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• W2076226710 abstract "We do not err because truth is difficult to see. It is visible at a glance. We err because this is more comfortable.—Solzhenitsyn What is the effect of perioperative blood transfusion on recurrence and survival in early-stage non-small cell lung cancer? This question has been posed numerous times, and several studies have attempted to answer it,1Tartter PI Burrows L Kirschner P. Perioperative blood transfusion adversely affects prognosis after resection of stage I (subset NO) non-oat cell lung cancer.J Thorac Cardiovasc Surg. 1984; 88: 659-662Abstract Full Text PDF PubMed Google Scholar, 2Hyman NH Foster RS DeMeules JE Costanza MC. Blood transfusions and survival after lung cancer resection.Am J Surg. 1985; 149: 502-507Abstract Full Text PDF PubMed Scopus (174) Google Scholar, 3Pastorino U Valente M Cataldo I LeQuaglie C Ravasi G. Perioperative blood transfusion and prognosis of resected state Ia lung cancer.Eur J Cancer Clin Oncol. 1986; 22: 1375-1378Abstract Full Text PDF PubMed Scopus (58) Google Scholar, 4Keller SM Groshen S Martini N Kaiser LR. Blood transfusion and lung cancer recurrence.Cancer. 1988; 62: 606-610Crossref PubMed Scopus (62) Google Scholar, 5Moores DWO Piantadosi S McKneally MF. Effect of penoperative blood transfusion on outcome in patients with surgically resected lung cancer.Ann Thorac Surg. 1989; 47: 346-351Abstract Full Text PDF PubMed Scopus (76) Google Scholar the latest being the study by Pena et al in the current issue of this journal (see page 84). In one regard, the article by Pena et al is mistitled in that it speaks to the “Significance of Perioperative Blood Transfusions …” (emphasis mine), as if another small retrospective study would be the definitive one. In another sense, the article is properly titled in that it seems to deal primarily with the statistical significance of blood transfusion as a prognostic factor. Some other authors have made the same methodologic error in equating clinical effect with statistical significance. However, significance testing does not answer the basic biologic question. More about this below. The origins of the blood transfusion hypothesis are well founded enough to make chest surgeons uncomfortable. Blood transfusions have a well-established beneficial effect on renal transplants, probably because of their immunosuppressive action,6Opelz G Graver B Terasaki PI. Induction of high kidney graft surival rate by multiple transfusion.Lancet. 1981; 1: 1223-1225Abstract PubMed Scopus (105) Google Scholar, 7Smith MD Williams JD Coles GA Salaman JR. The effect of blood transfusion on T-suppressor cells in renal dialysis patients.Transplant Proc. 1981; 13: 181-183PubMed Google Scholar, 8Sanfilippo F Vaughn WK Bollinger RR Spees EK. The influence of pre-transplant transfusions, using different products, on patient sensitization and renal allograft survival.Transplantation. 1984; 37: 350-356Crossref PubMed Scopus (20) Google Scholar and can produce a variety of immune dysfunctions.9Gascon P Zoumbos NC Young NS. Immunologic abnormalities in patients receiving multiple blood transfusions.Ann Intern Med. 1984; 100: 173-177Crossref PubMed Scopus (250) Google Scholar Because immunosuppression is detrimental for cancer patients, the hypothesis that blood transfusions might also be harmful was raised and studied in a variety of cancers. Harmful effects attributed to blood transfusion have been seen in colon cancer,10Corman J Arnous R St-Louis G Smeesters C. Perioperative blood transfusions and colorectal cancer outcome.Transplant Proceed. 1988; 20: 1128-1129PubMed Google Scholar,11Foster Jr, RS Costanza M Hyman NH Foster CB DeMeules JE. Blood transfusions and survival after resection of cancers of the breast, colon, and lung: the need for prospective randomized trials.Transplant Proc. 1988; 20: 1125-1127PubMed Google Scholar breast cancer,12Tartter PI Burrows L Papatestas AE Lesnick G Aufses AH. Perioperative blood transfusion has prognostic significance for breast cancer.Surgery. 