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Biomedical subjects

M L Samuels

Publications and source records attributed to M L Samuels.

At least 37 records · Page 2Linked to original sources
PubMed1986

Cyclic chemotherapy with cyclophosphamide, doxorubicin, and cisplatin plus vinblastine and bleomycin in advanced germinal tumors. Results with 100 patients.

One hundred patients with advanced mixed germ-cell tumors were treated with cisplatin, cyclophosphamide, and doxorubicin alternating with vinblastine and bleomycin (cyclic CISCAII/VBIV). The chemotherapy achieved an 89 percent continuous disease-free status (85 percent with chemotherapy, 4 percent with chemotherapy plus surgery). The mean follow-up duration for patients with continuous complete remission was 132 weeks (+/- 6.2), with a median of 126 weeks. Multivariate analysis using a stepwise logistic regression of prognostic variables revealed that a high serum level of the beta subunit of human chorionic gonadotropin (more than 50,000 mIU/ml) was of prognostic significance, followed by the Samuels staging criteria and extragonadal origin of disease. Thirty-two patients underwent exploratory surgery after they had had two courses of chemotherapy beyond the establishment of a stable mass and absent serum biomarkers. No viable cancer was found at exploration, and all patients remain alive and free of disease. The acute toxicity of the cyclic chemotherapy was formidable, but only one patient had a fatal complication. Thirty-six percent of the CISCAII courses and 44 percent of the VBIV courses were associated with leukopenic fever, and 5 percent of the CISCAII courses and 8 percent of the VBIV courses were associated with culture-positive infection. Long-term toxicity was unusual: bleomycin lung toxicity 1 percent, cardiac toxicity 1 percent. CISCAII/VBIV cyclic chemotherapy is superior to cisplatin, vinblastine, and bleomycin (PVB) chemotherapy; it results in a higher complete remission rate, a lower relapse rate, and a lower incidence of long-term complications. Patients with a high risk of failure of PVB chemotherapy (Samuels stage IIIB3 to IIIB5) or with extragonadal tumors should be treated with CISCAII/VBIV.

Adolescent↗
PubMed1986

Use of analysis of covariance in clinical trials: a clarification.

Criteria are discussed for using analysis of covariance (ANCOVA) and t-tests in analysis of clinical trials. Revisions are suggested in the guidelines given recently by Egger et al. (Controlled Clin Trials 6:12-24, 1985). Specifically, if one assumes that treatment groups have been successfully balanced by randomization, then ANCOVA is more powerful than the t-test under a broad range of conditions; this is true even in the model assumed by the t-test, and regardless of the presence of measurement error. If the balance cannot be assumed, then under certain conditions the t-test should be preferred over ANCOVA on grounds of validity.

Analysis of Variance↗
PubMed1986

Carcinoembryonic antigen and beta-human chorionic gonadotropin as serum markers for advanced urothelial malignancies.

Serum levels of carcinoembryonic antigen and beta-subunit of human chorionic gonadotropin were measured in 92 patients with advanced urothelial malignancies referred to us for chemotherapy. Elevations of carcinoembryonic antigen and/or beta-human chorionic gonadotropin occurred in 60 of the 92 patients (65 per cent). Minimal elevations (less than 50 per cent above the normal range) occurred in 25 patients (27 per cent), while 35 (38 per cent) had significant elevations (more than 50 per cent above the normal range). Of the latter patients carcinoembryonic antigen alone was elevated in 16 (17 per cent), beta-human chorionic gonadotropin alone in 13 (14 per cent) and both in 6 (6 per cent). Among the 24 patients with initially elevated levels whose markers were re-evaluated during therapy the marker levels correlated with disease course in all 15 whose elevations were more than 50 per cent and in 4 of 9 with minimal elevations. In patients with adenocarcinoma of the bladder the carcinoembryonic antigen level frequently was elevated (9 of 10). We conclude that serum levels of carcinoembryonic antigen or beta-human chorionic gonadotropin are significantly elevated (more than 50 per cent above the normal range) in 38 per cent of the patients with advanced urothelial malignancies and can be used as tumor markers, since they correlate with the clinical course of the patient and the response to therapy. Serum carcinoembryonic antigen levels usually are elevated in patients with bladder adenocarcinoma.

Adenocarcinoma↗
PubMed1985

Chemotherapy for adenocarcinomas of bladder and urachal origin: 5-fluorouracil, doxorubicin, and mitomycin-C.

