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ABSTRACT: The objective of this observational study was the early evaluation of the impact, a week after the first administration of epoetin alfa 40000 U once weekly and i.v. dose of 62.5 mg sodium ferric gluconate for seven days in improving hemoglobin levels in cancer patients affected by mild/moderate or severe anemia during chemotherapy. Twenty patients affected by solid tumors who received epoetin alfa 40000 U once weekly and daily i.v. sodium ferric gluconate for one week were evaluated: 90% of the patients showed hemoglobin increase, with a median level of hemoglobin increase of 0.73 g/L from baseline, and 50% of them showing a hemoglobin increase > 1 gr/L. The treatment was well tolerated and no adverse event was observed. The early increase of hemoglobin level from baseline is interesting and suggestive for the possibility of achieving an adequate hemoglobin level with a short-term treatment. It is still necessary to further explore the real need of iron supplementation to maintain adequate erythropoiesis prior and during epoetin therapy.
Journal of experimental & clinical cancer research: CR 06/2005; 24(2):197-201. · 1.50 Impact Factor
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S De Placido,
M De Laurentiis,
M De Lena,
V Lorusso,
A Paradiso, M D'Aprile,
G Pistillucci,
A Farris,
M G Sarobba,
S Palazzo,
L Manzione,
V Adamo,
S Palmeri,
F Ferraù,
R Lauria,
C Pagliarulo,
G Petrella,
G Limite,
R Costanzo,
A R Bianco
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ABSTRACT: The sequential doxorubicin --> CMF (CMF=cyclophosphamide, methotrexate, fluorouracil) regimen has never been compared to CMF in a randomised trial. The role of adding goserelin and tamoxifen after chemotherapy is unclear. In all, 466 premenopausal node-positive patients were randomised to: (a) CMF x 6 cycles (CMF); (b) doxorubicin x 4 cycles followed by CMF x 6 cycles (A --> CMF); (c) CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (CMF --> GT); and (d) doxorubicin x 4 cycles followed by CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (A --> CMF --> GT). The study used a 2 x 2 factorial experimental design to assess: (1) the effect of the chemotherapy regimens (CMF vs A --> CMF or arms a+c vs b+d) and (2) the effect of adding GT after chemotherapy (arms a+b vs c+d). At a median follow-up of 72 months, A --> CMF as compared to CMF significantly improved disease-free survival (DFS) with a multivariate hazard ratio (HR)=0.740 (95% confidence interval (CI): 0.556-0.986; P=0.040) and produced a nonsignificant improvement of overall survival (OS) (HR=0.764; 95% CI: 0.489-1.193). The addition of GT after chemotherapy significantly improved DFS (HR=0.74; 95% CI: 0.555-0.987; P=0.040), with a nonsignificant improvement of OS (HR=0.84; 95% CI: 0.54-1.32). A --> CMF is superior to CMF. Adding GT after chemotherapy is beneficial for premenopausal node-positive patients.
