6 results on '"Martins, Renato G."'
Search Results
2. Phase II trial of eribulin mesylate in recurrent or metastatic salivary gland malignancies.
- Author
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Rodriguez, Cristina P., Martins, Renato G., Baik, Christina, Chow, Laura Q., Santana‐Davila, Rafael, Goulart, Bernardo H., Lee, Sylvia, and Eaton, Keith D.
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ERIBULIN ,MICROTUBULES ,SALIVARY gland cancer ,CANCER treatment ,TOXICOLOGY ,ADENOID cystic carcinoma ,CANCER chemotherapy ,HISTOLOGY - Abstract
The article offers information on a study which examines the microtubule inhibitor eribulin in recurrent and metastatic salivary gland cancers (RMSGCs), that is a disease where no therapeutic standard exists. It mentions that adenoid cystic carcinomas (ACCs) are generally felt to be insensitive to cytotoxic chemotherapy due to their relatively slow growth pattern.
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- 2018
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3. Value-Based Care in Lung Cancer.
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Eaton, Keith D., Jagels, Barbara, and Martins, Renato G.
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TREATMENT of lung tumors ,CANCER chemotherapy ,MEDICAL care ,EVALUATION of medical care ,MEDICAL protocols ,RADIOGRAPHY ,POSITRON emission tomography ,VALUE-based healthcare - Abstract
Since the beginning of the 21st century, the treatment of lung cancer has changed dramatically. New treatments are improving survival outcomes for patients but have led to dramatic increases in cost. In a value‐based payment system, patients should have access to comprehensive outcome measurements, including survival rates, quality of life, and cost. High value in cancer care will optimize the outcomes that matter to patients relative to cost. [ABSTRACT FROM AUTHOR]
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- 2016
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4. A Phase II study of pulse dose imatinib mesylate and weekly paclitaxel in patients aged 70 and over with advanced non-small cell lung cancer.
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Bauman, Julie E., Eaton, Keith D., Wallace, Sarah G., Carr, Laurie L., Lee, Sang-Joon, Jones, Dennie V., Arias-Pulido, Hugo, Cerilli, Lisa A., and Martins, Renato G.
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LUNG cancer ,CANCER chemotherapy ,HYPERTENSION ,PACLITAXEL ,IMATINIB - Abstract
Background: In non-small cell lung cancer (NSCLC), interstitial hypertension is a barrier to chemotherapy delivery, and is mediated by platelet derived growth factor receptor (PDGFR). Antagonizing PDGFR with imatinib may improve intra-tumoral delivery of paclitaxel, increasing response rate (RR). Methods: This single-stage, open-label phase II study evaluated pulse dose imatinib and weekly paclitaxel in elderly patients with advanced NSCLC. Eligible patients were aged ≥ 70 with untreated, stage IIIB-IV NSCLC and ECOG performance status 0-2. Primary endpoint was RR. Secondary endpoints included median progression free and overall survival (PFS, OS) and correlatives of PDGFR pathway activation. Baseline Charlson Comorbidity Index (CCI) and Vulnerable Elder Survey-13 (VES-13) were correlated with outcomes. Results: Thirty-four patients with median age 75 enrolled. Eleven of 29 (38%) were frail by VES-13 score. Overall RR was 11/34 (32%; 95% CI 17%-51%), meeting the primary endpoint. Median PFS and OS were 3.6 and 7.3 months, respectively. High tumoral PDGF-B expression predicted inferior PFS. Frail patients by VES-13 had significantly worse median PFS (3.2 vs. 4.5 months; p=0.02) and OS (4.8 vs. 12 months; p=0.02) than non-frail. Conclusions: The combination of imatinib and paclitaxel had encouraging activity as measured by the primary endpoint of RR. However, PFS and OS were typical for elderly patients treated with single agent chemotherapy and the regimen is not recommended for further study. Adjunct imatinib did not overcome the established association of tumoral PDGF-B expression with inferior PFS. VES-13 was a powerful predictor of poor survival outcomes. Frailty should be further studied as a predictor of non-benefit from chemotherapy. Trial Registration: ClinicalTrials.gov NCT01011075 [ABSTRACT FROM AUTHOR]
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- 2012
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5. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study.
