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Biomedical subjects

J M Fowler

Publications and source records attributed to J M Fowler.

At least 19 recordsLinked to original sources
PubMed2001

Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group.

PURPOSE: To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous (IV) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin. PATIENTS AND METHODS: Patients were randomized to receive either IV paclitaxel 135 mg/m(2) over 24 hours followed by IV cisplatin 75 mg/m(2) every 3 weeks for six courses or IV carboplatin (area under curve 9) every 28 days for two courses, then IV paclitaxel 135 mg/m(2) over 24 hours followed by intraperitoneal (IP) cisplatin 100 mg/m(2) every 3 weeks for six courses. RESULTS: Of the 523 patients who entered this trial, 462 were determined to be assessable, with prognostic factors well balanced between the treatments. Neutropenia, thrombocytopenia, and gastrointestinal and metabolic toxicities were greater in the experimental arm. As a result, 18% of the patients received < or = two courses of IP therapy. Progression-free survival was superior for patients randomized to the experimental treatment arm (median, 28 v 22 months; relative risk, 0.78; log-rank P =.01, one-tail). There was a borderline improvement in overall survival associated with this regimen (median, 63 v 52 months; relative risk, 0.81; P =.05, one-tail). CONCLUSION: An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is not recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.

Aged↗
PubMed2001

Phase I trial of escalating doses of paclitaxel combined with fixed doses of cisplatin and doxorubicin in advanced endometrial cancer and other gynecologic malignancies: a Gynecologic Oncology Group study.

PURPOSE: The primary objective of this phase I trial was to determine the feasibility of administering a combination of paclitaxel, cisplatin, and doxorubicin with or without granulocyte colony-stimulating factor (G-CSF) in patients with advanced endometrial and other gynecologic cancers. PATIENTS AND METHODS: Patients were chemotherapy-naive. Doxorubicin was administered as a brief infusion, paclitaxel for 3 hours, and cisplatin for 60 minutes. Treatments were repeated every 3 weeks. For most dose levels, the cisplatin and doxorubicin were fixed at 60 mg/m(2) and 45 mg/m(2), whereas the paclitaxel was escalated in successive cohorts from 90 to 250 mg/m(2). Patients who had received previous radiotherapy to the whole pelvis were escalated separately from those who had not. RESULTS: Eighty patients received 320 cycles of therapy. When G-CSF was not used, myelosuppression prevented escalation beyond the starting dose for patients with or without previous pelvic radiotherapy. When G-CSF was added, neurotoxicity became dose-limiting for both groups. Ten patients were removed from the study for asymptomatic declines in ejection fraction, but no symptomatic congestive heart failure was observed. Major antitumor responses occurred in 46% of patients (six of 13) with measurable endometrial carcinoma and 50% of patients (eight of 16) with measurable cervical carcinoma. CONCLUSION: The combination of paclitaxel, doxorubicin, and cisplatin at relevant single-agent doses is active and feasible with the addition of G-CSF. A regimen of cisplatin 60 mg/m(2), doxorubicin 45 mg/m(2), and paclitaxel 160 mg/m(2) with G-CSF support is recommended for further testing.

Adult↗
PubMed2000

Phase I study of paclitaxel, carboplatin, and increasing days of prolonged oral etoposide in ovarian, peritoneal, and tubal carcinoma: a gynecologic oncology group study.

