Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO My JCO Subscriptions Customer Service Site Map

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Right arrowRights & Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Socinski, M. A.
Right arrow Articles by Kies, M. S.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Socinski, M. A.
Right arrow Articles by Kies, M. S.
Social Bookmarking
Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?
Journal of Clinical Oncology, Vol 20, Issue 5 (March), 2002: 1335-1343
© 2002 American Society for Clinical Oncology

Phase III Trial Comparing a Defined Duration of Therapy Versus Continuous Therapy Followed by Second-Line Therapy in Advanced-Stage IIIB/IV Non–Small-Cell Lung Cancer

By Mark A. Socinski, Michael J. Schell, Amy Peterman, Kamal Bakri, Steven Yates, Robert Gitten, Paul Unger, Joanna Lee, Ji-Hyun Lee, Maureen Tynan, Martha Moore, Merrill S. Kies

From the Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Department of Medicine and Center on Outcomes Research and Education, Northwestern University, Chicago, IL.

Address reprint requests to Mark A. Socinski, MD, Director, Multidisciplinary, Thoracic Oncology Program, CB #7305, University of North Carolina, Chapel Hill, NC 27599; email: socinski{at}med.unc.edu

PURPOSE: To compare four cycles of therapy versus continuous therapy to determine the optimal duration of chemotherapy in advanced non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Stage IIIB/IV NSCLC patients were randomized to arm A (four cycles of carboplatin at an area under the curve of 6 and paclitaxel 200 mg/m2 every 21 days) or arm B (continuous treatment with carboplatin/paclitaxel until progression). At progression, all patients on both arms were to receive second-line weekly paclitaxel at 80 mg/m2/wk. The primary end points were survival and quality of life (QOL).

RESULTS: Two hundred thirty patients were randomized. Fifty-seven percent of arm A patients completed four courses of therapy. In the 116 arm B patients, the median number of cycles delivered was four (range, zero to 19 cycles). Forty-two percent received five or more cycles; 18% received eight or more cycles. Overall response rates were 22% and 24% for arms A and B, respectively (P = .80). Median survival time and 1-year survival rates were 6.6 months and 28% for arm A and 8.5 months and 34% for arm B, respectively (log-rank P = .63). Rates of hematologic and nonhematologic toxicity were similar between the two arms, except for neuropathy. The rate of grade 2 to 4 neuropathy increased from 19.9% (95% confidence interval [CI], 13.6% to 26.2%) at cycle 4 to 43% (95% CI, 28.6% to 57.4%) at cycle 8. There were no differences in QOL. Only 45% of patients received second-line therapy (42% in arm A v 47% in arm B, P = .42).

CONCLUSION: This study shows no overall benefit in survival, response rates, or QOL to continuing treatment with carboplatin/paclitaxel beyond four cycles in advanced NSCLC.


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 JCOHome page
J. D. Patel, T. A. Hensing, A. Rademaker, E. M. Hart, M. G. Blum, D. T. Milton, and P. D. Bonomi
Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non-Small-Cell Lung Cancer
J. Clin. Oncol., July 10, 2009; 27(20): 3284 - 3289.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
Y. Y. Soon, M. R. Stockler, L. M. Askie, and M. J. Boyer
Duration of Chemotherapy for Advanced Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis of Randomized Trials
J. Clin. Oncol., July 10, 2009; 27(20): 3277 - 3283.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
B. H. Gronberg, R. M. Bremnes, O. Flotten, T. Amundsen, P. Fr. Brunsvig, H. H. Hjelde, S. Kaasa, C. von Plessen, F. Stornes, T. Tollali, et al.
Phase III Study by the Norwegian Lung Cancer Study Group: Pemetrexed Plus Carboplatin Compared With Gemcitabine Plus Carboplatin As First-Line Chemotherapy in Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., July 1, 2009; 27(19): 3217 - 3224.
[Abstract] [Full Text] [PDF]

Home page
 Proc Am Thorac SocHome page
T. E. Stinchcombe and M. A. Socinski
Current Treatments for Advanced Stage Non-Small Cell Lung Cancer
Proceedings of the ATS, April 15, 2009; 6(2): 233 - 241.
[Abstract] [Full Text] [PDF]