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Langer, Corey J, Gadgeel, Shirish M, Borghaei, Hossein, Papadimitrakopoulou, Vassiliki A, Patnaik, Amita, Powell, Steven F, Gentzler, Ryan D, Martins, Renato G, Stevenson, James P, Jalal, Shadia I, Panwalkar, Amit, Yang, James Chih-Hsin, Gubens, Matthew, Sequist, Lecia V, Awad, Mark M, Fiore, Joseph, Ge, Yang, Raftopoulos, Harry, Gandhi, Leena, and KEYNOTE-021 investigators
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CANCER treatment , *NON-small-cell lung carcinoma , *CANCER chemotherapy , *CARBOPLATIN , *PEMBROLIZUMAB , *BLIND experiment , *THROMBOCYTOPENIA , *THERAPEUTICS , *ANTINEOPLASTIC agents , *COMPARATIVE studies , *LUNG cancer , *LUNG tumors , *RESEARCH methodology , *MEDICAL cooperation , *MONOCLONAL antibodies , *RESEARCH , *STATISTICAL sampling , *EVALUATION research , *RANDOMIZED controlled trials - Abstract
Background: Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer (NSCLC) setting. The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy. We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC.Methods: In this randomised, open-label, phase 2 cohort of a multicohort study (KEYNOTE-021), patients were enrolled at 26 medical centres in the USA and Taiwan. Patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations were randomly assigned (1:1) in blocks of four stratified by PD-L1 tumour proportion score (<1% vs ≥1%) using an interactive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m2 every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy. The primary endpoint was the proportion of patients who achieved an objective response, defined as the percentage of patients with radiologically confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 assessed by masked, independent central review, in the intention-to-treat population, defined as all patients who were allocated to study treatment. Significance threshold was p<0·025 (one sided). Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned study treatment. This trial, which is closed for enrolment but continuing for follow-up, is registered with ClinicalTrials.gov, number NCT02039674.Findings: Between Nov 25, 2014, and Jan 25, 2016, 123 patients were enrolled; 60 were randomly assigned to the pembrolizumab plus chemotherapy group and 63 to the chemotherapy alone group. 33 (55%; 95% CI 42-68) of 60 patients in the pembrolizumab plus chemotherapy group achieved an objective response compared with 18 (29%; 18-41) of 63 patients in the chemotherapy alone group (estimated treatment difference 26% [95% CI 9-42%]; p=0·0016). The incidence of grade 3 or worse treatment-related adverse events was similar between groups (23 [39%] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [26%] of 62 in the chemotherapy alone group). The most common grade 3 or worse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia (seven [12%] of 59) and decreased neutrophil count (three [5%]); an additional six events each occurred in two (3%) for acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, and sepsis, and thrombocytopenia. In the chemotherapy alone group, the most common grade 3 or worse events were anaemia (nine [15%] of 62) and decreased neutrophil count, pancytopenia, and thrombocytopenia (two [3%] each). One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis compared with two (3%) of 62 patients in the chemotherapy group: one because of sepsis and one because of pancytopenia.Interpretation: Combination of pembrolizumab, carboplatin, and pemetrexed could be an effective and tolerable first-line treatment option for patients with advanced non-squamous NSCLC. This finding is being further explored in an ongoing international, randomised, double-blind, phase 3 study.Funding: Merck & Co. [ABSTRACT FROM AUTHOR]- Published
- 2016
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6. Phase I/II Study of Erlotinib Combined With Cisplatin and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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Herchenhorn, Daniel, Dias, Fernando L., Viegas, Célia M.P., Federico, Miriam H., Araújo, Carlos Manoel M., Small, Isabelle, Bezerra, Marcos, Fontão, Karina, Knust, Renata E., Ferreira, Carlos G., and Martins, Renato G.
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HEAD & neck cancer treatment , *CANCER chemotherapy , *CISPLATIN , *CANCER radiotherapy , *SQUAMOUS cell carcinoma , *CANCER treatment , *SURVIVAL analysis (Biometry) , *DRUG efficacy - Abstract
Purpose: Erlotinib, an oral tyrosine kinase inhibitor, is active against head-and-neck squamous cell carcinoma (HNSCC) and possibly has a synergistic interaction with chemotherapy and radiotherapy. We investigated the safety and efficacy of erlotinib added to cisplatin and radiotherapy in locally advanced HNSCC. Methods and Materials: In this Phase I/II trial 100 mg/m2 of cisplatin was administered on Days 8, 29, and 50, and radiotherapy at 70 Gy was started on Day 8. During Phase I, the erlotinib dose was escalated (50 mg, 100 mg, and 150 mg) in consecutive cohorts of 3 patients, starting on Day 1 and continuing during radiotherapy. Dose-limiting toxicity was defined as any Grade 4 event requiring radiotherapy interruptions. Phase II was initiated 8 weeks after the last Phase I enrollment. Results: The study accrued 9 patients in Phase I and 28 in Phase II; all were evaluable for efficacy and safety. No dose-limiting toxicity occurred in Phase I, and the recommended Phase II dose was 150 mg. The most frequent nonhematologic toxicities were nausea/vomiting, dysphagia, stomatitis, xerostomia and in-field dermatitis, acneiform rash, and diarrhea. Of the 31 patients receiving a 150-mg daily dose of erlotinib, 23 (74%; 95% confidence interval, 56.8%–86.3%) had a complete response, 3 were disease free after salvage surgery, 4 had inoperable residual disease, and 1 died of sepsis during treatment. With a median 37 months'' follow-up, the 3-year progression-free and overall survival rates were 61% and 72%, respectively. Conclusions: This combination appears safe, has encouraging activity, and deserves further studies in locally advanced HNSCC. [Copyright &y& Elsevier]
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- 2010
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