years. Despite some changes in radiation technique, cure rates for advanced stage cervical cancer remain disappointing. Radiation complications in those patients can also be severe. We report here a case of a patient who presented with renal failure from bilateral ureteral obstruction from stage III-B cervical squamous carcinoma. The patient underwent a primary total pelvic exenteration with low rectosigmoid reanastomosis, urinary conduit construction, and cecal neovagina construction as definitive treatment. She was found to have metastasis to the broad ligament, ovary, and fallopian tube. Surgical margins and lymph nodes were negative. The patient did not receive any radiation therapy or chemotherapy. The patient is alive, healthy, and without evidence of disease 8 years following treatment.

Adnexal Diseases↗
PubMed1990

Whole-abdominal radiotherapy for patients with minimal residual epithelial ovarian cancer.

Sixteen patients with advanced epithelial ovarian cancer who were treated with cytoreductive surgery followed by multiagent chemotherapy were found to have residual tumor masses less than 2 cm in greatest diameter at reexploration and were treated with whole-abdominal radiation (19-31 Gy). Thirteen patients also received pelvic boosts to a total pelvic dose of 41-53.7 Gy. Radiotherapy was completed in all but 2 patients after treatment delays in 7 patients. Early treatment complications included myelosuppression in 11 patients, diarrhea in 3, and a self-limited small bowel obstruction in one. Delayed complications were severe and included 9 patients with radiation enterocolitis, 8 of whom required intestinal resection or diversion. One additional patient with radiation cystitis required instillation of formalin to control bleeding. Two patients are without evidence of disease 28 and 30 months following radiotherapy, while the remaining 14 patients have recurred after a median progression-free interval of 9 months (range 1-30 months). All patients who recurred failed within the treatment field and died of cancer after a median interval of 19 months following radiotherapy and 9 months after documentation of progression. These data suggest that few patients with persistent ovarian cancer following surgery and chemotherapy will be salvaged with radiotherapy.

Abdomen↗
PubMed1990

Topical podofilox for the treatment of condylomata acuminata in women.

The purpose of this study was to determine the efficacy and safety of 0.5% podofilox solution (Condylox) for the treatment of genital warts in women. Thirty-seven women with anogenital warts applied the solution to the surface of these warts twice daily for 3 days, followed by 4 drug-free days. A minimum of two and a maximum of four treatment cycles were given. The subjects were evaluated weekly for the first 4 weeks and again at 6 and 10 weeks. At the end of 10 weeks, the mean number of warts per patient was reduced from 6.27 to 1.1, and half of the patients were completely cleared of warts. Only eight of 37 subjects (21.6%) developed new warts during the study period. Approximately 15% of patients reported "severe" local reactions to the treatment after the first treatment cycle, but this was reduced to only 5% by the last treatment cycle. During the same period, the patients reporting no side effects increased from 44 to 86%. The only woman who discontinued the study did so because of dizziness and epigastric discomfort, probably unrelated to drug use. Thus, 0.5% podofilox solution appears to be an effective treatment for condylomata acuminata, with acceptable side effects that are local and temporary.

Administration, Topical↗
PubMed1989

Radical hysterectomy and tailored postoperative radiation therapy in the management of bulky stage 1B cervical cancer.

Ninety-two patients with Stage IB cervical cancers having a diameter equal to or greater than 4.0 cm were treated with radical surgery. Thirty-two patients received postoperative radiotherapy because of operative findings suggestive of high risk of pelvic recurrence. All 32 irradiated patients were treated with a standard pelvic field. Four patients also received paraaortic radiotherapy, and ten received intravaginal brachytherapy. Postoperative complications were seen in five patients (two nonirradiated, three irradiated). Projected 5-year survival is 79% (71% 5-year survival in irradiated patients, and 83% 5-year survival in nonirradiated patients). Preoperative evaluation of tumor volume was not found to reliably predict histologic high risk factors such as depth of stromal invasion, risk of lymph node metastases, or presence of extracervical/uterine involvement. A primary surgical approach in this group of patients with large-diameter Stage IB cervical cancers allows definition of those patients who might benefit from a combined surgical and radiotherapeutic approach to treatment based on findings at operation.

Adenocarcinoma↗
PubMed1989

Ovarian epithelial tumors of low malignant potential.

