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Use of chemotherapy in patients with metastatic lung cancer
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Drug clinical trials based on preclinical research and small-scale basic science studies often fail, a particularly common theme in cancer research— the discipline in which most animal studies are done. Countless costs are incurred in UK cancer research laboratories but usually leads to inadequate clinical translation of data. Despite being highly scrutinised at the procedural level by the UK Home Office, animal studies lag behind clinical oncology trials for rigour. Results from a survey by the UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs; London, UK), which assessed quality of animal research, have now inspired UK Research Councils to implement requirements in funding applications that will allow deeper assessment of planned experimental design. Requirements will include
statistical power calculations and details about investigators’ proposed steps to minimise experimental bias. Applicants are expected to follow the NC3Rs’ ARRIVE guidelines (similar to the CONSORT guidelines), whose dissemination is hoped to “promote a cultural shift in reporting practices of animal research”, according to Katie Lidster from NC3Rs (London, UK). Andrew Rice, Department of Surgery and Cancer at Imperial College London (London, UK), wholeheartedly welcomes the new requirements but believes that they do not go far enough, saying that “other internal validity factors in experimental design and conduct should also be clearly elucidated at the application stage, for example randomisation and blinding of investigators”. Lee Ellis, professor of surgery and molecular and cellular oncology at the University of Texas MD Anderson Cancer Center (Houston,
TX, USA) adds, “it would be good to have statistics experts review basic science papers as is done in important clinical papers, big data studies, and in genomics or proteomics”. Rice hopes that the ARRIVE guidelines could, ultimately, lead to full and transparent reporting that will aid meta-analyses of animal studies and inform study design. However, he emphasises that “reporting of null and negative studies is an important facet of publication bias that biomedical science still needs to address”. Lidster clarifies, “our next step is to move beyond endorsement and focus on implementation of the ARRIVE guidelines”. The NC3Rs is working on several initiatives to improve reproducibility of animal research and increase the quality of animal studies.
Klaus Guldbrandsen/Science Photo Library
UK Research Councils’ new funding criteria for animal studies
Published Online April 24, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70195-6 For the Research Councils UK’s funding criteria for animal studies see http://www.rcuk.ac. uk/media/ announcements/150415/ For the NC3Rs’ ARRIVE guidelines see https://www. nc3rs.org.uk/arrive-guidelines
Dimitris Xanthos
Use of chemotherapy in patients with metastatic lung cancer Many patients with metastatic nonsmall-cell lung cancer (NSCLC) might not be receiving chemotherapy, suggests a study by Adrian G Sacher and colleagues. Sacher (Dana-Farber Cancer Institute, Boston, MA, USA) and colleagues noted that there is an apparent reticence of oncologists and referring physicians to advocate systemic treatment in patients with metastatic NSCLC, despite the data supporting the benefits of this treatment for most patients. The researchers did a retrospective, population-based study of all patients with stage IV NSCLC who were diagnosed during 2005–09 in Ontario, Canada. Of the 8113 patients included, 6169 (76%) reportedly did not receive chemotherapy. However, 1944 (24%) patients received at least one line of chemotherapy. With www.thelancet.com/oncology Vol 16 June 2015
time, the percentage of patients who received chemotherapy increased—from 283 (19%) in 2005 to 484 (26%) in 2009 (p<0·0001). The researchers noted that only 465 (13%) of patients aged 70 years and older received chemotherapy (odds ratio [OR] 0·29, 95% CI 0·26–0·33, p<0·0001). Compared with the adenocarcinoma subtype, patients with squamous carcinoma were less likely to receive chemotherapy (OR 1·30, 95% CI 1·10–1·53, p<0·0001). Median survival (from diagnosis) was 3·3 months (95% CI 3·2–3·4) for patients who did not receive chemotherapy, compared with 8·2 months (95% CI 7·7–8·6) for patients who received only first-line chemotherapy, and 16·2 months (15·1–17·0) for patients who received both first-line and second-line chemotherapy. Sacher commented that their study “accords with the findings of previous
studies in the USA and Canada by showing similarly low rates of chemotherapy use”. To address this, Philip Lammers (Meharry Medical College, TN, USA) commented, “we need to make an effort to find these patients earlier in their disease before they have substantial toxicity from the cancer, and to better educate physicians [and] patients on the numerous studies that show patients who receive chemotherapy have improved symptoms and a better [quality of life]”. Mauricio Burotto (Clinica Alemana Santiago, Chile), agrees that more education is needed, but also states, “Understanding and treating lung cancer will become more challenging as more subtypes of disease, all with different treatment approaches, are described”.
