DANIELA RIBEIRO NEBULONI
Índice h a partir de 2011
4
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
11 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 11
- Phase II trial of metformin and paclitaxel for patients with gemcitabine-refractory advanced adenocarcinoma of the pancreas(2015) BRAGHIROLI, Maria Ignez; FERRARI, Anezka C. R. de Celis; PFIFFER, Tulio Eduardo; ALEX, Alexandra Kichfy; NEBULONI, Daniela; CARNEIRO, Allyne S.; CAPARELLI, Fernanda; SENNA, Luiz; LOBO, Juliana; HOFF, Paulo Marcelo; RIECHELMANN, Rachel P.Background: In patients with adenocarcinoma of the pancreas, there are no standard second-line regimens. Many pre-clinical studies have shown that metformin alone or when combined with paclitaxel has antitumour effects on this tumour. We have tested here the combination of paclitaxel and metformin for patients with gemcitabine-refractory pancreatic cancer. Methods: An uncontrolled phase II trial was carried out based on a two-stage Simon's design, with metformin and paclitaxel for patients with locally advanced or metastatic pancreatic cancer whose disease had progressed during first line treatment with a gemcitabine-based regimen. The primary endpoint was the disease control rate at eight weeks as per response evaluation criteria in solid tumours (RECIST) 1.1. Patients received paclitaxel 80 mg/m(2) weekly for three weeks every 28 days and metformin 850 mg p.o. t.i.d. continuously until progression or intolerance state was reached. Results: Twenty patients were enrolled from July 2011 to January 2014: N = 6 (31.6%) achieved the primary endpoint, with all presenting stable disease. Median overall survival (OS) was 128 days (range 17-697) and the median progression free survival (PFS) was 44 days (range 14-210). Eight patients (40%) presented treatment-related G3-4 toxicities with the most common one being diarrhoea. Conclusions: Despite the encouraging pre-clinical evidence of the antitumour activity of metformin in adenocarcinoma of the pancreas, the primary endpoint of the disease control rate was not met. Besides, the treatment combination was poorly tolerated and could not be studied further. This study highlights the importance of performing clinical trials to reassure preclinical or observational data.
- Pregabalin for the Prevention of Oxaliplatin-Induced Painful Neuropathy: A Randomized, Double-Blind Trial(2017) ANDRADE, Daniel Ciampi De; TEIXEIRA, Manoel Jacobsen; GALHARDONI, Ricardo; FERREIRA, Karine S. L.; MILENO, Paula Braz; SCISCI, Nathalia; ZANDONAI, Alexandra; TEIXEIRA, William G. J.; SARAGIOTTO, Daniel F.; SILVA, Valquiria; RAICHER, Irina; CURY, Rubens Gisbert; MACARENCO, Ricardo; HEISE, Carlos Otto; BROTTO, Mario Wilson Iervolino; MELLO, Alberto Andrade De; MEGALE, Marcelo Zini; DOURADO, Luiz Henrique Curti; BAHIA, Luciana Mendes; RODRIGUES, Antonia Lilian; PARRAVANO, Daniella; FUKUSHIMA, Julia Tizue; LEFAUCHEUR, Jean-Pascal; BOUHASSIRA, Didier; SOBROZA, Evandro; RIECHELMANN, Rachel P.; HOFF, Paulo M.; SILVA, Fernanda Valerio Da; CHILE, Thais; DALE, Camila S.; NEBULONI, Daniela; SENNA, Luiz; BRENTANI, Helena; PAGANO, Rosana L.; SOUZA, Angela M. DeBackground. Patients with colorectal cancer (CRC) receiving oxaliplatin (OXA) develop acute and chronic painful oxaliplatin-induced peripheral neuropathy (OXAIPN). Acute and chronic OXA-related neuropathies have different pathophysiological bases, but both lead to a common phenomenon: central sensitization (CS) of nociceptive neuronal networks, leading to increased sensitivity (hyperlgesia, allodynia) in the somatosensory system, the common ground of chronic neuropathic pain. Because CS is related to increased risk of painful OXAIPN, we hypothesized that preemptive use of the anti-hyperalgesic drug pregabaline (known to decrease CS) during OXA infusions would decrease the incidence of chronic OXAIPN. Methods. Pain-free, chemotherapy-naive CRC patients receiving at least one cycle of modified-FLOX [5-FU(500 mg/m(2)) 1 leucovorin(20 mg/m(2))/week for] 6 weeks+oxaliplatin(85 mg/m2) at weeks 1-3-5 every 8 weeks] were randomized (1:1) into the study. Patients received either pregabalin or placebo for 3 days before and 3 days after each OXA infusion and were followed for up to 6 months. Clinical assessments were performed at baseline, at the end of chemotherapy, and after the follow-up period. The main outcome was average pain at the last visit assessed by the visual analogic scale (0-10) item of the Brief Pain Inventory (BPI). Secondary endpoints were presence of neuropathic pain according to the Douleur Neuropathique-4 (DN-4), pain dimensions (short-form McGill Pain Questionnaire [MPQ]), Neuropathic Pain Symptom Inventory (NPSI), and changes in nerve conduction studies (NCS) and side effect profile. Results. One hundred ninety-nine patients (57.0 +/- 10.7 years old, 98 female, 101 male) were randomized. Data from 56 patients were not included in the analyses (as they did not receive at least one full cycle of modified FLOX). Data from 78 patients in the pregabalin group and 65 patients in the placebo group were retained for analyses. At the last visit, pain intensity in the pregabalin group was 1.03 (95% confidence interval [CI] 50.79-1.26), and 0.85 (95% CI50.64-1.06) in the placebo group, which did not reach significance. Scores from the BPI, MPQ, DN-4, NPSI, and NCS and side-effect profiles and incidence of death did not differ between groups. Quality of life (QoL) score did not differ between groups (placebo = 576.9 +/- 23.1, pregabalin group 79.4 +/- 20.6). Mood scores were not significantly different between groups (placebo 9.7 [8.1-11.2]; pregabalin 6.8 [5.6-8.0]). Conclusion. The preemptive use of pregabalin during OXA infusions was safe, but did not decrease the incidence of chronic pain related to OXAIPN.
