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Comparison of tolerance of combination carboplatin and paclitaxel chemotherapy by age in women with ovarian cancer

Villella, Jeannine A; Chaudhry, Taimur; Pearl, Michael L; Valea, Fidel; DiSilvestro, Paul A; Pollack, Simcha; Chalas, Eva
OBJECTIVE:The objective of this study was to compare tolerance of treatment of ovarian cancer patients > or = 70 years to those < or =55. MATERIALS AND METHODS/METHODS:A retrospective review of all data relevant to comparison of clinical course in 31 women > or =70 years (Study Group) and 44 women < or =55 (Control Group), who received primary therapy for ovarian cancer between 1996 and 2001 was performed. The tolerance of the entire treatment plan was then compared using SAS 8.1 (Gary, IN), chi(2) test with Yates correction or Fischer's exact test, and the Student t test as appropriate. RESULTS:The mean age for the study group was 73, and for the control group 49. Statistically significant differences were as follows: the study group had a lower hemoglobin and serum albumin, higher performance status postoperatively, and received lower carboplatin dose and dose intensity. The groups were similar in stage at presentation, medical comorbidities, estimated blood loss, optimal cytoreduction rates, dose intensity of paclitaxel, completed number of chemotherapy cycles, time intervals from surgery to completion of therapy, and posttreatment performance status and nutritional status. The rate of grade 3 and 4 toxicities was low in both groups, and did not hinder delivery of therapeutic dose of chemotherapy. CONCLUSION/CONCLUSIONS:Women in the study group tolerated aggressive cytoreductive surgery and therapeutic doses of chemotherapy, despite poorer nutritional status and general health at time of diagnosis. Although older women are more likely to have chemotherapy dose reduction, the treatment remained within the recommended standard dosage.
PMID: 12217754
ISSN: 0090-8258
CID: 3459782

A randomized controlled trial of a regular diet as the first meal in gynecologic oncology patients undergoing intraabdominal surgery

Pearl, Michael L; Frandina, Martina; Mahler, Linda; Valea, Fidel A; DiSilvestro, Paul A; Chalas, Eva
OBJECTIVE: To prospectively evaluate the safety and efficacy of a regular diet as the first meal after intraabdominal surgery in gynecologic oncology patients. METHODS: During a 20-month period, 254 gynecologic oncology patients undergoing intraabdominal surgery were enrolled in a randomized controlled trial of a clear liquid diet compared with a regular diet as the first postoperative meal. All patients received their first meal on the first postoperative day in the absence of nausea, vomiting, or symptomatic abdominal distension. Standard criteria for discharge were used for all study patients. RESULTS: The clear liquid and the regular diet groups were similar in age, disease, surgical procedure distribution, surgery length, and estimated blood loss. The incidence of nausea, vomiting, abdominal distention, frequency and duration of nasogastric tube use, passage of flatus before discharge, and percentage of patients who tolerated their diets on the first attempt were comparable for both groups. For those patients who were intolerant of the first attempt at either a clear liquid or regular diet, the time to tolerance was comparable for both groups. The time to development of bowel sounds, passage of flatus, and hospital stay were comparable for both groups. Febrile morbidity, pneumonia, wound complications, and atelectasis occurred equally in both groups. There were no known anastamotic complications or aspirations in either group. Postoperative changes in hematologic indices and electrolytes were comparable in both groups. CONCLUSION: A regular diet as the first meal after intraabdominal surgery in gynecologic oncology patients is safe and efficacious
PMID: 12151142
ISSN: 0029-7844
CID: 33253

A randomized controlled trial of early oral analgesia in gynecologic oncology patients undergoing intra-abdominal surgery

