© 1994 by Oxford University Press
Journal of the National Cancer Institute, Vol. 86, No. 9, 673-680,
May 4, 1994
© 1994 Oxford University Press
A Randomized Trial Comparing Perioperative Chemotherapy and Surgery With Surgery Alone in Resectable Stage IIIA Non-Small-Cell Lung Cancer
*Department of Thoracic and Cardiovascular Surgery, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Department of Radiotherapy, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Division of Diagnostic Imaging, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Department of Pathology, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Department of Biomathematics, The University of Texas M. D. Anderson Cancer Center Houston, Tex
Department of Surgery, Mary Imogene Bas-sett Hospital Cooperstown, N.Y.
Houston Thorax Institute Houston, Tex
Veterans Hospital of Houston Tex
Correspondence to: Jack A. Roth, M.D., The University of Texas M. D. Anderson Cancer Center, Department of Thoracic and Cardiovascular Surgery, Box 109, 1515 Holcombe Blvd., Houston, TX 77030.
BACKGROUND:: Patients with resectable stage IIIA non-small-cell lung cancer have a low survival rate following standard surgical treatment. Nonrandomized trials in which induction chemotherapy or a combination of chemotherapy and radiation prior to surgery were used to treat patients with regionally advanced primary cancers have suggested that survival is improved when compared with treatment by surgery alone. Purpose: We performed a prospective, randomized study of patients with previously untreated, potentially resectable clinical stage IIIA non-small-cell lung cancer to compare the results of perioperative chemotherapy and surgery with those of surgery alone. Methods: This trial was designed to test the null hypothesis that the proportion of patients surviving 3 years is 12% for either treatment group against the alternate hypothesis that the 3-year survival rate would be 12% in the surgery alone group and 32% in the perioperative chemotherapy group. The estimated required sample size was 65 patients in each group. The trial was terminated at an early time according to the method of O'Brien and Fleming following a single unplanned interim analysis. The decision to terminate the trial was based on ethical considerations, the magnitude of the treatment effect, and the high degree of statistical significance attained. In total, 60 patients were randomly assigned between 1987 and 1993 to receive either six cycles of perioperative chemotherapy (cyclophosphamide, etoposide, and cisplatin) and surgery (28 patients) or surgery alone (32 patients). For patients in the former group, tumor measurements were made before each course of chemotherapy and the clinical tumor response was evaluated after three cycles of chemotherapy; they then underwent surgical resection. Patients who had documented tumor regression after preoperative chemotherapy received three additional cycles of chemotherapy after surgery. Results: After three cycles of preoperative chemotherapy, the rate of clinical major response was 35%. Patients treated with perioperative chemotherapy and surgery had an estimated median survival of 64 months compared with 11 months for patients who had surgery alone (P<.008 by logrank test; Pk<018 by Wilcoxon test). The estimated 2- and 3-year survival rates were 60% and 56% for the perioperative chemotherapy patients and 25% and 15% for those who had surgery alone, respectively. Conclusions: In this trial, the treatment strategy using perioperative chemotherapy and surgery was more effective than surgery alone. Implications: This clinical trial strengthens the validity of using perioperative chemotherapy in the management of patients with resectable stage IIIA non-small-cell lung cancer. Further investigation of the perioperative chemotherapy strategy in earlier stage lung cancer is warranted. [J Natl Cancer Inst 86: 673–680, 1994]
