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1.
BMC Cancer ; 18(1): 1144, 2018 Nov 20.
Article in English | MEDLINE | ID: mdl-30458807

ABSTRACT

BACKGROUND: A minority of European countries have participated in international comparisons with high level data on lung cancer. However, the nature and extent of data collection across the continent is simply unknown, and without accurate data collection it is not possible to compare practice and set benchmarks to which lung cancer services can aspire. METHODS: Using an established network of lung cancer specialists in 37 European countries, a survey was distributed in December 2014. The results relate to current practice in each country at the time, early 2015. The results were compiled and then verified with co-authors over the following months. RESULTS: Thirty-five completed surveys were received which describe a range of current practice for lung cancer data collection. Thirty countries have data collection at the national level, but this is not so in Albania, Bosnia-Herzegovina, Italy, Spain and Switzerland. Data collection varied from paper records with no survival analysis, to well-established electronic databases with links to census data and survival analyses. CONCLUSION: Using a network of committed clinicians, we have gathered validated comparative data reporting an observed difference in data collection mechanisms across Europe. We have identified the need to develop a well-designed dataset, whilst acknowledging what is feasible within each country, and aspiring to collect high quality data for clinical research.


Subject(s)
Data Collection/statistics & numerical data , Lung Neoplasms/diagnosis , Lung Neoplasms/therapy , Medical Oncology/statistics & numerical data , Data Collection/methods , Databases, Factual/statistics & numerical data , Europe , Humans , Medical Oncology/methods
2.
Br J Cancer ; 115(8): 974-982, 2016 10 11.
Article in English | MEDLINE | ID: mdl-27623234

ABSTRACT

BACKGROUND: Angiogenesis inhibition is an important strategy for cancer treatment. Ramucirumab, a human IgG1 monoclonal antibody that targets VEGF receptor 2 (VEGFR2), inhibits VEGF-A, -C, -D binding and endothelial cell proliferation. To attempt to identify prognostic and predictive biomarkers, retrospective analyses were used to assess tumour (HER2, VEGFR2) and serum (VEGF-C and -D, and soluble (s) VEGFR1 and 3) biomarkers in phase 3 REGARD patients with metastatic gastric/gastroesophageal junction carcinoma. METHODS: A total of 152 out of 355 (43%) patients randomised to ramucirumab or placebo had ⩾1 evaluable biomarker result using VEGFR2 immunohistochemistry or HER2, immunohistochemistry or FISH, of blinded baseline tumour tissue samples. Serum samples (32 patients, 9%) were assayed for VEGF-C and -D, and sVEGFR1 and 3. RESULTS: None of the biomarkers tested were associated with ramucirumab efficacy at a level of statistical significance. High VEGFR2 endothelial expression was associated with a non-significant prognostic trend toward shorter progression-free survival (high vs low HR=1.65, 95% CI=0.84,3.23). Treatment with ramucirumab was associated with a trend toward improved survival in both high (HR=0.69, 95% CI=0.38, 1.22) and low (HR=0.73, 95% CI=0.42, 1.26) VEGFR2 subgroups. The benefit associated with ramucirumab did not appear to differ by tumoural HER2 expression. CONCLUSIONS: REGARD exploratory analyses did not identify a strong potentially predictive biomarker of ramucirumab efficacy; however, statistical power was limited.


Subject(s)
Adenocarcinoma/drug therapy , Angiogenesis Inhibitors/therapeutic use , Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/therapeutic use , Neoplasm Proteins/antagonists & inhibitors , Receptors, Vascular Endothelial Growth Factor/blood , Stomach Neoplasms/drug therapy , Vascular Endothelial Growth Factor Receptor-2/antagonists & inhibitors , Vascular Endothelial Growth Factors/blood , Adenocarcinoma/blood , Adenocarcinoma/chemistry , Adult , Antibodies, Monoclonal, Humanized , Biomarkers, Tumor , Clinical Trials, Phase III as Topic , Disease-Free Survival , Esophagogastric Junction , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Multicenter Studies as Topic , Neoplasm Proteins/analysis , Neoplasm Proteins/blood , Randomized Controlled Trials as Topic , Receptor, ErbB-2/analysis , Retrospective Studies , Single-Blind Method , Stomach Neoplasms/blood , Stomach Neoplasms/chemistry , Stomach Neoplasms/mortality , Vascular Endothelial Growth Factor Receptor-2/analysis , Ramucirumab
3.
Radiother Oncol ; 116(1): 21-6, 2015 Jul.
Article in English | MEDLINE | ID: mdl-26163093

