BACKGROUND: Supportive care interventions can have a substantial impact on side effects of chemotherapy. Consequently, accurate reporting of such interventions is essential when interpreting clinical trial results. This study determined the prevalence and quality of reporting of supportive care treatment for common chemotherapy-induced toxicities in phase III, breast cancer chemotherapy trials. METHODS: A systematic review of phase III trials of breast cancer trials incorporating chemotherapy published in the last 5 years was undertaken. Trials were identified through MEDLINE, EMBASE, BIOSIS, and the Cochrane Library. Supportive treatments evaluated were use of antiemetics, colony-stimulating growth factors, and antibiotics. Reporting quality was rated as "good", "fair", "poor", or "absent" using predetermined criteria. RESULTS: Sixty-two trials met inclusion criteria. In 41 studies (66%), details regarding prophylactic antiemetic treatment were not provided. Growth factor use was not reported in 20 trials (32%). Instructions for the use of prophylactic antibiotics were absent in 45 trials (72%). CONCLUSION: There are significant deficiencies in reporting of use of prophylactic supportive care agents in breast cancer trials. Omission of supportive care instructions may impact substantially on patient management and health care system expenditure. Recommendations for the type, dose, and frequency of supportive care drugs should be provided and reported on in trials.
BACKGROUND: Supportive care interventions can have a substantial impact on side effects of chemotherapy. Consequently, accurate reporting of such interventions is essential when interpreting clinical trial results. This study determined the prevalence and quality of reporting of supportive care treatment for common chemotherapy-induced toxicities in phase III, breast cancer chemotherapy trials. METHODS: A systematic review of phase III trials of breast cancer trials incorporating chemotherapy published in the last 5 years was undertaken. Trials were identified through MEDLINE, EMBASE, BIOSIS, and the Cochrane Library. Supportive treatments evaluated were use of antiemetics, colony-stimulating growth factors, and antibiotics. Reporting quality was rated as "good", "fair", "poor", or "absent" using predetermined criteria. RESULTS: Sixty-two trials met inclusion criteria. In 41 studies (66%), details regarding prophylactic antiemetic treatment were not provided. Growth factor use was not reported in 20 trials (32%). Instructions for the use of prophylactic antibiotics were absent in 45 trials (72%). CONCLUSION: There are significant deficiencies in reporting of use of prophylactic supportive care agents in breast cancer trials. Omission of supportive care instructions may impact substantially on patient management and health care system expenditure. Recommendations for the type, dose, and frequency of supportive care drugs should be provided and reported on in trials.
Authors: Kathy D Miller; Linnea I Chap; Frankie A Holmes; Melody A Cobleigh; P Kelly Marcom; Louis Fehrenbacher; Maura Dickler; Beth A Overmoyer; James D Reimann; Amy P Sing; Virginia Langmuir; Hope S Rugo Journal: J Clin Oncol Date: 2005-02-01 Impact factor: 44.544
Authors: M Martín; A Lluch; M A Seguí; A Ruiz; M Ramos; E Adrover; A Rodríguez-Lescure; R Grosse; L Calvo; C Fernandez-Chacón; M Roset; A Antón; D Isla; P Martínez del Prado; L Iglesias; J Zaluski; A Arcusa; J M López-Vega; M Muñoz; J R Mel Journal: Ann Oncol Date: 2006-06-09 Impact factor: 32.976
Authors: O Feher; P Vodvarka; J Jassem; G Morack; S H Advani; K S Khoo; D C Doval; S Ermisch; D Roychowdhury; M A Miller; G von Minckwitz Journal: Ann Oncol Date: 2005-04-08 Impact factor: 32.976
Authors: Bent Ejlertsen; Henning T Mouridsen; Maj-Britt Jensen; Jørn Andersen; Søren Cold; Per Edlund; Marianne Ewertz; Brita B Jensen; Claus Kamby; Bo Nordenskjold; Jonas Bergh Journal: Eur J Cancer Date: 2007-02-16 Impact factor: 9.162
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Authors: M E R O'Brien; N Wigler; M Inbar; R Rosso; E Grischke; A Santoro; R Catane; D G Kieback; P Tomczak; S P Ackland; F Orlandi; L Mellars; L Alland; C Tendler Journal: Ann Oncol Date: 2004-03 Impact factor: 32.976
Authors: G Fountzilas; H P Kalofonos; U Dafni; C Papadimitriou; D Bafaloukos; P Papakostas; A Kalogera-Fountzila; H Gogas; G Aravantinos; L A Moulopoulos; T Economopoulos; D Pectasides; N Maniadakis; V Siafaka; E Briasoulis; C Christodoulou; D Tsavdaridis; P Makrantonakis; E Razis; P Kosmidis; D Skarlos; M A Dimopoulos Journal: Ann Oncol Date: 2004-10 Impact factor: 32.976
Authors: Johannes Wohlrab; Nikola Bangemann; Anke Kleine-Tebbe; Marc Thill; Sherko Kümmel; Eva-Maria Grischke; Rainer Richter; Sophie Seite; Diana Lüftner Journal: Breast Cancer (Dove Med Press) Date: 2014-08-01