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Journal of Clinical Oncology, Vol 25, No 6 (February 20), 2007: pp. 730 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.09.9432
In ReplyDepartment of Internal Medicine II, University Hospital, Friedrich-Schiller-University Jena, Germany; Coordinating Centre for Clinical Trials, Martin-Luther-University Halle-Wittenberg, Germany
University of Leipzig Hospitals and Clinics, Leipzig, Germany
Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany; Coordinating Centre for Clinical Trials, Martin-Luther-University Halle-Wittenberg, Germany We appreciate Dr Al-Batran et al's comments on our recent article in the Journal of Clinical Oncology.1 The patient population of our meta-analysis was predefined in advance in the protocol,2 as stated in our article,1 as "patients with histologically confirmed, advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastroesophageal junction." We explicitly described1 "trials including gastric and esophageal or gastric and pancreatic cancer were included, if sufficient information for the subgroup of patients with gastric cancer was available," and "authors were contacted to obtain any missing information." Following this premise, we included the trial by Ross et al.3 In this trial, patients with esophageal cancer, unknown histology, and, in smaller numbers, patients with a histology other than adenocarcinoma were included, the corresponding author of the study was contacted and asked to provide us with the data for patients with gastric and gastroesophageal (GE) junction adenocarcinoma only, which we included in our meta-analysis. Consequently, among 373 patients with gastric and GE-junction tumors (of a total of 580 patients in the entire trial), those with unknown histology, or a histology other than adenocarcinoma, were excluded. The remaining 334 patients were included in our analysis. All trials included in this meta-analysis were examined for differences in relevant prognostic factors, including the data from the trial by Ross et al.3 According to the protocol, tumor stage (advanced v metastatic disease), performance status (Eastern Cooperative Oncology Group [ECOG] 0-1 v 2-3), as well as the number of organs involved by metastatic disease (one v > one) were considered as the most important prognostic factors. A difference of more than 15% between study arms was defined in advance as a relevant difference. Data on these prognostic factors were available for the included patients from the trial by Ross et al3 and have been analyzed in detail. There were no important differences between the study groups according to this definition, although the group treated with mitomycin, cisplatin, and fluorouracil (MCF) had, in fact, 7.7% more patients with metastatic disease. Differences in all other prognostic factors were smaller and not relevant. The correct randomization of this trial—as well as our prespecified subgroup—is unaffected by the exclusion of similar numbers of patients with tumors of different location and histology from both treatment groups. Due to a similar rate of treatment-related deaths in both treatment groups, the increased toxicity of MCF is also unlikely to have an impact on survival in the patient population analyzed. We agree with Al-Batran et al that the overall number of trials and patients included in this comparison of the meta-analysis is relatively small. Particularly since the relative contribution of anthracyclines to efficacy might be altered if cisplatin is exchanged to oxaliplatin and fluorouracil to capecitabine—as in the recently published epirubicin, oxaliplatin, and capecitabine (EOX) regimen4—prospective clinical trials are highly desirable to further elucidate the role of anthracyclines in gastric cancer.5 Regarding the second point on our evaluation and discussion of the results of the study TAX 325,6 we consider it as a matter of personal judgment whether the observed treatment results are rated as a clinically important benefit. TAX 325 is only one of five randomized trials6-10 on docetaxel in patients with advanced gastric cancer, for which at least preliminary results have been published. We may repeat our explicit statement that the results of the other ongoing studies need to be awaited to draw definitive conclusions. A meta-analysis for docetaxel versus nondocetaxel containing regimens is in preparation. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The authors indicated no potential conflicts of interest. ACKNOWLEDGMENTS Supported by the German Ministry of Education and Research Grant No. BMBF/FKZ:01GH 0105 KKS Halle. REFERENCES
1. Wagner AD, Grothe W, Haerting J, et al: Chemotherapy in advanced gastric cancer: A systematic review and meta-analysis based on aggregate data. J Clin Oncol 24:2903-2906, 2006 2. Wagner AD, Grothe W, Behl S, et al: Chemotherapy for advanced gastric cancer (protocol for a Cochrane Review). Oxford, United Kingdom, Cochrane Library, issue 1, 2003 3. Ross P, Nicolson M, Cunningham D, et al: Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol 20:1996-2004, 2002 4. Cunningham D, Rao D, Starling N, et al: Randomised multicenter phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric (OG) cancer. The REAL-2 trial. J Clin Oncol 24:182s 2006 (abstr LBA4017) 5. Wagner AD, Fleig WE, Haerting J: Correspondence: In reply. J Clin Oncol 24:5474-5476, 2006 6. Moiseyenko VM, Ajani J, Tjulandin SA, et al: Final results of a randomized controlled phase III trial (TAX 325) comparing docetaxel (T) combined with cisplatin (C) and 5-fluouracil (F) to CF in patients (pts) with metastatic gastric adenocarcinoma (MGC). J Clin Oncol 23:308s, 2005 (abstr 4002) 7. Fahlke J, Ridwelski K, Schmidt C, et al: Docetaxel-cisplatin (DC) versus 5-fluorouracil-leucovorin-cisplatin (FLC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary safety results of a phase III study. J Clin Oncol 23:16s, 2005 (suppl 4045) 8. Hawkins R, Cunningham D, Soerbye H, et al: Randomized phase II trial of docetaxel plus irinotecan versus docetaxel plus 5-fluouracil in patients with untreated advanced gastric adenocarcinoma. Proc Am Soc Clin Oncol 22:257, 2003 (abstr 1032) 9. Thuss-Patience PC, Kretzschmar A, Repp M, et al: Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: A randomized phase II study. J Clin Oncol 23:494-501, 2005 10. Roth AD, Maibach R, Falk S, et al: Docetaxel-cisplatin-5-FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5-FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): A randomized phase II trial of the Swiss Group for Clinical Cancer Res (SAKK). J Clin Oncol 22:14s, 2004 (abstr 4020)
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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