SEARCH · PubMed Health

Results for “ECOG”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,063 records · Page 59Linked to original sources

PubMed1997

Comparison of melphalan and prednisone with vincristine, carmustine, melphalan, cyclophosphamide, and prednisone in the treatment of multiple myeloma: results of Eastern Cooperative Oncology Group Study E2479.

BACKGROUND: The Eastern Cooperative Oncology Group (ECOG) performed a Phase III comparison of melphalan and prednisone (MP) with vincristine, carmustine (BCNU), melphalan, cyclophosphamide, and prednisone (VBMCP) in an attempt to determine which of these regimens should be the standard treatment for multiple myeloma. METHODS: Four hundred seventy-nine previously untreated patients with multiple myeloma from 23 ECOG institutions were enrolled. Treatment, assigned by randomization, consisted of either 4-week cycles of MP or 5-week cycles of VBCMP. After 1 year of induction therapy, patients received MP or VBMCP maintenance therapy at 6- and 8- week intervals, respectively, until relapse. Patients who experienced treatment failure with MP were eligible for crossover therapy with VBMCP. RESULTS: Objective responses were obtained for 51% of patients receiving MP, as compared with 72% of patients receiving VBMCP (P < 0.001). Response duration was also longer with VBMCP (median, 18 months with MP vs. 24 months with VBMCP; P = 0.007). Overall survival was not significantly different between MP and VBMCP (P = 0.30). The 5-year survival for VBMCP was 26%, as compared with 19% for MP. VBMCP was associated with more nausea, peripheral nerve toxicity, alopecia, and neutropenia, but the infection rate was equal to that observed with MP. Both regimens were generally well tolerated. The main exception was that elderly patients who were confined to bed had a higher risk of death with VBMCP. The two regimens produced a similar incidence of late secondary myelodysplastic syndrome and acute leukemia. Crossover VBMCP for patients failing with MP was only minimally effective, with an objective response rate of 20% and median survival of 11 months after crossover. CONCLUSIONS: VBMCP is more effective than MP in producing and sustaining remission of multiple myeloma. It is associated with a marginal survival advantage and an apparently greater chance of surviving 5 years for patients who can tolerate moderately intensive combination chemotherapy. Cancer 1997;79:1561-7. 1997 American Cancer Society.

Adult↗

PubMed1997

Experience with ifosfamide and etoposide combination chemotherapy in extensive-disease small-cell lung cancer.

BACKGROUND: Ifosfamide, an isomeric analogue of cyclophosphamide, has significant activity against many human tumors including lung cancer, testicular cancer, lymphoma and sarcoma, and may be superior to its analogue. Herein, we report our preliminary experience using ifosfamide and etoposide (IE) combination chemotherapy in previously untreated patients with extensive-disease (ED) small-cell lung cancer (SCLC). METHODS: Patients with histologically or cytologically confirmed SCLC, measurable or assessable ED, no previous chemotherapy or thoracic irradiation, younger than 70 years of age, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-3, and adequate marrow, liver, and renal functions were eligible for treatment which consisted of ifosfamide 2.0 g/m2/d given intravenously (i.v.) for 3 days with mesna 400 mg/m2/dose i.v. administered 0, 4, and 8 hours after the daily administration of ifosfarnide, and etoposide 80 mg/m2/d i.v. given for 3 days in every 4 weeks for a maximum of 6 cycles. RESULTS: Between January 1994 and February 1995, 10 patients were enrolled into the treatment. All were men with a mean age of 63 +/- 6 years. Five patients had an ECOG PS of 0 or 1, 4 patients of 2, and 1 patient of 3. A total of 45 cycles of IE were given. The mean number of cycles per patient was 4.5 +/- 2.1. Six patients completed 6 courses of therapy. Thirty-two of 45 cycles (71%) of IE were given at full doses, while the remaining 13 cycles (29%) were given at 75% of doses. Nine patients were assessable for response. Eight patients had a partial remission and one patient had stable disease. The overall response rate was 89%. The median survival was 8 months (range, 0 to 23 months) and the median failure-free survival duration was 5.5 months (range, 0 to 18 months). The 1- and 2-year survival rates were 30% and 0%, respectively. Myelotoxicity was the most important toxicity, particularly neutropenia, while thrombocytopenia and anemia were mild. Five of 10 patients (50%) experienced grade 4 neutropenia, which occurred in 2 patients during the first course of IE and resulted in one patient death from early sepsis. Other nonhematologic toxicities were mild. CONCLUSIONS: Our preliminary experience demonstrates that ifosfamide is an active drug against SCLC and combination chemotherapy with IE results in similar response rate and median survival, but probably higher myelotoxicity than reported studies in patients with ED SCLC.