bookPart Outros agentes quimioterápicos(2013) MEDEIROS, Rodrigo Bovolin de; NEBULONI, Daniela Ribeiro; TOLOI, Diego de Araújo- Regorafenib in Patients with Antiangiogenic-Naive and Chemotherapy-Refractory Advanced Colorectal Cancer: Results from a Phase IIb Trial(2019) RIECHELMANN, Rachel P.; LEITE, Luiz S.; BARIANI, Giovanni M.; GLASBERG, Joao; RIVELLI, Thomas G.; FONSECA, Leonardo Gomes da; NEBULONI, Daniela R.; I, Maria Braghiroli; QUEIROZ, Marcelo A.; ISEJIMA, Alice M.; KAPPELER, Christian; KIKUCHI, Luciana; HOFF, Paulo M.Background Regorafenib is a multikinase inhibitor with antiangiogenic effects that improves overall survival (OS) in metastatic colorectal cancer (mCRC) after failure of standard therapies. We investigated the efficacy and safety of regorafenib in antiangiogenic therapy-naive chemotherapy-refractory advanced colorectal cancer. Patients and Methods This single-center, single-arm, phase IIb study (NCT02465502) enrolled adults with mCRC whose disease had progressed on, or who were intolerant to, standard therapy, but who were antiangiogenic therapy-naive. Patients received regorafenib 160 mg once daily for 3 weeks per 4-week cycle. The primary endpoint was progression-free survival (PFS) rate at week 8. Results Of 59 treated patients, almost half had received at least four prior lines of therapy. Patients received a median of 86% of the planned dose. The week 8 PFS rate was 53% (95% confidence interval [CI], 39.1-64.3); median PFS was 3.5 months (95% CI, 1.8-3.6). Median OS was 7.4 months (95% CI, 5.3-8.9). Tumor response (RECIST version 1.1) was 2%, and metabolic response rate (criteria from the European Organisation for Research and Treatment of Cancer) was 41%. The most frequently reported regorafenib-related grade >= 3 adverse events were hypertension (36%), hand-foot skin reaction (HFSR, 25%), and hypophosphatemia (24%). There were no regorafenib-related deaths. An exploratory analysis showed that patients with grade >= 2 HFSR had longer OS (10.2 months) with regorafenib treatment versus those with grades 0-1 (5.4 months). Conclusion These findings support the antitumor activity of regorafenib in antiangiogenic-naive patients with chemotherapy-refractory mCRC. Implications for Practice The multikinase inhibitor regorafenib improved overall survival in the phase III CORRECT and CONCUR trials in heavily pretreated patients with treatment-refractory metastatic colorectal cancer (mCRC). Exploratory subgroup analysis from CONCUR suggested that regorafenib treatment prior to targeted therapy (including bevacizumab) may improve outcomes. In this single-center, single-arm phase IIb study, regorafenib demonstrated antitumor activity in 59 antiangiogenic-naive patients with chemotherapy-refractory mCRC. Further studies should assess the efficacy of regorafenib in this patient population, as well as explore the reasons behind improved outcomes among patients who had a metabolic response and those who developed hand-foot skin reaction.
