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S C Remick

Publications and source records attributed to S C Remick.

At least 37 records · Page 2Linked to original sources
PubMed1999

AIDS-related Kaposi's sarcoma: a phase II study of liposomal doxorubicin. The TLC D-99 Study Group.

TLC D-99 is a unique liposomal formulation of doxorubicin that consists of phosphatidyl choline/cholesterol. The objectives of the study were to evaluate safety and efficacy of two doses of TLC D-99 in the treatment of patients with AIDS-related Kaposi's Sarcoma (KS). Forty HIV-infected persons with biopsy-proven KS were randomized to receive TLC D-99 at doses of either 10 (low) or 20 (high) mg/m2 every 2 weeks. Patients assigned to the low-dose arm could be escalated to the high-dose arm if their KS progressed after 3 cycles of therapy. Median age was 35 years (range, 26-47) and median CD4 count was 13 (range, 0-440). Nineteen patients were assigned to receive the low dose, and 21 patients were assigned to the high dose. Partial response occurred in 15% (6 of 40) of the patients or in 5% (1 of 19) and 24% (5 of 21) in the low- and high-dose arms, respectively; stable disease was observed in 65% (26 of 40) or in 68% (13 of 19) and 62% (13 of 21) in the low and high doses, respectively. Neutropenia was the major toxicity and was observed in 68 and 81% of patients with the low- and high-dose arms, respectively; grade 4 neutropenia was observed in 16 and 14%, respectively. Mild alopecia was noted in only 8%. Therefore, TLC D-99 is active against AIDS-related KS, and the response is dose-dependent.

Acquired Immunodeficiency Syndrome↗
PubMed1998

A brief intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for advanced non-small cell lung cancer: results of a phase II trial.

To evaluate the efficacy and toxicity of a brief, intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for patients with stage IIIB and IV non-small cell lung cancer (NSCLC) and a favorable performance status. Thirty patients with no prior chemotherapy were enrolled in this phase II protocol. Patients received cisplatin 50 mg/m2, ifosfamide 2 g/m2, mesna, and a 7-day course of oral etoposide beginning on days 1, 15, 29, 43. and 57 for a total treatment duration of 10 weeks. Filgrastim was administered for 7 days after each course of oral etoposide. Megestrol acetate 250 mg PO was administered throughout the duration of chemotherapy. Thirty patients were evaluable for toxicity and 27 for response. Among those evaluable for response, partial remission occurred in 11 (41%) patients, and median survival was 10.5 months. Nadir neutrophil count of < 500/mm3 occurred in 19 (63%) patients. Weight loss occurred in only nine patients (median 3.4 kg, range 1.6-7.3). There was no difference between pre- and post-treatment weights (P=0.35). Two patients developed pulmonary embolism. Grade 3 or 4 non-hematologic toxicity occurred infrequently. This regimen appears to be similar in efficacy to the most active regimens reported by other investigators. Innovative features of the regimen include the brief treatment duration, the use of serial 7-day courses of filgrastim to facilitate weekly chemotherapy treatments, and the use of megestrol acetate to minimize constitutional symptoms. However the use of megestrol acetate in this setting may be associated with an increased risk of thromboembolic complications. This may provide a model for other palliative regimens specifically designed for patients with a favorable performance status and advanced NSCLC.

Adenocarcinoma↗
PubMed1998

Fumagillin analog in the treatment of Kaposi's sarcoma: a phase I AIDS Clinical Trial Group study. AIDS Clinical Trial Group No. 215 Team.

PURPOSE: Angiogenesis is a major component of Kaposi's sarcoma (KS) and a critical process in tumor growth. The present study was designed primarily to test the toxicity and pharmacokinetics (PK) of the angiogenesis inhibitor TNP-470 and secondarily to evaluate tumor response in patients with early AIDS-related KS. PATIENTS AND METHODS: Patients with AIDS-related KS were required to have cutaneous disease with > or = 5 measurable lesions and no evidence of pulmonary, symptomatic gastrointestinal, or acutely life-threatening KS. Thirty-eight patients received TNP-470 by weekly intravenous infusion over 1 hour at one of six dose levels for up to 24 weeks. RESULTS: The dose levels tested included 10, 20, 30, 40, 50 and 70 mg/m2. Median CD4 count was 24 cells/microl (range, 0 to 460). Fourteen patients (36%) had > or = 50 cutaneous lesions and 19 (49%) had oral lesions. Adverse events included neutropenia (n = 2), hemorrhage (n = 3), and urticaria (n = 1). PK studies showed wide interpatient and intrapatient variability. Elimination half-life values were short (range, 0.01 to 0.61 hours). Seven patients (18%) achieved a partial response. The median time to partial response was 4 weeks (range, 2 to 25), and the median duration of response was 11 weeks (range, 3 to 26+). CONCLUSION: TNP-470, administered as a weekly, 1-hour infusion to patients with early AIDS-KS is well-tolerated at doses up to and including the highest dose tested. Tumor responses were observed in a substantial number of cases and occurred at various dose levels. TNP-470 should be evaluated further in patients with AIDS-KS as a single agent and in combination with other biologic response modifiers in early disease or after initial response to cytotoxic chemotherapy.

