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M Marangolo

Publications and source records attributed to M Marangolo.

At least 55 records · Page 3Linked to original sources
PubMed1999

Treatment of small cell lung cancer.

Small cell lung cancer represents approximately 25% of all lung cancers. During the 1980s enormous efforts have been made to try to create a breakthrough in this peculiar disease but, despite the excellent results obtained in the early 1980s with multidrug chemotherapy, no significant improvements have been achieved in the 1990s. Overall response rates are in the range of 60-90% for patients with limited disease and 40-70% for those with extended disease, with pathological remissions in the range of 20-50%. Nevertheless, the majority of patients with small cell lung cancer continues to relapse and ultimately dies of the disease. New strategies under clinical evaluation are the multimodality approach, such as concurrent chemoradiation, and the use of dose-intensive regimes or even high-dose chemotherapy supported by autologous haemopoietic rescue. In the near future other strategies will be possible, owing to the tremendous increase in the knowledge of biological properties of this disease. This article aims to summarize the research so far, the current strategies and the probable future of the treatment of small cell lung cancer.

Carcinoma, Small Cell↗
PubMed1997

Cisplatin-gemcitabine combination in advanced non-small-cell lung cancer: a phase II study.

PURPOSE: The nucleoside analog, gemcitabine, has shown activity as a single agent in the treatment of metastatic non-small-cell lung cancer (NSCLC). Its combination with cisplatin in preclinical models suggested synergy between the two drugs. The aim of the study was to evaluate the clinical efficacy and toxicity of the cisplatin-gemcitabine combination in advanced NSCLC. PATIENTS AND METHODS: Forty-eight consecutive previously untreated NSCLC patients entered the trial from January to June 1994. The median age was 60 years (range, 37 to 70) and performance status (PS) was 0 or 1; 22 patients had unresectable stage III disease (21 stage IIIB and one stage IIIA) and 26 had stage IV disease. Gemcitabine 1 g/m2 was administered weekly (days 1, 8, and 15) followed by a 1-week rest and cisplatin 100 mg/m2 on day 2 of each 28-day cycle. Survival and response were determined in accordance with the intention-to-treat principle in all enrolled patients. RESULTS: Of 48 assessable patients, one (stage IV) had a complete response (CR) and 25 achieved a partial response (PR). The overall response rate was 54% (95% confidence interval [CI], 40% to 68%). Thrombocytopenia was the main side effect, with 52% of patients experiencing grade III to IV toxicity, which was usually short-lived and responsible for the omission of gemcitabine administration on day 15 in 50% of chemotherapy courses. The median survival time was 61.5 weeks (95% CI, 40 to 71). CONCLUSION: The combination of gemcitabine and cisplatin induced a high response rate in both stage IIIB and IV NSCLC, with modest side effects. The regimen deserves further careful evaluation in a phase III prospective randomized trial.

Adult↗
PubMed1996

Phase II study of intensive chemotherapy with carboplatin, ifosfamide and etoposide plus recombinant human granulocyte colony-stimulating factor and sequential radiotherapy in locally advanced, unresectable non-small-cell lung cancer.

From June 1991 to August 1994, 61 patients with stage III unresectable non-small-cell lung cancer (NSCLC; 16 cases of stage IIIA with N2 bulky disease and 45 cases of stage IIIB) were treated with ifosfamide given i.v. at 3 g/m2 on day 1, carboplatin given i.v. at 200 mg/m2 on days 1 and 2, etoposide given i.v. at 120 mg/m2 on days 1-3 (ICE) and recombinant human granulocyte colony-stimulating factor (rhG-CSF) given s.c. at 5 micrograms/kg on days 4-13. Chemotherapy was given every 3 weeks for up to three cycles and, unless the disease progressed, was followed by thoracic radiotherapy on the tumor volume (total dose 60 Gy) and mediastinum (40 Gy). All patients had measurable or evaluable unresectable disease and a performance status (Eastern Cooperative Oncology Group) of 0-1. Only 61% of the enrolled patients received the full program of chemoradiotherapy according to the study design. At the end of sequential chemo-radiotherapeutic treatment, 41% of the patients had an objective response (24 partial responses and 1 complete response), 31% showed no change and 28% had progressive disease. The response rate noted for patients in stage IIIA with N2 bulky disease and that recorded for patients in stage IIIB did not differ significantly. The median time to progression was 5.4 months and the median survival was 8.2 months, with the 1-year survival rate being 31%. Sites of progression were mostly intrathoracic. Haematological toxicity was the main side effect, with grade III-IV thrombocytopenia being reported in 24% of the 165 courses of intensive ICE chemotherapy given. Febrile neutropenia was described in six courses (three patients). Non-haematological toxicities and radiotherapy-related side effects were generally mild and easily manageable. In conclusion, in unresectable stage III NSCLC a short program of moderately intensified ICE chemotherapy with rhG-CSF protection followed by sequential radiotherapy failed to increase the percentage of objective responses and reached a median survival comparable with that previously achieved with standard doses.