Aged↗

PubMed1997

PSA evolution: a prognostic factor during treatment of advanced prostatic carcinoma with total androgen blockade. Data from a Belgian multicentric study of 546 patients.

OBJECTIVES: To study the prognostic value of the prostate-specific antigen (PSA) response and its relationship with other initial prognostic factors during the treatment of advanced prostatic carcinoma with total androgen blockade. METHODS: Five hundred forty-six patients with advanced loco-regional (M0) or distant metastatic (M1) prostatic carcinoma treated with flutamide combined with either orchiectomy or LHRH analogues were included in this analysis. Initial patients characteristics and the PSA response were evaluated in relation to progression-free survival using a univariate and multivariate (Cox regression) analysis. RESULTS: The following prognostic factors were indicative of a decrease in progression-free survival: the absence of PSA normalization (< 4 ng/ml) after 3 or 6 months, M1 stage, high G grade, ECOG performance status > 1, presence of pain and absence of dysuria. In M1 patients the combination of PSA normalization after 3 or 6 months with initial G grade and ECOG performance status had the strongest predictive value. CONCLUSIONS: This study demonstrates that PSA normalization after 3 or 6 months along with initial tumor stage, grade and health status of the patient are the most important prognostic factors related to progression-free survival in the hormonal treatment of advanced prostatic carcinoma.

Aged↗

PubMedDate not supplied

A phase II study of weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (HDFL) in the treatment of recurrent or metastatic colorectal cancers.

Previous report suggested that weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin is a highly active and relatively low toxic regimen for the treatment of colorectal carcinoma (J Clin Oncol 9: 625-30, 1991). This phase II study was conducted to test this important observation by a slightly modified regimen in a larger group of patients. The weekly HDFL regimen consisted of 5-FU 2600 mg/m2/week and leucovorin 300 mg/m2/week (maximum 500 mg) in a 24-hour intravenous infusion. Between February 1992 and December 1995, a total of 42 patients with non-resectable, recurrent or metastatic colorectal adenocarcinoma were enrolled onto the study. Twenty-nine (69.0%) patients had prior exposure to lower-dose 5-FU. There were 22 men and 20 women with median age of 60 (20-75) years. They received a total of 855 and an average of 20.4 (4 to 65) courses of HDFL chemotherapy. Most patients were treated at outpatient clinics and the drugs were infused by an ambulatory pump system via a Port-A catheter. The median duration of follow-up was 22 months. ECOG Gr 2-3 stomatitis, diarrhea, nausea, and vomiting developed in 6 (14.3%), 6 (14.3%), 5 (11.9%), and 5 (11.9%) patients, respectively. Twenty (47.6%) patients had developed hand-foot syndrome. There was no hematological toxicities except 3 (7.1%) patients developed ECOG Gr 1-2 leucopenia. The overall response rate was 42.9% (28%-59%, 95% C.I.) with 2 complete responses and 16 partial responses. Eight (61.5%; 31%-86%, 95% C.I.) of 13 patients, who had no previous 5-FU exposure, responded (1 complete response, 7 partial responses). Ten (34.5%, 17%-54%, 95% C.I.) of 29 patients, who had had previous lower-dose 5-FU exposure, responded (1 complete response and 9 partial responses). The median duration of response was 5 months (1+ to 23+ months). The median overall survival of the whole group of 42 patients and the 18 responders was 10 and 22 months, respectively. Our data supported the original results of HDFL regimen in the treatment of colorectal cancers. HDFL regimen can be used either as first-line or second-line treatment for non-resectable, recurrent or metastatic colorectal cancers.

Adult↗

PubMed1998

[Physiology of sleep-wakefulness rhythms].

