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1.
Tumori ; 84(1): 39-44, 1998.
Article in English | MEDLINE | ID: mdl-9619712

ABSTRACT

In a prospective trial conducted by the Gruppo Onco Urologico Piemontese, newly diagnosed prostate cancer patients with bone metastases were randomized to receive goserelin (3.6 mg subcutaneously every 4 weeks) or goserelin plus mitomycin at 14 mg/m2 i.v. every 6 weeks. Treatment was planned to be continued until progression. The study was interrupted because of inadequate accrual rate when 63 patients had been recruited. A long-term follow-up (median, 47 months), performed to counterbalance the limited number of patients included, revealed no difference in time to progression and overall survival between the study treatments. However, 56.5% of assessable patients allocated to the chemotherapy arm presented a > or =90% reduction of prostate-specific antigen levels compared with 36.3% in the goserelin group, and previously elevated levels normalized in 73.9% versus 45.4%. Non-progressing patients received 5-7 cycles of mitomycin C with acceptable toxicity, but the cytotoxic treatment was interrupted early in all cases within the first year due to cumulative myelotoxicity. In conclusion, the results, although inconclusive, fail to support a clear advantage in terms of cost/benefit of chemotherapy plus hormone therapy over hormone treatment alone in advanced prostate cancer with bone involvement.


Subject(s)
Antibiotics, Antineoplastic/therapeutic use , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bone Neoplasms/drug therapy , Goserelin/therapeutic use , Mitomycin/therapeutic use , Neoplasms, Hormone-Dependent/drug therapy , Prostatic Neoplasms/drug therapy , Aged , Bone Neoplasms/blood , Bone Neoplasms/secondary , Disease Progression , Disease-Free Survival , Humans , Male , Middle Aged , Neoplasms, Hormone-Dependent/blood , Prospective Studies , Prostate-Specific Antigen/blood , Prostatic Neoplasms/blood , Prostatic Neoplasms/pathology , Survival Analysis , Treatment Outcome
2.
Cancer Chemother Pharmacol ; 41(4): 333-8, 1998.
Article in English | MEDLINE | ID: mdl-9488603

ABSTRACT

We assessed the activity and tolerability of a cisplatin, epirubicin, and lonidamine combination regimen as first-line chemotherapy in 28 advanced breast cancer patients. The schedule of treatment was as follows: 60 mg/ m2 epirubicin followed by 40 mg/m2 cisplatin given on days 1 and 2 every 21 days, with 450 mg lonidamine being given per os (three tablets) on days of chemotherapy administration and in the period intervening between one cycle and the next. Patients received a median of 5 (range 1-6) cycles. Overall, 22 patients were evaluable for response and 28, for toxicity. Four patients refused to continue the treatment after the first course, one was lost to follow-up, and one died due to toxicity (septic shock). The incidence of grade 3/4 nausea and vomiting was found to be greater than that expected with epirubicin and lonidamine alone. The addition of cisplatin resulted in an increase in platelet and hemoglobin toxicities, whereas the WBC toxicity did not differ from that expected with epirubicin and lonidamine. The hematological toxicity was found to be cumulative, leading to treatment delay in about 50% of patients at the fifth and sixth courses. The activity of this cytotoxic regimen was noteworthy, with the overall response rate being 81.8% (31.8% complete responses and 50.0% partial responses) in evaluable patients. This response rate decreased to 64.2% when all registered patients were included according to an intent-to-treat analysis. In conclusion, the association of cisplatin, epirubicin, and lonidamine given on the schedule described herein, appears to be very active but substantially toxic. We are now testing this combination in a randomized comparison, with the cisplatin dose being reduced to 30 mg/m2 given on days 1 and 2.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Administration, Oral , Adult , Aged , Anemia/chemically induced , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/pathology , Cisplatin/administration & dosage , Epirubicin/administration & dosage , Female , Humans , Indazoles/administration & dosage , Infusions, Intravenous , Middle Aged , Nausea/chemically induced , Pilot Projects , Thrombocytopenia/chemically induced , Treatment Outcome , Vomiting/chemically induced
3.
Anticancer Res ; 17(4A): 2763-8, 1997.
Article in English | MEDLINE | ID: mdl-9252712