Adenocarcinoma↗
PubMed1996

Psychological stress symptoms before and after autologous bone marrow transplantation in patients with solid tumors.

This study sought to examine patterns of changes of psychological stress symptoms in autologous bone marrow transplantation (ABMT) recipients. Forty-nine patients affected by solid tumors were assessed using the Symptom Questionnaire on admission to hospital (before high-dose chemotherapy and ABMT) and before discharge. Symptoms of anxiety and anger tended to decrease and relaxation of improve over time. Nevertheless, on admission to hospital 30-50% of the patients reported severe to moderate symptoms of anxiety and depression. Before discharge, the prevalence was still high (20-35%). The implications of these findings are discussed in terms of the need to monitor the evolution of emotional functioning of cancer patients undergoing ABMT.

Adult↗
PubMed1996

Paclitaxel and radiotherapy in the treatment of advanced non-small cell lung cancer.

Sixteen patients affected by previously untreated non-small cell lung cancer stage IIIB or IV received radiotherapy and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as radiation sensitizer in an open, nonrandomized pilot study to find the maximum tolerated dose of the drug concomitantly combined with radiation. Paclitaxel was given as a 3-hour infusion once weekly at a dose escalating by 10 mg/m2/wk for every patient cohort, starting at 40 mg/m2/wk and continuing to 80 mg/m2/wk. Conventionally fractionated (2 Gy/d for 5 d/wk for 5 weeks) radiotherapy up to 50 Gy was delivered to the primary tumor and mediastinum with a 6-mv linear accelerator. Hematologic toxicity has been very low; grade 3 World Health Organization nonhematalogic toxicities have been registered only at the 80 mg/m2/wk dose level. Seven patients achieved a major response, three patients had stable disease, and five patients progressed; three patients are still responding, whereas the others are relapsed and five of them died of disease. The median duration of response was 5 months. Paclitaxel may be safely combined with radiation at the maximum tolerated dose of 70 mg/m2/wk. Our data seem to confirm the radiosensitizing effect of the drug, independent of the dose level. Low doses of paclitaxel given as a single agent are unable to control metastatic disease.

Adult↗
PubMed1996

Phase I/II study of paclitaxel and radiotherapy in non-small cell lung cancer.

To establish the maximum tolerated dose of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as a radiosensitizing agent and to determine its optimal therapeutic dose when combined with conventionally fractionated radiotherapy in the treatment of non-small cell lung cancer, a phase I/II study was undertaken in 16 treatment-naive patients. Beginning at 40 mg/m2/wk with doses escalated in 10 mg/m2 increments until dose-limiting toxicity was encountered, paclitaxel was administered over 3 hours to successive three-patient cohorts. Radiotherapy (2 Gy/d x 5 d/wk; maximum total dose, 50 Gy) was delivered after the paclitaxel infusion. Treatment continued for 5 successive weeks. All 16 patients are evaluable for response and toxicity. Hematologic toxicity was low, with red blood cells and platelets remaining stable and leukocyte decreases (mean, 60%) attributed to radiotherapy. Nonhematologic toxicity included grade 2/3 esophagitis and neurologic sequelae. Responses were noted at all paclitaxel dose levels, including two complete and five partial responses, but the median time to progression was only 5 months. Paclitaxel may be combined safely with radiotherapy without major toxicity, and the radiosensitizing effect of paclitaxel was evident at all doses.

Adult↗
PubMed1994

High-dose intra-arterial plus intraperitoneal chemotherapy combined with hemofiltration in liver metastases from colorectal cancer.