AIDS-Related Opportunistic Infections↗
PubMed1997

Breast cancer in a man with human immunodeficiency virus infection.

Non-acquired immunodeficiency syndrome (AIDS)-defining neoplasms are being increasingly recognized in patients infected with the human immunodeficiency virus (HIV). The incidence of Hodgkin's disease and seminoma has recently been reported to be increasing in these patients. This article describes the second case of breast cancer in an HIV-infected male patient. A total of 11 cases of coincident breast cancer and HIV infection have previously been reported. It may be prudent to consider breast cancer in the differential diagnosis of an axillary mass in an HIV-infected patient.

Adult↗
PubMed1996

Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293.

The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.

Adenocarcinoma↗
PubMed1996

Lung cancer in patients with HIV-infection.

PURPOSE: To identify and review the clinical characteristics and natural history of lung cancer in HIV-seropositive patients. A secondary objective was to compare the clinical features of HIV-seropositive and HIV-indeterminate lung cancer cases at our institution. PATIENTS AND METHODS: Sixteen patients with HIV infection and lung cancer were diagnosed between January 1988 and March 1995 at our institution and the clinical records were reviewed. HIV-indeterminate lung cancer cases were identified by the Albany Medical Center Hospital (AMCH) Tumor Registry. A Medline database search of HIV infection/AIDS and lung cancer was undertaken through December 1994. The New York State Department of Health (NYSDOH), Bureau of Cancer Epidemiology provided information on the incidence of lung cancer among residents of New York State by county of residence. Case reports and series regarding the clinical features of HIV-seropositive patients with lung cancer were reviewed. A more focused comparison between HIV-seropositive and HIV-indeterminate male lung cancer cases between 35 and 54 years of age at our institution was performed. The following clinical variables were identified in our 16 patients and 109 cases extracted from available clinical reports: sex, age, year and county of residence at time of lung cancer diagnosis, cigarette smoking history, HIV risk behavior, CD4 count at time of lung cancer diagnosis, CDC classification of HIV disease, interval in months from time of HIV seropositivity to lung cancer diagnosis, pathology and stage of lung cancer, performance status, treatment, response, and survival. RESULTS: Lung cancer in HIV-seropositive patients is characterized by the following: a younger age at time of diagnosis when compared to HIV-indeterminate cases; the majority of cases occur in a background of extensive cigarette smoking; over 80% of patients present with advanced stage of lung cancer (stage III and IV); up to 50% of cases have asymptomatic to mildly symptomatic HIV infection with a median CD4 lymphocyte count of 233 per microliter; there is a predominance of adenocarcinoma histopathology; and shortened survival when compared to HIV-indeterminate cases. CONCLUSION: Current reports of lung carcinoma in HIV-seropositive patients suggest that the natural history of this disease is different than in HIV-indeterminate cases. Lung cancer must be considered in the differential diagnosis of a solitary mass lesion on chest X-ray in HIV-seropositive patients.

Adult↗
PubMed1996

Non-AIDS-defining cancers.

As the AIDS epidemic advances, the spectrum of malignancies encountered is expanding. Several non-AIDS-defining cancers are seen in increased incidence in HIV-infected patients. These include basal cell carcinoma of the skin, squamous cell carcinoma of the anus, Hodgkin's disease, seminoma, and pediatric leiomyosarcoma. There appears to be an emerging role for various concurrent viral infections in the HIV-infected host that are likely implicated in the pathogenesis of AIDS-related neoplasms. It will be important to track the epidemiologic and biologic features of non-AIDS cancers in HIV-infected patients. It is likely that further clues about malignant transformation and oncogenesis unraveled in this setting will have broader clinical implications.

Acquired Immunodeficiency Syndrome↗
PubMed1996

Concurrent 72-hour continuous infusion of etoposide and cisplatin in metastatic breast cancer.

