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Biomedical subjects

E Piana

Publications and source records attributed to E Piana.

At least 19 recordsLinked to original sources
PubMed2006

Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study).

BACKGROUND: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. PATIENTS AND METHODS: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m(2) intravenously (i.v.) followed by weekly doses of 250 mg/m(2), CPT 11 180 mg/m(2) i.v. on day 1, LFA 100 mg/m(2) i.v. followed by 5-FU 400 mg/m(2) i.v. bolus, and 600 mg/m(2) i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. RESULTS: Thirty-eight patients were enrolled (median age 63.5 years, range 39-83; median Karnofsky performance status 90, range 70-100; stomach 89.5% and GEJ 10.5%; locally advanced disease 13.2% and metastatic disease 86.8%). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1% [95% confidence interval (CI) 27.5% to 60.9%]. The median time-to-progression was 8 months (95% CI 7-9). At the median follow-up time of 11 months, 55.3% of patients were alive, with a median expected survival time of 16 months (95% CI 9-23). Grade 3-4 toxicity included neutropenia (42.1%), acne-like rash (21.1%), diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), and hypertransaminasemia (5.3%). There was one (2.6%) treatment-related death. CONCLUSIONS: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.

Adenocarcinoma↗
PubMed2001

Oxaliplatin and protracted continuous 5-fluorouracil infusion in patients with pretreated advanced colorectal carcinoma.

BACKGROUND: Both OHP and 5-FU are clinically active as single agents in the treatment of metastatic colorectal cancer (MCRC). Clinical and laboratory studies suggest a synergistic interaction between these agents. This phase II study was performed to evaluate the activity of a schedule including OHP and protracted 5-FU infusion in 5-FU-resistant MCRC. PATIENTS AND METHODS: From October 1997 to January 2000, 50 patients with measurable progressive MCRC after one or more 5-FU-based regimens were treated. OHP (2-3-hour i.v. infusion) on day 1 and 5-FU (protracted i.v. infusion using elastomeric/electronic pump through a central venous catheter) on days 1-21 were administered every 3 weeks, at the following 4 dose levels: 1) OHP 100 mg/m2 + 5-FU 200 mg/m2 (21 patients); 2) OHP 100 mg/m2 + 5-FU 250 mg/m2 (3 patients); 3) OHP 130 mg/m2 + 5-FU 200 mg/m2 (10 patients); 4) OHP 130 mg/m2 + 5-FU 250 mg/m2 (6 patients). RESULTS: Objective responses were 1 (2%) CR; 10 (20%) PR, for a median duration of 8 months; 23 (46%) stable diseases, for a median duration of 6 months: 16 (32%) progressions. CR + PR was higher in patients who had previously received no more than one line of chemotherapy for metastatic disease as compared with patients who had received two or more lines of therapy (33% vs. 5%, P < 0.01). The median time to progression was four months (one to nine). All dose levels (313 cycles) were well tolerated with mild toxicity. Major toxicity (grade 3 WHO) included: anaemia in 1 patient (2%), nausea and vomiting in 1 patient (2%), diarrhoea in 4 patients (8%) and stomatitis in 1 patient (2%); grade I and 2 peripheral neuropathy were encountered, respectively, in 30 (60%) and 8 (16%) patients. The median survival was 13 months (9-17), with 32 patients still alive after a median follow-up of 8 months. CONCLUSIONS: This study suggests that 1) OHP plus protracted 5-FU infusion is an active combination in MCRC patients resistant to pre-treatment bolus 5-FU; 2) it has a good tolerability profile and 3) the optimum dose level is OHP 130 mg/m2 and 5-FU 250 mg/m2.

Adult↗
PubMed2001

Combination chemotherapy with mitoxantrone, methotrexate, and mitomycin (MMM regimen) in malignant pleural mesothelioma: a phase II study.