British Journal of Cancer 03/2005; 92(3):467-74. · 5.04 Impact Factor
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A Piga,
R Nortilli,
G L Cetto,
N Cardarelli,
S Luzi Fedeli,
G Fiorentini, M D'Aprile,
F Giorgi,
A P Parziale,
A Contu,
R Montironi,
R Gesuita,
F Carle,
R Cellerino
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ABSTRACT: The aim of this study was to assess the activity and toxicity of a platinum-based treatment on a group of patients with unknown primary tumours (UPTs). Patients with a diagnosis of UPT underwent a standard diagnostic procedure. Treatment was started within 2 weeks from diagnosis and consisted of carboplatin 400 mg m-2 day 1, doxorubicin 50 mg m-2 day 1, etoposide 100 mg m-2 days 1–3, every 21 days. Response was evaluated after three courses and treatment continued in case of objective response (OR) or symptom control. A total of 102 patients were eligible. The median age was 59 years, sex male/female 54/48, histology was mainly adenocarcinoma or poorly differentiated carcinoma. Nodes, bone, liver and lung were the most frequently involved sites. In all, 79 patients received at least three courses of treatment; 26 patients received six courses or more. Six complete responses and 21 partial responses were observed, for a total of 27 of 102 ORs or 26.5% (95% confidence interval 18.2–36.1%). The median survival was 9 months and median progression-free survival was 4 months. Toxicity was moderate to severe, with 57.8% of patients experiencing grade III–IV haematological toxicity, mainly leucopenia. The regimen employed has shown activity in tumours of unknown primary site, but was associated with significant toxicity. Such toxicity may be considered unjustified, given the large proportion of patients with tumours not likely to respond. Efforts should therefore be addressed to identify predictors of response to chemotherapy, thus limiting aggressive treatment to those patients who could benefit from it.Keywords: carcinoma of unknown primary site, chemotherapy, phase II study
British Journal of Cancer 04/2004; 90(10):1898-1904. · 5.04 Impact Factor
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ABSTRACT: Many active cytotoxic drugs and several regimens exist for breast cancer therapy. However, these conventional treatments have not changed the outcome of patients with locally advanced and metastatic disease. As a consequence, the dynamic balance between chemotherapy-induced side effects and benefits attributable to relief of cancer-related symptoms must be carefully considered in this setting. Gemcitabine is a pyrimidine nucleoside antimetabolite that has shown activity in a variety of solid tumors, a good toxicity profile, and non-overlapping toxicity with other chemotherapeutic drugs. As a single agent, gemcitabine yields response rates ranging from 14 to 37% as first-line treatment for advanced breast cancer and 12-30% as salvage therapy for patients previously treated with anthracycline and/or taxane treatment. Combined with vinorelbine, platinum, anthracyclines, and taxanes as doublets or triplets, response rates of 50 to 80% have been reported in phase II clinical studies. Gemcitabine in combination with anthracyclines and taxanes has been evaluated in the neoadjuvant setting in patients with early-stage breast cancer with interesting clinical and pathological response rates. Preliminary results of gemcitabine in combination with the biologic agent, trastuzumab, are encouraging. Phase III trials of gemcitabine combinations compared to standard regimens are ongoing with the aim to assess the independent contribution of gemcitabine.
International Journal of Oncology 03/2004; 24(2):389-98. · 2.40 Impact Factor
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Journal of experimental & clinical cancer research: CR 10/2003; 22(3):497-8. · 1.50 Impact Factor
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ABSTRACT: Although bone marrow is a common site of micrometastases for non-small cell lung cancer (NSCLC), thrombocytopathia and hemorrhagic diathesis are rare causes of death.
A 57-year-old patient was admitted to the emergency room because of massive nosebleeding and hemoptysis. Routine blood analysis showed thrombocytopenia and prolonged bleeding time; results of functional platelet tests suggested concomitant thrombocytopathia. Routine chest X-ray revealed an 18 mm large spot in the right superior lobe. During the first hour of recovery the patient had another episode of nosebleeding. A bone marrow biopsy showed a wide infiltration with neoplastic cells. Histology was compatible with NSCLC. The clinical conditions and hematological parameters progressively deteriorated, and on the third day the patient died because of hypovolemic shock.
This is a very rare clinical presentation of NSCLC characterized by massive bleeding due to thrombocytopenia and thrombocytopathia secondary to wide bone marrow infiltration.