As the most important site for sleep-wakefulness change, the role of the hypothalamus is particularly emphasized based on our long term experimental data. After rostral midbrain transection, ECoG of the isolated forebrain recovered sleep-wakefulness change, with circadian rhythm, one week after transection. In this preparation, after additional bilateral preoptic or posterior hypothalamic lesions, ECoG "insomnia" or "coma" pattern appeared, respectively. Therefore, the mechanism of sleep-wakefulness change of the forebrain primarily does not depend on the lower brain stem structures such as the raphe nuclei and midbrain reticular formation. Hypothalamic sleep-wakefulness mechanism usually receives strong influence from the suprachiasmatic nucleus, but it can exert its own ultradian "rhythms" (very irregular though) in intact rats or in rats with suprachiasmatic lesions.

Animals↗

PubMed1998

[Primary gastrointestinal lymphomas: response to eradicative therapy and prognostic factors in 52 patients].

BACKGROUND: To analyze the response to eradicative therapy and prognostic factors in 52 patients with primary gastrointestinal lymphoma (PGIL) diagnosed at a single institution in a 13 year period. PATIENTS AND METHODS: The main clinical, biological and evolutive data were recorded. Pathologic diagnosis of PGIL was made according to the Working Formulation. Clinical stage was determined by the Ann Arbor system modified by Mushoff. The results of therapy as well as the influence of such characteristics on complete remission (CR), disease-free survival (DFS) and overall survival (OS) were studied. RESULTS: Mean age of the series was 53 years (SD 15). Thirty patients were males. HIV infection preceded PGIL diagnosis in 10 cases. Seventeen had bad performance status (ECOG 2-4) and 30 B symptoms. The PGIL localization was gastric in 31 cases and 29 had a low grade malignant lymphoma. B phenotype was demonstrated in 98% and 22 patients presented advanced stages (IIE2-IV). Treatment was radical surgery followed by intensive chemotherapy in 32 cases, intensive chemotherapy alone in 17, and surgical resection in 3. CR was obtained in 34 patients and 6 of them relapsed. The projected DFS from CR at 9 years was 72% and OS was 26%. CR and survival were not influenced by PGIL localization and treatment type. The main unfavourable prognostic factors were advanced stage (CR and OS), B symptoms (DFS and OS) and advanced ECOG score (CR, DFS and OS). Previous HIV infection had an independent prognostic influence on both CR and OS. CONCLUSIONS: In patients with PGIL, the achievement of CR, DFS and survival have been independent of the type of eradicative treatment used. Performance status, B symptoms and clinical stage have been the main prognostic factors. HIV infection carried an independent prognostic significance.

Adult↗

PubMed1998

[Two cases of mesial temporal lobe epilepsy associated with old intracerebral hemorrhage in the lateral temporal lobe without "dual pathology"].

Two cases of intractable temporal lobe epilepsy associated with old intracerebral hemorrhage in the lateral temporal lobe were reported. Although preoperative magnetic resonance imaging (MRI) failed to reveal hippocampal atrophy with T2 hyperintensity, electrocorticographic (ECoG) recording with chronic invasive subdural electrodes indicated the mesial temporal lobe to be an ictal onset zone. After anterior temporal lobectomy involving the lesion and hippocampectomy, the patients became seizure-free. Hippocampal sclerosis, namely "dual pathology", was not noted on histological examination. Careful ECoG recording with chronic subdural electrodes is mandatory even when the preoperative MRI does not demonstrate the radiological hippocampal sclerosis.

Adult↗

PubMed1998

Patient management strategies for interferon alfa-2b as adjuvant therapy of high-risk melanoma.

PURPOSE/OBJECTIVES: To review results of Eastern Cooperative Oncology Group (ECOG) trial E1684 in the context of nursing issues concerning interferon alfa-2b (IFN alpha-2b) as adjuvant therapy for high-risk melanoma. DATA SOURCES: Published results of ECOG trial E1684 and additional safety data provided by the trial sponsor. Selection of material was based on information that would expand on published safety results and present patient-management strategies relevant to oncology nurses. DATA SYNTHESIS: High-dose IFN alpha-2b significantly prolonged median relapse-free survival (< 0.01) and overall survival (p = 0.047), but side effects required extensive nursing interventions. With appropriate patient management, including dose modifications, 74% of patients who did not relapse received a full course of therapy. CONCLUSIONS: Adjuvant, high-dose IFN alpha-2b can significantly prolong relapse-free and overall survival in patients with high-risk melanoma, but nursing interventions are required to ensure patient compliance. IMPLICATIONS FOR NURSING PRACTICE: Accurate nursing assessment and appropriate interventions can help patients safely complete this effective adjuvant therapy.

