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Journal of Clinical Oncology, Vol 24, No 28 (October 1), 2006: pp. 4669 © 2006 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.08.4277
In ReplyDana-Farber Cancer Institute, Boston, MA We appreciate Dr Gelibter and colleagues interest in our phase II trial of capecitabine, oxaliplatin, and erlotinib.1 We agree with them that biologic drugs are not harmless and can increase the risks of chemotherapy regimens due to both overlapping toxicities as well as additional ones. At the time when we initiated the trial, much of the data for combining capecitabine and oxaliplatin were from European studies and the dose of 1,000 mg/m2 twice a day (total 2,000 mg/m2/d) of capecitabine seemed to be a tolerable dose with 130 mg/m2 of oxaliplatin. However, during the conduct of this trial, data emerged from trials that 1,000 mg/m2/twice daily capecitabine with oxaliplatin was not as well tolerated in the US population.2,3 Thus, when our trial was accruing and increased gastrointestinal toxicities were detected, we felt it was most sensible to alter the capecitabine dose. As Dr Gelibter et al note, lowering the capecitabine dose led to appreciably lower rates of grade 3 or 4 emesis, dehydration, and fatigue. In regard to the diarrhea, it should be noted that the Borner et al4 study published in the Journal of Clinical Oncology in 2002 (which Gelibter et al cite) recommended a dose of 1,250 mg/m2/twice daily for previously untreated patients and 1,000 mg/m2/twice daily for previously treated patients and the rates of grade 3 or 4 diarrhea per patient (the figure we report) were 35% and 50%, respectively. Nonetheless, we agree that our study demonstrates that the potential risks of adding biologic therapy to standard cytotoxic chemotherapy should not be underestimated as the oncology community moves forward in studying new agents. 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)
REFERENCES
1. Meyerhardt JA, Zhu AX, Enzinger PC, et al: Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. J Clin Oncol 24:1892-1897, 2006 2. Shields AF, Zalupski MM, Marshall JL, et al: Treatment of advanced colorectal carcinoma with oxaliplatin and capecitabine: A phase II trial. Cancer 100:531-537, 2004[CrossRef][Medline] 3. Hochster HS, Welles L, Hart L, et al: Safety and efficacy of bevacizumab (Bev) when added to oxaliplatin/fluoropyrimidine (O/F) regimens as first-line treatment of metastatic colorectal cancer (mCRC): TREE 1 & 2 Studies. J Clin Oncol 24:249s, 2005 (abstr 3515) 4. Borner MM, Dietrich D, Stupp R, et al: Phase II study of capecitabine and oxaliplatin in first- and second-line treatment of advanced or metastatic colorectal cancer. J Clin Oncol 20:1759-1766, 2002
Related Correspondence
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Copyright © 2006 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
