Annals of Oncology 26: 1269–1273, 2015
letters to the editor
V. Pumo, A. Di Mari, S. Rametta Giuliano, S. Bordonaro, E. Lanteri & P. Tralongo* Medical Oncology Unit, Umberto I Hospital, RAO, Siracusa, Italy (*E-mail: [email protected])
disclosure The authors have declared no conflicts of interest.
1. Pivot X, Gligorov J, Müller V et al. Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 2014; 25(10): 1979–1987. 2. Storey P, Hilll HH JR, St Luois RH et al. Subcutaneous infusion for control cancer symptoms. J Pain Symptom Manage 1990; 5: 33–41. 3. Ismael G, Hegg R, Meuhlbauer S et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012; 13: 869–879. 4. Zandviliet AS, Schellen JH, Bejinen JH et al. Population pharmacokinetics and pharmacodynamics for treatment optimization in clinical oncology. Clin Pharmacokinet 2008; 47: 487–513. 5. Wang X, Yang KH, Wanyan P et al. Comparison of the efficacy and safety of denosumab versus bisphosphonates in breast cancer and bone metastases treatment: a meta-analysis of randomized controlled trials. Oncol Lett 2014; 7(6): 1997–2002.
doi: 10.1093/annonc/mdv143 Published online 18 March 2015
Reply to the letter to the editor ‘Patients’ preference and informed consent’ by Pumo et al. We thank Pumo et al. [1] for their interest in the article on patient preference in PrefHer (ClinicalTrials.gov number NCT01401166) [2]. First, it should be clarified that patients did not choose subcutaneous (s.c.) or intravenous (i.v.) trastuzumab (Herceptin® SC or IV, F. Hoffmann-La Roche Ltd, Basel, Switzerland) administration in PrefHer; patients were randomized to receive four cycles of each formulation during the crossover period (s.c. then i.v. or vice versa). Following the crossover period, patients were scheduled to continue with i.v. trastuzumab in Cohort 1 (unless participating in the exploratory analysis of satisfaction with s.c. self-administration using the single-use injection device) or s.c. trastuzumab in Cohort 2. With regards to informed consent and the s.c. trastuzumab safety profile, the ethics committee-approved informed consent form contained a section on safety of both s.c. and i.v. trastuzumab; within the s.c. section, there was additional information warning patients that the side effects of s.c. trastuzumab could be different from those of i.v. trastuzumab, particularly in terms of infusion reactions and symptoms at the injection/infusion sites. Information on the form was also in line with the
© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from http://annonc.oxfordjournals.org/ at The University of British Colombia Library on November 14, 2015
We have read and appreciated the study conducted by Pivot et al. [1] on the patients’ preference on the administration (i.v. versus s.c.) of trastuzumab. The data confirm that it is now possible for the patients to choose the mode of drug administration and offer the opportunity to bring out some considerations regarding the information received by the patients about the therapeutic effects before the choice. Over the past few years, many new drugs have become available in different formulations (s.c., oral, i.v.). In some cases, the new formulation has therapeutic impact with pharmacodynamic-cynetic difference (morphine) [2], in others just only in patients’ preference. In the last case, we consider this an important patients’ choice as long as the patients in properly informed in order to choose in full awareness. The PrefHer study reported no clinically relevant differences during the switch between i.v. and s.c. administration and that the patients choose the s.c. administration. An earlier paper by Hismael et al. emphasized different percentage of serious adverse events between the two groups: 21% in the patients treated with s.c. compared with 12% in those treated with i.v.; 8.1% of infections and infestations were reported in the s.c. group versus 4.4% in the i.v. Four fatal adverse events, one in the i.v. and three in s.c. treatment, were also registered, each of which occurred during neoadjuvant treatment; of these, two—both in the s.c. treatment—were considered related to treatment [3]. We consider the administration of s.c. a great opportunity [4] because it reduces the commitment of medical resources and nursing activity, determining cost reduction and, finally, most important, improves the patients’ quality of life [5]. At the same time, we consider it essential that the patients’ choice to select the type of treatment should be done after proper information on the advantages/disadvantages, efficacy/potential side effects. Considering this, it could be of interest to know if the patients of the PrefHer study, when they declared that they prefer the s.c. administration, have been informed well in advance about the potential side effects.
references
letters to the editor
Patients’ preference and informed consent
letters to the editor
V. Pumo, A. Di Mari, S. Rametta Giuliano, S. Bordonaro, E. Lanteri & P. Tralongo* Medical Oncology Unit, Umberto I Hospital, RAO, Siracusa, Italy (*E-mail: [email protected])
disclosure The authors have declared no conflicts of interest.