Pearl, Michael L; McCauley, Dayna L; Thompson, Jill; Mahler, Linda; Valea, Fidel A; Chalas, Eva
OBJECTIVE:To evaluate the safety and efficacy of early oral analgesia after intra-abdominal surgery in gynecologic oncology patients. METHODS:Over a 2.5-year period, 227 gynecologic oncology patients undergoing intra-abdominal surgery were enrolled in a randomized controlled trial of early oral versus traditional parenteral analgesia. All patients initially received parenteral morphine via a patient-controlled analgesia (PCA) pump with a basal dose of 0.5 mg/h and a PCA dose of 1 mg with a 10-minute lockout. On the first postoperative day, all patients began a clear liquid diet, which was advanced as tolerated. Patients allocated to early oral analgesia were switched from parenteral to oral morphine. They received a scheduled dose of 20 mg every 4 hours with an additional dose of 10 mg every 2 hours as needed for breakthrough pain. Patients allocated to traditional parenteral analgesia continued to receive parenteral morphine via a PCA pump with basal and PCA doses. On the second postoperative day, the scheduled oral and basal parenteral doses were discontinued. The oral and parenteral PCA doses were continued until 24 hours before discharge, at which time the patient was switched to oxycodone 5 mg/acetaminophen 325 mg. RESULTS:There were no significant differences among the groups in any demographic or clinical indices, including age, case distribution, surgery length, blood loss, time to return of bowel function, length of hospital stay, pain, sedation, and satisfaction scores, and incidence of nausea, vomiting, or major postoperative complications. CONCLUSIONS:Early oral analgesia in gynecologic oncology patients undergoing intra-abdominal surgery is safe and efficacious.
PMID: 11978276
ISSN: 0029-7844
CID: 3459762

Sustained complete remission in a patient with platinum-resistant ovarian yolk sac tumor [Case Report]

Jeyakumar, A; Chalas, E; Hindenburg, A
BACKGROUND:Yolk sac tumors of the ovary are generally very responsive to chemotherapy; however, they are difficult to manage in the setting of platinum resistance where treatment options are limited and outcomes are poorer. CASE/METHODS:We present a 39-year-old woman who had a platinum-resistant yolk sac ovarian tumor. She achieved complete remission on an innovative regimen of docetaxel, gemcitabine, and thalidomide. CONCLUSION/CONCLUSIONS:The combination of docetaxel, gemcitabine, and thalidomide might be an active regimen for platinum-resistant ovarian nondysgerminomas and further investigation of this combination is warranted.
PMID: 11520160
ISSN: 0090-8258
CID: 3459752

Panniculectomy in morbidly obese gynecologic oncology patients

Pearl, M L; Valea, F A; Disilvestro, P A; Chalas, E
BACKGROUND:It is clear that morbid obesity presents a serious risk to women undergoing major intra-abdominal gynecologic surgery. Unfortunately, many gynecologic malignancies and benign conditions are best treated surgically. Thus, the gynecologic surgeon must choose an incision that permits adequate exposure with acceptables rates of complications. Panniculectomy as an approach to the peritoneal cavity is becoming increasingly popular. Recent reports suggest that panniculectomy is reasonably straightforward to perform, provides adequate exposure and is associated with an acceptable rate of manageable complications. In these circumstances, panniculectomy is not a cosmetic procedure, but medically necessary to perform indicated major gynecologic intra-abdominal surgery. AIMS/OBJECTIVE:To present our experience with panniculectomy in morbidly obese women undergoing major intra-abdominal surgery on a gynecologic oncology service. METHODS:The medical records of 48 morbidly obese women (Quetelet Index > 40 kg/m2) with a large dependent pannus who underwent major intra-abdominal surgery via a panniculectomy between May 1990 and October 1999 were reviewed. Data regarding demographics, concomitant medical conditions, operative indications and results, and postoperative outcomes were abstracted for analysis. RESULTS:The mean age was 54.9 years, the mean body mass was 130.2 kg, the mean height was 1.63 m and the mean Quetelet Index was 49.3 kg/m2. The mean operating time was 188 min and the mean estimated blood loss was 615 ml. Two patients suffered intraoperative urologic injuries which were repaired without sequelae; there were no bowel, vascular or neurologic injuries. Eighteen patients had a suprafascial wound breakdown (3 complete and 15 superficial) and 15 patients developed an infection. There were no documented deep venous thromboses, pulmonary emboli or fascial dehiscences. Two patients died in the postoperative period; one from a myocardial infarction on Day 2 and one from overwhelming sepsis on Day 76. CONCLUSIONS:Morbid obesity is associated with substantial operative and postoperative risks. Panniculectomy provides operative exposure with acceptable risks of complications.
PMID: 12774339
ISSN: 1028-5229
CID: 3459822

Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients

Pearl, M L; Fischer, M; McCauley, D L; Valea, F A; Chalas, E
BACKGROUND:To evaluate the efficacy of a miniaturized portable transcutaneous electrical nerve stimulation (TENS) unit (ReliefBand) as an adjunct to standard antiemetic therapy for controlling nausea and vomiting induced by cisplatin-based chemotherapy in gynecologic oncology patients. METHODS:Forty-two patients were enrolled in a randomized, double-blind, placebo-controlled parallel-subjects trial with a follow-up crossover trial. All patients received a standardized antiemetic protocol, then wore the ReliefBand continuously for 7 days. RESULTS:Thirty-two patients were evaluable for the parallel-subjects component, 16 in each group. The percentage of patients with absent or minimal nausea was 59% overall, which was similar to that for both the active (56%) and placebo (62%) groups. The incidence and severity of nausea and vomiting was similar for each group. Eighteen patients completed two consecutive cycles and were evaluable for the crossover component. The average age of the crossover patients and their dose intensity were comparable with those of the overall study population (56.3 versus 58.6 years and 22.7 versus 22.7 mg/m2/week, respectively). The percentage of cycles with absent or minimal nausea was 47% overall, which was similar to that of the active (50%) and placebo (44%) cycles. However, the severity of nausea was significantly lower in the active cycles during days 2 to 4. Patients averaged less than one episode of vomiting daily in each cycle. CONCLUSIONS:The ReliefBand is an effective adjunct to standard antiemetic agents for controlling nausea induced by cisplatin-based chemotherapy in gynecologic oncology patients.
PMID: 10452208
ISSN: 0162-220x
CID: 3459742

Changes and challenges for women in academic obstetrics and gynecology - Discussion [Editorial]

Stone, ML; Sarto, G; Seltzer, VL; Chalas, E; Anderson, B; Cefalo, RC; Bickel, J; Cruikshank, DP; Haseltine, FP; Woods, JR; Roberts, JM; Resnik, R; Pearse, W; Morgenstern, LL; Schulman, H; Wallach, EE
ISI:000079842100014
ISSN: 0002-9378
CID: 3460462

A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery

Pearl, M L; Valea, F A; Fischer, M; Mahler, L; Chalas, E
OBJECTIVE:To evaluate the safety and efficacy of early oral feeding after intra-abdominal surgery in gynecologic oncology patients. METHODS:During a 1-year period, 200 gynecologic oncology patients undergoing intra-abdominal surgery were enrolled in a randomized controlled trial of early compared with traditional oral postoperative feeding. Patients allocated to early postoperative oral feeding began a clear liquid diet on the first postoperative day and then advanced to a regular diet as tolerated. Patients allocated to traditional postoperative oral feeding received nothing by mouth until return of bowel function (defined as the passage of flatus in the absence of vomiting or abdominal distention), then began a clear liquid diet, and advanced to a regular diet as tolerated. RESULTS:Age, case distribution, surgery length, blood loss, and first passage of flatus were similar in the early and traditional feeding groups. Significantly more patients in the early group developed nausea. Despite this, the incidence of vomiting, abdominal distention, incidence and duration of nasogastric tube use, and percentage of patients who tolerated clear liquid and regular diets on the first attempt were comparable in both groups. Time to development of bowel sounds, time to initiation of clear liquid and regular diets, and hospital stay were significantly longer in the traditional group. Major complications (eg, pneumonia, atelectasis, and wound complications) and febrile morbidity occurred equally in both groups. There were no known anastamotic complications or aspirations in either group. Postoperative changes in hematologic indices and electrolytes were comparable in both groups. CONCLUSION/CONCLUSIONS:Early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery is safe and well tolerated.
PMID: 9649101
ISSN: 0029-7844
CID: 3460422