The prognosis of malignant pleural mesothelioma is poor, with a median survival time from diagnosis of 7 to 17 months. At present there is no standardized treatment of this neoplasia. Between July 1995 and January 1999, 22 patients with malignant pleural mesothelioma were enrolled in our study. The characteristics of patients were: 16 men and 6 women; median age 61 years (range, 49-77 years); stage (according to Butchart): 8 patients stage I, 10 stage II, 2 stage III, and 2 stage IV; cytologic diagnosis in 5 cases and histologic diagnosis in 17 cases. The treatment consisted of mitoxantrone 10 mg/m2 intravenous (IV) or intrapleural (IPL), methotrexate 35 mg/m2 IV, and mitomycin 7 mg/m2 IV on day 1 and repeated every 3 weeks, with mitomycin in alternate cycles (MMM regimen). One complete response (4.5%) (42 months of duration) and 6 partial responses (27.3%) (5, 5, 7, 9, 14, and 19 months of duration) were achieved; the overall response rate (ORR) was 31.8% (95% CI, 12.4-51.3%); 7 patients were stable under this treatment (31.8%). According to the pathologic type, ORR for the only epithelial type was 39.9% (95% CI, 15.2-64.8%). Median time to progression was 6 months (range, 1-22). The overall median survival time was 13.5 months (range, 1-50); the median survival time of responders significantly differed from that of nonresponders (18.0 versus 8.5 months; p = 0.017). This treatment produced a considerable clinical benefit, with improvement of dyspnea (68.4%) and pain (33.3%); 15 of 19 patients (78.9%) with pleural effusion at the time of diagnosis showed an important reduction in pleural fluid during chemotherapy. Hematologic toxicity was the main side effect; World Health Organization grade III to IV of neutropenia, anemia, and thrombocytopenia were observed in 81.8%, 13.6%, and 22.7% of patients, respectively. From the data presented here, this regimen can be considered active in the treatment of malignant pleural mesothelioma.

Aged↗
PubMed2001

Prospective phase II study of single-agent gemcitabine in untreated elderly patients with stage IIIB/IV non-small-cell lung cancer.

The purpose of this study was to evaluate the efficacy and tolerability of single-agent gemcitabine in untreated elderly patients with stage IIIb/IV non-small-cell lung cancer (NSCLC). Since April 1997, 46 consecutive patients have been enrolled in this multicenter study. Gemcitabine 1,000 mg/m2 was administered as a 30-minute intravenous infusion on days 1, 8, and 15 every 28 days. Primary patient characteristics were: male/female 38/8; median age 73 years (range: 70-82 years); median Karnofsky performance status (PS) 90 (range: 70-100); stage IIIb 61% and stage IV 39%; histotype: epidermoid 48%, adenocarcinoma 43%, and large cell carcinoma 9%. No complete response was observed, but 10 (21.7%) patients achieved partial response (PR) (95% confidence limits: 11-36%), 27 (58.7%) had stable disease (SD), and 7 (15%) progressed early (at the first evaluation). The median duration of PR and SD was 8 months (range: 4-23+ months) and 4 months (range: 2-9 months), respectively. Subjective response evaluating PS and symptoms such as dyspnea, pain, and cough was evaluated in 40 patients; 11 (27.5%) improved, 15 (37.5%) remained stable, and 14 (35%) worsened. The median time to progression was 4 months, the median survival was 9 months, and 1-year survival was 44%. After a median follow-up of 10.5 months, 14 patients are still alive. There were no grade 4 toxicities. Grade 3 neutropenia and thrombocytopenia occurred in 19% and 2% of patients, respectively. Nonhematologic toxicities were mild. Grade I/II side effects of nausea/vomiting, transient fever, increase of hepatic transaminases, transient peripheral edema at lower extremity (not related to cardiac or renal disease or phlebothrombosis) were reported. This phase II study confirms the activity and favorable toxicity profile of single-agent gemcitabine in the treatment of elderly patients with advanced NSCLC.

Aged↗
PubMed1999

Anthracyclines in non-small-cell lung cancer: do they have a therapeutic role?