Onkologie 07/2003; 26(3):272-4. · 0.87 Impact Factor
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V Lorusso,
G Palmieri,
A R Bianco,
G Abate,
G Catalano,
F De Vita,
F Dammacco,
V M Lauta,
G Lucarelli,
G Polimeno,
G Mantovani, M D'Aprile,
F Marzullo,
M De Lena
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ABSTRACT: From January 1992 to December 1995, 129 patients with previously untreated non-Hodgkin's lymphoma were randomised in a phase III multicenter trial to receive CEOP-B/VIMB or ProMACE-CytaBOM. Eligibility criteria included intermediate or high grade lymphoma (follicular large cell, diffuse small cleaved-cell, diffuse mixed, diffuse large-cell and immunoblastic) with an Ann Arbor stage II bulky, III or IV. All patients entered into the study were considered evaluable according to intent to treat analysis. At a median follow-up of 60 months there were no significant differences between the treatment response rates [82% (60%CR) for CEOP-B/VIMB vs. 81% (69% CR) for ProMACE-CytaBOM]. Conversely, with regard to disease-free survival, a significant difference was observed between the two treatment arms (42% for CEOP-B/VIMB vs. 24% for ProMACE-CytaBOM at 5 years; p=0.046). However, this difference did not translate in a significant difference in overall survival (45% vs. 39% at 5 years). Moreover, when response rates and outcome were analysed for different prognostic subgroups according to International Prognostic Index, no significant differences were observed between the treatment groups. It is important to note that neither regimen was able to improve outcome of poor risk patients who fared badly with both treatments (median survival 9 and 8 months respectively). Toxicity was also similar in both treatments with grade 3-4 leukopenia observed in 39% and 47% of cases and grade 3-4 thrombocytopenia in 24% and 27% of cases respectively. In conclusion, in this study CEOP-B/VIMB was not superior to ProMACE-CytaBOM in aggressive lymphomas and the alternating strategy failed to improve outcome of poor risk patients in which newer more aggressive treatments are needed.
International Journal of Oncology 02/2000; 16(1):149-54. · 2.40 Impact Factor
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C Gridelli,
F Perrone,
G P Ianniello,
L Brancaccio,
R V Iaffaioli,
C Curcio, M D'Aprile,
R Cioffi,
S Cigolari,
A Rossi,
G Palazzolo,
E Veltri,
M Pergola,
S De Placido,
C Gallo,
S Monfardini,
A R Bianco
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ABSTRACT: To evaluate the activity and toxicity of the combination carboplatin plus vinorelbine in extensive small-cell lung cancer (SCLC).
A two-stage optimal Simon design was applied. To proceed after the first stage, responses from 8 of 11 treated patients were needed. Overall, 31 responses of 43 treated patients were required to comply with the design parameters. Inclusion criteria were cytohistologically proven SCLC; extensive disease; age of 70 years or less; Eastern Cooperative Oncology group performance status (ps ECOG) of 2 or less; normal cardiac, hepatic, renal, and bone marrow functions; and no previous chemotherapy. Patients were staged by physical examination; biochemistry; chest radiograph; brain, thoracic; and abdominal computed tomographic (CT) scans, and bone scan. All patients received carboplatin 300 mg/m2 intravenously (i.v.) day 1 and vinorelbine 25 mg/m2 i.v. on days 1 and 8 every 4 weeks up to six cycles. Of 43 enrolled patients, 36 were men and 7 women, with a median age of 63 years (range, 46 to 70 years).
All patients were assessable for response and toxicity. We observed 32 (74%) objective responses, with 23% complete responses. Median time to progression was 25 weeks, and median survival was 37 weeks. The treatment was well tolerated. The reported main toxicities were leukopenia grade 3 in 21% of patients and grade 4 in 5% of patients, anemia grade 2 in 11% of patients and grade 3 in 2% of patients, and thrombocytopenia grade 3 in 7% of patients.
These data show that carboplatin plus vinorelbine is an active and well-tolerated regimen in extensive SCLC. In view of the activity, low toxicity, and ease of administration, it may be a reasonable alternative to more toxic cisplatin-containing regimens.
Journal of Clinical Oncology 04/1998; 16(4):1414-9. · 18.37 Impact Factor
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ABSTRACT: This study analyses and compares the results of local regional control, distant metastases and survival in two series of patients irradiated from 1986 to 1992 in our radiation oncology centre following quadrantectomy or tumourectomy for early stage breast cancer.
The quadrantectomy group consisted of 152 women, 109 (72%) with T1 and 43 (28%) with T2 tumours. Axillary nodes in this group were positive in 51 (33%) patients. The tumourectomy group included 123 women, 71 (58%) with T1 and 52 (42%) with T2 tumours. Positive axillary nodes were found in 56 (46%) of these patients. All quadrantectomy and tumourectomy patients received a dose of 50 Gy in 5 weeks to the whole breast, followed by a 10-16 Gy electron boost. Node positive patients in the tumourectomy group also received 50 Gy to the axillary apex and supraclavicular region. In both surgical groups, node positive premenopausal and postmenopausal patients received adjuvant CMF or tamoxifen therapy, respectively.
