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Journal of Clinical Oncology, Vol 17, Issue 9 (September), 1999: 2692
© 1999 American Society for Clinical Oncology

Phase III Study of Concurrent Versus Sequential Thoracic Radiotherapy in Combination With Mitomycin, Vindesine, and Cisplatin in Unresectable Stage III Non–Small-Cell Lung Cancer

Kiyoyuki Furuse, Masahiro Fukuoka, Masaaki Kawahara, Hideki Nishikawa, Yoshiki Takada, Shinzoh Kudoh, Nobuyuki Katagami, Yutaka Ariyoshi, for the West Japan Lung Cancer Group

From the Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases; Department 2 of Internal Medicine, Osaka Prefectural Habikino Hospital; Department of Internal Medicine, National Toneyama Hospital for Chest Diseases; Department 1 of Internal Medicine, Osaka City University; and Department of Respiratory Disease, Osaka Medical Center Cancer and Cardiovascular Diseases, Osaka; Department of Radiology, Hyogo Medical Center for Adults, Hyogo; Department of Respiratory Disease, Kobe City General Hospital, Kobe; and Department of Respiratory Disease, Aichi Cancer Center, Nagoya, Japan.

Address reprint requests to Kiyoyuki Furuse, MD, Office of the Consultant, Division of Respiratory Diseases, Health Insurance Union, Osaka Central Hospital, 3-3-17, Niwashirodai, Sakai, Osaka 590-0133 Japan.

PURPOSE: A phase III study was performed to determine whether concurrent or sequential treatment with radiotherapy (RT) and chemotherapy (CT) improves survival in unresectable stage III non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Patients were assigned to the two treatment arms. In the concurrent arm, chemotherapy consisted of cisplatin (80 mg/m2 on days 1 and 29), vindesine (3 mg/m2 on days 1, 8, 29, and 36), and mitomycin (8 mg/m2 on days 1 and 29). RT began on day 2 at a dose of 28 Gy (2 Gy per fraction and 5 fractions per week for a total of 14 fractions) followed by a rest period of 10 days, and then repeated. In the sequential arm, the same CT was given, but RT was initiated after completing CT and consisted of 56 Gy (2 Gy per fraction and 5 fractions per week for a total of 28 fractions).

RESULTS: Three hundred twenty patients were entered onto the study. Pretreatment characteristics were well balanced between the treatment arms. The response rate for the concurrent arm was significantly higher (84.0%) than that of the sequential arm (66%) (P = .0002). The median survival duration was significantly superior in patients receiving concurrent therapy (16.5 months), as compared with those receiving sequential therapy (13.3 months) (P = .03998). Two-, 3-, 4-, and 5-year survival rates in the concurrent group (34.6%, 22.3%, 16.9%, and 15.8%, respectively) were better than those in the sequential group (27.4%, 14.7%, 10.1%, and 8.9%, respectively). Myelosuppression was significantly greater among patients on the concurrent arm than on the sequential arm (P = .0001).

CONCLUSION: In selected patients with unresectable stage III NSCLC, the concurrent approach yields a significantly increased response rate and enhanced median survival duration when compared with the sequential approach.