We conducted a multiinstitutional phase II clinical trial to determine the toxicity, response, and survival rate of concurrent 72-h continuous infusion of etoposide and cisplatin in patients with metastatic breast cancer. A total of 26 women were enrolled, 4 of whom received no prior chemotherapy for metastatic disease. All patients were evaluated for toxicity, response, and survival employing the National Cancer Institute (NCI) Common Toxicity Criteria and the Eastern Cooperative Oncology Group (ECOG) response criteria. A total of 84 cycles of therapy were administered, median 3 (range 1 to 6). Severe grade 3 and grade 4 neutropenia occurred in 22 cycles (26%), and there were only 11 episodes (11%) of similar grade thrombocytopenia. Nausea and vomiting were seen in one third of cycles. A single patient (4%) had a complete remission, and seven patients (27%) had partial remissions for an overall objective response rate of 31% (95% confidence interval, 13 to 49%). Three of four patients (75%) without prior therapy for metastatic disease had objective responses. Median survival was 7 months. This combination regimen is active in extensively treated patients with metastatic breast cancer. It is responsible to further investigate the role of etoposide-cisplatin combination chemotherapy as firstline therapy for patients with metastatic breast cancer.

Adult↗
PubMed1996

Prevalence of human herpesvirus 8 DNA sequences in several patient populations.

We have undertaken a large-scale study of various tissues from normal controls and patients with Kaposi's sarcoma (KS) or other malignancies, both with and without human immunodeficiency virus infection, to determine the prevalence of human herpesvirus 8 (HHV-8) DNA. A total of 566 specimens were analyzed by PCR for the presence of HHV-8 DNA. Of the samples tested, 251 were obtained from patients with KS and 315 were obtained from patients without KS. HHV-8 DNA was detected in 103 (41%) of the 251 samples from patients with KS. In particular, 92% of KS tumor specimens were positive. None of the tissues from patients without KS showed evidence of HHV-8 DNA. Sequencing and phylogenetic analyses indicate a high degree of conservation (97.5 to 100%) among the HHV-8 strains tested.

DNA, Viral↗
PubMed1996

Continuous infusion etoposide in advanced AIDS-related kaposi sarcoma.

We conducted a preliminary phase II clinical trial to determine the toxicity, response, and survival rate of 72-hour continuous infusion etoposide administered to patients with AIDS-related Kaposi sarcoma. Nine patients with biopsy proven and measurable disease AIDS-related Kaposi sarcoma were treated with a continuous infusion of etoposide at a dose of 100 mg/m2 per day for 3 days every 3 weeks. All patients were evaluated for toxicity, response, and survival employing the NCI Common Toxicity Criteria, and both the Eastern Cooperative Oncology Group (ECOG) and AIDS Clinical Trials Group (ACTG) response criteria. All patients enrolled had at least two on-study poor risk factors by ACTG staging criteria. A total of 17 cycles of therapy were administered. Thirty-five percent of cycles were associated with grade 3 or greater leukopenia. Infectious complications were common, and there was one toxic death. Two partial responses (22%) by ACTG criteria were observed (95% confidence interval, 0% to 51%). In the absence of objective responses using more strict solid tumor response criteria and toxicity encountered we believe further evaluation of a 72-hour continuous infusion schedule of etoposide in patients with advanced AIDS and poor risk Kaposi's sarcoma is not warranted.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Practice effects with the NIMH AIDS abbreviated neuropsychological battery.

The degree of practice effects with the Brief NIMH Neuropsychological Battery for HIV Infection and AIDS is reported using a 7-10 day test-retest interval. The patient groups were asymptomatic and symptomatic of HIV while the control group was made up of "at risk" volunteers. Statistically significant practice effects were obtained on the California Verbal Learning Test, the Paced Auditory Serial Addition Task and the Visual Search Test among the infected individuals. The controls subjects demonstrated statistically significant practice effects on all of the neuropsychological tests. The implications of these findings in prospective studies are discussed.

Journal Article↗
PubMed1994

Didanosine compared with continuation of zidovudine in HIV-infected patients with signs of clinical deterioration while receiving zidovudine. A randomized, double-blind clinical trial. The Bristol-Myers Squibb AI454-010 Study Group.

