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At least 289 records · Page 16Linked to original sources
PubMed1992

Hexamethylmelamine and low or moderate dose cisplatin with or without pyridoxine for treatment of advanced ovarian carcinoma: a study of the Eastern Cooperative Oncology Group.

A total of 248 analyzable patients with Stages III-IV ovarian epithelial cancer (114 with and 134 without prior chemotherapy) were randomized to one of four cisplatin (DDP)-hexamethylmelamine (HMM) regimens. In each, HMM, 200 mg/m2 was given orally daily on days 8-21 of each 21-day cycle. DDP was given i.v. on Day 1 at a dose of 37.5 mg/m2 (regimens A and B) or 75 mg/m2 (regimens C and D). In addition, since pyridoxine administration has been reported to reduce the neurotoxicity of HMM, that agent was given at a dose of 300 mg/m2 orally on Days 1-21 in regimens B and D. Randomization was stratified for performance status (0-1, 2-3) and largest tumor diameter at entry (greater than 2- less than or equal to 10 cm, greater than 10 cm) for previously untreated patients, and for performance status and time from initial diagnosis to entry on study (less than or equal to 1 year, greater than 1 year) for previously treated patients. The overall response rate (PR + CR) was 54%, with 25% of patients achieving a complete response. The 61% response rate with the higher dose DDP regimens was significantly greater than the 47% response rate with the lower dose regimens (p = 0.031). Multivariate analysis identified higher DDP dose, age less than 60 years, no prior chemotherapy, small tumor bulk and favorable tumor grade as significant prognosticators for response. The overall median response duration was 8.3 months (range 1-70 months). Prior chemotherapy, pyridoxine administration, recent diagnosis, and large tumor size were identified by multivariate analysis as factors adversely affecting response duration. Patients treated with the higher dose DDP regimens had more severe nausea, vomiting, and neurotoxicity. This study demonstrates that the combination of DDP + HMM is an effective regimen for advanced ovarian carcinoma that yields response rates comparable to other more complex regimens, and that there is a dose-response relationship for DDP in ovarian cancer. Although pyridoxine administration significantly reduced neurotoxicity, its adverse effect on response duration suggests that the agent should not be administered with DDP or HMM. The mechanism by which pyridoxine may unfavorably affect response duration deserves further investigation.

Altretamine↗
PubMed1988

Advanced ovarian cancer: long-term results of treatment with intensive cisplatin-based chemotherapy of brief duration.

STUDY OBJECTIVE: To determine the efficacy of a 6-month course of combination chemotherapy with hexamethylmelamine, cyclophosphamide, doxorubicin, and cisplatin (H-CAP) in the treatment of advanced ovarian carcinoma. DESIGN: Prospective, non-randomized, single-institution trial with a 6-month course of chemotherapy, followed by second-look laparotomy for restaging. Minimum follow-up after completion of therapy is 83 months. PATIENTS: Fifty-five patients with advanced (stage III or IV), intermediate- or high-grade epithelial carcinoma of the ovary. Twenty patients had limited residual tumor (3 cm or less maximal tumor diameter) after initial cytoreductive surgery; 35 had extensive residual disease. INTERVENTIONS: All patients received chemotherapy with hexamethylmelamine (150 mg/m2 body surface area orally on days 1 to 14), cyclophosphamide (350 mg/m2 intravenously on days 1 and 8), doxorubicin (20 mg/m2 intravenously on days 1 and 8), and cisplatin (60 mg/m2 intravenously on day 1). Courses were repeated at 4-week intervals; 41 patients (75%) received six courses; 10 patients received five courses, 3 patients received four courses, and 1 patients received three courses. Forty-seven patients underwent second-look laparotomy after completion of therapy; 8 had their disease restaged clinically. RESULTS: Fifty-three of fifty-five patients (96%) had either partial or complete response to treatment. Nineteen of forty-seven patients who had a second-look laparotomy had a surgically documented complete response; 17 of these 19 patients began chemotherapy with limited residual tumor. Ten patients (18%) remain disease-free 83 to 108 months after therapy, whereas three additional patients died of other diseases without clinical evidence of recurrent ovarian cancer. Nine of twenty patients who began chemotherapy with limited residual tumor remain disease-free, as compared to only 1 of 35 patients with more extensive tumor (P less than 0.001). All long-term, disease-free survivors had surgically documented complete response at second-look laparotomy. CONCLUSIONS: Treatment with cisplatin-based combination chemotherapy after aggressive cytoreductive surgery should be considered standard treatment for advanced ovarian carcinoma. Our intensive, 6-month course of treatment produced results comparable to those previously reported with prolonged treatment.

Adult↗
PubMed1989

Peritoneal carcinomatosis of unknown primary site in women. A distinctive subset of adenocarcinoma.