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P. Misthos, E. Sepsas, K. Athanassiadi, S. Kakaris, and I. Skottis Skip metastases: analysis of their clinical significance and prognosis in the IIIA stage of non-small cell lung cancer Eur. J. Cardiothorac. Surg., April 1, 2004; 25(4): 502 - 508. [Abstract] [Full Text] [PDF]
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A. Spira and D. S. Ettinger Multidisciplinary Management of Lung Cancer N. Engl. J. Med., January 22, 2004; 350(4): 379 - 392. [Full Text] [PDF]
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M. Machtay, J. H. Lee, J. P. Stevenson, J. B. Shrager, K. M. Algazy, J. Treat, and L. R. Kaiser Two commonly used neoadjuvant chemoradiotherapy regimens for locally advanced stage III non-small cell lung carcinoma: Long-term results and associations with pathologic response J. Thorac. Cardiovasc. Surg., January 1, 2004; 127(1): 108 - 113. [Abstract] [Full Text] [PDF]
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M. K. Ferguson Optimal management when unsuspected N2 nodal disease is identified during thoracotomy for lung cancer: cost-effectiveness analysis J. Thorac. Cardiovasc. Surg., December 1, 2003; 126(6): 1935 - 1942. [Abstract] [Full Text] [PDF]
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A. Marra and G. Stamatis Reply to the editor J. Thorac. Cardiovasc. Surg., November 1, 2003; 126(5): 1665 - 1666. [Full Text] [PDF]
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G. V. Scagliotti, R. Fossati, V. Torri, L. Crino, G. Giaccone, G. Silvano, M. Martelli, M. Clerici, F. Cognetti, and M. Tonato Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non-Small-Cell Lung Cancer J Natl Cancer Inst, October 1, 2003; 95(19): 1453 - 1461. [Abstract] [Full Text] [PDF]
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M. M. DeCamp, T. W. Rice, D. J. Adelstein, M. A. Chidel, L. A. Rybicki, S. C. Murthy, and E. H. Blackstone Value of accelerated multimodality therapy in stage IIIA and IIIB non-small cell lung cancer J. Thorac. Cardiovasc. Surg., July 1, 2003; 126(1): 17 - 25. [Abstract] [Full Text] [PDF]
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H. Kimura, N. Iwai, S. Ando, K. Kakizawa, N. Yamamoto, H. Hoshino, and T. Anayama A prospective study of indications for mediastinoscopy in lung cancer with CT findings, tumor size, and tumor markers Ann. Thorac. Surg., June 1, 2003; 75(6): 1734 - 1739. [Abstract] [Full Text] [PDF]
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T. Osaki, K. Sugio, T. Hanagiri, M. Takenoyama, T. Yamashita, M. Sugaya, M. Yasuda, and K. Yasumoto Survival and prognostic factors of surgically resected T4 non-small cell lung cancer Ann. Thorac. Surg., June 1, 2003; 75(6): 1745 - 1751. [Abstract] [Full Text] [PDF]
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A. Pataer, S. Chada, K. K. Hunt, J. A. Roth, and S. G. Swisher Adenoviral melanoma differentiation-associated gene 7 induces apoptosis in lung cancer cells through mitochondrial permeability transition-independent cytochrome c release J. Thorac. Cardiovasc. Surg., June 1, 2003; 125(6): 1328 - 1335. [Abstract] [Full Text] [PDF]
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L. J. Wirth, J. Lucca, P. Ostler, P. Fidias, C. Lynch, P. A. Janne, R. S. Herbst, B. E. Johnson, D. J. Sugarbaker, D. J. Mathisen, et al. Induction Docetaxel and Carboplatin Followed by Weekly Docetaxel and Carboplatin with Concurrent Radiotherapy, then Surgery in Stage III Non-Small Cell Lung Cancer: A Phase I Study Clin. Cancer Res., May 1, 2003; 9(5): 1698 - 1704. [Abstract] [Full Text] [PDF]
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Y. Sakao, T. Sakuragi, M. Natsuaki, and T. Itoh Clinicopathological analysis of prognostic factors in clinical IA peripheral adenocarcinoma of the lung Ann. Thorac. Surg., April 1, 2003; 75(4): 1113 - 1117. [Abstract] [Full Text] [PDF]
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S. G. Spiro and J. C. Porter Lung Cancer--Where Are We Today?: Current Advances in Staging and Nonsurgical Treatment Am. J. Respir. Crit. Care Med., November 1, 2002; 166(9): 1166 - 1196. [Abstract] [Full Text] [PDF]
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