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Ann Thorac Surg 2001;72:1438
© 2001 The Society of Thoracic Surgeons
a Section of Thoracic Surgery, Department of General Oncologic Surgery, City of Hope National Medical Center, 1500 E. Duarte Rd, Duarte, CA 91010, USA
e-mail: fgrannis{at}coh.org
To the Editor
Richard Feins chastises physicians in an editorial entitled, "Clinical Trials in Lung Cancer: Truth, Justice, and the American Way" [1]. Although he makes cogent observations, he strays from accurate and responsible commentary when he blames apathetic clinicians for failures of research accrual. Investigators must examine their own deficiencies when clinical trials experience poor accrual.
The responsibility of physicians is clear. If, in their estimation, one treatment arm offers better survival or quality of life, medical ethics demand that they must recommend against participation. For example, after careful review of available evidence, this surgeon concluded that the best chance of survival in Stage IIIA N2 non-small cell lung cancer (NSCLC) follows surgical resection including mediastinal node dissection, followed by postoperative adjuvant radiation therapy (PORT). He could not, therefore, ethically recommend patient participation in Random Clinical Trials (RCTs) boosted by Feins. JRB.10 has an arm wherein N2 patients receive no PORT, and ECOG 3590 has a mediastinal node sampling-only arm. The superb results in ECOG patients treated with mediastinal dissection and PORT appear to validate this decision [2].
The European Big Lung Trial accrued only 9%; 40% of potential subjects were clinically ineligible and 23% were logistically ineligible [3]. One-third of eligible patients refused chemotherapy (ChT). In the U.S. also, despite buoyant descriptions of potential benefit, many patients refuse ChT. Although Feins does not specifically mention ChT, one can read between the lines that he is whooping up neo-adjuvant RCTs. Many experienced clinicians and patients share the skepticism regarding the value of ChT for NSCLC. Over the past 30 years, there have been thousands of lung cancer ChT clinical trials. The results, despite adroit spin doctoring cannot, in candor, be characterized as anything other than miserable. Should it surprise us that many patients and physicians fail to support such trials?
Survival benefits in trials of preoperative ChT for NSCLC are minimal at best. Long-term follow-up of the widely quoted studies that form the basis for preoperative ChT do not achieve statistical significance [4]. Perhaps, for consistency, Feins might recommend that Medicare not pay for preoperative ChT?
Although I and every responsible thoracic surgeon hope that experimental protocols will discover effective ChT, biological, or multimodality treatments, a healthy cynicism is justified with regard to individual trials. There is unwarranted overemphasis on ChT strategies for lung cancer treatment, with the lion’s share of research dollars going to such trials, while research in potentially productive areas of tobacco control, primary tobacco prevention, smoking cessation, screening, surgery, radiation therapy, and supportive care goes unfunded.
Feins oversteps the line of responsible criticism when he accuses radiation oncologists of self-interest, and recommends that Medicare not pay for PORT. For Feins to suggest that those who hold a dissenting view are intellectually dishonest is unfortunate. He should apologize for this unfair characterization.
Many intelligent, ethical, physicians believe that there is good RCT evidence that PORT markedly reduces local recurrence with perhaps a small survival advantage [5]. Local recurrence is a catastrophe causing suffering from rib and spinal invasion, and dyspnea from airway invasion, and pleural or pericardial effusions. PORT’s ability to prevent these complications is sufficiently compelling to convince experienced clinicians to advise PORT, in high-risk patients. Medical oncologists routinely administer ChT with survival benefits measured in weeks [6].
Mayo Clinic reports show statistically significant survival improvement in N2 patients treated with PORT [7]. ECOG 3590, criticized by Feins for including PORT, demonstrated low incidence of local recurrence (13%) after PORT and mediastinal dissection, with median survival of more than 5 years [2].
References
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