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Journal of Clinical Oncology, Vol 23, No 34 (December 1), 2005: pp. 8915-8916 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.04.0113
In Reply:Juravinski Cancer Centre and McMaster University, Hamilton, Canada
Princess Margaret Hospital and University of Toronto, Toronto, Canada
British Columbia Cancer Agency and University of British Columbia, Vancouver, Canada
Cross Cancer Institute and University of Alberta, Edmonton, Canada
The National Cancer Institute of Canada Clinical Trials Group, Queens University, Kingston, Canada We appreciate the interest of Das et al in our trial testing doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) alone in patients with limited stage Hodgkin's lymphoma.1 They make several points with which we agree and others we would debate. Our trial was based on the hypothesis that overall survival should be the primary outcome of trials testing new therapies in these patients, as this outcome will capture the contributing components of disease control and long-term treatment-related toxicity. Based on the results of randomized trials, optimum chemotherapy for these patients from the perspective of disease control would consist of ABVD, mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) -ABV(D), or a regimen that includes comparable agents; as ABVD is associated with fewer long-term toxicities, this regimen is preferred over MOPP-ABV(D). A review of randomized trials testing such regimens as a single modality in patients with limited stage disease has been recently published2 and includes the results of our trial, that of Straus et al,3 and the subset analyses pertaining to those with limited stage disease extracted from the trials that included patients with all stages of Hodgkin's lymphoma reported by Nachman et al4 and Laskar et al.5 These trials reported similar results with improvements in disease control of approximately 7% observed in patients receiving radiation therapy, but with no survival differences detected. For chemotherapy to be used as a single modality, regimens that provide optimum disease control should be tested. As a result, trials testing MOPP or epirubicin, bleomycin, vinblastine, and prednisone (EBVP) as a single modality provide information that is now less relevant. Das et al make reference to the European Organisation for Research and Treatment of Cancer H9 trial testing EBVP as a single modality; unfortunately after the initiation of this trial, this regimen was demonstrated as providing inferior disease control in comparison with MOPP-ABV, and thus by inference ABVD.6 Our trial was not designed to evaluate the role of radiation therapy in patients with more advanced stages of disease, including those with bulky disease involving the mediastinum or other sites. Finally, our ability to determine best treatment policies for these patients has become increasingly difficult because of the mutually exclusive objectives of testing therapy that is regarded as being the current standard of care and yet requiring long-term follow-up in order to evaluate long-term survival as the major outcome of interest. Standard treatments may well change while a specific trial is in progress. Our trial reflects this dilemma, as we indicated in our Discussion, where we state that the radiation therapy provided to patients in our control group is no longer the standard of care and is not recommended. We agree that lower doses of radiation therapy to smaller treatment fields may reduce the risk of some long-term treatment-related toxicities, but a new generation of trials will be needed to address this issue. At present, we believe that the optimum provision of therapy for these patients should include a thorough discussion of the trade-offs involved in balancing the improvement in disease control that results from including radiation therapy versus the avoidance of long-term risks associated with using ABVD alone.7 Within this context, treatment with ABVD alone is a reasonable option. Our data also suggest that response-adapted approach to therapy based on the initial response to chemotherapy alone warrants further evaluation. Authors' Disclosures of Potential Conflicts of Interest
Although all authors completed the disclosure declaration, the following author or immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. 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.
Dollar Amount Codes (A) < $10,000 (B) $10,000-99,999 (C)
Acknowledgment This work was completed by the National Cancer Institute of Canada Clinical Trials Group and the Eastern Cooperative Oncology Group. REFERENCES
1. Meyer RM, Gospodarowicz MK, Connors JM, et al: A randomized comparison of ABVD chemotherapy with a strategy that includes radiation therapy in patients with limited-stage Hodgkin's lymphoma. J Clin Oncol 23:4634-4642, 2005 2. Meyer RM: Is there convincing evidence for the use of chemotherapy alone in patients with limited stage Hodgkin's lymphoma? Eur J Haematol 75:115-120, 2005 (suppl 66)
3. Straus DJ, Portlock CS, Qin J, et al: Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood 104:3483-3489, 2004
4. Nachman JB, Sposto R, Herzog P, et al: Randomized comparison of low-dose involved-field radiotherapy and no radiotherapy for children with Hodgkin's disease who achieve a complete response to chemotherapy. J Clin Oncol 20:3765-3771, 2002
5. Laskar S, Gupta T, Vimal S, et al: Consolidation radiation after complete remission in Hodgkin's disease following six cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine chemotherapy: Is there a need? J Clin Oncol 22:62-68, 2004 6. Burgers JMV, Tirelli U, Monconduit M, et al: Combination of radiotherapy and chemotherapy is advisable in all patients with clinical stage I-II Hodgkin's disease. Six-year results of the EORTC-GPMC controlled clinical trials ‘H7-VF', ‘H7-F’ and 'H7-U’. Int J Radiat Oncol Biol Phys 39 Suppl 1:173, 1997 (abstr 77) 7. Meyer RM, Ambinder RF, Stroobants S: Hodgkin' lymphoma: Evolving concepts with implications for practice. Hematology (Am Soc Hematol Educ Program) 184-202, 2004
Related Correspondence
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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$100,000 (N/R) Not Required