PURPOSE: Given the activity of prolonged oral etoposide in platinum and paclitaxel-resistant ovarian carcinoma, a phase I trial was conducted that combined increasing days of oral etoposide therapy with paclitaxel and carboplatin in chemotherapy-naive patients with ovarian peritoneal and tubal carcinoma to establish a maximum-tolerated dose (MTD) of this combination. PATIENTS AND METHODS: Paclitaxel at 175 mg/m(2) given over 3 hours and carboplatin at an area under the curve of 5 were administered on day 1 followed by oral etoposide 50 mg/m(2)/d beginning on day 2. The number of days of etoposide therapy was escalated on the basis of toxicity. Toxicity end points included neutropenic sepsis, grade 4 thrombocytopenia, or grade 3 neutropenia or thrombocytopenia during etoposide administration. Cycles were repeated every 21 days for a maximum of six courses. Due to hematologic toxicity, the duration of the paclitaxel infusion was decreased to 1 hour for a second stage of accrual. RESULTS: Of 52 patients studied, 29 were in the first stage of accrual. Dose-limiting toxicity occurred with 8 days of oral etoposide, making the MTD six days of therapy. Twenty-three patients were entered into the second stage of accrual. Dose-limiting toxicity occurred at 12 days of oral etoposide, making the MTD 10 days of therapy. Three patients developed acute myeloid leukemia 16, 27, and 35 months after receiving a cumulative dose of 200 mg/m(2), 1,200 mg/m(2), and 2,400 mg/m(2), respectively. CONCLUSION: One-hour paclitaxel, carboplatin, and oral etoposide at 50 mg/m(2)/d for 10 days is tolerable without supportive therapy. The leukemogenic potential is cause for concern and precludes its use in chemotherapy-naive ovarian carcinoma.

Adenocarcinoma↗
PubMed1999

Quality assurance of second opinion pathology in gynecologic oncology.

OBJECTIVE: To determine the effect of routine second review of pathologic material that was sent to Ohio State University before initiation of therapy. METHODS: All the gynecologic-oncologic histopathology review diagnoses made during a 1-year period were compared with original pathologic diagnoses. When there was a discrepant diagnosis with the second interpretation, the case was reviewed by at least two pathologists. Discrepancies were coded as no diagnostic disagreement, no diagnostic disagreement but pertinent information not included, diagnostic disagreement without clinical consequences, diagnostic disagreement with minor clinical significance, or diagnostic disagreement with major clinical significance. Proportions and confidence intervals were calculated. RESULTS: Pathology reports from 295 referred patients were reviewed. Two hundred forty-five (83.1%) showed no discrepancy. Discrepancies were found in 50 cases (16.9%). There was significant information missing in four cases (1.4%), diagnostic disagreement with no clinical significance in 22 cases (7.5%), and diagnostic disagreement with minor clinical significance in 10 cases (3.4%). In 14 cases (4.7%, 95% confidence interval 2.28, 7.12) the changes in diagnoses had major therapeutic or prognostic implications that included changes from malignant or low malignant potential to benign (seven cases), malignant to low malignant potential (three cases), change in tumor type (two cases), and assessment of invasion (two cases). The cost of reviewing 295 specimens was approximately $39,235. The cost of identifying each major discrepancy was about $2802. CONCLUSION: Routine pathology review of gynecologic-oncologic cases before definite treatment revealed notable discrepancies in diagnoses. In 4.7% of cases, the change in diagnosis had a major effect on proper treatment planning or a significant prognostic implication.

Female↗
PubMed1998

Pretreatment surgical staging of patients with cervical carcinoma: the case for lymph node debulking.

BACKGROUND: The routine use of extraperitoneal surgical staging prior to radiation therapy in patients with bulky or locally advanced cervical carcinoma remains controversial. METHODS: A review was performed of 266 patients with cervical carcinoma who underwent extraperitoneal pelvic and paraaortic lymphadenectomy prior to receiving radiotherapy. Patients were divided into groups based on their lymph node status. Group A had negative lymph nodes; Group B had resected, microscopic lymph node metastases; Group C had macroscopically positive lymph nodes that were resectable at the time of surgery; and Group D had unresectable lymph nodes. All patients received standard radiotherapy utilizing external beam and brachy-therapy. Patients with lymph node metastases received extended field irradiation. Survival probabilities were computed by the Kaplan-Meier product limits method with statistical significance determined by the Mantel-Cox log rank test. RESULTS: Lymph node metastases were detected in 50% of patients. Five- and 10-year disease free survival rates were similar for all patients in Groups B and C. All patients in Group D recurred. There was a 10.5% incidence of severe radiation-related morbidity and a 1.1% incidence of treatment-related deaths. CONCLUSIONS: Pretreatment extraperitoneal staging of patients with bulky or locally advanced cervical carcinoma may afford a survival benefit via the debulking of macroscopically positive lymph nodes without significantly increasing treatment-related morbidity or mortality.