BACKGROUND: Owing to its low level of activity together with its potential cardiotoxicity, doxorubicin (DXR) has been considered as having a marginal role in the treatment of NSCLC. Its analogue, epirubicin (EPI), has also shown a poor antitumor activity in the treatment of NSCLC when used at 'standard' doses (= 90 mg/m2). On the contrary, high-dose epirubicin (HD-EPI) (> 90 mg/m2) has demonstrated antitumor activity as a single agent in the treatment of advanced NSCLC in six small phase II studies (mean 25%, range 17%-36%). RESULTS: A series of consecutive studies on the activity of HD-EPI alone or in combination regimens were carried out at the Division of Medical Oncology of S. Orsola-M. Malpighi Hospital. After activity was confirmed in advanced disease with doses between 120 and 165 mg/m2 (PR in 6 of 24 = 25%), a phase II study was carried out on the combination of HD-EPI 120 mg/m2 + cisplatinum (CP) 60 mg/m2 in stage IIIB-IV NSCLC. PR was achieved in 54% of 35 patients with a median survival of nine months. A subsequent multicenter phase III trial compared HD-EPI and vinorelbine (VNR), both combined with CP. Two hundred twenty-eight patients with locally advanced or metastatic NSCLC were randomized to receive either EPI 120 mg/m2 plus CP 60 mg/m2 on day 1 or VNR 25 mg/m2 on day 1 and 8 plus CP 60 mg/m2 on day 1. Both treatments were recycled every 21 days. Eligible patients were 212 and 210 patients evaluable for objective response (100 on HD-EPI and 110 on VNR), respectively. The CR + PR rate was 32% vs. 26% (P = NS) for a median duration of nine and eight months, respectively. Median survival was 10 and 9.5 months, respectively. Grade III-IV leucopenia occurred in 38% and 21% on HD-EPI and VNR, respectively (P = 0.01), thrombocytopenia in 6% and 0% (P = 0.02), anemia in 8% and 7% (NS). Non-hematological toxicity was moderate and the only difference between the treatments was alopecia (88% vs. 33% on HD-EPI and VNR, respectively). Supraventricular arrhythmia occurred in three patients on HD-EPI; a > 15% LVEF decrease by MUGA scan was observed in 22.5% and 14% patients on HD-EPI and VNR, respectively (NS). No congestive heart failure was observed. CONCLUSIONS: EPI can be safely administered at a dose of 120-135 mg/m2 in non-pretreated patients showing a significant antitumor activity in NSCLC. If the cumulative dose of 800-900 mg/m2 is not exceeded, clinical manifestations of cardiotoxicity are very rare. However, grade 3-4 myelotoxicity and alopecia are very common and can limit the use of this drug in the palliative treatment of this disease. Interesting results are observed in an ongoing pilot study that employed HD-EPI + CP + VNR + G-CSF in the induction therapy of locally advanced NSCLC.

Adult↗
PubMed1998

Multicenter randomized clinical trial on high-dose epirubicin plus cis-platinum versus vinorelbine plus cis-platinum in advanced non small cell lung cancer.

BACKGROUND: High dose Epirubicin (HD-EPI) (>90 mg/m2) and Vinorelbine (VNR) demonstrated antitumor activity as single agent (about 20%) in the treatment of advanced NSCLC. This trial compares these two agents combined with cisplatin (CP). PATIENTS AND METHODS: From August 1992 to February 1996, 228 patients with locally advanced or metastatic NSCLC were randomized to receive either EPI 120 mg/m2 as i.v. bolus plus Cisplatin (CP) 60 mg/m2 on day 1 (regimen A) or VNR 25 mg/m2 as i.v. bolus on day 1 and 8 plus CP 60 mg/m2 on day 1 (regimen B). Both treatments were recycled every 21 days up to a maximum cumulative dose of EPI of 840 mg/m2 or 12 cycles. Eligible patients were 212 and 198 patients were evaluable for objective response (95 in arm A and 103 in arm B). The main characteristics of eligible patients were: male/female 179/33; median age 61 (42-72); median Karnofsky PS 80 (70-100); stage IIIA 12%, stage IIIB 40%, stage IV 41%, recurrence 7%; histotype: epidermoid 48%, adenoca 36%, others 16%. RESULTS: The following response rates were observed in regimens A and B, respectively; CR, 1 and 2%, PR, 32 and 25% (P = 0.4567). Median CR + PR duration was 9 and 8 months, respectively. Median survival was 10.5 and 9.6 months, respectively. Grade III-IV leucopenia occurred in 38 and 21% in arm A and arm B, respectively(P = 0.01), thrombocytopenia in 6 and 0% (P = 0.02), anemia in 8 and 7% (n.s.). Non-hematological toxicity was moderate and the only difference between the treatments was alopecia (88 vs. 33% in arm A and B, respectively). Supraventricular arrhythmia occurred in three patients on regimen A; a >15% LVEF absolute decrease was observed in 9 (22.5%) and three (14%) patients on arm A and arm B, respectively (n.s.). No congestive heart failure was observed. CONCLUSION: HD-EPI+CP and VNR+CP are both active combinations in advanced NSCLC with a similar response rate, response duration and survival but regimen A was significantly more toxic (myelosuppression and alopecia).

