{"title":"Cystosarcoma phyllodes. Diagnosis and management.","authors":"J C Rosenfeld, D A DeLaurentis, H Lerner","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The diagnosis and management of cystosarcoma phyllodes is analyzed by reviewing the literature and presenting cases from our institution. This rare neoplasm of the female breast represents less than 1% of all breast tumors. Most patients present in the fourth and fifth decades of life. The predominant complaint is a palpable mass in the breast. Systemic manifestations occur after metastases have developed. Treatment is surgical excision. There is some controversy, however, over which type of surgical procedure should be performed. We recommend total mastectomy. Local recurrence and metastases do occur and have been related to inadequate surgery and various histological characteristics (mitotic activity, tumor margin, and stromal cellular atypia).</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"187-93"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17327549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R T Eagan, S Frytak, R E Lee, E T Creagan, J N Ingle, W C Nichols
{"title":"A case for preplanned thoracic and prophylactic whole brain radiation therapy in limited small-cell lung cancer.","authors":"R T Eagan, S Frytak, R E Lee, E T Creagan, J N Ingle, W C Nichols","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Thirty patients with previously untreated limited small-cell lung cancer were treated in a prospectively randomized trial comparing chemotherapy versus chemotherapy plus prophylactic whole brain radiation therapy. Without preplanned thoracic radiation therapy in addition to the chemotherapy, 78% of patients failed in the lung (52% in the lung solely) as the first site of treatment failure. In those patients not receiving prophylactic whole brain irradiation, 73% failed in the CNS at the time of first and second failure versus 13% of the group randomized to prophylactic whole brain radiation therapy (and those two before the radiation was given). A strong case can be made for the use of both preplanned thoracic and prophylactic whole brain radiation therapy in conjunction with combination chemotherapy, at least until much more effective chemotherapy is found.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"261-6"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17332220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M M Kligerman, A L Blumberg, J H Glick, D F Nelson, D Glover, J M Yuhas, H I Amols, R L Goodman
{"title":"Phase I trials of WR2721 in combination with radiation therapy and with the alkylating agents cyclophosphamide and cis-platinum.","authors":"M M Kligerman, A L Blumberg, J H Glick, D F Nelson, D Glover, J M Yuhas, H I Amols, R L Goodman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Three phase I trials of the radioprotector S-2-(3-aminopropylamino) ethylphosphorothioic acid (WR2721) have accessed 60 patients. Study 1 is devised to determine the maximum tolerated dose (MTD) of a single dose of the protector 15 to 30 minutes before a single radiation treatment of a size used routinely in palliative management. Study 2 plans to determine the MTD for up to 15 daily doses of the drug over 3 weeks during palliative radiotherapy. Also, the multipe-dose study will establish the MTD before palliative irradiation for fewer than five fractions a week. Study 3 uses the existing single-dose MTD determined in Study 1 as pretreatment 15 to 30 minutes before cyclophosphamide or cis-platinum. Toxic symptoms include emesis, hypotension, hypertension, somnolence, and sneezing. Only one serious episode of hypotension, considered idiosyncratic, and one instance of moderate to severe vomiting have occurred. Forty-one patients have been entered in Study 1 and a dose of 600 mg/m2 has been reached. The next step is to proceed to the planned highest level of 740 mg/m2. Of five patients in the multiple-dose study, one has been given, without toxicity, WR2721 at the level of 100 mg/m2 for 15 fractions over 3 weeks. Fourteen patients are accessed to the alkylating agent study. Using protector doses of 450 mg/m2, a cyclophosphamide level of 1500 mg/m2 has been accomplished. However, two of three patients who received 450 mg/m2 of WR2721 before 120 mg/m2 of cis-platinum have shown moderate elevation of the serum creatinine, both of which returned to normal.