STUDY OBJECTIVE: To define the clinical features and results of systemic treatment in women with adenocarcinoma of unknown primary site involving predominantly the peritoneal surfaces. DESIGN: Retrospective analysis of 18 patients treated at a single institution between 1978 and 1984. PATIENTS: All 18 women had abdominal carcinomatosis and had no primary site identified at laparotomy. Nine patients had limited residual tumor (maximal tumor diameter, 3 cm or less) after initial cytoreductive surgery, and 9 patients had extensive residual disease. INTERVENTIONS: In general, patients were treated according to standard guidelines for treatment of advanced ovarian carcinoma. All patients had initial laparotomy with attempted cytoreduction; of these 18 patients, 16 subsequently received cisplatin-based chemotherapy. Patients were restaged either clinically (10 patients) or with second-look surgery (8 patients). RESULTS: The median survival for all patients was 23 months. Five patients had complete response to chemotherapy, and three patients remain disease-free 41, 59, and 77 months after diagnosis. Patients with limited residual disease had longer median survival than did those with extensive residual disease (31 months compared with 11 months). CONCLUSIONS: Women with adenocarcinoma of unknown primary site involving predominantly the peritoneal surface should be distinguished from other patients with adenocarcinoma of unknown primary site because they have a more indolent disease course, a higher response rate to systemic therapy, and a chance for long-term, disease-free survival after therapy. Although optimal treatment is undefined, we recommend that these patients be treated using the guidelines established for therapy of advanced ovarian carcinoma, including initial surgical cytoreduction followed by cisplatin-based combination chemotherapy.

Adenocarcinoma↗
PubMed1978

Small-cell carcinoma of the lung: therapeutic management.

Although bronchogenic carcinoma generally remains a tumor resistant to treatment, marked progress in the therapy of the small-cell undifferentiated subtype has occurred in the past 5 years. Many aspects of its growth and metastatic spread are such that it is not satisfactorily treated surgically. However, it is sensitive to both radiation and a variety of chemotherapeutic agents. Use of these agents in combination seems to produce a greater antitumor effect than single drugs. The combination of radiation and chemotherapy results in marked tumor regressions. Untreated, this carcinoma has a very short median survival (2 months). Administration of current "aggressive" combination therapy regimens has resulted in median survivals of nearly 1 year with some patients still living 3 years after therapy.

Alkylating Agents↗
PubMed1981

Epithelial carcinoma of the ovary: current strategies.

Epithelial ovarian cancer is usually diagnosed late in its biologic course (70% of cases are diagnosed as stage III or IV). Recent advances in chemotherapy and radiation therapy offer the possibility of long-term disease-free survival and the potential for cure. The selection of treatment for disease confined to the pelvis (stage I or II) remains controversial. After total abdominal hysterectomy, bilateral salpingo-oophorectomy, and omentectomy, high risk patients probably should receive abdominopelvic irradiation or chemotherapy; the relative roles of these two modalities are currently under study. Stage III consists of cases of minimal residual disease at surgery, minimal residual disease after debulking surgery, and residual large bulky tumor masses. Patients with minimal residual disease are best treated with either abdominopelvic radiation or chemotherapy; patients with stage IV or bulky stage III disease, with chemotherapy. Despite the multiplicity of active single agents, only one study to date has shown a statistically significant improvement in survival for patients with advanced disease utilizing combination chemotherapy.

Alkylating Agents↗
PubMed1979

cis-Dichlorodiammineplatinum(II) and hexamethylmelamine in the treatment of non-oat cell lung cancer: a pilot study of the Southeastern Cancer Study Group.

Fifty-one patients with metastatic non-oat cell carcinoma of the lung were treated with a combination of cis-dichlorodiammineplatinum(II) and hexamethylmelamine. The overall response rate (all cell types) was 16%. Four of 20 patients with adenocarcinoma had a partial response and an additional five patients classified as having stable disease had tumor regression less than 50%. The median survival of responders and of those with stable disease (all types) was 8 and 7 months respectively, significantly longer than the median survival of patients who progressed (median survival, 2 months [P less than 0.05]). The major dose-limiting toxicity was nausea and vomiting in over half of the patients; hematologic toxicity and peripheral neuropathy were the other adverse effects of the combination.

Adenocarcinoma↗
PubMed1978

Variable oral absorption of hexamethylmelamine in man.

Plasma levels of hexamethylmelamine were measured by a sensitive and specific gas chromatographic assay in 11 patients after they received oral doses ranging from 120 to 300 mg/m2. Peak levels were reached in 0.5--3 hours and ranged from 0.2 to 20.8 micrograms/ml. The area under the curve ranged from 70.2 to 3606.6 micrograms/ml x minute. The half-life of the beta-phase of elimination also showed considerable variability, ranging between 4.66 and 10.2 hours. These parameters were not related to the dose administered. No plasma accumulation of the drug was observed after daily treatment with hexamethylmelamine for 14--21 days.