Home page
 Eur Respir JHome page
J-P. Sculier and D. Moro-Sibilot
First- and second-line therapy for advanced nonsmall cell lung cancer
Eur. Respir. J., April 1, 2009; 33(4): 915 - 930.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
P. M. Fidias, S. R. Dakhil, A. P. Lyss, D. M. Loesch, D. M. Waterhouse, J. L. Bromund, R. Chen, M. Hristova-Kazmierski, J. Treat, C. K. Obasaju, et al.
Phase III Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., February 1, 2009; 27(4): 591 - 598.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
C. Gridelli, P. Maione, A. Rossi, M. L. Ferrara, M. A. Bareschino, C. Schettino, P. C. Sacco, and F. Ciardiello
Potential Treatment Options After First-Line Chemotherapy for Advanced NSCLC: Maintenance Treatment or Early Second-Line?
Oncologist, February 1, 2009; 14(2): 137 - 147.
[Abstract] [Full Text] [PDF]

Home page
 Ann. Thorac. Surg.Home page
M. J. Edelman, M. Suntharalingam, W. Burrows, K. F. Kwong, N. Mitra, Z. Gamliel, M. Riley, L. B. Cooper, N. L. Kennedy, S. Buskirk, et al.
Phase I/II Trial of Hyperfractionated Radiation and Chemotherapy Followed by Surgery in Stage III Lung Cancer
Ann. Thorac. Surg., September 1, 2008; 86(3): 903 - 910.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. P. Belani, S. Ramalingam, M. C. Perry, R. V. LaRocca, D. Rinaldi, P. S. Gable, and W. J. Tester
Randomized, Phase III Study of Weekly Paclitaxel in Combination With Carboplatin Versus Standard Every-3-Weeks Administration of Carboplatin and Paclitaxel for Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., January 20, 2008; 26(3): 468 - 473.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
S. Ramalingam and C. Belani
Systemic Chemotherapy for Advanced Non-Small Cell Lung Cancer: Recent Advances and Future Directions
Oncologist, January 1, 2008; 13(suppl_1): 5 - 13.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
T. E. Stinchcombe and M. A. Socinski
Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer
Oncologist, January 1, 2008; 13(suppl_1): 28 - 36.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
M. A. Socinski and T. E. Stinchcombe
Duration of First-Line Chemotherapy in Advanced Non Small-Cell Lung Cancer: Less Is More in the Era of Effective Subsequent Therapies
J. Clin. Oncol., November 20, 2007; 25(33): 5155 - 5157.
[Full Text] [PDF]

Home page
 JCOHome page
J. O. Park, S.-W. Kim, J. S. Ahn, C. Suh, J. S. Lee, J. S. Jang, E. K. Cho, S. H. Yang, J.-H. Choi, D. S. Heo, et al.
Phase III Trial of Two Versus Four Additional Cycles in Patients Who Are Nonprogressive After Two Cycles of Platinum-Based Chemotherapy in Non Small-Cell Lung Cancer
J. Clin. Oncol., November 20, 2007; 25(33): 5233 - 5239.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
R. Stupp, M. E. Hegi, M. R. Gilbert, and A. Chakravarti
Chemoradiotherapy in Malignant Glioma: Standard of Care and Future Directions
J. Clin. Oncol., September 10, 2007; 25(26): 4127 - 4136.
[Abstract] [Full Text] [PDF]

Home page
 ChestHome page
M. A. Socinski, R. Crowell, T. E. Hensing, C. J. Langer, R. Lilenbaum, A. B. Sandler, and D. Morris
Treatment of Non-small Cell Lung Cancer, Stage IV: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition)
Chest, September 1, 2007; 132(3_suppl): 277S - 289S.
[Abstract] [Full Text] [PDF]

Home page
 Jpn J Clin OncolHome page
J. Hong, S. H. Park, S. J. Choi, S. H. Lee, K. C. Lee, J.-I. Lee, S. Y. Kyung, C. H. An, S. P. Lee, J. W. Park, et al.
Nail Toxicity after Treatment with Docetaxel: A Prospective Analysis in Patients with Advanced Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., June 21, 2007; (2007) hym042v1.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
S Novello, P Bruzzi, C Barone, R Buosi, A Masotti, G Michetti, M Fioretti, S Barbera, M Spatafora, L Garetto, et al.
Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone
Ann. Onc., May 1, 2007; 18(5): 903 - 908.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
M. A. Socinski, A. Ivanova, K. Bakri, J. Wall, M. Q. Baggstrom, T. A. Hensing, A. Mears, M. Tynan, J. Beaumont, A. H. Peterman, et al.
A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer
Ann. Onc., January 1, 2006; 17(1): 104 - 109.
[Abstract] [Full Text] [PDF]

Home page
 AM J HOSP PALLIAT CAREHome page
M. P. Davis
Integrating palliative medicine into an oncology practice
American Journal of Hospice and Palliative Medicine, November 1, 2005; 22(6): 447 - 456.
[PDF]