AIMS: Twenty-three patients with liver metastases from colorectal cancer were entered into a prospective, phase II pilot study to evaluate the efficacy and feasibility of intra-arterial high-dose chemotherapy (IAHC) + intraperitoneal chemotherapy (IPC) combined with hemofiltration. METHODS: All patients had abdominal laparotomy to position a hepatic artery infusion port and in 15 cases an implantable system for IPC. A double-lumen filtration catheter was placed in the vena cava via the saphenous or femoral vein and connected to a modified hemofiltration unit. The treatment schedule consisted of mitomycin (30-50 mg/m2) and epirubicin (60-90) mg/m2) as IAHC combined with cisplatin (60 mg/m2) given in a 2000 ml saline solution by IPC. The high-dose IAHC-IPC was followed by 4 cycles of intra-arterial standard dose chemotherapy through the arterial port-a-cath (6 mg/m2 mitomycin and 20 mg/m2 epirubicin) and if possible by another cycle of high dose IAHC-IPC. RESULTS: We delivered a total of 31 cycles of IAHC, 21 of which were combined with IPC. Ten cycles of IAHC were administered without concurrent IPC because of painful adhesions, clinical contraindications or patient refusal. Seven of 23 patients (30%) were pretreated and with progressive disease after systemic chemotherapy. Among 22 evaluable patients, we obtained 2 complete remissions (9%) and 11 partial remissions (50%); moreover, 4 of 7 pretreated patients obtained a response to treatment. As a result, an objective tumor response was observed in 59% of patients (13/22). Therefore, a dose-response behavior was demonstrated also in tumors with a low chemosensitivity. The median duration of response and survival was 10 and 14 months, respectively. Toxicity was usually mild, but we reported one toxic death due to treatment complications. CONCLUSIONS: Further prospective randomized studies are needed to confirm the results of our study.

Adult↗
PubMed1994

Prognostic factors and survival in non-Hodgkin's lymphomas: the experience of the Istituto Oncologico Romagnolo (IOR).

In an attempt to evaluate natural history, prognostic factors and survival, the data of 340 patients with NHL were collected. 267 patients were evaluable for the analysis of prognostic factors and survival. The tumor samples were reviewed and reclassified according to the Kiel classification. At completion, 180 patients were affected by low-grade (LG)-NHL and 87 patients had high-grade (HG)-NHL. Numerous potential prognostic factors were analysed in univariate and multivariate analyses. Globally 154 patients (57.4%) obtained complete remission (CR) and 65 patients (24.3%) partial remission (PR). The response rate was similar in LG and HG-NHL groups. 5-years survival was 52% for all patients (53% in LG-NHL and 44% in HG-NHL). Median survival was 62 months in LG-NHL and 38 months in HG-NHL (p = n.s.). At the univariate analysis overall survival (OS) in LG-NHL was favourably influenced by age < 65 years (p = 0.004), performance status > 80 (p < 0.02), early clinical stage (p < 0.001), absence of systemic symptoms (p < 0.001), low serum LDH (p < 0.001) and achievement of CR (p < 0.001), while in the HG-NHL only by age (p = 0.005) and achievement of CR (p < 0.001). The multivariate analysis showed early clinical stage, low serum LDH, absence of systemic symptoms and achievement of CR as independent prognostic factors in LG-NHL and only achievement of CR in HG-NHL.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Conservative treatment for T2-T4 bladder cancer with primary chemotherapy and radiotherapy: a pilot study.

AIMS AND BACKGROUND: After radical cystectomy, with or without pelvic radiotherapy, more than 50% of patients affected by infiltrating bladder cancer died of distant metastases. Polychemotherapy yields 25% complete remissions (CR) in patients with invasive transitional cell bladder carcinoma; although many concerns exist about the duration of such CR. This study was undertaken with the aim of evaluating the efficacy and safety of an integrated chemo-radiotherapeutic treatment, in order to broaden indications to a conservative surgical therapy. METHODS: Thirty-three consecutive patients with bladder urothelial cancer T2-T4, N0, M0, have been treated. Patients received neoadjuvant chemotherapy (rescue-M-VEC) consisted of methotrexate 30 mg/sqm plus folinic acid 15 mg after 24 h on days 1, 15, 22; vinblastine 3 mg/sqm on days 1, 15 and 22; epidoxorubicin 30 mg/sqm on day 1; cisplatin 70 mg/sqm on day 1. This cycle was repeated on day 29. After 2 cycles of rescue-M-VEC, patients underwent pelvic cobalt teletherapy 40 Gy combined with low dose cisplatin 25 mg/sqm/week. After restaging, responding patients underwent further radiation therapy (24 Gy) as booster consolidation. RESULTS: After 2 cycles of chemotherapy and pelvic radiotherapy 14/31 evaluable patients (45.2%) achieved CR and 11/31 (35.4%) partial remission, with an overall response rate of 80.6% (25/31). With a median follow up of 21 months the actuarial survival rate at 24 months was equal to 79.8%. Eleven radical cystectomies were performed, 6 of which at restaging in non responding patients and 5 during the follow up due to relapse. Of the 25 patients selected for bladder conservation, 12 (48%) have not yet shown relapses. Three out of 31 (9.7%) patients died of distant metastases. No severe toxicity has been observed: moreover no patient developed stomatitis after chemotherapy. CONCLUSIONS: Our results seem encouraging but longer follow-up and further phase III studies need to be carried out to demonstrate the feasibility of conservative treatment in muscle infiltrating bladder cancer.

