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Article ; Online: Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed.

Milosevic, M / Edwards, J / Tsang, D / Dunning, J / Shackcloth, M / Batchelor, T / Coonar, A / Hasan, J / Davidson, B / Marchbank, A / Grumett, S / Williams, N R / Macbeth, F / Farewell, V / Treasure, T

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

2020 Volume 22, Issue 10, Page(s) 1314–1324

Abstract: Aim: Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. ...

Abstract	Aim: Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial. Method: Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis. Results: From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group. Conclusion: Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.
MeSH term(s)	Colorectal Neoplasms/pathology ; Colorectal Neoplasms/surgery ; Humans ; Lung Neoplasms/surgery ; Metastasectomy ; Neoplasm Staging ; Retrospective Studies ; Survival Rate
Language	English
Publishing date	2020-06-14
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1440017-0
ISSN	1463-1318 ; 1462-8910
ISSN (online)	1463-1318
ISSN	1462-8910
DOI	10.1111/codi.15113
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Zs.A 5799: Show issues

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Article: Artificial neural networks: a new model for assessing prognostic factors.

Grumett, S A / Snow, P B

Annals of oncology : official journal of the European Society for Medical Oncology

2000 Volume 11, Issue 4, Page(s) 383–384

MeSH term(s)	Breast Neoplasms/genetics ; Breast Neoplasms/therapy ; Chemotherapy, Adjuvant ; Decision Making, Computer-Assisted ; Female ; Genes, p53/genetics ; Humans ; Neoplasm Staging ; Neural Networks, Computer ; Prognosis ; Radiotherapy, Adjuvant
Language	English
Publishing date	2000-04
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	1025984-3
ISSN	1569-8041 ; 0923-7534
ISSN (online)	1569-8041
ISSN	0923-7534
DOI	10.1023/a:1008344718234
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Zs.A 2862: Show issues

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Article ; Online: Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Quality of Life and Cancer Control Among Older and Frail Patients With Advanced Gastroesophageal Cancer: The GO2 Phase 3 Randomized Clinical Trial.

Hall, Peter S / Swinson, Daniel / Cairns, David A / Waters, Justin S / Petty, Russell / Allmark, Christine / Ruddock, Sharon / Falk, Stephen / Wadsley, Jonathan / Roy, Rajarshi / Tillett, Tania / Nicoll, Jonathan / Cummins, Sebastian / Mano, Joseph / Grumett, Simon / Stokes, Zuzana / Kamposioras, Konstantinos-Velios / Chatterjee, Anirban / Garcia, Angel /

Waddell, Tom / Guptal, Kamalnayan / Maisey, Nick / Khan, Mohammed / Dent, Jo / Lord, Simon / Crossley, Ann / Katona, Eszter / Marshall, Helen / Grabsch, Heike I / Velikova, Galina / Ow, Pei Loo / Handforth, Catherine / Howard, Helen / Seymour, Matthew T

JAMA oncology

2021 Volume 7, Issue 6, Page(s) 869–877

Abstract: Importance: Older and/or frail patients are underrepresented in landmark cancer trials. Tailored research is needed to address this evidence gap.: Objective: The GO2 randomized clinical trial sought to optimize chemotherapy dosing in older and/or ... ...

