Intraperitoneal chemotherapy following neoadjuvant chemotherapy and optimal interval tumor reductive surgery for advanced ovarian cancer.

OBJECTIVES: Intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and interval tumor reductive surgery (TRS) for advanced ovarian cancer is feasible, however, the impact on disease outcomes remains unclear. We compare outcomes of patients treated with IP chemotherapy versus intravenous (IV) chemotherapy following NACT and interval TRS. METHODS: In this retrospective review, patients with advanced ovarian cancer were included if they received NACT followed by optimal interval TRS between 1/2004 and 4/2017. Patients were excluded if they had an ECOG PS >1, received >6 cycles of NACT or postoperative chemotherapy, and/or received bevacizumab during primary therapy. Primary outcomes were progression free survival (PFS) and overall survival (OS). RESULTS: There were 134 patients included in this study, 37 (28%) received IP and 97 (72%) received IV chemotherapy postoperatively. Patients in the IV group were older (median 66.3 vs 59.7 years, p = 0.0039) though there were no differences in BMI, race, BRCA status, stage, or histology. Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS. On univariate analysis, increasing number of NACT cycles (HR 1.914, 95% CI 1.024-3.497) and residual disease at completion of TRS (HR 1.541, 95% CI 1.042-2.248) were associated with decreased PFS; IP chemotherapy was associated with increased PFS (HR 0.633, 95% CI 0.414-0.944). These associations remained on multivariate analysis. Toxicity was comparable between the groups. CONCLUSIONS: IP after NACT and optimal interval TRS was associated with in improved PFS compared to IV chemotherapy without significant differences in toxicity.

A phase 2, randomized, double-blind, placebo- controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a Gynecologic Oncology Group partners study.

BACKGROUND: A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. PATIENTS AND METHODS: Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo. Randomization was stratified by platinum-free interval (≤6 versus >6-12 months) and Gynecologic Oncology Group (GOG) performance status (0 versus 1). Treatment cycles were repeated every 28 days until disease progression. RESULTS: The addition of motolimod to PLD did not significantly improve overall survival (OS; log rank one-sided P = 0.923, HR = 1.22) or progression-free survival (PFS; log rank one-sided P = 0.943, HR = 1.21). The combination was well tolerated, with no synergistic or unexpected serious toxicity. Most patients experienced adverse events of fatigue, anemia, nausea, decreased white blood cells, and constipation. In pre-specified subgroup analyses, motolimod-treated patients who experienced injection site reactions (ISR) had a lower risk of death compared with those who did not experience ISR. Additionally, pre-treatment in vitro responses of immune biomarkers to TLR8 stimulation predicted OS outcomes in patients receiving motolimod on study. Immune score (tumor infiltrating lymphocytes; TIL), TLR8 single-nucleotide polymorphisms, mutational status in BRCA and other DNA repair genes, and autoantibody biomarkers did not correlate with OS or PFS. CONCLUSIONS: The addition of motolimod to PLD did not improve clinical outcomes compared with placebo. However, subset analyses identified statistically significant differences in the OS of motolimod-treated patients on the basis of ISR and in vitro immune responses. Collectively, these data may provide important clues for identifying patients for treatment with immunomodulatory agents in novel combinations and/or delivery approaches. TRIAL REGISTRATION: Clinicaltrials.gov, NCT 01666444.

Outcomes following percutaneous upper gastrointestinal decompressive tube placement for malignant bowel obstruction in ovarian cancer.

OBJECTIVE: The objective of this study was to evaluate peri-operative and survival outcomes of ovarian cancer patients undergoing percutaneous upper gastrointestinal decompression for malignant bowel obstruction (MBO). METHODS: Retrospective chart review was used to identify patients with ovarian, peritoneal, or fallopian tube cancer who underwent palliative decompressive treatment for MBO from 1/2002 to 12/2010. Kaplan-Meier methods were used to estimate the median survival (MS) and multivariate analysis used to determine if any variables were associated with the hazard of death. RESULTS: Fifty-three patients met inclusion criteria. Median length of diagnosis prior to intervention was 21 months. Fifteen (28.3%) patients experienced complications and 9 required revision. Forty-nine (92.5%) experienced relief of symptoms after placement, and 91% tolerated some form of oral intake. Following placement, 19 (36%) patients received additional chemotherapy and 21(41%) patients received total parental nutrition (TPN). Thirty-five patients were discharged home/outpatient facility, 16 to hospice care, and 2 died prior to discharge. MS for all patients was 46 days. Patients who received chemotherapy had a MS of 169 days compared to 33 days (p<0.001). We failed to find an association between survival and TPN or performance status. CONCLUSIONS: Malignant bowel obstruction is a common complication of ovarian cancer. Management is palliative; risks and benefits of any therapy must be considered. Percutaneous decompressive therapy provides relief from associated symptoms, and allows patients to be discharged home. Median survival in this group is limited, and decisions regarding aggressive therapy should be individualized.

