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  • 1
    Electronic Resource
    Electronic Resource
    Familial occurrence of multiple nonmelanoma skin cancer
    Amsterdam : Elsevier
    Cancer Genetics and Cytogenetics 61 (1992), S. 1-5 
    Details
    ISSN: 0165-4608
    Source: Elsevier Journal Backfiles on ScienceDirect 1907 - 2002
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://linkinghub.elsevier.com/retrieve/pii/0165-4608(92)90361-B
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  • 2
    Electronic Resource
    Electronic Resource
    Phase I study of paclitaxel and oral etoposide in previously untreated non-small-cell and extensive small-cell lung cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 485-489 
    Details
    ISSN: 1569-8041
    Keywords: etoposide ; lung cancer ; paclitaxel ; phase I study
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: This phase I study of paclitaxel and oral etoposide was performedto determine the safety of the combination in patients with advanced lungcancer who had received no prior chemotherapy, and to identify a dose forphase II testing. Patients and methods: Patients with locally advanced or metastaticnon-small-cell lung cancer (NSCLC) or extensive small-cell lung cancer (SCLC),who had received no prior chemotherapy were treated with intravenouspaclitaxel given as a three hour infusion (starting dose 100mg/m2) and oral etoposide, 100 mg daily for five days. Twoschedules of administration were used with the paclitaxel given on day 1(schedule A) or day 5 (schedule B) of a 21 day cycle. Results: Forty-nine patients were entered on the study, four of whom hadSCLC. All patients were evaluable for toxicity. The maximum tolerated dose waspaclitaxel 200 mg/m2 on day 1, in combination with oraletoposide 100 mg daily on days 1 to 5 (schedule A). The dose limitingtoxicities were mucositis, myalgia, diarrhoea, and paraesthesiae. Usingschedule B, myelosuppression, with febrile neutropenia was dose limiting ata paclitaxel dose of 160 mg/m2. Amongst the 45 patients withNSCLC there were three complete and eight partial responses (24%;95% CI 13%–40%), while there was one completeresponse in the four patients with SCLC. Conclusion: Paclitaxel 200 mg/m2 on day 1, with oraletoposide 100 mg daily on days 1 to 5 can be administered safely, and is therecommended dose for phase II studies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008291606695
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  • 3
    Electronic Resource
    Electronic Resource
    Open label, multi-centre phase II study of raltitrexed (`Tomudex') in patients with inoperable squamous-cell carcinoma of head and neck (2000)
    Springer
    Annals of oncology 11 (2000), S. 239-241 
    Details
    ISSN: 1569-8041
    Keywords: head and neck cancer ; phase II trial ; raltitrexed
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Raltitrexed (`Tomudex') is a folate based inhibitorof thymidylate synthase which has been registered in Europe and Australia forthe treatment of advanced colorectal cancer. In a European phase I trial ofraltitrexed anti-tumour activity was seen in two patients with head and neckcancer, prompting the current study. Patients and methods:From November 1996 to December 1998, 24patients with metastatic or recurrent squamous-cell carcinoma of the head andneck from 7 Australian centres received raltitrexed, 3 mg/m2 givenintravenously over 15 minutes every 3 weeks, for a maximum of 6 cycles.Patients were required to be chemotherapy naïve and have measurabledisease, age 〉18 years, WHO performance status initially ≤2, nosignificant intercurrent illness or organ dysfunction and a life expectancy〉12 weeks. Results:Twenty-two men and two women, median age 65 years, medianperformance status 1 were enrolled. Fifteen patients (63%) had receivedboth prior surgery and radiotherapy. In 15 patients (63%) there wasrecurrent locoregional disease only. Twelve patients (50%) received onecycle of treatment with only four patients (17%) receiving four or morecycles of treatment. No patient achieved a complete or partial response,although 5 patients experienced stable disease which lasted a median of 188days (range 61–436). The median survival for the whole group was 101days (range 20–436). Raltitrexed was generally well tolerated withminimal anti-proliferative toxicity. Conclusions:Single-agent raltitrexed does not demonstratesignificant anti-tumour response rates in patients with predominantly locallyrecurrent head and neck cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008369629944