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M. A. Socinski, D. E. Morris, J. S. Halle, D. T. Moore, T. A. Hensing, S. A. Limentani, R. Fraser, M. Tynan, A. Mears, M. P. Rivera, et al.
Induction and Concurrent Chemotherapy With High-Dose Thoracic Conformal Radiation Therapy in Unresectable Stage IIIA and IIIB Non-Small-Cell Lung Cancer: A Dose-Escalation Phase I Trial
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Y. Hasegawa, S. Takanashi, K. Okudera, M. Aoki, K. Basaki, H. Kondo, T. Takahata, N. Yasui-Furukori, T. Tateishi, Y. Abe, et al.
Weekly Paclitaxel and Nedaplatin With Concurrent Radiotherapy for Locally Advanced Non-small-cell Lung Cancer: a Phase I/II Study
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Ann. Thorac. Surg.Home page
K. Suzuki, H. Asamura, S.-i. Watanabe, and R. Tsuchiya
Combined Resection of Superior Vena Cava for Lung Carcinoma: Prognostic Significance of Patterns of Superior Vena Cava Invasion
Ann. Thorac. Surg., October 1, 2004; 78(4): 1184 - 1189.
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Ann OncolHome page
B. Jeremic
Reply to the article "Continuously infused carboplatin used as radiosensitizer in locally unresectable non-small-cell lung cancer: a multicenter phase III study", by Groen et al. (Ann Oncol 2004; 15: 427-432)
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Ann OncolHome page
M. A. Socinski, C. Zhang, J. E. Herndon II, R. O. Dillman, G. Clamon, E. Vokes, W. Akerley, J. Crawford, M. C. Perry, S. L. Seagren, et al.
Combined modality trials of the Cancer and Leukemia Group B in stage III non-small-cell lung cancer: analysis of factors influencing survival and toxicity
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Clin. Cancer Res.Home page
Y. Ichinose, Y. Nakai, S. Kudoh, H. Semba, S. Yoshida, T. Nukiwa, H. Yamamoto, Y. Yamane, and H. Niitani
Uracil/Tegafur Plus Cisplatin with Concurrent Radiotherapy for Locally Advanced Non-Small-Cell Lung Cancer: A Multi-institutional Phase II Trial
Clin. Cancer Res., July 1, 2004; 10(13): 4369 - 4373.
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J. S. Friedberg, R. Mick, J. P. Stevenson, T. Zhu, T. M. Busch, D. Shin, D. Smith, M. Culligan, A. Dimofte, E. Glatstein, et al.
Phase II Trial of Pleural Photodynamic Therapy and Surgery for Patients With Non-Small-Cell Lung Cancer With Pleural Spread
J. Clin. Oncol., June 1, 2004; 22(11): 2192 - 2201.
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Ann OncolHome page
W. Eberhardt, M. Stuschke, and G. Stamatis
Preoperative chemoradiation approaches to locally advanced non-small-cell lung cancer: one man's pride, another man's burden?
Ann. Onc., March 1, 2004; 15(3): 365 - 367.
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J.-P. Sculier, J.-J. Lafitte, T. Berghmans, P. Van Houtte, J. Lecomte, J. Thiriaux, A. Efremidis, G. Koumakis, V. Giner, M. Richez, et al.
A phase III randomised study comparing two different dose-intensity regimens as induction chemotherapy followed by thoracic irradiation in patients with advanced locoregional non-small-cell lung cancer
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NEJMHome page
A. Spira and D. S. Ettinger
Multidisciplinary Management of Lung Cancer
N. Engl. J. Med., January 22, 2004; 350(4): 379 - 392.
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JCOHome page
D. G. Pfister, D. H. Johnson, C. G. Azzoli, W. Sause, T. J. Smith, S. Baker Jr, J. Olak, D. Stover, J. R. Strawn, A. T. Turrisi, et al.
American Society of Clinical Oncology Treatment of Unresectable Non-Small-Cell Lung Cancer Guideline: Update 2003
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K. Kubota, K. Watanabe, H. Kunitoh, K. Noda, Y. Ichinose, N. Katakami, T. Sugiura, M. Kawahara, A. Yokoyama, S. Yokota, et al.
Phase III Randomized Trial of Docetaxel Plus Cisplatin Versus Vindesine Plus Cisplatin in Patients With Stage IV Non-Small-Cell Lung Cancer: The Japanese Taxotere Lung Cancer Study Group