Home page
 JCOHome page
C. Butts, N. Murray, A. Maksymiuk, G. Goss, E. Marshall, D. Soulieres, Y. Cormier, P. Ellis, A. Price, R. Sawhney, et al.
Randomized Phase IIB Trial of BLP25 Liposome Vaccine in Stage IIIB and IV Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 20, 2005; 23(27): 6674 - 6681.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
J. R. Goffin, I. C. Anderson, J. G. Supko, J. P. Eder Jr., G. I. Shapiro, T. J. Lynch, M. Shipp, B. E. Johnson, and A. T. Skarin
Phase I Trial of the Matrix Metalloproteinase Inhibitor Marimastat Combined with Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer
Clin. Cancer Res., May 1, 2005; 11(9): 3417 - 3424.
[Abstract] [Full Text] [PDF]

Home page
 JNCI J Natl Cancer InstHome page
V. Westeel, E. Quoix, D. Moro-Sibilot, M. Mercier, J.-L. Breton, D. Debieuvre, P. Richard, M.-A. Haller, B. Milleron, D. Herman, et al.
Randomized Study of Maintenance Vinorelbine in Responders With Advanced Non-Small-Cell Lung Cancer
J Natl Cancer Inst, April 6, 2005; 97(7): 499 - 506.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
R. Lal, J. Dickson, D. Cunningham, I. Chau, A. R. Norman, P. J. Ross, C. Topham, G. Middleton, M. Hill, and J. Oates
A Randomized Trial Comparing Defined-Duration With Continuous Irinotecan Until Disease Progression in Fluoropyrimidine and Thymidylate Synthase Inhibitor--Resistant Advanced Colorectal Cancer
J. Clin. Oncol., August 1, 2004; 22(15): 3023 - 3031.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
M. J. Edelman, J. I. Clark, K. Chansky, K. Albain, N. Bhoopalam, G. R. Weiss, J. K. Giguere, K. Kelly, J. Crowley, and D. R. Gandara
Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806): Carboplatin/Gemcitabine followed by Paclitaxel or Cisplatin/Vinorelbine followed by Docetaxel
Clin. Cancer Res., August 1, 2004; 10(15): 5022 - 5026.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
M. A. Socinski
Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Review of Standard Treatment Paradigms
Clin. Cancer Res., June 15, 2004; 10(12): 4210S - 4214S.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
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]

Home page
 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
J. Clin. Oncol., January 15, 2004; 22(2): 330 - 353.
[Full Text] [PDF]

Home page
 JCOHome page
E. F. Smit, J. P.A.M. van Meerbeeck, P. Lianes, C. Debruyne, C. Legrand, F. Schramel, H. Smit, R. Gaafar, B. Biesma, C. Manegold, et al.
Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non-Small-Cell Lung Cancer: A Phase III Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975
J. Clin. Oncol., November 1, 2003; 21(21): 3909 - 3917.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Gridelli, C. Gallo, F. A. Shepherd, A. Illiano, F. Piantedosi, S. F. Robbiati, L. Manzione, S. Barbera, L. Frontini, E. Veltri, et al.
Gemcitabine Plus Vinorelbine Compared With Cisplatin Plus Vinorelbine or Cisplatin Plus Gemcitabine for Advanced Non-Small-Cell Lung Cancer: A Phase III Trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group
J. Clin. Oncol., August 15, 2003; 21(16): 3025 - 3034.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
A. Bottomley, F. Efficace, R. Thomas, V. Vanvoorden, and S. H. Ahmedzai
Health-Related Quality of Life in Non-Small-Cell Lung Cancer: Methodologic Issues in Randomized Controlled Trials
J. Clin. Oncol., August 1, 2003; 21(15): 2982 - 2992.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
T. Thigpen
Maybe More Is Better
J. Clin. Oncol., July 1, 2003; 21(13): 2454 - 2456.
[Full Text] [PDF]

Home page
 Pharmacol. Rev.Home page
R. Danesi, F. De Braud, S. Fogli, T. M. De Pas, A. Di Paolo, G. Curigliano, and M. Del Tacca
Pharmacogenetics of Anticancer Drug Sensitivity in Non-Small Cell Lung Cancer
Pharmacol. Rev., March 1, 2003; 55(1): 57 - 103.
[Abstract] [Full Text] [PDF]

Home page
 ChestHome page
M. A. Socinski, D. E. Morris, G. A. Masters, and R. Lilenbaum
Chemotherapeutic Management of Stage IV Non-small Cell Lung Cancer
Chest, January 1, 2003; 123(1_suppl): 226S - 243S.
[Abstract] [Full Text] [PDF]

Home page
 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.
[Abstract] [Full Text] [PDF]


About
JCO		 Editorial
Roster		 Advertising
Information		 Librarians &
Institutions		 Rights &
Permissions		 PDA Services

Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online