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  • 4
    Electronic Resource
    Electronic Resource
    Phase I and subsequent phase II study of filgrastim (r-met-HuG-CSF) and dose intensified cyclophosphamide plus epirubicin in patients with non-Hodgkin's lymphoma and advanced solid tumors (1999)
    Springer
    Annals of oncology 10 (1999), S. 907-914 
    Details
    ISSN: 1569-8041
    Keywords: cyclophosphamide ; dose-escalation ; epirubicin ; filgrastim ; G-CSF ; non-Hodgkin's lymphoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: To define a maximum tolerated dose (MTD) for the combination of epirubicin and cyclophosphamide with filgrastim (r-met-HuG-CSF) in patients with advanced solid tumors and non-Hodgkin's lymphoma (NHL). Patients and methods: Thirty-five patients with advanced solid tumors were enrolled in stages I and II. Twenty-one patients were treated in stage I in sequential cohorts of at least three patients at increasing dosage levels of cyclophosphamide and epirubicin, for up to six cycles every 21 days. At the completion of stage I, a MTD for epirubicin was established. Fourteen patients were treated in stage II, in cohorts of three or more. The epirubicin dose remained constant at the MTD dosage from stage I. Cyclophosphamide was further dose-escalated to establish its MTD. Twenty-one patients with previously untreated non-Hodgkin's lymphoma were treated in stage III with the MTD established in the prior stages. Results: The MTD in stage I was epirubicin 150 mg/m2 and cyclophosphamide 1500 mg/m2 with cumulative neutropenia as the dose-limiting toxicity (DLT). Cumulative thrombocytopenia prevented further dose-escalation of cyclophosphamide in stage II. The stage III regimen consisted of six, 21-day cycles of epirubicin 150 mg/m2, cyclophosphamide 1500 mg/m2, vincristine 2 mg, and prednisolone 100 mg for five days with filgrastim support. Nineteen of twenty-one patients (90%) completed six cycles of treatment, eight (38%) without dose reduction. Common toxicity criteria (CTC) grade 4 neutropenia (neutrophil nadir 〈0.5 × 109/l) was documented in 85 of 118 cycles (72%). Neutropenic fever was documented in 17 of 21 patients (81%) on at least one occasion. Severe thrombocytopenia (〈25 × 109/l) was seen in fourteen of 118 cycles (12%) and increased with cycle number. There was no significant non-hematological toxicity. Conclusion: Significant dose-escalation of epirubicin and cyclophosphamide was possible with filgrastim support. The MTD achieved was approximately double that of standard-dose therapy. This study forms the basis of an ongoing randomized study evaluating dose-intensification in intermediate grade NHL.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008353522601
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  • 5
    Electronic Resource
    Electronic Resource
    The optimal 5-fluorouracil regimen for the adjuvant therapy of colon cancer: Where to from here? (2000)
    Springer
    Annals of oncology 11 (2000), S. 915-918 
    Details
    ISSN: 1569-8041
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008378215303
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  • 6
    Electronic Resource
    Electronic Resource
    Repetitive high-dose therapy with ifosfamide, thiotepa and paclitaxel with peripheral blood progenitor cell and filgrastim support for metastatic and locally advanced breast cancer: Results of a phase I study (1999)
    Springer
    Annals of oncology 10 (1999), S. 479-481 
    Details
    ISSN: 1569-8041
    Keywords: high-dose therapy ; ifosfamide ; paclitaxel ; thiotepa ; transplantation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: This phase I study was designed to determine the optimal dosages of a novel repetitive high-dose therapy regimen for patients with metastatic breast cancer (MBC). Patients and methods: The planned treatment was three cycles of high-dose ifosfamide, thiotepa and conventional-dose paclitaxel delivered every 28 days with progressive dose-escalation in successive cohorts. Each cycle was supported by peripheral blood progenitor cells (PBPC) and filgrastim. Results: Twenty-three patients were entered into this trial. Of the planned 69 treatment cycles, 59 were delivered and fifteen patients completed all three cycles. The dose-limiting toxicities were renal tubular acidosis, encephalopathy, mucositis and enterocolitis. There was one treatment-related hemorrhagic death. Conclusions: The recommended doses for phase II or III studies are ifosfamide (10 g/m2), thiotepa (350 mg/m2) and paclitaxel (175 mg/m2).
