Reply to M. Markman -- Ferrandina 28 (19): e321 -- Journal of Clinical Oncology

Markman:  Serious Ethical Dilemma of Single-Agent Pegylated Liposomal Doxorubicin Employed As a Control Arm in Ovarian Cancer Chemotherapy Trials -- Markman JCO commentary

  Ferrandina Response to Markman:

http://jco.ascopubs.org/cgi/content/full/28/19/e321?cmpid=jco_etoc_1July2010
"...Overall, I think that there will be no need for institutional review boards of community-based centers or universities to take up a formal position in this context. Indeed, I think that the more and more diffuse use in the clinical practice of PLD 40 mg/m² will be, in and by itself, stronger than any regulatory rules, and that the lower and safer PLD dose level will tacitly replace the US Food and Drug Administration–approved dosage in clinical trials.

Time has already come for this change: looking through the randomized clinical trials utilizing PLD as a control arm, we found that four (NCT00976911 [ClinicalTrials.gov] , NCT00913835 [ClinicalTrials.gov] , NCT00635193 [ClinicalTrials.gov] , NCT00657878 [ClinicalTrials.gov] ) of seven of the ongoing studies are already employing the PLD dosage of 40 mg/m² instead of 50 mg/m² (www.clinicaltrials.gov."

Serious Ethical Dilemma of Single-Agent Pegylated Liposomal Doxorubicin Employed As a Control Arm in Ovarian Cancer Chemotherapy Trials -- Markman JCO commentary

"...It is essential that those reading this letter do not misinterpret its meaning. There is absolutely no intent in this discussion to vilify any individual, organization, or company involved in the oncology drug development paradigm. It is unquestionably the case that all working in this arena have as their major goal the advancement of antineoplastic strategies that are effective, relatively safe, and that improve the survival and quality of life of patients with cancer.