goserelin and Liver-Neoplasms

This pilot study aimed to test the possibility of therapeutic benefit imparted by early intervention based on sequential tumour marker (TM) measurements during follow-up of primary breast cancer (PBC) patients.. Patients with oestrogen receptor positive PBC with no clinical and/or radiological evidence of metastases were recruited and followed-up 3-monthly with clinical assessment and TM (CA15.3 and CEA) measurements. The clinical team was blinded to the TM results. Asymptomatic patients who developed raised TMs (based on pre-defined cut-offs) were randomised to either 'treatment change' (either start or change of adjuvant endocrine agent to another agent) or 'no change' (control). Patients who developed symptomatic metastases came off the study. The primary and secondary endpoints were intervals from randomisation to symptomatic metastases and to last follow-up/death respectively.. Eighty-five patients (median age = 54 years (30-72)) were recruited with a median follow-up of 81 months (1-124). Sixteen patients were randomised as described. There was no significant difference (treatment change versus no change) with regards to interval from randomisation to symptomatic metastases - 23 (2-62) and 22 (1-63) months respectively (p = 0.9), as well as interval from randomisation to last follow-up/death - 36 (7-63) and 37 (10-63) months respectively (p = 0.9).. Despite long follow-up (up to 10+ years), this small study has thus far shown no significant difference in outcome. However, we have confirmed the feasibility of this study design but a larger study will be required to show if there is a benefit to this approach.

Topics: Adult; Aged; Anastrozole; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Breast Neoplasms; Carcinoembryonic Antigen; Early Detection of Cancer; Female; Follow-Up Studies; Goserelin; Humans; Liver Neoplasms; Lung Neoplasms; Middle Aged; Mucin-1; Nitriles; Pilot Projects; Single-Blind Method; Tamoxifen; Treatment Outcome; Triazoles

The aim of the study was to evaluate the efficacy of antiandrogen therapy on overall survival and response in unresectable hepatocellular carcinoma (HCC).. A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were randomly assigned to receive one of the following treatments: pure antiandrogen plus placebo (A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administered monthly by subcutaneous injection. Treatment was given until death. Response was evaluated every 8 weeks according to World Health Organization (WHO) criteria.. Six patients were considered ineligible. One patient had a complete response (A+P arm) and three had a partial response (two in the LHRH+P arm and one in the A+LHRH arm). An overall log-rank test did not demonstrate any significant difference in survival among the four arms. Taking the factorial design into account, comparison of survival showed no significant difference between Anandron-containing regimens and others, or between LHRH-containing regimens and others. No serious side effects occurred for any regimen.. This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC.

Topics: Androgen Antagonists; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Hepatocellular; Double-Blind Method; Female; Gonadotropin-Releasing Hormone; Goserelin; Humans; Imidazoles; Imidazolidines; Liver Neoplasms; Male; Survival Rate; Triptorelin Pamoate

The EORTC conducted two randomized phase III trials of maximal androgen blockade (MAB) in 695 patients with metastatic prostate cancer. Trial 30,843 compared orchidectomy or buserelin to buserelin plus cyproterone acetate and showed no significant difference in survival while trial 30,853 showed that Zoladex plus flutamide had a significantly longer survival than orchidectomy. Reasons for this discrepancy were sought.. In order to determine whether differences in patient characteristics could explain these possibly contradictory results, a Cox proportional hazards regression model was used to identify prognostic factors for survival in each study. Patients were divided into risk groups (good or poor prognosis with 3.5 and 1.75 years' median survival, respectively) based on their alkaline phosphatase, hemoglobin, performance status, pain score, T category and G grade at entry on study.. The survival advantage of MAB in 30,853 was limited to patients with a good prognosis (164/302 (54%) of the patients). In 30,843, only 93/337 patients (28%) had a good prognosis so there were insufficient data to draw separate conclusions in these patients. Despite the limitations of subgroup analyses, these results show that patients in 30,843 had on the average a worse prognosis than patients in 30,853. Hence there were fewer good prognosis patients who could potentially benefit from MAB, thus providing one possible explanation for the overall negative conclusion.. These studies once again underline the importance of taking into account patient characteristics when designing and interpreting metastatic prostate cancer trials. They also provide criteria which may be used to define risk groups as part of a protocol's patient eligibility criteria. In the design of future trials assessing MAB, a sufficient number of good prognosis patients should be entered to reliably assess treatment efficacy in this subgroup.

Topics: Aged; Analysis of Variance; Androgen Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Buserelin; Combined Modality Therapy; Cyproterone Acetate; Disease-Free Survival; Flutamide; Goserelin; Humans; Liver Neoplasms; Lung Neoplasms; Male; Middle Aged; Multivariate Analysis; Neoplasm Staging; Orchiectomy; Prognosis; Proportional Hazards Models; Prostatic Neoplasms; Risk Assessment; Survival Rate

This European Organization for Research and Treatment of Cancer (EORTC) trial 30853 is the fifth EORTC--Genitourinary Group randomized phase III trial of endocrine treatment for patients with newly diagnosed metastatic prostate cancer. Special attention was given to the assessment of response and/or progression. Each of the following factors was assessed separately as nonspecific and subjective criteria of response or progression: performance status, pain, alkaline and acid phosphatase, hemoglobin, urinary symptoms, and prostate-specific antigen (PSA). Objective progression was based on measurable disease. The observed sequence of progression was: (1) protein-specific antigen; (2) bone; (3) pain; and (4) performance status. Protein-specific antigen, an optional parameter, was the first sign of progression in more than 50% of patients whose disease had progressed.

Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Flutamide; Goserelin; Humans; Liver Neoplasms; Lymphatic Metastasis; Male; Orchiectomy; Prospective Studies; Prostatic Neoplasms

Topics: Adult; Antineoplastic Agents, Hormonal; Bone Neoplasms; Breast Neoplasms; Drug Resistance, Neoplasm; Female; Goserelin; Humans; Liver Neoplasms; Neoplasm Recurrence, Local; Premenopause