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008317205955
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  • 7
    Electronic Resource
    Electronic Resource
    A phase I trial of docetaxel and gemcitabine in patients with advanced cancer (2000)
    Springer
    Annals of oncology 11 (2000), S. 421-426 
    Details
    ISSN: 1569-8041
    Keywords: chemotherapy ; docetaxel ; gemcitabine ; non-small-cell lung cancer ; phase I trials ; taxanes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Docetaxel and gemcitabine are active in a broad rangeof malignancies. The objective of this phase I trial was to determine themaximally tolerated doses of the combination of docetaxel and gemcitabine. Patients and methods:Patients with advanced cancer, WHOperformance status 0–2, who had received up to one prior chemotherapyregimen were treated with gemcitabine on days 1 and 8 and docetaxel on day 8repeated every 21 days. Prophylactic ciprofloxacin was commenced on day 11 ofeach cycle and continued until the neutrophil count reached 1.0 ×109/l. G-CSF was not administered. Dose levels studied weredocetaxel/gemcitabine: 60/800, 60/1000, 75/1000, 75/1200, 85/1200 and 100/1200mg/m2. Results:Thirty-nine patients were entered and all were assessablefor toxicity. The highest administered dose level was 100 mg/m2docetaxel and 1200 mg/m2 gemcitabine with dose limiting toxicitiesof febrile neutropenia, grade 4 neutropenia ≥7 days, grade 4thrombocytopenia, grade 3 stomatitis and/or grade 3 fatigue in three out ofsix patients. Treatment was well tolerated (40 cycles) in the 10 patientstreated at the recommended dose level (85/1200) with only a single episode offebrile neutropenia and grade 3 or 4 non-hematologic toxicity was infrequent.There was no significant pulmonary toxicity. Responses were seen in a rangeof malignancies including non-small-cell lung cancer. Conclusions:The recommended dose level of 85 mg/m2docetaxel and 1200 mg/m2 gemcitabine has a favourable toxicityprofile and is suitable for further investigation in phase II trials. Thisnon-platinum containing regimen warrants further investigation as a potentialalternative to platinum containing regimens in non-small-cell lung cancer andother malignancies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008384326701
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  • 8
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    PIK3CA, BRAF, and PTEN in Advanced Colorectal Cancer Treated by Cetuximab or Best Supportive Care (2014)
    The American Association for Cancer Research (AACR)
    Details
    Publication Date: 2014-02-04
    Description: Purpose: Cetuximab improves survival in patients with K-ras wild-type advanced colorectal cancer. We examined the predictive and prognostic significance of additional biomarkers in this setting, in particular BRAF , PIK3CA , and PTEN. Experimental Design: Available colorectal tumor samples were analyzed from the CO.17 study. BRAF mutations were identified in tumor-derived DNA by direct sequencing and PIK3CA mutations were identified using a high-resolution melting screen with confirmation by sequencing. PTEN expression by immunohistochemistry (IHC) was performed on tissue microarrays. For each biomarker, prognostic and predictive effects were examined using a Cox model with tests for treatment–biomarker interaction. Results: A total of 572 patients with pretreated colorectal cancer were randomly assigned to receive cetuximab or best supportive care (BSC). Of 401 patients assessed for BRAF status, 13 (3.2%) had mutations. Of 407 patients assessed for PIK3CA status, 61 (15%) had mutations. Of 205 patients assessed for PTEN, 148 (72%) were negative for IHC expression. None of BRAF , PIK3CA , or PTEN was prognostic for overall or progression-free survival in the BSC arm. None was predictive of benefit from cetuximab, either in the whole study population or the K-ras wild-type subset. In the K-ras wild-type subgroup, the overall survival adjusted HR according to BRAF mutation status was 1.39 (interaction P = 0.69), PIK3CA mutation status HR = 0.79 (interaction P = 0.63), and PTEN expression HR = 0.75 (interaction P = 0.61). Conclusions: In chemotherapy-refractory colorectal cancer, neither PIK3CA mutation status nor PTEN expression were prognostic, nor were they predictive of benefit from cetuximab. Evaluation of predictive significance of BRAF mutations requires a larger sample size. Clin Cancer Res; 20(3); 744–53. ©2013 AACR .