Antineoplastic Agents↗

PubMed1998

[Electroencephalogram findings in lesionectomies: preliminary results].

INTRODUCTION: Use of the electrocorticogram (EcoG) in planning lesionectomies is a controversial subject at present. MATERIAL AND METHODS: We describe a series of 5 patients with epileptic crises, 3 with arteriovenous malformations in whom the lesion was completely resected, followed by postoperative angiography, and two with gliomas with low grade malignancy in whom iridium 192 was implanted. RESULTS: 1. The most frequent reason for consultation was convulsions. 2. In our series of patients the commonest site was the frontal zone of the right hemisphere. 3. Potentials with epileptiform characteristics were registered at the edges of the lesions and occasionally over the lesion itself. In two cases electro-clinical crises were seen. 4. The lesions were resected from normal tissue independently of the EcoG results. CONCLUSION: Although they are preliminary findings, the results of the study support the usefulness of this technique to guide the surgical procedures used for the treatment of intractable epilepsy.

Adolescent↗

PubMed1998

Summating potential and action potential ratio in Meniere's disease before and after treatment.

OBJECTIVE: This study aimed to compare the summating potential and action potential ratio (SP:AP) in patients with Meniere's disease before and after various surgical and medical treatments as an indication of change in endolymphatic hydrops to study the progression of Meniere's disease. STUDY DESIGN: The study design was a retrospective case review. SETTING: The study was conducted at an otology-neurotology referral center. PATIENTS: Eighty-eight ears of 84 patients with Meniere's disease received medical treatment in 18 ears and surgical treatments including endolymphatic shunt in 12 ears, streptomycin perfusion of the lateral semicircular canal in 9 ears, streptomycin perfusion of the middle ear in 33 ears, and dexamethasone perfusion of the middle ear in 16 ears. INTERVENTION: Transtympanic electrocochleography (ECoG) was performed in all patients before treatment and 1-57 months after treatment (mean, 13.5 months) with a 2-year interval in 28 patients. MAIN OUTCOME MEASURE: An enlarged SP:AP ratio (> or = 0.40) was used as the diagnostic criterion for endolymphatic hydrops. RESULTS: Overall, an enlarged SP:AP ratio was found in 75% of ears before treatment and 78% after treatment. The SP:AP ratio, when enlarged, remained enlarged in 91% of ears. A nonenlarged SP:AP ratio before treatment became enlarged after treatment in 41% of ears. In American Academy of Otolaryngology-Head and Neck Surgery stage 1 Meniere's disease (pure-tone threshold average < or = 25 dB), an enlarged SP:AP was found in 58% of ears before treatment and 79% after. Twenty-five (89%) of 28 patients followed for 2 years were free of vestibular symptoms after treatment, and in 22 patients (79%), the SP:AP remained enlarged. The distribution of an enlarged SP:AP ratio was associated with the duration of disease (chi-square = 33.5552, p < 0.01). CONCLUSIONS: The development of endolymphatic hydrops, as indicated by an enlarged SP:AP, is part of the progression of Meniere's disease. The longer the duration of the disease, the more likely the SP:AP ratio will be enlarged. These findings indicate that endolymphatic hydrops as detected by ECoG was not reversed in this study by the treatments used. Despite the absence of definitive spells of vertigo in most patients, endolymphatic hydrops as evidenced by an enlarged SP:AP ratio persisted.

Adolescent↗

PubMed1998

[Prognostic factors in low-grade lymphoma].