Female↗
PubMed1998

Laparoscopy versus laparotomy: an evaluation of adhesion formation after pelvic and paraaortic lymphadenectomy in a porcine model.

OBJECTIVE: Our purpose was to determine whether there is a difference in adhesion formation after pelvic and paraaortic lymphadenectomy with transperitoneal laparoscopy compared with both extraperitoneal laparotomy and transperitoneal laparotomy in a porcine model. STUDY DESIGN: Ninety female hogs underwent pelvic and paraaortic lymphadenectomy: 40 with transperitoneal laparoscopy, 40 with extraperitoneal laparotomy, and 10 with transperitoneal laparotomy. Three weeks after the initial surgery, a laparotomy was performed to assess adhesion formation. RESULTS: The transperitoneal laparotomy group had significantly higher adhesion formation, with a 100% (10 of 10) adhesion rate. In the transperitoneal laparoscopy group, 12 of 40 hogs (30%) had adhesions develop versus 8 of 38 (21%) in the extraperitoneal laparotomy group (p = not significant). Also no differences were found in the transperitoneal laparoscopy and extraperitoneal laparotomy groups when comparing adhesion thickness or the total surface area of adhesions. More anterior abdominal wall adhesions were noted in the extraperitoneal laparotomy group (5 of 38) than in the transperitoneal laparoscopy group (0 of 40, p = 0.02). CONCLUSIONS: Pelvic and paraaortic lymphadenectomy performed with transperitoneal laparoscopy does not increase adhesion formation when compared with extraperitoneal laparotomy in a porcine model. The transperitoneal laparoscopy (and extraperitoneal laparotomy) approach also induces significantly fewer adhesions than transperitoneal laparotomy.

Animals↗
PubMed1997

The effect of sartorius transposition on wound morbidity following inguinal-femoral lymphadenectomy.

In spite of efforts to reduce complications associated with inguinal-femoral lymphadenectomy (IFL), morbidity continues to be substantial. We sought to assess the efficacy of sartorius transposition (ST) in reducing groin wound complications following IFL, in patients with vulvar malignancy. The records of 101 patients with vulvar cancer undergoing IFL through separate incisions between March 1975 and December 1994 were examined. Sixty-two patients undergoing ST (group 1) were compared to 38 who did not (group 2). The groups were similar with respect to age, weight, tobacco/alcohol use, prior abdominal/vulvar surgery, prevalence of diabetes, hypertension, or peripheral vascular disease, and previous exposure to irradiation or chemotherapy. Additionally, there was no significant difference with respect to extent of disease, incidence of macro-/microscopic groin metastases, use of groin drains, and use of perioperative antibiotics or deep venous thrombosis prophylaxis. Groin wound complications were less frequent in patients undergoing ST (group 1). The incidence of groin cellulitis was 30% in group 1 compared with an incidence of 58% in group 2 (P = 0.011). Significant groin wound morbidity, defined as either wound breakdown or cellulitis, was seen less frequently in group 1 (41% vs 66%; P = 0.029). Employing a multivariate analysis, only patient weight < 150 lbs and performance of ST were established as independently associated with a reduction in groin morbidity following IFL (P = 0.0281 and P = 0.0075, respectively). In conclusion, despite waning enthusiasm for its performance, ST appeared to significantly reduce the incidence of wound morbidity after IFL. Our data confirmed that separate incisions, and improved perioperative antibiotics, have not eliminated the value inherent in this surgical modification. We suggest a prospective trial to further establish the benefit of sartorius transposition during IFL.

Female↗
PubMed1997

A simplified method for detubularization in the construction of a continent ileocolic reservoir (Miami pouch).