Abstract	Importance: Older and/or frail patients are underrepresented in landmark cancer trials. Tailored research is needed to address this evidence gap. Objective: The GO2 randomized clinical trial sought to optimize chemotherapy dosing in older and/or frail patients with advanced gastroesophageal cancer, and explored baseline geriatric assessment (GA) as a tool for treatment decision-making. Design, setting, and participants: This multicenter, noninferiority, open-label randomized trial took place at oncology clinics in the United Kingdom with nurse-led geriatric health assessment. Patients were recruited for whom full-dose combination chemotherapy was considered unsuitable because of advanced age and/or frailty. Interventions: There were 2 randomizations that were performed: CHEMO-INTENSITY compared oxaliplatin/capecitabine at Level A (oxaliplatin 130 mg/m2 on day 1, capecitabine 625 mg/m2 twice daily on days 1-21, on a 21-day cycle), Level B (doses 0.8 times A), or Level C (doses 0.6 times A). Alternatively, if the patient and clinician agreed the indication for chemotherapy was uncertain, the patient could instead enter CHEMO-BSC, comparing Level C vs best supportive care. Main outcomes and measures: First, broad noninferiority of the lower doses vs reference (Level A) was assessed using a permissive boundary of 34 days reduction in progression-free survival (PFS) (hazard ratio, HR = 1.34), selected as acceptable by a forum of patients and clinicians. Then, the patient experience was compared using Overall Treatment Utility (OTU), which combines efficacy, toxic effects, quality of life, and patient value/acceptability. For CHEMO-BSC, the main outcome measure was overall survival. Results: A total of 514 patients entered CHEMO-INTENSITY, of whom 385 (75%) were men and 299 (58%) were severely frail, with median age 76 years. Noninferior PFS was confirmed for Levels B vs A (HR = 1.09 [95% CI, 0.89-1.32]) and C vs A (HR = 1.10 [95% CI, 0.90-1.33]). Level C produced less toxic effects and better OTU than A or B. No subgroup benefited from higher doses: Level C produced better OTU even in younger or less frail patients. A total of 45 patients entered the CHEMO-BSC randomization: overall survival was nonsignificantly longer with chemotherapy: median 6.1 vs 3.0 months (HR = 0.69 [95% CI, 0.32-1.48], P = .34). In multivariate analysis in 522 patients with all variables available, baseline frailty, quality of life, and neutrophil to lymphocyte ratio were independently associated with OTU, and can be combined in a model to estimate the probability of different outcomes. Conclusions and relevance: This phase 3 randomized clinical trial found that reduced-intensity chemotherapy provided a better patient experience without significantly compromising cancer control and should be considered for older and/or frail patients. Baseline geriatric assessment can help predict the utility of chemotherapy but did not identify a group benefiting from higher-dose treatment. Trial registration: isrctn.org Identifier: ISRCTN44687907.
MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Capecitabine ; Frail Elderly ; Humans ; Male ; Oxaliplatin ; Quality of Life ; Stomach Neoplasms/drug therapy
Chemical Substances	Oxaliplatin (04ZR38536J) ; Capecitabine (6804DJ8Z9U)
Language	English
Publishing date	2021-05-12
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2021.0848
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Article: Neural networks in the prediction of survival in patients with colorectal cancer.

Grumett, Simon / Snow, Pete / Kerr, David

Clinical colorectal cancer

2003 Volume 2, Issue 4, Page(s) 239–244

Abstract: It is important to predict outcome for colorectal cancer patients following surgery, as almost 50% of patients undergoing a potentially curative resection will experience relapse. It is clear that present prognostic categories such as Dukes or TNM ... ...

Abstract	It is important to predict outcome for colorectal cancer patients following surgery, as almost 50% of patients undergoing a potentially curative resection will experience relapse. It is clear that present prognostic categories such as Dukes or TNM staging are too broad, and further refining is required to prognosticate for high-risk subgroups. One approach is to determine a phenotype associated with recurrence. We compared 2 methods of analyzing such data. Pathologic data from a large clinical trial was analyzed for 403 patients. The outcome modeled was disease recurrence. The results from logistic regression analysis and a neural network approach are compared with respect to receiver operator characteristic plots, which estimate the fit of the model. The best logistic regression model gives a result of 66%, and the neural network approach 78%. The conclusion from this study is that the neural network approach is superior to regression analysis. Further analyses are in progress using a larger patient sample size (n > 1000), improved statistical models, and a more refined neural network.
MeSH term(s)	Colorectal Neoplasms/mortality ; Humans ; Logistic Models ; Models, Statistical ; Neoplasm Recurrence, Local ; Neural Networks (Computer) ; Outcome Assessment (Health Care) ; Predictive Value of Tests ; Prognosis ; Survival Analysis
Language	English
Publishing date	2003-02
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	2112638-0
ISSN	1533-0028
ISSN	1533-0028
DOI	10.3816/CCC.2003.n.005
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Zs.A 5798: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Amelanotic melanoma presenting with cervical lymphadenopathy.