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 4","pages":"469-74"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17337454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Zinostatin and doxorubicin. A combination phase I study.","authors":"B F Issell, S J Ginsberg, R L Comis","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Because of encouraging single-agent activity for both zinostatin and doxorubicin in hepatocellular cancer, a phase I tolerance study with these drugs in combination was undertaken. The dose of zinostatin given daily for 5 consecutive days and repeated every 6 weeks was fixed at 2250 units/M2. The starting dose of doxorubicin was 45 mg/m2 on days 1 and 22 of every 6-week cycle, but this was escalated or deescalated by increments of 33% as tolerated. The occurrence of unpredictable severe and prolonged cumulative myelosuppressive toxicity in most patients resulted in considerable management difficulties. In addition, three patients developed congestive heart failure at cumulative doxorubicin doses ranging from 195 to 270 mg/m2 and two patients developed possible drug-related nephrotoxicity. Until reasons for the pharmacogenetic variability observed with zinostatin are defined, combination studies employing this drug are not recommended.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"323-6"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17332835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A clinical trial of pyrazofurin in combination with 5-azacytidine in acute adult nonlymphocytic leukemia.","authors":"D A Van Echo, D F Chiuten, S Markus, P H Wiernik","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Twenty adult patients with relapsed acute nonlymphocytic leukemia were given intravenously the combination of pyrazofurin (PF) 7.5-30 mg/m2 x 1 on day 1 plus 5-azacytidine (AZA) 150-250 mg/m2/d in three divided doses for 5 days. Four patients are early deaths secondary to infection or hemorrhage and are invaluable for response. Three patients achieved a response (two patients had a CR, the third patient had a CR, relapsed, and then a PR). Duration of response was short (41-94 days). Hematologic toxicity was universal and similar at al dose ranges studied. The median pretreatment WBC and platelet counts were 500 and 32,000/microliter, respectively, and the nadirs were 500 and 15,000/microliter. Recovery only occurred in those patients who achieved a response. Nonhematologic toxicity consisted of skin rash (100% of the courses), mucositis (60%), myalgia (93%), nausea and vomiting (83%), and hypotension (47%). In conclusion, although there is interesting preclinical data to suggest that the combination of PF and AZA has synergistic cytotoxicity on leukemic cells, this human clinical trial demonstrates that the combination has significantly more nonhematologic toxicity than AZA alone and no therapeutic advantage over treatment with AZA alone.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"129-33"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17232163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S Krauss, S Lowenbraun, A Bartolucci, R Buchanan, R Birch
{"title":"Alternating non-cross-resistant drug combinations in the treatment of metastatic small-cell carcinoma of the lung.","authors":"S Krauss, S Lowenbraun, A Bartolucci, R Buchanan, R Birch","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In a randomized trial of the Southeastern Cancer Study Group, patients with metastatic small-cell lung carcinoma were treated with a combination of cyclophosphamide (500 mg/m2 I.V.), Adriamycin (50 mg/m2 I.V.), DTIC (250 mg/m2 I.V.), and vincristine (1 mg/m2 I.V.) every 4 weeks for three cycles. Complete and partial responders to this induction regimen were then randomized to receive either the same combination every 4 weeks for an additional six cycles versus a non-cross-resistant drug combination of BCNU (100 mg/m2 I.V.), procarbazine (100 mg/m2 p.o. daily x 10 days), methotrexate (25 mg/m2 I.V.), and vinblastine (5 mg/m2 I.V.) every 4 weeks for six cycles versus alternating treatments with the two regimens for a total of six cycles of therapy. Patients who were less than good responders received six cycles of the non-cross-resistant drug combination. Of 202 evaluable patients, 40% responded (complete + partial responses) to induction; the complete response rate for the whole group was low (14%). Patients randomized to the BPMV combination, or crossed over to it, failed to improve upon their response to induction. Patients who responded to induction had a median survival of 41 weeks versus 20.6 weeks for the nonresponders, p less than 0.001. Performance status greater than or equal to 60%, and absence of prior radiotherapy were associated with improved survival (30 and 31.5 weeks, respectively). The toxicity of these regimens was acceptable. Failure to improve on results of our earlier protocol were probably due to the long (weeks) interval between treatments, inclusion of a relatively inactive but toxic drug (DTIC) in the induction combination which limited doses of the more active agents, and the use of a non-cross-resistant drug regimen which was inactive.