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In Reply

Hospital Bremen East, Germany

Hendrik-Tobias Arkenau

Hospital Bremen East, Bremen, Germany

Stefan Kubicka

Medical School Hannover, Hannover, Germany

Richard Greil

Private Medical University Hospital Salzburg, Germany

Thomas Seufferlein

University of Ulm University Clinic, Ulm, Germany

Werner Freier

Private Oncology Clinic, Hildesheim, Germany

Albrecht Kretzschmar

Helios Clinic Berlin-Buch, Berlin, Germany

Ullrich Graeven

Hospital Maria Hilf, Mönchengladbach, Germany

Axel Grothey

Division of Medical Oncology, Mayo Clinic, Rochester, MN

Axel Hinke

Research Institute WISP, Langenfeld, Germany

Wolff Schmiegel

Ruhr-University Bochum, Bochum, Germany

Hans-Joachim Schmoll

University of Halle Medical Center, Halle, Germany

We appreciated the letter by Dr Büchele, regarding our recently published article, "Capecitabine Plus Oxaliplatin Versus Fluorouracil/Leucovorin Plus Oxaliplatin: A Randomized Comparison in Metastatic Colorectal Cancer."¹ We do, however, think that some of the issues raised in his letter need to be clarified.

Dr Büchele clearly overestimates the role of inferential statistics as exclusive. As a consequence of his argumentation, point estimates (ie, the hazard ratio) would not be reported or discussed at all, but only their confidence intervals (or even P values only). One has to keep in mind that, given the data observed, the estimated treatment effect has the highest probability to reflect the true difference. Our text does not contain any claim of a "proven hypothesis" of inferiority.

The incorrect value in Table 3 has been corrected as of July 11, 2007, in the online version. However, we cannot change the survival data for capecitabline plus oxaliplatin (XELOX) and FOLFOX (NO16966 study) in this table because these data have been presented at the 43rd Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-5, 2007, well after our article had been accepted for publication.² The same applies to the issue concerning the correct preliminary results of the NO16966 study, as also presented by Dr Büchele.³

We can understand Dr Büchele's concerns, especially since new results emerged, but these were presented after our articles had been published.

For clarification and to specify the status quo of capecitabine plus oxaliplatin (CAPOX)/XELOX, we have already replied to a letter by Dr Cassidy including a provisional meta-analysis comprising the results mentioned by Dr Büchele. The results of this first meta-analysis demonstrated that the combination of capecitabine and oxaliplatin is an alternative option for patients with metastatic colorectal cancer resulting in similar PFS compared to infusional fluorouracil/oxaliplatin–based regimens.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

ACKNOWLEDGMENTS

Hans-Joachim Schmoll is writing on behalf of the Arbeitsgemeinschaft Internistische Onkologie (AIO) Colorectal Study Group.

REFERENCES

1. Porschen R, Arkenau H-T, Kubicka S, et al: Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: A final report of the AIO colorectal study group. J Clin Oncol 25 : 4217 -4223, 2007[Abstract/Free Full Text]

2. Cassidy J, Clarke C, Diaz-Rubio E, et al: XELOX compared to FOLFOX4: Survival and response results from XELOX-1/NO16966, a randomized phase III trial of first-line treatment for patients with metastatic colorectal cancer (MCRC). J Clin Oncol 25 : 18s , 2007 (suppl; abstr 4030)

3. Saltz L, Clarke C, Diaz Rubio E, et al: Bevacizumab (Bev) in combination with XELOX or FOLFOX 4: Updated efficacy results from XELOX-1/NO16966, a randomized phase III trial in first-line metastatic colorectal cancer [slideset]. J Clin Oncol 25 : 18s , 2007 (suppl; abstr 4028)

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Related Correspondence

• Comments on Final Report of the AIO Colorectal Cancer Group Study: Fluorouracil/Oxaliplatin Versus Capecitabine/Oxaliplatin
  Thomas Buechele
  JCO 2007 25: 5041-5042 [Full Text]

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