Evidence-based research for intraperitoneal chemotherapy in epithelial ovarian cancer.

Intraperitoneal (IP) therapy is the administration of chemotherapy or biologic agents directly into the peritoneal cavity. A recent Gynecologic Oncology Group trial showed a survival advantage for women with advanced ovarian cancer and small residual disease after initial surgical staging and debulking who received IP therapy when compared to the standard IV regimen. The results prompted a National Cancer Institute announcement recommending the use of IP therapy in women who meet the criteria.

Chemotherapy-induced peripheral neuropathy.

Purpose/objectives: To review the literature documenting the scope, treatment, and prevention of chemotherapy-induced neuropathy.

Data Sources: Published abstracts, primary research literature, and textbook chapters.

Data Synthesis: Recent improvements in the management of other treatment-related toxicities have led to peripheral neuropathy becoming a dose-limiting toxicity of commonly used chemotherapeutic groups such as platinols, vinca alkaloids, and taxanes.

Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: a gynecologic oncology group study.

Purpose/objectives: To evaluate the psychometric properties of two adapted scales, one for functional status and one for peripheral neuropathy secondary to neurotoxic chemotherapy.

Design: Repeated measures methodologic design conducted within a Gynecologic Oncology Group (GOG) phase III clinical trial that randomly assigned patients with advanced epithelial ovarian cancer to cisplatin and cyclophosphamide or cisplatin and paclitaxel.

Setting: 8 GOG institutions participating in the GOG clinical trial.

Treatment advances in ovarian cancer.

Ovarian cancer is the fifth leading cause of cancer death among women. Although many patients respond to initial surgery and platinum-based chemotherapy regimens, recurrence is common, and many individuals require treatment with multiple agents. A number of drugs not cross-reactive with platinums or taxanes are effective as secondary treatment for women with recurrent ovarian cancer.

Limited access trial using amifostine for protection against cisplatin- and three-hour paclitaxel-induced neurotoxicity: a phase II study of the Gynecologic Oncology Group.

Purpose: The purpose of this study was to determine whether amifostine (WR-2721) prevents or ameliorates clinically significant (grade 2 to 4) neurotoxicity associated with cisplatin and 3-hour paclitaxel chemotherapy.

Materials And Methods: The chemotherapy program consisted of intravenous paclitaxel 175 mg/m2 over 3 hours followed by amifostine 740 mg/m2 and cisplatin 75 mg/m2 administered over 90 minutes beginning 15 minutes after amifostine administration. At baseline, before each treatment cycle, and for 3 months after completing chemotherapy, patients were evaluated for evidence of neurotoxicity and other treatment-related adverse effects using three methods: standard clinical evaluation (National Cancer Institute common toxicity criteria [CTC] grading), a neurotoxicity questionnaire to assess symptoms and limitations imposed by peripheral neuropathy, and vibration perception threshold (VPT) testing.

Identification of risk factors for requiring transfusion during front-line chemotherapy for ovarian cancer.

Objective: Anemia requiring red blood cell (RBC) transfusion is common in ovarian cancer (OC) patients receiving post-debulking surgery chemotherapy. Erythropoietin use has been shown to decrease transfusion requirements in patients receiving chemotherapy. We sought to identify pretreatment risk factors that could identify patients at increased risk for requiring RBC transfusion during first-line treatment for ovarian cancer.

Complications associated with intraperitoneal chemotherapy catheters.

Purpose: The goal of this work was to determine the complication rate and any predisposing risk factors associated with subcutaneous intraperitoneal (ip) catheters used in the treatment of patients with advanced ovarian cancer.

Methods: We retrospectively reviewed the charts of 301 patients who had a subcutaneous Bardport catheter placed for administration of ip chemotherapy at Memorial Sloan--Kettering Cancer Center (MSKCC) from December 1989 to May 1997.

Results: Thirty (10%) patients were identified as having catheter-related complications, with 19 (6.

Effect of adjuvant tamoxifen on the endometrium in women with breast cancer: a prospective study using office endometrial biopsy.

Purpose: To determine the frequency of developing abnormal pathologic changes in the endometria of tamoxifen-treated women. To characterize the type of pathologic changes involved.

Patients And Methods: Between October 1991 and September 1998, 159 patients initiating tamoxifen therapy for breast cancer confined to the breast and axillary lymph nodes were entered in a prospective study.

Clinicopathologic features of BRCA-linked and sporadic ovarian cancer.

Context: Most hereditary ovarian cancers are associated with germline mutations in BRCA1 or BRCA2. Attempts to define the clinical significance of BRCA mutation status in ovarian cancer have produced conflicting results, especially regarding survival.

Objective: To determine whether hereditary ovarian cancers have distinct clinical and pathological features compared with sporadic (nonhereditary) ovarian cancers.

Patient guide to peripheral neuropathy.