The development of continent urinary diversions was an important step forward in improving the quality of life of patients undergoing pelvic exenteration. While the technique is relatively simple, it can be very time-consuming and uses a significant portion of the patient's colon in its construction. Here a modification of the technique for construction of a continent ileocolic reservoir which results in a similar reservoir that uses less colon and requires less time to construct is presented. We also report results of the use of this technique in seven patients.

Aged↗
PubMed1997

Chemoprophylaxis with ciprofloxacin in ovarian cancer patients receiving paclitaxel: a randomized trial.

The objective of this study was to evaluate the efficacy of oral ciprofloxacin in preventing febrile morbidity superimposed on the neutropenia induced from a paclitaxel regimen in ovarian cancer patients. Eligible patients received paclitaxel at doses of 135 to 175 mg/m2 alone or in combination with a platinum agent. They were randomized to either an observation (control) group or a ciprofloxacin prophylaxis group. Patients in the ciprofloxacin group received 500 mg ciprofloxacin orally twice a day once the absolute neutrophil count (ANC) was less than 500/mm3 and continued until the ANC was greater than 1000/mm3. Ninety patients were enrolled between the control (n = 45) and ciprofloxacin (n = 45) groups. They received 371 cycles of a paclitaxel-based regimen with 177 and 194 cycles in the control and ciprofloxacin groups, respectively. Ciprofloxacin prophylaxis was prescribed for 138 (71%) of the cycles in the ciprofloxacin group and was given for a mean duration of 7.7 days per cycle. The groups were similar in disease status and risk factors for neutropenia. Fifteen patients in the control group developed febrile neutropenia versus 12 of those in the ciprofloxacin group (P = 0.69). The mean ANC and mean length of hospital stay for neutropenic fever were also similar between groups. There was a greater frequency of an ANC < 100 associated with those prophylaxed with ciprofloxacin (P = 0.01). Only 44% of the febrile episodes were associated with a positive culture. Staphylococcus aureus was the most frequently reported organism isolated. Considering these results, it does not appear that febrile neutropenia is reduced by ciprofloxacin during grade IV neutropenia.

Administration, Oral↗
PubMed1997

The effect of prolonged cycles of chemotherapy on quality of life in gynaecologic cancer patients.

OBJECTIVE: The aim of this study was to determine if the prescription of prolonged cycles of chemotherapy to patients with a variety of gynaecologic cancers has an adverse effect on quality of life (QOL). METHODS: Patients attending a single gynaecologic oncology clinic who received greater than 6 cycles of chemotherapy were identified. Prior to each chemotherapy cycle, patients were asked to complete a modified Functional Assessment Cancer Therapy-General (FACT-G) quality of life form. QOL scores were compared to their baseline or pretreatment score (cycle 1 score), as well as to their score representing the completion of primary therapy (cycle 6 score). RESULTS: Seventeen patients were identified as having received greater than 6 cycles of systemic cytotoxic chemotherapy. The total number of chemotherapy cycles analyzed was 95. Comparing QOL scores for cycle 1 and 6 to cycles 7-16, we found no significant alteration (improvement or deterioration) in the following subscale scores: physical well being (PWB), social well being (SWB), and functional well being (FWB). Similarly, overall QOL as represented by the summed individual scores was also not affected by the prescription of up to 16 cycles of chemotherapy. Analysis of the emotional well being (EWB) subscale scores revealed a significant downward trend after the 12th cycle of therapy as compared to the 6th cycle (p = 0.04), however this trend was not significant when compared to the pretreatment or cycle 1 scores (p = 0.16). There was however a statistically significant progressive deterioration in the subscale score of the relationship with the doctor (RWD). This was most marked after the 10th cycle of therapy (p < 0.0001). When split by disease status, we again found no statistically significant alteration in PWB, SWB, RWD, EWB, FWB and overall QOL for cycle 1 and 6 as compared to cycles 7-17. However, those patients who were able to attain a complete clinical response (CCR) disease status, achieved a higher SWB (p = 0.003), RWD (p = 0.02), EWB (p = 0.03), and overall QOL scores (p = 0.04) while their PWB scores were not statistically different from patients with stable (p = 0.7) or progressive disease (p = 0.6). CONCLUSION: In conclusion, the prescription of prolonged cycles of chemotherapy to patients with gynaecologic cancers does not result in an overall deterioration of QOL. Further more an improvement in subscale and overall QOL was demonstrated in those patients able to attain a complete clinical response (CCR).