ABSTRACT

BACKGROUND: To optimize palliation in incurable locally advanced non-small cell lung cancer (NSCLC), the International Atomic Energy Agency conducted a prospective randomized study (NCT00864331) comparing protracted palliative radiotherapy (RT) course with chemotherapy (CHT) followed by short-course palliative RT. METHODS AND MATERIALS: Treatment-naive patients with histologically confirmed NSCLC, stage IIIA/IIIB, received either 39Gy in 13 fractions as RT alone (arm A, n=31) or 2-3 platinum-based CHT cycles followed by 10Gy in a single fraction or 16Gy in 2 fractions separated by one week (arm B, n=34). Primary outcome was overall survival. RESULTS: Treatment groups were balanced with respect to various variables. Median survival for all 65 patients was 8months, while median survival was 7.1 and 8.1months for the two arms, respectively (log-rank p=0.4 by study arm, and p=0.6 by Cox regression and stratified by country and sub-stage). One and three year survival rates for the two arms were 29%, and 9% and 41%, and 6%, respectively. There were no differences in any of the following endpoints: any failure, local failure, regional failure, contralateral thoracic failure, and distant failure between the two arms. High-grade (⩾3) toxicity was similar between the two arms. Symptoms, adverse events of any kind, KPS and body-mass index, were not different during treatment and during follow-up. There was no grade 5 toxicity. CONCLUSIONS: This incomplete and underpowered trial only hinted similar outcome between the treatment arms. Therefore, combined CHT-RT can perhaps be considered, in limited resource setting, where access to RT remains inadequate.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/therapy , Lung Neoplasms/therapy , Palliative Care , Adult , Aged , Female , Follow-Up Studies , Humans , International Agencies , Male , Middle Aged , Neoplasm Staging , Nuclear Energy , Prospective Studies , Survival Rate
4.
J Clin Oncol ; 31(2): 195-202, 2013 Jan 10.
Article in English | MEDLINE | ID: mdl-23233719

ABSTRACT

PURPOSE: Recent data showed improvement in progression-free survival (PFS) when adding everolimus to exemestane in patients with advanced breast cancer experiencing recurrence/progression after nonsteroidal aromatase inhibitor (AI) therapy. Here, we report clinical outcomes of combining the mammalian target of rapamycin (mTOR) inhibitor temsirolimus with letrozole in AI-naive patients. PATIENTS AND METHODS: This phase III randomized placebo-controlled study tested efficacy/safety of first-line oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) versus letrozole/placebo in 1,112 patients with AI-naive, hormone receptor-positive advanced disease. An independent data monitoring committee recommended study termination for futility at the second preplanned interim analysis (382 PFS events). RESULTS: Patients were balanced (median age, 63 years; 10% stage III, 40% had received adjuvant endocrine therapy). Those on letrozole/temsirolimus experienced more grade 3 to 4 events (37% v 24%). There was no overall improvement in primary end point PFS (median, 9 months; hazard ratio [HR], 0.90; 95% CI, 0.76 to 1.07; P = .25) nor in the 40% patient subset with prior adjuvant endocrine therapy. An exploratory analysis showed improved PFS favoring letrozole/temsirolimus in patients ≤ age 65 years (9.0 v 5.6 months; HR, 0.75; 95% CI, 0.60 to 0.93; P = .009), which was separately examined by an exploratory analysis of 5-month PFS using subpopulation treatment effect pattern plot methodology (P = .003). CONCLUSION: Adding temsirolimus to letrozole did not improve PFS as first-line therapy in patients with AI-naive advanced breast cancer. Exploratory analyses of benefit in younger postmenopausal patients require external confirmation.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Administration, Oral , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/pathology , Disease-Free Survival , Double-Blind Method , Female , Humans , Letrozole , Middle Aged , Neoplasm Metastasis , Nitriles/administration & dosage , Nitriles/adverse effects , Placebos , Postmenopause , Sirolimus/administration & dosage , Sirolimus/adverse effects , Sirolimus/analogs & derivatives , Treatment Outcome , Triazoles/administration & dosage , Triazoles/adverse effects
5.
Lung Cancer ; 70(1): 7-13, 2010 Oct.
Article in English | MEDLINE | ID: mdl-20576312