    Print ISSN: 1078-0432
    Electronic ISSN: 1557-3265
    Topics: Medicine
    Published by The American Association for Cancer Research (AACR)
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  • 9
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    Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study (2016)
    Oxford University Press
    Details
    Publication Date: 2016-06-28
    Description: Background The combination of aflibercept with FOLFIRI has been shown to significantly prolong overall survival in patients with metastatic colorectal cancer (mCRC) after progression on oxaliplatin-based therapy. This trial evaluated the addition of aflibercept to oxaliplatin-based first-line treatment of patients with mCRC. Patients and methods Patients with mCRC were randomized to receive first-line therapy with mFOLFOX6 plus aflibercept (4 mg/kg) or mFOLFOX6 alone. The primary end point of this phase II study was the progression-free survival (PFS) rate at 12 months in each arm. The analysis of efficacy between the arms was a pre-planned secondary analysis. Results Of 236 randomized patients, 227 and 235 patients were evaluable for the primary efficacy analysis and safety, respectively. The probabilities of being progression-free at 12 months were 25.8% [95% confidence interval (CI) 17.2–34.4] for the aflibercept/mFOLFOX6 arm and 21.2% (95% CI 12.2–30.3) for the mFOLFOX6 arm. The median PFS was 8.48 months (95% CI 7.89–9.92) for the aflibercept/mFOLFOX6 arm and 8.77 months (95% CI 7.62–9.27) for the mFOLFOX6 arm; the hazard ratio of aflibercept/mFOLFOX6 versus mFOLFOX6 was 1.00 (95% CI 0.74–1.36). The response rates were 49.1% (95% CI 39.7–58.6) and 45.9% (95% CI 36.4–55.7) for patients treated with and without aflibercept, respectively. The most frequent treatment-emergent grade 3/4 adverse events (AEs) excluding laboratory abnormalities reported for aflibercept/mFOLFOX6 versus mFOLFOX6 were neuropathy (16.8% versus 17.2%) and diarrhea (13.4% versus 5.2%). Neutropenia grade 3/4 occurred in 36.1% versus 29.3%. The most common vascular endothelial growth factor inhibition class-effect grade 3/4 AEs for aflibercept/mFOLFOX6 versus mFOLFOX6 were hypertension (35.3% versus 1.7%), proteinuria (9.2% versus 0%), deep vein thrombosis (5.9% versus 0.9%) and pulmonary embolism (5.9% versus 5.2%). Conclusion No difference in PFS rate was observed between treatment groups. Adding aflibercept to first-line mFOLFOX6 did not increase efficacy but was associated with higher toxicity. Clinical Trial Number NCT00851084, www.clinicaltrials.gov , EudraCT 2008-004178-41.
    Print ISSN: 0923-7534
    Electronic ISSN: 1569-8041
    Topics: Medicine
    Published by Oxford University Press
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  • 10
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    FCGR, Cetuximab, and Colorectal Cancer Survival (2016)
    The American Association for Cancer Research (AACR)
    Details
    Publication Date: 2016-05-14
    Description: Purpose: Two germline Fc- receptor (FCGR) polymorphisms, rs1801274 [ FCGR2A;His(H)131Arg(R) ] and rs396991 [ FCGR3A;Phe(F)158Val(V) ] produce altered proteins through amino acid substitutions; both are reported to be associated with cetuximab-related outcomes. We performed a validation of these polymorphisms in NCIC CTG CO.17, a randomized trial of cetuximab monotherapy in refractory, metastatic colorectal cancer expressing EGFR. Experimental Design: DNA extracted from formalin-fixed paraffin-embedded tissue was genotyped. In addition to log-rank tests, Cox proportional hazard models assessed their relationships with overall (OS) and progression-free survival (PFS), adjusting for clinically important prognostic factors, along with a polymorphism–treatment arm interaction term. Results: Somatic KRAS status was wild-type for exon 2 in 153 (52%) of 293 patients, from whom tumor DNA was available. For FCGR2A H/H , a genotype–treatment interaction for KRAS wild-type patients was observed for OS ( P = 0.03). In KRAS wild-type patients carrying FCGR2A H/H , cetuximab (vs. no cetuximab) improved survival substantially, with adjusted HRs (aHR) of 0.36 (OS) and 0.19 (PFS) and absolute benefits of 5.5 months (OS; P = 0.003) and 3.7 months (PFS; P = 0.02). In contrast, patients carrying FCGR2A R alleles ( H/R or R/R ) had aHRs of only 0.78 (OS; 2.8-month benefit) and 0.53 (PFS; 1.6-month benefit). No relationships were found for rs396991 ( FCGR3A ). Conclusions: In the CO.17 trial, cetuximab worked best for patients with KRAS wild-type colorectal cancers carrying FCGR2A H/H genotypes. Significantly lower benefits were observed in patients carrying germline FCGR2A R alleles. Clin Cancer Res; 22(10); 2435–44. ©2016 AACR .
    Print ISSN: 1078-0432
    Electronic ISSN: 1557-3265
    Topics: Medicine
    Published by The American Association for Cancer Research (AACR)
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