J Thorac Cardiovasc Surg 2003;125:442-443
© 2003 The American Association for Thoracic Surgery
Missing data from mesothelioma study
Yossef Aelony, MD
Clinical Professor of Medicine, Harbor-UCLA Rancho Palos Verdes, Director of Pulmonary Function Laboratory, Southern California Permanente Medical Group, Harbor City, CA 90710
To the Editor:
The phase II trial of surgery and radiation of malignant mesothelioma by Rusch and colleagues
1 is an important addition to the literature, documenting contemporary efforts to control and eventually cure this so far incurable malignant process. The 8% mortality after extrapleural pneumonectomy reflects the tremendous strides in surgical technics effected in recent decades. The rigorous staging confirms a major attempt to bring better science to this capricious disease.
Nevertheless, Rusch and colleagues 1 have excluded a host of important information from their publication. I hope that they will be able to strengthen the report by rectifying some of these omissions:
- To understand the real world from which their patients were selected, we need to know how many patients were refused entry into their study.
- The benefits of combined resection and radiation therapy might be put into better perspective if we could see the survival data and curves on the patients refused entry into the study. All hospital tumor boards certified by the American Cancer Society will have this information.
- Because early studies by Devalle and coworkers 2 indicated a late surgical mortality of 11% beyond the usual 30-day perioperative period, it is important to learn whether such events still occurred in the 1990s. Similarly, early reports noted by Ruffie and colleagues 3 indicated 10% late suicides after surgery. A statement regarding the occurrence or nonoccurrence of suicidal deaths during long-term follow-up is important in assessing the quality of life and the suffering of the patients.
- What were the lengths of the hospital stays of the included and the excluded surgical groups? How many days of hospitalization were required in long-term follow-up for the complications of radiation therapy and surgery? These data are important in assessing the patients' quality of life as well as the cost of care.
- How many of the patients had large recurrent or persistent pleural effusions? Several investigators have suggested a survival advantage for this group relative to those with a soft-tissue mass.
- It is interesting that 69% of this selected group of surgical patients had such high staging (III and IV). By comparison, Sugarbaker and associates 4 found 136 of 183 (74%) to have stage I and II disease in a series that had excluded 2 to 3 patients for every patient accepted. Does this difference indicate that Sugarbaker and associates 4 had a more effective technique to screen out patients with stage III and IV disease for surgical resection? It is disappointing that so few patients with stage I and II disease were found in the study of Rusch and colleagues. 1 Perhaps rigorous intraoperative staging upgrades preoperative stage to the extent that few patients with stage I and II disease remain, even with prompt evaluation after the onset of symptoms. Presumably nonsurgical disease would be falsely staged lower because of the absence of mediastinal sampling, laparoscopy, and so on, making comparison of surgical and nonsurgical groups more difficult.
- The median survival was stated to be 17 months in this study, but that number excluded the 7 deaths and the 21 patients whose disease could not be completely resected. Obviously, we need to know the median survival of all patients operated on, including perioperative deaths, if we are to provide honest informed consent with surgical referrals.
- Rigorous statistical assessment of surgical trials becomes even more important in light of a recent consecutive, unselected series of 26 patients with malignant mesothelioma with pleural effusion and treated by medical thoracoscopic talc pleurodesis as the primary modality of care. They had a median survival of 19.4 months and have a mean survival that is now reaching 22.8 months. 5-7 Although Rusch 7 has previously indicated the difficulties of doing randomized controlled studies in this disease, such studies may be necessary to separate theoretic from the real benefits of surgery.
References
- Rusch VW, Rosenzweig K, Venkatraman E, Leon L, Raben A, Harrison L, et al. A phase II trial of surgical resection and adjuvant high-dose hemithoracic radiation for malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2001:122:788-95.
- Devalle M, Faber LP, Dittle CF, Jensik RJ. Extrapleural pneumonectomy for diffuse, malignant mesothelioma. Ann Thorac Surg. 1986;42:612-8.[Abstract/Free Full Text]
- Ruffie P, Feld R, Minkin S, Cornier Y, Boutan-Laroze A, Ginsberg R, et al. Diffuse malignant mesothelioma of the pleura in Ontario and Quebec: a retrospective study of 332 patients. J Clin Oncol. 1989:7:1157-68.
- Sugarbaker DJ, Flores RM, Jaklitsch MT, Richards WG, Strauss GM, Corson JM, et al. Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. J Thorac Cardiovasc Surg. 1999;117:54-65.[Abstract/Free Full Text]
- Aelony Y. Controversy: treatment of mesotheliomatous pleural effusion. Experimental therapy versus thoracoscopic talc poudrage? Pro: talc poudrage therapy. J Bronchol. 2001;8:54-9.
- Aelony Y, Yao J. Malignant pleural mesothelioma: a case series with prolonged survival averaging 22.4 months after treatment with thoracoscopic talc poudrage pleurodesis. Am J Respir Crit Care Med. 1999;159/3;part 2:A212.
- Rusch VW. Trials in malignant mesothelioma LCSG 851 and 882. Chest 1994;106(6 Suppl):359S-62S.[Abstract/Free Full Text]