Karnwal, Abhishek / Hadjihannas, Edward / Sherif, Ali / Grumett, Simon / Karnwal, Sudha / Mathews, John

BMJ case reports

2009 Volume 2009

Abstract: We present a rare case of an amelanotic melanoma of unknown primary presenting with cervical lymphadenopathy. A 20-year-old man presented with large left sided neck lump, associated dysphagia and weight loss. Examination revealed a hard mass in the left ... ...

Abstract	We present a rare case of an amelanotic melanoma of unknown primary presenting with cervical lymphadenopathy. A 20-year-old man presented with large left sided neck lump, associated dysphagia and weight loss. Examination revealed a hard mass in the left posterior triangle of neck and sacral sensory loss. Fine needle aspiration cytology of the mass suggested a poorly differentiated carcinoma. Computed tomography showed a left sided, 8×13 cm cervical mass with liver, lung and bony metastases. Histological examination of the lymph nodal mass confirmed the diagnosis of a metastatic amelanotic melanoma. The patient was treated with glucocorticoids, radiation therapy for the sacral bony deposit, and chemotherapy. Despite an initial reduction of his target lesions, his condition subsequently deteriorated and he died 4 months after diagnosis.
Language	English
Publishing date	2009-04-07
Publishing country	England
Document type	Journal Article
ISSN	1757-790X
ISSN (online)	1757-790X
DOI	10.1136/bcr.06.2008.0101
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Article ; Online: A population-scale temporal case-control evaluation of COVID-19 disease phenotype and related outcome rates in patients with cancer in England (UKCCP).

Starkey, Thomas / Ionescu, Maria C / Tilby, Michael / Little, Martin / Burke, Emma / Fittall, Matthew W / Khan, Sam / Liu, Justin K H / Platt, James R / Mew, Rosie / Tripathy, Arvind R / Watts, Isabella / Williams, Sophie Therese / Appanna, Nathan / Al-Hajji, Youssra / Barnard, Matthew / Benny, Liza / Burnett, Alexander / Bytyci, Jola /

Cattell, Emma L / Cheng, Vinton / Clark, James J / Eastlake, Leonie / Gerrand, Kate / Ghafoor, Qamar / Grumett, Simon / Harper-Wynne, Catherine / Kahn, Rachel / Lee, Alvin J X / Lomas, Oliver / Lydon, Anna / Mckenzie, Hayley / Panneerselvam, Hari / Pascoe, Jennifer S / Patel, Grisma / Patel, Vijay / Potter, Vanessa A / Randle, Amelia / Rigg, Anne S / Robinson, Tim M / Roylance, Rebecca / Roques, Tom W / Rozmanowski, Stefan / Roux, René L / Shah, Ketan / Sheehan, Remarez / Sintler, Martin / Swarup, Sanskriti / Taylor, Harriet / Tillett, Tania / Tuthill, Mark / Williams, Sarah / Ying, Yuxin / Beggs, Andrew / Iveson, Tim / Lee, Siow Ming / Middleton, Gary / Middleton, Mark / Protheroe, Andrew / Fowler, Tom / Johnson, Peter / Lee, Lennard Y W

Scientific reports

2023 Volume 13, Issue 1, Page(s) 11327

Abstract: Patients with cancer are at increased risk of hospitalisation and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, the SARS-CoV-2 phenotype evolution in patients with cancer since 2020 has not ... ...