After a median follow-up of 58 months, 89% of women in the tumourectomy group and 87% in the quadrantectomy group were alive and 80 and 73%, respectively, were free of disease. Breast and nodal failures were detected in 4.9 and 0.8% of cases, respectively, in the tumourectomy group, as compared to 5.9 and 3.3% of cases, respectively, in the quadrantectomy group. Distant relapses were observed in 16 and 18% of patients in the former and latter groups, respectively. Actuarial overall and disease-free survival was similar in the two series, with 5-year rates of 90 and 72%, respectively, in the tumourectomy group, and of 91 and 78%, respectively, in the quadrantectomy group. The differences in survival are not statistically different.
Our findings show that tumourectomy and quadrantectomy, followed by adequate radiotherapy, provide comparable results in terms of local-regional control and survival.
Radiotherapy and Oncology 02/1998; 46(1):39-45. · 5.58 Impact Factor
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E Bajetta,
N Zilembo,
S Barni,
C Noberasco,
A Martinetti,
L Ferrari,
G Schieppati,
R Buzzoni,
A Jirillo,
M Amichetti, M D'Aprile,
G Comella,
E Bichisao,
G F Bolelli,
A Attili,
E Bombardieri
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ABSTRACT: In postmenopausal breast cancer (BC) patients, tamoxifen (TAM) is frequently used in first-line therapy, and for those relapsing under TAM, aromatase inhibitors would be the drug of choice. Formestane, a new aromatase inhibitor, has been demonstrated to be as effective as TAM in first-line therapy. This trial was carried out to investigate the pharmacokinetics and antitumor activity of two formestane doses in BC patients at first relapse, as well as their effects on estrogen levels, evaluated by means of a new analytical method.
One hundred fifty-two postmenopausal BC patients were randomly given formestane 250 mg or 500 mg intramuscularly every two weeks. The blood samples for estrogen measurements were taken on the first day of therapy, at 4 and 10 weeks, and every 12 weeks thereafter. Tumor response was first evaluated after 2.5 months, and then every three months.
Seventy-three patients received formestane 250 mg and 79 received 500 mg. After four weeks, plasma estrone, estradiol and estrone sulphate levels were significantly (P < 0.001) suppressed in both groups. The overall response rates were 30% and 40% on 250 mg and 500 mg, respectively.
Both of the formestane doses are effective in reducing plasma estrogen levels in BC patients at first relapse, and the new analytical method improved the quality of results. The antitumor response was highly satisfactory.
Annals of Oncology 07/1997; 8(7):649-54. · 6.43 Impact Factor
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C Gridelli,
F Perrone,
C Gallo,
F De Marinis,
G Ianniello,
S Cigolari,
S Cariello,
F Di Costanzo, M D'Aprile,
A Rossi,
R Migliorino,
R Bartolucci,
A R Bianco,
M Pergola,
S Monfardini
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ABSTRACT: More than 30% of lung cancers arise in patients aged 70 years or more; however, because elderly patients are not considered to tolerate chemotherapy, they are generally excluded from clinical trials and are not considered eligible for aggressive cisplatin-based chemotherapy in clinical practice. The aims of the present study were to test tolerability and activity of weekly vinorelbine in advanced non-small cell lung cancer (NSCLC) patients aged 70 years or more, and to define whether minimum conditions existed for a randomised comparison with best supportive care. The study was designed as a multicentre two-stage phase II trial according to Simon's optimal design: 8 or more responses out of 43 treated patients were expected at the end of the trial. Patients aged 70 years or more were eligible if they had a cytological or histological diagnosis of NSCLC at stage IIIb-IV and a performance status less than or equal to two according to the ECOG scale. Vinorelbine was given intravenously (i.v.) at a dose of 30 mg/m2 every week for 12 doses. As planned, 43 patients entered the study; median age was 73 years (range 70-80); 11 patients were older than 75 years. Median dose-intensity (mg/m2/week) of vinorelbine was 21.2 (range 7.5-30) and was not affected by age of patients. Toxicity was generally mild, mainly haematological and never life-threatening. ECOG performance status improved in 26% of patients; cough and pain improved in more than 40% of patients symptomatic at entry, while dyspnoea improved in 28%; approximately half the patients had a stabilisation of their symptoms. 10 patients (23-95% exact confidence interval (CI): 12-39%) obtained a partial response. Median time to progression was 11 weeks (95% CI 8-30) and median survival 36 weeks (95% CI 28-53). One-year estimated progression-free and overall survival rates are 16% and 36%, respectively. In conclusion, vinorelbine was well tolerated and active in the treatment of elderly NSCLC patients. A phase III trial (ELVIS-Elderly Lung Cancer Vinorelbine Italian Study) comparing best supportive care versus best supportive care plus vinorelbine is now ongoing.