Eight patients with unresectable adenocarcinoma of the bladder or urachus were treated with chemotherapy. Four had received cisplatin-based chemotherapy (CISCA), all 4 failed to respond. All 8 received intravenous and/or intra-arterial 5-fluorouracil, doxorubicin hydrochloride (Adriamycin), and mitomycin-C. Three of the 5 responding patients had short responses while 2 had achieved long-term control of disease. One is in complete remission for eleven plus months, and 1 patient had a partial remission of nineteen plus months. Five patients had serum CEA levels measured at presentation. In the 3 patients with an elevated CEA at presentation who responded to chemotherapy a corresponding drop in the initial level was seen. 5-Fluorouracil-based chemotherapy is effective in the management of adenocarcinoma of the bladder.

Adenocarcinoma↗
PubMed1985

Cyclophosphamide, doxorubicin and cisplatin chemotherapy for patients with locally advanced urothelial tumors with or without nodal metastases.

Thirty-eight patients with primary urothelial tumors recurring in the pelvis or nodal presentation were treated with intravenous or intra-arterial cyclophosphamide, doxorubicin and cisplatin chemotherapy. The 38 patients were selected owing to unresectability by local criteria (12 patients) or by virtue of nodal metastases (26 patients). Histologically, the patients either had pure transitional cell carcinoma (29), transformation to a histological subtype of transitional cell carcinoma (7) or pure squamous cell carcinoma (2). An over-all 50 per cent complete remission rate was achieved with an 18 per cent objective pelvic response rate, and 32 per cent failed to respond to chemotherapy. Responses by histological subtype revealed that patients with pure transitional cell carcinoma had a 62 per cent complete remission rate, those with transitional forms had a 14 per cent complete remission rate and none with squamous cell carcinoma responded to chemotherapy. A significant difference in the incidence of responses among patients with transitional carcinoma and those with transition forms was seen (p less than 0.02). Complete remissions were independent of disease site. Nineteen patients achieved a complete remission with a mean duration of 86 weeks and median of 81 weeks (range 33 to 172 weeks). Toxicity of the chemotherapy was moderate with a high incidence of peripheral neuropathy and leukopenic infections. No deaths of chemotherapy were encountered. Patients with locally advanced or metastatic transitional cell carcinoma of the urothelium to lymph nodes can benefit from intravenous and intra-arterial cyclophosphamide, doxorubicin and cisplatin chemotherapy.

Adult↗
PubMed1985

Primary chemotherapy followed by a selective retroperitoneal lymphadenectomy in the management of clinical stage II testicular carcinoma: a preliminary report.

In 28 patients with primary clinical stage II testicular carcinoma (retroperitoneal mass of less than 10 cm. in diameter) or persistently elevated levels of serum biomarkers after orchiectomy primary chemotherapy was administered followed by selective lymphadenectomy for patients with a persistent retroperitoneal mass. Of the patients 21 were treated with cyclophosphamide, doxorubicin, cisplatin/vinblastine and bleomycin, and 7 who were not candidates for this regimen received less aggressive chemotherapy. All 28 patients were free of disease after a mean followup of 93.6 weeks and a median of 89 weeks (range 28 to 199.5 weeks). No patient who achieved complete remission has had relapse. Of the 28 patients 1 had a seminoma and an elevated alpha-fetoprotein level, 15 had embryonal carcinoma (Dixon-Moore category II) and 12 had teratocarcinomas (Dixon-Moore category IV). Only 1 of the 15 patients with embryonal carcinoma required surgical exploration for a persistent radiographic abnormality, whereas 6 of the 12 patients with Dixon-Moore category IV tumors required surgical exploration (p less than 0.0147). This delayed approach did not increase surgical complications. Our experience with primary chemotherapy followed by selective lymphadenectomy for stage II testicular carcinoma resulted in universal survival. Only 8 of the 28 patients (29 per cent) required lymphadenectomy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1985

Testicular cancer in homosexual men with cellular immune deficiency: report of 2 cases.

Embryonal cell carcinoma of the testis was seen in 2 homosexuals with peripheral lymphadenopathy of the head and neck, and abnormal cellular immunity measured by reduced T helper cells and increased T suppressor cells. One patient had no history of venereal disease but had taken marijuana, nitrites and methyl-dextroamphetamines regularly. The other patient had a history of syphilis, gonorrhea, hepatitis and venereal warts but rarely used inhalant recreational drugs. Both patients had smoked cigarettes. Neither patient had any known risk factors that predisposed to testicular cancer. Biopsy of a supraclavicular lymph node in 1 patient showed histological features of reactive follicular hyperplasia similar to those described previously in the acquired immune deficiency syndrome. These cases of testicular cancer increase the spectrum of rare cancers developing in young male homosexuals with acquired cellular immune abnormalities.