Forty-one patients with epithelial ovarian tumors of low malignant potential are discussed. Twenty-three patients presented with Stage I, four with Stage II and 14 with Stage III disease. All patients with Stage I disease were solely treated surgically. Twelve patients with Stage II and III disease also received postoperative chemotherapy. Four of ten patients had persistent disease at second look laparotomy. Chemotherapy was not used in six patients with Stage II and III disease when the tumor was considered to have been removed completely. Forty of the 41 patients are currently alive and free of disease at two to nine years of follow-up study. Vigorous and, at times, multiple surgical procedures remain the primary treatment of ovarian tumors of low malignant potential.

Adult↗
PubMed1988

Interferon alpha-n1 (Wellferon) for refractory genital warts: efficacy and tolerance of low dose systemic therapy.

This multi-center trial compared two doses of parenterally administered interferon alpha-n1 (Wellferon) in men and women with recurrent/resistant genital warts. Patients received either 1 or 3 MU/m2 daily for 14 days, then 3 times weekly for 4 weeks; non-responders could receive an additional four weeks of treatment. A total of 107 patients were enrolled, and 102 were evaluable after six weeks of study. The principal dose comparison was in 57 women assigned alternately to the two doses. Median lesion measurements were reduced significantly from baseline at weeks 2, 4 and 6 in both groups. Statistical analysis showed no difference in response to 1 versus 3 MU/m2. The overall complete response (CR) plus partial response (PR) rate at week 6 was 69% for the two doses. Two additional groups of 21 women and 24 men were treated at the higher dose with CR plus PR rates of 75 and 50%, respectively. Week 10 disease evaluations for all groups showed 19 of 77 patients to be completely cleared. Of these 19, only one had recurrent disease at the end of the 6-month study period. Analysis of the incidence of symptomatic side effects showed a significantly higher frequency among women treated with 3 MU/m2 than among women treated with 1 MU/m2. Five dose reductions and two withdrawals for toxicity occurred, all in the high dose group. This study demonstrates that parenterally administered Wellferon produces clearance of resistant genital warts in many patients, and that rates of clearance do not appear to vary between groups receiving moderate or low dose therapy.

Adult↗
PubMed1987

Prophylactic mezlocillin in radical hysterectomy.

The role of prophylactic antibiotics in radical hysterectomy patients was studied in a double-blind randomized prospective study of mezlocillin (Mezlin, Miles Pharmaceuticals), a broad-spectrum semisynthetic penicillin, compared to placebo. Thirty evaluable patients received 4 g mezlocillin or saline placebo intravenously one-half hour before surgery, a second dose four to six hours later, and a final dose six hours after that. The rate of wound infection, postoperative use of additional antibiotics, fever index, and the incidence of standard febrile morbidity were all significantly lower in the mezlocillin group. Short-term perioperative prophylactic antibiotics are indicated in patients undergoing radical hysterectomy.

Adult↗
PubMed1986

Accurate laboratory predictions of the clinical response of patients with advanced ovarian cancer to treatment with cyclophosphamide, doxorubicin, and cisplatin.

Seventy-six patients with advanced ovarian cancer treated with cyclophosphamide, doxorubicin, and cisplatin (CAP) at 3-week intervals were tested for the response of their tumors to treatment with CAP in the subrenal capsule tumor implant assay. Thirty-four of the patients' tumors were assayed prospectively before clinical treatment and 33 were assayed retrospectively, after clinical treatment with CAP. Nine of the patients' tumors were assayed both prospectively and retrospectively. All of the patients underwent a tumor debulking laparotomy. Of the patients with clinically measurable residual disease, 17 had a partial response of at least 50% regression of disease, and 11 had a progression of disease. Of the patients with known residual but nonmeasureable disease, 7 had surgically verified complete responses, 8 at least 50% regression, and 23 had progression of disease: 10 had no evidence of disease clinically but had not had surgical confirmation. Twenty-six of the tumors were adenocarcinomas not otherwise specified (2 grade I, 2 grade II, and 22 grade III), 39 were serous adenocarcinomas (7 grade I, 9 grade II, and 23 grade III), 7 were endometrioid adenocarcinoma (all grade III), 3 were mucinous adenocarcinomas (1 each of grade I, II, and III) and 1 was an adenosquamous carcinoma (grade III). Thirty-four of the patients failed the therapy. The subrenal capsule (SRC) assay predicted 21 of these failures (4 prospective and 17 retrospective). Thirty-two of the patients responded to CAP chemotherapy. The SRC assay accurately predicted the clinical regression of the tumors of 22 of the patients (15 prospective and 7 retrospective). Second-look laparotomy confirmed 7 patients with no evidence of disease, 5 patients with minimal disease, and 5 patients with a greater than 50% reduction of their disease. The SRC assay predicted the response of all these patients except 2 with partial responses to chemotherapy. Thus, while the overall positive predictive value of the SRC assay in this study is 65%, it is 100% for those patients whose tumors respond completely and for those who have minimal residual disease after CAP chemotherapy.