Aged↗
PubMed1993

Prospective randomised trial comparing fluorouracil versus doxifluridine for the treatment of advanced colorectal cancer.

Doxifluridine (dFUR) is a fluoropyrimidine derivative that has shown activity on a variety of solid tumours. The purpose of this study was to compare its therapeutic effect with a standard fluorouracil (FU) regimen in patients with locally advanced or metastatic colorectal cancer. 222 previously untreated patients were randomised to receive dFUR (4000 mg/m2) or FU (500 mg/m2) daily for 5 days every 28 days. The primary tumour originated in the colon in two-thirds of the cases in both groups; approximately 90% of patients had metastatic extension, and liver involvement was present in 69% of the patients in the dFUR and FU groups. A good performance status (ECOG 0-1) was recorded in 90% of cases in both arms. A median of five cycles was administered to the patients (range 1-12). Only one partial response among 110 patients in the FU arm and one complete response and five partial responses out of 112 evaluable patients in the dFUR group were observed. Time to progression was significantly longer in the dFUR group (P = 0.02); overall survival, while longer in the dFUR arm (48 weeks vs. 39 weeks), was not significantly so (P = 0.08). Toxicity was acceptable in both arms, although grade 3-4 neurological side-effects and leukopenia were more common after dFUR infusion. Despite the low response rate, our results indicate that dFUR may be a superior alternative to FU. The possibility of enhancing significantly the activity of dFUR with biochemical modulators should be further investigated.

Adult↗
PubMed1992

Treatment of pelvic osteosarcoma.

Pelvic osteosarcoma is a very rare disease, with poor prognosis affecting young people. Since June 1987 we have observed 26 patients, F/M: 12/14, median age 23 years (range 14-55), 7 with lung metastases at diagnosis. Four patients underwent surgery as first line treatment; 4 patients received intravenous (i.v.) chemotherapy; eighteen out of 26 received 1-3 cycles of neoadjuvant chemotherapy consisting of high dose i.v. methotrexate plus leucovorin rescue, intraarterial cisplatin and i.v. epidoxorubicin. We obtained 8 PR, 9 SD, 1 PD. Hemipelvectomy has been performed in 4 cases (0%, 0%, 50%, 70% necrosis). The other 14 patients, judged not operable, received radiotherapy plus daily low doses of cisplatin. All patients have been treated with i.v. epidoxorubicin, ifosfamide, high dose methotrexate, cisplatin and etoposide. Two out of four patients who underwent surgery died at 17 and 18 months, 2 are alive and free of disease at 28+ and 17+ months from surgery. Among the 14 patients treated with radiotherapy, 9 died with a median survival of 18 months (5-22); 5 are alive with a median survival of 20 months (14-31). Although pelvic osteosarcoma has a limited cure rate at present, results could be improved in the future by means of earlier diagnosis and better combined treatment.

Adolescent↗
PubMed1992

High-dose chemotherapy supported with autologous bone marrow transplantation (ABMT) in germ cell tumors: a phase two study.

In this paper, the first Italian multicentre experience with high-dose chemotherapy and ABMT in germ cell cancer is presented. Twenty-eight patients underwent treatment with a carboplatin-etoposide w/o ifosfamide high-dose combination. Seventeen patients were in progression of disease, 9 were responsive to salvage treatments or failed to achieve CR to front line, and 2 had stable disease (both with an elevated marker level) at the time of transplantation. Five patients, all of whom were in sensitive relapse at transplantation, are alive and disease-free at > 17 months' follow-up. Two patients died 15 days after ABMT, one of veno-occlusive disease and one of rapid uncontrolled tumor progression. In highly pretreated patients this schedule seems to provide an option of cure for a cohort of patients failing to achieve CR to standard salvage regimens for germ cell cancer. Definitive conclusions may eventually be drawn with a more homogeneous group of patients. This type of approach should continue to be taken in sensitive relapse patients only, as responses in progressive cases are very transient, with virtually no cures. The question of whether high-dose programs are better than standard chemotherapy will in any case be answered only in a randomized prospective trial.

Adolescent↗