Acquired Immunodeficiency Syndrome↗
PubMed1985

Chemotherapy of extragonadal germ cell tumors.

Forty-nine patients with histologically proven germ cell tumors arising in extragonadal sites were retrospectively reviewed. Included in the review were an additional seven patients with undifferentiated tumors with a pathologic appearance compatible with that of a germ cell tumor and elevated levels of serum biomarkers (beta subunit of human chorionic gonadotropin [beta-HCG] +/- alpha-fetoprotein [AFP]. Nineteen patients had a pure seminoma arising in an extragonadal site, whereas 30 patients had nonseminomatous germ cell tumors. Seven patients had primary undifferentiated tumors with elevated levels of serum biomarkers. Sixteen (84%) of the 19 patients with pure extragonadal seminomas with normal levels of serum AFP are alive and free of disease. Eighteen of these 19 patients received platinum-containing regimens and four had received prior chemotherapy that failed. Of the patients with nonseminomatous germ cell tumors, 12 (40%) of the 30 are alive and free of disease with vinblastine/bleomycin +/- cisplatin (13 patients) or CISCAII (cisplatin, cyclophosphamide, and doxorubicin) (nine patients) alternating CISCAII/VBIV (eight patients) chemotherapy. None of the seven patients with undifferentiated germ cell tumors are alive and free of disease. Three of the five patients with pure anterior mediastinal endodermal sinus tumors treated with chemotherapy remain alive and free of disease. Of the seven patients with choriocarcinomas arising in extragonadal sites, three are alive and free of disease. A classification for patients with extragonadal germ cell tumors incorporating site of origin, histology, and likelihood of being truly extragonadal is proposed. The implications of this classification are discussed.

Abdominal Neoplasms↗
PubMed1985

Improved survival with cyclic chemotherapy for nonseminomatous germ cell tumors of the testis.

Forty-eight patients with advanced nonseminomatous germ cell tumors of the testis received a combination of cyclophosphamide, doxorubicin, and cisplatin (CISCAII) and a modified combination of vinblastine and bleomycin (VBIV) cyclic chemotherapy. Forty-four (92%) have achieved a complete remission. No patient in complete remission has relapsed with a mean follow-up of 139.0 weeks (SEM 7.0 weeks). The patients were stratified according to the modified Samuels clinical staging criteria. Thirty-seven (77%) had advanced disease (stage III-B3 to III-B5), ten of whom had advanced visceral non-lung disease (stage III-B5). Chemotherapy was individualized by tumor volume and response to therapy. Two courses were delivered after complete remission or the development of a stable mass with negative serum biomarkers. Twenty-four patients (50%) were explored for a persistent and stable mass. No viable cancer was found; 15 (62%) had mature teratomas and nine (38%) had scar. No patients suffered from doxorubicin cardiotoxicity, clinical pulmonary bleomycin toxicity, or persistent cisplatin renal failure. Four patients died. One patient, an unrecognized drug abuser, died of toxicity. Three with far-advanced tumors died of progressive disease. CISCAII/VBIV cyclic chemotherapy is superior to chemotherapy with vinblastine, bleomycin, and cisplatin, resulting in a 92% complete remission rate and a significant reduction in long-term toxicity.

Adolescent↗
PubMed1985

Combined intravenous and intra-arterial cyclophosphamide, doxorubicin, and cisplatin (CISCA) in the management of select patients with invasive urothelial tumors.

Twenty-eight patients with unresectable urothelial tumors who had no evidence of distant visceral metastasis were managed with iv CISCA (cyclophosphamide, doxorubicin, and cisplatin) and intra-arterial (ia) CISCA chemotherapy. Ten patients had locally advanced disease only and 18 had locally advanced disease with nodal metastasis (ten in pelvic nodes; seven in pelvic and para-aortic nodes; and one in pelvic, para-aortic, and mesenteric nodes). Eleven patients (39%) achieved a complete remission, with a median duration of 49 weeks (range, 25-108). Seven patients (25%) achieved on objective response and ten patients (36%) failed to respond. Iv and ia CISCA chemotherapy is effective in the management of advanced urothelial tumors. Patients with locally advanced disease with or without the presence of nodal metastasis are a select population in whom frequent complete remissions can be achieved.

