Pasquale Incoronato

Mitomycin C plus vindesine or cisplatin plus epirubicin in previously treated patients with symptomatic advanced non-small-cell lung cancer

SummaryA total of 40 previously treated patients with symptomatic advanced non-small-cell lung cancer (NSCLC) were subjected to second-line chemotherapy with mitomycin C plus vindesine (MV) or cisplatin plus epirubicin (PE). The 12 patients treated with the MV regimen showed no objective response (OR) or symptom palliation. In the 28 patients who received the PE regimen, we obtained a 25% partial response rate, with amelioration of tumor-related symptoms occurring in 35.7% of cases and improvement in the performance status being noted in 25% of subjects. Both regimens were well tolerated. These data show that the administration of cisplatin-based secondline chemotherapy to patients with symptomatic advanced NSCLC may be useful.

Phase I study of epirubicin plus vinorelbine with or without G-CSF in advanced non-small cell lung cancer

The present phase I study was designed to determine the maximum tolerated dose (MTD) of epirubicin, administered every 3 weeks to patients with advanced non-small cell lung cancer (NSCLC), and combined with a conventional dose of vinorelbine [25 mg/m2 intravenously (i.v.) days 1 and 8] with or without the support of granulocyte-colony stimulating factor (G-CSF). 18 patients entered the study. The patients received the following four dose levels of epirubicin (i.v., day 1): 50 mg/m2 (3 patients) and 60 mg/m2 (6 patients) without G-CSF, 75 mg/m2 (3 patients) and 90 mg/m2 (6 patients) with G-CSF (5 micrograms/kg days 4-6 and 9-15). In the patients treated without G-CSF the MTD of epirubicin was 60 mg/m2 and leukopenia was the dose-limiting toxicity. In the patients treated with G-CSF the MTD was 90 mg/m2, myelotoxicity being the dose-limiting toxicity. We observed 1/3 partial response (PR) with epirubicin at the dose of 75 mg/m2 and 2/6 PR at 90 mg/m2. These results would indicate the usefulness of a phase II study with epirubicin at the dose of 90 mg/m2 in association with conventional dose of vinorelbine with the support of G-CSF in advanced NSCLC.

Mitomycin C and vindesine: an ineffective combination chemotherapy in the treatment of malignant pleural mesothelioma.

Twelve patients with malignant pleural mesothelioma were subjected to mitomycin C (MMC) and vindesine (VDS) chemotherapy (MMC 10 mg/m2, i.v., d 1; VDS, 3 mg/m2, i.v., d 1–8, every 4 weeks). No objective response was obtained; 3 (25%) patients had stable disease and 9 (75%) progression of disease. We conclude that MMC plus VDS is an ineffective combination chemotherapy in the treatment of malignant pleural mesothelioma.

Complete regression of laryngeal involvement by classic Kaposi's sarcoma with low-dose alpha-2b interferon.

We report the case of an 82-year old Italian female with laryngeal involvement of classic Kaposis sarcoma. We obtained a complete regression of laryngeal lesion with low-dose alpha-2b interferon.

Phase II study of mitomycin C, etoposide and vindesine in metastatic stage IV non-small-cell lung cancer

SummaryA total of 72 patients with metastatic stage IV non-small-cell lung cancer (NSCLC) were treated with combination chemotherapy comprising the MEV regimen (mitomycin C, 8 mg/m2 given i. v. on day 1; etoposide, 100 mg/m2 given i.v. on days 1–3; and vindesine, 3 mg/m2 given i.v. on day 1; treatment repeated every 3 weeks). In 64 evaluable patients, the objective response rate was 37% (complete responses, 4.7%; partial responses, 32.3%). The median survival was 7.6 months for all patients. The treatment was very well tolerated. MEV proved to be an active and non-toxic regimen for the treatment of metastatic NSCLC.

Phase I study of ifosfamide plus high-dose epirubicin in advanced non-small-cell lung cancer

Abstract The present phase I study was designed to determine the maximum tolerated dose (MTD) of epirubicin given in combination with ifosfamide at a dose of 3 g/m2, recycled every 4 weeks, in patients with advanced non-small-cell lung cancer (NSCLC). A total of 18 patients entered the study; they received the following four dose levels of epirubicin (i. v., day 1): 75 (6 patients), 90 (3 patients), 105 (3 patients), and 120 mg/m2 (6 patients). The MTD of epirubicin was 120 mg/m2, neutropenia being the dose-limiting toxicity. We observed 1/6, 1/3 1/3, and 2/6 partial responses (PRs) at epirubicin dose levels of 75, 90, 104, and 120 mg/m2, respectively. A phase II study of epirubicin given at a dose of 120 mg/m2 in association with conventional-dose ifosfamide in advanced NSCLC is in order.