Loss of p53 function in uterine papillary serous carcinoma

Kovalev, S; Marchenko, N D; Gugliotta, B G; Chalas, E; Chumas, J; Moll, U M
In contrast to endometrioid carcinoma, uterine papillary serous carcinoma (UPSC) is an aggressive type of endometrial cancer. Loss of p53 function is critical for the molecular pathogenesis of UPSC. Both UPSC and its putative precursor, endometrial intraepithelial carcinoma (EIC), show abnormal p53 overexpression in most tumors. To further assess the nature of p53 alterations in UPSC, we systematically reevaluated a subset of our previous cohort of UPSC patients. In the current study, we correlate mutations of the p53 gene as detected by direct sequencing of exons 5 through 8 with p53 accumulation and expression of Waf-1 in 32 UPSC tumors. Waf-1 is a downstream effector of p53-mediated G1 arrest after DNA damage and, thus, an indicator of p53 functionality. Although 78% of tumors exhibited strong nuclear p53 immunoreactivity in 100% of tumor cells, we were able to detect p53 mutations in 53%. As expected, all p53 mutant tumors (17 cases) exhibited p53 overexpression. Seventy percent of those (12 tumors) showed concomitant lack of Waf-1 expression consistent with transcriptionally inactive p53, whereas the other five tumors showed Waf-1 staining in only a minor fraction of tumor cells consistent with p53-independent Waf-1 expression. In contrast, 47% (15 cases) of tumors failed to exhibit p53 mutations; interestingly, more than half of those (eight cases) showed strong nuclear p53 accumulation in all tumor cells but lacked concomitant Waf-1 expression. These findings are consistent with a mutation-dependent and -independent type of p53 inactivation in UPSC that are both associated with nuclear overexpression. Our findings suggest that the combined immunocytochemical analysis of p53 and Waf-1 is a valuable means of assessing the functional status of p53. In summary, p53 alterations are common in UPSC and probably responsible for its aggressive biological behavior.
PMID: 9635683
ISSN: 0046-8177
CID: 3460412

Panniculectomy and supraumbilical vertical midline incisions in morbidly obese gynecologic oncology patients

Pearl, M L; Valea, F A; Chalas, E
BACKGROUND:We reviewed the outcomes of panniculectomy and supraumbilical vertical midline incisions in morbidly obese women undergoing gynecologic operations. STUDY DESIGN/METHODS:Medical records were reviewed for 62 morbidly obese women with a large dependent pannus who underwent gynecologic operations on the Gynecologic Oncology Service at the State University of New York at Stony Brook between May 1990 and July 1997. Thirty-five patients underwent panniculectomy and 27 had a supraumbilical vertical midline incision, forming the study groups. The patient charts were abstracted for demographic, perioperative, and postoperative data. RESULTS:For the entire study population, the average age was 56 years, the mean body mass was 128.6 kg, and the mean Quetelet Index was 48.3 kg/m2. The mean operative time and estimated blood loss were similar for both groups. Eight percent of the patients had urologic injuries, evenly distributed between the groups. Postoperative infections, wound breakdowns, and hospital stay were greater for the panniculectomy group than for the supraumbilical vertical midline incision group (p < 0.05). Uniform use of subcutaneous closed-suction drains (since 1995) was associated with a significant reduction in the incidence of wound breakdowns and a shorter hospital stay in the panniculectomy group. CONCLUSIONS:Panniculectomy and supraumbilical vertical midline incision provide reasonable peritoneal access with acceptable rates of postoperative complications for morbidly obese women undergoing gynecologic operations.
PMID: 9632152
ISSN: 1072-7515
CID: 3460402