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Gummadi T.,University of Minnesota | Valpione S.,Istituto Oncologico | Kim C.,University of Minnesota | Mittapalli R.K.,University of Minnesota | And 5 more authors.
Melanoma Research | Year: 2015

The impact of BRAF mutations in metastatic melanoma on the incidence of brain metastases and melanoma prognosis and the effect of BRAF inhibitors on the incidence of brain metastases has not been defined. Therefore, a retrospective analysis of patients with metastatic melanoma treated at three institutions was carried out to examine the impact of BRAF mutations and a BRAF inhibitor, vemurafenib, on the incidence of brain metastases. A retrospective review of 436 records revealed no difference in the incidence of brain metastases between patients with BRAF-mutated tumors versus those without (incidence rate ratio=1.11, 95% confidence interval: 0.80-1.53; P=0.53). A lower incidence of brain metastases was observed in patients with BRAF-mutated tumors who took vemurafenib before the development of brain metastases versus those who did not (incidence rate ratio=0.51, 95% confidence interval: 0.30-0.86; P=0.009). Although treatment with vemurafenib led to improvement in extracranial disease control, it did not significantly affect progression of existing intracranial disease and survival in these patients (P=0.7). Although our previous preclinical data have indicated that penetration of vemurafenib into the brain is limited, our retrospective analysis showed that there was a lower incidence of brain metastases in patients with BRAF-mutated tumors who took vemurafenib before the diagnosis of brain metastases. © 2015 Wolters Kluwer Health, Inc. All rights reserved. Source

Chiarion-Sileni V.,Melanoma and Skin Cancer Unit | Guida M.,Istituto Oncologico | Ridolfi L.,Immunotherapy and Somatic Cell Therapy Unit | Romanini A.,Medical Oncology Unit | And 6 more authors.
British Journal of Cancer | Year: 2011

Background:This study compared the central nervous system (CNS) metastasis incidence between a temozolomide- and a dacarbazine-based regimen in untreated stage IV melanoma patients.Methods:A total of 150 patients were randomly assigned to receive either oral temozolomide (200 mg m 2 per day; days 1-5) or intravenous dacarbazine (800 mg m 2; day 1), in combination with intravenous cisplatin (75 mg m 2; day 1) and subcutaneous interleukin-2 (3 MU twice daily; days 9-18), every 28 days (CTI and CDI).Results:A total of 149 patients were eligible for an intention-to-treat analysis (CTI: n74, CDI: n75). The 1-year cumulative CNS incidence failure was 20.6% for CTI and 31.1% for CDI (P0.22). In all 24 patients in CTI (32%) and 34 (45%) in CDI developed CNS metastases; 31 patients died of early systemic progression, before CNS evaluation. Median survival time was 8.4 months in the CTI and 8.7 in the CDI arm; in patients with CNS metastases the median survival time was 13.5 months in the CTI and 11.5 in the CDI arm. No difference in toxicity was observed between the two arms.Conclusion:The incidence of CNS failures in metastatic melanoma was not significantly reduced and the clinical course was not modified substituting a dacarbazine-based regimen with a temozolomide-based regimen. Patients who developed CNS metastases did not have a worse prognosis than patients progressing in other sites and should not be excluded from new investigational studies. © 2011 Cancer Research UK All rights reserved. Source

Luciani A.,San Paolo Hospital | Biganzoli L.,Sandro Pitigliani Medical Oncology Unit | Colloca G.,University Cattolica Sacro Cuore | Falci C.,Istituto Oncologico | And 10 more authors.
Journal of Geriatric Oncology | Year: 2015

Objective: Some parameters of the Comprehensive Geriatric Assessment (CGA) are predictive of chemotherapy toxicity. The Vulnerable Elders Survey-13 (VES-13) is a short instrument that has been tested as a means of identifying patients who need a full CGA, but its ability to predict chemotherapy toxicity is still unclear. We performed a pooled analysis of four published clinical trials studying VES-13 as a means of diagnosing vulnerability, in order to evaluate its accuracy in predicting the risk of grade 3/4 toxicity in older patients undergoing chemotherapy. Materials and Methods: The study involved patients aged ≥ 66. years with a diagnosis of solid or hematological cancer, all of whom were administered VES-13. The number of medications taken by each patient, their comorbidities, their Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score and index, the type of chemotherapy and treatment line, and their Mini Mental State Evaluation (MMSE), and Mini Nutritional Assessment (MNA) scores were recorded. Information was available concerning the grades 3-4 hematological and non-hematological toxicities experienced by each patient. Results: The study involved 648 patients aged ≥ 66 years (mean age 76.2 ±4.5, range 66-90) of whom 336 (51.9%) were female. VES-13 identified 287 patients (44.3%) as vulnerable. Grades 3-4 hematological and non-hematological toxicities were more prevalent in the vulnerable subjects (35.2% vs 20.8%, p < 0.0001, and 18.5% vs 10.8%, p = 0.0055), who were also at higher risk of both (adjusted ORs 2.15, 95% CI 1.46-3.17, p < 0.001); and 1.66 (95% CI 1.02-2.72, p = 0.043). Conclusions: VES-13 could be considered to be a good candidate for future prospective studies to assess older patients with cancer at risk of toxicity. © 2015 Elsevier Inc. Source

Gebbia V.,University of Palermo | Maiello E.,IRCCS | Giuliani F.,Istituto Oncologico | Borsellino N.,Ospedale Buccheri la Ferla | And 2 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2010

Background: Patients with advanced pancreatic cancer failing gemcitabine- based first-line chemotherapy are still in relatively good clinical conditions and may still require second-line chemotherapy, which is frequently administered in daily clinical practice given to without solid scientific support. Patients and Methods: A retrospective survey was carried out including 40 patients with stage III or IV gemcitabine-refractory pancreatic carcinoma. Patients received standard FOLFIRI regimen biweekly until progression or unacceptable toxicity. Response evaluation criteria in solid tumors and National Cancer Institute common toxicity criteria were employed respectively for response and toxicity assessment. Results: Six partial responses (15%) and 14 stabilizations of disease (35%) were recorded for a tumor growth control rate of 50%. The median time to progression was 3.7 (range, 1-6.5 months), and median overall survival was 6 months (range, 2-8.2 months). A stabilization of performance status and a subjective improvement of cancer-related symptoms were recorded in 21 patients (52.5%). No correlation has been found between length of time to progression during first-line chemotherapy and length of that reported in the second-line setting or objective response. Grade 3-4 diarrhea and mucositis was observed in 15% and 10% of cases, respectively. Conclusions: Data presented in this article demonstrate that the second-line FOLFIRI regimen are able to induce an objective response in a relatively small fraction of patients with gemcitabine-refractory adenocarcinoma of the pancreas. The use of second-line chemotherapy should be carefully proposed to patients with good performance status or those who had a good response to first-line therapy. Copyright © 2010 by Lippincott Williams & Wilkins. Source

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