Adult↗
PubMed1992

The antiemetic efficacy and the cost-benefit ratio of ondansetron calculated with a new approach to health technology assessment (real cost-benefit index).

In a phase II study including 80 patients treated with highly emetic drugs such as cisplatin, carboplatin or cyclophosphamide > 600 mg/day) we confirmed the potential of ondansetron to prevent cancer chemotherapy- related acute nausea and vomiting. With a total dose of 19.0-37.3 mg ondansetron we achieved 82%-100% acute (0-24 hours) vomiting free patients. Using ondansetron for the prevention of acute nausea and vomiting increases the total chemotherapy costs by 6%. The real cost-benefit ratio for the treatment of acute nausea and vomiting shows better values for ondansetron than for all other recommended regimens.

Adult↗
PubMed1990

Comparative phase II study of idarubicin versus doxorubicin in advanced breast cancer.

The aim of the present study is to confirm the antitumor activity of orally administered idarubicin (IDA) in patients with advanced breast cancer. Doxorubicin (ADRIA) was chosen as control treatment and the patients were randomized to receive either IDA or ADRIA according to a 2:1 ratio. Sixty-three patients, 77% of whom were pretreated with chemotherapy excluding anthracyclines, entered the study. The doses were: IDA 45 mg/m2 orally on 3 consecutive days every 28 days: ADRIA 75 (60) mg/m2 intravenously every 21 days. A complete + partial response (CR + PR) was observed in 11/37 (30%) evaluable cases treated with IDA and in 6/19 (32%) cases treated with ADRIA. If all the patients were included, the CR + PR remission rates were 27.5 and 27%, respectively. There were no significant differences as regards time to remission, duration of remission and survival. None of 10 cases who crossed over the treatments responded to the second therapy. The most frequent side effects of IDA were myelosuppression and nausea/vomiting. The only significant statistical difference between the two anthracyclines was the lower incidence of alopecia after IDA. Although there were 3 cases of cardiotoxicity after ADRIA, 2 of which severe, no case of clinical cardiotoxicity was observed after IDA. The present study confirms that orally administered IDA is an active agent in advanced breast cancer.

Breast Neoplasms↗
PubMed1987

Medroxyprogesterone acetate at very high doses in postmenopausal advanced breast cancer patients.

Twenty-six postmenopausal consecutive patients with advanced breast cancer were treated with very high medroxyprogesterone acetate doses (4000 mg/day orally for 30 days and then 3000 mg/day orally until progression or intolerance). The dominant metastatic lesion was bone in 13 patients, soft tissue in 3 patients and viscera in 10 patients (C.I. = V/ST + 0 = 0.62). An objective partial remission was achieved in 16 pts (61%), no change in 8 (31%), progression in 2 (8%). The median duration of objective remission was 7.5+ months with a median survival of 14.5+ months in responders. Toxicity was minor and only two patients discontinued the treatment because of side-effects. These results confirm the utility of medroxyprogesterone acetate at very high doses in these patients and the feasibility of this kind of dose.

Adult↗
PubMed1986

A pilot study of oral idarubicin in metastatic melanoma.

Seventeen patients with disseminated melanoma were treated with Idarubicin (IDA) at the dose of 15 mg/m2 daily for 3 consecutive days every 4 weeks by oral route. One complete remission and one partial remission were achieved (remission rate: 12%). The treatment was well tolerated. We conclude that oral IDA may be considered for a pilot trial in a regimen of combination therapy in patients with metastatic melanoma.