Adenocarcinoma↗
PubMed1996

Gynecologic reconstruction with a rectus abdominis myocutaneous flap: an update.

This series reports the outcomes and significant complications associated with the rectus myocutaneous flap when used for pelvic or inguinal reconstruction in patients with gynecologic cancers. Perioperative variables were retrospectively reviewed to identify social and medical risk factors as well as intraoperative and postoperative complications that predisposed to rectus flap failure. Fifteen patients with gynecologic malignancies underwent reconstructive procedures using a vertically oriented rectus abdominis myocutaneous flap for either vaginal (n = 14) or inguinal (n = 1) reconstruction. The patients' primary cancers were cervical (n = 11), rectal (n = 1), ovarian (n = 1), vulvar (n = 1), and vaginal (n = 1). The median age was 50 years. The median follow-up was 17 months. All flaps were mobilized in conjunction with a radical salvage operation. There were no cases of vaginal prolapse and no abdominal wound infections. However, 4 patients (27%) had major postoperative morbidity in this small series. There was one wound dehiscence and three episodes of necrosis of the subcutaneous and cutaneous portions of the flap. All 4 of these patients required additional operative intervention or debridement. Eleven patients had complete healing of the flap. The rectus abdominis myocutaneous flap is a valuable option for gynecologic reconstructive procedures. Perioperative strategies for improving flap viability include the identification of risk factors that may compromise flap perfusions such as prior abdominal incisions, peripheral vascular disease, and obesity. Meticulous surgical technique is required to preserve the vascular pedicle. These strategies may be useful in preoperative counseling, the perioperative evaluation, and the intraoperative management.

Adult↗
PubMed1996

Mixed mesodermal sarcoma of the ovary in a young patient.

Mixed mesodermal tumors (MMT) of the ovary are rare and have a poor prognosis. This ovarian malignancy usually occurs in postmenopausal women. We report an unusual ovarian MMT in a young woman given treatment similar to one used for ovarian germ cell malignancies. We believe this is the youngest patient reported with an homologous MMT of the ovary.

Adult↗
PubMed1995

The utility of preoperative screening colonoscopy in gynecologic oncology.

The American Cancer Society (ACS) recommends that asymptomatic women, age 50 and over, undergo sigmoidoscopy every 3 to 5 years, after two negative yearly exams. Epidemiologic evidence suggests that women with gynecologic or breast cancers have an increased risk of developing colon cancer. It is unclear whether the ACS guidelines are applicable for women with a new diagnosis of gynecologic malignancy. This retrospective study was undertaken to assess the usefulness of preoperative colonoscopy in our gynecologic oncology patient population. Patients undergoing evaluation for a major operative procedure for known or suspected gynecologic malignancies were referred for colonoscopy at the discretion of their attending surgeon. Five hundred patients' charts were reviewed to identify 212 patients in whom preoperative colonoscopy was performed (the study group). In this group, 17 cases of colonic polyps, 5 cases of synchronous colon cancer, and 2 cases of cancer metastatic to the colon were discovered, representing 11% of the study group. Whereas 23% of the patients screened were less than 50 years of age, only two cases of polyps occurred in this age group, and no cases of cancer. Patients aged 70 or greater made up 28% of the study group, but accounted for 41% of the cases of polyps and 40% of the colon cancers. Twenty-nine percent of the study group had adenocarcinoma of the endometrium, representing 7 of 17 cases of polyps, 1 of 5 colon cancers, and 1 of 2 metastatic cancers. Although this retrospective study involved colonoscopy, the locations of the observed lesions were within the theoretic reach of a flexible sigmoidoscope in 75% of cases. We conclude that in the preoperative workup of gynecologic oncology patients, no colon screening is needed in the asymptomatic patient less than 50 years of age. ACS guidelines are appropriate for patients aged 50-70, but for those 70 or greater we would consider full colonoscopy.