Animals↗
PubMed1985

Malignant ovarian germ cell tumors: a review of thirty-six cases.

Thirty-six patients with malignant ovarian germ cell tumors were treated between 1972 and 1983, including 16 with immature teratoma, five with endodermal sinus tumor, seven with dysgerminoma, and eight with mixed germ cell tumors. The median age at presentation was 18 years and mean primary tumor diameter was 18 cm. Twenty-five of the 27 patients who were treated with multiple-agent chemotherapy underwent second-look procedures, only two of which revealed persistent malignancy. No patients have developed recurrence after a negative second-look operation. Two of the three patients with failure of initial chemotherapeutic regimens had complete remissions with second regimens. Two patients have died of malignancy, one who presented with a Stage IA mixed germ cell tumor and one noncompliant patient with a Stage IA, grade 2 immature teratoma. The other 34 patients are alive without evidence of disease from 21 to 141 months, with a median follow-up of 68 months. These data confirm that multiple-agent chemotherapy has dramatically improved the prognosis for patients with malignant nondysgerminomatous ovarian germ cell tumors.

Adolescent↗
PubMed1985

A simplified method for right atrial catheter insertion.

Using the technique described, Hickman catheters can be inserted by a single operator at low cost and risk. The simplicity of insertion and removal with this method makes the use of this device preferable to standard temporary central venous catheters in most instances.

Cardiac Catheterization↗
PubMed1985

Action of 2-beta-D-ribofuranosylthiazole-4-carboxamide (tiazofurin) against untreated human ovarian cancers in the murine xenograft assay.

The activity of 2-beta-D-ribofuranosylthiazole-4-carboxamide (tiazofurin) was determined in nine untreated human ovarian cancer specimens, using the murine subrenal capsule xenograft assay. Tumor cytotoxic effect was demonstrated in seven out of the nine tumors implanted. The drug was well tolerated by the test animals. Tiazofurin may prove to be an effective chemotherapeutic agent in the treatment of ovarian cancer.

Animals↗
PubMed1985

Management of condyloma acuminatum.

This article describes an approach to the evaluation and treatment of condyloma acuminatum (anogenital warts) that is based on the results of new clinical research on the biology of the human papillomavirus. A more extensive diagnostic protocol, including routine cervicovaginal examination and Papanicolaou smear, is proposed for female patients because of the close association of genital human papillomavirus infections with cervical carcinoma. Two highly effective therapies, cryosurgery and carbon dioxide laser photocoagulation, are described and compared with older regimens. Recent developments in immunotherapy for resistant condyloma acuminatum are also discussed.

Clinical Trials as Topic↗
PubMed1985

Immature teratoma of the ovary with predominant malignant retinal anlage component. A parthenogenically derived tumor.

An immature teratoma with predominant malignant retinal anlage component occurred in the ovary of a 17-year-old woman. Karyotype analysis from Q-banded preparations revealed that the tumor was parthenogenically derived and exhibited chromosome instability and aneuploidy. On light-microscopical examination, the malignant elements resembled retinal anlage. Ultrastructurally, large, polygonal, pigmented cells had features of ependymal epithelium: a continuous, well-developed basal lamina; microvilli; parallel arrays of rough endoplasmic reticulum; and very large, densely pigmented melanosomes. Adjacent cells identified by light microscopy as immature neuroglia contained glial fibrillary acidic protein by immunohistochemical staining. The presence of neuroglia, not a feature of tumors of neural crest origin, and the ependymal characteristics of the pigmented cells indicate that the neoplasm was most likely of neural groove derivation.

Adolescent↗