PURPOSE: Prognostic factors in low grade non-Hodgkin's lymphoma (LGL) are not well established. The aim of this study is to investigate prognostic factors on LGL treated in our institution during the last decade. PATIENTS AND METHODS: The study was carried out on 70 cases of newly diagnosed LGL, most treated with CVP or clorambucil and prednisone. The median follow-up was 37 months (1-132). Variables reported as prognostic factors in previous series were subjected to bivariate and multivariate analysis. RESULTS: Relevant clinical features were: Ann Arbor III-IV stage 74%, ECOG > or = 2-17%, bone marrow involvement 60% and large tumor burden according to MD Anderson criteria 21%. Complete response (CR) was achieved in 50% and partial response in 29%. In bivariate analysis factors related with poor CR were B symptoms, large tumor burden, high LDH and more than one extranodal site involvement. Logistic regression showed that large tumor burden (p = 0.02; OR = 0.07) and B symptoms (p = 0.07; OR = 0.14) were the best prognostic factors of poor CR. Five year global survival (GS) was 55%, with a median of 76 months. In univariate analysis factors related with GS were ECOG > or = 2, B symptoms, bulky, large tumor burden, retroperitoneo involvement and absence of CR. In multivariate analysis the only factor related with poor GS was large tumor burden (p < 0.00001; RR = 5.93). When therapeutic response was included in the model, absence of CR (p = 0.008; RR = 3.40) and large tumour burden (p = 0.005; RR = 3.86) were the factors selected. CONCLUSIONS: In LGL tumor burden was the most important prognostic variable. Tumor response showed less importance than in high grade lymphomas.

Adult↗

PubMedDate not supplied

Experimental model studies of pesticide exposure.

The neurotoxic effects of Dimethoate (Dim), Dichlorvos (DDVP) and Methyl-Parathion (MP) respectively were investigated on the central nervous system (CNS) and peripheral nervous system (PNS) of rats after different treatment schedules at the macro and single unit cell level. At the macro investigations 1/25, 1/50 and 1/100 of the respective LD50 values of each pesticide were administered to different groups by gavage daily in the following programs: Pregnancy variation (P) to females from 5th to 15th days of pregnancy; Pregnancy and lactation variation (P+L): to females as above and during lactation for 4 weeks; Pregnancy+lactation+post weaning variation (P+L+P) as above plus to the young male rats (F1 generation) up to 8 weeks. Neurotoxicological investigations were conducted on the F1 rats at the age of 12 weeks. Spontaneous electrocorticograms (ECoG) were recorded on the anesthetized rats from the somatosensory, visual and auditory cortex. Cortical evoked potentials (EP) were recorded from the same areas subsequently. Conduction velocity and refractory periods of the tail nerve was investigated. Treatment by Dim, DDVP and MP during P and P+L of the mothers did not influence the bioelectric activity of the offsprings significantly. The same treatment by the P+L+P programme, resulted in significant changes. Frequency of the spontaneous ECoG waves grew significantly in all dose groups of P+L+P group. Latency time become shorter after somatosensory. light or acoustic stimuli respectively on one hand and the beginning of the of answer of these by the evoked potential (EP) waves on the other hand. Conduction velocity of the tail nerve diminished, refractory periods grew dose dependently and significantly at the P+L+P programs with all the three pesticides. Cortical single unit activity was studied after the i.p administration of 1/5 LD50 of the three organophosphates (OP). The decrease of the firing frequencies was observed. The amplitude of the hippocampal population spikes increased. The changes observed in these studies point toward a higher excitation state of the CNS and a disturbed conduction of the nervous impulses of the peripheral nerves. These results could be taken into consideration when deciding on human contaminations by OP-s.

Animals↗

PubMed1996

[Seizure activity and lesions of neuronal cells by intrahippocampal injection of guanidinosuccinic acid in rats].

Intrahippocampal injection(ihci) of guanidinosuccinic acid (GSA) to rats, induced typical generarized clonic seizures and epileptiform discharges in electrohippocampogram (EHG) and electrocorticogram (ECoG), degenerative changes of neuronal cells in the injected side hippocampus. The pyramidal cells in CA1 area were found to be more vulnerable to GSA than the granular cells. Phenobarbital and phenytoin are typical antiepiletics, but in no case did they successfully protect against GSA induced convulsions, epileptiform discharges in the EHG and ECoG and neurolysis. Ketamine, a selective noncompetitive NMDA receptor antagonist, was shown to protect against not only seizures, but also neuronal cell damage induced by GSA. All these results indicate that GSA very like the endogenous excitatory amino acid, glutamic acid, it also has such effects mentioned above. Therefore, the NMDA receptor may mediate both effects of GSA.