Adult↗
PubMed1984

The prognostic significance of endodermal sinus tumor histology among patients treated for stage III nonseminomatous germ cell tumors of the testes.

A retrospective study was undertaken to determine the prognostic significance of endodermal sinus tumor (EST) elements in 56 patients with Stage III nonseminatous germ cell tumors of the testes (NSGCTT). The study patients were treated with conventional vinblastine, bleomycin and cisplatinum chemotherapy prior to our recognition of EST as a distinct entity. Twenty-one (37.5%) of the patients had EST elements in their tumors. Nineteen patients had EST in their primary testis tumor, whereas two had EST in metastatic sites only. Prognostic criteria (tumor volume, Dixon-Moore classification and chemotherapy vinblastin and bleomycin [VB] and VB plus cisplatin [VB + P] ) were similar in EST and non-EST patients. Long-term disease-free survival was significantly poorer for patients with Stage III NSGCTT containing EST (38%) compared with those not containing EST (71%) (P = 0.04). All 12 patients with small volume disease (III-B1-III-B2), independent of the presence of EST, are alive and free of disease for more than 2 years. Only 6 of 18 patients (33%) with advanced disease and EST are alive and free of disease, whereas 17 of 26 (65%) of patients with advanced disease not containing EST are alive and free of disease (P = 0.074). The addition of single agent bolus cisplatin to the treatment of patients with advanced disease achieved no improvement in survival. Endodermal sinus tumor must be included in future studies of advanced Stage III NSGCTT as an important prognostic variable.

Abdominal Neoplasms↗
PubMed1984

Surgery in the management of stage III germinal cell tumors. Observations on the M.D. Anderson Hospital experience, 1971-1979.

Sixty patients with initial stage III germinal tumors treated with conventional vinblastine, bleomycin and cisplatin chemotherapy (VB + P) were surgically explored. Twenty-two patients not treated with an initial retroperitoneal node dissection were surgically explored to pathologically confirm a complete remission following chemotherapy. Thirty-eight patients had a persistent mass in the absence of elevated serum markers. Seventeen (28%) patients had viable carcinoma at surgery. Eight (47%) of the 17 patients with viable carcinoma at surgery died of recurrent tumor. All but three patients with persistent viable carcinoma at surgery were treated with surgery followed by chemotherapy. Fourteen patients were found to have mature teratoma and one (7%) developed recurrent carcinomatosis. Two (8%) of the 25 patients found to have scar died. One patient died of recurrent carcinomatosis and one of postoperative complications. Ten additional patients with a suboptimal response to chemotherapy were surgically explored for attempted salvage. All ten died of recurrent tumor, with a median postoperative survival of 7 months. We believe optimal individualized chemotherapy is required for the management of stage III testis cancer. Therapeutic benefit for surgery can be demonstrated only in unusual circumstances. Attempted surgical excision of a clinically active germinal tumor is futile; hence patients with elevated serum biomarkers should not be explored. Patients with non-seminomatous germinal tumors and a residual postchemotherapy mass must be explored. The excision of mature teratoma is mandatory, as is documentation of the absence of viable carcinoma prior to cessation of therapy.

Adolescent↗
PubMed1983

Superior vena cava obstruction in small cell bronchogenic carcinoma. Clinical parameters and survival.

A clinical pathologic review with analysis of prognostic factors was conducted in 56 patients who were seen at the University of Texas M. D. Anderson Hospital and Tumor Institute between 1969 and 1980 with the syndrome of superior vena cava (SVC) obstruction secondary to small cell bronchogenic carcinoma. Most patients were men (60%), nonambulatory (61%), and had demonstrable extrathoracic disease (70%). The most common symptoms and signs of SVC obstruction were jugular venous distention (100%), swollen face (88%), and dyspnea (50%). Swollen arms (34%) and engorgement of thoracic veins (32%) were also common. Initial treatment consisted of irradiation alone, 17 patients (30%); chemotherapy alone, 32 patients (57%); or both, 7 patients (13%). Patients receiving chemotherapy initially had poor prognoses, as evidenced by the greater proportion of nonambulatory patients (72%) in this group. All but two patients received chemotherapy at some point during their clinical courses. There were 12 (21%) early deaths; 2 (12%) in the radiation arm; 9 (28%) in the chemotherapy arm; and 1 (14%) in the combined modality group. All treatment modalities were rapidly effective in controlling the symptoms associated with SVC obstruction. Within 1 week from onset of treatment, 9 of 14 (64%) evaluable patients responded to irradiation, 23 of 23 (100%) to chemotherapy, and 5 of 6 (83%) to combined modality treatment. The type of initial treatment did not influence survival significantly, although patients who achieved complete clinical remissions survived longer (median, 62 weeks). Death was usually due to disease progression in distant sites. Multivariate analysis indicated that the most important prognosticators of patients' survival were pretreatment performance status, disease-extent score, and age.