European Journal of Cancer 04/1997; 33(3):392-7. · 5.54 Impact Factor
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ABSTRACT: In attempt to develop a new chemotherapeutic regimen including carboplatin (CBDCA), epirubicin (EPI), and VP-16 in extensive small cell lung cancer, with a higher dose intensity compared with previous experience of our group, we determined the maximum tolerated dose (MTD) of VP-16 when administered in association with CBDCA (300 mg/ m2, i.v., day 1) and EPI (75 mg/m2, i.v., day 1), recycling chemotherapy every 3 weeks, with the support of granulocyte-colony-stimulating factor (G-CSF). A total of 15 patients received three dose levels of VP-16 (mg/m2, i.v., daily on days 1-3): 100 (three patients), 120 (six), and 140 (six). G-CSF was administered subcutaneously at the dose of 5 micrograms/kg/day on days 6-15 of each chemotherapy course. The MTD was established at 140 mg/m2 and myelotoxicity, grade 4 neutropenia with death for sepsis in one case and grade 3 thrombocytopenia in three cases, was dose limiting. The recommended dose of VP-16 for a phase II study is 140 mg/m2.
American Journal of Clinical Oncology 01/1997; 19(6):589-91. · 2.01 Impact Factor
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C Gridelli,
F Perrone,
S Palmeri, M D'Aprile,
F Cognetti,
A Rossi,
V Gebbia,
R Pepe,
E Veltri,
G Airoma,
A Russo,
P Incoronato,
A F Scinto,
G Palazzolo,
M Natali,
V Leonardi,
C Gallo,
S De Placido,
A R Bianco
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ABSTRACT: To compare mitomycin C plus vindesine plus etoposide (MEV) vs. mitomycin C plus vindesine plus cisplatin (MVP) in the treatment of stage IV non-small-cell lung cancer.
204 patients were entered in a phase III multicentre randomised trial from June 1990 to December 1994 and stratified according to the ECOG performance status (0-1 vs. 2). MVP was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/m2+cisplatin 100 mg/m2 i.v. day 1 and vindesine 3 mg/m2 i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/ m2 i.v. day 1 and etoposide 100 mg/m2 i.v. days 1 to 3 with cycles repeated every 3 weeks. For both treatments a maximum of 6 cycles was planned. Response and toxicity were evaluated according to WHO. Subjective responses were assessed by numerical scales. Analyses were made on the basis of intent to treat.
The objective response rate was 21.4% (1 CR + 21 PR among 103 patients) in the MEV and 28.7% (1 CR + 28 PR among 101 patients) in the MVP arm (P = 0.48). Symptoms were similar in the two arms. 196 patients progressed and 182 died. The median times to progression were 10 weeks (95% CI 9-12) and 12 weeks (95% CI 10-15) and median survivals were 29 weeks (95% CI 25-36) and 28 weeks (95% CI 25-35) in the MEV and MVP arms, respectively. The relative risks of progressing and of dying were 0.89 (95% CL 0.66-1.20) and 0.96 (95% CL 0.71-1.30), respectively, for patients receiving MVP as compared with those receiving MEV at multivariate analysis adjusted by sex, age, histologic type, number of metastatic sites, performance status at entry, and centre.