1. Pivot X, Gligorov J, Müller V et al. Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 2014; 25(10): 1979–1987. 2. Storey P, Hilll HH JR, St Luois RH et al. Subcutaneous infusion for control cancer symptoms. J Pain Symptom Manage 1990; 5: 33–41. 3. Ismael G, Hegg R, Meuhlbauer S et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012; 13: 869–879. 4. Zandviliet AS, Schellen JH, Bejinen JH et al. Population pharmacokinetics and pharmacodynamics for treatment optimization in clinical oncology. Clin Pharmacokinet 2008; 47: 487–513. 5. Wang X, Yang KH, Wanyan P et al. Comparison of the efficacy and safety of denosumab versus bisphosphonates in breast cancer and bone metastases treatment: a meta-analysis of randomized controlled trials. Oncol Lett 2014; 7(6): 1997–2002.
doi: 10.1093/annonc/mdv143 Published online 18 March 2015
Reply to the letter to the editor ‘Patients’ preference and informed consent’ by Pumo et al. We thank Pumo et al. [1] for their interest in the article on patient preference in PrefHer (ClinicalTrials.gov number NCT01401166) [2]. First, it should be clarified that patients did not choose subcutaneous (s.c.) or intravenous (i.v.) trastuzumab (Herceptin® SC or IV, F. Hoffmann-La Roche Ltd, Basel, Switzerland) administration in PrefHer; patients were randomized to receive four cycles of each formulation during the crossover period (s.c. then i.v. or vice versa). Following the crossover period, patients were scheduled to continue with i.v. trastuzumab in Cohort 1 (unless participating in the exploratory analysis of satisfaction with s.c. self-administration using the single-use injection device) or s.c. trastuzumab in Cohort 2. With regards to informed consent and the s.c. trastuzumab safety profile, the ethics committee-approved informed consent form contained a section on safety of both s.c. and i.v. trastuzumab; within the s.c. section, there was additional information warning patients that the side effects of s.c. trastuzumab could be different from those of i.v. trastuzumab, particularly in terms of infusion reactions and symptoms at the injection/infusion sites. Information on the form was also in line with the
© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from http://annonc.oxfordjournals.org/ at The University of British Colombia Library on November 14, 2015
We have read and appreciated the study conducted by Pivot et al. [1] on the patients’ preference on the administration (i.v. versus s.c.) of trastuzumab. The data confirm that it is now possible for the patients to choose the mode of drug administration and offer the opportunity to bring out some considerations regarding the information received by the patients about the therapeutic effects before the choice. Over the past few years, many new drugs have become available in different formulations (s.c., oral, i.v.). In some cases, the new formulation has therapeutic impact with pharmacodynamic-cynetic difference (morphine) [2], in others just only in patients’ preference. In the last case, we consider this an important patients’ choice as long as the patients in properly informed in order to choose in full awareness. The PrefHer study reported no clinically relevant differences during the switch between i.v. and s.c. administration and that the patients choose the s.c. administration. An earlier paper by Hismael et al. emphasized different percentage of serious adverse events between the two groups: 21% in the patients treated with s.c. compared with 12% in those treated with i.v.; 8.1% of infections and infestations were reported in the s.c. group versus 4.4% in the i.v. Four fatal adverse events, one in the i.v. and three in s.c. treatment, were also registered, each of which occurred during neoadjuvant treatment; of these, two—both in the s.c. treatment—were considered related to treatment [3]. We consider the administration of s.c. a great opportunity [4] because it reduces the commitment of medical resources and nursing activity, determining cost reduction and, finally, most important, improves the patients’ quality of life [5]. At the same time, we consider it essential that the patients’ choice to select the type of treatment should be done after proper information on the advantages/disadvantages, efficacy/potential side effects. Considering this, it could be of interest to know if the patients of the PrefHer study, when they declared that they prefer the s.c. administration, have been informed well in advance about the potential side effects.
references
letters to the editor
Patients’ preference and informed consent