Abstract	Patients with cancer are at increased risk of hospitalisation and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, the SARS-CoV-2 phenotype evolution in patients with cancer since 2020 has not previously been described. We therefore evaluated SARS-CoV-2 on a UK populationscale from 01/11/2020-31/08/2022, assessing case-outcome rates of hospital assessment(s), intensive care admission and mortality. We observed that the SARS-CoV-2 disease phenotype has become less severe in patients with cancer and the non-cancer population. Case-hospitalisation rates for patients with cancer dropped from 30.58% in early 2021 to 7.45% in 2022 while case-mortality rates decreased from 20.53% to 3.25%. However, the risk of hospitalisation and mortality remains 2.10x and 2.54x higher in patients with cancer, respectively. Overall, the SARS-CoV-2 disease phenotype is less severe in 2022 compared to 2020 but patients with cancer remain at higher risk than the non-cancer population. Patients with cancer must therefore be empowered to live more normal lives, to see loved ones and families, while also being safeguarded with expanded measures to reduce the risk of transmission.
MeSH term(s)	Humans ; Male ; Female ; Case-Control Studies ; Treatment Outcome ; Neoplasms/complications ; Neoplasms/epidemiology ; COVID-19/complications ; COVID-19/epidemiology ; England/epidemiology ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-36990-9
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Article ; Online: Association of SARS-CoV-2 Spike Protein Antibody Vaccine Response With Infection Severity in Patients With Cancer: A National COVID Cancer Cross-sectional Evaluation.

Lee, Lennard Y W / Tilby, Michael / Starkey, Thomas / Ionescu, Maria C / Burnett, Alex / Hattersley, Rosie / Khan, Sam / Little, Martin / Liu, Justin K H / Platt, James R / Tripathy, Arvind / Watts, Isabella / Williams, Sophie Therese / Appanna, Nathan / Al-Hajji, Youssra / Barnard, Matthew / Benny, Liza / Buckley, Andrew / Cattell, Emma /

Cheng, Vinton / Clark, James / Eastlake, Leonie / Gerrand, Kate / Ghafoor, Qamar / Grumett, Simon / Harper-Wynne, Catherine / Kahn, Rachel / Lee, Alvin J X / Lydon, Anna / McKenzie, Hayley / Panneerselvam, Hari / Pascoe, Jennifer / Patel, Grisma / Patel, Vijay / Potter, Vanessa / Randle, Amelia / Rigg, Anne S / Robinson, Tim / Roylance, Rebecca / Roques, Tom / Rozmanowski, Stefan / Roux, René L / Shah, Ketan / Sintler, Martin / Taylor, Harriet / Tillett, Tania / Tuthill, Mark / Williams, Sarah / Beggs, Andrew / Iveson, Tim / Lee, Siow Ming / Middleton, Gary / Middleton, Mark / Protheroe, Andrew S / Fittall, Matthew W / Fowler, Tom / Johnson, Peter

JAMA oncology

2022 Volume 9, Issue 2, Page(s) 188–196

Abstract: Importance: Accurate identification of patient groups with the lowest level of protection following COVID-19 vaccination is important to better target resources and interventions for the most vulnerable populations. It is not known whether SARS-CoV-2 ... ...