Adult↗
PubMed1983

The role of surgery following chemotherapy in stage III germ cell neoplasms.

After curative chemotherapy 58 patients with metastatic germinal tumors and 2 with extragonadal germinal tumors underwent an operation either to confirm a clinical complete response or to remove a residual mass. Biomarker status was converted to negative in all patients. Retroperitoneal lymphadenectomy was done in 22 patients after a complete clinical response was achieved and in 23 after an apparent complete response was achieved except for a residual retroperitoneal mass. Thoracotomy was done for a residual mass in 13 patients, while 2 underwent bilateral thoracotomy. Scarring was found in 25 patients (42 per cent), teratoma in 14 (23 per cent) and active tumor in 17 (28 per cent). One patient with scarring and primary seminoma died of disseminated seminoma, while 1 with primary teratocarcinoma died of disseminated disease, for a false negative rate of 3 per cent. Four patients with a residual mass showed unexpected findings: 2 had granulomas in the lung, 1 had carcinoid of the lung and 1 had retroperitoneal neurofibroma. Thus, there was a 7 per cent incidence of a mass being other than scar, teratoma or residual tumor. There was 1 operative death and 10 deaths of tumor, for an 18 per cent death rate. Of the 17 patients with active tumor 9 responded to salvage chemotherapy with stable complete remission and a minimum followup of 18 months. In addition to the 60 patients the advanced disease in 10 was surgically debulked after failure of chemotherapy and this procedure was followed by salvage chemotherapy. All 10 patients died, with a median survival of 7 months. The lack of responsiveness to chemotherapy was not improved by incomplete removal of tumor.

Humans↗
PubMed1983

Doxorubicin, mitomycin-C, and 5-fluorouracil (DMF) in the treatment of metastatic hormonal refractory adenocarcinoma of the prostate, with a note on the staging of metastatic prostate cancer.

Sixty-two patients with metastatic hormonal refractory adenocarcinoma of the prostate received a combination of doxorubicin, mitomycin-C, and 5-fluorouracil (DMF). Thirty (48%) of the patients achieved an objective response. Response criteria excluded disease "stabilization" as a manifestation of response. Four clinical prognostic categories were identified: osseous I (OI) had metastatic axial skeletal involvement (23 patients); osseous II (OII) had axial and extremity skeletaL involvement (18 patients); visceral I (VI) had pulmonary metastasis (9 patients); and visceral II (VII) had pulmonary metastasis and involvement of other viscera (12 patients). The 20 responding patients survived a median of 47.5 weeks, whereas the 32 nonresponding patients survived a median of 23.8 weeks (n = 0.002). Response rates were highest among patients with OI (52%) and VI (88%) disease; response rates were lower amont patients with OII (33%) and VII (33%) disease. Responding patients in each clinical category survived longer than nonresponding patients except for those patients with VII disease. The median duration of response for patients with OI disease was 11 months, for OII 9.5 months, for VI patients it was 6.5 months, and VII patients it was 5 months. DMF is an effective treatment of metastatic hormonal refractory prostate cancer, resulting in consistent objective responses. The staging system employed identifies four clinical categories of metastatic prostate cancer and allows for accurate comparison of diet and stratification of study populations.

Adenocarcinoma↗
PubMed1982

The growing teratoma syndrome.

Six patients with metastatic mixed germ-cell tumors who had been treated successfully with chemotherapy had recurring solitary enlarging masses. Four had enlarging pulmonary masses and two patients had enlarging abdominal masses. Each had the presumed chemotherapy refractory mass surgically resected and was found to have mature teratoma with absence of malignant histologies. The growth in two patients can be attributed to tense and expansile cysts; the remaining four had firm masses. All patients remain free of disease without further therapy at 5, 13, 14, 25, 66, and 108 months. Early recognition of this previously unreported and unusual clinical circumstance of a benign teratoma to grow after chemotherapy will allow for surgical salvage.

Adolescent↗