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2 results on '"Gioeni, L"'

1. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer.

Author

Aglietta, M., Barone, C., Sawyer, M. B., Moore, M. J., Miller, W. H., Bagalà, C., Colombi, F., Cagnazzo, C., Gioeni, L., Wang, E., Huang, B., Fly, K. D., and Leone, F.

Subjects
*PANCREATIC cancer treatment, *MONOCLONAL antibodies, *NUCLEOSIDES, *CANCER chemotherapy, *METASTASIS, *IMMUNOTHERAPY
Abstract

It has previously been shown that anti-CTLA4 agents induce tumor responses through modulation of the immune system in patients with metastatic melanoma. Immune suppression also occurs in pancreatic cancer, and therefore combination of immunotherapy with standard chemotherapy may be synergistic. Here, we show that the tremelimumab and gemcitabine combination is safe and tolerable warranting further study.Background Tremelimumab (CP-675,206) is a fully human monoclonal antibody binding to cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) on T cells that stimulates the immune system by blocking the CTLA4-negative regulatory signal. Combination with standard chemotherapy may strengthen antitumor therapy. This is a phase Ib, multisite, open-label, nonrandomized dose escalation trial evaluating the safety, tolerability, and maximum tolerated dose (MTD) of tremelimumab combined with gemcitabine in patients with metastatic pancreatic cancer. Patients and methods Gemcitabine (1000 mg/m2 on days 1, 8, and 15 of each 28-day cycles) was administrated with escalating doses of i.v. tremelimumab (6, 10, or 15 mg/kg) on day 1 of each 84-day cycle for a maximum of 4 cycles. The first 18 patients had an initial 4-week gemcitabine-only lead-in period. Dose-limiting toxicities (DLTs) related to tremelimumab were evaluated during the first 6 weeks after the first dose of tremelimumab. Results From June 2008 to August 2011, 34 patients were enrolled and received at least one dose of tremelimumab. No DLTs related to tremelimumab were observed at any dose, even when the maximum dose established for tremelimumab (15 mg/kg) was used. Most frequent grade 3/4 toxicities were asthenia (11.8%) and nausea (8.8%). Only one patient had a serious drug-related event (diarrhea with dehydration). The median overall survival was 7.4 months (95% confidence interval 5.8–9.4 months). At the end of treatment, two patients achieved partial response. Both patients received tremelimumab 15-mg/kg group (n = 2/19, 10.5%). Conclusion Tremelimumab plus gemcitabine demonstrated a safety and tolerability profile, warranting further study in patients with metastatic pancreatic cancer. ClinicalTrials.gov ID NCT00556023. [ABSTRACT FROM AUTHOR]

Published
2014
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2. Panitumumab in combination with infusional oxaliplatin and oral capecitabine for conversion therapy in patients with colon cancer and advanced liver metastases. The MetaPan study

Author

Luisa Gioeni, Carmine Pinto, Stefano Cascinu, Salvatore Siena, Giuseppe Fornarini, Raffaele Pugliese, Francesco Leone, Donatella Marino, Andrea Sartore-Bianchi, Massimo Aglietta, Francesca Di Fabio, Luciano De Carlis, Salvatore Artale, Lorenzo Capussotti, Celeste Cagnazzo, Marco Tampellini, Leone, F, Artale, S, Marino, D, Cagnazzo, C, Cascinu, S, Pinto, C, Fornarini, G, Tampellini, M, Di Fabio, F, Sartore Bianchi, A, De Carlis, L, Pugliese, R, Capussotti, L, Gioeni, L, Siena, S, Aglietta, M., DE CARLIS, L, and Aglietta, M

Subjects
Oncology, Male, Cancer Research, Organoplatinum Compounds, Colorectal cancer, medicine.disease_cause, Deoxycytidine, Metastasis, capecitabine plus oxaliplatin (XELOX) chemotherapy, Antineoplastic Combined Chemotherapy Protocols, education.field_of_study, Colonic Neoplasm, Panitumumab, Liver Neoplasms, Antibodies, Monoclonal, Middle Aged, Oxaliplatin, Treatment Outcome, colon cancer, Liver Neoplasm, liver resection, Colonic Neoplasms, Drug Therapy, Combination, Female, KRAS, Fluorouracil, medicine.drug, Human, Adult, medicine.medical_specialty, Population, liver metastasis, panitumumab, Disease-Free Survival, Capecitabine, Internal medicine, medicine, Humans, liver metastasi, education, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Organoplatinum Compound, Cancer, medicine.disease, business
Abstract

BACKGROUND Preoperative chemotherapy improves the outcome in patients with colorectal cancer with liver metastases. In the current study, the authors evaluated the activity of a conversion treatment with the combination of capecitabine plus oxaliplatin (XELOX) used in association with panitumumab in patients with unresectable, liver-only, metastatic colon cancer. METHODS Chemotherapy-naive patients with unresectable liver metastases from colon cancer with no other metastatic disease sites were enrolled. All patients received upfront therapy with XELOX plus panitumumab (P-XELOX) and were reevaluated for resectability every 4 cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints were overall survival (OS), progression-free survival, the percentage of patients whose disease became radically resectable, and the safety of the P-XELOX combination. RESULTS A total of 49 patients were recruited, 35 of whom had wild-type KRAS (wtKRAS) and 14 of whom (who were enrolled before study amendment) had unknown (9 patients) or mutated (5 patients) KRAS mutational status. Forty-six patients were evaluable for response. After conversion P-XELOX therapy, the ORR in the general population was 54%, with 2 complete responses, 23 partial responses, and 14 cases of stable disease. In patients with wtKRAS, the ORR of the patients reached 65% (2 CRs and 19 PRs), which allowed 15 patients with initial unresectable liver metastasis to be reclassified as having resectable disease. Survival analysis demonstrated a median progression-free survival of 8.5 months and a median OS of 21.9 months. Patients who underwent surgery were found to have a significantly better OS when compared with those who did not undergo surgery (P

Published
2013

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