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Prospective Randomized Trial of Surgery in Small Cell Lung Cancer






With all these issues in mind, the Lung Cancer Study Group set out to design a prospective randomized trial to determine the role of surgery in small cell lung cancer. The rationale for adjuvant surgery after induction chemotherapy in small cell lung cancer was threefold and is listed in Table 10–4. Because the available surgical data, such as those in Tables 10–1 through 10–3, suggested that peripheral stage I small cell lung cancer exists, albeit rarely, and is most likely to be biologically different from the typical central airway tumor with regional node (at least) metastasis, the decision was made to exclude the peripheral lesions and restrict eligibility to those tumors that were diagnosed by the bronchoscope. Because of the question regarding non–small cell histology in resection specimens from small cell lung cancer patients, the study was designed to allow pathology review of all diagnostic material prior to randomization to ensure that all subjects had pure small cell lung cancer according to the LCSG pathology reference center. Limited-stage small cell lung cancer patients were enrolled and given five cycles of the CAV regimen (Cytoxan, Adriamycin, and vincristine), which was the standard of care at the inception of the trial. While the patients were receiving the five cycles of induction therapy, the pathology review was performed.

All patients with pure small cell lung cancer who achieved at least a partial response to chemotherapy were randomized to have (provided they agreed) a pulmonary resection followed by thoracic and cranial irradiation, or to have the radiation therapy without the surgery. Thus, surgery was the only variable in the trial, and the nonsurgical parts of the treatment were the standard of care. Surgery consisted of removal of the lobe of origin of the tumor, including pneumonectomy if necessary, and mediastinal lymph node removal according to the mediastinal staging protocol of the LCSG. The pulmonary resection was done even in the cases of complete clinical remission, based on pretreatment tumor diagrams and bronchoscopic maps. The study was conducted between 1983 and 1989 by an intergroup consortium consisting of the Lung Cancer Study Group, the Eastern Cooperative Oncology Group, and the European Organization for Research and Treatment of Cancer. A total of 328 patients were enrolled. Two-thirds responded to chemotherapy and two-thirds of the responders were randomized—a total of 146 patients. The patients who were not randomized either declined or were judged unresectable or unfit for surgery despite response to chemotherapy. The results

of the study are listed in Table 10–5. The survival curves for the two arms of the study are essentially identical, with a small (3-month) but not significant survival

advantage in the nonsurgical arm. There was no subset identified for whom surgery was beneficial, including patients with no identifiable cancer in the surgical specimen (pathologic complete responders) and patients with only non–small cell residual. The conclusion reached was that surgery does not play a beneficial role in multimodality treatment of central airway small cell lung cancer—the “garden variety” type.


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