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Journal of Clinical Oncology, Vol 22, No 20 (October 15), 2004: pp. 4235-4236 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.133
In Reply:Nevada Cancer Institute, Las Vegas, NV Thank you for your comments and questions regarding our study of malignant plueral mesothelioma (MPM), comparing permetrexed plus cisplatin (PC) to cisplatin (C). In that study, we were able to show a survival advantage of approximately 3 months for MPM patients treated with PC as compared with patients treated with C.1 In reply to your ten points: (1) Indeed quality-of-life data are being submitted for publication of the study. Such data were not included in the article due to space limitations. Gralla et al summarized the data in abstract form.2 In that report, virtually every aspect of the quality of life of patients receiving the doublet therapy was superior to that of patients receiving the single-agent (C). Only a minority of patients had received a thoracotomy for diagnostic and therapeutic reasons. Although a control group receiving best supportive care (BSC) would have been ideal as a comparison with the PC arm, ethical considerations precluded using such an arm. (2) The point about weight loss as a prognostic factor in prediction of outcome from MPM is a good one. However, performance status (which closely migrates with weight loss) is a more powerful predictive factor2 and thus was used as a stratification factor in the study. (3) The median survival of untreated MPM has been the subject of much discussion. The median survival of 335 MPM patients treated on 10 consecutive phase II trials by members of the Cancer and Leukemia Group B (CALGB) cooperative cancer study group was 7 months from day of registration.3 Most patients, in my experience, have had symptoms antedating the diagnosis by 3 to 6 months. Thus, a median survival of 10 to13 months from onset of symptoms is clinically accurate. Fortunately, the randomized nature of the trial of PC versus C establishes 13 months from the start of doublet treatment as the new benchmark of median survivals for patients with MPM. (4) The eligibility criteria did allow patients who had stopped nonsteroidal anti-inflammatory drugs recently. Thus these criteria likely excluded few patients. (5) The methods for diagnosing MPM are equally balanced between both arms. (6) For clinicians to know the survival of untreated healthy patients with MPM is no longer possible or necessary with publication of this definitive study. For patients with performance status 2 who experienced little benefit from PC therapy, studies comparing BSC with a nontoxic therapy would still be needed and are ethical. A median survival of 19 months in Dr Aelony’s MPM patients is excellent indeed, but may reflect a number of biases inherent in such a small series. (7) Positron emission tomography scanning was used in some centers,4 but it was not a parameter used in staging or response assessment in this study. (8) Pleural fluid pH may well be a new prognostic factor, but prospective multicenter validation is required for such a factor and must be considered before its widespread use. Moreover, patients are often referred to centers that treat MPM after thoracentesis, thus rendering a second thoracentesis medically unnecessary. (9) No clinical staging system has been able to incorporate radialogical parameters successfully. However, Pass et al reported that tumor volume (measured using a complex technique) predicted outcome for MPM.5 Improved software has now been developed for measuring the dimensions of MPM on the chest wall.6 This ability to accurately measure the thickness of the MPM down to a thickness as small as 2 to 3 mm may soon replace the currently inaccurate TNM system for prognosis of mesothelioma. Furthermore, gene expression and serum proteomic profiling offer even greater potential for prognostication.7,8 Author’s Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES
1. Vogelzang NJ, Rusthoven J, Symanowski J, et al: A phase III study of pemetrexed in combination with cisplatin vs. cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21: 2636-2644, 2003 2. Gralla RJ, Hollen PJ, Liepa AM, et al: Improving quality of life in patients with malignant pleural mesothelioma: Results of the randomized pemetrexed + cisplatin vs cisplatin trial using the lcss-meso instrument. Proc Am Soc Clin Oncol 22: 621a, 2003 (abstr 2496)
3. Herndon JE, Green MR, Chahinian P, et al: Factors predictive of survival among 337 patients with mesothelioma treated between 1984 and 1994 by the Cancer and Leukemia Group B. Chest 113: 723-731, 1998
4. Flores RM, Akhurst T, Gonen M, et al: Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg 126: 11-16, 2003
5. Pass HI, Temeck BK, Kranda K, et al: Preoperative tumor volume is associated with outcome in malignant pleural mesothelioma. J Thorac Cardiovasc Surg 115: 310-318, 1998 6. Armato SG, Oxnard GR, MacMahon H, et al: Measurement of mesothelioma on thoracic CT scans: A comparison of manual and computer-assisted techniques. Medical Physics 31: 1105-1115, 2004[CrossRef][Medline]
7. Singhal S, Wiewrodt R, Malden LD, et al: Gene expression profiling of malignant mesothelioma. Clin Cancer Res 9: 3080-3097, 2003 8. Robinson BWS, Creaney J, Lake R, et al: Mesothelin-family proteins and diagnosis of mesothelioma. Lancet 362: 1612-1616, 2003[CrossRef][Medline] Related Correspondence
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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