Animals↗

PubMed2026

Prognostic modeling of overall survival in metastatic pancreatic cancer: an inflammation-based tool validated in PANTHEIA-SEOM cohort.

PURPOSE: To develop and internally validate the PANTHEIA-SIRI prognostic model, which integrates log-transformed systemic inflammation response index (SIRI) with clinical predictors, to estimate overall survival (OS) in metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with first-line chemotherapy. METHODS: We used data from the multicenter PANTHEIA-SEOM registry. OS was defined from chemotherapy start. The model was fitted as a Weibull accelerated failure time model in the survival-analysis population with multiple imputation. Predictors were log-transformed baseline SIRI, modeled with restricted cubic splines, ECOG, tumor burden, chemotherapy regimen, and anorexia-cachexia syndrome. Internal validation used a separate, non-overlapping cohort from the same registry; the centers contributing to each cohort are listed in a supplementary annex. TRIPOD was followed. Discrimination was assessed with Harrell´s C-index and calibration with IPCW Brier scores and IPA. RESULTS: The derivation cohort comprised 672 patients with SIRI data (593 analyzed for survival) across 22 Spanish hospitals (2015-2025); 80.1% had died after a median OS of 9.9 months. The imputation-pooled derivation C-index was 0.654 (95% CI, 0.627-0.681); optimism-corrected, 0.629. Internal validation used 62 separate patients from the same registry; 96.8% had died after a median OS of 9.2 months. The validation C-index was 0.603 (95% CI, 0.518-0.687). Calibration was adequate at 6 and 12 months. CONCLUSIONS: The PANTHEIA-SIRI model provides individualized OS estimates in mPDAC with routine clinical predictors. Its open-access calculator ( https://pantheia-siri.shinyapps.io/calc/ ) may support prognostic communication, treatment-intensity selection, and supportive-care planning. Routine clinical implementation will require further validation in larger, fully independent cohorts.

Cachexia↗

PubMed1996

A randomized trial of megestrol acetate with or without premarin in the treatment of potentially responsive metastatic breast cancer. A Study of the Eastern Cooperative Oncology Group (E2185).

BACKGROUND: Human breast cancer cells in vitro exhibit increased levels of progestin receptors (PgR) after brief exposure to physiologic concentrations of estrogens. Prior clinical studies have positively correlated the responsiveness of metastatic breast cancer to progestin therapy with the level of PgR in the tumor cells. METHODS: These observations were used as the scientific basis for a randomized clinical trial by the Eastern Cooperative Oncology Group (ECOG) to compare the effectiveness of megestrol acetate (MEG) alone in a daily dose of 160 mg with MEG alternated with premarin in a dose of 1.25 mg/day on the first 3 days of a 14 day cycle (PRE/MEG). From 1985 through 1989, 266 eligible and fully evaluable patients were randomized to 1 of the treatment arms and accrued to this trial. All patients were postmenopausal with biochemical estrogen cytosol protein receptor (ER) positive (> or = 10 fm/mg) tumors. The treatment groups were balanced with respect to performance status, number of involved organ systems, and PgR levels. RESULTS: Forty-five of 135 (33%) (95% confidence interval [CI], 25-42%) patients receiving MEG experienced a partial (PR) or complete (CR) response. Thirty-one of 131 (23%) (95% CI, 17-32%) patients receiving PRE/MEG achieved a PR or CR. Survival was not influenced by treatment selection. However, median time to progression was seven months for patients receiving MEG and four months for the group receiving PRE/MEG (P = 0.03). The treatment failure hazard rate was higher for patients with a short disease free interval after primary treatment of the breast cancer, poor performance status, non-white race, and visceral disease. Survival was negatively impacted by short disease free interval, administration of prior radiation therapy, prior treatment for metastatic disease, and hepatic involvement. CONCLUSIONS: Sequential treatment with premarin and megestrol acetate is not superior to treatment with megace alone in potentially hormone responsive patients with advanced breast cancer.