Abstract	Importance: Accurate identification of patient groups with the lowest level of protection following COVID-19 vaccination is important to better target resources and interventions for the most vulnerable populations. It is not known whether SARS-CoV-2 antibody testing has clinical utility for high-risk groups, such as people with cancer. Objective: To evaluate whether spike protein antibody vaccine response (COV-S) following COVID-19 vaccination is associated with the risk of SARS-CoV-2 breakthrough infection or hospitalization among patients with cancer. Design, setting, and participants: This was a population-based cross-sectional study of patients with cancer from the UK as part of the National COVID Cancer Antibody Survey. Adults with a known or reported cancer diagnosis who had completed their primary SARS-CoV-2 vaccination schedule were included. This analysis ran from September 1, 2021, to March 4, 2022, a period covering the expansion of the UK's third-dose vaccination booster program. Interventions: Anti-SARS-CoV-2 COV-S antibody test (Elecsys; Roche). Main outcomes and measures: Odds of SARS-CoV-2 breakthrough infection and COVID-19 hospitalization. Results: The evaluation comprised 4249 antibody test results from 3555 patients with cancer and 294 230 test results from 225 272 individuals in the noncancer population. The overall cohort of 228 827 individuals (patients with cancer and the noncancer population) comprised 298 479 antibody tests. The median age of the cohort was in the age band of 40 and 49 years and included 182 741 test results (61.22%) from women and 115 737 (38.78%) from men. There were 279 721 tests (93.72%) taken by individuals identifying as White or White British. Patients with cancer were more likely to have undetectable anti-S antibody responses than the general population (199 of 4249 test results [4.68%] vs 376 of 294 230 [0.13%]; P < .001). Patients with leukemia or lymphoma had the lowest antibody titers. In the cancer cohort, following multivariable correction, patients who had an undetectable antibody response were at much greater risk for SARS-CoV-2 breakthrough infection (odds ratio [OR], 3.05; 95% CI, 1.96-4.72; P < .001) and SARS-CoV-2-related hospitalization (OR, 6.48; 95% CI, 3.31-12.67; P < .001) than individuals who had a positive antibody response. Conclusions and relevance: The findings of this cross-sectional study suggest that COV-S antibody testing allows the identification of patients with cancer who have the lowest level of antibody-derived protection from COVID-19. This study supports larger evaluations of SARS-CoV-2 antibody testing. Prevention of SARS-CoV-2 transmission to patients with cancer should be prioritized to minimize impact on cancer treatments and maximize quality of life for individuals with cancer during the ongoing pandemic.
MeSH term(s)	Female ; Adult ; Male ; Humans ; Middle Aged ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; Cross-Sectional Studies ; Antibody Formation ; Quality of Life ; COVID-19/epidemiology ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccines ; Neoplasms/epidemiology ; Antibodies, Viral ; Delivery of Health Care
Chemical Substances	COVID-19 Vaccines ; spike protein, SARS-CoV-2 ; Spike Glycoprotein, Coronavirus ; Vaccines ; Antibodies, Viral
Language	English
Publishing date	2022-12-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2022.5974
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Article ; Online: Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients.

Ahmad, Saif S / Qian, Wendi / Ellis, Sarah / Mason, Elaine / Khattak, Muhammad A / Gupta, Avinash / Shaw, Heather / Quinton, Amy / Kovarikova, Jarmila / Thillai, Kiruthikah / Rao, Ankit / Board, Ruth / Nobes, Jenny / Dalgleish, Angus / Grumett, Simon / Maraveyas, Anthony / Danson, Sarah / Talbot, Toby / Harries, Mark /

Marples, Maria / Plummer, Ruth / Kumar, Satish / Nathan, Paul / Middleton, Mark R / Larkin, James / Lorigan, Paul / Wheater, Matthew / Ottensmeier, Christian H / Corrie, Pippa G

Melanoma research

2015 Volume 25, Issue 5, Page(s) 432–442

Abstract: Before licensing, ipilimumab was first made available to previously treated advanced melanoma patients through an expanded access programme (EAP) across Europe. We interrogated data from UK EAP patients to inform future clinical practice. Clinicians ... ...

Abstract	Before licensing, ipilimumab was first made available to previously treated advanced melanoma patients through an expanded access programme (EAP) across Europe. We interrogated data from UK EAP patients to inform future clinical practice. Clinicians registered in the UK EAP provided anonymized patient data using a prespecified variable fields datasheet. Data collected were baseline patient characteristics, treatment delivered, toxicity, response, progression-free survival and overall survival (OS). Data were received for 193 previously treated metastatic melanoma patients, whose primary sites were cutaneous (82%), uveal (8%), mucosal (2%), acral (3%) or unknown (5%). At baseline, 88% of patients had a performance status (PS) of 0-1 and 20% had brain metastases. Of the patients, 53% received all four planned cycles of ipilimumab; the most common reason for stopping early was disease progression, including death from melanoma. Toxicity was recorded for 171 patients, 30% of whom experienced an adverse event of grade 3 or higher, the most common being diarrhoea (13%) and fatigue (9%). At a median follow-up of 23 months, the median progression-free survival and OS were 2.8 and 6.1 months, respectively; the 1-year and 2-year OS rates were 31 and 14.8%, respectively. The 2-year OS was significantly lower for patients with poorer PS (P<0.0001), low albumin concentrations (P<0.0001), the presence of brain metastases (P=0.007) and lactate dehydrogenase levels more than two times the upper limit of normal (P<0.0001) at baseline. These baseline characteristics are negative predictors of benefit from ipilimumab and should be taken into consideration before prescription.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/therapeutic use ; Cancer Vaccines/therapeutic use ; Disease Progression ; Europe/epidemiology ; Female ; Follow-Up Studies ; Health Services Accessibility/standards ; Humans ; Ipilimumab ; Male ; Melanoma/mortality ; Melanoma/pathology ; Melanoma/therapy ; Middle Aged ; Retrospective Studies ; Salvage Therapy ; Skin Neoplasms/mortality ; Skin Neoplasms/pathology ; Skin Neoplasms/therapy ; Survival Analysis ; United Kingdom/epidemiology
Chemical Substances	Antibodies, Monoclonal ; Cancer Vaccines ; Ipilimumab
Language	English
Publishing date	2015-07-29
Publishing country	England
Document type	Journal Article
ZDB-ID	1095779-0
ISSN	1473-5636 ; 0960-8931
ISSN (online)	1473-5636
ISSN	0960-8931
DOI	10.1097/CMR.0000000000000185
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Zs.A 3378: Show issues