ABSTRACT

Randomized trials suggest that the outcome of metastatic breast cancer (BC) patients is not affected by the currently available therapies. Although response rates per se may be associated with survival prolongation, patients experiencing objective response may be those patients fated to have the longest natural disease history. The separation of responders from progressing patients after first-line chemotherapy could allow the selection of a more homogeneous subgroup in which further treatment strategies might achieve a better control of the disease. This study investigated the influence of some patient characteristics, disease characteristics, and previous treatments on the outcome of non progressing patients after first-line chemotherapy with epirubicin administration. We also evaluated the effect of the maintenance endocrine therapy in improving response rate and overall survival (OS). From May 91 to May 93, 207 patients were enrolled in a randomized trial aiming to compare the activity of epirubicin (120 mg/sqm) +/- lonidamine (600 mg/daily). Among the 169 patients attaining complete (CR), partial response (PR) or disease stabilization (SD), 65 were not randomly submitted to maintenance endocrine therapy (MET). Liver involvement, previous adjuvant chemotherapy and previous hormonal therapy (administered in adjuvant setting or for advanced disease) were found to negatively influence OS both in univariate and multivariate analysis. Differences in OS stratifying patients according to DFI, estrogen receptor status and PS did not attain statistical significance. Patients receiving MET survived significantly longer than those submitted to observation and this difference maintained the statistical significance also within patient subsets homogeneous for specific prognostic features. In conclusion, most prognostic factors for advanced BC have been confirmed in our series of patients obtaining CR, PR or SD to full dose epirubicin. The positive prognostic impact of MET is impressive and deserves confirmation in randomized studies.


Subject(s)
Breast Neoplasms/drug therapy , Epirubicin/therapeutic use , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Female , Humans , Indazoles/therapeutic use , Middle Aged , Multivariate Analysis , Neoplasm Metastasis , Prognosis , Survival Analysis
4.
Br J Cancer ; 75(5): 698-702, 1997.
Article in English | MEDLINE | ID: mdl-9043027

ABSTRACT

In order to study the relationship between circulating levels of CA 15-3 and the disease extent in predicting survival, we prospectively followed 312 breast cancer (BC) patients, from October 1988 to March 1995, from the time of first relapse. CA 15-3 values were assessed before treatment onset. Disease extent was defined as the percentage of liver or lung involvement and the number of bone segments positive at scintigraphy. The covariates were primary tumour characteristics (T, N and hormone receptor status) and patient characteristics at recurrence (menopause, performance status and age). Higher CA 15-3 serum levels were found in patients with visceral metastases or with pleural effusion. A logistic regression model selected disease extent in liver, lung and bone as independent variables for the determination of abnormal CA 15-3 values. Univariate survival analysis confirmed the positive prognostic influence of low CA 15-3 serum levels, absence of visceral metastases and the presence of only one metastatic site. Multivariate Cox's survival analysis selected disease extent in liver, lung, bone and soft tissue but not level of CA 15-3 as prognostic factors. In conclusion, CA 15-3 is not an independent variable in determining survival, its prognostic role being linked to the disease extent. This association suggests that CA 15-3 may be useful in assessing disease extent when this is not easily assessable.


Subject(s)
Biomarkers, Tumor/blood , Breast Neoplasms, Male/blood , Breast Neoplasms, Male/pathology , Breast Neoplasms/blood , Breast Neoplasms/pathology , Mucin-1/blood , Adult , Aged , Aged, 80 and over , Analysis of Variance , Female , Humans , Male , Middle Aged , Multivariate Analysis , Neoplasm Metastasis , Predictive Value of Tests , Survival Analysis
5.
J Clin Oncol ; 14(4): 1165-72, 1996 Apr.
Article in English | MEDLINE | ID: mdl-8648371