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"147-53"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17327545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Phase II study of hexamethylmelamine for disseminated prostatic carcinoma.","authors":"A Drelichman, R Brownlee, M Al-Sarraf","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Hexamethylmelamine (NSC-13875) was given to 15 patients with disseminated prostatic cancer in a daily x 21 schedule at 6-week intervals. The schedule was 320 mg/m2/day in four divided doses for good-risk patients and 240 mg/m2/day for poor-risk patients. No response was observed in 14 evaluable patients, but seven patients had stable disease. Limiting toxicity was nausea and vomiting which developed in 80% of the patients and it was the reason for discontinuation of therapy in one patient. Hematologic toxicity was acceptable, and occurred in 80% of the patients. Leukopenia was more frequent than thrombocytopenia, occurring in 80% and 20%, respectively. All patients had been previously treated with hormones, but 6/15 were never exposed to cytotoxic chemotherapy.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"309-12"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17844853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J M Strong, J G Schwade, D Gangji, D D Shoemaker, D K Upton
{"title":"Misonidazole dose and tumor level relationships. Effects of individual variation in rate of misonidazole metabolism and absorption from the gastrointestinal tract.","authors":"J M Strong, J G Schwade, D Gangji, D D Shoemaker, D K Upton","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 1","pages":"41-6"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18228872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J W Myers, W A Knight, R B Livingston, C Fabian, J Costanzi
{"title":"Phase I-II trial of methyl-GAG in advanced colon cancer. a Southwest Oncology Group pilot study.","authors":"J W Myers, W A Knight, R B Livingston, C Fabian, J Costanzi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Forty-four patients with advanced colon or rectal cancer were treated with methyl-GAG on a weekly schedule. Of the 40 evaluable patients, 35 (87%) had received prior chemotherapy. Objective tumor regression was seen in six patients (one CR, five PR's). An additional nine patients had stable disease for a median of 42 weeks. The median survival (42+ weeks) for responding and stable disease patients was significantly better (p = 0.0001 Wilcoxan test) than those with progressive disease (11 weeks). Toxicity was reversible and included mild to moderate mucositis, nausea, vomiting, diarrhea, and thrombocytopenia. Responses observed in this study warrant further trials in patients with colon cancer who have no prior chemotherapy.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 3","pages":"277-9"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18297554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S B Greenberg, J R Glassburn, J Antoniades, L W Brady
{"title":"Management of carcinoma of the uterus stage II.","authors":"S B Greenberg, J R Glassburn, J Antoniades, L W Brady","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A total of 34 patients with Stage II endometrial carcinoma were evaluated for treatment in the department of Radiation Therapy at Hahnemann Medical College and Hospital from January 1958 to December 1977. Nineteen patients were treated by a standard radiation therapy technique using two radium placements and external beam therapy designed to give a high central tumor dose and also to give adequate radiation to the pelvic lymph nodes. A second group of 15 patients was treated by a wide variety of treatment programs, in most cases a combination of radiation and surgery. No significant difference can be seen between the results in the two groups. Excellent local control was obtained with one failure in each group. The high rate of distant failure indicates inaccuracies in the clinical staging and the diagnostic work-up methods available during this time. A more extensive pretreatment work-up utilizing computerized tomography, lymphangiography, or surgical exploration might improve the clinical staging and allow individualization of the treatment program.</p>","PeriodicalId":75672,"journal":{"name":"Cancer clinical trials","volume":"4 2","pages":"183-6"},"PeriodicalIF":0.0,"publicationDate":"1981-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"18262296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}