Administration, Oral↗
PubMed1985

Prolactin levels and hormonal profile in postmenopausal patients with advanced breast cancer during endocrine treatments.

Seventy postmenopausal patients with advanced breast cancer, the majority not having been pretreated, underwent a hormonal profile study (LH, FSH, PRL, E2, testosterone, TSH, T3, T4, FT3, FT4 serum levels) by RIA standard methods. The result was that these patients had the same mean hormonal profile of normal controls. The hormonal profile was studied in 66 patients before and after one month of treatment with medroxyprogesterone acetate at high doses (MAP h.d.) (45 patients), tamoxifen (TAM) (10 pts.) and MAP h.d. + TAM + bromocriptine (MTB) (11 pts.). No significant difference in the pre-treatment hormonal profile was observed in either patients who responded to the subsequent treatment or in those who did not. MAP h.d. induced a marked inhibition of gonadotropins, E2, testosterone, T3, T4 while PRL, TSH and FT3 remained unchanged and FT4 increased. TAM induced a decrease of gonadotropins and T4 while all the other hormones remained unchanged. MTB induced the same effects of MAP h.d. as well as a decrease of PRL serum levels. All hormonal variations except PRL occurred independently of the clinical response. A particular behaviour of PRL was evident after one month of treatment with MAP h.d. and TAM: patients who did not respond had a statistically significant increase of PRL serum levels while in responders the PRL serum levels decreased or remained unchanged. Specifically 24 out of 28 (86%) patients with an increase greater than 20% of the PRL levels were non-responders.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1984

Clinical trial of combined hormone therapy (MAP + TAM) for metastatic breast cancer.

High dose MAP (medroxyprogesterone acetate) and TAM (tamoxifen) were administered orally to 31 postmenopausal patients with advanced breast cancer. CR (complete remission) was achieved in 1 (3%) and PR (partial remission) in 11 (32%) patients for a median duration of 12 months. The treatment was well tolerated and in no instance was interrupted because of toxicity. This study does not support the hypothesis that the combination of MAP and TAM gives better results than the single agents.

Aged↗
PubMed1984

The effect of high dose medroxyprogesterone acetate on water and salt metabolism in advanced cancer patients.

Ten advanced cancer patients (both with hormone-sensitive and non-hormone sensitive tumors) were treated with high dose medroxyprogesterone acetate (MAP, greater than 500 mg/day). We determined body weight, lean body mass, blood pressure, sodium blood level, urinary excretion, and exchangeable sodium pool by the 22Na method before and after treatment. These data seem to exclude a fluid retentive effect for high-dose MAP.

Antineoplastic Agents↗
PubMed1980

[Urinary hydroxyproline in advanced breast carcinoma and response to treatment with medroxyprogesterone acetate (MAP) in high doses].

The Authors have studied total urinary hydroxyproline (TUH), together with other hematochemical analyses, in 104 patients suffering from advanced breast cancer with or without bone metastases. TUH escretion is higher in patients with osseous lesions and, if simultaneous pathologic values of TUH and serum alcaline phosphatase occur, the presence of bone metastases is statistically even more probable. Moreover TUH seems to vary in accordance with the clinical response of the disease at osseous level in 46 patients treated with Medroxyprogesterone acetate (MPA) at high doses, showing itself as a possible marker of not negligible clinical value.

Adult↗
PubMed1978

[Proposed model for evaluation of toxicity in antineoplastic chemo-hormonotherapy].

A detailed code for the evaluation of side-effects due to antiblastics in accordance with clinical, pharmacological and chronobiological parameters is described. Eight types of toxicity are recognised: systemic or local, cutaneous and adnexal, gastroenteric, haematochemical, cardiovascular, respiratory, genital and urinary, and nervous. Improvement of the objectivity and comparability of results in clinical oncology is proposed by means of a balanced points system for the expression of such effects, and methods for the summary expression of the toxicity of a single case or a uniform group of cases. The method of evaluation proposed also permits statistical comparison between different treatment protocols.

Alopecia↗