Mitomycin C etoposide and vinorelbine (MEV II) in the treatment of metastatic stage IV non small cell lung cancer.

Aims and Background In a prior study with a new non-cisplatin-based regimen including mytomycin C, etoposide and vindesine (MEV I) we observed a 37% response rate and very low toxicity in stage IV non small cell lung cancer. In an attempt to improve the activity of MEV I we evaluated a new regimen, MEV II, a modification of MEV I in which vinorelbine replaced vindesine. Methods 21 Patients with metastatic stage IV non small cell lung cancer entered the phase II trial and were treated with the MEV II regimen (mitomycin C 8 mg/m2, i.v., d 1, etoposide 100 mg/m2, i.v., d 1-3, vinorelbine 30 mg/m2, i.v., d 1, every 4 weeks. Results We observed a partial response rate of 30% (95% confidence limits 10-50) with a median survival of 6 months. The worst reported toxicity was leukopenia grade 4 in 10% of patients including one who died of sepsis and grade 3 in 20%. Conclusions The MEV II regimen showed a similar activity but greater toxicity than MEV I.

Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

Background On the basis of the results of two pivotal phase III clinical trials, eribulin mesylate is currently approved in EU for the treatment of advanced breast cancer (aBC) in patients who have previously received an anthracycline and a taxane in either the adjuvant or the metastatic setting, and at least one chemotherapeutic regimen for metastatic disease. Methods In our study, we investigated the efficacy and tolerability of eribulin as second or further line chemotherapy in 137 women affected by aBC. Results Eribulin as monotherapy provided benefit in terms of progression-free survival (PFS), response rate (RR) and disease control rate (DCR) independently of its use as second or late-line therapy. The overall RR and DCR were 17.5% and 64%, respectively. In particular, DCR and overall RR were 50% and 13.6%, 65.4% and 21.1%, 70.4% and 14.8% and 66.7% and 16.7% in second, third, fourth and further lines of treatment, respectively. Median PFS (mPFS) according to the line of therapy was 5.7, 6.3, 4.5 and 4.0 months in patients treated with eribulin in second, third, fourth and over the fourth line, respectively. No significant difference in terms of mPFS was found between the various BC subtypes. Overall, eribulin resulted safe and most adverse events were of grade 1 or 2 and easily manageable. Grades 3–4 toxicities were neutropaenia and neurotoxicity. Conclusions With the limitations due to the observational nature of our findings, eribulin was shown to be an effective and safe therapeutic option in heavily pretreated patients with aBC.

Exemestane and Everolimus combination treatment of hormone receptor positive, HER2 negative metastatic breast cancer: A retrospective study of 9 cancer centers in the Campania Region (Southern Italy) focused on activity, efficacy and safety

Exemestane (Exe) in combination with Everolimus (Eve) represents an important treatment option for patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC), which was previously treated with non-steroidal aromatase inhibitors (NSAI). Data from unselected populations may be useful for defining the optimal therapeutic algorithm within a clinical setting. Data from 264 HR+, HER2-MBC patients who received Exe-Eve treatment in combination, following the failure of NSAIs was retrospectively analyzed. Different lines of endocrine treatment (ET) were investigated to evaluate the efficacy and toxicity of the treatment within the ‘everyday clinical practice’ population. The disease control rate (DCR) was 73.1%, with no statistically significant difference among the different settings. At a median follow-up of 42 months, the median progression free survival (PFS) was 11.6, 9.7 and 7.5 months for patients treated with Exe-Eve as first, second or third line therapy, respectively. There was a statistically significant correlation with younger age, no previous adjuvant chemotherapy (CT), no previous adjuvant endocrine therapy (ET), HT duration ≥36 months, involvement of liver and/or lung, no prior CT for metastatic disease and PS=0 at the start of treatment. The median overall survival (OS) was 33.0 months; at a median follow-up of 67 months, the median OS was 43.1, 31.7 and 27.9 months in patients treated with Exe-Eve in first, second or third line therapy, respectively. On multivariate analysis, diabetes and previous CT for metastatic disease were revealed to correlate with a worse outcome. Conversely, the presence of mucositis was significantly associated with long-term survival. Overall, Exe-Eve was typically well tolerated and the majority toxicities were G1 or 2, while treatment discontinuation due to unacceptable toxicity was only required in 5.7% of patients. Despite the limitations due to the observational nature of this study, the findings suggest that treatment with Exe-Eve is an active and safe therapeutic option for endocrine-sensitive MBC patients in a real-world clinical setting, regardless of treatment lines.