© 2004 by Oxford University Press
© 2004 Oxford University Press
CORRESPONDENCE |
RESPONSE: Re: Randomized Trial of Adjuvant Therapy in Colon Carcinoma: 10-Year Results of NSABP Protocol C-01
Correspondence to: Roy Smith, MD, The Regional Cancer Center, 2500 West 12th St., Erie, PA 16505 (e-mail: rsmith{at}trcc.org)
Alikhan et al. correctly point out the conclusions from the long-term follow-up of patients treated on the NSABP protocol C-01, previously published (1). With prolonged follow-up, disease-free survival and overall survival benefits initially reported in this group of patients are no longer evident. The disappearance of benefits observed in the C-01 trial was likely due to a combination late disease recurrence and increased mortality associated with co-morbidities. Readers should be cautious in drawing conclusions from this data relative to the benefits of adjuvant chemotherapy in more recent times. The chemotherapy regimen is used in the C-01 trial are now considered inadequate and with serious late-occurring side effects. The immunotherapy regimen may have a modulating effect on associated co-morbidities rather than a direct effect on the patients’ risk of recurrence. For these reasons, these regimens should not be used to prevent disease recurrence among this population of patients. The loss of survival benefits after prolonged follow-up in these patients, however, does imply that the sustained use of systemic interventions with non–cross-resistant regimens or therapies targeting specific components of critical tumor growth pathways may be of benefit. Unfortunately, whether this same pattern of loss of survival benefits with prolonged follow-up is also observed among patients treated with newer and more acceptable adjuvant therapies remains unknown. As implied by Alikhan et al. the introduction of target therapies may lead to the use of prolonged targeted treatments to prevent recurrence and prolong overall survival. Adjuvant trials currently in progress, which include more recently introduced chemotherapy agents (e.g., oxaliplatin or irinotecan) and targeted therapies (e.g., bevacizumab or cetuximab), may represent the first steps toward a treatment paradigm that addresses the concerns indicated by the C-01 results and described by Alikhan et al. I hope that this is so.
REFERENCE
1 Smith RE, Colangelo L, Wieand HS, Begovic M,Wolmark N. Randomized trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP protocol C-01. J Natl Cancer Inst 2004;96:1128–32.
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J Natl Cancer Inst 2004 96: 1794.
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