Antineoplastic Agents, Hormonal↗

PubMed1996

Phase II study of the oral cyclophosphamide and oral etoposide combination in hormone-refractory prostate carcinoma patients.

BACKGROUND: Hormonotherapy temporarily controls symptoms in 80% of patients with metastatic prostate carcinoma. Once progression occurs, no consensus exists on further therapy. Oral etoposide (VP-16) has shown clinical efficacy in advanced small cell lung carcinoma, breast cancer, germ cell tumors, and lymphomas, A synergistic effect between etoposide and alkylating agents such as estramustine was recently reported. We began a prospective Phase II study of an oral combination of cyclophosphamide (CPM) and VP-16 in patients with hormone-refractory [correction of refactory] prostate carcinoma (HRPC). METHODS: Patients were orally treated with CPM (100 mg/day) and VP-16 (50 mg/day) for 14 days every 28 days. Therapy continued until there was evidence of disease progression. RESULTS: From November, 1992, to February, 1995, 20 patients with HRPC were entered into the study. Patients were eligible if they had an ECOG performance status (PS) of 0 to 2. All of the patients presented with bone metastasis, and 70% presented with bone pain. Seventy-five percent had failed at least two hormonal manipulations. The mean duration of treatment was 5 months (range 2-12). Performance status improved in 26% of the patients, and bone pain was relieved in 71%. An objective response was defined as a decrease of 50% or more in the prostate-specific antigen (PSA) level. One patient demonstrated a complete response, and six patients had partial responses assessed by PSA plasma levels (objective response rate: 35%). The mean duration of response was 8 +/- 6 months (range: 2-24). Median survival was 11 months. Toxicities were minimal. CONCLUSIONS: The combination of oral CPM and VP-16 may be an active and well tolerated regimen for patients with HRPC.

Administration, Oral↗

PubMed1998

Adjuvant therapy of melanoma.

Patients with AJCC Stage IIB and III melanoma have a poor 5-year survival rate which has been the driving force behind attempts to find an effective adjuvant therapy for this stage of disease that would effectively reduce relapse and improve survival. Immunotherapy with bacillus Calmette-Guerin (BCG), Corynebacterium parvum, and levamisole have not been successful in achieving this goal, nor have trials with chemotherapy in the adjuvant setting, including high-dose chemotherapy with autologous bone marrow transplantation. The recent Eastern Cooperative Oncology Group (ECOG) 1684 study showed significant improvement in relapse-free and overall survival with high doses of alpha interferon (IFNalpha) given for 1 year. Lower dosages of IFNalpha have to date been unsuccessful in impacting upon long-term survival. Recent data with vaccines have been encouraging, and the GM2-KLH vaccine is the focus of ongoing intergroup study comparing this treatment with IFNalpha in resected Stage IIB and III melanoma. The various regimens are reviewed in this article.

Antineoplastic Agents↗

PubMedDate not supplied

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial.

The Telephone Counseling Trial for Breast Cancer Survivors is a randomized, controlled study designed to test the impact of a telephone-based counseling intervention on quality of life of early-stage breast cancer patients who have completed adjuvant treatment. A psychoeducational counseling model is utilized to promote adaptive coping to re-entry stressors and survivorship issues. Adaptation is fostered through the exploration of thematic materials, application of active coping strategies, encouragement of a personal expression of the breast cancer experience and the provision of psychological support. Patients are being recruited in collaboration with two NCI-designated clinical cooperative oncology groups: the Eastern Cooperative Oncology Group (ECOG) and the Southwest Cooperative Oncology Group (SWOG). The recruitment goal is 400 breast cancer survivors with Stage 1, Stage 2 and Stage 3 disease (with no greater than 10 positive lymph nodes involved). Patients are being enrolled by data managers on-site during their last treatment visit. The intervention is being delivered by the Cancer Information and Counseling Line (CICL) of the AMC Cancer Research Center. It includes 16 telephone outcalls which are delivered over a 12-month period. Primary outcome measures are quality of life, mood, social support, self-efficacy, and sexual functioning, assessed at baseline, 3, 6, 12 and 18 months follow-up. This article provides a description of the intervention protocol and study design. It is argued that this study could provide a model for developing and testing other psychosocial interventions within clinical cooperative groups nationwide.

Adaptation, Psychological↗