Effect of chemotherapy delays and dose reductions on progression free and overall survival in the treatment of epithelial ovarian cancer.

INTRODUCTION: Hematologic, gastrointestinal, and neurologic complications are common side effects of the platinum and taxane-based chemotherapy used in the primary treatment of epithelial ovarian cancer (EOC). These side effects and the impact of the resultant chemotherapy dose modification on disease free interval have not been extensively studied. The goal of this study was to determine the effect of chemotherapy delays and dose reductions on progression free survival (PFS) and overall survival (OS). METHODS: A review of patients with primary epithelial ovarian, peritoneal, and fallopian tube carcinoma treated between 1/2000 and 12/2007 was performed. Inclusion criteria were advanced stage disease and first line chemotherapy with a platinum and taxane regimen. Cox proportional hazard models were used to determine the effect of chemotherapy reductions and delays on PFS and OS. RESULTS: One hundred and fifty seven patients met the inclusion criteria. Patients were divided into four groups: no delays or reductions (48%), delay only (27%), reduction only (8%), and both delay and reduction (18%). The mean number of delays/reductions per patient was 1.1 (range=0-5) and therapy was delayed a mean of 8 days. The most common reasons for delays/reductions were neutropenia (n=51), thrombocytopenia (n=45), and neuropathy (n=18). There were no differences detected in PFS or OS between groups. CONCLUSIONS: There were no differences detected in survival between patients who required dose adjustments and treatment delays and those who did not. The lack of association between survival and chemotherapy alterations suggests that in specific circumstances patients with advanced ovarian cancer should have individualized treatment plans.

Which factors predict bowel complications in patients with recurrent epithelial ovarian cancer being treated with bevacizumab?

BACKGROUND: Increased rates of bowel perforation in patients with recurrent epithelial ovarian cancer (EOC) treated with bevacizumab have been reported, but the risk factors for this association are uncertain. We sought to identify factors associated with bowel perforation and fistula formation in recurrent EOC patients treated with bevacizumab. METHODS: A chart review of all patients treated with bevacizumab for recurrent EOC at a single institution was performed. Pertinent patient characteristics and treatment information were collected. Univariate logistic regression was performed to analyze multiple variables. RESULTS: One hundred twelve patients who were treated with 160 different bevacizumab regimens were identified. The median age was 60 years (range, 29-78 years). Patients had received a median of 4 prior chemotherapy regimens (range, 1-10). The median number of cycles was 4 (range, 0.5-31). Ten patients (9%) were diagnosed with bowel perforations, and another 2 patients (1.8%) were diagnosed with fistulas. The 30-day mortality following perforation was 50%, with 30% of patients dying within 1 week. Patients with rectovaginal nodularity were more likely to develop a bowel perforation or fistula than those who did not have this finding, OR=3.64 (95% CI=1.1 to 12.1, p=0.04). None of the other variables were significantly associated with bowel perforations or fistula formation. CONCLUSIONS: Rectovaginal nodularity is associated with an increased risk of bowel perforation or fistula formation for patients with recurrent EOC treated with bevacizumab. Careful consideration should be given prior to initiating bevacizumab treatment in EOC patients with rectovaginal nodularity since the mortality rate with bevacizumab associated bowel perforations is 50%.

Correlation between patient weight and defects in DNA mismatch repair: is this the link between an increased risk of previous cancer in thinner women with endometrial cancer?