Age Factors↗
PubMed1995

Management of pelvic venous stenosis with intravascular stainless steel stents.

Patients with gynecologic malignancies may develop stenosis of the large pelvic veins as a result of their disease or its treatment. The percutaneous insertion of a stainless steel vascular stent is a novel approach to the management of an extrinsically compressed vein. The objective of this study was to review the results of treating lower extremity edema secondary to a pelvic venous stenosis through the percutaneous insertion of a stainless steel vascular stent. A retrospective review was performed on gynecologic oncology patients who presented with an edematous lower extremity and underwent an evaluation to diagnose proximal venous stenosis. The evaluation included sonography, venography, and balloon angioplasty prior to the percutaneous insertion of a stainless steel vascular stent. If a venous thrombosis was documented, thrombolysis with urokinase was performed prior to evaluation for venous stenosis. Records were reviewed for the etiology of the venous stenosis, the location and type of stent inserted, and the ability of the stent to maintain patency and provide symptomatic relief. Patency was evaluated at 1-week and then at 1-, 3-, and 6-month intervals. The probability of vascular stent patency was calculated using life table analysis. Ten patients with cervical (n = 4), corpus (n = 3), ovarian (n = 1), vulvar (n = 1), and vaginal (n = 1) cancer had one or more vascular stents inserted for the treatment of a stenosed pelvic vein. The etiologies of venous stenosis were radiation fibrosis and surgery (n = 5), postoperative fibrosis (n = 3), and metastatic tumor (n = 2). The stented vessels were the left common (n = 5) or left external (n = 4) iliac veins, the right common (n = 1) or right external (n = 3) iliac veins, and the right common femoral vein (n = 1). The median follow-up was 21 months. All patients had subjective resolution of their edematous extremity while the stents were patent. The interval probability of patency of stented veins was greater than 85% at each evaluation interval. Patency was 100% for patients beyond 6 months of follow-up. There were no major complications. The percutaneous intravascular insertion of a stainless steel stent was safe and subjectively effective in the management of venous stenosis associated with a gynecologic cancer. A prospective trial with objective endpoints may be warranted.

Adult↗
PubMed1995

Nonsurgical management strategies for the functional complications of ileocolonic continent urinary reservoirs.

Urinary diversion with creation of a continent ileocolonic reservoir was performed in 25 patients with gynecological malignancies at our institution between September 1989 and September 1994. A retrospective review was conducted and cases were analyzed for functional complications associated with reservoir formation. Functional reservoir complications were defined as (1) difficulty with catheterization, (2) reservoir fistulae, (3) reservoir stones, and (4) ureteral stenosis. Management strategies and outcomes for these complications were determined. All patients had received prior pelvic radiation therapy. There was no surgical mortality. Median follow-up was 21 months, and 16 patients (64%) are currently alive. Fourteen of the patients (56%) had one or more complications attributable to a functional aspect of the continent reservoir. Two patients had difficulty with catheterization (8%), two patients had reservoir leak (8%), and one patient had reservoir stones (4%). Nonsurgical management strategies were used in these cases including balloon dilation of the ileocecal valve, stomal dilation, ureteral stenting, percutaneous nephrostomy, and endoscopic lithotripsy. All cases of catheterization problems, reservoir fistulae, and reservoir stones were resolved with nonoperative techniques. Thirteen of 50 ureters (26%) had some degree of stenosis. Percutaneous balloon dilation was utilized in nine cases of ureteral stenosis. Relief of stenosis was complete in five, partial in two, and not achieved in two of the cases. No patients required a reoperation for a reservoir complication. In conclusion, continent ileocolonic urinary diversion can be performed in patients previously treated with radiotherapy; however, functional reservoir problems may occur. Interventional radiology strategies are useful in managing many of these problems and reexploration can be successfully avoided.

Adult↗