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Journal of Clinical Oncology, Vol 25, No 35 (December 10), 2007: pp. 5670-5671 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.14.3321
In ReplyDepartment of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan
Department of Gynecology, The Jikei University School of Medicine, Tokyo, Japan We thank Dr Clark and colleagues for their contribution to validation for transportability of a prognostic index for advanced epithelial ovarian cancer (PIEPOC).1 The Edinburgh cohort is one of the largest and highest-quality, hospital-based database of ovarian cancer patients in the world.2 The sample size (n = 894) is sufficient to validate for transportability, and the patient characteristics, except for regimen of chemotherapy, were fairly similar among two cohorts. Their analysis confirmed that the PIEPOC has good accuracy and is transportable to a Western population. The Gynecologic Oncology Group in the United States recently identified the same independent prognostic factors (age, performance status, tumor histology, and residual tumor volume) in the stage III epithelial ovarian cancer population (n = 1,895) as factors that we used for the PIEPOC, though they commented that separate analyses of residual disease in patients with stage III and IV cancer seemed prudent.3 We may say that the prognostic factors in Japanese population is identical to those in Western population. We don't think that one potential difficulty with the PIEPOC is its use of performance status, because performance status is widely used in clinical practice as well as in clinical trials, and its reliability and validity as a measure have been well-established, at least in Japan. Our next question is, "What is performance status?" However, we have no answer to the question up to this time of publication. As a point, we are surprised to see differences in prognosis among two cohorts. Overall 2-year survivals were 0.68 in the Japan Multinational Trial Organization (JMTO) cohort and 0.43 in Edinburgh cohort, and overall 5-year survivals were 0.45 (95%CI, 0.41 to 0.49) and 0.16 (95%CI, 0.13 to 0.18), respectively. The worse prognosis in Edinburgh cohort is possibly due to inclusion of a older cohort (before 1993) relative to JMTO cohort and difference in distribution of age among two cohorts (median, 55 years in JMTO cohort v 61 years in Edinburgh cohort). Regimen of postoperative chemotherapy might affect the prognosis of Edinburgh cohort that showed lower survival than JMTO cohort. Most of JMTO cohort were treated by either with cyclophosphamide and cisplatin combination or paclitaxel and carboplatin combination, whereas 61% of Edinburgh cohort were treated with single agent; among them, 20% were treated with carboplatin, and 30% were treated with cisplatin only. In this context of lung cancer, even if the identical control regimen of chemotherapy was intended for use in two prospectively designed, independent clinical trials, the overall survival of the Japanese population was longer than that of the US population (median, 14 months v 9 months in the paclitaxel and carboplatin arms) in a phase III randomized trial in patients with stage IIIB or IV non–small-cell lung cancer (Southwest Oncology Group–Japan Common Arm Trial, JMTO LC00-03, and SWOG 0003).4,5 These differences in prognosis might be caused by genetic and environmental factors including diet; however, the relationship has been poorly understood. Our next goals are to improve the PIEPOC by incorporating genetic and environmental factors and to provide more informative prognostic index. One most promising approach is to carry out well-designed common arm trials with correlative pharmacogenomic and biomarker studies.4,5 AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES
1. Teramukai S, Ochiai K, Tada H, et al: PIEPOC: A new prognostic index for advanced epithelial ovarian cancer–Japan Multinational Trial Organization OC01-01. J Clin Oncol 25:3302-3306, 2007 2. Clark TG, Stewart ME, Altman DG, et al: A prognostic model for ovarian cancer. Br J Cancer 85:944-952, 2001[CrossRef][Medline] 3. Winter WE 3rd, Maxwell GL, Tian C, et al: Prognostic factors for stage III epithelial ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol 25:3621-3627, 2007 4. Crowley J, Furuse K, Kawahara M, et al: Second Japan-SWOG common arm analysis of paclitaxel/carboplatin in advanced stage non–small-cell lung cancer (NSCLS): A model for testing population-related pharmacogenomics. J Clin Oncol 24;18s, 2006 (suppl; abstr 7050)[CrossRef] 5. Kawahara M, Ogawara M, Nishiwaki K, et al: Phase III randomized study of vinorelbine, gemcitabine followed by docetaxel (VGD) versus paclitaxel and carboplatin (PC) in patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol 24:18s, 2006 (suppl; abstr 7013)[CrossRef]
Related Correspondence
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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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