The objective is to determine the relationship between obesity and defects in DNA mismatch repair (MMR) in women with endometrial cancer and to establish whether our previous finding of a higher rate of previous malignancy in thinner women with endometrial cancer is related to these factors. Specimens from 109 patients with primary uterine cancer were used to create a tissue microarray, which was stained with antibodies against MMR genes MLH1, MSH2, MSH6, and PMS2. Genotyping of normal and tumor tissues for microsatellite instability (MSI) was performed. Patients were stratified by body mass index (BMI) and correlated with a history of previous malignancy and defects in MMR. The average BMI of the overall population was 33 kg/m(2). Defective MMR was seen in 22% of tumors. The mean BMI in patients with tumors with MSI was 30.5, compared with 33.8 in microsatellite stable (MSS) tumors (P= 0.06); MSS tumors were more commonly seen in patients with a BMI more than 40 (25% vs 5% in patients with tumors with MSI, P= 0.07). Prior to their diagnosis of endometrial cancer, 16/109 (15%) patients reported having a prior malignancy, 11 (69%) had breast cancer, and 1 had colorectal cancer. Patients with tumors with MSI had previous cancer in 17% of cases, compared with 14% of patients with MSS tumors (P= 0.75). Our previous finding of an increased rate of prior malignancy in thinner patients with endometrial cancer does not appear to be due to alterations in MMR, and hereditary nonpolyposis colorectal cancer-associated cancers are rarely the prior malignancy.

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.

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.

First Report of Daylily Rust in the United States.

In August 2000, rust symptoms were observed on the leaves of daylily plants (Hemerocallis sp. cv. Pardon Me) at a nursery in Dearing, GA. Based on urediniospore characters, the pathogen was tentatively identified as Puccinia hemerocallidis Thuem. Urediniospores were globose to ellipsoid and measured 19 to 30 × 17 to 22 µm (average size of 22 × 19 µm), corresponding to the previously reported description from Japan (1). Teliospores were absent from the sample but were found on daylily plants (cv. Star Struck) with symptoms similar to cv. Pardon Me from the same nursery in Dearing beginning in October 2000. However, the teliospores differed from those in the published description in that many one-celled teliospores (i.e., mesospores), measuring 32 to 43 × 14 to 19 µm (average size of 38 × 16 µm), were produced in addition to two-celled teliospores, which measured 41 to 53 × 16 to 21 µm (average size of 46 × 18 µm). Similar mesospores were present in a slide from an isotype specimen of P. hemerocallidis (US 72719) housed in the U.S. National Fungus Collection (Beltsville, MD). Daylily plants (cv. Pardon Me) were reinoculated with urediniospores by shaking infected plants over uninfected plants and exposing plants to 100% relative humidity for 24 h. Initial symptoms of small, discrete, yellow spots and streaks on the upper surfaces of leaves developed within 3 to 7 days, and uredia with urediniospores were evident at 7 to 14 days after inoculation. Daylily rust is native to Asia and may have been introduced into Georgia on plant materials sent from Central America. The original source of daylily rust is unclear because Central American producers also purchase and import plants from the United States for propagation and then sell divisions back to U.S. growers. Daylily rust is a disease of major concern for both daylily producers and gardeners. References: (1) N. Hiratsuka, et al. The Rust Flora of Japan. Tsukuba Shuppankai, Ibaraki, Japan, 1992.

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.

Carbon dioxide embolism during laparoscopy: effect of insufflation pressure in pigs.

Carbon dioxide embolism is a rare but potentially devastating complication of laparoscopy. To determine the effects of insufflation pressure on the mortality from carbon dioxide embolism, six swine had intravascular insufflation with carbon dioxide for 30 seconds using a Karl Storz insufflator at a flow rate of 35 mL/kg/min. The initial insufflation pressure was 15 mm Hg. Following recovery from the first embolism, intravascular insufflation using a pressure of 20 mm Hg at the same flow rate was performed in the surviving animals. Significantly less carbon dioxide (8.3 +/- 2.7 versus 16.7 +/- 3.9 mL/kg; p < 0.02) was insufflated intravascularly at 15 mm Hg than at 20 mm Hg pressure. All of the pigs insufflated at 15 mm Hg pressure with a flow rate of 35 mL/kg/min survived. In contrast, 4 of the 5 pigs insufflated at 20 mm Hg pressure died. The surviving pig died when insufflated with 25 mm Hg pressure following an embolism of 15.7 mL/kg. Intravascular injection was often associated with an initial rise in end-tidal carbon dioxide tension, followed by a rapid fall in all cases where the embolism proved fatal. Insufflation should be begun with a low pressure and a slow flow rate to limit the volume of gas embolized in the event of inadvertent venous cannulation. Insufflation should immediately be stopped if a sudden change in end-tidal carbon dioxide tension occurs.

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.

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.

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.

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.

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).

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.

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.