OBJECTIVE: To determine the benefits of switching to didanosine compared with continuing zidovudine among patients infected with human immunodeficiency virus (HIV) who have previously used zidovudine and have signs of clinical deterioration. DESIGN: Randomized, double-blind, two-armed, parallel, comparative clinical trial with a blinded, compassionate crossover provision at 12 weeks. SETTING: Outpatient clinics at 19 tertiary care medical centers. PATIENTS: 312 patients infected with HIV who had received zidovudine for 6 months or more, had CD4 cell counts of 300/mm3 or less, and had signs of clinical deterioration within 12 weeks before study entry. INTERVENTION: Peroral didanosine tablets (600 mg/d adjusted for weight, "high dose") or zidovudine capsules (600 mg/d). MEASUREMENTS: Primary study end points were death, a new acquired immunodeficiency syndrome (AIDS)--defining event, or the combination of two new or recurrent HIV-related diagnoses with a 50% decrease in CD4 cells. RESULTS: Switching to didanosine was associated with fewer end points than continuing zidovudine (relative risk [RR] for zidovudine:didanosine = 1.5; 95% Cl, 1.1 to 2.0). This benefit was consistent across subgroups of patients with either AIDS-related complex or AIDS and was most apparent among those with a CD4 count at entry of 100/mm3 or more (RR = 2.2; Cl, 1.1 to 4.4). CONCLUSIONS: This study shows a positive treatment effect for switching from zidovudine to didanosine among patients with either AIDS-related complex or AIDS and validates the common practice of using clinical signs or a decrease in the CD4 count as an indication for changing therapy.

AIDS-Related Complex↗
PubMed1994

Continuous infusion bleomycin in AIDS-related Kaposi's sarcoma.

PURPOSE: To determine the toxicity, response, and survival rate of 72-hour continuous infusion bleomycin administered to patients with AIDS-related Kaposi's sarcoma. PATIENTS AND METHODS: Seventeen patients with biopsy-proven and measurable-disease AIDS-related Kaposi's sarcoma were treated with a continuous infusion of bleomycin at a dose of 20 mg/m2/d for 3 days every 3 weeks. All patients were evaluated for toxicity, response, and survival using the National Cancer Institute common toxicity criteria, and both the Eastern Cooperative Oncology Group (ECOG) and AIDS Clinical Trials Group (ACTG) response criteria. Fourteen of 17 patients (82%) enrolled had at least two on-study poor-risk factors by ACTG staging criteria. RESULTS: A total of 59 cycles of therapy were administered. Only one cycle (2%) was complicated by an absolute neutrophil count less than 500, and there were no episodes of febrile neutropenia. Fifty-four percent of cycles were associated with fever during the infusion, and five cycles (8%) were complicated by grade 3 rash. There were no other clinically significant (> or = grade 3) toxicities. There were seven partial remissions (41%) by ECOG criteria (95% confidence interval, 18% to 64%) and 11 partial remissions (65%) by ACTG criteria (95% confidence interval, 42% to 88%). Three of five (60%) previously treated patients had a partial remission with this schedule of bleomycin. The median survival duration was 7 months, with a range of 2.5 to 25 months. CONCLUSION: This continuous infusion schedule of bleomycin is active in patients with advanced-stage AIDS-related Kaposi's sarcoma and has acceptable toxicity. This regimen should be further evaluated in patients with earlier stage Kaposi's sarcoma and as salvage therapy.

Acquired Immunodeficiency Syndrome↗
PubMed1993

Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy.

OBJECTIVE: To evaluate the safety and efficacy of zalcitabine (also known as dideoxycytidine [ddC]) in patients with advanced human immunodeficiency virus (HIV) infection. DESIGN: Open-label, randomized study. SETTING: AIDS Clinical Trials Units, university-affiliated medical centers, and private practice groups. PATIENTS: Patients with the acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex who had tolerated zidovudine for 48 weeks or more. INTERVENTION: Fifty-nine patients received zidovudine (500 to 1200 mg/d) and 52 patients received zalcitabine (2.25 mg/d). MEASUREMENTS: The primary end points were survival and time to an AIDS-defining event or death. RESULTS: Because significantly more patients withdrew from zidovudine therapy, the median duration of treatment was greater in the zalcitabine group than in the zidovudine group (279.0 days compared with 174.5 days; P = 0.001). The estimated 12-month, event-free probabilities were 53% for the zalcitabine group and 57% for the zidovudine group (relative risk, 1.02; 95% CI, 0.5 to 2.2). The estimated 12-month survival rates were 81% for the zalcitabine group and 75% for the zidovudine group (relative risk, 1.39; CI, 0.5 to 3.8). The rate of decline in CD4 lymphocyte counts was significantly slower in the zalcitabine group than in the zidovudine group (-0.08 cells/day compared with -0.17 cells/day). Patients in the zalcitabine group had gained an average of 0.5 kg at week 20 and 0.4 kg at week 24, whereas patients in the zidovudine group had lost an average of 1.8 kg at week 20 and 2.4 kg at week 24 (P = 0.04 and P = 0.05, respectively). Moderate to severe peripheral neuropathy and ulcerative stomatitis occurred in 10 and 9 patients, respectively, in the zalcitabine group. CONCLUSIONS: The sample size for this study was smaller than planned, and no differences in survival and clinical end points were found. Slower rates of decline in CD4 lymphocyte counts and weight, however, were noted for the zalcitabine group.

