|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
Originally published as JCO Early Release 10.1200/JCO.2009.24.0853 on September 21 2009 © 2009 American Society of Clinical Oncology.
Reply to M. CavoAlfred Hospital, Melbourne, Victoria, Australia
Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia Thank you for the opportunity to respond to the comments of Cavo et al1 relating to the recently published Australasian Leukemia and Lymphoma Group (ALLG) randomized trial comparing thalidomide and alternate-day prednisolone (TAP) consolidation therapy with alternate-day prednisolone (AP) maintenance therapy following autologous stem-cell transplantation for multiple myeloma.2 We feel that two issues raised by Cavo et al merit clarification. First, they have misinterpreted and misrepresented one of the key findings from the study. They state that continuation of consolidation therapy with TAP beyond 4 months failed to further improve the rate of at least very good partial response (VGPR). This is incorrect. The data presented clearly show that with TAP the highest proportion of patients with at least VGPR is achieved at 8 months after commencement of consolidation and maintained at 12 months (65% and 61%, respectively). Furthermore, the proportion of patients achieving a complete response (CR) continued to rise throughout the 12-month consolidation phase reaching a maximum of 21% in the TAP arm by 12 months. Given these facts, we cannot support their suggestion of limiting post-ASCT thalidomide consolidation to only 4 to 6 months. We argue that data from the two randomized studies of post-ASCT thalidomide2,3 involving 866 patients should be considered superior to data from two uncontrolled trials totalling only 50 patients.4,5 Second, Cavo et al1 quite correctly point out that we did not specify how many patients actually converted to CR during the 12-month consolidation period. Re-examination of our data on file shows that during the 12-month TAP consolidation phase, 21 patients (18%) converted from a PR or VGPR to CR. This compared to only 10 patients (8%) in the AP arm over the same time period. Finally, we can only agree with Cavo et al that further study of post-ASCT strategies in myeloma is necessary. Moreover, based on the Intergroup Francophone du Myèlome data3 and our findings, the comparator for further studies should be thalidomide 100 mg daily and alternate-day prednisolone with a target of 12 months of consolidation therapy. However, it is clearly evident from current or planned studies of post-ASCT approaches that commercial interests appear to have taken precedence over rational scientific practice with no attempt apparently being made to validate newer agents through randomized comparisons with thalidomide. If Cavo et al were puzzled, imagine the response of our regulatory authorities when they have to deal with requests to approve and fund such strategies. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors. Employment or Leadership Position: None Consultant or Advisory Role: Andrew Spencer, Celgene (C); H. Miles Prince, Celgene (C) Stock Ownership: None Honoraria: Andrew Spencer, Celgene; H. Miles Prince, Celgene Research Funding: H. Miles Prince, Celgene Expert Testimony: None Other Remuneration: None Acknowledgment Supported by grants from Pharmion Corporation, Amgen Inc, and the Myeloma Research Group, Alfred Hospital, Melbourne, Victoria, Australia. REFERENCES
1. Cavo M, Pantani L, Tacchetti P: Thalidomide maintenance in multiple myeloma: Certainties and controversies. J Clin Oncol 27:e186–e187, 2009. 2. Spencer A, Prince HM, Roberts AW, et al: Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol 27:1788–1793, 2009. 3. Attal M, Harousseau JL, Leyvraz S, et al: Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood 108:3289–3294, 2006. 4. Alexanian R, Weber D, Giralt S, et al: Consolidation therapy of multiple myeloma with thalidomide-dexamethasone after intensive chemotherapy. Ann Oncol 13:1116–1119, 2002. 5. Sahebi F, Spielberger R, Kogut NM, et al: Maintenance thalidomide following single-cycle autologous peripheral blood stem-cell transplant in patients with multiple myeloma. Bone Marrow Transplant 37:825–829, 2006.[CrossRef][Medline]
Related Article
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