ABSTRACT

Systemic chemotherapy plays the major role in the management of patients with small cell lung cancer. Cisplatin plus etoposide is the most widely used regimen and is considered as standard in patients with limited disease. Cisplatin plus irinotecan improved survival compared to cisplatin plus etoposide in a Japanese trial but failed to do so in two trials in Caucasians. Cisplatin plus topotecan had similar efficacy compared to cisplatin plus etoposide in patients with extensive disease. In the second-line setting, topotecan showed similar efficacy but better tolerability compared to cyclophosphamide, doxorubin plus vincristine. Oral topotecan was as efficacious as its intravenous formulation and was shown to improve survival compared to best supportive care alone in patients previously treated with chemotherapy. Thus topotecan is considered as the standard second-line chemotherapy in patients with small cell lung cancer.


Subject(s)
Lung Neoplasms/drug therapy , Small Cell Lung Carcinoma/drug therapy , Topotecan/administration & dosage , Administration, Oral , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Combined Modality Therapy , Humans , Lung Neoplasms/radiotherapy , Small Cell Lung Carcinoma/radiotherapy , Topoisomerase I Inhibitors/administration & dosage
6.
Wien Klin Wochenschr ; 122(11-12): 368-79, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20549373

ABSTRACT

In breast cancer, early detection as well as new developments in therapeutic options has resulted in less patients presenting with metastatic disease. However, about one-third of women with early stage breast cancer will eventually develop metastatic disease. Furthermore, approximately 20-30% of patients with breast cancer have tumors that overexpress human epidermal growth factor receptor (HER-2), which is associated with an aggressive tumor phenotype and poor prognosis. The identification of the HER-2 protein led to the development of highly effective therapeutics directed at this receptor. Trastuzumab, a recombinant, humanized, monoclonal antibody that binds to the extracellular domain of the HER-2 protein, has shown significant clinical benefit in metastatic and early-stage HER-2-positive breast cancer. Since the cancer recurs after adjuvant therapy in some women, and metastatic breast cancer eventually develops resistance to trastuzumab, there is a need for alternative treatment modalities to block HER-2 signaling. One of these treatment options is lapatinib, an orally active small molecule that inhibits the tyrosine kinases of HER-2 and the epidermal growth factor receptor type 1 (EGFR). In this consensus statement current treatment options in metastatic and locally advanced disease are discussed with a special focus on lapatinib.


Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Evidence-Based Medicine/standards , Quinazolines/therapeutic use , Algorithms , Antineoplastic Agents/adverse effects , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Disease Progression , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Delivery Systems , Drug Therapy, Combination , ErbB Receptors/antagonists & inhibitors , Europe , Female , Humans , Lapatinib , Neoplasm Staging , Neoplasms, Hormone-Dependent/drug therapy , Neoplasms, Hormone-Dependent/pathology , Quinazolines/adverse effects , Randomized Controlled Trials as Topic , Receptor, ErbB-2/antagonists & inhibitors , Receptors, Estrogen/analysis , Receptors, Progesterone/analysis
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