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Article: The role of mitomycin C in the treatment of patients with advanced colorectal cancer resistant to 5-fluorouracil-folinic acid chemotherapy.

Grumett, S A / Archer, V R / Midgley, R / Mulholland, P / Nicum, S / Blewitt, L / Kerr, D J

Annals of oncology : official journal of the European Society for Medical Oncology

2001 Volume 12, Issue 4, Page(s) 575

MeSH term(s)	Antibiotics, Antineoplastic/therapeutic use ; Colorectal Neoplasms/drug therapy ; Drug Resistance, Neoplasm ; Fluorouracil/therapeutic use ; Humans ; Infusions, Intravenous ; Leucovorin/therapeutic use ; Mitomycin/therapeutic use ; Neoplasm Metastasis
Chemical Substances	Antibiotics, Antineoplastic ; Mitomycin (50SG953SK6) ; Leucovorin (Q573I9DVLP) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2001-04
Publishing country	England
Document type	Letter
ZDB-ID	1025984-3
ISSN	1569-8041 ; 0923-7534
ISSN (online)	1569-8041
ISSN	0923-7534
DOI	10.1023/a:1011106917263
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Zs.A 2862: Show issues

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Article ; Online: Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial.

Corrie, P G / Marshall, A / Nathan, P D / Lorigan, P / Gore, M / Tahir, S / Faust, G / Kelly, C G / Marples, M / Danson, S J / Marshall, E / Houston, S J / Board, R E / Waterston, A M / Nobes, J P / Harries, M / Kumar, S / Goodman, A / Dalgleish, A /

Martin-Clavijo, A / Westwell, S / Casasola, R / Chao, D / Maraveyas, A / Patel, P M / Ottensmeier, C H / Farrugia, D / Humphreys, A / Eccles, B / Young, G / Barker, E O / Harman, C / Weiss, M / Myers, K A / Chhabra, A / Rodwell, S H / Dunn, J A / Middleton, M R / Nathan, Paul / Lorigan, Paul / Dziewulski, Peter / Holikova, Sonja / Panwar, Udaiveer / Tahir, Saad / Faust, Guy / Thomas, Anne / Corrie, Pippa / Sirohi, Bhawna / Kelly, Charles / Middleton, Mark / Marples, Maria / Danson, Sarah / Lester, James / Marshall, Ernest / Ajaz, Mazhar / Houston, Stephen / Board, Ruth / Eaton, David / Waterston, Ashita / Nobes, Jenny / Loo, Suat / Gray, Gill / Stubbings, Helen / Gore, Martin / Harries, Mark / Kumar, Satish / Goodman, Andrew / Dalgleish, Angus / Martin-Clavijo, Agustin / Marsden, Jerry / Westwell, Sarah / Casasola, Richard / Chao, David / Maraveyas, Anthony / Patel, Poulam / Ottensmeier, Christian / Farrugia, David / Humphreys, Alison / Eccles, Bryony / Dega, Renata / Herbert, Chris / Price, Christopher / Brunt, Murray / Scott-Brown, Martin / Hamilton, Joanna / Hayward, Richard Larry / Smyth, John / Woodings, Pamela / Nayak, Neena / Burrows, Lorna / Wolstenholme, Virginia / Wagstaff, John / Nicolson, Marianne / Wilson, Andrew / Barlow, Clare / Scrase, Christopher / Podd, Timothy / Gonzalez, Michael / Stewart, John / Highley, Martin / Grumett, Simon / Talbot, Toby / Nathan, Kannon / Coltart, Robert / Gee, Bruce