ABSTRACT

PURPOSE: Some evidence in vitro and in vivo shows that lonidamine (LND) can positively modulate the activity of doxorubicin and epirubicin (EPI). On this basis, a multicenter prospective randomized trial was performed in patients with advanced breast cancer (BC) to determine if the addition of LND to EPI could increase the response rate of EPI alone. PATIENTS AND METHODS: From May 1991 to May 1993, 207 patients were enrolled onto this study and randomized to receive intravenous (IV) EPI (60 mg/m2 on days 1 and 2) alone or with LND (600 mg orally daily). EPI administration was repeated every 21 days until tumor progression or for a maximum of eight cycles. LND was administered continuously until chemotherapy withdrawal. RESULTS: Response rate was significantly superior for the EPI plus LND scheme compared with the single-agent EPI either considering assessable patients (60.0% v 39.8%; P < .01) or including all registered patients according to an intention-to-treat analysis (55.3% v 37.5%; P < .02). The distribution of the response rate according to the site of disease did not show any significant difference between the treatment arms, except for the patient subgroup with liver metastases in which the combination EPI plus LND resulted in a significant improvement of responses than EPI alone. Toxicity was moderate, and except for myalgia, no adjunctive side effects were observed in the EPI plus LND arm. Overall survival and time to progression were similar in both groups. CONCLUSION: This study confirms in vivo that the administration of EPI is enhanced by the concomitant LND administration.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Indazoles/pharmacology , Adult , Aged , Antibiotics, Antineoplastic/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/pathology , Drug Synergism , Epirubicin/administration & dosage , Female , Humans , Indazoles/administration & dosage , Middle Aged , Neoplasm Staging , Prospective Studies , Survival Analysis , Treatment Outcome
6.
Eur J Cancer ; 30A(14): 2082-4, 1994.
Article in English | MEDLINE | ID: mdl-7857707

ABSTRACT

The role of circulating tumour markers in providing prognostic information has been scarcely studied. We evaluated the prognostic significance of two mucinous markers: CA 15-3 and CA 125 in 115 breast cancer patients at first recurrence of disease. At diagnosis of advanced disease bone involvement was found in 64 patients, lung in 57, skin lymph nodes in 21, liver in 20, and brain in 5. Patients were recruited and treated in the same institution with conventional chemo- or endocrine therapy. The follow-up ranged from 3 to 54+ months (median 35). Serum samples were drawn at first recurrence of disease before the start of any endocrine and/or chemotherapy. Patients with CA 15-3 < 30 U/ml survived significantly longer than those with CA 15-3 > 30 U/ml (median 50+ versus 26 months, P < 0.02). Similarly, overall survival of patients with CA 125 < 35 U/ml was significantly higher in comparison with patients with CA 125 > 35 U/ml (median 34.5 versus 18.5 months, P < 0.001). CA 125, but not CA 15-3, maintained its prognostic value in the subgroup of patients with visceral metastases. Both markers were found to be independent prognostic variables in multivariate analysis according to Cox's model. CA 15-3 and CA 125 appeared to be powerful prognostic indicators, in addition to visceral metastases, in patients with advanced breast cancer.


Subject(s)
Biomarkers, Tumor/blood , Breast Neoplasms/mortality , CA-125 Antigen/blood , Mucin-1/blood , Neoplasm Recurrence, Local/blood , Adult , Aged , Aged, 80 and over , Breast Neoplasms/blood , Female , Humans , Middle Aged , Multivariate Analysis , Neoplasm Metastasis , Prognosis , Survival Analysis
7.
Gynecol Endocrinol ; 5(2): 83-94, 1991 Jun.
Article in English | MEDLINE | ID: mdl-1656706