Absorption↗
PubMed1979

Histologic grade in advanced ovarian cancer.

The histologic grade of epithelial ovarian tumors was found to be a major prognostic factor for survival in patients with advanced (stage III-IV) disease. In addition, a grading system based on cytologic detail (modified Broders' grades I-IV) identified groups with a differential response to chemotherapy. The overall improvement in survival observed with combination chemotherapy was related primarily to an increased survival of patients with grade II and III lesions. Although the survival of patients with grade I lesions was markedly better than for patients with grade IV lesions, in neither case was it influenced by the choice of single-agent or combination chemotherapy. In prospective clinical trials in advanced disease, modified Broders' grades should be included as a separate stratification factor.

Altretamine↗
PubMed1979

Combination chemotherapy for alkylator-resistant ovarian carcinoma: a preliminary report of a Southwest Oncology Group trial.

The Southwest Oncology Group has carried out a phase III study of combination chemotherapy in patients with advanced epithelial ovarian cancer who had become resistant to prior drug treatment. Patients previously treated with only alkylating agents were given adriamycin-5-fluorouracil-hexamethylmelamine-cis-dichlorodiammineplatinum(II) combination. There have been 12 partial and two complete responses among 29 evaluable patients (at least one full treatment course) entered in this four-drug combination, for a 48% response rate. Two (7%) additional patients showed objective improvement. The median duration of response was 5.8 months. Ten (34%) of 29 patients have died. The median duration of survival was 12+ months. Patients who had previously received adriamycin plus alkylating agent therapy were treated with 5-fluorouracil-hexamethylmelamine-cis-dichlorodiammineplatinum(II). Only 23 (31%) of these 74 patients have had partial responses while an additional 7% have had objective "improvement"; 27 (36%) of these patients have died. The median duration of survival was 14 months. Both drug regimens were well-tolerated. There were no drug-related deaths. Although thrombocytopenia was dose-limiting in up to 40% of the patients, the mean lowest platelet counts in the four- and three-drug regimens were 116,000 and 123,000/mm3, respectively. There were no cases of serious azotemia (ie, BUN level greater than 40 mg/100 ml) or severe peripheral neuropathy.

Alkylating Agents↗
PubMed1979

Phase II trial of cyclophosphamide, hexamethylmelamine, adriamycin, and cis-dichlorodiammineplatinum(II) combination chemotherapy in advanced ovarian carcinoma.

A monthly four-drug regimen of cyclophosphamide, adriamycin, and cis-dichlorodiammineplatinum(II), each given iv of Day 1, and hexamethylmelamine, given orally on Days 1--14 (CHAP), was administered to 39 women with advanced epithelial ovarian carcinoma who had previously failed alkylating agent therapy. Of 35 evaluable patients with a measurable disease parameter, seven (20%) achieved a clinical complete response and ten (29%) achieved a clinical partial response. The median duration of complete response is greater than 9 months and the median duration of partial response is 4 months. Ninety percent of the patients required dose adjustments because of profound leukopenia, thrombocytopenia, or gastrointestinal intolerance. CHAP is an active but toxic regimen in the management of advanced ovarian cancer. The toxicity encountered reflected the intensity of the drug schedule as well as the combined influences of advanced stage of disease, poor nutritional and performance status, and prior therapy. The efficacy of this CHAP regimen warrants a controlled trial compared to other active drug programs.

Alkylating Agents↗
PubMed1979

The CHAD and HAD regimens in advanced ovarian cancer: combination chemotherapy including cyclophosphamide, hexamethylmelamine, adriamycin, and cis-dichlorodiammineplatinum(II).

Combination chemotherapy consisting of hexamethylmelamine, adriamycin, and cis-dichlorodiammineplatinum(II) was given to 27 patients with advanced epithelial ovarian cancer whose disease had progressed while receiving therapy including alkylating agents. Eighteen patients (67%) had objective partial or complete remissions for a projected median duration of 7 months. Based on this high level of activity in this poor-risk group, the three drugs were combined with cyclophosphamide in a four-drug regimen (CHAD) for initial therapy suitable for outpatient administration. Nineteen of 21 evaluable patients (90.4%) receiving CHAD responded. Complete clinical remissions were noted in ten patients (47.6%) and were confirmed at "second-look" laparotomy in two of these. An additional five patients without evaluable disease after initial surgery are free from relapse at 4--15 months. Toxicity was only moderately severe; 28% of the patients had wbc counts less than 2000/microliters at some point. Nephrotoxicity from cis-dichlorodiammineplatinum(II) was almost completely prevented by a 2-hour outpatient regimen of hydration and diuresis. A prospective randomized trial is planned comparing CHAD to melphalan in previously untreated women with advanced ovarian cancer.

Adult↗