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B. Movsas, J. Moughan, R. Komaki, H. Choy, R. Byhardt, C. Langer, M. Goldberg, M. Graham, D. Ettinger, D. Johnstone, et al.
Radiotherapy Patterns of Care Study in Lung Carcinoma
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Ann. Thorac. Surg.Home page
Y. Ichinose, Y. Fukuyama, H. Asoh, C. Ushijima, T. Okamoto, J. Ikeda, J. Okamoto, and M. Sakai
Induction chemoradiotherapy and surgical resection for selected stage IIIB non-small-cell lung cancer
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Ann. Thorac. Surg.Home page
B. Jeremic, F. B. Zimmermann, and M. Molls
Induction chemotherapy followed by concurrent chemoradiotherapy and operation in locally advanced non-small cell lung cancer
Ann. Thorac. Surg., September 1, 2003; 76(3): 979 - 979.
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JCOHome page
L. V. Sequist and T. J. Lynch
Aggressive Treatment for the Fit Elderly With Non-Small-Cell Lung Cancer? Yes!
J. Clin. Oncol., September 1, 2003; 21(17): 3186 - 3188.
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S. E. Schild, P. J. Stella, S. M. Geyer, J. A. Bonner, W. L. McGinnis, J. A. Mailliard, J. Brindle, A. Jatoi, and J. R. Jett
The Outcome of Combined-Modality Therapy for Stage III Non-Small-Cell Lung Cancer in the Elderly
J. Clin. Oncol., September 1, 2003; 21(17): 3201 - 3206.
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ThoraxHome page
R Booton, M Jones, and N Thatcher
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The OncologistHome page
G. V. Scagliotti and A. T. Turrisi III
Docetaxel-Based Combined-Modality Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Oncologist, August 1, 2003; 8(4): 361 - 374.
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D. R. Gandara, K. Chansky, K. S. Albain, B. R. Leigh, L. E. Gaspar, P. N. Lara Jr, H. Burris, P. Gumerlock, J. P. Kuebler, J. D. Bearden III, et al.
Consolidation Docetaxel After Concurrent Chemoradiotherapy in Stage IIIB Non-Small-Cell Lung Cancer: Phase II Southwest Oncology Group Study S9504
J. Clin. Oncol., May 15, 2003; 21(10): 2004 - 2010.
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ThoraxHome page
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Lung cancer * 5: State of the art radiotherapy for lung cancer
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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.
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S. C. Formenti, M. Volm, K. A. Skinner, D. Spicer, D. Cohen, E. Perez, A. C. Bettini, S. Groshen, C. Gee, B. Florentine, et al.
Preoperative Twice-Weekly Paclitaxel With Concurrent Radiation Therapy Followed by Surgery and Postoperative Doxorubicin-Based Chemotherapy in Locally Advanced Breast Cancer: A Phase I/II Trial
J. Clin. Oncol., March 1, 2003; 21(5): 864 - 870.
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Clin. Cancer Res.Home page
Y. Chen, K. Pandya, P. C. Keng, D. Johnstone, J. Li, Y.-J. Lee, T. Smudzin, and P. Okunieff
Phase I/II Clinical Study of Pulsed Paclitaxel Radiosensitization for Thoracic Malignancy: A Therapeutic Approach on the Basis of Preclinical Research of Human Cancer Cell Lines
Clin. Cancer Res., March 1, 2003; 9(3): 969 - 975.
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Clin. Cancer Res.Home page
S. G. Swisher, J. A. Roth, R. Komaki, J. Gu, J. J. Lee, M. Hicks, J. Y. Ro, W. K. Hong, J. A. Merritt, K. Ahrar, et al.
Induction of p53-regulated Genes and Tumor Regression in Lung Cancer Patients after Intratumoral Delivery of Adenoviral p53 (INGN 201) and Radiation Therapy
Clin. Cancer Res., January 1, 2003; 9(1): 93 - 101.
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ChestHome page
J. R. Jett, W. J. Scott, M. P. Rivera, and W. T. Sause
Guidelines on Treatment of Stage IIIB Non-small Cell Lung Cancer
Chest, January 1, 2003; 123 (2009): 221S - 225S.
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Am. J. Respir. Crit. Care Med.Home page
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.