Annals of oncology : official journal of the European Society for Medical Oncology

2018 Volume 29, Issue 8, Page(s) 1843–1852

Abstract: Background: Bevacizumab is a recombinant humanised monoclonal antibody to vascular endothelial growth factor shown to improve survival in advanced solid cancers. We evaluated the role of adjuvant bevacizumab in melanoma patients at high risk of ... ...

Abstract	Background: Bevacizumab is a recombinant humanised monoclonal antibody to vascular endothelial growth factor shown to improve survival in advanced solid cancers. We evaluated the role of adjuvant bevacizumab in melanoma patients at high risk of recurrence. Patients and methods: Patients with resected AJCC stage IIB, IIC and III cutaneous melanoma were randomised to receive either adjuvant bevacizumab (7.5 mg/kg i.v. 3 weekly for 1 year) or standard observation. The primary end point was detection of an 8% difference in 5-year overall survival (OS) rate; secondary end points included disease-free interval (DFI) and distant metastasis-free interval (DMFI). Tumour and blood were analysed for prognostic and predictive markers. Results: Patients (n=1343) recruited between 2007 and 2012 were predominantly stage III (73%), with median age 56 years (range 18-88 years). With 6.4-year median follow-up, 515 (38%) patients had died [254 (38%) bevacizumab; 261 (39%) observation]; 707 (53%) patients had disease recurrence [336 (50%) bevacizumab, 371 (55%) observation]. OS at 5 years was 64% for both groups [hazard ratio (HR) 0.98; 95% confidence interval (CI) 0.82-1.16, P = 0.78). At 5 years, 51% were disease free on bevacizumab versus 45% on observation (HR 0.85; 95% CI 0.74-0.99, P = 0.03), 58% were distant metastasis free on bevacizumab versus 54% on observation (HR 0.91; 95% CI 0.78-1.07, P = 0.25). Forty four percent of 682 melanomas assessed had a BRAFV600 mutation. In the observation arm, BRAF mutant patients had a trend towards poorer OS compared with BRAF wild-type patients (P = 0.06). BRAF mutation positivity trended towards better OS with bevacizumab (P = 0.21). Conclusions: Adjuvant bevacizumab after resection of high-risk melanoma improves DFI, but not OS. BRAF mutation status may predict for poorer OS untreated and potential benefit from bevacizumab. Clinical trial information: ISRCTN 81261306; EudraCT Number: 2006-005505-64.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Bevacizumab/administration & dosage ; Chemotherapy, Adjuvant/methods ; Dermatologic Surgical Procedures ; Disease-Free Survival ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Humans ; Male ; Melanoma/mortality ; Melanoma/pathology ; Melanoma/therapy ; Middle Aged ; Mutation ; Neoplasm Recurrence, Local/epidemiology ; Neoplasm Recurrence, Local/prevention & control ; Neoplasm Staging ; Proto-Oncogene Proteins B-raf/genetics ; Skin Neoplasms/mortality ; Skin Neoplasms/pathology ; Skin Neoplasms/therapy ; Survival Analysis ; Time Factors ; Watchful Waiting ; Young Adult
Chemical Substances	Bevacizumab (2S9ZZM9Q9V) ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
Language	English
Publishing date	2018-11-01
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1025984-3
ISSN	1569-8041 ; 0923-7534
ISSN (online)	1569-8041
ISSN	0923-7534
DOI	10.1093/annonc/mdy229
Database	MEDical Literature Analysis and Retrieval System OnLINE

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