In the present study, no significant differences were observed in response rate, survival or palliation of symptoms between the MEV and MVP regimens, while toxicity was significantly more frequent and severe with MVP. Thus, MEV should be considered a reasonable alternative to the MVP regimen in the treatment of stage IV NSCLC.
Annals of Oncology 11/1996; 7(8):821-6. · 6.43 Impact Factor
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European Journal of Cancer 01/1996; 31A(13-14):2424-6. · 5.54 Impact Factor
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ABSTRACT: A phase II study was performed to evaluate the clinical and immunological effects of a regimen of cisplatin (DDP) and etoposide (VP-16) combined with thymosin-alpha 1 (TA1) and low-dose interferon-alpha 2a (IFN) in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Chemoimmunotherapy cycles were repeated every 3 weeks. There were 24 responses (two complete, 22 partial) among 56 assessable patients. Median survival was 12.6 months. Overall, treatment was well tolerated. Natural killer cell activity and lymphocyte subtypes were depressed by chemotherapy, but this effect was less prominent in patients receiving TA1 and IFN in comparison with a concomitant group of patients treated with DDP and VP-16 only. The combination of DDP and VP-16 and TA1 and IFN is effective in advanced NSCLC with acceptable toxicity. However, the results of this study need to be confirmed in a randomised trial.
European Journal of Cancer 01/1996; 31A(13-14):2403-5. · 5.54 Impact Factor
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ABSTRACT: It has recently been shown that postoperative radiotherapy combined with 5-fluorouracil (5FU) resulted in an increase of survival and local control in patients with rectal cancer. However, hematological and intestinal toxicity were also increased. Experimental and clinical studies showed an increased radiation effect with an acceptable toxicity by delivering 5FU via a continuous intravenous infusion. From July 1988, 38 patients radically operated on for stages B2-C rectal cancer were irradiated in our hospital with 3 fractions per day of 100 cGY to a total dose of 5,600 cGY. Of these 38 patients, 13 underwent postoperative radiotherapy alone, and 25 received postoperative radiotherapy combined with concomitant protracted infusion of 5FU at doses of 250 and 300 mg/m2 per day. In addition, 14 patients with inoperable, locally advanced tumors or postoperative recurrences, were treated with the same combination schedule of 5FU and radiotherapy to a total radiation dose of 6,500 cGy. After a median follow-up of 43 months, the actuarial 3-year overall and disease-free survival rates in the postoperative group of patients were 68% and 68%, respectively, in the combined modality group, as compared to 51% and 36%, respectively, in the radiation alone group. Patients with inoperable tumors exhibited 3-year overall and disease-free survival rates of 24% and 32%, respectively. The main toxicity was rectal tenesmus, diarrhea, dysuria, and, less frequently, leukopenia. These symptoms were responsible for a treatment delay of more than 5 days in 2 of 6 and in 7 of 33 patients who received 5FU doses of 300 and 250 mg/m2 per day, respectively, as compared to 2 of 13 patients treated with radiotherapy alone.
American Journal of Clinical Oncology 11/1995; 18(5):369-75. · 2.01 Impact Factor
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ABSTRACT: The evaluation of drug efficacy in patients with advanced prostatic cancer who have progressed to hormonal therapy is difficult, although palliation of the pain related to bone involvement still represents an important endpoint. In this study, epirubicin (EpiADM) plus medroxyprogesterone acetate (MPA) were given to advanced prostatic cancer patients with symptomatic bone involvement who had progressed to hormonal therapy. EpiADM was administered at a dose of 30 mg/m2 i.v. weekly and MPA at a daily dose of 1,000 mg p.o. for the first month and 500 mg thereafter. Fifty-four patients entered the trial, all of whom were evaluable. Amelioration of pain and a > or = 50% reduction in analgesic intake were observed in 52% of cases, with a mean duration of 4 months. Of the 28 responsive patients, 26 had already received two lines of hormonal therapy or were resistant to first-line therapy. Of the 23 patients with measurable lesions, 6 obtained a > or = 50% tumor shrinkage at these sites. The treatment was well tolerated, and no cardiac toxicity was observed up to a total cumulative EpiADM dose of 660 mg/m2. In conclusion, this regimen seems to have a palliative effect in patients with advanced prostatic cancer who have progressed to hormonal therapy, and it is feasible in an outpatient setting.