bookPart Tumor estromal do trato gastrointestinal(2013) NEBULONI, Daniela Ribeiro; GUMZ, Brenda; COSTA, Frederico P.- Regorafenib in antiangiogenic-naive, chemotherapy-refractory advanced colorectal cancer: A phase IIb trial.(2018) RIECHELMANN, Rachel Pimenta; LEITE, Luiz Antonio Senna; GLASBERG, Joao; BARIANI, Giovanni Mendonca; RIVELLI, Thomas Giollo; NEBULONI, Daniela R.; PUTY, Fabiola; KAPPELER, Christian; PEREIRA, Kaline M. C.; QUEIROZ, Marcelo A.; HOFF, Paulo Marcelo
- Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study(2022) D'ALESSANDRO, Eduardo Guilherme; NAGY, Daniela Ribeiro Nebuloni; BRITO, Christina May Moran de; ALMEIDA, Elisangela Pinto Marinho; BATTISTELLA, Linamara Rizzo; CECATTO, Rebeca BoltesChemotherapy-induced peripheral neuropathy (CIPN) can cause loss of independence and poor quality of life (QoL) due to severe disabilities, but in spite of its importance there is still a lack of data for the management of CIPN. Acupuncture has showed promising results and may be a cost-effective option for the treatment. Objectives To evaluate the effect of acupuncture treatment on neurological symptoms of CIPN and QoL of oncological patients. Methods We performed a clinical, single-centre, randomised and controlled pilot study that involved 33 adult patients with cancer and CIPN randomised into two groups (control and acupuncture treated with 10 sessions, two times per week). Both groups were subjected to a complete physical examination and clinical assessment with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale V.2.0, FIM Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Scale and Visual Analogue Scale for pain before and 5 weeks after treatment. Results There were no adverse events, and we found statistical differences in groups in physical (p=0.03) and function (p=0.04) domains of EORTC QLQ-C30 when comparing control and acupuncture groups. About NCI CTCAE Scale and neuropathy sensory symptoms, we found better results in acupuncture group, comparing pretreatment and post-treatment analyses (p=0.01). In control group, we have no differences after 5 weeks (p=0.11). Conclusion Although these results suggest an interesting effect of acupuncture on this patient population, the clinical significance has remained unclear. Given the tendency towards benefit and the lack of adverse effects, the authors recommend a follow-up acupuncture trial using higher follow-up time and better sample size.
conferenceObject Phase II trial of inetforrnin and paclitaxel for patients with gemcitabine-refractory advanced adenocarcinoma of the pancreas(2014) FERRARI, Anezlca Carvalho Rubin De Celia; PFIFFER, Tulio Eduardo Flesch; ALEX, Alexandra Khichfy; NEBULONL, Danielle R.; CARNELRO, Allyne Q.; CAPARELL, Fernanda Cunha; LEITE, Luiz Antonio Senna; BRAGHIROLI, Maria Ignez Freitas Meiro; LOBO, Juliana; HOFF, Paulo Marcelo; RIECHELMANN, Rachel Pimenta- Evaluation of F-18-FDG PET-CT as a prognostic marker in advanced biliary tract cancer(2018) BRAGHIROLI, Maria I.; MOTA, Jose M.; DUARTE, Paulo S.; MORITA, Tiago O.; BARIANI, Giovanni M.; NEBULONI, Daniela; BUCHPIGUEL, Carlos A.; HOFF, Paulo M.; RIECHELMANN, Rachel P.BackgroundAdvanced biliary tract cancers have a dismal prognosis. Treatment with gemcitabine plus cisplatin has resulted in a significant improvement in survival; however, early assessment of outcomes poses a challenge.ObjectiveWe carried out a prospective study to evaluate the prognostic role of fluorine-18 fluorodeoxyglucose (F-18-FDG) PET-CT scans in patients with advanced biliary tract cancer.Patients and methodsPatients with advanced unresectable or metastatic biliary tract cancer starting first-line chemotherapy with gemcitabine plus cisplatin underwent F-18-FDG PET-CT studies at baseline and after two cycles of therapy. The total lesion glycolysis (TLG) measured at baseline as well as the variation in TLG between the two studies were analyzed as prognostic indicators of overall survival. The survival analyses were carried out using Kaplan-Meier curves and the comparison of survival curves was performed using the Breslow test.ResultsOf the 42 patients included, 37 had the first F-18-FDG PET-CT and 27 had the second F-18-FDG PET-CT. Patients with lower TLG values at baseline or after two cycles of therapy presented a higher median survival than patients with higher baseline TLG values. Patients with a higher decrease in the TLG values between the two studies also had a higher median survival time. However, these results only trended for statistical significance (P values ranging between 0.05 and 0.16).ConclusionLower baseline TLG measured by F-18-FDG PET-CT as well as a decrease in metabolic uptake after chemotherapy were associated with a trend toward longer median survival among patients with advanced biliary cancers.
- A randomized, open-label, parallel-design phase III study to compare adjuvant 5-FU plus oxaliplatin (mFLOX) versus observation in locally advanced rectal cancer after neoadjuvant chemoradiation(2020) BRAGHIROLI, M. I.; MONIZ, C. M. V.; RIECHELMANN, R. S. P.; DORNELLAS, A. F. L.; CAPARELLI, F.; ALBAN, L.; ALEX, A.; BARIANI, G. M.; LEITE, L. A. Senna; RIVELLI, T. Giollo; NEBULONI, D.; ORTEGA, C.; BRAGHIROLI, O. F. M.; MOUTINHO, K.; NAHAS, S.; NAHAS, C.; COTTI, G.; SABBAGA, J.; CECONELLO, I.; HOFF, P. M.