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E. E. Vokes, J. E. Herndon II, J. Crawford, K. A. Leopold, M. C. Perry, A. A. Miller, and M. R. Green
Randomized Phase II Study of Cisplatin With Gemcitabine or Paclitaxel or Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemoradiotherapy for Stage IIIB Non-Small-Cell Lung Cancer: Cancer and Leukemia Group B Study 9431
J. Clin. Oncol., October 15, 2002; 20(20): 4191 - 4198.
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K. S. Albain, J. J. Crowley, A. T. Turrisi III, D. R. Gandara, W. B. Farrar, J. I. Clark, K. R. Beasley, and R. B. Livingston
Concurrent Cisplatin, Etoposide, and Chest Radiotherapy in Pathologic Stage IIIB Non-Small-Cell Lung Cancer: A Southwest Oncology Group Phase II Study, SWOG 9019
J. Clin. Oncol., August 15, 2002; 20(16): 3454 - 3460.
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Ann OncolHome page
C. Pottgen, W. Eberhardt, S. Bildat, G. Stuben, G. Stamatis, L. Hillejan, S. Sohrab, H. Teschler, S. Seeber, H. Sack, et al.
Induction chemotherapy followed by concurrent chemotherapy and definitive high-dose radiotherapy for patients with locally advanced non-small-cell lung cancer (stages IIIa/IIIb): a pilot phase I/II trial
Ann. Onc., March 1, 2002; 13(3): 403 - 411.
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DTBHome page
Chemotherapy and non-small-cell lung cancer
DTB, February 1, 2002; 40(2): 9 - 11.
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I. Sekine, Y. Nishiwaki, T. Ogino, A. Yokoyama, M. Saito, K. Mori, I. Tsukiyama, S. Tsuchiya, K. Hayakawa, K. Yoshimura, et al.
Phase II Study of Twice-Daily High-Dose Thoracic Radiotherapy Alternating With Cisplatin and Vindesine for Unresectable Stage III Non-Small-Cell Lung Cancer: Japan Clinical Oncology Group Study 9306
J. Clin. Oncol., February 1, 2002; 20(3): 797 - 803.
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Randomized Phase I Study of Standard-fractionated or Accelerated-hyperfractionated Radiotherapy with Concurrent Cisplatin and Vindesine for Unresectable Non-Small Cell Lung Cancer: a Report of Japan Clinical Oncology Group Study (JCOG 9601)
Jpn. J. Clin. Oncol., October 1, 2001; 31(10): 488 - 494.
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J. Thorac. Cardiovasc. Surg.Home page
D. H. Grunenwald, F. Andre, C. Le Pechoux, P. Girard, C. Lamer, A. Laplanche, M. Tarayre, R. Arriagada, and T. Le Chevalier
Benefit of surgery after chemoradiotherapy in stage IIIB (T4 and/or N3) non-small cell lung cancer
J. Thorac. Cardiovasc. Surg., October 1, 2001; 122(4): 796 - 802.
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The OncologistHome page
T. L. Evans and T. J. Lynch Jr.
Lung Cancer
Oncologist, October 1, 2001; 6(5): 407 - 414.
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BMJHome page
J. S Tobias and D. Ball
Synchronous chemoradiation for squamous carcinomas
BMJ, April 14, 2001; 322(7291): 876 - 878.
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JCOHome page
T. J. Robnett, M. Machtay, J. P. Stevenson, K. M. Algazy, and S. M. Hahn
Factors Affecting the Risk of Brain Metastases After Definitive Chemoradiation for Locally Advanced Non-Small-Cell Lung Carcinoma
J. Clin. Oncol., March 1, 2001; 19(5): 1344 - 1349.
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D. Lau, B. Leigh, D. Gandara, M. Edelman, R. Morgan, V. Israel, P. Lara, R. Wilder, J. Ryu, and J. Doroshow
Twice-Weekly Paclitaxel and Weekly Carboplatin With Concurrent Thoracic Radiation Followed by Carboplatin/Paclitaxel Consolidation for Stage III Non-Small-Cell Lung Cancer: A California Cancer Consortium Phase II Trial
J. Clin. Oncol., January 15, 2001; 19(2): 442 - 447.
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J. A. Hayman, M. K. Martel, R. K. Ten Haken, D. P. Normolle, R. F. Todd III, J. F. Littles, M. A. Sullivan, P. W. Possert, A. T. Turrisi, and A. S. Lichter
Dose Escalation in Non-Small-Cell Lung Cancer Using Three-Dimensional Conformal Radiation Therapy: Update of a Phase I Trial
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