1985; 97: 225-230PubMed Google Scholar sarcoma,13Rosenberg SA Seipp CA White DE Wesley R. Perioperative blood transfusions are associated with increased rates of recurrence and decreased survival in patients with high-grade soft-tissue sarcomas of the extremities.J Clin Oncol. 1985; 3: 698-709Crossref PubMed Scopus (153) Google Scholar and prostate cancer,14Heal JM Chuang C Blumberg N. Perioperative blood transfusions and prostate cancer recurrence and survival.Am J Surg. 1988; 156: 374-380Abstract Full Text PDF PubMed Scopus (70) Google Scholar although perhaps not incontrovertibly established in all tumor types. Not all relevant studies, even those restricted to lung cancer, have employed the same methods or the same extent of reporting. However, some important consistency can be seen. Table 1 shows the reported hazard ratios (transfused vs not transfused) from the published reports on lung cancer. The results of the various studies are similar, with overlapping confidence intervals, except for the report by Pastorino et al.3Pastorino U Valente M Cataldo I LeQuaglie C Ravasi G. Perioperative blood transfusion and prognosis of resected state Ia lung cancer.Eur J Cancer Clin Oncol. 1986; 22: 1375-1378Abstract Full Text PDF PubMed Scopus (58) Google Scholar These estimates are most consistent with a modest increase in relative risk due to blood transfusion of 1.25 to 1.9Table 1Summary of Estimated Hazard Ratios and Confidence IntervalsReportHazard Ratio95% Confidence IntervalEndpointTartter et al1Tartter PI Burrows L Kirschner P. Perioperative blood transfusion adversely affects prognosis after resection of stage I (subset NO) non-oat cell lung cancer.J Thorac Cardiovasc Surg. 1984; 88: 659-662Abstract Full Text PDF PubMed Google Scholar1.991.09-3.64SurvivalHyman et al2Hyman NH Foster RS DeMeules JE Costanza MC. Blood transfusions and survival after lung cancer resection.Am J Surg. 1985; 149: 502-507Abstract Full Text PDF PubMed Scopus (174) Google Scholar1.251.04-1.49SurvivalPastorino et al3Pastorino U Valente M Cataldo I LeQuaglie C Ravasi G. Perioperative blood transfusion and prognosis of resected state Ia lung cancer.Eur J Cancer Clin Oncol. 1986; 22: 1375-1378Abstract Full Text PDF PubMed Scopus (58) Google Scholar––Keller et al4Keller SM Groshen S Martini N Kaiser LR. Blood transfusion and lung cancer recurrence.Cancer. 1988; 62: 606-610Crossref PubMed Scopus (62) Google ScholarStage I1.240.67-1.81RecurrenceStage II1.920.28-3.57RecurrenceMoores et al5Moores DWO Piantadosi S McKneally MF. Effect of penoperative blood transfusion on outcome in patients with surgically resected lung cancer.Ann Thorac Surg. 1989; 47: 346-351Abstract Full Text PDF PubMed Scopus (76) Google Scholar1.401.01-1.94*Not reported in original publication.Recurrence1.571.14-2.16*Not reported in original publication.SurvivalPena et al1.30.8-2.2Survival* Not reported in original publication. Open table in a new tab The reported differences in statistical significance15Keller SM Groshen S Kaiser L. Blood transfusion and lung cancer recurrence [letter].Ann Thorac Surg. 1989; 48: 746-747Abstract Full Text PDF PubMed Scopus (3) Google Scholar,16Piantadosi S Moores DWO. Reply [letter].Ann Thorac Surg. 1989; 48: 746-747Abstract Full Text PDF PubMed Google Scholar can be largely understood as a consequence of differences in the precision of the estimated hazard ratios. This problem can be avoided during the planning stages of a study by increasing sample size to increase precision. This is equivalent to increasing power or decreasing the type II error rate. For these types of retrospective studies, the investigators may not always be able to control the type II error. When standard methods were used to estimate statistical power,17Freedman LS. Tables of the number of patients required in clinical trials using the logrank test.Stat Med. 1982; 1: 121-129Crossref PubMed Scopus (536) Google Scholar,18Piantadosi S. Clinical Trials Design Program. Biosoft, 1990Google Scholar the study of Pena et al was found to have less than 40 percent power to detect a 1.5-fold hazard of recurrence or death, even assuming that all events were balanced between the transfusion