ABSTRACT

The aim of the present study was to analyze the effects of exogenous melatonin (MT) upon pituitary and adrenal responsiveness to releasing hormones in different phases of the menstrual cycle. We evaluated the response of FSH and LH to 100 micrograms gonadotropin releasing hormone, of TSH and prolactin (PRL) to 200 micrograms thyrotropin releasing hormone (TRH), and of cortisol to 10 micrograms ACTH 1-17. We studied eight young women with normal ovulatory cycles in the early follicular (days 5-7) and luteal (days 22-24) phases. Stimulation tests were performed at 18.00 in baseline conditions as well as 1 h after oral intake of exogenous MT (2 mg as a gelatine capsule). We did not observe any significant change in FSH, LH, TSH and cortisol responses to their respective releasing hormones in either phase of the cycle. PRL response to TRH was higher after MT in the follicular phase, when evaluated in terms of net increment and integrated area of response (p less than 0.02 versus baseline conditions for both variables). In the luteal phase, we recorded larger interindividual variability and higher responses after MT were observed in five out of eight subjects. These results suggest that MT may play a facilitatory role in the TRH-induced PRL release in women of reproductive age.


Subject(s)
Melatonin/pharmacology , Menstrual Cycle/drug effects , Prolactin/metabolism , Thyrotropin-Releasing Hormone/pharmacology , Adrenal Glands/drug effects , Adrenal Glands/metabolism , Adrenocorticotropic Hormone/pharmacology , Adult , Circadian Rhythm , Drug Synergism , Female , Follicle Stimulating Hormone/metabolism , Follicular Phase/drug effects , Humans , Hydrocortisone/metabolism , Luteal Phase/drug effects , Luteinizing Hormone/metabolism , Peptide Fragments/pharmacology , Pituitary Gland/drug effects , Pituitary Gland/metabolism , Thyrotropin/metabolism , Time Factors
8.
J Steroid Biochem Mol Biol ; 37(6): 983-7, 1990 Dec 20.
Article in English | MEDLINE | ID: mdl-2285610

ABSTRACT

A number of studies performed in vitro and on experimental animals supported the view that pineal gland inhibits neoplastic growth. Data in humans are scanty and controversial. In the present study we measured serum melatonin (MT), prolactin (PRL) and growth hormone (GH) concentrations, at 08.00 and 24.00, in 132 cancer patients and in 58 healthy control subjects. The patients were stratified according to histology and stage of disease as follows: 30 stage I-II and 45 stage III-IV breast cancer (BC); 39 stage III-IV lung cancer; 18 advanced gastrointestinal (GI) cancer. We also measured MT levels, at the same time-points, in 20 women with primary BC before and after radical mastectomy. Finally, we evaluated the circadian rhythm of serum MT in 18 patients with advanced cancer. On the whole, the patients with advanced tumors showed serum MT levels significantly higher than controls, without any correlation with PRL and GH values. When looking at stage III-IV vs stage I-II BC patients, significantly higher MT levels have been found in the former group. The surgical removal of the primary BC was not associated with any changes in MT values at both time points considered. A highly significant rhythm of serum MT was recorded in advanced cancer patients and the rhythmic parameters were substantially superimposable on those of the control subjects.


Subject(s)
Circadian Rhythm , Melatonin/blood , Neoplasms/metabolism , Adult , Aged , Aged, 80 and over , Female , Growth Hormone/blood , Humans , Male , Middle Aged , Neoplasm Staging , Neoplasms/surgery , Prolactin/blood
9.
Chronobiol Int ; 7(3): 259-61, 1990.
Article in English | MEDLINE | ID: mdl-2268888

ABSTRACT

We evaluated the circadian profiles of serum melatonin (MT) and cortisol in 6 patients with Cushing's disease while those of serum MT and GH were evaluated in 8 patients with acromegaly. The control group consisted of 15 healthy subjects in whom MT, cortisol and GH were determined. The presence of a circadian rhythmicity was validated by the cosinor method, while the diurnal and nocturnal amount of MT secretion were expressed in terms of area under the curve. Gross alterations of MT rhythm were not apparent in Cushing's patients. In acromegalics, we observed a blunted day-night oscillation of MT accounted for by a significant increase of its secretion during the day-time period.


Subject(s)
Acromegaly/blood , Circadian Rhythm/physiology , Cushing Syndrome/blood , Melatonin/blood , Adolescent , Adult , Growth Hormone/blood , Humans , Hydrocortisone/blood , Middle Aged
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