open access
Critical appraisal of clinical trials in oncology — part II


- The Department of Chemotherapy, Copernicus Memorial Multidisciplinary Centre for Oncology and Traumatology, Lodz; Chemotherapy Clinic, Medical University of Lodz, Poland
- Aestimo, Krakow, Poland
- Jagiellonian University Medical College, Krakow, Poland
open access
Abstract
Abstract
Keywords
oncology; clinical trials; critical appraisal; publication analysis; research methodology; interpretation of results


Title
Critical appraisal of clinical trials in oncology — part II
Journal
Issue
Article type
Review paper
Pages
158-166
Published online
2019-06-26
Page views
942
Article views/downloads
601
DOI
10.5603/OCP.2019.0013
Bibliographic record
Oncol Clin Pract 2019;15(3):158-166.
Keywords
oncology
clinical trials
critical appraisal
publication analysis
research methodology
interpretation of results
Authors
Piotr Potemski
Joanna Połowinczak-Przybyłek
Rafał Wójcik
Marcin Kaczor


- Price TJ, Peeters M, Kim TW, et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014; 15(6): 569–579.
- Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008; 359(17): 1757–1765.
- Grothey A, Sobrero AF, Shields AF, et al. Duration of adjuvant chemotherapy for stage III colon cancer. N Engl J Med. 2018; 378(13): 1177–1188.
- André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004; 350(23): 2343–2351.
- Price T, Kim TW, Li J, et al. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016; 68: 51–59.
- Austin PC, Mamdani MM, Juurlink DN, et al. Testing multiple statistical hypotheses resulted in spurious associations: a study of astrological signs and health. J Clin Epidemiol. 2006; 59(9): 964–969.
- Szydlo RM, Gabriel I, Olavarria E, et al. Sign of the Zodiac as a predictor of survival for recipients of an allogeneic stem cell transplant for chronic myeloid leukaemia (CML): an artificial association. Transplant Proc. 2010; 42(8): 3312–3315.
- Ryan CJ, Smith MR, de Bono JS, et al. COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013; 368(2): 138–148.
- Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014; 66(5): 815–825.
- Ryan C, Smith M, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015; 16(2): 152–160.
- Méjean A, Ravaud A, Thezenas S, et al. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018; 379(5): 417–427.
- Hudes G, Carducci M, Tomczak P, et al. Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007; 356(22): 2271–2281.
- Motzer RJ, Tannir NM, McDermott DF, et al. CheckMate 214 Investigators. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018; 378(14): 1277–1290.
- https://clinicaltrials.gov/ct2/show/NCT02282020.
- Kim TW, Elme A, Kusic Z, et al. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016; 115(10): 1206–1214.
- Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007; 25(13): 1658–1664.
- Moore MJ, Goldstein D, Hamm J, et al. National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007; 25(15): 1960–1966.
- Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012; 30(28): 3499–3506.
- Joulain F, Proskorovsky I, Allegra C, et al. Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer. Br J Cancer. 2013; 109(7): 1735–1743.
- Chau I, Joulain F, Iqbal SU, et al. A VELOUR post hoc subset analysis: prognostic groups and treatment outcomes in patients with metastatic colorectal cancer treated with aflibercept and FOLFIRI. BMC Cancer. 2014; 14: 605.
- Saltz LB, Clarke S, Díaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008; 26(12): 2013–2019.
- Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol. 2015; 26(8): 1547–1573.
- Del Paggio JC, Azariah B, Sullivan R, et al. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit? Ann Oncol. 2017; 28(1): 157–162.