groups. Stated another way, at least 260 events would be required to reliably detect a hazard ratio of 1.5 (90 percent power, two-sided 0.05 alpha level test). With 20 percent censoring, 312 patients would be required to yield 260 events. Thus, it is not surprising that the authors failed to detect blood transfusion as a statistically significant prognostic factor. In fact, this was the most likely outcome if the true hazard ratio is approximately 1.5. In assessing these kinds of studies, the reader must keep in mind that no evidence of effect is not the same as evidence of no effect. This distinction can be further blurred by wrongly viewing the p value as a summary of prognostic (or treatment) effects. The estimated hazard ratios and confidence limits are the most useful summary of these data.19Braitman LE. Confidence intervals assess both clinical significance and statistical significance.Ann Intern Med. 1991; 114: 515Crossref PubMed Scopus (126) Google Scholar What is distressing about the study by Pena et al is their inability to see clearly that the results are consistent with a modest harmful effect due to blood transfusion. If this single retrospective study were the only evidence available, one could claim little or no support for the hypothesis that perioperative transfusions shorten event-free survival. However, with sound biologic rationale, an observed effect in other diseases and cancers, independent studies supporting a detrimental effect of the same magnitude in lung cancer, and some reasonably good-quality studies demonstrating statistical significance, one cannot interpret this new underpowered study as evidence of no effect. Neither reanalysis of existing data nor a “prospective study” is likely to answer this question convincingly. Note that, in most respects, the Lung Cancer Study Group study was “prospective” in that rigorous staging, evaluation, and (most importantly) outcome ascertainment were prospective because of active follow-up of patients accrued to various clinical trials. The perioperative transfusion data were collected concurrently in the operative notes, although not added to the trial data base until later (“retrospectively”). Therefore, a fully “prospective” study would constitute only a minor methodologic improvement. In contrast, a major gain in knowledge could be accomplished by performing a randomized clinical trial. Although this has been suggested explicitly11Foster Jr, RS Costanza M Hyman NH Foster CB DeMeules JE. Blood transfusions and survival after resection of cancers of the breast, colon, and lung: the need for prospective randomized trials.Transplant Proc. 1988; 20: 1125-1127PubMed Google Scholar and implicitly,20Kirschner PA. Does transfusion modify the outcome of cancer resections?.Ann Thorac Surg. 1989; 47: 336-337Abstract Full Text PDF PubMed Scopus (4) Google Scholar it seems not to have received the serious attention it deserves. Such a trial is ethically feasible because so many clinicians seem to doubt the effect. Minimizing the use of (allogeneic) blood products is a feasible surgical intervention for all but urgent procedures. The power calculations outlined above would be relevant again. With approximately 400 patients randomized and followed up for four to five years, hazard ratios in the range of 1.5 can be reliably detected. Apart from answering the basic question, such a multi-institutional collaboration would have other beneficial effects. This seems to be an excellent opportunity to learn something simultaneously about the biology of cancer and clinical care instead of trying to rely on unconvincing data-base analyses. In summary, there is evidence from the study by Pena et al and from the studies of others that perioperative blood transfusions are associated with a modest harmful effect in surgically resected non-small cell lung cancer patients having risk ratio elevations in the range of 1.5 after controlling for extent of disease. Prospective randomized trials may be the only way to demonstrate convincingly the benefit of no transfusion." @default.
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