Purpose/objectives: To describe a booklet used to educate patients who experience peripheral neuropathy secondary to neurotoxic chemotherapy treatment.

Data Sources: Journal articles, neurologic physical assessment, symptom management books.

Data Synthesis: The booklet defines peripheral neuropathy, the types of nerves most often affected, common causes and symptoms, and management strategies with an emphasis on safety issues.

Phase II study of "dose-dense" high-dose chemotherapy treatment with peripheral-blood progenitor-cell support as primary treatment for patients with advanced ovarian cancer.

Purpose: We performed a pilot phase II study to evaluate the potential for delivery of rapidly sequenced high-dose chemotherapy treatments rescued with autologous peripheral-blood progenitor cells (PBP) in patients with previously untreated, advanced ovarian cancer.

Patients And Methods: A single cycle of mobilization was used, primed with cyclophosphamide (CPA)/paclitaxel (Txl) and filgrastim (granulocyte colony-stimulating factor [G-CSF]), followed by three cycles of high-dose carboplatin (CBDCA)/Txl and one cycle of high-dose melphalan (MEL), each rescued by PBP. We then analyzed the outcome for a total of 56 consecutive patients treated with high-dose chemotherapy as part of this program.

Palliative benefit of external-beam radiation in the management of platinum refractory epithelial ovarian carcinoma.

In vitro studies and clinical experience have suggested that patients with platinum-refractory epithelial ovarian carcinoma exhibit cross-resistance to radiation. Salvage with radiation in these patients is rare. However, radiation is often utilized to palliate symptoms caused by these chemotherapy-resistant tumors.

A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment.

Purpose: To determine the efficacy of three courses of intraperitoneal (i.p.) cisplatin (CDDP) and etoposide (VP-16) as consolidation therapy following pathologically negative second-look surgical reassessment for Stage IIC-IV epithelial ovarian cancer (EOC).

High-intensity intravenous cyclophosphamide and cisplatin, interim surgical debulking, and intraperitoneal cisplatin in advanced ovarian carcinoma: a pilot trial with ten-year follow-up.

Purpose: This trial was undertaken to study the effect of intensified intravenous cyclophosphamide/cisplatin and interim surgical debulking, followed by intraperitoneal cisplatin on surgically defined complete remission rate and survival in advanced ovarian cancer.

Patients And Methods: Forty patients with stage IIB through IV ovarian cancer were entered and 36 were evaluable for response and survival and approximately 10 years. Following a first laparotomy for diagnosis and debulking, the patients received two cycles, spaced 28 days apart, of intravenous cisplatin 30-40 mg/m2/day with hypertonic saline for 4 to 5 days and cyclophosphamide 200 mg/m2/day for 5 days.

Adjuvant chemotherapy versus chemotherapy plus pelvic irradiation for high-risk cervical cancer patients after radical hysterectomy and pelvic lymphadenectomy (RH-PLND): a randomized phase III trial.

Objective: To compare the clinical efficacy of adjuvant chemotherapy a lone vs chemotherapy plus whole pelvic radiation therapy (RT) on recurrence rates, patterns of recurrence, and survival of patients post-RH-PLND for cervical cancer at high risk for recurrence.

Methods: Prospective multicenter randomized Phase III trial. Patients with Stage IB-IIA cervical cancer undergoing RH-PLND were eligible.

The impact of diabetes mellitus on the toxicity of therapy for advanced ovarian cancer.

A retrospective review was undertaken to obtain more precise information about neurotoxicity, nephrotoxicity, and the effects of dexamethasone on the frequency and severity of hyperglycemia in diabetic patients with epithelial ovarian cancer treated with paclitaxel and/or cisplatin. Thirty-three patients were identified from 1254 patients over a 10-year period. In the cisplatin-treated patients, 21 of 24 (67%) had progression of neurological symptoms, three experienced grade 3 sensory neuropathy, and two had ototoxicity.

Follow-up of Memorial Sloan-Kettering Cancer Center patients treated on National Cancer Institute Treatment Referral Center protocol 9103: paclitaxel in refractory ovarian cancer.

Purpose: To examine the short-term and long-term results of paclitaxel therapy in patients with advanced heavily pretreated, cisplatin-refractory ovarian cancer.

Patients And Methods: The results of treatment for patients entered onto National Cancer Institute (NCI) Treatment Referral Center protocol 9103 at the Memorial Sloan-Kettering Cancer Center (MSKCC) were reviewed to evaluate toxicity, efficacy, and survival.

Results: Of 46 individuals with measurable disease treated on the protocol at MSKCC, the objective response rate was only 4%.

Arterial, peritoneal, and intraventricular access devices.

Objective: To provide an overview of access devices used to treat cancers through the arterial, peritoneal, and intraventricular body systems.