American Journal of Clinical Oncology 07/1995; 18(3):239-44. · 2.01 Impact Factor
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ABSTRACT: Thirty-three patients with limited small cell lung cancer (SCLC) received carboplatin, epirubicin and VP-16 chemotherapy, concurrent 'split course' thoracic radiotherapy, followed by surgery for patients achieving an objective response (OR). High-risk patients and those staged T4-N3 (IIIB) at diagnosis, were excluded from surgery. After induction chemoradiotherapy we obtained 90.9% OR, with 63.3% obtaining complete response (CR). Ten patients (30.3%) were eligible for surgery after induction therapy. Five patients (15.1%) were subjected to surgery and five additional patients refused. Of the five patients who were subjected to surgery, four had a complete response (CR), (three pathological confirmations), and one had a partial response (PR), (unresectable). The median survival time for all patients was 16 months with 12.1% of the long-term survivors still living after 2 years and 9% still living after 3 and 4 years. Toxicity consisted mainly of myelosuppression. This study shows a high activity of the chemotherapy and the chemoradiotherapeutic regimen employed but a low feasibility for adjuvant surgery in SCLC.
Lung Cancer 08/1994; 11(1-2):83-91. · 3.43 Impact Factor
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ABSTRACT: In our study, 72 SCLC patients, 23 with limited and 49 with extensive disease, were treated with carboplatin, epirubicin, and VP-16 (CEV) chemotherapy (CBDCA 300 mg/m2 day 1, EDX 50 mg/m2 day 1, VP-16 100 mg/m2 i.v. days 1-3, every 4 weeks). Patients with limited disease were also subjected to concurrent "split-course" chest radiotherapy followed by surgery in responders if they were not staged IIIB at diagnosis. In limited disease we obtained 96.5% objective responses (OR) with 52.5% complete responses (CR), a median survival of 14 months, with 13% long-term survivors at 30 months. In extensive disease we obtained 83.6% OR with 28.5% CR, and a median survival of 10 months. Toxicity consisted mainly of manageable myelosuppression, especially for limited disease. These data show high activity of CEV chemotherapeutic regimen.
American Journal of Clinical Oncology 05/1994; 17(2):160-2. · 2.01 Impact Factor
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ABSTRACT: The prognosis and the quality of life of patients with carcinoid tumors is related either to symptoms from the substances secreted or to progressive tumor growth. Medical treatment with cytotoxic agents is of marginal value for increasing life expectancy and reducing clinical symptoms. Recent studies with interferon have shown interesting results. In the present investigation, 22 patients with carcinoid tumors and syndrome were treated with recombinant interferon alpha-2a (r-IFN alpha-2a) at the dose of 6 x 10(6) IU intramuscularly daily for 8 weeks and three times weekly thereafter. The primary tumor was localized in the foregut (n = 11), midgut (n = 7), hindgut (n = 1), and unknown site (n = 3). Most cases had liver metastasis. Seventeen patients had elevated 5-hydroxyindoloacetic acid (5-HIAA) excretion and 5 had flushing and/or diarrhea as the only clinical manifestation. Six cases presented a complete syndrome (flushing, diarrhea and 5-HIAA excretion). Control of symptoms was obtained in 80% and a 5-HIAA level reduction in 58% of the patients. The interferon treatment was more effective for control of the carcinoid syndrome than for control of tumor growth. The treatment was well tolerated and fever, myalgia, anorexia and fatigue were the most frequent side-effects.
Acta Oncologica 02/1993; 32(2):235-8. · 3.33 Impact Factor