Adult↗
PubMed1993

Concurrent radiation therapy and chemotherapy for locally unresectable squamous cell head and neck cancer: an Eastern Cooperative Oncology Group pilot study.

PURPOSE: The feasibility and success of an intensive chemoradiotherapeutic protocol for patients with locally advanced, unresectable squamous cell head and neck cancer was tested in this limited-institution, Eastern Cooperative Oncology Group phase II pilot study. MATERIALS AND METHODS: Between December 1987 and September 1989, 57 patients were entered onto this trial. The treatment protocol consisted of three courses of a 4-day continuous fluorouracil infusion, a single cisplatin bolus injection, and concurrent split-course radiotherapy. After 30 Gy of radiation and two chemotherapy courses, patients were evaluated for response and for the possibility of surgical resection. RESULTS: Fifty-five of 57 registered patients are assessable for toxicity and 52 are assessable for response and survival. Toxicity was significant, but tolerable, although there were three toxic deaths. A complete response to this treatment was ultimately achieved by 77% of patients. Twenty-four patients remain relapse-free. The projected Kaplan-Meier 4-year relapse-free survival rate is 45% and the overall survival rate is 49%. Median relapse-free and overall survival durations are 26 and 37 months, respectively. Of the 28 treatment failures, 79% were locoregional. Fourteen patients underwent surgery. Six remain relapse-free. CONCLUSION: This aggressive concurrent chemoradiotherapy protocol appears feasible within a cooperative group. Treatment results are promising and appear durable. A randomized phase III clinical trial is currently underway.

Adult↗
PubMed1993

Novel oral combination chemotherapy in the treatment of intermediate-grade and high-grade AIDS-related non-Hodgkin's lymphoma.

PURPOSE: To determine the toxicity, response, and survival rate of orally administered combination chemotherapy in patients with AIDS-related intermediate- and high-grade non-Hodgkin's lymphoma. Secondary objectives included prospective quality-of-life assessment and quantitation of cell-associated p24 antigen (p24 Ag) by flow cytometry. PATIENTS AND METHODS: Eighteen patients with biopsy-proven lymphoma were treated with oral chemotherapy consisting of lomustine (CCNU) 100 mg/m2 on day 1, etoposide 200 mg/m2 on days 1 through 3; cyclophosphamide 100 mg/m2 on days 22 through 31, and procarbazine 100 mg/m2 on days 22 through 31 at 6-week intervals. A variety of clinical assessments were performed: prospective quality-of-life assessment using the Functional Living Index-Cancer (FLIC) and Brief Symptom Inventory (BSI) instruments; indirect immunofluorescence with flow cytometry to measure cell-associated p24 antigen; and price of the oral regimen compared with two other intravenous combination chemotherapy regimens. RESULTS: The overall objective response rate using Eastern Cooperative Oncology Group (ECOG) criteria was 61% (95% confidence interval, 39% to 84%), with seven complete remissions (39%) and four partial remissions (22%). The median survival duration was 7 months, with a range of 11 days to 36 months. The treatment-related mortality rate was 11%. One patient developed CNS progression. Myelosuppression was the most frequent and severe toxicity encountered. Predictor variables of performance status (PS), prior history of thrush, and CD4 lymphocyte count were found to be of prognostic value. In a separate analysis, scores on the three subscales of the BSI were also found to be predictive of complete response. The price of this regimen is several thousand dollars less than that of other intravenous combination chemotherapy regimens. CONCLUSION: This regimen is active in patients with AIDS-related non-Hodgkin's lymphoma. Because it is important to design systemic cytotoxic chemotherapy regimens that are cost-effective, considerate of quality-of-life issues, and efficacious in this patient population, this approach should be compared with standard intravenous combination chemotherapy regimens in randomized controlled clinical trials.

Adult↗