Published Online April 24, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70194-4 For the study by Sacher and colleagues see Cancer 2015; published online April 17. DOI:10.1002/cncr.29386
Sanjeet Bagcchi e263
Drug clinical trials based on preclinical research and small-scale basic science studies often fail, a particularly common theme in cancer research— the discipline in which most animal studies are done. Countless costs are incurred in UK cancer research laboratories but usually leads to inadequate clinical translation of data. Despite being highly scrutinised at the procedural level by the UK Home Office, animal studies lag behind clinical oncology trials for rigour. Results from a survey by the UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs; London, UK), which assessed quality of animal research, have now inspired UK Research Councils to implement requirements in funding applications that will allow deeper assessment of planned experimental design. Requirements will include
statistical power calculations and details about investigators’ proposed steps to minimise experimental bias. Applicants are expected to follow the NC3Rs’ ARRIVE guidelines (similar to the CONSORT guidelines), whose dissemination is hoped to “promote a cultural shift in reporting practices of animal research”, according to Katie Lidster from NC3Rs (London, UK). Andrew Rice, Department of Surgery and Cancer at Imperial College London (London, UK), wholeheartedly welcomes the new requirements but believes that they do not go far enough, saying that “other internal validity factors in experimental design and conduct should also be clearly elucidated at the application stage, for example randomisation and blinding of investigators”. Lee Ellis, professor of surgery and molecular and cellular oncology at the University of Texas MD Anderson Cancer Center (Houston,
TX, USA) adds, “it would be good to have statistics experts review basic science papers as is done in important clinical papers, big data studies, and in genomics or proteomics”. Rice hopes that the ARRIVE guidelines could, ultimately, lead to full and transparent reporting that will aid meta-analyses of animal studies and inform study design. However, he emphasises that “reporting of null and negative studies is an important facet of publication bias that biomedical science still needs to address”. Lidster clarifies, “our next step is to move beyond endorsement and focus on implementation of the ARRIVE guidelines”. The NC3Rs is working on several initiatives to improve reproducibility of animal research and increase the quality of animal studies.
Klaus Guldbrandsen/Science Photo Library
UK Research Councils’ new funding criteria for animal studies
Published Online April 24, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70195-6 For the Research Councils UK’s funding criteria for animal studies see http://www.rcuk.ac. uk/media/ announcements/150415/ For the NC3Rs’ ARRIVE guidelines see https://www. nc3rs.org.uk/arrive-guidelines
Dimitris Xanthos
Use of chemotherapy in patients with metastatic lung cancer Many patients with metastatic nonsmall-cell lung cancer (NSCLC) might not be receiving chemotherapy, suggests a study by Adrian G Sacher and colleagues. Sacher (Dana-Farber Cancer Institute, Boston, MA, USA) and colleagues noted that there is an apparent reticence of oncologists and referring physicians to advocate systemic treatment in patients with metastatic NSCLC, despite the data supporting the benefits of this treatment for most patients. The researchers did a retrospective, population-based study of all patients with stage IV NSCLC who were diagnosed during 2005–09 in Ontario, Canada. Of the 8113 patients included, 6169 (76%) reportedly did not receive chemotherapy. However, 1944 (24%) patients received at least one line of chemotherapy. With www.thelancet.com/oncology Vol 16 June 2015
time, the percentage of patients who received chemotherapy increased—from 283 (19%) in 2005 to 484 (26%) in 2009 (p<0·0001). The researchers noted that only 465 (13%) of patients aged 70 years and older received chemotherapy (odds ratio [OR] 0·29, 95% CI 0·26–0·33, p<0·0001). Compared with the adenocarcinoma subtype, patients with squamous carcinoma were less likely to receive chemotherapy (OR 1·30, 95% CI 1·10–1·53, p<0·0001). Median survival (from diagnosis) was 3·3 months (95% CI 3·2–3·4) for patients who did not receive chemotherapy, compared with 8·2 months (95% CI 7·7–8·6) for patients who received only first-line chemotherapy, and 16·2 months (15·1–17·0) for patients who received both first-line and second-line chemotherapy. Sacher commented that their study “accords with the findings of previous
studies in the USA and Canada by showing similarly low rates of chemotherapy use”. To address this, Philip Lammers (Meharry Medical College, TN, USA) commented, “we need to make an effort to find these patients earlier in their disease before they have substantial toxicity from the cancer, and to better educate physicians [and] patients on the numerous studies that show patients who receive chemotherapy have improved symptoms and a better [quality of life]”. Mauricio Burotto (Clinica Alemana Santiago, Chile), agrees that more education is needed, but also states, “Understanding and treating lung cancer will become more challenging as more subtypes of disease, all with different treatment approaches, are described”.
Published Online April 24, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70194-4 For the study by Sacher and colleagues see Cancer 2015; published online April 17. DOI:10.1002/cncr.29386
Sanjeet Bagcchi e263