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Annals of Oncology Advance Access published online on April 28, 2005

Annals of Oncology, doi:10.1093/annonc/mdi215
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© 2005 European Society for Medical Oncology
Received October 21, 2004
Revised January 28, 2005
Accepted February 8, 2005

Original article

Advanced bronchioloalveolar carcinoma: a phase II trial of paclitaxel by 96-hour infusion (SWOG 9714): a Southwest Oncology Group study

H. L. West 1*, J. J. Crowley 2, R. B. Vance 3, W. A. Franklin 4, R. B. Livingston 5, S. R. Dakhil 6, J. K. Giguere 7, S. E. Rivkin 1, M. Kraut 8, K. Chansky 2, and D. R. Gandara 9

1 Swedish Cancer Institute/Puget Sound Oncology Consortium, Seattle, WA, USA;
2 Southwest Oncology Group Statistical Center, Seattle, WA, USA;
3 University of Mississippi Medical Center, Jackson, MS, USA;
4 University of Colorado, Denver, CO, USA;
5 University of Washington/Seattle Cancer Care Alliance, Seattle, WA, USA;
6 Wichita Community Clinical Oncology Program, Wichita, KS, USA;
7 Greenville Community Clinical Oncology Program,Greenville, SC, USA;
8 Providence Cancer Institute,Southfield, MI, USA;
9 University of California, Davis, Sacramento, CA, USA

* To whom correspondence should be addressed.
H. L. West, E-mail: howard.west{at}swedish.org


   Abstract

Background: There are no published prospective trials of chemotherapy for advanced bronchioloalveolar carcinoma (BAC), a subtype of non-small-cell lung cancer for which there is no current standard therapy. This phase II study assesses the efficacy and toxicity of 96-h paclitaxel in chemotherapy-naive patients with advanced BAC.

Patients and methods: Patients with histologically confirmed stage IIIB (with pleural effusion) or stage IV BAC were eligible. Treatment consisted of paclitaxel 35 mg/m2/24 h continuously infused over 96 h (days 1-4) every 21 days for up to six courses.

Results: A total of 58 eligible patients were enrolled. The objective response rate was 14% (all partial responses, 9% confirmed); 40% of patients demonstrated stable disease. The median progression-free and overall survivals were 5 and 12 months, respectively. Grade 3 or greater toxicities included neutropenia/granulocytopenia (43%), febrile neutropenia (12%), infection (22%), and stomatitis/pharyngitis (10%); there were five treatment-related deaths.

Conclusions: S9714 represents the first prospective multi-institutional cooperative group trial focusing on treatment outcomes in BAC. Studies targeting this population are feasible, and while first-line paclitaxel administered as a prolonged infusion is active in this setting, toxicities limits the utility of this regimen. S9714 serves as a historical control for BAC patients against which future therapeutic approaches can be compared.

Keywords: bronchioloalveolar carcinoma; paclitaxel; prolonged infusion; non-small lung cancer.
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