Conclusions: Short-term and long-term devices have been developed over the last 35 years for cancer treatment. Although less amenable to standard methods of therapy, the various access devices available to access the arterial, peritoneal, and intraventricular systems have provided a safe and reliable means for drug therapy.

Mitomycin-C plus a 3-day continuous intravenous infusion of 5-fluorouracil: an inactive salvage regimen for platinum-resistant ovarian carcinoma.

In a Phase II trial, patients with refractory ovarian cancer were given 10 mg/m2 mitomycin-C i.v. every 8 weeks and 1000 mg/m2/day 5-fluorouracil for 3 consecutive days by continuous intravenous infusion repeated every 4 weeks.

Evidence supporting the superiority of intraperitoneal cisplatin compared to intraperitoneal carboplatin for salvage therapy of small-volume residual ovarian cancer.

Purpose: To examine the relative efficacy of cisplatin-based intraperitoneal (IP) therapy versus carboplatin-based IP therapy as salvage treatment of small-volume residual ovarian cancer.

Patients And Methods: We retrospectively examined the surgically defined response rates of patients with ovarian cancer treated at the Memorial Sloan-Kettering Cancer Center on four organoplatinum-based salvage IP trials (cisplatin/etoposide, cisplatin/cytarabine, carboplatin/etoposide, carboplatin/etoposide + recombinant human erythropoietin). Additional criteria for inclusion in this analysis were: (a) small-volume residual disease (microscopic disease only or largest residual tumor mass < or = 0.

Relationship between saliva and serum CA 125 in women with and without epithelial ovarian cancer.

Objective: To determine the distribution of saliva CA 125 levels in women with and without ovarian cancer, and to determine whether there is a correlation between saliva and serum CA 125 levels in either group.

Methods: CA 125 levels were measured by immunoradiometric assay in the serum and saliva of 50 women with epithelial ovarian cancer known to have elevated serum CA 125 levels (above 35 U/mL) and in 50 women seen for benign gynecologic conditions.

Results: Serum and saliva CA 125 values followed a log-normal distribution in both groups.

Impact of age on survival of patients with ovarian cancer.

In an effort to determine if there are significant differences in outcome between elderly (> or = 65 years of age) and younger (< 65 years of age) women with epithelial ovarian cancer we examined the survival of patients with this malignancy who underwent their initial surgical evaluation at the Memorial Sloan-Kettering Cancer Center from January 1987-January 1991. The actuarial median overall survival for the 98 younger patients has not been reached but will exceed 4 years, compared to a median survival of 24 months for the 48 elderly patients (P < 0.0001).

Salvage intraperitoneal mitoxantrone therapy of ovarian cancer: influence of increasing the volume of treatment.

Despite the demonstrated activity of intraperitoneal mitoxantrone in patients with small volume-platinum-refractory ovarian cancer, previous reports have revealed that many patients fail to achieve adequate distribution of the cytotoxic drug throughout the peritoneal cavity when delivered in a "standard" 2-liter treatment volume. In an effort to improve the distribution and therapeutic efficacy of intraperitoneal mitoxantrone, 22 patients with platinum-refractory ovarian cancer were treated with the drug at a dose of 10 mg/m2 given in 2 liters of normal saline followed by an additional 1-2 liters every 2 weeks for eight cycles. The surgically defined complete response rate in 17 patients evaluable for response with platinum-refractory ovarian cancer was 24%, with an overall response rate of 29%.

The use of recombinant human erythropoietin to prevent carboplatin-induced anemia.

Anemia is a frequent and potentially serious toxicity associated with the use of carboplatin, particularly when this agent is administered in the salvage setting. In an effort to evaluate a possible role for human erythropoietin (rh-E) in preventing or minimizing carboplatin-induced anemia we analyzed the impact of the agent on anemia and transfusion requirements of women with ovarian cancer who were treated on one of two nonrandomized trials employing identical second-line carboplatin-based intraperitoneal regimens, with the only difference in the regimens being the addition of rh-E (Study 1, without rh-E; Study 2, with rh-E). There was a statistically significant difference in the incidence of documented nadir hemoglobin levels of < 9 g/dl (Study 1, 60%; Study 2, 13%; P < 0.

Epithelial ovarian cancer in the elderly. The Memorial Sloan-Kettering Cancer Center experience.

Background: There is evidence of differences between older (> or = 65 years of age) and younger (< 65 years of age) women with ovarian cancer.

Methods: To evaluate differences in the care of older versus younger patients with ovarian cancer, a retrospective review was conducted of the records of 146 patients who had their initial surgery for ovarian cancer at the Memorial Sloan-Kettering Cancer Center from January 1987-January 1991.

Results: There was a significant difference in stage at presentation between the older (48 patients) and younger (98 patients) populations (Stage I/II: older 10%; younger 25%; P < 0.